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 present office action is in response to the Arguments/Remarks filed 09/28/2026. As directed by the amendment, claims 26-28, and 30-45 have been amended and no claim has been newly added. Thus, claims 26-45 are presented pending in this application.
Applicant has amended “Related Applications” section under specification to address minor informalities in the specification . Therefore, the previously held specification objections are hereby withdrawn.
Applicant has amended claims 26-28, and 30-45 to address minor informalities. Therefore, the previously held claim objections are hereby withdrawn.
Applicant has amended claims 34, and 42 to overcome the rejections under 35 U.S.C. §112. Therefore, the previously held claim rejections are hereby withdrawn.
Response to Arguments
Applicant’s arguments, see section under “Claim Rejections Under 35 U.S.C. § 103” of Page 2, filed 09/28/2026, have been fully considered and are persuasive as the prior arts of record in the preceding Office action do not specifically discloses or suggested amended limitation, “dynamically adapting the one or more threshold values to the user’s inhaler technique competence”. Therefore, the previously held rejections have been withdrawn.
However, upon further consideration, a new ground of rejection is made as necessitated by the amendments as discussed below.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
The following limitation is interpreted under 35 U.S.C. 112(f) in accordance with the above presumptions:
processing means in claims 26, 33 and 43
feedback means in claim 28
The following is considered the corresponding structure for the above limitation:
The “processing means” is interpreted as to a CPU or the like such as one or more microcontrollers as described in ¶0099.
The “feedback means” is interpreted as to LEDs, a speaker, or a vibratory motor as described in ¶0099, or an external computing device, a user’s smartphone, an application, or a remote computing device as described in ¶0067, 0109, 0112.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 26-45 are rejected under 35 U.S.C. 103 as being unpatentable over Loh et al. (US 20220105285 A1) in view of Naumov et al. (US 20220148730 A1) and Finke et al. (US 20200193806 A1).
Regarding claim 26, Loh et al. discloses, an inhaler monitoring device for automatically monitoring and improving user inhaler technique competence (¶0011, “…to enhancing or maximizing the likelihood of such individuals' inhalation therapy regimen compliance”; ¶0031, “IVHC usage data indicative of user inhalation technique and user inhalation therapy regimen compliance…analyzing IVHC usage data and generating IVHC usage scores”) comprising:
a body (a receiver 102, Fig 2A) comprising an inlet (a portion which an inhaler is connected as shown Fig 2A) and an outlet (an opposite portion which connected to a spacer/intermediate sleeve portion and a mouth portion 190 as shown, Fig 2A; the channel is provided to allow fluid communication from an inhaler 90 to the mouth portion 190 via 102 and 160 as shown in Fig 2A) which are in fluid communication with respect to one another to define a channel therebetween;
wherein the inlet is for coupling to an inhaler (the inhaler 90 connected to 102 as shown in Fig 2A) for dispensing a medication (¶0074, “where the inhaler 90 carries a corresponding pressurized medical aerosol canister 92”; ¶0075, “ a medical aerosol discharged from the inhaler 90 can be introduced… by which the patient can inhale gaseous substances or gases”) and the outlet is for coupling to a spacer (the intermediate sleeve portion 190 is connected to the opposite portion of 102 as shown in Fig 2A) through which a user can inhale the dispensed medication from the inhaler (¶0074-0075);
one or more sensors (a set of gas flow sensors 120, and other sensors 145, Fig 3) which are configured to measure one or more inhalation characteristics when the user inhales the dispensed medication from the inhaler through the inhaler monitoring device via the spacer in-use (¶0085-0086, “The set of gas flow sensors 120 is configured for sensing, sampling, or measuring air inflow values corresponding to or generated by distal-to-proximal air flow into or within the intelligent receiver…can also be configured for sensing, sampling, estimating, or measuring the discharge of the inhaler's medical aerosol dose…can measure air inflow into the intelligent receiver 102 while the patient is drawing air… can also measure a combination of air inflow”; ¶0100, “an additional set of sensors…exhaled breath sensors…a gas flow sensor 194a and/or a chemical species or chemical composition sensor”; ¶0139, “starts sampling sensor data values relevant to the current inhalation session, including sampling air inflow rate data values”); and
processing means (a processing unit 142, Fig 3) which is configured to determine feedback information based on one or more of the inhalation characteristics of the user (¶0139-0151, implies that the sensed data are processed and determined that the air flow rate is above the minimum acceptable air inflow rate and stored with data values, associated date and time with the event count, etc.; ¶0152-0159, implies the sensed data are used to generate the composite inhalation technique score and the inhalation therapy regimen compliance score); and
wherein the processing means is configured to wirelessly communicate with an external computing device and/or a remote computing device (¶0053, “Each IVHC carries one or more types of communication units or interfaces (e.g., wireless and/or wire-based communication units or interfaces) configured for communicating or transferring stored data to one or more external electronic/computing destinations, devices, or systems”).
While Loh et al. discloses, the processing means is configured to wirelessly communicate with an external computing device and/or a remote computing device (¶0106) such as a patient/parent computing device 500 can be a mobile computing device including a processing unit (e.g., a microprocessor); a memory for storing program instruction sets (e.g., an operating system and software modules or application programs/apps) executable by the processing unit and data (¶0106) and a remote therapy management server 600 can include one or more physical and/or virtual servers includes one or more processing units; a memory for storing program instruction sets (e.g., an operating system and software modules or application programs) executable by the processing unit(s) and data; one or more data storage devices (¶0116), Loh et al. does not specifically discloses, wherein the processing means is configured to wirelessly communicate with an external computing device and/or a remote computing device to apply an AI algorithm to the one or more inhalation characteristics to dynamically and automatically learn and adapt the feedback information and provide the feedback information to the user for improved user inhaler technique competence.
However, Naumov et al. which is analogous art to the claimed invention for a plurality of inhalers, where each inhaler comprising medicament, a processor, memory, and a transmitter, multiple processing modules that may reside at least partially on a user device (abstract) and the inhaler is also configured to send the data indicating the usage events and the time of the usage events to another device (¶0011) wirelessly via a transmission module of the inhaler (¶0062), teaches wherein the processing means is configured to wirelessly communicate (¶0011, 0062) with an external computing device and/or a remote computing device (¶0111, a system for capturing data from the inhaler…. a computer or server 408 that comprise… a digital health platform (DHP)… may include computer software configured to perform the functions described”) to apply an AI algorithm to the one or more inhalation characteristics to dynamically and automatically learn and adapt the feedback information and provide the feedback information to the user for improved user inhaler technique competence (¶0184-0190, “…to provide the analyzed and manipulated data… back to the user device or to the computer…analyze the inhalation parameters to determine compliance and/or risk information… send an alert to and/or send a notification for display on the user device associated with a user when their compliance score is below a threshold, future compliance score is below a threshold, and/or risk score exceeds a threshold….the inhalation parameter may be used to assess the user's compliance”; ¶0206-0210, “The DHP 406 may identify one or more patterns (e.g., trends) associated with a user using a supervised or unsupervised machine learning algorithm…. may use machine learning, such as a predictive model (e.g., a decision tree model, a gradient boost model, adaboost mode, a weighted model, etc.) to determine the individualized compliance score, the individualized future compliance score, and/or the individualized risk score… The predictive model may determine weights for each variable and/or relationship”; ¶0233, “may train a machine learning algorithm. The DHP 406 may train, at 406, the machine learning algorithm using training data”) in order to assist user to improve compliance and adherence to the technique (¶0218-0220). (¶0184-0190, 0206-0210, 0218-0220, 0233)
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Loh et al. to include wherein the processing means is configured to wirelessly communicate with an external computing device and/or a remote computing device to apply an AI algorithm to the one or more inhalation characteristics to dynamically and automatically learn and adapt the feedback information and provide the feedback information to the user for improved user inhaler technique competence as taught by Naumov et al. in order to assist user to improve compliance and adherence to the technique (¶0218-0220).
While Loh et al. further discloses, wherein the feedback information comprises a user score (an example of the technique score as shown Fig 7C) which is determined based on the user’s inhalation characteristics (¶0052, “an inhalation technique score can include or be a consolidated value (e.g., a single value, such as a mathematical average) that accounts for air inflow rate fluctuations that occur during each of the inhalation session's inhalation events”) with respect to one or more threshold values for the one or more inhalation characteristics (¶0161, “…can specify one or more thresholds or requirements that the patient's inhalation therapy regimen compliance scores”) and Loh et al. as modified above further discloses the AI algorithm is capable of machine learning and determine weights for each variable and/or relation in order to improve compliance and adherence to the technique (Naumov et al.: ¶0184-0190, 0206-0210, 0218-0220, 0233), Loh et al. does not specifically discloses, wherein the AI algorithm is configured to dynamically adapt the one or more threshold values to the user’s inhaler technique competence.
However, Finke et al. which is analogous art to the claimed invention for improving adherence to an inhalation therapy via by dynamically adapting the therapy protocol, and by providing real-time therapy-related functionality, such as patient training and support at the control device during the inhalation process (¶0005) and wherein inhalation data and/or measurement data generated by one or more sensors (¶0018) while a control unit which is capable of executing instructions (¶0104; Examiner notes that the control unit of Finke et al. is capable of performing the same function via a processor and a computer program) Examiner notes that AI algorithm has a limited weight configured to guide the user to a therapy adherence (¶0028-0033) and the optimal breathing maneuver may be determined and characterized by a set of key variables related to inhalation characteristics such as peak inspiratory flow rate, inspiratory volume, inhalation period, and etc. (¶0043), teaches the control device configured to dynamically adapt the one or more threshold values to the user’s inhaler technique competence (¶0035, “trigger a selection of sensor data based on defined thresholds, which may also be appropriately adapted during the course of the therapy protocol, for example when the health state of the user improves or deteriorates” which implies that the threshold values are dynamically adjusted depending on the health state of the user) in purpose of improving the inhalation therapy by adjusting the define threshold accordingly to the user’s health state (¶0005,0035).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Loh et al. as modified above to include wherein the AI algorithm is configured to dynamically adapt the one or more threshold values to the user’s inhaler technique competence as taught by Finke et al. in purpose of improving the inhalation therapy by adjusting the define threshold accordingly to the user’s health state (¶0005,0035).
Regarding claim 27, Loh et al. in view of Naumov et al. and Finke et al. discloses the device of claim 26 as discussed above.
Loh et al. further discloses, wherein the inhalation characteristics comprise one or more characteristics selected from the group consisting of: airflow characteristics (¶0085, “The set of gas flow sensors 120 is configured for sensing, sampling, or measuring air inflow values”), inhalation rate (¶0101, “sensing air inflow rate”; ¶0150, implies that air inflow rate used to determine the inhalation event as the airflow is created by user inhaling); and volume of medication inhaled (¶0086, “configured for sensing, sampling, estimating, or measuring the discharge of the inhaler's medical aerosol dose”).
Regarding claim 28, Loh et al. in view of Naumov et al. and Finke et al. discloses the device of claim 26 as discussed above.
Loh et al. further discloses, feedback means (a user interface 130, Fig 2B; ¶0078, “a set of display elements/devices such as a plurality of LEDs 136a-d and/or a display screen”) which is configured to provide a visual, audible and/or haptic feedback to the user based on the feedback information (¶0051, “the feedback includes or is visual feedback, and the set of feedback elements include a plurality of LEDs and/or a display screen,”) and/or the one or more of the inhalation characteristics (¶0141, implies that the LED would be active based on the most-recent sampled air flow rate), wherein the feedback means is configured to provide the feedback to the user in real time (¶0051, “a set of feedback elements configured for providing feedback to the patient as part of an inhalation session, which indicates on a near-real time or essentially real time”).
Regarding claim 29, Loh et al. in view of Naumov et al. and Finke et al. discloses the device of claim 26 as discussed above.
While Loh et al. further discloses, at least one movement sensor (¶0047, “one or more additional, auxiliary, or adjunct sensors, such as at least one of a spatial orientation sensor (e.g., in the form of a gyroscope)”) and a set of transducers/sensors (¶0031) and the set of sensors can also include additional gas flow sensors and/or other types of sensors (¶0047), Loh et al. is silent wherein the one or more sensors are selected from the group consisting of: wherein the one or more sensors are selected from the group consisting of: at least one air pressure sensor; and at least one environmental sensor.
However, Naumov et al. teaches at least one pressure sensor (¶0190, a pressure sensor configured to detect a use of the inhaler and sense or measure an inhalation parameter) and at least one environmental sensor (¶0327, a barometric pressure sensor, a differential pressure sensor) in order to further assess the user's compliance, which may provide valuable insight into the state of the user's respiratory disease (¶0190) and to eliminate or minimize any distortions caused by environmental conditions (¶0341)
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Loh et al. to include at least one air pressure sensor; and at least one environmental sensor as taught by Naumov et al. in order to further assess the user's compliance, which may provide valuable insight into the state of the user's respiratory disease (¶0190) and to eliminate or minimize any distortions caused by environmental conditions (¶0341).
Regarding claim 30, Loh et al. in view of Naumov et al. and Finke et al. discloses the device of claim 26 as discussed above.
Loh et al. further discloses, wherein the feedback information comprises at the least the inhalation characteristics of the user (¶0051,¶0141).
Regarding claim 31, Loh et al. in view of Naumov et al. and Finke et al. discloses the device of claim 26 as discussed above.
Loh et al. wherein a separate user score is determined in respect of the each of the different inhalation characteristics of the user.
However, Naumov et al. teaches wherein a separate user score (¶0023, “The score may include the compliance score, the future compliance score, and/or the risk score for the user. The training data may include the time, the one or more inhalation parameters, and the geographic location associated with each of the plurality of usage events”; ¶0201, “the compliance score may indicate how compliant a user has been with respect to the user of one or more of their inhalers, the future compliance score may indicate a prediction of how compliant the user will be going forward with respect to the use of one or more of their inhalers, and the risk score may indicate the state of the user's respiratory disease”) is determined in respect of the each of the different inhalation characteristics of the user (¶0201-0205, implies that the scores are based on inhaler data with a respective user profile such as certain inhalation parameters like peak inhalation flow, inhalation volume etc. which may be different characteristics than inflow rate of Loh et al.) in order to provide feedback to the user related to how compliant the user has been with the inhaler usage, how compliant the user will be going forward, and/or the state of the user’s respiratory disease (¶0201).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the inhaler of Loh et al. to include wherein a separate user score is determined in respect of the each of the different inhalation characteristics of the user as taught by Naumov et al. in order to provide feedback to the user related to how compliant the user has been with the inhaler, how compliant the user will be going forward, and/or the state of the user’s respiratory disease (¶0201).
Regarding claim 32, Loh et al. in view of Naumov et al. and Finke et al. discloses the device of claim 26 as discussed above.
While Loh et al. further discloses, wherein the inlet (the mouth piece portion 190 is connected indirectly to the opposite portion of 102 via 160 as shown in Fig 2A) is for coupling to a mouthpiece into which the user can exhale (¶0075, “the mouthpiece portion 190 includes a patient breathing or inhalation/exhalation aperture… exhale gases as part of their breathing activity; ¶0076, “a set of exhaled gas vents or apertures 196 corresponding to or carried by the mouthpiece portion 190 by which gases exhaled by the patient can be vented or discharged from the IVHC 100 without entering the intermediate sleeve member's lumen”) and a set of exhaled breath sensors which is electrically coupled to and control by the processing unit (¶0100), Loh et al. does not specifically discloses, spirometry functionality to acquire and/or determine spirometry measurements of the user; wherein the one or more sensors are configured to acquire spirometry data; and wherein the spirometry measurements comprise a peak expiratory flow, a forced vital capacity, and/or an expiratory volume.
However, Naumov et al. teaches, spirometry functionality to acquire and/or determine spirometry measurements of the user (¶0038, “may include a spirometer or similarly operating device to enable measurement of lung function metric…perform measurements to obtain metrics related to a subject's lung capacity…measure the volume of air inhaled and/or exhaled by the subject”); wherein the one or more sensors are configured to acquire spirometry data (¶0038); and wherein the spirometry measurements comprise a peak expiratory flow, a forced vital capacity, and/or an expiratory volume (¶0341, “collected from the inhaler 100 in real-time, such as one or more of an average flow of an inhalation/exhalation, a peak flow of an inhalation/exhalation (e.g. a maximum inhalation received), a volume of an inhalation/exhalation, a time to peak of an inhalation/exhalation, and/or the duration of an inhalation/exhalation”; ¶0342, peak expiratory flow metric and/or FEV) in order to translate the sensed data into other metrics that indicate the subject's lung function and/or lung health that are understood to medical practitioners (¶0342) and provide compliance and adherence feedback to the subject including the personalized data about the subject, such as real-time data related to the subject's lung function and/or medical treatment (¶0340).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify device of Loh et al. to include spirometry functionality to acquire and/or determine spirometry measurements of the user; wherein the one or more sensors are configured to acquire spirometry data; and wherein the spirometry measurements comprise a peak expiratory flow, a forced vital capacity, and/or an expiratory volume as taught by Naumov et al. in order to translate the sensed data into other metrics that indicate the subject's lung function and/or lung health that are understood to medical practitioners (¶0342) and provide compliance and adherence feedback to the subject including the personalized data about the subject, such as real-time data related to the subject's lung function and/or medical treatment (¶0340).
Regarding claim 33, Loh et al. discloses, an inhaler apparatus (IVHC 100, Fig 2a) comprising:
an inhaler (an inhaler 90, Fig 2a; ¶0074, “where the inhaler 90 carries a corresponding pressurized medical aerosol canister 92”; ¶0075, “ a medical aerosol discharged from the inhaler 90 can be introduced… by which the patient can inhale gaseous substances or gases”) configured to dispense medication;
a spacer (an intermediate sleeve member 160, Fig 2A); and
an inhaler monitoring device for automatically monitoring and improving user inhaler technique competence (¶0011, “…to enhancing or maximizing the likelihood of such individuals' inhalation therapy regimen compliance”; ¶0031, “IVHC usage data indicative of user inhalation technique and user inhalation therapy regimen compliance…analyzing IVHC usage data and generating IVHC usage scores”) comprising:
a body (a receiver 102, Fig 2A) comprising an inlet (a portion which an inhaler is connected as shown Fig 2A) and an outlet (an opposite portion which connected to a spacer/intermediate sleeve portion and a mouth portion 190 as shown, Fig 2A; the channel is provided to allow fluid communication from an inhaler 90 to the mouth portion 190 via 102 and 160 as shown in Fig 2A) which are in fluid communication with respect to one another to define a channel therebetween;
wherein the inlet is for coupling to an inhaler (the inhaler 90 connected to 102 as shown in Fig 2A) for dispensing a medication (¶0074, “where the inhaler 90 carries a corresponding pressurized medical aerosol canister 92”; ¶0075, “ a medical aerosol discharged from the inhaler 90 can be introduced… by which the patient can inhale gaseous substances or gases”) and the outlet is for coupling to a spacer (the intermediate sleeve portion 190 is connected to the opposite portion of 102 as shown in Fig 2A) through which a user can inhale the dispensed medication from the inhaler (¶0074-0075);
one or more sensors (a set of gas flow sensors 120, and other sensors 145, Fig 3) which are configured to measure one or more inhalation characteristics when the user inhales the dispensed medication from the inhaler through the inhaler monitoring device via the spacer in-use (¶0085-0086, “The set of gas flow sensors 120 is configured for sensing, sampling, or measuring air inflow values corresponding to or generated by distal-to-proximal air flow into or within the intelligent receiver…can also be configured for sensing, sampling, estimating, or measuring the discharge of the inhaler's medical aerosol dose…can measure air inflow into the intelligent receiver 102 while the patient is drawing air… can also measure a combination of air inflow”; ¶0100, “an additional set of sensors…exhaled breath sensors…a gas flow sensor 194a and/or a chemical species or chemical composition sensor”; ¶0139, “starts sampling sensor data values relevant to the current inhalation session, including sampling air inflow rate data values”); and
processing means (a processing unit 142, Fig 3) which is configured to determine feedback information based on one or more of the inhalation characteristics of the user (¶0139-0151, implies that the sensed data are processed and determined that the air flow rate is above the minimum acceptable air inflow rate and stored with data values, associated date and time with the event count, etc.; ¶0152-0159, implies the sensed data are used to generate the composite inhalation technique score and the inhalation therapy regimen compliance score); and
wherein the processing means is configured to wirelessly communicate with an external computing device and/or a remote computing device (¶0053, “Each IVHC carries one or more types of communication units or interfaces (e.g., wireless and/or wire-based communication units or interfaces) configured for communicating or transferring stored data to one or more external electronic/computing destinations, devices, or systems”).
While Loh et al. discloses, the processing means is configured to wirelessly communicate with an external computing device and/or a remote computing device (¶0106) such as a patient/parent computing device 500 can be a mobile computing device including a processing unit (e.g., a microprocessor); a memory for storing program instruction sets (e.g., an operating system and software modules or application programs/apps) executable by the processing unit and data (¶0106) and a remote therapy management server 600 can include one or more physical and/or virtual servers includes one or more processing units; a memory for storing program instruction sets (e.g., an operating system and software modules or application programs) executable by the processing unit(s) and data; one or more data storage devices (¶0116), Loh et al. does not specifically discloses, wherein the processing means is configured to wirelessly communicate with an external computing device and/or a remote computing device to apply an AI algorithm to the one or more inhalation characteristics to dynamically and automatically learn and adapt the feedback information and provide the feedback information to the user for improved user inhaler technique competence.
However, Naumov et al. which is analogous art to the claimed invention for a plurality of inhalers, where each inhaler comprising medicament, a processor, memory, and a transmitter, multiple processing modules that may reside at least partially on a user device (abstract) and the inhaler is also configured to send the data indicating the usage events and the time of the usage events to another device (¶0011) wirelessly via a transmission module of the inhaler (¶0062), teaches wherein the processing means is configured to wirelessly communicate (¶0011, 0062) with an external computing device and/or a remote computing device (¶0111, a system for capturing data from the inhaler…. a computer or server 408 that comprise… a digital health platform (DHP)… may include computer software configured to perform the functions described”) to apply an AI algorithm to the one or more inhalation characteristics to dynamically and automatically learn and adapt the feedback information and provide the feedback information to the user for improved user inhaler technique competence (¶0184-0190, “…to provide the analyzed and manipulated data… back to the user device or to the computer…analyze the inhalation parameters to determine compliance and/or risk information… send an alert to and/or send a notification for display on the user device associated with a user when their compliance score is below a threshold, future compliance score is below a threshold, and/or risk score exceeds a threshold….the inhalation parameter may be used to assess the user's compliance”; ¶0206-0210, “The DHP 406 may identify one or more patterns (e.g., trends) associated with a user using a supervised or unsupervised machine learning algorithm…. may use machine learning, such as a predictive model (e.g., a decision tree model, a gradient boost model, adaboost mode, a weighted model, etc.) to determine the individualized compliance score, the individualized future compliance score, and/or the individualized risk score… The predictive model may determine weights for each variable and/or relationship”; ¶0233, “may train a machine learning algorithm. The DHP 406 may train, at 406, the machine learning algorithm using training data”) in order to assist user to improve compliance and adherence to the technique (¶0218-0220).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Loh et al. to include wherein the processing means is configured to wirelessly communicate with an external computing device and/or a remote computing device to apply an AI algorithm to the one or more inhalation characteristics to dynamically and automatically learn and adapt the feedback information and provide the feedback information to the user for improved user inhaler technique competence as taught by Naumov et al. in order to assist user to improve compliance and adherence to the technique (¶0218-0220).
While Loh et al. further discloses, wherein the feedback information comprises a user score (an example of the technique score as shown Fig 7C) which is determined based on the user’s inhalation characteristics (¶0052, “an inhalation technique score can include or be a consolidated value (e.g., a single value, such as a mathematical average) that accounts for air inflow rate fluctuations that occur during each of the inhalation session's inhalation events”) with respect to one or more threshold values for the one or more inhalation characteristics (¶0161, “…can specify one or more thresholds or requirements that the patient's inhalation therapy regimen compliance scores”) and Loh et al. as modified above further discloses the AI algorithm is capable of machine learning and determine weights for each variable and/or relation in order to improve compliance and adherence to the technique (Naumov et al.: ¶0184-0190, 0206-0210, 0218-0220, 0233), Loh et al. does not specifically discloses, wherein the AI algorithm is configured to dynamically adapt the one or more threshold values to the user’s inhaler technique competence.
However, Finke et al. which is analogous art to the claimed invention for improving adherence to an inhalation therapy via by dynamically adapting the therapy protocol, and by providing real-time therapy-related functionality, such as patient training and support at the control device during the inhalation process (¶0005) and wherein inhalation data and/or measurement data generated by one or more sensors (¶0018) while a control unit which is capable of executing instructions (¶0104; Examiner notes that the control unit of Finke et al. is capable of performing the same function via a processor and a computer program) Examiner notes that AI algorithm has a limited weight configured to guide the user to a therapy adherence (¶0028-0033) and the optimal breathing maneuver may be determined and characterized by a set of key variables related to inhalation characteristics such as peak inspiratory flow rate, inspiratory volume, inhalation period, and etc. (¶0043), teaches the control device configured to dynamically adapt the one or more threshold values to the user’s inhaler technique competence (¶0035, “trigger a selection of sensor data based on defined thresholds, which may also be appropriately adapted during the course of the therapy protocol, for example when the health state of the user improves or deteriorates” which implies that the threshold values are dynamically adjusted depending on the health state of the user) in purpose of improving the inhalation therapy by adjusting the define threshold accordingly to the user’s health state (¶0005,0035).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Loh et al. as modified above to include wherein the AI algorithm is configured to dynamically adapt the one or more threshold values to the user’s inhaler technique competence as taught by Finke et al. in purpose of improving the inhalation therapy by adjusting the define threshold accordingly to the user’s health state (¶0005,0035).
Regarding claim 34, Loh et al. discloses, an inhaler monitoring system (¶0031-0032, implies the inhaler monitoring system which sense or measure signals correlated with IVHC usage and analyze date and generate usage scores), the inhaler monitoring system comprising: the inhaler apparatus as claimed in claim 33 (Loh et al. in view of Naumov et al. and Finke et al: the device of claim 33 as discussed above); and
the external computing device or the remote computing device (¶0106, “a patient/parent computing device 500 can be a mobile computing device including a processing unit (e.g., a microprocessor); a memory for storing program instruction sets (e.g., an operating system and software modules or application programs/apps) executable by the processing unit and data”);
wherein the inhaler monitoring device is configured to transmit the feedback information to the computing device (¶0053, “Each IVHC carries one or more types of communication units or interfaces (e.g., wireless and/or wire-based communication units or interfaces) configured for communicating or transferring stored data to one or more external electronic/computing destinations, devices, or systems”); and
wherein the computing device is configured to receive the feedback information and provide this to the user (¶0054-0064, implies that the feedback information is provided to the user via the computing device and/or the server; Fig 4-6 - block diagrams showing portions of particular program instruction sets or software modules).
Regarding claim 35, Loh et al. in view of Naumov et al. and Finke et al. discloses, the system of claim 34 as discussed above.
Loh et al. further discloses, wherein the feedback information comprises media data which is provided to the user by the computing device (¶0054-0064), wherein the media data is selected from the group consisting of video, image and audio media data (¶0131, “ Such user/visual interfaces can include conventional user/visual interface elements, in a manner readily understood by individuals having ordinary skill in the art”; Figs 7A-7G).
Regarding claim 36, Loh et al. in view of Naumov et al. and Finke et al. discloses, the system of claim 34 as discussed above.
While Loh et al. further discloses, wherein the feedback information comprises a user score (an example of the technique score as shown Fig 7C) which is determined based on the user’s inhalation characteristics (¶0052, “an inhalation technique score can include or be a consolidated value (e.g., a single value, such as a mathematical average) that accounts for air inflow rate fluctuations that occur during each of the inhalation session's inhalation events”), Loh et al. does not specifically discloses, wherein a separate user score is determined for each of the one or more inhalation characteristics of the user, wherein the user score for each of the one or more inhalation characteristics is dynamically weighted based on one or more of the user’s inhalation characteristics.
However, Naumov et al. teaches wherein a separate user score (¶0023, “The score may include the compliance score, the future compliance score, and/or the risk score for the user. The training data may include the time, the one or more inhalation parameters, and the geographic location associated with each of the plurality of usage events”; ¶0201, “the compliance score may indicate how compliant a user has been with respect to the user of one or more of their inhalers, the future compliance score may indicate a prediction of how compliant the user will be going forward with respect to the use of one or more of their inhalers, and the risk score may indicate the state of the user's respiratory disease”) is determined in respect of the each of the different inhalation characteristics of the user (¶0201-0205, implies that the scores are based on inhaler data with a respective user profile such as certain inhalation parameters like peak inhalation flow, inhalation volume etc. which may be different characteristics than inflow rate of Loh et al.); wherein the user score for each of the one or more inhalation characteristics is dynamically weighted based on one or more of the user’s inhalation characteristic (¶0201-0205; ¶0210,” The predictive model may determine weights for each variable and/or relationship.”) in order to provide feedback to the user related to how compliant the user has been with the inhaler usage, how compliant the user will be going forward, and/or the state of the user’s respiratory disease (¶0201).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the inhaler of Loh et al. to include wherein a separate user score is determined for each of the one or more inhalation characteristics of the user, wherein the user score for each of the one or more inhalation characteristics is dynamically weighted based on one or more of the user’s inhalation characteristics as taught by Naumov et al. in order to provide feedback to the user related to how compliant the user has been with the inhaler, how compliant the user will be going forward, and/or the state of the user’s respiratory disease (¶0201).
Regarding claim 37, Loh et al. in view of Naumov et al. and Finke et al. discloses, the system of claim 34 as discussed above.
Loh et al. further discloses, a central server (¶0116, “The remote therapy management server 600 can include one or more physical and/or virtual servers, which can include or be cloud-based computing machines, in a manner readily understood by individuals having ordinary skill in the relevant art. Thus, in various embodiments the remote therapy management server 600 inherently or by definition includes one or more processing units; a memory for storing program instruction sets (e.g., an operating system and software modules or application programs) executable by the processing unit(s) and data; one or more data storage device”) which is communicatively coupled to the computing device and/or inhaler monitoring device (¶0059-0065 implies data communication to the computing device and the inhaler monitoring device of the inhaler; ¶0071,” Each IVHC 100 is configured for data communication with at least one external computing device or computing system, including a set of patient/parent computing devices… for network communication with a remote therapy management server communication with a set of physician computing devices”).
Regarding claim 38, Loh et al. in view of Naumov et al. and Finke et al. discloses, the system of claim 37 as discussed above.
Loh et al. further discloses, wherein the central server is configured to consolidate the feedback information provided by the inhaler monitoring device and/or the user inhalation characteristics with supplemental data (¶0059, “the remote therapy management server is configured for maintaining a patient management database that stores information corresponding to multiple patients and their IVHC”; ¶0119, “data corresponding to or derived from sampled signal data values generated or obtained by the patient's IVHC 100, such as inhalation technique scores, composite inhalation technique scores, inhalation therapy regimen compliance scores; and patient respiratory attack data”; ¶0122, “analytical data can provide indications of, be correlated with, or correspond to patients' inhalation therapy regimen compliance scores, inhalation therapy technique scores, and/or respiratory attack data, e.g., based on one or more of patient age range(s), gender(s), geographical location(s), and/or other factors”).
While Loh et al. discloses, the server provides data corresponding to or derived from sampled signal data values generated or obtained by the patient's IVHC and further analyze using the database managers to retrieve and store patient-related data and physician-related data (¶0119-0122), Loh does not specifically discloses, the central server is configured to determine an advisory action based on the consolidated user inhalation characteristics and supplemental data.
However, Naumov et al. discloses, the central server (¶0111, the server that comprises a Care Provider facing processing module and include computer software configured to perform the functions described in relation to the DHP) is configured to determine an advisory action (¶0023, “The score may include the compliance score, the future compliance score, and/or the risk score for the user. The training data may include the time, the one or more inhalation parameters, and the geographic location associated with each of the plurality of usage events”; ¶0201, “the compliance score may indicate how compliant a user has been with respect to the user of one or more of their inhalers, the future compliance score may indicate a prediction of how compliant the user will be going forward with respect to the use of one or more of their inhalers, and the risk score may indicate the state of the user's respiratory disease”) based on the consolidated user inhalation characteristics and supplemental data (¶0164, “a Care Provider facing processing module residing on a computer or server associated with a health care provider… data may include any of the data described with reference to the inhalers described herein, such as usage events, error events, inhalation profiles, associated timestamps, medicament type, etc. The inhaler data may be associated with an inhaler and/or a user profile, for example, at the processing module”; ¶0217-0287, implies the processes of DHP providing advisory action based on the one or more inhalation parameters and supplemental data involving environmental conditions and geographic location, drug information such as desirable dosage, and one or more third party application providing a self-assessment data via FitBit, Apple watch, etc. and providing suggestions to improve compliance and adherence for inhalation) in order to provide feedback to the user related to how compliant the user has been with the inhaler usage, how compliant the user will be going forward, and/or the state of the user’s respiratory disease (¶0201).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Loh et al. to include, the central server is configured to determine an advisory action based on the consolidated user inhalation characteristics and supplemental data as taught by Naumov et al. in order to provide feedback to the user related to how compliant the user has been with the inhaler usage, how compliant the user will be going forward, and/or the state of the user’s respiratory disease (¶0201).
Regarding claim 39, Loh et al. in view of Naumov et al. and Finke et al. discloses, the system of claim 38 as discussed above.
Modified Loh et al. further discloses wherein the supplemental data comprises further data regarding the medication being received by the user and/or further environmental information regarding the location where the user made use of the inhaler apparatus and/or third party user data (Naumov et al.:¶0217-0287).
Regarding claim 40, Loh et al. in view of Naumov et al. and Finke et al. discloses, the system of claim 38 as discussed above.
Modified Loh et al. further discloses, wherein the advisory action comprises a non-adherence action and/or a risk action (Naumov et al.:¶0201), wherein a non-adherence action comprises wherein the central server is configured to communicate with the computing device to notify the user of one or more actions to take to improve the user’s inhalation characteristics, wherein the risk action comprises wherein the central server is configured to communicate with the computing device to notify the user of the user’s risk of their medical condition deteriorating or improving based on their inhalation characteristics (Naumov et al.:¶0217-0287 implies alerting or notifying the risk of medical conditions or suggesting attribute to improve)
Regarding claim 41, Loh et al. in view of Naumov et al. and Finke et al. discloses, the system of claim 37 as discussed above.
While Loh et al. discloses, the server configured for communication with each mobile/portable computing device (¶0037), the server can include a physician/clinician application program executing thereon, which can manage data communication with clinician or physician computing devices or systems (¶0060), and alerting physician and the server when an emergency signal is activated (¶0104), Loh et al does not specifically discloses, wherein the central server is configured to contact the user’s clinician or guardian based on their inhalation characteristics.
However, Naumov et al. teaches wherein the central server is configured to contact the user’s clinician or guardian based on their inhalation characteristics (¶0220, implies that the server is capable of contacting the user’s clinician, the user’s health provider based on the user’s one or more inhalation characteristics to provide suggestion which attribute the user should attempt to improve upon for improving the user’s compliance score”).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Loh et al. to include wherein the central server is configured to contact the user’s clinician or guardian based on their inhalation characteristics as taught by Naumov et al. in order to provide suggestion which attribute the user should attempt to improve upon for improving the user’s compliance score (¶0220).
Regarding claim 42, Loh et al. in view of Naumov et al. and Finke et al. discloses, the system of claim 37 as discussed above.
Modified Loh et al. further discloses wherein the AI algorithm is trained with the user’s inhalation characteristics over a period of time (Naumov et al: ¶0184-0190; ¶0206-0210; ¶0218-0220; ¶0233).
Regarding claim 43, Loh et al. discloses, a method for monitoring inhaler technique competence (¶0011, “…to enhancing or maximizing the likelihood of such individuals' inhalation therapy regimen compliance”; ¶0031, “IVHC usage data indicative of user inhalation technique and user inhalation therapy regimen compliance…analyzing IVHC usage data and generating IVHC usage scores”), the method comprising:
receiving one or more inhalation characteristics of a user (¶0085-0086, “The set of gas flow sensors 120 is configured for sensing, sampling, or measuring air inflow values corresponding to or generated by distal-to-proximal air flow into or within the intelligent receiver…can also be configured for sensing, sampling, estimating, or measuring the discharge of the inhaler's medical aerosol dose…can measure air inflow into the intelligent receiver 102 while the patient is drawing air… can also measure a combination of air inflow”; ¶0100, “an additional set of sensors…exhaled breath sensors…a gas flow sensor 194a and/or a chemical species or chemical composition sensor”; ¶0139, “starts sampling sensor data values relevant to the current inhalation session, including sampling air inflow rate data values”);
determining feedback information based on the one or more inhalation characteristics of the user (¶0139-0151, implies that the sensed data are processed and determined that the air flow rate is above the minimum acceptable air inflow rate and stored with data values, associated date and time with the event count, etc.; ¶0152-0159, implies the sensed data are used to generate the composite inhalation technique score and the inhalation therapy regimen compliance score); and
providing the feedback information to the user (¶0051, “a set of feedback elements configured for providing feedback to the patient as part of an inhalation session, which indicates on a near-real time or essentially real time…the feedback includes or is visual feedback, and the set of feedback elements include a plurality of LEDs and/or a display screen”; ¶0141, implies that the LED would be active based on the most-recent sampled air flow rate);
wherein the feedback information comprises a user score (an example of the technique score as shown Fig 7C) which is determined based on the user’s one or more inhalation characteristics (¶0052, “an inhalation technique score can include or be a consolidated value (e.g., a single value, such as a mathematical average) that accounts for air inflow rate fluctuations that occur during each of the inhalation session's inhalation events”); and
wherein the processing means wirelessly communicates data regarding the inhalation characteristics with an external computing device and/or a remote computing device (¶0053, “Each IVHC carries one or more types of communication units or interfaces (e.g., wireless and/or wire-based communication units or interfaces) configured for communicating or transferring stored data to one or more external electronic/computing destinations, devices, or systems”).
While Loh et al. discloses, the processing means is configured to wirelessly communicate with an external computing device and/or a remote computing device (¶0106) such as a patient/parent computing device 500 can be a mobile computing device including a processing unit (e.g., a microprocessor); a memory for storing program instruction sets (e.g., an operating system and software modules or application programs/apps) executable by the processing unit and data (¶0106) and a remote therapy management server 600 can include one or more physical and/or virtual servers includes one or more processing units; a memory for storing program instruction sets (e.g., an operating system and software modules or application programs) executable by the processing unit(s) and data; one or more data storage devices (¶0116), Loh et al. does not specifically discloses, wherein the processing means is configured to wirelessly communicate with an external computing device and/or a remote computing device to apply an AI algorithm to the one or more inhalation characteristics to dynamically and automatically learn and adapt the feedback information and provide the feedback information to the user for improved user inhaler technique competence.
However, Naumov et al. which is analogous art to the claimed invention for a plurality of inhalers, where each inhaler comprising medicament, a processor, memory, and a transmitter, multiple processing modules that may reside at least partially on a user device (abstract) and the inhaler is also configured to send the data indicating the usage events and the time of the usage events to another device (¶0011) wirelessly via a transmission module of the inhaler (¶0062), teaches wherein the processing means is configured to wirelessly communicate (¶0011, 0062) with an external computing device and/or a remote computing device (¶0111, a system for capturing data from the inhaler…. a computer or server 408 that comprise… a digital health platform (DHP)… may include computer software configured to perform the functions described”) to apply an AI algorithm to the one or more inhalation characteristics to dynamically and automatically learn and adapt the feedback information and provide the feedback information to the user for improved user inhaler technique competence (¶0184-0190, “…to provide the analyzed and manipulated data… back to the user device or to the computer…analyze the inhalation parameters to determine compliance and/or risk information… send an alert to and/or send a notification for display on the user device associated with a user when their compliance score is below a threshold, future compliance score is below a threshold, and/or risk score exceeds a threshold….the inhalation parameter may be used to assess the user's compliance”; ¶0206-0210, “The DHP 406 may identify one or more patterns (e.g., trends) associated with a user using a supervised or unsupervised machine learning algorithm…. may use machine learning, such as a predictive model (e.g., a decision tree model, a gradient boost model, adaboost mode, a weighted model, etc.) to determine the individualized compliance score, the individualized future compliance score, and/or the individualized risk score… The predictive model may determine weights for each variable and/or relationship”; ¶0233, “may train a machine learning algorithm. The DHP 406 may train, at 406, the machine learning algorithm using training data”) in order to assist user to improve compliance and adherence to the technique (¶0218-0220).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Loh et al. to include wherein the processing means is configured to wirelessly communicate with an external computing device and/or a remote computing device to apply an AI algorithm to the one or more inhalation characteristics to dynamically and automatically learn and adapt the feedback information and provide the feedback information to the user for improved user inhaler technique competence as taught by Naumov et al. in order to assist user to improve compliance and adherence to the technique (¶0218-0220).
While Loh et al. further discloses, wherein the feedback information comprises the inhaler technique information which is determined based on the user’s inhalation characteristics (¶0052, “an inhalation technique score can include or be a consolidated value (e.g., a single value, such as a mathematical average) that accounts for air inflow rate fluctuations that occur during each of the inhalation session's inhalation events”) with respect to one or more threshold values for the one or more inhalation characteristics (¶0161, “…can specify one or more thresholds or requirements that the patient's inhalation therapy regimen compliance scores”) and Loh et al. as modified above further discloses the AI algorithm is capable of machine learning and determine weights for each variable and/or relation in order to improve compliance and adherence to the technique (Naumov et al.: ¶0184-0190, 0206-0210, 0218-0220, 0233), Loh et al. does not specifically discloses, wherein the AI algorithm is configured to dynamically adapt the one or more threshold values to the user’s inhaler technique competence.
However, Finke et al. which is analogous art to the claimed invention for improving adherence to an inhalation therapy via by dynamically adapting the therapy protocol, and by providing real-time therapy-related functionality, such as patient training and support at the control device during the inhalation process (¶0005) and wherein inhalation data and/or measurement data generated by one or more sensors (¶0018) while a control unit which is capable of executing instructions (¶0104; Examiner notes that the control unit of Finke et al. is capable of performing the same function via a processor and a computer program) Examiner notes that AI algorithm has a limited weight configured to guide the user to a therapy adherence (¶0028-0033) and the optimal breathing maneuver may be determined and characterized by a set of key variables related to inhalation characteristics such as peak inspiratory flow rate, inspiratory volume, inhalation period, and etc. (¶0043), teaches the control device configured to dynamically adapt the one or more threshold values to the user’s inhaler technique competence (¶0035, “trigger a selection of sensor data based on defined thresholds, which may also be appropriately adapted during the course of the therapy protocol, for example when the health state of the user improves or deteriorates” which implies that the threshold values are dynamically adjusted depending on the health state of the user) in purpose of improving the inhalation therapy by adjusting the define threshold accordingly to the user’s health state (¶0005,0035).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Loh et al. as modified above to include wherein the AI algorithm is configured to dynamically adapt the one or more threshold values to the user’s inhaler technique competence as taught by Finke et al. in purpose of improving the inhalation therapy by adjusting the define threshold accordingly to the user’s health state (¶0005,0035).
Regarding claim 44, Loh et al. in view of Naumov et al. and Finke et al. discloses the method of claim 43 as discussed above.
Loh et al. does not specifically discloses, receiving one or more spirometry measurements of the user.
However, Naumov et al. teaches, receiving one or more spirometry measurements of the user (¶0038, “may include a spirometer or similarly operating device to enable measurement of lung function metric…perform measurements to obtain metrics related to a subject's lung capacity…measure the volume of air inhaled and/or exhaled by the subject”; ¶0341, “collected from the inhaler 100 in real-time, such as one or more of an average flow of an inhalation/exhalation, a peak flow of an inhalation/exhalation (e.g. a maximum inhalation received), a volume of an inhalation/exhalation, a time to peak of an inhalation/exhalation, and/or the duration of an inhalation/exhalation”; ¶0342, peak expiratory flow metric and/or FEV) in order to translate the sensed data into other metrics that indicate the subject's lung function and/or lung health that are understood to medical practitioners (¶0342) and provide personalized data about the subject, such as real-time data related to the subject's lung function and/or medical treatment related to the compliance and adherence feedback (¶0340).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify method of Loh et al. to include receiving one or more spirometry measurements of the user as taught by Naumov et al. in order to translate the sensed data into other metrics that indicate the subject's lung function and/or lung health that are understood to medical practitioners (¶0342) and provide personalized data about the subject, such as real-time data related to the subject's lung function and/or medical treatment related to the compliance and adherence feedback (¶0340).
Regarding claim 45, Loh et al. in view of Naumov et al. and Finke et al. discloses the method of claim 44 as discussed above.
Modified Loh et al. further discloses, wherein the spirometry measurements are selected from the group consisting of a peak expiratory flow, a forced vital capacity and a forced expiratory volume (Naumov et al.: ¶0340-0342).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Javed (US 20220280040 A1) is cited for a process comprising a repeated adjustment of such routines and plans provides such dynamic and personalized optimization. For example, a patient having their own baseline and an adaptive algorithm that learns the individual thresholds for such a baseline (¶0120).
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAEICK JANG whose telephone number is (703)756-4569. The examiner can normally be reached M-F 8:30 - 4:30.
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/J.J./Examiner, Art Unit 3785
/JOSEPH D. BOECKER/Primary Examiner, Art Unit 3785
