DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claims 8 and 19 objected to because of the following informalities: “the M consecutive records” in ln 4 of claim 8 and ln 5 of claim 19 should read ---M consecutive records---. Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2, 5, 7, 12-13, 16 and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Klimowicz (US 2003/0136400 A1).
Regarding claim 1, Klimowicz discloses a method of predicting atomization time adapted to an atomization device (abstract), the atomization device including a control module (#28 fig 1-2, par 0044 “controller of circuit board 28”), an atomization module (#16 fig 1-2, par 0039 “aerosol generator”) and a breathing sensing module (#32 fig 1-3, par 0041, 0043), and the method comprising: configuring the breath sensing module to detect one or more inhalations of a user using the atomization device (par 0041), so as to generate one or more records of initial breath data correspondingly (par 0044 discloses recording the duration the flow is above a threshold T1-T3, see also fig 4, par 0041 and 0043 disclosing recording the flow rate over time); and configuring the control module to: compare the one or more records of inhalation data in the records of initial breath data with a valid inhalation standard to obtain one or more records of valid inhalation data (par 0016, fig 4 disclose a threshold flow rate thus disclosing a flow rate that the sensed flow is compared to in order to determine if the user is inhaling/if the inhalation is valid); statistically analyze the one or more records of the valid inhalation data to generate a predicted value of inhalation time (par 0045 "the controller can use information based on the sensed breathing of a user, and thus, for example, determine an average over several breaths of the time T1 and time T3 and thus the value of time T3-T1" disclosing statistical analysis through averaging the records); calculate an atomization time according to the predicted value of the inhalation time (T1-T2 fig 4, par 0033 disclosing T1 as the start of atomization and T2 as the stop time for the atomizer, and par 0045 “determine an average over several breaths of the time T1 and time T3 and thus the value of time T3-T1. This information can be factored into the calculation of the length of the time T3-T2 to determine when time T2 should be set” disclosing this atomization time is according to the predicted inhalation time T1-T3); and generate a driving signal to drive the atomization module to perform atomization according to the atomization time (par 0045 “With this information, device 10 is able to initialize itself by calculating an aerosol operation or delivery time).
Regarding claim 2, Klimowicz discloses the method of claim 1. Klimowicz further discloses the breath sensing module includes at least one of a pressure sensor and a flow sensor (par 0041 “flow sensor 32”), and each of the one or more records of the inhalation data includes at least one of pressure data, flow data (par 0041 “circuit board 28 may be configured to record the flow rate of air over time”) and duration corresponding to each inhalation of the user.
Regarding claim 5, Klimowicz discloses the method of claim 2. Klimowicz further discloses the process of statistically analyzing the one or more records of the valid inhalation data to generate the predicted value of the inhalation time further includes: obtaining N records of the duration corresponding to last N records of the one or more records of the valid inhalation data (par 0045 discloses recording the duration of several breaths reaching the flow threshold); and calculating the predicted value of the inhalation time according to the obtained N records of the duration (par 0045 “determine an average over several breaths of the time T1 and time T3 and thus the value of time T3-T1”), wherein N is a positive integer greater than or equal to 2 (par 0045 discloses “several” breaths thus disclosing at least 2).
Regarding claim 7, Klimowicz discloses the method of claim 5. Klimowicz further discloses the process of calculating the predicted value of the inhalation time according to the obtained N records of the duration further includes: calculating an average of the obtained N records of the duration to serve as the predicted value of the inhalation time (par 0045 “determine an average over several breaths of the time T1 and time T3 and thus the value of time T3-T1”).
Regarding claim 12, Klimowicz discloses an atomization device (abstract), comprising: an atomization module (#16 fig 1-2, par 0039 “aerosol generator”); a breathing sensing module (#32 fig 1-3, par 0041, 0043) configured to detect one or more inhalations of a user using the atomizing device (par 0041), so as to generate one or more records of initial breath data correspondingly (par 0044 discloses recording the duration the flow is above a threshold T1-T3, see also fig 4, par 0041 and 0043 disclosing recording the flow rate over time); and a control module (#28 fig 1-2, par 0044 “controller of circuit board 28”) electrically connected to the atomization module and the breath sensing module (par 0041), wherein the control module is configured to: compare the one or more records of inhalation data in the records of initial breath data with a valid inhalation standard to obtain one or more records of valid inhalation data (par 0016, fig 4 disclose a threshold flow rate thus disclosing a flow rate that the sensed flow is compared to in order to determine if the user is inhaling/if the inhalation is valid); statistically analyze the one or more records of the valid inhalation data to generate a predicted value of inhalation time (par 0045 "the controller can use information based on the sensed breathing of a user, and thus, for example, determine an average over several breaths of the time T1 and time T3 and thus the value of time T3-T1" disclosing statistical analysis through averaging the records); calculate an atomization time according to the predicted value of the inhalation time (T1-T2 fig 4, par 0033 disclosing T1 as the start of atomization and T2 as the stop time for the atomizer, and par 0045 “determine an average over several breaths of the time T1 and time T3 and thus the value of time T3-T1. This information can be factored into the calculation of the length of the time T3-T2 to determine when time T2 should be set” disclosing this atomization time is according to the predicted inhalation time T1-T3); and generate a driving signal to drive the atomization module to atomize a to-be-atomized medicine according to the atomization time (par 0045 “With this information, device 10 is able to initialize itself by calculating an aerosol operation or delivery time”).
Regarding claim 13, Klimowicz discloses the device of claim 12. Klimowicz further discloses the breath sensing module includes at least one of a pressure sensor and a flow sensor (par 0041 “flow sensor 32”), and each of the one or more records of the inhalation data includes at least one of pressure data, flow data (par 0041 “circuit board 28 may be configured to record the flow rate of air over time”) and duration corresponding to each inhalation of the user.
Regarding claim 16, Klimowicz discloses the device of claim 13. Klimowicz further discloses the process of statistically analyzing the one or more records of the valid inhalation data to generate the predicted value of the inhalation time further includes: obtaining N records of the duration corresponding to last N records of the one or more records of the valid inhalation data (par 0045 discloses recording the duration of several breaths reaching the flow threshold); and calculating the predicted value of the inhalation time according to the obtained N records of the duration (par 0045 “determine an average over several breaths of the time T1 and time T3 and thus the value of time T3-T1”), wherein N is a positive integer greater than or equal to 2 (par 0045 discloses “several” breaths thus disclosing at least 2).
Regarding claim 18, Klimowicz discloses the device of claim 16. Klimowicz further discloses the process of calculating the predicted value of the inhalation time according to the obtained N records of the duration further includes: calculating an average of the obtained N records of the duration to serve as the predicted value of the inhalation time (par 0045 “determine an average over several breaths of the time T1 and time T3 and thus the value of time T3-T1”).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 3-4 and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Klimowicz as applied to claims 2 and 13 above, and further in view of Denyer12 (US 2012/0143073 A1).
Regarding claim 3, Klimowicz discloses the method of claim 2. Klimowicz further discloses the valid inhalation standard includes at least one of a pressure threshold, a flow threshold correspondingly (par 0013 “the flow rate of inspiratory breath is above a threshold flow rate”), and a time threshold, and the process of comparing the one or more records of the inhalation data with the valid inhalation standard to obtain the one or more records of the valid inhalation data includes: executing a determination process for each record of the inhalation data, wherein, each record of the inhalation data is determined to be one of the records of the valid inhalation data when the corresponding pressure data is lower than the pressure threshold or the corresponding flow data is higher than the flow threshold (par 0013, par 0016, fig 4 disclose a threshold flow rate thus disclosing a flow rate that the sensed flow is compared to in order to determine if the user is inhaling/if the inhalation is valid).
Klimowicz is silent to a time threshold and the determination process determining valid inhalation data when the corresponding duration is greater than the time threshold.
Denyer12 teaches a flow threshold (“lower ideal flow limit” fig 3) and a time threshold (“inhalation target (seconds)” fig 3) and determining valid inhalation when both cooresponding flow data is higher than a flow threshold (par 0029) and a cooresponding duration is greater than the time threshold (par 0048-0049).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize an inhalation duration threshold in addition to a flow threshold as taught by Denyer12 in the method of Klimowicz as duration can monitor that the therapy is having effect (Denyer12: par 0049) and can prevent the method from recognizing false positives of flow increase not related to a proper breath length.
Regarding claim 4, Klimowicz discloses the method of claim 2. Klimowicz further discloses the valid inhalation standard includes at least one of a pressure threshold, a flow threshold correspondingly (par 0013 “the flow rate of inspiratory breath is above a threshold flow rate”), and a time threshold, and the process of comparing the one or more records of the inhalation data with the valid inhalation standard to obtain the one or more records of the valid inhalation data includes: executing a determination process for each record of the inhalation data, wherein, each record of the inhalation data is determined to be one of the records of the valid inhalation data when the corresponding pressure data is lower than the pressure threshold or the corresponding flow data is higher than the flow threshold (par 0013, par 0016, fig 4 disclose a threshold flow rate thus disclosing a flow rate that the sensed flow is compared to in order to determine if the user is inhaling/if the inhalation is valid).
Klimowicz is silent to a time threshold and the determination process determining valid inhalation data when the corresponding duration is greater than the time threshold; wherein the time determination value is obtained by multiplying the predicted value of the inhalation time by a user ratio associated with the user.
Denyer12 teaches a flow threshold (“lower ideal flow limit” fig 3) and a time threshold (“inhalation target (seconds)” fig 3) and determining valid inhalation when both cooresponding flow data is higher than a flow threshold (par 0029) and a cooresponding duration is greater than the time threshold (par 0048-0049); wherein the time determination value is obtained by multiplying the predicted value of the inhalation time by a user ratio associated with the user (par 0048 discloses the duration threshold being a percent of a baseline capacity).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize an inhalation duration threshold in addition to a flow threshold as taught by Denyer12 in the method of Klimowicz as duration can monitor that the therapy is having effect (Denyer12: par 0049) and can prevent the method from recognizing false positives of flow increase not related to a proper breath length.
Regarding claim 14, Klimowicz discloses the device of claim 13. Klimowicz further discloses the valid inhalation standard includes at least one of a pressure threshold, a flow threshold correspondingly (par 0013 “the flow rate of inspiratory breath is above a threshold flow rate”), and a time threshold, and the process of comparing the one or more records of the inhalation data with the valid inhalation standard to obtain the one or more records of the valid inhalation data includes: executing a determination process for each record of the inhalation data, wherein, each record of the inhalation data is determined to be one of the records of the valid inhalation data when the corresponding pressure data is lower than the pressure threshold or the corresponding flow data is higher than the flow threshold (par 0013, par 0016, fig 4 disclose a threshold flow rate thus disclosing a flow rate that the sensed flow is compared to in order to determine if the user is inhaling/if the inhalation is valid).
Klimowicz is silent to a time threshold and the determination process determining valid inhalation data when the corresponding duration is greater than the time threshold.
Denyer12 teaches a flow threshold (“lower ideal flow limit” fig 3) and a time threshold (“inhalation target (seconds)” fig 3) and determining valid inhalation when both cooresponding flow data is higher than a flow threshold (par 0029) and a cooresponding duration is greater than the time threshold (par 0048-0049).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize an inhalation duration threshold in addition to a flow threshold as taught by Denyer12 on the device of Klimowicz as duration can monitor that the therapy is having effect (Denyer12: par 0049) and can prevent the method from recognizing false positives of flow increase not related to a proper breath length.
Regarding claim 15, Klimowicz discloses the device of claim 13. Klimowicz further discloses Klimowicz further discloses the valid inhalation standard includes at least one of a pressure threshold, a flow threshold correspondingly (par 0013 “the flow rate of inspiratory breath is above a threshold flow rate”), and a time threshold, and the process of comparing the one or more records of the inhalation data with the valid inhalation standard to obtain the one or more records of the valid inhalation data includes: executing a determination process for each record of the inhalation data, wherein, each record of the inhalation data is determined to be one of the records of the valid inhalation data when the corresponding pressure data is lower than the pressure threshold or the corresponding flow data is higher than the flow threshold (par 0013, par 0016, fig 4 disclose a threshold flow rate thus disclosing a flow rate that the sensed flow is compared to in order to determine if the user is inhaling/if the inhalation is valid).
Klimowicz is silent to a time threshold and the determination process determining valid inhalation data when the corresponding duration is greater than the time threshold; wherein the time determination value is obtained by multiplying the predicted value of the inhalation time by a user ratio associated with the user.
Denyer12 teaches a flow threshold (“lower ideal flow limit” fig 3) and a time threshold (“inhalation target (seconds)” fig 3) and determining valid inhalation when both cooresponding flow data is higher than a flow threshold (par 0029) and a cooresponding duration is greater than the time threshold (par 0048-0049); wherein the time determination value is obtained by multiplying the predicted value of the inhalation time by a user ratio associated with the user (par 0048 discloses the duration threshold being a percent of a baseline capacity).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize an inhalation duration threshold in addition to a flow threshold as taught by Denyer12 in the method of Klimowicz as duration can monitor that the therapy is having effect (Denyer12: par 0049) and can prevent the method from recognizing false positives of flow increase not related to a proper breath length.
Claims 6 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Klimowicz as applied to claims 5 and 16 above, and further in view of Moloney (US 2020/0163387 A1).
Regarding claim 6, Klimowicz discloses the method of claim 5. Klimowicz is silent to when a record quantity of the one or more records of the valid inhalation data is less than N, durations of vacant records of the valid inhalation data relative to N are replaced by a predetermined time value and used to calculate the predicted value of the inhalation time. Klimowicz instead requires an initialization period of several breaths before operation (par 0045-0046).
Moloney teaches a similar method for user specific inhaling in which when a record quantity of the one or more records of the valid inhalation data is less than N, durations of vacant records of the valid inhalation data relative to N are replaced by a predetermined time value and used to calculate the predicted value of the inhalation time (par 0025 “the memory may be provided with N instances of an average puff duration pre-loaded at manufacture so that the system does not have to operate differently during initial use. Over time, these pre-loaded values are supplanted by measured values from the user”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize pre-loaded values as taught by Moloney in the method of Klimowicz as doing so allows for the device to function and administer medication during the initializing process.
Regarding claim 17, Klimowicz discloses the device of claim 16. Klimowicz is silent to when a record quantity of the one or more records of the valid inhalation data is less than N, durations of vacant records of the valid inhalation data relative to N are replaced by a predetermined time value and used to calculate the predicted value of the inhalation time. Klimowicz instead requires an initialization period of several breaths before operation (par 0045-0046).
Moloney teaches a similar method for user specific inhaling in which when a record quantity of the one or more records of the valid inhalation data is less than N, durations of vacant records of the valid inhalation data relative to N are replaced by a predetermined time value and used to calculate the predicted value of the inhalation time (par 0025 “the memory may be provided with N instances of an average puff duration pre-loaded at manufacture so that the system does not have to operate differently during initial use. Over time, these pre-loaded values are supplanted by measured values from the user”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize pre-loaded values as taught by Moloney in the method of Klimowicz as doing so allows for the device to function and administer medication during the initializing process.
Claims 8 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Klimowicz as applied to claims 2 and 13 above, and further in view of Prince (US 2018/0169356 A1).
Regarding claim 8, Klimowicz discloses the method of claim 2. Klimowicz is silent to in response to the durations corresponding to the M consecutive records of the inhalation data being less than a time standard of the valid inhalation standard, replacing a last one of the consecutive M records of the inhalation data with one record of the valid inhalation data, wherein M is a positive integer greater than or equal to 2.
Prince teaches a similar breath learning method wherein in response to the durations corresponding to the M consecutive records of the inhalation data being less than a time standard of the valid inhalation standard, replacing a last one of the consecutive M records of the inhalation data with one record of the valid inhalation data (par 0017).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize Prince’s replacing method in the method of Klimowicz as doing so presents the calculation from crashing due to consecutive short breaths (Prince: par 0017).
Modified Klimowicz is silent to M is a positive integer greater than or equal to 2. However, it would have further been obvious to require M to be greater than or equal to 2 in order to accommodate for false positives readings of a shortened breath.
Regarding claim 19, Klimowicz discloses the device of claim 13. Klimowicz is silent to in response to the durations corresponding to the M consecutive records of the inhalation data being less than a time standard of the valid inhalation standard, replacing a last one of the consecutive M records of the inhalation data with one record of the valid inhalation data, wherein M is a positive integer greater than or equal to 2.
Prince teaches a similar breath learning method wherein in response to the durations corresponding to the M consecutive records of the inhalation data being less than a time standard of the valid inhalation standard, replacing a last one of the consecutive M records of the inhalation data with one record of the valid inhalation data (par 0017).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize Prince’s replacing method on the device of Klimowicz as doing so presents the calculation from crashing due to consecutive short breaths (Prince: par 0017).
Modified Klimowicz is silent to M is a positive integer greater than or equal to 2. However, it would have further been obvious to require M to be greater than or equal to 2 in order to accommodate for false positives readings of a shortened breath.
Claims 9 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over modified Klimowicz as applied to claims 3 and 14 above, and further in view of Anderson (US 6,958,691 B1).
Regarding claim 9, modified Klimowicz discloses the method of claim 3. Klimowicz is silent to the control module includes a filtering standard having a locking time threshold and an unlocking time threshold, and the method further comprises: configuring the control module to: after the one or more records of the inhalation data are determined to be the valid inhalation data and in response to the duration corresponding to a current inhalation of the user being greater than the locking time threshold, activate an invalidation of a function triggered by the control module sending a drive signal to drive the atomization module when one of the inhalations contiguous to the current inhalation of the user is detected to be a valid inhalation; and when a stop time that is continually accumulated after the user stops inhaling is greater than the unlocking time threshold, deactivate the invalidation of the function triggered by the control module sending the drive signal.
Anderson teaches a similar atomization method wherein a control module includes a filtering standard having a locking time threshold (col 6 ln 39-46 discloses locking actuation when a user breaths consecutively, thus the locking time threshold is the same threshold as determining inhalation) and an unlocking time threshold (col 6 ln 39-46 discloses unlocking after a period of 3 to 30 seconds), and the method further comprises: configuring the control module to: after the one or more records of the inhalation data are determined to be the valid inhalation data and in response to the duration corresponding to a current inhalation of the user being greater than the locking time threshold, activate an invalidation of a function triggered by the control module sending a drive signal to drive the atomization module when one of the inhalations contiguous to the current inhalation of the user is detected to be a valid inhalation (col 6 ln 39-46 discloses activating a lock/invalidating actuation signals when the locking threshold is met/a first inhalation is registered); and when a stop time that is continually accumulated after the user stops is greater than the unlocking time threshold, deactivate the invalidation of the function triggered by the control module sending the drive signal (col 6 ln 39-46 discloses unlocking/deactivating the invalidation after the unlocking time threshold is met).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the locking and unlocking thresholds of Anderson in the method of modified Klimowicz as doing so protects the user from inadvertently receiving multiple doses of medicament (Anderson: col 6 ln 39-46).
Modified Klimowicz is silent to the stop time being accumulated after the user stops inhaling, and instead relies on a stop time after the actuation occurs. However, it would have been obvious to one of ordinary skill to rely on a stop time commencing at the completion of inhalation in order to provide a more accurate basis for determining it is safe for the user to breath again, in case the user takes an abnormally long initial breath.
Regarding claim 20, modified Klimowicz discloses the device of claim 14. Klimowicz is silent to the control module includes a filtering standard having a locking time threshold and an unlocking time threshold, and the method further comprises: configuring the control module to: after the one or more records of the inhalation data are determined to be the valid inhalation data and in response to the duration corresponding to a current inhalation of the user being greater than the locking time threshold, activate an invalidation of a function triggered by the control module sending a drive signal to drive the atomization module when one of the inhalations contiguous to the current inhalation of the user is detected to be a valid inhalation; and when a stop time that is continually accumulated after the user stops inhaling is greater than the unlocking time threshold, deactivate the invalidation of the function triggered by the control module sending the drive signal.
Anderson teaches a similar atomization method wherein a control module includes a filtering standard having a locking time threshold (col 6 ln 39-46 discloses locking actuation when a user breaths consecutively, thus the locking time threshold is the same threshold as determining inhalation) and an unlocking time threshold (col 6 ln 39-46 discloses unlocking after a period of 3 to 30 seconds), and the method further comprises: configuring the control module to: after the one or more records of the inhalation data are determined to be the valid inhalation data and in response to the duration corresponding to a current inhalation of the user being greater than the locking time threshold, activate an invalidation of a function triggered by the control module sending a drive signal to drive the atomization module when one of the inhalations contiguous to the current inhalation of the user is detected to be a valid inhalation (col 6 ln 39-46 discloses activating a lock/invalidating actuation signals when the locking threshold is met/a first inhalation is registered); and when a stop time that is continually accumulated after the user stops is greater than the unlocking time threshold, deactivate the invalidation of the function triggered by the control module sending the drive signal (col 6 ln 39-46 discloses unlocking/deactivating the invalidation after the unlocking time threshold is met).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the locking and unlocking thresholds of Anderson on the device of modified Klimowicz as doing so protects the user from inadvertently receiving multiple doses of medicament (Anderson: col 6 ln 39-46).
Modified Klimowicz is silent to the stop time being accumulated after the user stops inhaling, and instead relies on a stop time after the actuation occurs. However, it would have been obvious to one of ordinary skill to rely on a stop time commencing at the completion of inhalation in order to provide a more accurate basis for determining it is safe for the user to breathe again, in case the user takes an abnormally long initial breath.
Claims 10 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Klimowicz as applied to claims 1 and 12 above, and further in view of Denyer6 (US 6,584,971 B1).
Regarding claim 10, Klimowicz discloses the method of claim 1. Klimowicz further discloses the atomization time is the predicted value of the inhalation time multiplied by a predetermined ratio (par 0017 “the controller further calculates an aerosol generator operation time period that is equal to the initialization time period minus a stored value in the controller that is an estimate of a time period to move substantially all of an aerosol produced from the aerosol generator through a dead space volume with generally aerosol free chase air from a breath. The stored value can be a percentage of the time period T3-T1”).
Klimowicz is silent to the atomization time does not exceed an upper limit of a dosing time.
Denyer6 teaches a similar atomization device wherein an atomization time is the predicted value of the inhalation time multiplied by a predetermined ratio (col 1 ln 58-63) and the atomization time does not exceed an upper limit of a dosing time (col 4 ln 31-36).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate an upper dosing limit as taught by Denyer6 in the method of Klimowicz in order to prevent atomization disruption caused by very long breaths (Denyer6: col 4 ln 31-32).
Regarding claim 21, Klimowicz discloses the device of claim 12. Klimowicz further discloses the atomization time is the predicted value of the inhalation time multiplied by a predetermined ratio (par 0017 “the controller further calculates an aerosol generator operation time period that is equal to the initialization time period minus a stored value in the controller that is an estimate of a time period to move substantially all of an aerosol produced from the aerosol generator through a dead space volume with generally aerosol free chase air from a breath. The stored value can be a percentage of the time period T3-T1”).
Klimowicz is silent to the atomization time does not exceed an upper limit of a dosing time.
Denyer6 teaches a similar atomization device wherein an atomization time is the predicted value of the inhalation time multiplied by a predetermined ratio (col 1 ln 58-63) and the atomization time does not exceed an upper limit of a dosing time (col 4 ln 31-36).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate an upper dosing limit as taught by Denyer6 on the device of Klimowicz in order to prevent atomization disruption caused by very long breaths (Denyer6: col 4 ln 31-32).
Claims 11 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Klimowicz as applied to claims 1 and 12 above, and further in view of Denyer05 (US 2005/0229931 A1).
Regarding claim 11, Klimowicz discloses the method of claim 1. Klimowicz is silent to the atomization device has a standby time, and when a valid inhalation is not detected for more than the standby time after the atomization device is started, the atomization device returns to a locked state.
Denyer05 teaches a similar method wherein the atomization device has a standby time (“is 10 minute timeout expired?” fig 3A thus disclosing a standby time of 10 minutes), and when a valid inhalation is not detected for more than the standby time after the atomization device is started, the atomization device returns to a locked state (fig 3A disclosing auto-off when the standby time has expired an no inhalation start has been detected).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the standby time of Denyer05 in the method of Klimowicz as doing so can help preserve the battery of the associated device by allowing it to turn off when the standby time has expired.
Regarding claim 22, Klimowicz discloses the device of claim 12. Klimowicz is silent to the atomization device has a standby time, and when a valid inhalation is not detected for more than the standby time after the atomization device is started, the atomization device returns to a locked state.
Denyer05 teaches a similar method wherein the atomization device has a standby time (“is 10 minute timeout expired?” fig 3A thus disclosing a standby time of 10 minutes), and when a valid inhalation is not detected for more than the standby time after the atomization device is started, the atomization device returns to a locked state (fig 3A disclosing auto-off when the standby time has expired an no inhalation start has been detected).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the standby time of Denyer05 on the device of Klimowicz as doing so can help preserve the battery of the associated device by allowing it to turn off when the standby time has expired.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Henry US 20020189615 A1 discloses an inhaler with dose control
Jones US 6990975 B1 discloses medicament delivery trigger point based on averaged breath cycles
Tunnel US 8807131 B1 discloses compliance monitoring that filters out false positives when duration is too short or too long
Germinario US 20190134330 A1 discloses and inhaler utilizing an N number of 5 for averaging breaths
Stenzler US 20190240428 A1 discloses replacing a preset target value with an averaged value from previous treatments
Weitzel US 20200016345 A1 discloses an inhaler with adaptive dosing
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KIRA B DAHER whose telephone number is (571)270-0190. The examiner can normally be reached M-F 8am-5pm.
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/KIRA B DAHER/Examiner, Art Unit 3785
/BRADLEY H PHILIPS/Primary Examiner, Art Unit 3799
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