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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed 10/29/2025 has been entered.
Status of Claims
This action is a non-final rejection
Claims 1-3, 6-9, 11-12, 14-15, 18-22, 24-25 are pending
Claims 4-5, 10, 13, 16-17, 23, 26 were cancelled
Claims 1, 15, 21 were amended
Claims 1-3, 6-9, 11-12, 14-15, 18-22, 24-25 are rejected under 35 USC § 103
Priority
Acknowledgement is made of Applicant’s claim for a domestic priority date of 7-31-2019
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 4-11-2022, 8-3-2022, 10-13-2023, and 3-25-2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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
non-obviousness.
Claims 1, 3, 6-9, 11-12 are rejected under 35 U.S.C. 103 as being un-patentable by Sutherland et.al. (WO 2017141194 A1) hereinafter “Sutherland”, in view of Morrison et.al. (WO 2016033421 A1) hereinafter “Morrison”, in view of Guthrie et.al. (US 20110253139 A1) hereinafter “Guthrie”; in view of Kulkarni et.al. (WO 2019012558 A1) hereinafter “Kulkarni”, in further view of “Kejriwal” et.al. (US 7579894 B2) hereinafter “Kejriwal”
Regarding claim 1 Sutherland teaches:
An adherence monitor (adherence monitor 10) for attachment to an inhaler (inhaler 1) having a drug canister (canister 2) covered by a canister cover, an actuator (actuator 3) holding the drug canister, the actuator having a mouthpiece (mouthpiece 5), and a dosing device operable to allow the drug canister to be actuated to release a dose (dose counter 4), the monitor comprising: (See at least [0058] via: “…Referring to Figure 1 A there is shown an existing pMDI medicament inhaler (Symbicort™ pMDI inhaler by AstraZeneca) device described in European Patent No. EP1875412. Figure 1 B shows the pMDI with an adherence monitor…”; in addition see at least [0059] via: “…The medicament inhaler 1 includes a store of medicament in the form of a pressurised medicament canister 2, and an actuator 3 (for housing the canister 2). The medicament inhaler includes a dose counter 4 which when pressed down, pushes the canister 2 into actuation/firing position..”; in addition see at least [0060] via: “…The inhaler 1 is also provided with a spray stem (not shown) extending from the canister 2, which is adapted to engage with a spray-directing element (not shown) housed within the actuator 3. When the canister 2 is pushed down into the actuator 3, the spray stem and spray-directing element combine to deliver a metered dose of medicament out through the mouthpiece 5 (not shown) of the actuator 3, and into the mouth of the user (who sucks on the mouthpiece 5 at the same time that the medicament is dispensed)…”; in addition see at least [0064] via: “…The dose counter 4 comprises a counter housing 8 and a counter mechanism (not shown). The housing 8, is provided with a shield-like downward- directed surface 9 the bottom edge of which abuts the top of the cap 6 when it is fitted onto the mouthpiece 5. When the cap 6 is on the mouthpiece 5, it blocks the movement of the housing 8, so that firing of the inhaler is impossible..”; in addition see at least [0065] via: “…the downwards directed surface 9, is provided with an aperture (not shown) that is adapted to receive a protrusion (not shown) from the top edge (not shown) of the actuator body 3 in a mating relationship. When the housing 8 is depressed in order to actuate the inhaler device 1 , the protrusion extends through the aperture into the counter housing 8 and actuates the counter mechanism..”; in addition see at least [0067] via: “…The adherence monitor 10 according to this implementation is housed within a second housing 11 , which is releasably attachable to the inhaler 1 (or more specifically to the actuator 3)…”; in addition see at least [0068] via: “…Referring to Figures 2-4, the second housing 11 is configured to only partially enclose the inhaler 1 when the inhaler is received in the adherence monitor 10. That is, the second housing 1 1 is configured to enclose the sides and front of the inhaler 1, and is fitted with a hinged door 12 which covers an opening at the front of the second housing 11 . This opening allows for the inhaler 1 to be placed into, secured and/or removed from, the second housing 11 . The hinged door is made with transparent plastics, to allow patients to refer to the medication label placed on the downward-directed surface 9 when the inhaler is positioned within the adherence monitor 10…”)
an actuation detection sensor (electromechanical switch 14) [comprising a barometric pressure sensor] operable to sense the physical movement of the drug canister (movement of the ..surface 9 .. actuates the switch) when actuated (when the inhaler is fired); (See at least [0095] via: “…The adherence monitor 10 may include a dose detection means in the form of a first electromechanical switch 14 (see Figure 3), which is in electronic communication with the ECM. The switch 14 may be located on the inner surface of the top portion of the adherence monitor 1. The location of the switch 14 must be such that during the movement of the downward-directed surface 9 the edge of the surface 9 actuates the switch when the inhaler is fired and the dose of the medicament is dispensed..”; in addition see at least [0096] via: “… When a dose of medicament is dispensed and the switch 14 is actuated, an appropriate signal is sent to the ECM, where the dispensing of the dose is recorded, and the date and time of the dispensing of the dose is also recorded…”; in addition see at least [0097] via: “…In some forms the adherence monitor 10 may include a dose detection means in a form of a switch or sensor located in or on the second housing 11 and configured to detect that the dose of the medicament is dispensed. The dose detection means may include one or more of an acoustic sensor, vibrational sensor, thermistor, pressure sensor, pressure switch, force sensor resistor, audible sensor, optical sensor or proximity sensor, mechanical switch. Depending on the type of switch or sensor selected, different signals may be used to detect a dose detection being dispensed: change in pressure, temperature, volume, visible or IR light intensity, etc…”)
an inhalation data sensor (audio or optical inhalation sensor) [comprising the barometric pressure sensor] operable to sense air pressure change created by inhalation (the flow or pressure of the user's inhalation) of the dose from the actuation [via a flow through the air gap]; (See at least [0108] via: “…adherence monitor 10 and/or the ECM may also be able to monitor criteria such as geographical location, temperature, humidity, the orientation of the inhaler 1 , the condition of the medicament, the amount of medicament left, the condition of the battery or whether it is installed, the flow or pressure of the user's inhalation, an audio sensor for detecting inhalation or for determining if the main body portion has been rotated with respect to the base portion, and so on. To this effect, the ECM may include an audio or optical inhalation sensor, thermistor sensor or accelerometer, or be connected to a GPS (e.g. the adherence data from the smartphone paired with the adherence monitor 10 may be matched with the GPS data relating to the location of adherence events received by the smartphone..”; in addition see at least [0097] via: “…In some forms the adherence monitor 10 may include a dose detection means in a form of a switch or sensor located in or on the second housing 11 and configured to detect that the dose of the medicament is dispensed. The dose detection means may include one or more of an acoustic sensor, vibrational sensor, thermistor, pressure sensor, pressure switch, force sensor resistor, audible sensor, optical sensor or proximity sensor, mechanical switch. Depending on the type of switch or sensor selected, different signals may be used to detect a dose detection being dispensed: change in pressure, temperature, volume, visible or IR light intensity, etc…”). and
a controller (electronics control module) coupled to the actuation detection sensor (switch 14) the accelerometer (accelerometer) ,and the inhalation data sensor (inhalation sensor) to record (dose is recorded) an actuation event (switch 14 is actuated). (See at least [0093] via: “…The adherence monitor 10 includes an electronics control module (ECM or processor, not shown) which is included within either a side or the base of the second housing 11 . The ECM is adapted to monitor and/or manipulate and/or store and/or transmit compliance data relating to patient usage of the inhaler 1 . The electronic controls and sensors are distributed throughout the device…”; in addition see at least [0096] via: “… When a dose of medicament is dispensed and the switch 14 is actuated, an appropriate signal is sent to the ECM, where the dispensing of the dose is recorded, and the date and time of the dispensing of the dose is also recorded…”; in addition see at least [0108] via: “…the ECM may include an audio or optical inhalation sensor, thermistor sensor or accelerometer …”)
However Sutherland is silent the air gap of the inhaler which is taught by Morrison
wherein an external surface of the canister cover is structured to define an air gap (radial gap) between the canister cover (boot 730) and the drug canister (canister 720) (See at least [page 15, lines 23-32] via: “…Figure 7 illustrates an example in which a compliance module 710 is clipped on to a pMDI 700. pMDI 700 comprises a canister 720 received in a boot 730. A lip 711 of the compliance module hooks over the top of the boot wall in the radial gap between the boot wall and the canister. The compliance module is thereby clipped onto the inhaler without any modification to the inhaler. Arrow A shows the airflow when a user inhales through mouthpiece 740. Air passes down the radial gap between the canister and the boot, entrains aerosol sprayed from nozzle 721 on device actuation, and passes out into the user's mouth through mouthpiece 740. A MEMS pressure sensor 712 in the compliance module is pneumatically coupled to the flow channel formed by the radial gap between the boot and the canister by a capillary tube 713. The capillary tube follows the line of the external wall of the lip round into the gap but stops short of the bottom of the lip. This ensures that the lip blocks all air to the capillary tube except for that from below, i.e. within the boot. ..”)
comprising a barometric pressure sensor (See at least [page7, lines 27-28] via: “…The module could further comprise an additional MEMS barometric pressure sensor configured for monitoring environmental barometric activity..”; in addition see at least [page10, lines 16-18] via: “…The method could further comprise: monitoring environmental barometric activity using an additional MEMS barometric pressure sensor; and calibrating said sensor having the sensor port pneumatically coupled to said flow channel against said additional sensor…”; in addition see at least [page12 lines 3-4] via: “…Using a barometric sensor enables use of the barometric pressure as a baseline throughout the measurement cycle, thereby addressing the uncertainty of other single port approaches..”; in addition see at least [page12, lines 5-11] via: “…Also, having knowledge of the local barometric pressure can provide some insight into patient lung function. It is suspected that changes in atmospheric pressure, such as those associated with approaching storm fronts, may have an effect on patient breathing, possibly even related to asthma and COPD events. arometric pressure sensors are already in stressed condition, having an integral reference port sealed within the device under vacuum. This means that they have low hysteresis in the region of interest. Due to the extremely small size and mass of their sensing elements, MEMS sensors are capable of reacting to extremely small pressure changes. Some are capable of resolving pressure changes as low as 1 Pa..”)
via a flow through the air gap (air flows in through the gap) (See at least [page 15, lines 34-40] via: “…Figure 8 …With the compliance module in place and dust cap 850 removed, when a user inhales through mouthpiece 840 air flows in through the gap between cover 815 and boot 830, past electronics unit 814 including the MEMS pressure sensor, down the radial gap between the boot and canister, entrains aerosol sprayed from the canister nozzle on device actuation, and passes out into the user's mouth through mouthpiece 840..”)
determine that the inhaler is held in the correct orientation based on the orientation of the accelerometer (See at least [page 14, lines 35-36] via: “…an orientation sensor to check the device is in the proper orientation for efficient dosing such as an accelerometer or a gyroscope..”)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified Sutherland to incorporate the teachings of Morrison. Those in the art would have recognized that Sutherland’s teaching regarding an adherence monitoring device for a medication delivery device, the monitoring device including at least a switch to sense the movement of the canister when the inhaler is fired, an inhalation sensor to sense that the dose of inhaler was delivered and electronics to record when the dose was dispensed could be modified to include Morrisson’s teaching regarding an inhaler that comprises a barometric pressure sensor, an orientation sensor and a canister within a boot with an air gap between the boot wall and the canister through which air flows. The combination of Sutherland and Morrison is useful to provide an aerosol (combination of air and medication in canister) sprayed from the canister into the user's mouth through a mouthpiece, with the barometric pressure sensor providing a measurement of the appropriate pressure for the optimal delivery of the aerosol to the user and an orientation sensor to provide the proper orientation of the sensor for efficient dosing.
However Sutherland, and Morrison are silent whether the inhaler has exceeded a threshold value of shaking samples as taught by Guthrie.
an accelerometer configured to determine shaking samples and whether the inhaler has exceeded a threshold value of shaking samples (See at least [0165] via: “…In one embodiment of the third aspect, the inhaler module can record the time of a "shake" event in memory. The accelerometer can be programmed to provide an output when a shake event occurs according to predefined characteristic. Alternatively, the accelerometer can provide, from time to time, accelerometer output and the microprocessor can process the accelerometer output to determine when a shake event occurs. For example, the microcontroller may be programmed to recognize a shake event if the accelerometer output indicates that a pre-defined threshold of force is surpassed in all three axes. A shake event can be defined differently depending on a number of factors, for example different medications may need a different amount of shaking at a different level in order to register as a shake event. Generally, a shake event can be defined by a sequence of vibrations that exceed an acceleration threshold for a predetermined amount of time…”; in addition see at least [0133] via: “…The inhaler module 30 also can include an accelerometer as shown in FIG. 30 which can be used to wake the device from sleep mode upon sufficient motion, such as shaking of the inhaler module 30. The accelerometer also can determine if the inhaler was sufficiently shaken to mix the medicine and the propellant in the canister 107 of the inhaler 100, …. In one embodiment, the accelerometer may detect forces in three axis up to 8 g for shake detection. The accelerometer may communicate its output with the inhaler module microcontroller..”)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified Sutherland, and Morrison to incorporate the teachings of Guthrie. Those in the art would have recognized that Sutherland’s teaching regarding an adherence monitoring device for a medication delivery device, the monitoring device including at least a switch to sense the movement of the canister when the inhaler is fired, an inhalation sensor to sense that the dose of inhaler was delivered and electronics to record when the dose was dispensed could be modified to include Guthrie’s teaching regarding an accelerometer output that wakes up the device from sleep mode after a predefined threshold of shaking force has been surpassed. The combination of Sutherland and Guthrie is useful in activating the electronics of the inhaler only once shaking the inhaler above a threshold level has been implemented in order to insure that the medications within the canister have mixed appropriately so that the appropriate mix of medication can be supplied to the user.
However Sutherland, Morrison and Guthrie are silent the active or sleep state of the adherence monitor which is taught by Kulkarni
determine a listening state or sleep state (activating the jacket from sleep/stand-by state) of the adherence monitor based on exceeding the threshold value (See at least [page 11, line 34] via: “…an accelerometer for sensing a shake imposed upon the device and activating the jacket from sleep/stand-by state…”)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified Sutherland, Morrison and Guthrie to incorporate the teachings of Kulkarni. Those in the art would have recognized that Sutherland’s teaching regarding an adherence monitoring device for a medication delivery device, the monitoring device including at least a switch to sense the movement of the canister when the inhaler is fired, an inhalation sensor to sense that the dose of inhaler was delivered and electronics to record when the dose was dispensed could be modified to include Kulkarni’s teaching regarding an accelerometer coupled to the monitor device. The combination of Sutherland and Kulkarni is useful to activate the electronics when the inhaler is picked up by the patient in this way allowing the electronics to be in energy saving mode so that battery power is conserved when not in use.
However Sutherland, Morrison, Guthrie and Kulkarni are silent determine a blanking window state wherein the inhaler is prevented from double tapping or an accidental dose detection as taught by Kejriwal
in response to determining the adherence monitor is in the listening state, determine a blanking window state wherein the inhaler is prevented from double tapping or an accidental dose detection (See at least [page 11, line 34] via: “…Depending upon how the output of mechanical switches is utilised, the bouncing effect may appear as multiple actuations of the switch. For example, if the switch is a simple push to activate type switch, it may appear as though the user has activated the switch several times when in fact they have simply operated the switch once...”; .... To overcome this problem circuits, known as debounce circuits, have been used to mitigate the effects of switch bounce. These circuits typically involve taking the input from the switch and delaying it for a predetermined period of time. If the switch continues to stay in the same state for the duration of the delay, the circuit provides an output indicating the new state of the switch only after the predetermined amount of time...”)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified Sutherland, Morrison, Guthrie and Kulkarni to incorporate the teachings of Kejriwal. Those in the art would have recognized that Sutherland’s teaching regarding an adherence monitoring device for a medication delivery device, the monitoring device including at least a switch to sense the movement of the canister when the inhaler is fired, an inhalation sensor to sense that the dose of inhaler was delivered and electronics to record when the dose was dispensed could be modified to include Kehriwal’s teaching regarding a circuit for debouncing used to mitigate the effects of switch bounce. The combination of Sutherland and Kehriwal is useful to prevent inadvertently activating the electronics of the inhaler more than once in case it was tapped twice or more by mistake.
Regarding claim 3 Sutherland, Morrison, Guthrie, Kulkarni and Kejriwal teach the invention as claimed and detailed above with respect to claim 1. Sutherland also teaches:
wherein the actuation detection sensor is one of the group of an infrared sensor (optical sensor), or a contact switch (mechanical switch), acoustic sensor, vibrational sensor, thermistor, pressure sensor, pressure switch, force sensor resistor, audible sensor, optical sensor or proximity sensor, mechanical switch. Depending on the type of switch or sensor selected, different signals may be used to detect a dose detection being dispensed: change in pressure, temperature, volume, visible or IR light intensity, etc…”)
Regarding claim 6 Sutherland, Morrison, Guthrie, Kulkarni and Kejriwal teach the invention as claimed and detailed above with respect to claim 1. Sutherland also teaches:
wherein the inhaler includes a shield attached to the canister cover, and wherein the actuation detection sensor (switch 14) detects the movement (movement of the downward-directed surface 9) of the shield as indicating actuation of the inhaler. (See at least [0095] via: “…The adherence monitor 10 may include a dose detection means in the form of a first electromechanical switch 14 (see Figure 3), which is in electronic communication with the ECM. The switch 14 may be located on the inner surface of the top portion of the adherence monitor 1. The location of the switch 14 must be such that during the movement of the downward-directed surface 9 the edge of the surface 9 actuates the switch when the inhaler is fired and the dose of the medicament is dispensed…”)
Regarding claim 7 Sutherland, Morrison, Guthrie, Kulkarni and Kejriwal teach the invention as claimed and detailed above with respect to claim 1. Sutherland also teaches:
wherein the inhalation data sensor is a pressure sensor, wherein the controller is operable to determine a pressure curve during inhalation of the dose from the inhaler. (See at least [0108] via: “…adherence monitor 10 and/or the ECM may also be able to monitor criteria such as geographical location, temperature, humidity, the orientation of the inhaler 1 , the condition of the medicament, the amount of medicament left, the condition of the battery or whether it is installed, the flow or pressure of the user's inhalation, an audio sensor for detecting inhalation or for determining if the main body portion has been rotated with respect to the base portion, and so on. To this effect, the ECM may include an audio or optical inhalation sensor, thermistor sensor or accelerometer, or be connected to a GPS (e.g. the adherence data from the smartphone paired with the adherence monitor 10 may be matched with the GPS data relating to the location of adherence events received by the smartphone)…”)
Regarding claim 8 Sutherland, Morrison, Guthrie, Kulkarni and Kejriwal teach the invention as claimed and detailed above with respect to claim 1. Sutherland also teaches:
wherein the controller is operable to apply a time stamp to collected data indicating actuation of the inhaler. (See at least [0096] via: “…When a dose of medicament is dispensed and the switch 14 is actuated, an appropriate signal is sent to the ECM, where the dispensing of the dose is recorded, and the date and time of the dispensing of the dose is also recorded. ..”)
Regarding claim 9 Sutherland, Morrison, Guthrie, Kulkarni and Kejriwal teach the invention as claimed and detailed above with respect to claim 1. Sutherland also teaches:
further comprising a transceiver coupled to the controller, wherein the controller is operable to send the data based on the actuation event to an external client device in communication with the transceiver. (See at least [0109] via: “…Adherence monitor 10 may also include a communication device for transmitting the adherence data. In one embodiment, this may be a USB port located on the second housing 1 1 of the adherence monitor 10. Any other suitable wired connections or ports may be used…”; in addition see at least [0106] via: “…The adherence monitor 10 may also include a user interface (not shown) enabling the user to access data recorded or received by the adherence monitor and also change the settings of the adherence monitor (for example, date/time, visual/audio alert settings). The user interface may also be used to access any data received (or transmitted) by the adherence monitor or to control the upload of the data from the adherence monitor to an external electronic device. The user interface may be located in the exterior surface of the second housing 11..”; in addition see at least [0111] via: “…The data may be transmitted to a remote computer server or to an adjacent electronic device such as a smart phone or electronic tablet. The adherence monitor may be paired with a smartphone loaded with a software application which allows the smartphone to access, process, and/or present the data collected by the adherence monitor. The smartphone may be configured to transfer the data obtained from the adherence monitor to a web services platform. The data may be transmitted in real time, manually or at predetermined set times …”)
Regarding claim 11 Sutherland, Morrison, Guthrie, Kulkarni and Kejriwal teach the invention as claimed and detailed above with respect to claim 1. Sutherland also teaches:
further comprising an attachment detection sensor operable to detect when the inhaler is attached to the adherence monitor. (See at least [0103] via: “…As seen in Figure 10, the adherence monitor 10 may also include a inhaler sensor 19 for detection whether monitor 10 is attached to inhaler 1. The inhaler sensor 19 may be an IR optical sensor or a proximity sensor. Any other suitable sensor may be used. In some forms the inhaler sensor 19 may be located in an internal surface of the second housing 11..”)
Regarding claim 12 Sutherland, Morrison, Guthrie, Kulkarni and Kejriwal teach the invention as claimed and detailed above with respect to claim 1. Sutherland also teaches:
further comprising an activation button operable by a user to activate the controller and the sensors. (See at least [0105] via: “…The indication means may be in the form of one or more LEDs, or in the form of some other visual and/or audio and/or vibrational indicator. Adherence monitor 10 also includes a multi-function user button for monitoring and controlling several aspects of operation. For example, pushing the button once may result in a green light showing if the adherence monitor 10 is fitted to the inhaler 1 correctly, and in normal working order. Conversely, a red light may indicate a problem. Pushing the button twice may provide for another aspect of the adherence monitor to be checked or reported, and furthermore pushing and holding the button may result in yet another function or check being done..”)
Claim 2 is rejected under 35 U.S.C. 103 as being un-patentable by Sutherland, in view of Morrison, in view of Guthrie, in view of Kulkarni, in view of Kejriwal and in further view of Riebe et.al. (WO 2017015303 A2) hereinafter “Riebe”
Regarding claim 2 Sutherland, Morrison, Guthrie, Kulkarni and Kejriwal teach the invention as claimed and detailed above with respect to claim 1. Sutherland, Morrison Guthrie, Kulkarni and Kejriwal are silent the following claim that is taught by Riebe:
wherein the accelerometer is further configured to output a signal indicative of movement of the inhaler prior to actuation ..”; (See at least [page 30, lines 6-17] via: “…In accordance with the control system 1000 of Figure 14, embodiments may enhance compliance with a dosing regimen by simplifying the inhalation process, providing additional safeguards against improper use of the aerosol delivery unit, and/or by providing targeted information to the user. For example, the control system 1000 may be configured to sense shaking or agitation of the aerosol delivery unit in a period before attempted use via the one or more accelerometers 1026 (or other sensors) and temporarily prevent actuation of the canister 1050 by the actuator 1028 if it is determined that sufficient shaking or agitation has not occurred. The control system 1000 may also provide an indication (e.g. , haptic, audible or visual signal) to the user that additional shaking or agitation is required prior to release of the aerosolized matter…”)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified Sutherland, Morrison, Guthrie, Kulkarni and Kejriwal to incorporate the teachings of Riebe. Those in the art would have recognized that Sutherland’s teaching regarding an adherence monitoring device for a medication delivery device, the monitoring device including at least a switch to sense the movement of the canister when the inhaler is fired, an inhalation sensor to sense that the dose of inhaler was delivered and electronics to record when the dose was dispensed could be modified to include Riebe’s teaching regarding providing to the user a signal that shaking of the canister is required prior to actuation and or preventing actuation of the canister unless sufficient shaking has occurred. The combination of Sutherland and Riebe is useful in activating the electronics of the inhaler to actuate the inhaler only once shaking the inhaler has been implemented in order to insure that the medications within the canister have mixed appropriately before use so that the appropriate mix of medication is supplied to the user.
Claims 15, 21, 24-25 are rejected under 35 U.S.C. 103 as being un-patentable by Sutherland, in view of Morrison, in view of Kejriwal, in further view of Guthrie
Regarding claim 15 Sutherland teaches:
An adherence monitor (adherence monitor 10) for attachment to an inhaler (inhaler 1) having a drug canister (canister 2), an actuator (actuator 3) holding the drug canister, [covered by a canister cover, wherein an external surface of the canister cover is structured to define an air gap between the canister cover and the drug canister], the actuator having a cylindrical body having one end holding the drug canister with a mouthpiece (mouthpiece 5) on the opposite end, and a dosing device (dose counter 4) attached to the drug canister, the dosing device including a front shield surface, the dosing device operable to allow the drug canister to be actuated to release a dose (When the canister 2 is pushed down .. the .. spray-directing element .. deliver a metered dose of medicament), the monitor comprising: (See at least [0058] via: “…Referring to Figure 1 A there is shown an existing pMDI medicament inhaler (Symbicort™ pMDI inhaler by AstraZeneca) device described in European Patent No. EP1875412. Figure 1 B shows the pMDI with an adherence monitor…”; in addition see at least [0059] via: “…The medicament inhaler 1 includes a store of medicament in the form of a pressurised medicament canister 2, and an actuator 3 (for housing the canister 2). The medicament inhaler includes a dose counter 4 which when pressed down, pushes the canister 2 into actuation/firing position..”; in addition see at least [0060] via: “…The inhaler 1 is also provided with a spray stem (not shown) extending from the canister 2, which is adapted to engage with a spray-directing element (not shown) housed within the actuator 3. When the canister 2 is pushed down into the actuator 3, the spray stem and spray-directing element combine to deliver a metered dose of medicament out through the mouthpiece 5 (not shown) of the actuator 3, and into the mouth of the user (who sucks on the mouthpiece 5 at the same time that the medicament is dispensed)…”; in addition see at least [0064] via: “…The dose counter 4 comprises a counter housing 8 and a counter mechanism (not shown). The housing 8, is provided with a shield-like downward- directed surface 9 the bottom edge of which abuts the top of the cap 6 when it is fitted onto the mouthpiece 5. When the cap 6 is on the mouthpiece 5, it blocks the movement of the housing 8, so that firing of the inhaler is impossible..”; in addition see at least [0067] via: “…The adherence monitor 10 according to this implementation is housed within a second housing 11 , which is releasably attachable to the inhaler 1 (or more specifically to the actuator 3)…”; in addition see at least [0068] via: “…Referring to Figures 2-4, the second housing 11 is configured to only partially enclose the inhaler 1 when the inhaler is received in the adherence monitor 10. That is, the second housing 1 1 is configured to enclose the sides and front of the inhaler 1, and is fitted with a hinged door 12 which covers an opening at the front of the second housing 11 . This opening allows for the inhaler 1 to be placed into, secured and/or removed from, the second housing 11 . The hinged door is made with transparent plastics, to allow patients to refer to the medication label placed on the downward-directed surface 9 when the inhaler is positioned within the adherence monitor 10…”)
a pair of curved side walls that conform to the sides of the cylindrical body of the actuator, each of the side walls having an open front edge and a closed back edge (See specifically figures 1A. 1B & 2); (See figures 1-10)
a side arm (See hinged door 12 figures 2-4 ) attached to one of the side walls to overlap the cylindrical body of the actuator, wherein the mouthpiece of the inhaler is accessible and the front shield surface is exposed; (See at least [0068] via: “…Referring to Figures 2-4, the second housing 11 is configured to only partially enclose the inhaler 1 when the inhaler is received in the adherence monitor 10. That is, the second housing 11 is configured to enclose the sides and front of the inhaler 1 , and is fitted with a hinged door 12 which covers an opening at the front of the second housing 11 . This opening allows for the inhaler 1 to be placed into, secured and/or removed from, the second housing 1 1 . The hinged door is made with transparent plastics, to allow patients to refer to the medication label placed on the downward-directed surface 9 when the inhaler is positioned within the adherence monitor 10
an actuation detection sensor [comprising a barometric pressure sensor] operable to sense the physical movement of the drug canister when actuated; (See at least [0095] via: “…The adherence monitor 10 may include a dose detection means in the form of a first electromechanical switch 14 (see Figure 3), which is in electronic communication with the ECM. The switch 14 may be located on the inner surface of the top portion of the adherence monitor 1. The location of the switch 14 must be such that during the movement of the downward-directed surface 9 the edge of the surface 9 actuates the switch when the inhaler is fired and the dose of the medicament is dispensed..”; in addition see at least [0096] via: “… When a dose of medicament is dispensed and the switch 14 is actuated, an appropriate signal is sent to the ECM, where the dispensing of the dose is recorded, and the date and time of the dispensing of the dose is also recorded…”; in addition see at least [0097] via: “…In some forms the adherence monitor 10 may include a dose detection means in a form of a switch or sensor located in or on the second housing 11 and configured to detect that the dose of the medicament is dispensed. The dose detection means may include one or more of an acoustic sensor, vibrational sensor, thermistor, pressure sensor, pressure switch, force sensor resistor, audible sensor, optical sensor or proximity sensor, mechanical switch. Depending on the type of switch or sensor selected, different signals may be used to detect a dose detection being dispensed: change in pressure, temperature, volume, visible or IR light intensity, etc…”)
an inhalation data detection sensor [comprising a barometric pressure sensor] operable to sense air pressure change created by the actuation [via a flow through the air gap] (See at least [0108] via: “…adherence monitor 10 and/or the ECM may also be able to monitor criteria such as geographical location, temperature, humidity, the orientation of the inhaler 1 , the condition of the medicament, the amount of medicament left, the condition of the battery or whether it is installed, the flow or pressure of the user's inhalation, an audio sensor for detecting inhalation or for determining if the main body portion has been rotated with respect to the base portion, and so on. To this effect, the ECM may include an audio or optical inhalation sensor, thermistor sensor or accelerometer, or be connected to a GPS (e.g. the adherence data from the smartphone paired with the adherence monitor 10 may be matched with the GPS data relating to the location of adherence events received by the smartphone); and
an electronics housing (second housing 11) attached to the closed back edges of the side walls. (See at least [0093] via: “…The adherence monitor 10 includes an electronics control module (ECM or processor, not shown) which is included within either a side or the base of the second housing 11 . The ECM is adapted to monitor and/or manipulate and/or store and/or transmit compliance data relating to patient usage of the inhaler 1 . The electronic controls and sensors are distributed throughout the device. To allow for more ergonomic feel of the device, the PCB is angled in relation to the device, and this allows for a wider base of the device and narrow top. Flex-rigid PCB may be used to mount the ECM and sensors…”; in addition see at least [0097] via: “…In some forms the adherence monitor 10 may include a dose detection means in a form of a switch or sensor located in or on the second housing 11 and configured to detect that the dose of the medicament is dispensed. The dose detection means may include one or more of an acoustic sensor, vibrational sensor, thermistor, pressure sensor, pressure switch, force sensor resistor, audible sensor, optical sensor or proximity sensor, mechanical switch. Depending on the type of switch or sensor selected, different signals may be used to detect a dose detection being dispensed: change in pressure, temperature, volume, visible or IR light intensity, etc …”)
a controller in the electronics housing coupled to the sensors to record an actuation event [wherein in response to determining the adherence monitor is in a listening state, determine a blanking window state such that the inhaler is prevented from double tapping or an accidental dose detection]; (See at least [0093] via: “…The adherence monitor 10 includes an electronics control module (ECM or processor, not shown) which is included within either a side or the base of the second housing 11. The ECM is adapted to monitor and/or manipulate and/or store and/or transmit compliance data relating to patient usage of the inhaler 1 . The electronic controls and sensors are distributed throughout the device…”; in addition see at least [0096] via: “… When a dose of medicament is dispensed and the switch 14 is actuated, an appropriate signal is sent to the ECM, where the dispensing of the dose is recorded, and the date and time of the dispensing of the dose is also recorded…”)
However Sutherland is silent the air gap of the inhaler which is taught by Morrison
covered by a canister cover, wherein an external surface of the canister cover is structured to define an air gap (radial gap) between the canister cover (boot 730) and the drug canister (canister 720) (See at least [page 15, lines 23-32] via: “…Figure 7 illustrates an example in which a compliance module 710 is clipped on to a pMDI 700. pMDI 700 comprises a canister 720 received in a boot 730. A lip 711 of the compliance module hooks over the top of the boot wall in the radial gap between the boot wall and the canister. The compliance module is thereby clipped onto the inhaler without any modification to the inhaler. Arrow A shows the airflow when a user inhales through mouthpiece 740. Air passes down the radial gap between the canister and the boot, entrains aerosol sprayed from nozzle 721 on device actuation, and passes out into the user's mouth through mouthpiece 740. A MEMS pressure sensor 712 in the compliance module is pneumatically coupled to the flow channel formed by the radial gap between the boot and the canister by a capillary tube 713. The capillary tube follows the line of the external wall of the lip round into the gap but stops short of the bottom of the lip. This ensures that the lip blocks all air to the capillary tube except for that from below, i.e. within the boot. ..”)
comprising a barometric pressure sensor (See at least [page7, lines 27-28] via: “…The module could further comprise an additional MEMS barometric pressure sensor configured for monitoring environmental barometric activity..”; in addition see at least [page10, lines 16-18] via: “…The method could further comprise: monitoring environmental barometric activity using an additional MEMS barometric pressure sensor; and calibrating said sensor having the sensor port pneumatically coupled to said flow channel against said additional sensor…”; in addition see at least [page12 lines 3-4] via: “…Using a barometric sensor enables use of the barometric pressure as a baseline throughout the measurement cycle, thereby addressing the uncertainty of other single port approaches..”; in addition see at least [page12, lines 5-11] via: “…Also, having knowledge of the local barometric pressure can provide some insight into patient lung function. It is suspected that changes in atmospheric pressure, such as those associated with approaching storm fronts, may have an effect on patient breathing, possibly even related to asthma and COPD events. arometric pressure sensors are already in stressed condition, having an integral reference port sealed within the device under vacuum. This means that they have low hysteresis in the region of interest. Due to the extremely small size and mass of their sensing elements, MEMS sensors are capable of reacting to extremely small pressure changes. Some are capable of resolving pressure changes as low as 1 Pa..”)
via a flow through the air gap (See at least [page 15, lines 34-40] via: “…Figure 8 …With the compliance module in place and dust cap 850 removed, when a user inhales through mouthpiece 840 air flows in through the gap between cover 815 and boot 830, past electronics unit 814 including the MEMS pressure sensor, down the radial gap between the boot and canister, entrains aerosol sprayed from the canister nozzle on device actuation, and passes out into the user's mouth through mouthpiece 840..”)
determine that the inhaler is held in the correct orientation based on the orientation of the accelerometer (See at least [page 14, lines 35-36] via: “…an orientation sensor to check the device is in the proper orientation for efficient dosing such as an accelerometer or a gyroscope..”)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified Sutherland to incorporate the teachings of Morrison. Those in the art would have recognized that Sutherland’s teaching regarding an adherence monitoring device for a medication delivery device, the monitoring device including at least a switch to sense the movement of the canister when the inhaler is fired, an inhalation sensor to sense that the dose of inhaler was delivered and electronics to record when the dose was dispensed could be modified to include Morrisson’s teaching regarding an inhaler that comprises a barometric pressure sensor and a canister within a boot with an air gap between the boot wall and the canister through which air flows. The combination of Sutherland and Morrison is useful to provide an aerosol (combination of air and medication in canister) sprayed from the canister into the user's mouth through a mouthpiece, with the barometric pressure sensor providing a measurement of the appropriate pressure for the optimal delivery of the aerosol to the user and an orientation sensor to provide the proper orientation of the sensor for efficient dosing.
However Sutherland and Morrison are silent determining a blanking window state wherein the inhaler is prevented from double tapping or an accidental dose detection as taught by Kejriwal
in response to determining the adherence monitor is in the listening state, determine a blanking window state wherein the inhaler is prevented from double tapping or an accidental dose detection (See at least [page 11, line 34] via: “…Depending upon how the output of mechanical switches is utilised, the bouncing effect may appear as multiple actuations of the switch. For example, if the switch is a simple push to activate type switch, it may appear as though the user has activated the switch several times when in fact they have simply operated the switch once...”; .... To overcome this problem circuits, known as debounce circuits, have been used to mitigate the effects of switch bounce. These circuits typically involve taking the input from the switch and delaying it for a predetermined period of time. If the switch continues to stay in the same state for the duration of the delay, the circuit provides an output indicating the new state of the switch only after the predetermined amount of time...”)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified Sutherland and Morrison, to incorporate the teachings of Kejriwal. Those in the art would have recognized that Sutherland’s teaching regarding an adherence monitoring device for a medication delivery device, the monitoring device including at least a switch to sense the movement of the canister when the inhaler is fired, an inhalation sensor to sense that the dose of inhaler was delivered and electronics to record when the dose was dispensed could be modified to include Kehriwal’s teaching regarding a circuit for debouncing used to mitigate the effects of switch bounce. The combination of Sutherland and Kehriwal is useful to prevent inadvertently activating the electronics of the inhaler more than once in case it was tapped twice or more by mistake.
However Sutherland, Morrison and Kejriwal are silent whether the inhaler has exceeded a threshold value of shaking samples as taught by Guthrie.
an accelerometer coupled to the controller configured to determine shaking samples and whether the inhaler has exceeded a threshold value of shaking samples such that the controller is operable to activate the sensors in response to exceeding the threshold value (See at least [0165] via: “…In one embodiment of the third aspect, the inhaler module can record the time of a "shake" event in memory. The accelerometer can be programmed to provide an output when a shake event occurs according to predefined characteristic. Alternatively, the accelerometer can provide, from time to time, accelerometer output and the microprocessor can process the accelerometer output to determine when a shake event occurs. For example, the microcontroller may be programmed to recognize a shake event if the accelerometer output indicates that a pre-defined threshold of force is surpassed in all three axes. A shake event can be defined differently depending on a number of factors, for example different medications may need a different amount of shaking at a different level in order to register as a shake event. Generally, a shake event can be defined by a sequence of vibrations that exceed an acceleration threshold for a predetermined amount of time…”; in addition see at least [0133] via: “…The inhaler module 30 also can include an accelerometer as shown in FIG. 30 which can be used to wake the device from sleep mode upon sufficient motion, such as shaking of the inhaler module 30. The accelerometer also can determine if the inhaler was sufficiently shaken to mix the medicine and the propellant in the canister 107 of the inhaler 100, …. In one embodiment, the accelerometer may detect forces in three axis up to 8 g for shake detection. The accelerometer may communicate its output with the inhaler module microcontroller..”)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified Sutherland, Morrison and Kejriwal to incorporate the teachings of Guthrie. Those in the art would have recognized that Sutherland’s teaching regarding an adherence monitoring device for a medication delivery device, the monitoring device including at least a switch to sense the movement of the canister when the inhaler is fired, an inhalation sensor to sense that the dose of inhaler was delivered and electronics to record when the dose was dispensed could be modified to include Guthrie’s teaching regarding an accelerometer output that wakes up the device from sleep mode after a predefined threshold of shaking force has been surpassed. The combination of Sutherland and Guthrie is useful in activating the electronics of the inhaler only once shaking the inhaler above a threshold level has been implemented in order to insure that the medications within the canister have mixed appropriately so that the appropriate mix of medication can be supplied to the user
Regarding claim 21 Sutherland teaches:
An adherence monitor (adherence monitor 10) for attachment to an inhaler (inhaler 1) having a drug canister (canister 2), [covered by a canister cover, wherein an external surface of the canister cover is structured to define an air gap between the canister cover and the drug canister], an actuator (actuator 3) holding the drug canister, the actuator having one end holding the drug canister with a mouthpiece (mouthpiece 5) on the opposite end, and a canister cover covering the drug canister, the drug canister operable to be actuated to release a dose (dose counter 4), the monitor comprising: (See at least [0058] via: “…Referring to Figure 1 A there is shown an existing pMDI medicament inhaler (Symbicort™ pMDI inhaler by AstraZeneca) device described in European Patent No. EP1875412. Figure 1 B shows the pMDI with an adherence monitor…”; in addition see at least [0059] via: “…The medicament inhaler 1 includes a store of medicament in the form of a pressurised medicament canister 2, and an actuator 3 (for housing the canister 2). The medicament inhaler includes a dose counter 4 which when pressed down, pushes the canister 2 into actuation/firing position..”; in addition see at least [0060] via: “…The inhaler 1 is also provided with a spray stem (not shown) extending from the canister 2, which is adapted to engage with a spray-directing element (not shown) housed within the actuator 3. When the canister 2 is pushed down into the actuator 3, the spray stem and spray-directing element combine to deliver a metered dose of medicament out through the mouthpiece 5 (not shown) of the actuator 3, and into the mouth of the user (who sucks on the mouthpiece 5 at the same time that the medicament is dispensed)…”; in addition see at least [0064] via: “…The dose counter 4 comprises a counter housing 8 and a counter mechanism (not shown). The housing 8, is provided with a shield-like downward- directed surface 9 the bottom edge of which abuts the top of the cap 6 when it is fitted onto the mouthpiece 5. When the cap 6 is on the mouthpiece 5, it blocks the movement of the housing 8, so that firing of the inhaler is impossible..”; in addition see at least [0067] via: “…The adherence monitor 10 according to this implementation is housed within a second housing 11 , which is releasably attachable to the inhaler 1 (or more specifically to the actuator 3)…”; in addition see at least [0068] via: “…Referring to Figures 2-4, the second housing 11 is configured to only partially enclose the inhaler 1 when the inhaler is received in the adherence monitor 10. That is, the second housing 1 1 is configured to enclose the sides and front of the inhaler 1, and is fitted with a hinged door 12 which covers an opening at the front of the second housing 11 . This opening allows for the inhaler 1 to be placed into, secured and/or removed from, the second housing 11 . The hinged door is made with transparent plastics, to allow patients to refer to the medication label placed on the downward-directed surface 9 when the inhaler is positioned within the adherence monitor 10…”)
a body fitting around the canister cover; (See 4, 8 9 in figures 1A and 1B and 11, 12 in figures 2-4.
an electronics housing (second housing 11) attached to the body; (See at least [0093] via: “…The adherence monitor 10 includes an electronics control module (ECM or processor, not shown) which is included within either a side or the base of the second housing 11 . The ECM is adapted to monitor and/or manipulate and/or store and/or transmit compliance data relating to patient usage of the inhaler 1 . The electronic controls and sensors are distributed throughout the device. To allow for more ergonomic feel of the device, the PCB is angled in relation to the device, and this allows for a wider base of the device and narrow top. Flex-rigid PCB may be used to mount the ECM and sensors…”; in addition see at least [0097] via: “…In some forms the adherence monitor 10 may include a dose detection means in a form of a switch or sensor located in or on the second housing 11 and configured to detect that the dose of the medicament is dispensed. The dose detection means may include one or more of an acoustic sensor, vibrational sensor, thermistor, pressure sensor, pressure switch, force sensor resistor, audible sensor, optical sensor or proximity sensor, mechanical switch. Depending on the type of switch or sensor selected, different signals may be used to detect a dose detection being dispensed: change in pressure, temperature, volume, visible or IR light intensity, etc …”)
an actuation detection sensor (electromechanical switch 14) [comprising a barometric pressure sensor] operable to sense the drug canister (movement of the ..surface 9 .. actuates the switch) when actuated (when the inhaler is fired); (See at least [0095] via: “…The adherence monitor 10 may include a dose detection means in the form of a first electromechanical switch 14 (see Figure 3), which is in electronic communication with the ECM. The switch 14 may be located on the inner surface of the top portion of the adherence monitor 1. The location of the switch 14 must be such that during the movement of the downward-directed surface 9 the edge of the surface 9 actuates the switch when the inhaler is fired and the dose of the medicament is dispensed..”; in addition see at least [0096] via: “… When a dose of medicament is dispensed and the switch 14 is actuated, an appropriate signal is sent to the ECM, where the dispensing of the dose is recorded, and the date and time of the dispensing of the dose is also recorded…”; in addition see at least [0097] via: “…In some forms the adherence monitor 10 may include a dose detection means in a form of a switch or sensor located in or on the second housing 11 and configured to detect that the dose of the medicament is dispensed. The dose detection means may include one or more of an acoustic sensor, vibrational sensor, thermistor, pressure sensor, pressure switch, force sensor resistor, audible sensor, optical sensor or proximity sensor, mechanical switch. Depending on the type of switch or sensor selected, different signals may be used to detect a dose detection being dispensed: change in pressure, temperature, volume, visible or IR light intensity, etc…”)
an inhalation data detection sensor (audio or optical inhalation sensor) [comprising the barometric pressure sensor] operable to sense air pressure change created by the actuation (the flow or pressure of the user's inhalation) [via a flow through the air gap]; (See at least [0108] via: “…Furthermore, and for example only, adherence monitor 10 and/or the ECM may also be able to monitor criteria such as geographical location, temperature, humidity, the orientation of the inhaler 1 , the condition of the medicament, the amount of medicament left, the condition of the battery or whether it is installed, the flow or pressure of the user's inhalation, an audio sensor for detecting inhalation or for determining if the main body portion has been rotated with respect to the base portion, and so on. To this effect, the ECM may include an audio or optical inhalation sensor, thermistor sensor or accelerometer, or be connected to a GPS (e.g. the adherence data from the smartphone paired with the adherence monitor 10 may be matched with the GPS data relating to the location of adherence events received by the smartphone). and
a controller (electronics control module) in the electronics housing coupled to the sensors (sensors) to record (dose is recorded) an actuation event (switch 14 is actuated) [wherein in response to determining the adherence monitor is in a listening state, determine a blanking window state such that the inhaler is prevented from double tapping or an accidental dose detection]. (See at least [0093] via: “…The adherence monitor 10 includes an electronics control module (ECM or processor, not shown) which is included within either a side or the base of the second housing 1 1 . The ECM is adapted to monitor and/or manipulate and/or store and/or transmit compliance data relating to patient usage of the inhaler 1 . The electronic controls and sensors are distributed throughout the device…”; in addition see at least [0096] via: “… When a dose of medicament is dispensed and the switch 14 is actuated, an appropriate signal is sent to the ECM, where the dispensing of the dose is recorded, and the date and time of the dispensing of the dose is also recorded…”)
However Sutherland is silent the air gap of the inhaler which is taught by Morrison
covered by a canister cover, wherein an external surface of the canister cover is structured to define an air gap (radial gap) between the canister cover (boot 730) and the drug canister(canister 720) (See at least [page 15, lines 23-32] via: “…Figure 7 illustrates an example in which a compliance module 710 is clipped on to a pMDI 700. pMDI 700 comprises a canister 720 received in a boot 730. A lip 711 of the compliance module hooks over the top of the boot wall in the radial gap between the boot wall and the canister. The compliance module is thereby clipped onto the inhaler without any modification to the inhaler. Arrow A shows the airflow when a user inhales through mouthpiece 740. Air passes down the radial gap between the canister and the boot, entrains aerosol sprayed from nozzle 721 on device actuation, and passes out into the user's mouth through mouthpiece 740. A MEMS pressure sensor 712 in the compliance module is pneumatically coupled to the flow channel formed by the radial gap between the boot and the canister by a capillary tube 713. The capillary tube follows the line of the external wall of the lip round into the gap but stops short of the bottom of the lip. This ensures that the lip blocks all air to the capillary tube except for that from below, i.e. within the boot. ..”)
comprising a barometric pressure sensor (See at least [page7, lines 27-28] via: “…The module could further comprise an additional MEMS barometric pressure sensor configured for monitoring environmental barometric activity..”; in addition see at least [page10, lines 16-18] via: “…The method could further comprise: monitoring environmental barometric activity using an additional MEMS barometric pressure sensor; and calibrating said sensor having the sensor port pneumatically coupled to said flow channel against said additional sensor…”; in addition see at least [page12 lines 3-4] via: “…Using a barometric sensor enables use of the barometric pressure as a baseline throughout the measurement cycle, thereby addressing the uncertainty of other single port approaches..”; in addition see at least [page12, lines 5-11] via: “…Also, having knowledge of the local barometric pressure can provide some insight into patient lung function. It is suspected that changes in atmospheric pressure, such as those associated with approaching storm fronts, may have an effect on patient breathing, possibly even related to asthma and COPD events. arometric pressure sensors are already in stressed condition, having an integral reference port sealed within the device under vacuum. This means that they have low hysteresis in the region of interest. Due to the extremely small size and mass of their sensing elements, MEMS sensors are capable of reacting to extremely small pressure changes. Some are capable of resolving pressure changes as low as 1 Pa..”)
via a flow through the air gap (air flows in through the gap) (See at least [page 15, lines 34-40] via: “…Figure 8 …With the compliance module in place and dust cap 850 removed, when a user inhales through mouthpiece 840 air flows in through the gap between cover 815 and boot 830, past electronics unit 814 including the MEMS pressure sensor, down the radial gap between the boot and canister, entrains aerosol sprayed from the canister nozzle on device actuation, and passes out into the user's mouth through mouthpiece 840..”)
determine that the inhaler is held in the correct orientation based on the orientation of the accelerometer (See at least [page 14, lines 35-36] via: “…an orientation sensor to check the device is in the proper orientation for efficient dosing such as an accelerometer or a gyroscope..”)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified Sutherland to incorporate the teachings of Morrison. Those in the art would have recognized that Sutherland’s teaching regarding an adherence monitoring device for a medication delivery device, the monitoring device including at least a switch to sense the movement of the canister when the inhaler is fired, an inhalation sensor to sense that the dose of inhaler was delivered and electronics to record when the dose was dispensed could be modified to include Morrisson’s teaching regarding an inhaler that comprises a barometric pressure sensor and a canister within a boot with an air gap between the boot wall and the canister through which air flows. The combination of Sutherland and Morrison is useful to provide an aerosol (combination of air and medication in canister) sprayed from the canister into the user's mouth through a mouthpiece, with the barometric pressure sensor providing a measurement of the appropriate pressure for the optimal delivery of the aerosol to the user and an orientation sensor to provide the proper orientation of the sensor for efficient dosing.
However Sutherland and Morrison are silent determining a blanking window state wherein the inhaler is prevented from double tapping or an accidental dose detection as taught by Kejriwal
in response to determining the adherence monitor is in the listening state, determine a blanking window state wherein the inhaler is prevented from double tapping or an accidental dose detection (See at least [page 11, line 34] via: “…Depending upon how the output of mechanical switches is utilised, the bouncing effect may appear as multiple actuations of the switch. For example, if the switch is a simple push to activate type switch, it may appear as though the user has activated the switch several times when in fact they have simply operated the switch once...”; .... To overcome this problem circuits, known as debounce circuits, have been used to mitigate the effects of switch bounce. These circuits typically involve taking the input from the switch and delaying it for a predetermined period of time. If the switch continues to stay in the same state for the duration of the delay, the circuit provides an output indicating the new state of the switch only after the predetermined amount of time...”)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified Sutherland and Morrison, to incorporate the teachings of Kejriwal. Those in the art would have recognized that Sutherland’s teaching regarding an adherence monitoring device for a medication delivery device, the monitoring device including at least a switch to sense the movement of the canister when the inhaler is fired, an inhalation sensor to sense that the dose of inhaler was delivered and electronics to record when the dose was dispensed could be modified to include Kehriwal’s teaching regarding a circuit for debouncing used to mitigate the effects of switch bounce. The combination of Sutherland and Kehriwal is useful to prevent inadvertently activating the electronics of the inhaler more than once in case it was tapped twice or more by mistake.
However Sutherland, Morrison and Kejriwal are silent whether the inhaler has exceeded a threshold value of shaking samples as taught by Guthrie.
an accelerometer coupled to the controller configured to determine shaking samples and whether the inhaler has exceeded a threshold value of shaking samples such that the controller is operable to activate the sensors in response to exceeding the threshold value (See at least [0165] via: “…In one embodiment of the third aspect, the inhaler module can record the time of a "shake" event in memory. The accelerometer can be programmed to provide an output when a shake event occurs according to predefined characteristic. Alternatively, the accelerometer can provide, from time to time, accelerometer output and the microprocessor can process the accelerometer output to determine when a shake event occurs. For example, the microcontroller may be programmed to recognize a shake event if the accelerometer output indicates that a pre-defined threshold of force is surpassed in all three axes. A shake event can be defined differently depending on a number of factors, for example different medications may need a different amount of shaking at a different level in order to register as a shake event. Generally, a shake event can be defined by a sequence of vibrations that exceed an acceleration threshold for a predetermined amount of time…”; in addition see at least [0133] via: “…The inhaler module 30 also can include an accelerometer as shown in FIG. 30 which can be used to wake the device from sleep mode upon sufficient motion, such as shaking of the inhaler module 30. The accelerometer also can determine if the inhaler was sufficiently shaken to mix the medicine and the propellant in the canister 107 of the inhaler 100, …. In one embodiment, the accelerometer may detect forces in three axis up to 8 g for shake detection. The accelerometer may communicate its output with the inhaler module microcontroller..”)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified Sutherland, Morrison and Kulkarni to incorporate the teachings of Guthrie. Those in the art would have recognized that Sutherland’s teaching regarding an adherence monitoring device for a medication delivery device, the monitoring device including at least a switch to sense the movement of the canister when the inhaler is fired, an inhalation sensor to sense that the dose of inhaler was delivered and electronics to record when the dose was dispensed could be modified to include Guthrie’s teaching regarding an accelerometer output that wakes up the device from sleep mode after a predefined threshold of shaking force has been surpassed. The combination of Sutherland and Guthrie is useful in activating the electronics of the inhaler only once shaking the inhaler above a threshold level has been implemented in order to insure that the medications within the canister have mixed appropriately so that the appropriate mix of medication can be supplied to the user
Regarding claim 24 Sutherland, Morrison, Kejriwal, and Guthrie teach the invention as claimed and detailed above with respect to claim 21. Sutherland also teaches:
wherein the canister cover is physically moveable to actuate the drug canister. (See at least [0065] via: “… Secondly, the downwards directed surface 9, is provided with an aperture (not shown) that is adapted to receive a protrusion (not shown) from the top edge (not shown) of the actuator body 3 in a mating relationship. When the housing 8 is depressed in order to actuate the inhaler device 1 , the protrusion extends through the aperture into the counter housing 8 and actuates the counter mechanism..”)
Regarding claim 25 Sutherland, Morrison, Kejriwal, Guthrie teach the invention as claimed and detailed above with respect to claims 21&24. Sutherland also teaches:
wherein the actuation detection sensor is a limit switch activated when the canister cover is moved. (See at least [0095] via: “…The adherence monitor 10 may include a dose detection means in the form of a first electromechanical switch 14 (see Figure 3), which is in electronic communication with the ECM. The switch 14 may be located on the inner surface of the top portion of the adherence monitor 1. The location of the switch 14 must be such that during the movement of the downward-directed surface 9 the edge of the surface 9 actuates the switch when the inhaler is fired and the dose of the medicament is dispensed…”; in addition see at least [0096] via: “…When a dose of medicament is dispensed and the switch 14 is actuated, an appropriate signal is sent to the ECM, where the dispensing of the dose is recorded, and the date and time of the dispensing of the dose is also recorded…”)
Claim 14 is rejected under 35 U.S.C. 103 as being un-patentable by Sutherland, in view of Morrison, in view of Guthrie, in view of Kulkarni, in view of in view of Kejriwal and in further view of Biswas et.al. (US 20160144141 A1) hereinafter “Biswas”
Regarding claim 14 Sutherland, Morrison, Guthrie, Kulkarni and Kejriwal teach the invention as claimed and detailed above with respect to claim 1. Nevertheless Sutherland and Morison are silent the following limitation that is taught by Kulkarni:
wherein the inhalation data sensor (pressure-sensor) is […] to be exposed to a gap between the adherence monitor and the canister cover of the inhaler. (See at least [page 4, lines 5-7] via: “…In another embodiment, the adherence-monitoring and tracking device comprises a housing for accommodating a metered dose inhaler (MDI) defined by an assembly of a canister and a mouth-piece..”; in addition see at least [page 9, lines 1-6] via: “…The device 100 comprises an in-built transducer in the form of a pressure-sensor (depicted later in Fig. 3). The device 100 comprises an enclosure to receive a metered-dose inhaler (MDI), it automatically detects inhalation-flow corresponding to the MDI, as the pressure sensor of the device 100 gets oriented in the flow path from a canister to mouthpiece of the MDI. Thereafter, the device 100 feeds data to an in-built microprocessor on a real-time basis at a periodic-interval of at-least 10-milliseconds..”)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified Sutherland, Morrison, Guthrie, and Kejriwal to incorporate the teachings of Kulkarni. Those in the art would have recognized that Sutherland’s teaching regarding an adherence monitoring device for a medication delivery device, the monitoring device including at least a switch to sense the movement of the canister when the inhaler is fired, an inhalation sensor to sense that the dose of inhaler was delivered and electronics to record when the dose was dispensed could be modified to include Kulkarni’s teaching regarding an in-built transducer in the form of a pressure-sensor coupled to the monitor device. The combination of Sutherland and Kulkarni is useful in providing an alternate method based on pressure differentials of sensing that the dose of inhaler was delivered compared to the optical sensor of Sutherland in order to provide a more robust and precise method of determining that the right amount of dose was delivered.
Furthermore, Sutherland, Morrison, Guthrie, Kulkarni and Kejriwal are silent the following limitation that is taught by Biswas
positioned on a circuit board (circuit board) (See at least [0062] via: “…FIGS. 5 and 6 show the electronics housed in cap 1 in more detail. The printed circuit board (PCB) 6 includes a force sensor 7, pressure sensor 8, accelerometer 9, microcontroller 10, wireless chipset 11, rechargeable battery pack 12, power management chips (not shown) and other discrete components as needed. The PCB 6 is a flexible/rigid board as shown in FIG. 5 that wraps around the inner wall of the cap 1 connecting the feedback and sensor electronics to the main board in the extension 4…”)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified Sutherland, Morrison, Guthrie, Kulkarni and Kejriwal to incorporate the teachings of Biswas. Those in the art would have recognized that Sutherland’s teaching regarding an adherence monitoring device for a medication delivery device, the monitoring device including at least a switch to sense the movement of the canister when the inhaler is fired, an inhalation sensor to sense that the dose of inhaler was delivered and electronics to record when the dose was dispensed could be modified to include Biswas’ teaching regarding a built in printed circuit board coupled to the monitor device. The combination of Sutherland and Biswas is useful in providing a circuit board onto which an electronic control module may be attached to electronically process the required information to insure and control adherence of the patient to the required doses and timing of inhalation medication prescribed.
Claims 18-20, 22, are rejected under 35 U.S.C. 103 as being un-patentable by Sutherland, in view of Morrison in view of Kejriwal, in view of Guthrie in further view of Biswas
Regarding claim 18 Sutherland, Morrison, Kejriwal and Guthrie teach the invention as claimed and detailed above with respect to claim 15. Sutherland also teaches:
further comprising [… ] a first surface including a connector connected to the actuation detection sensor, wherein the actuation detection sensor (switch 14) is mounted on one of the side walls in proximity to the shield surface of the inhaler, and a second opposite surface mounting the inhalation data sensor (inhalation sensor) in proximity to a gap between a top cover of the side walls and the actuator of the inhaler. (See at least [0095] via: “…The adherence monitor 10 may include a dose detection means in the form of a first electromechanical switch 14 (see Figure 3), which is in electronic communication with the ECM. The switch 14 may be located on the inner surface of the top portion of the adherence monitor 1. The location of the switch 14 must be such that during the movement of the downward-directed surface 9 the edge of the surface 9 actuates the switch when the inhaler is fired and the dose of the medicament is dispensed…”; in addition see at least [0108] via: “…adherence monitor 10 and/or the ECM may also be able to monitor criteria such as geographical location, temperature, humidity, the orientation of the inhaler 1 , the condition of the medicament, the amount of medicament left, the condition of the battery or whether it is installed, the flow or pressure of the user's inhalation, an audio sensor for detecting inhalation or for determining if the main body portion has been rotated with respect to the base portion, and so on. To this effect, the ECM may include an audio or optical inhalation sensor, thermistor sensor or accelerometer, or be connected to a GPS (e.g. the adherence data from the smartphone paired with the adherence monitor 10 may be matched with the GPS data relating to the location of adherence events received by the smartphone…”)
Nevertheless Sutherland, Morrison, Kejriwal and Guthrie are silent the following limitation that is taught by Biswas:
a printed circuit board (printed circuit board ) in the electronics housing (cap 1 ), the printed circuit board having (See at least [0062] via: “…FIGS. 5 and 6 show the electronics housed in cap 1 in more detail. The printed circuit board (PCB) 6 includes a force sensor 7, pressure sensor 8, accelerometer 9, microcontroller 10, wireless chipset 11, rechargeable battery pack 12, power management chips (not shown) and other discrete components as needed. The PCB 6 is a flexible/rigid board as shown in FIG. 5 that wraps around the inner wall of the cap 1 connecting the feedback and sensor electronics to the main board in the extension 4…”; in addition see at least [0064] via: “…The pressure sensor 8 used in the inhaler attachment, as shown in an embodiment in FIG. 7, measures the air flow rate through the cap 1 to analyze the inspiration and expiration rate during the inhaler 18 usage. The cap 1 introduces resistance in the path of respiratory flow in/out of the MDI 18. … The pressure sensor 8 is placed just below the vents 3 at the beginning of the cap extension 4 such that the pressure sensor 8 measures the air pressure present at that point. A pressure sensor port 19 of the pressure sensor 8 is situated on the opposite side (i.e., on the outside of the cap 1) measuring the ambient pressure…”)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified Sutherland, Morrison Kejriwal and Guthrie to incorporate the teachings of Biswas. Those in the art would have recognized that Sutherland’s teaching regarding an adherence monitoring device for a medication delivery device, the monitoring device including at least a switch to sense the movement of the canister when the inhaler is fired, an inhalation sensor to sense that the dose of inhaler was delivered and electronics to record when the dose was dispensed could be modified to include Biswas’ teaching regarding a built in printed circuit board coupled to the monitor device. The combination of Sutherland and Biswas is useful in providing a circuit board onto which an electronic control module may be attached to electronically process the required information to insure and control adherence of the patient to the required doses and timing of inhalation medication prescribed.
Regarding claim 19 Sutherland, Morrison, Kejriwal, Guthrie and Biswas teach the invention as claimed and detailed above with respect to claims 15 & 18. Sutherland also teaches:
further comprising an attachment detection sensor mounted on the first surface of the printed circuit board operable to detect the attachment of the inhaler to the adherence monitor. (See at least [0103] via: “…As seen in Figure 10, the adherence monitor 10 may also include a inhaler sensor 19 for detection whether monitor 10 is attached to inhaler 1. The inhaler sensor 19 may be an IR optical sensor or a proximity sensor. Any other suitable sensor may be used. In some forms the inhaler sensor 19 may be located in an internal surface of the second housing 11..”)
Regarding claim 20 Sutherland, Morrison, Kejriwal, Guthrie and Biswas teach the invention as claimed and detailed above with respect to claims 15 &18. Sutherland also teaches:
wherein the electronics housing includes a back panel having an activation button operable to activate the controller and the sensors. (See at least [0105] via: “…The indication means may be in the form of one or more LEDs, or in the form of some other visual and/or audio and/or vibrational indicator. Adherence monitor 10 also includes a multi-function user button for monitoring and controlling several aspects of operation. For example, pushing the button once may result in a green light showing if the adherence monitor 10 is fitted to the inhaler 1 correctly, and in normal working order. Conversely, a red light may indicate a problem. Pushing the button twice may provide for another aspect of the adherence monitor to be checked or reported, and furthermore pushing and holding the button may result in yet another function or check being done..”)
Regarding claim 22 Sutherland, Morrison, Kejriwal, Guthrie teach the invention as claimed and detailed above with respect to claim 21. Sutherland also teaches:
further comprising […] a first surface with the actuation detection sensor (switch 14), and a second opposite surface mounting the inhalation data sensor (inhalation sensor) in proximity to a gap between a top cover of the electronics housing and the canister cover of the inhaler, and wherein the electronics housing includes a panel having an activation button (multi-function user button) operable to activate the controller and the sensors. (See at least [0095] via: “…The adherence monitor 10 may include a dose detection means in the form of a first electromechanical switch 14 (see Figure 3), which is in electronic communication with the ECM. The switch 14 may be located on the inner surface of the top portion of the adherence monitor 1. The location of the switch 14 must be such that during the movement of the downward-directed surface 9 the edge of the surface 9 actuates the switch when the inhaler is fired and the dose of the medicament is dispensed…”; in addition see at least [0108] via: “…adherence monitor 10 and/or the ECM may also be able to monitor criteria such as geographical location, temperature, humidity, the orientation of the inhaler 1 , the condition of the medicament, the amount of medicament left, the condition of the battery or whether it is installed, the flow or pressure of the user's inhalation, an audio sensor for detecting inhalation or for determining if the main body portion has been rotated with respect to the base portion, and so on. To this effect, the ECM may include an audio or optical inhalation sensor, thermistor sensor or accelerometer, or be connected to a GPS (e.g. the adherence data from the smartphone paired with the adherence monitor 10 may be matched with the GPS data relating to the location of adherence events received by the smartphone…”; in addition see at least [0105] via: “…The indication means may be in the form of one or more LEDs, or in the form of some other visual and/or audio and/or vibrational indicator. Adherence monitor 10 also includes a multi-function user button for monitoring and controlling several aspects of operation. For example, pushing the button once may result in a green light showing if the adherence monitor 10 is fitted to the inhaler 1 correctly, and in normal working order. Conversely, a red light may indicate a problem. Pushing the button twice may provide for another aspect of the adherence monitor to be checked or reported, and furthermore pushing and holding the button may result in yet another function or check being done..”)
Nevertheless Sutherland, Morrison, Kejriwal, and Guthrie are silent the following limitation that is taught by Biswas:
a printed circuit board (printed circuit board ) in the electronics housing (cap 1), the printed circuit board having (See at least [0062] via: “…FIGS. 5 and 6 show the electronics housed in cap 1 in more detail. The printed circuit board (PCB) 6 includes a force sensor 7, pressure sensor 8, accelerometer 9, microcontroller 10, wireless chipset 11, rechargeable battery pack 12, power management chips (not shown) and other discrete components as needed. The PCB 6 is a flexible/rigid board as shown in FIG. 5 that wraps around the inner wall of the cap 1 connecting the feedback and sensor electronics to the main board in the extension 4…”; in addition see at least [0064] via: “…The pressure sensor 8 used in the inhaler attachment, as shown in an embodiment in FIG. 7, measures the air flow rate through the cap 1 to analyze the inspiration and expiration rate during the inhaler 18 usage. The cap 1 introduces resistance in the path of respiratory flow in/out of the MDI 18. … The pressure sensor 8 is placed just below the vents 3 at the beginning of the cap extension 4 such that the pressure sensor 8 measures the air pressure present at that point. A pressure sensor port 19 of the pressure sensor 8 is situated on the opposite side (i.e., on the outside of the cap 1) measuring the ambient pressure…”)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified Sutherland, Morrison, Kejriwal, Guthrie to incorporate the teachings of Biswas. Those in the art would have recognized that Sutherland’s teaching regarding an adherence monitoring device for a medication delivery device, the monitoring device including at least a switch to sense the movement of the canister when the inhaler is fired, an inhalation sensor to sense that the dose of inhaler was delivered and electronics to record when the dose was dispensed could be modified to include Biswas’ teaching regarding a built in printed circuit board coupled to the monitor device. The combination of Sutherland and Biswas is useful in providing a circuit board onto which an electronic control module may be attached to electronically process the required information to insure and control adherence of the patient to the required doses and timing of inhalation medication prescribed.
Prior Art Made of Record
The prior art made of record and not relied upon is considered pertinent to Applicant's disclosure, and is listed in the attached form PTO-892 (Notice of References Cited). Unless expressly noted otherwise by the Examiner, all documents listed on form PTO-892 are cited in their entirety
GORMACK (WO 2017051389 A1) -Adherence Monitor For Medicament Inhaler, Has Two Sensors Associated With Cap Such That Removal Of Cap Triggers Sensors, Where Cap Is Tethered To Body Of Inhaler And Inhaler Is Provided With Mouthpiece For Operatively Inhaling Medicament -teaches: The monitor (8) has two sensors associated with a cap (7) such that removal of the cap triggers the sensors. A processor receives data from the sensors such that a control device determines that cap removal event is occurred if the two sensors are triggered. The cap is tethered to a body of a medicament inhaler (1). The medicament inhaler is provided with a mouthpiece (6) for operatively inhaling medicament. The sensors are mechanically triggered by operation of a tether (15) to generate or interrupt an electrical signal to the control device.
BAINBRIDGE (WO 2016111633 A1) - Monitor For Detecting That Dose Of Medicament Is Dispensed By E.g. Ellipta Inhaler, During Treatment Of E.g. Asthma, Involves Processor For Determining That Dose Of Medicament Is Dispensed If Cap Removal Data Indicates That Cap Is Removed -teaches: The monitor has a processor including an analysis software and for operatively receiving acoustic data from an acoustic sensor and cap removal data from a cap removal sensor. The processor determines that dose of medicament is dispensed if the cap removal data indicates that a cap (4) is removed, and the acoustic data indicates that an acoustic signal consistent with dispensing of medicament is occurred. The acoustic data is analyzed by the analysis software to detect acoustic signals consistent with dispensing of medicament.
Response to Arguments
Applicant's arguments filed 10-29-2025, have been fully considered but not found
persuasive.
Applicant amended independent claims 1, 15, 21 in addition to cancelling claims 4-5, 10, 13, 16-17, 23, 26 as posted in the above analysis with additions underlined and deletions as .
In response to applicant's arguments regarding claim rejection under 35 U.S.C § 103.
The Applicant argues that the prior art used fails to teach the amendments to claims 1, 15 and 21 that recite: “determine that the inhaler is held in the correct orientation based on the orientation of the accelerometer”
Accordingly, the Applicant requests the withdrawal of all rejections under 35 U.S.C. § 103
The Examiner disagrees with the Applicant’s arguments because they are not persuasive.
Morrison teaches the above cited amendment. See paragraph [page 14, lines 35-36].
As a result, the Examiner, restates the previous rejection of the invention under 35 USC §103.
For reasons of record and as set forth above, the examiner maintains the rejection of claims 1-3, 6-9, 11-12, 14-15, 18-22, 24-25 that are rejected under 35 USC §103 based on prior art. In reaching this decision, the Examiner considered all evidence presented and all arguments actually made by Applicant.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PIERRE L MACCAGNO whose telephone number is (571)270-5408. The examiner can normally be reached M-F 8:00 to 5:00.
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/PIERRE L MACCAGNO/Examiner, Art Unit 3687
/MAMON OBEID/Supervisory Patent Examiner, Art Unit 3687
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