DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendment filed 1/20/2026 has been entered. Applicant's amendments overcome the previous claim objections. Claims 19 and 20 have been added. Claims 1-20 remain pending.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-5, 10-11, 13, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Holtz et al. (US 2019/0125990 A1), hereafter Holtz, in view of Jewett (US 5544647), hereafter Jewett.
Regarding claim 1, Holtz discloses an attachment for use with an inhaler (Fig. 1D, 1E, label 200 is attached to inhaler 100; par. 0063 ln 1-4) having a metal spray canister storing a pressurized drug (Fig. A, annotated below; a metered dose inhaler would have been well understood in the art as comprising a metal canister and storing a drug in the canister in a pressurized way) and an electrically non-conductive actuator that ensures the drug is received from the metal spray canister in an aerosol form (Fig. A, annotated below; a metered dose inhaler would have been widely understood as being manually activated to deliver a drug in an aerosol form), the attachment comprising: a self-capacitance sensor [attachment has at least one capacitive sensor, par. 0064 ln 14-17; Applicant’s specification (clean version, page labeled 27, ln 14) defines “self-capacitance” is a capacitance sensor that is used alone] mounted on the electrically non-conductive actuator (Fig. 1E, attachment 200 mounted on inhaler actuator 100), the self-capacitance sensor being configured to detect a user interaction with the metal spray canister and measure a capacitance resulting from the user interaction (the capacitive sensor detects changes in capacitance when the user grasps or activates the inhaler, par. 0064 ln 18-24; examiner notes: activating the inhaler would involve contacting the metal spray canister. The capacitive sensor would be capable of detecting the metal spray canister as it is capable of detecting anything that is conductive or has a dielectric constant different from that of air, par. 0064 ln 18-21), and wherein the self-capacitance sensor is powered off when the user interaction with the metal spray canister is undetected (capacitance reading during stand-by mode is taken twice per second, par. 0084; this can be understood to mean a capacitance reading is taken and if no change is detected, the capacitance is not measured again for 0.5 seconds, during which time it can be understood by inherency that the capacitance sensor is not powered, whereas if a significant change is detected, the capacitance readings continue at an increased rate until actuation concludes, par. 0097; par. 0084-0085 support this finding of inherency since it is disclosed that capacitance readings only require minor current drain as opposed to an ongoing audio analysis, meaning capacitance readings are not ongoing).
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Fig. A, adapted from Fig. 1D of Holtz
Holtz does not disclose wherein the measured capacitance changes when the user interaction includes adjusting a distance between the metal spray canister and the self-capacitance sensor.
Jewett teaches an inhaler (Fig. 1; abstract ln 1) wherein the measured capacitance changes when the user interaction includes adjusting a distance between the metal spray canister and the self-capacitance sensor (proximity sensor 42” is a capacitive sensor which can detect movement of the canister 16”; Fig. 10, col. 8 ln 53-col. 9 ln 31) for the purpose of counting the number of inhaler actuations (col. 3 ln 11-14).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the attachment of Holtz to additionally detect the capacitance change of the metal spray canister caused by a change in distance between the metal spray canister and a self-capacitance sensor as taught by Jewett for the purpose of counting the number of inhaler actuations (See Jewett: col. 3 ln 11-14).
Regarding claim 2, the modified Holtz discloses the attachment according to claim 1 (shown above), wherein the self-capacitance sensor is configured to detect the capacitance change occurring due to a change of a position of the metal spray canister while moving relative to the actuator (Jewett col. 9 ln 5-7).
Regarding claim 3, the modified Holtz discloses the attachment according to claim 1 (shown above), wherein the self-capacitance sensor is configured to detect the capacitance change occurring when the measured capacitance value has changed while the metal spray canister moves relative to the actuator (Jewett col. 9 ln 5-7).
Regarding claim 4, the modified Holtz discloses the attachment according to claim 2 (shown above), further comprising a self-capacitance sensor array (Holtz par. 0066 ln 22-25; Fig. 2a-b, capacitive sensing areas 272a-c), wherein the self-capacitance sensor array includes plural self-capacitance sensors (Holtz Fig. 2a-b, capacitive sensing areas 272a-c), the self-capacitance array is configured to detect the capacitance change during a movement of the metal spray canister relative to the actuator (a practitioner in the art would have understood that an array of self-capacitance sensors could perform the same function as a single self-capacitance sensor).
Regarding claim 5, the modified Holtz discloses the attachment according to claim 3 (shown above), further comprising: a self-capacitance sensor array (Holtz par. 0066 ln 22-25; Fig. 2a-b, capacitive sensing areas 272a-c) wherein the self-capacitance sensor array includes plural self-capacitance sensors (Holtz Fig. 2a-b, capacitive sensing areas 272a-c), the self-capacitance array is configured to detect a change of a measured capacitance value while the metal spray canister is moving relative to actuator (a practitioner in the art would have understood that an array of self-capacitance sensors could perform the same function as a single self-capacitance sensor).
Regarding claim 10, Holtz discloses an attachment for use with an inhaler (Fig. 1D, 1E, label 200 is attached to inhaler 100; par. 0063 ln 1-4) having a metal spray canister that stores a pressurized drug (Fig. B, annotated below; a metered dose inhaler would have been well understood in the art as comprising a metal canister and storing a drug in the canister in a pressurized way) and an actuator that ensures the drug is received from the metal spray canister in an aerosol form (Fig. A, annotated below; a metered dose inhaler would have been widely understood as being manually activated to deliver a drug in an aerosol form), the attachment comprising: a mutual capacitance sensor [attachment can have multiple capacitive sensors, par. 0064 ln 14-17; when two capacitance sensors are used together they can form a mutual capacitance sensor as defined by Applicant specification (clean version of specification, page labeled 35, ln 1-3)], the mutual capacitance sensor being configured to detect a user interaction with the metal spray canister and measure a capacitance value resulting from the user interaction (the capacitive sensor detects changes in capacitance when the user grasps or activates the inhaler, par. 0064 ln 18-24; examiner notes: activating the inhaler would involve contacting the metal spray canister. The capacitive sensor would be capable of detecting the metal spray canister as it is capable of detecting anything that is conductive or has a dielectric constant different from that of air, par. 0064 ln 18-21), and wherein the mutual capacitance sensor is powered off when the user interaction with the metal spray canister is undetected (capacitance reading during stand-by mode is taken twice per second, par. 0084; this can be understood to mean a capacitance reading is taken and if no change is detected, the capacitance is not measured again for 0.5 seconds, during which time it can be understood by inherency that the capacitance sensor is not powered, whereas if a significant change is detected, the capacitance readings continue at an increased rate until actuation concludes, par. 0097; par. 0084-0085 support this finding of inherency since it is disclosed that capacitance readings only require minor current drain as opposed to an ongoing audio analysis, meaning capacitance readings are not ongoing).
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Fig. B, adapted from Fig. 1D of Holtz
Holtz does not disclose wherein the measured capacitance value changes when the user interaction includes adjusting a distance between the metal spray canister and the mutual capacitance sensor.
Jewett teaches an inhaler (Fig. 1; abstract ln 1) wherein the measured capacitance value changes when the user interaction includes adjusting a distance between the metal spray canister and the mutual capacitance sensor (proximity sensor 42” is a capacitance sensor which can detect movement of the canister 16”; Fig. 10, col. 8 ln 53-col. 9 ln 31) for the purpose of counting the number of inhaler actuations (col. 3 ln 11-14).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the attachment of Holtz to additionally detect a change in capacitance value of the mutual capacitance sensor caused by a change in distance between the metal spray canister and the mutual capacitance sensor as taught by Jewett for the purpose of counting the number of inhaler actuations (See Jewett: col. 3 ln 11-14).
Regarding claim 11, the modified Holtz discloses the attachment according to claim 10 (shown above), wherein the attachment is configured for detecting a capacitance value change occurring due to a change of a position of the metal spray canister while moving relative to the actuator (Jewett col. 9 ln 5-7).
Regarding claim 13, the modified Holtz discloses the attachment according to claim 11 (shown above), wherein the change of the position of the metal spray canister is monitored by a mutual capacitance sensor array including plural mutual capacitance sensors (Holtz par. 0066 ln 22-25; Fig. 2a-b, capacitive sensing areas 272a-c) when the metal spray canister moves relative to the actuator (a practitioner in the art would have understood that an array of capacitance sensors could perform the same function as a single capacitance sensor).
Regarding claim 19, the modified Holtz discloses the attachment according to claim 1 (shown above), wherein the self-capacitance sensor is configured to measure the capacitance for a first time period, and wherein when the measured capacitance is unchanged during the first time period, the self-capacitance sensor is powered off for a second time period (capacitance reading during stand-by mode is taken twice per second, Holtz par. 0084; this can be understood to mean a capacitance reading is taken, which would take time amounting to a first time period, and if no change is detected, the capacitance is not measured again for half a second, during which time it can be understood that the capacitance sensor is not powered).
Regarding claim 20, the modified Holtz discloses the attachment according to claim 1 (shown above), wherein the self-capacitance sensor is configured to measure the capacitance for a first time period, and wherein when the measured capacitance increases during the first time period, the self-capacitance sensor is configured to continue measuring the capacitance for a second time period (capacitance reading during stand-by mode is taken twice per second, Holtz par. 0084; this can be understood to mean a capacitance reading is taken, which would take time amounting to a first time period, and if a significant change is detected, the capacitance readings continue at an increased rate until actuation concludes, par. 0097).
Claims 6, 8, 15, 17 are rejected under 35 U.S.C. 103 as being unpatentable over Holtz in view of Jewett, and further in view of Biswas et al. (US 2016/0144141 A1), hereafter Biswas.
Regarding claim 6, the modified Holtz discloses the attachment according to claim 1 (shown above).
Holtz does not disclose a pressure sensor, wherein the pressure sensor monitors a pressure drop around the metal spray canister to monitor breathing of the user.
Biswas teaches an inhaler attachment (Fig. 7; par. 0064 ln 1-4) comprising a pressure sensor (Fig. 7, pressure sensor 8), wherein the pressure sensor monitors a pressure drop around the metal spray canister to monitor breathing of the user (par. 0064 ln 1-8; par. 0065 ln 1-18) for the purpose of confirming whether the medication was inhaled by the patient (par. 0066 ln 3-8).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the attachment of Holtz to further comprising a pressure sensor as taught by Biswas for the purpose of confirming whether the medication was inhaled by the patient (See Biswas: par. 0066 ln 3-8).
Regarding claim 8, the modified Holtz discloses the attachment according claim 1 (shown above), wherein the self-capacitance sensor is configured to determine a contact of the user to the metal spray canister (Holtz par. 0064 ln 18-24).
The modified Holtz does not disclose the self-capacitance sensor activates a pressure sensor or a microphone or a vibration sensor and electronic circuit elements controlling the pressure sensor or the microphone or the vibration sensor.
Biswas teaches a capacitive sensor (Fig. 3, capacitive touch film 17; par. 0069 ln 1-2) which activates a pressure sensor or a microphone or a vibration sensor and electronic circuit elements controlling the pressure sensor or the microphone or the vibration sensor (capacitive sensor initiates activation of the board which includes a pressure sensor; par. 0069 ln 6-17) for the purpose of saving power (par. 0069 ln 17-24).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to further modify the device of Holtz to have the self-capacitance sensor activate the pressure sensor for the purpose of saving power (See Biswas: par. 0069 ln 17-24).
Regarding claim 15, the modified Holtz discloses the attachment according to claim 10 (shown above).
The modified Holtz does not disclose a pressure sensor, wherein the pressure sensor tracks a pressure drop around the metal spray canister to monitor a breathing of the user.
Biswas teaches an inhaler attachment (Fig. 7; par. 0064 ln 1-4) comprising a pressure sensor (Fig. 7, pressure sensor 8), wherein the pressure sensor tracks a pressure drop around the metal spray canister to monitor a breathing of the user (par. 0064 ln 1-8; par. 0065 ln 1-18) for the purpose of confirming whether the medication was inhaled by the patient (par. 0066 ln 3-8).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the attachment of Holtz to further comprising a pressure sensor as taught by Biswas for the purpose of confirming whether the medication was inhaled by the patient (See Biswas: par. 0066 ln 3-8).
Regarding claim 17, the modified Holtz discloses the attachment according claim 10 (shown above), wherein the mutual capacitance sensor is configured to measure the capacitance change by detecting the contact of the user to the metal spray canister (Holtz par. 0064 ln 18-24).
The modified Holtz does not disclose the sensor activating a pressure sensor or a microphone or a vibration sensor and electronic circuit elements controlling the pressure sensor or the microphone or the vibration sensor.
Biswas teaches a capacitive sensor (Fig. 3, capacitive touch film 17; par. 0069 ln 1-2) activating a pressure sensor or a microphone or a vibration sensor and electronic circuit elements controlling the pressure sensor or the microphone or the vibration sensor (capacitive sensor initiates activation of the board which includes a pressure sensor; par. 0069 ln 6-17) for the purpose of saving power (par. 0069 ln 17-24).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to further modify the device of Holtz to have the capacitance sensor activate the pressure sensor for the purpose of saving power (See Biswas: par. 0069 ln 17-24).
Claims 7 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Holtz in view of Jewett, and further in view of Merrell et al. (US 2020/0345588 A1), hereafter Merrell.
Regarding claim 7, the modified Holtz discloses the attachment according to claim 1 (shown above).
The modified Holtz does not disclose a microphone, a piezo crystal or a vibration sensor monitoring a sound or vibrations to monitor breathing of the user.
Merrell teaches an inhaler attachment (Fig. 1-5, monitor unit 30) comprising a microphone, a piezo crystal or a vibration sensor monitoring a sound or vibrations to monitor a breathing of the user (monitor unit 30 includes a microphone to monitor inhalation sounds, par. 0064 ln 18-33) for the purpose of detecting incorrect usage (par. 0064 ln 25-33).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the attachment of Holtz to further comprise a microphone as taught by Merrell for the purpose of detecting incorrect usage (See Merrell: par. 0064 ln 25-33).
Regarding claim 16, the modified Holtz discloses the attachment according to claim 10 (shown above).
The modified Holtz does not disclose a microphone, a piezo crystal or a vibration sensor monitoring a sound or vibrations to monitor a breathing of the user.
Merrell teaches an inhaler attachment (Fig. 1-5, monitor unit 30) comprising a microphone, a piezo crystal or a vibration sensor monitoring a sound or vibrations to monitor a breathing of the user (monitor unit 30 includes a microphone to monitor inhalation sounds, par. 0064 ln 18-33) for the purpose of detecting incorrect usage (par. 0064 ln 25-33).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the attachment of Holtz to further comprise a microphone as taught by Merrell for the purpose of detecting incorrect usage (See Merrell: par. 0064 ln 25-33).
Claims 9 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Holtz in view of Jewett, and further in view of Biswas.
Regarding claim 9, the modified Holtz teaches the attachment according claim 4 (shown above).
The modified Holtz does not disclose the self-capacitance sensor is configured to open the self-capacitance sensor array following a contact by the user.
Biswas teaches an inhaler attachment (Fig. 7; par. 0064 ln 1-4) wherein a capacitive sensor activates additional sensors following a contact by the user (capacitive sensor initiates activation of the board which includes additional sensors; par. 0069 ln 6-17) for the purpose of saving power (par. 0069 ln 17-24).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to further modify the attachment of Holtz to activate the additional sensors, such as the self-capacitance sensor array, following a contact by the user as taught by Biswas for the purpose of saving power (See Biswas: par. 0069 ln 17-24).
Regarding claim 18, the modified Holtz discloses the attachment according claim 13 (shown above) wherein the mutual capacitance sensor is configured to measure a mutual capacitance change (the capacitive sensor detects changes in capacitance, Holtz par. 0064 ln 18-24).
The modified Holtz does not disclose the mutual capacitance sensor opens the mutual capacitance sensor array following the contact of the user.
Biswas teaches an inhaler attachment (Fig. 7; par. 0064 ln 1-4) wherein a capacitive sensor activates additional sensors following a contact by the user (capacitive sensor initiates activation of the board which includes additional sensors; par. 0069 ln 6-17) for the purpose of saving power (par. 0069 ln 17-24).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to further modify the attachment of Holtz to activate the additional sensors, such as the capacitance sensor array, following a contact by the user as taught by Biswas for the purpose of saving power (See Biswas: par. 0069 ln 17-24).
Claims 12 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Holtz in view of Jewett, and further in view of Alizoti et al. (US 2017/0333645 A1), hereafter Alizoti.
Regarding claim 12, the modified Holtz discloses the attachment according to claim 10 (shown above).
The modified Holtz does not disclose the attachment is configured for detecting a capacitance value change occurring when the aerosol form detected by the attachment has changed while the metal spray canister moves relative to the actuator.
Alizoti teaches a system for a metered dose inhaler (abstract ln 1-3) configured for detecting a capacitance value change occurring when the aerosol form detected by the attachment has changed while a user pushes the metal spray canister into the actuator. (capacitor detects the capacitance change of the aerosol once the inhaler is activated, par. 0197) for the purpose of detecting aerosol presence for inhaler actuation (par. 0197 ln 3-6).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the attachment of Holtz to detect the capacitance change of the aerosol as taught by Alizoti for the purpose of detecting aerosol presence for inhaler actuation (See Alizoti: par. 0194 ln 3-6).
Regarding claim 14, the modified Holtz discloses the attachment according to claim 12 (shown above), further comprising: a mutual capacitance sensor array (Holtz par. 0066 ln 22-25; Fig. 2a-b, capacitive sensing areas 272a-c) wherein the mutual capacitance sensor array includes plural mutual capacitance sensors for detecting a user pushing the metal spray canister into the actuator (Jewett col. 9 ln 5-7; a practitioner in the art would have understood that an array of capacitance sensors could perform the same function as a single capacitance sensor).
Response to Arguments
Applicant's arguments filed 1/20/2026 have been fully considered but they are not persuasive.
Applicant argues that Holtz does not disclose the capacitance sensor is powered off if user interaction is undetected. However, Holtz discloses that a capacitance reading can be taken twice per second wherein each reading requires a small amount of power (par. 0084). From this, it can be understood that between the readings, the capacitance sensor is unpowered. This is supported by par. 0085 which states that the capacitance-based approach requires a smaller amount of power when compared to an ongoing audio analysis, meaning the capacitance readings are not ongoing.
Applicant’s arguments regarding Jewett have been considered, but Jewett is not relied upon to teach this limitation.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/K.R./Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785