DETAILED ACTION
Acknowledgements
This office action is in response to the claims filed August 7, 2025.
Claims 1-19, 22-40, and 42-60 are pending.
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 .
Information Disclosure Statement(s)
The information disclosure statement (IDS) submitted on 12/07/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-19, 22-40, and 42-60 are rejected to under 35 U.S.C 101 as not being directed to eligible subject matter based on the grounds set out in detail below:
Independent Claims 1, 22, and 42:
Eligibility Step 1 (does the subject matter fall within a statutory category?):
Independent claim 1 falls within the statutory category of method
Independent claim 22 falls within a statutory category of machine
Independent claim 42 falls within the statutory category of article of manufacture
Eligibility Step 2A-1 (does the claim recite an abstract idea, law of nature, or natural phenomenon?): Independent claims 1, 22, and 42 claimed invention is directed to an abstract idea without significantly more.
The claim elements which set forth the abstract idea in the independent claims 1, 22, and 42 (claim 1 being representative) are:
A method of determining a recommendation to change a treatment regimen of a respiratory ailment, the treatment regimen including a plurality of steps, the method comprising:
collecting use data …[…]…or rescue respiration medicament to the patient…[…]…;
transmitting the use data…[…]…;
storing the use data …[…]…accessible…[…]…;
based on the collected use data and patient context data, determining a patient value associated with the treatment regimen…[…]…;
making a comparison of the patient value to a threshold level;
providing a recommendation to change the step of the treatment regimen based on the comparison to the threshold level;
and providing a notification of recommendation of the change of the step of the treatment regimen.
The abstract idea is “certain methods of organizing human activity” by following rules and instructions to determine a recommended change in a patients treatment regimen (see MPEP § 2106.04(a)(2))
Eligibility Step 2A-2 (does the claim recite additional elements that integrate the judicial exception into a practical application?): For Independent claims 1, 22, and 42 judicial exception is not integrated into a practical application.
Independent claim 1 recites the additional elements below:
a respiration medicament device to deliver controller
communication interface
a storage device
a data analysis engine
Examiner takes the applicable considerations stated in MPEP 2106.04 (d) and analyzes them below in light of the instant applications disclosure and claim elements as a whole.
No additional element is recited as executing the abstract idea. The additional elements, (a), is recited generally linking the abstract idea to the respiratory therapies environment
The additional element, (b), is recited as a general purpose computer component as “apply-it” or an equivalent to gather data
The additional element, (c), is recited as “apply-it” or an equivalent to store data
The additional element, (d), is recited as “apply-it” or an equivalent to analyze data
Independent claim 22 recites the additional elements below not already recited in the independent claim 1:
A system
Examiner takes the applicable considerations stated in MPEP 2106.04 (d) and analyzes them below in light of the instant applications disclosure and claim elements as a whole.
The additional elements, (a), is recited as executing the abstract idea as “apply-it” or an equivalent
Independent claim 42 recites the additional elements below not already recited in the independent claim 1:
A non-transient computer-readable storage medium having instructions embodied thereon, the instructions being executable by one or more processors
Examiner takes the applicable considerations stated in MPEP 2106.04 (d) and analyzes them below in light of the instant applications disclosure and claim elements as a whole.
The additional elements, (a), is recited as executing the abstract idea as “apply-it” or an equivalent
Accordingly, independent claims 1, 22, and 42 as a whole do not integrate the recited abstract idea into a practical application (MPEP 2106.05(f) and 2106.04(d)(1).
Eligibility Step 2B (Does the claim amount to significantly more?): The independent claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements as analyzed above in step 2A prong 2, are merely applying and or generally linking the abstract idea and therefore, do not amount to significantly more. The claims are patent ineligible.
Dependent Claims 2-19, 22-40, and 42-60
Eligibility Step 1 (does the subject matter fall within a statutory category?):
Dependent claims 2-19 fall within the statutory category of method.
Dependent claims 22-40 fall within the statutory category of machine
Dependent claims 42-60 fall within the statutory category of article of manufacture
Eligibility Step 2A-1 (does the claim recite an abstract idea, law of nature, or natural phenomenon?): Dependent claims 2-19, 22-40, and 42-60 claimed invention is directed to an abstract idea without significantly more. The claims continue to limit the independent claims 1, 22, and 42 abstract idea by (1) further limiting the type of respiratory ailment, (2) further limiting the treatment regiment, (3) further limiting the threshold, (4) further limiting the gathered data, (5) further limiting the analyzing of data. Therefore, the dependent claims inherit the same abstract idea of “certain methods of organizing human activity” by following rules and instructions to determine a recommended change in a patients treatment regimen (see MPEP § 2106.04(a)(2))
Eligibility Step 2A-2 (does the claim recite additional elements that integrate the judicial exception into a practical application?): For claims 2-19, 22-40, and 42-60 this judicial exception is not integrated into a practical application.
The dependent claims recite the below additional elements not already recited in the independent claims:
Machine learning model (a generalized linear model, a tree-based model or a neural network)
A mobile computing device
Examiner takes the applicable considerations stated in MPEP 2106.04 (d) and analyzes them below in light of the instant applications disclosure and claim elements as a whole.
The additional elements, (a), are recited as generally linking the abstract idea to artificial intelligence
The additional elements, (b), are recited as “apply-it” or an equivalent to communicate data
Accordingly, dependent claims 2-19, 22-40, and 42-60 as a whole do not integrate the recited abstract idea into a practical application (MPEP 2106.05(f) and 2106.04(d)(1).
Eligibility Step 2B (Does the claim amount to significantly more?): The dependent claims do not include additional elements that amount to significantly more for the same reasons given in Prong 2. The claims are patent ineligible.
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-18, 22-39, and 42-59 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Edwards et. al (hereinafter Edwards) (US20200345955A1)
As per claim 1, Edwards teaches:
A method of determining a recommendation to change a treatment regimen of a respiratory ailment, the treatment regimen including a plurality of steps, the method comprising: ([0056] discloses, “Attempts have been made to assess the risk of an impending respiratory disease exacerbation , such as an asthma or COPD exacerbation , by monitoring various subject - related and environmental factors .” and see [0058] discloses, “For a higher probability of exacerbation , a step change in the treatment regimen may , for instance , be justified to a regimen configured for subjects at greater acute risk.”)
collecting use data of a respiration medicament device to deliver controller or rescue respiration medicament to the patient via a communication interface; ([0071] discloses, “The model may thus enable determination of the probability of the asthma exacerbation occurring during a predetermined period , termed the “ exacerbation period ” , which follows the first period during which the inhalation data , i.e. the number of rescue inhalations and the parameter data , are collected . The exacerbation period may be , for example , 1 to 10 days , such as 5 days . The exacerbation period may be selected based on the capability of the model to predict an exacerbation within such a period , whilst also ensuring that the predetermined period is sufficiently long for appropriate therapeutic steps to be taken , if necessary.” And see [0183] discloses, “In the first weighted predictive model , the most significant features in determining the probability of an asthma exacerbation were found to be : the number of rescue inhalations 61 % ; inhalation trends 16 % ; peak inhalation flow 13 % ; inhalation volume 8 % ; and night albuterol use 2 % . Such inhalation features were collected by the Digi haler , which recorded peak inhalation flow , time to peak inhalation flow , inhalation volume , inhalation duration , night - time usage , and trends of these parameters over time.” And see [0151] discloses, “The external device 15 may include a display and software for visually presenting the usage parameters may be stored as personalized data that may be stored for predicting” and see [0191] and see [0265])
transmitting the use data to a storage device; ([0151] discloses, “The external device 15 may include a display and software for visually presenting the usage parameters may be stored as personalized data that may be stored for predicting” and see [0152] discloses, “Although illustrated as being stored on the personal data storage device 17 , in some examples , all or a portion of the probability of the respiratory disease exacerbation , as represented by block 18A , the no inhalation events , low inhalations events , good inhalation events , excessive inhalation events and / or exhalation events , as represented by block 18B , and / or the underuse events , overuse events and optimal use events , as represented by block 18C , may be stored on the external device 15.” And see [0142] discloses, “In a non - limiting example , the processor 14 may be provided separately from the respective first and / or second inhaler ( s ) , in which case the processor 14 receives the number of rescue inhalations and parameter data transmitted to it from the sensor system 12A and the use - detection system 12B of the first and / or second inhalers . By processing the data in such an external processing unit , such as in the processing unit of an external device , the battery life of the inhaler may be advantageously preserved.”)
storing the use data in the storage device accessible to a data analysis engine; ([0151] discloses, “The external device 15 may include a display and software for visually presenting the usage parameters may be stored as personalized data that may be stored for predicting” and see [0152] discloses, “Although illustrated as being stored on the personal data storage device 17 , in some examples , all or a portion of the probability of the respiratory disease exacerbation , as represented by block 18A , the no inhalation events , low inhalations events , good inhalation events , excessive inhalation events and / or exhalation events , as represented by block 18B , and / or the underuse events , overuse events and optimal use events , as represented by block 18C , may be stored on the external device 15.” And see [0142] discloses, “In a non - limiting example , the processor 14 may be provided separately from the respective first and / or second inhaler ( s ) , in which case the processor 14 receives the number of rescue inhalations and parameter data transmitted to it from the sensor system 12A and the use - detection system 12B of the first and / or second inhalers . By processing the data in such an external processing unit , such as in the processing unit of an external device , the battery life of the inhaler may be advantageously preserved.”)
based on the collected use data and patient context data, determining a patient value associated with the treatment regimen via the data analysis engine; ([0080] discloses, “In a relatively simple example , an increase in the number of rescue inhalations using the first inhaler ( relative to a baseline period for the subject in question ) and / or a decrease in the number of routine inhalations using the second inhaler ( indicative of lower adherence to a treatment regimen ) , may together with inhalation parameters indicating worsening lung function leading to a higher probability of the respiratory disease exacerbation.” And see [0081] discloses, “In a specific example , a decrease in adherence to a maintenance medicament regimen from 80 % to 55 % , an increase in rescue inhaler use by 67.5 % , a drop in peak inhalation flow by 34 % , a drop in inhalation volume by 23 % ( all changes from patient's baseline ) , two exacerbations in the previous year , and a BMI over 28 may result in a probability of an asthma exacerbation in the next 5 days , with an ROC - AUC ( see the below discussion of FIGS . 8 and 17 ) of 0.87.” and see [0082] discloses, “More generally , the number of rescue inhalations ( e.g. including any related trends in the number of rescue inhalations ) may be the most significant factor in the probability determination.”)
making a comparison of the patient value to a threshold level; ([0090] discloses, “The processor may , for example , be configured to control a user interface to issue a prompt to the user so that the user inputs the indication . The prompt may be issued based on the initial probability determined from the inhalation(s) and the inhalation parameter ( s ) , but not on the indication . For example , the prompt may be issued based on the initial probability reaching or exceeding a predetermined threshold . In this manner , the user may be prompted by the system to input the indication on the basis of the initial probability signaling a potential impending exacerbation . By the user then inputting the indication , the ( overall ) probability which also takes account of the indication may assist to confirm or validate the initial probability.”)
providing a recommendation to change the step of the treatment regimen based on the comparison to the threshold level; ([0107] discloses, “Further provided is a method for treating an asthma exacerbation in a subject , the method comprising : performing the method as defined above ; determining whether the probability reaches or exceeds a predetermined upper threshold ; or determining whether the probability reaches or is lower than a predetermined lower threshold ; and treating the asthma based on the probability reaching or exceeding the predetermined upper threshold ; or based on the prob ability reaching or being lower than the predetermined lower threshold.” And see [0108] discloses, “The treating may comprise using an inhaler to deliver the rescue medicament to the subject when the probability reaches or exceeds the predetermined upper threshold” and see [0109] discloses, “The treatment may comprise modifying an existing treatment . The existing treatment may comprise a first treatment regimen , and the modifying the existing treatment of the asthma may comprise changing from the first treatment regimen to a second treatment regimen based on the probability reaching or exceeding the predetermined upper threshold , wherein the second treatment regimen is configured for higher risk of asthma exacerbation than the first treatment regimen.”)
and providing a notification of recommendation of the change of the step of the treatment regimen. ([0155] discloses, “Although not illustrated by in the method 20 , the system 10 may be configured to notify the user if the probability of asthma exacerbation exceeds or is lower than a threshold . For example , the system 10 may be configured to determine whether the probability reaches or exceeds a predetermined upper threshold and / or reaches or is lower than a predetermined lower threshold . In response , the system 10 may be configured to treat the patient , for example , by initiating a switch ( e.g. through a message to the patient's health care provider ) of the patient's treatment regimen to a treatment regimen that is configured for higher ( or lower ) risk of asthma exacerbation than the original treatment regimen.”)
As per claim 2, Edwards further teaches:
The method of claim 1, wherein the respiratory ailment is asthma or COPD. ([0007] discloses, “Accordingly , the present disclosure provides a system for determining a probability of an asthma exacerbation in a subject , the system comprising:”)
As per claim 3, Edwards further teaches:
The method of claim 1, wherein each step of the treatment regimen includes an associated controller respiration medicament or a rescue respiration medicament. ([0108] discloses, “The treating may comprise using an inhaler to deliver the rescue medicament to the subject when the probability reaches or exceeds the predetermined upper threshold”)
As per claim 4, Edwards further teaches:
The method of claim 1, wherein the treatment regimen is defined by Global Initiative for Asthma (GINA) guidelines or the National Heart Lung Blood Institute guidelines. ([0043] discloses, “According to the GINA ( Global Initiative for Asthma ) Guidelines , a step - wise approach is taken to the treatment of asthma.”)
As per claim 5, Edwards further teaches:
The method of claim 1, wherein the threshold level is one of an adherence percentage over a period of time, a number of rescue medicaments over a period of time, a score on a respiratory test, or a visit to a treatment facility. ([0080] discloses, “In a relatively simple example , an increase in the number of rescue inhalations using the first inhaler ( relative to a baseline period for the subject in question ) and / or a decrease in the number of routine inhalations using the second inhaler ( indicative of lower adherence to a treatment regimen ) , may together with inhalation parameters indicating worsening lung function leading to a higher probability of the respiratory disease exacerbation.” And see [0081] discloses, “In a specific example , a decrease in adherence to a maintenance medicament regimen from 80 % to 55 % , an increase in rescue inhaler use by 67.5 % , a drop in peak inhalation flow by 34 % , a drop in inhalation volume by 23 % ( all changes from patient's baseline ) , two exacerbations in the previous year , and a BMI over 28 may result in a probability of an asthma exacerbation in the next 5 days , with an ROC - AUC ( see the below discussion of FIGS . 8 and 17 ) of 0.87.” and see [0082] discloses, “More generally , the number of rescue inhalations ( e.g. including any related trends in the number of rescue inhalations ) may be the most significant factor in the probability determination.”)
As per claim 6, Edwards further teaches:
The method of claim 5, wherein the respiratory test is one of the COPD assessment test (CAT) or the asthma control test (ACT). ([0097] discloses, “The questionnaire may be relatively short , i.e. with relatively few questions , in order to minimize burden on the subject . The number and nature of the questions may nevertheless be such as to ensure that the indication enables the exacerbation probability determination to be enhanced relative to the scenario where no indication is inputted.” And see [0098] discloses, “More generally , the object of the questionnaire is to ascertain a contemporaneous or relatively recent ( e.g. within the past 24 hours ) indication in order to obtain “ in the moment ” understanding of the subject's well - being in respect of their respiratory disease ) with a few timely questions which are relatively quickly answered . The questionnaire may be translated into the local language of the subject.” And see [0099] discloses, “Conventional control questionnaires , and especially the most established being ACQ / T ( Asthma Control Questionnaire / Test ) in asthma , or CAT ( COPD Assessment Test ) in COPD tend to focus on patient recall of symptoms in the past . Recall bias , and a focus on the past instead of the present is likely to negatively influence their value for the purposes of predictive analysis. And see [0100] The following is provided by way of non - limiting example of such a questionnaire.”)
As per claim 7, Edwards further teaches:
The method of claim 1, wherein the recommendation is a step-up in treatment when the comparison is above the threshold level. ([0107] discloses, “Further provided is a method for treating an asthma exacerbation in a subject , the method comprising : performing the method as defined above ; determining whether the probability reaches or exceeds a predetermined upper threshold ; or determining whether the probability reaches or is lower than a predetermined lower threshold ; and treating the asthma based on the probability reaching or exceeding the predetermined upper threshold ; or based on the prob ability reaching or being lower than the predetermined lower threshold.” And see [0108] discloses, “The treating may comprise using an inhaler to deliver the rescue medicament to the subject when the probability reaches or exceeds the predetermined upper threshold” and see [0109] discloses, “The treatment may comprise modifying an existing treatment . The existing treatment may comprise a first treatment regimen , and the modifying the existing treatment of the asthma may comprise changing from the first treatment regimen to a second treatment regimen based on the probability reaching or exceeding the predetermined upper threshold , wherein the second treatment regimen is configured for higher risk of asthma exacerbation than the first treatment regimen.” And see [0111] discloses, “In an embodiment , the second treatment regimen comprises administering a biologics medication to the sub ject . The relatively high cost of biologics means that step ping up the subject's treatment to include administering of a biologics medication tends to require careful consideration and justification.”)
As per claim 8, Edwards further teaches:
The method of claim 1, wherein the recommendation is a step-down in treatment when the comparison is below the threshold level. ([0113] discloses, “Modifying the existing treatment of the asthma may comprise changing from the first treatment regimen to a third treatment regimen based on the probability reaching or being lower than the predetermined lower threshold , wherein the third treatment regimen is configured for lower risk of asthma exacerbation than the first treatment regimen.” And see [0114] discloses, “In particular , the subject may be moved from the first treatment regimen onto the third treatment regimen which is configured for lower risk of respiratory disease exacerbation than the first treatment regimen . This may , for example , involve progressing the subject to a lower step specified in the GINA or GOLD guidelines .”)
As per claim 9, Edwards further teaches:
The method of claim 1, wherein the patient context data is one of demographic data, environmental data, weather data, and social determinants of health. ([0056] discloses, “Attempts have been made to assess the risk of an impending respiratory disease exacerbation , such as an asthma or COPD exacerbation , by monitoring various subject - related and environmental factors .” and see [0078] discloses, “More generally , additional data sources may also be added to the model , such as environmental data relating to the weather or pollution levels . Such additional data may be weighted such as to have less significance on the prob ability determination than the number of rescue inhalations and optionally less significance than the inhalation parameter data.”)
As per claim 10, Edwards further teaches:
The method of claim 9, wherein the demographic data is collected from interfacing with an electronic health record system or self-reported by the patient. ([0075] discloses, “The biometric parameter may be , for instance , one or more selected from body weight ,height ,body mass index , blood pressure , including systolic and / or diastolic blood pressure , sex , race , age , smoking history , sleep / activity patterns , exacerbation history , other treatments or medicaments administered to the subject , etc. In an embodiment , the biometric parameter includes age , body mass index and exacerbation history . In a preferred embodiment , the bio metric parameter includes exacerbations and medical his tory , body mass index , and blood pressure…[…]” and see [0072] discloses, “A data input unit may , for instance , be included in the system to enable the subject and / or healthcare provider to input the biometric parameter.” / examiner notes age, sex, race are examples of a type of demographic data)
As per claim 11, Edwards further teaches:
The method of claim 1, wherein the recommendation of the change is made at a predetermined interval over a period of time. ([0058] discloses, “For a higher probability of exacerbation , a step change in the treatment regimen may , for instance , be justified to a regimen configured for subjects at greater acute risk . Alternatively , in the case of a lower probability of exacerbation over a prolonged period , enhanced accuracy of the probability determination may be used as guidance to justify downgrading or even removal of an existing treatment regimen . This may , for example , mean that the subject may no longer be required to take higher dose of medicament which is no longer commensurate with the status of their respiratory disease.” / examiner notes under BRI that the regimen is at predetermined intervals thus the changes are disclosed as predetermined the acuity of the risk)
As per claim 12, Edwards further teaches:
The method of claim 1, further comprising inputting the collected data to a machine learning model to output the threshold value, wherein the machine learning model is trained from collected context data, use data, and outcomes from the treatment regimen from a population of patients. ([0191] discloses, “Algorithms were trained on patient - specific inhalation information collected from Digihalers , as well as age , BMI , blood pressure , and the number of exacerbations and hospitalizations in the past 12 months . Baseline features and features prior to prediction , comparison between the two , and trends of changes in these features were subjected to supervised machine learning algorithms . A 4 - fold cross validation technique was used to compare performance metrics and gradient boosting trees were chosen as the most suitable algorithm . As before , the generated model was evaluated receiver operating characteristic area under curve ( ROC AUC ) analysis.”)
As per claim 13, Edwards further teaches:
The method of claim 12, wherein the machine learning model includes a clinical decision label for the threshold output. . ([0107] discloses, “Further provided is a method for treating an asthma exacerbation in a subject , the method comprising : performing the method as defined above ; determining whether the probability reaches or exceeds a predetermined upper threshold ; or determining whether the probability reaches or is lower than a predetermined lower threshold ; and treating the asthma based on the probability reaching or exceeding the predetermined upper threshold ; or based on the prob ability reaching or being lower than the predetermined lower threshold.” And see [0108] discloses, “The treating may comprise using an inhaler to deliver the rescue medicament to the subject when the probability reaches or exceeds the predetermined upper threshold” and see [0109] discloses, “The treatment may comprise modifying an existing treatment . The existing treatment may comprise a first treatment regimen , and the modifying the existing treatment of the asthma may comprise changing from the first treatment regimen to a second treatment regimen based on the probability reaching or exceeding the predetermined upper threshold , wherein the second treatment regimen is configured for higher risk of asthma exacerbation than the first treatment regimen.” And see [0111] discloses, “In an embodiment , the second treatment regimen comprises administering a biologics medication to the sub ject . The relatively high cost of biologics means that step ping up the subject's treatment to include administering of a biologics medication tends to require careful consideration and justification.” / examiner under BRI interprets the final predicted outcome clearly given to user as the clinical decision label)
As per claim 14, Edwards further teaches:
The method of claim 12, wherein the machine learning model is based on one of a generalized linear model, a tree-based model or a neural network. ([0084] discloses, “In a non - limiting example , the model is constructed using a decision trees technique . Other suitable techniques , such as building a neural network or a deep learning model may also be contemplated by the skilled person.”)
As per claim 15, Edwards further teaches:
The method of claim 1, further comprising categorizing the use between preemptive or emergency use. ([0110] discloses, “Such preemptive intervention may mean that the subject need not proceed to suffer the exacerbation , and be subjected to the associated risks , in order for the progression to the second treatment regimen to be justified.” And see [0143] discloses, “The first and / or second inhaler may thus , for example , prompt the subject to take preemptive steps , such as inhaling the rescue medicament one or more times , to mitigate or remove the risk of an exacerbation.”)
As per claim 16, Edwards further teaches:
The method of claim 1, further comprising outputting a report of the collected use and context data. ([0190] discloses, “A second weighted predictive model was developed using the same data , in an effort to improve on the first weighted predictive model . Biometric parameters were included in the modelling . In particular , case report form ( CRF ) data , such as medical history , body mass index ( BMI ) , and blood pressure , were combined with Digihaler data and subjected to the machine learning algorithm in order to refine the predictive model.”)
As per claim 17, Edwards further teaches:
The method of claim 1, further comprising collecting the context data through a survey displayed by an application executed by a mobile computing device operated by the patient. ([0091] discloses, “This may be , for instance , regarded as an “ analytics data driven ” use of the indication : the user input is requested when the inhalation and inhalation parameter data indicate possible worsening of the subject's respiratory disease.” And see [0092] discloses, “The user interface may , for example , prompt the user or subject to provide the indication via a pop - up notification link to complete a short questionnaire . The logic determining when this pop - up notification is provided may , for example , be driven by shifts in key variables , such as changes in the number and / or time of rescue and / or controller inhalations , and inhalation parameters.” And see [0270] discloses, “Further , a mobile application residing on the mobile device may generate feedback for the user based on data received from the electronics module 120. For example , the mobile application may generate daily , weekly , or monthly report , provide confirmation of error events or notifications , provide instructive feedback to the subject , and / or the like.” And see [0104])
As per claim 18, Edwards further teaches:
The method of claim 1, wherein the notification is provided electronically to one of the patient, a caregiver, or a healthcare provider. ([0155] discloses, “Although not illustrated by in the method 20 , the system 10 may be configured to notify the user if the probability of asthma exacerbation exceeds or is lower than a threshold . For example , the system 10 may be configured to determine whether the probability reaches or exceeds a predetermined upper threshold and / or reaches or is lower than a predetermined lower threshold . In response , the system 10 may be configured to treat the patient , for example , by initiating a switch ( e.g. through a message to the patient's health care provider ) of the patient's treatment regimen to a treatment regimen that is configured for higher ( or lower ) risk of asthma exacerbation than the original treatment regimen.” And see [0118] discloses, “FIG . 1 shows a block diagram of a system 10 according to an embodiment . The system 10 comprises a first inhaler 100 and a processor 14.”)
As per claims 22-39 they are system claims which repeat the same limitations of claims 1-18 the corresponding method claims, as a collection of elements as opposed to a series of process steps. Since the teachings of Edwards disclose the underlying process steps that constitute the methods of claims 1-18, it is respectfully submitted that they provide the underlying structural elements that perform the steps as well. As such, the limitations of claims 22-39 are rejected for the same reasons given above for claims 1-18.
As per claims 42-59 they are article of manufacture claims which repeat the same limitations of claim 1-18, the corresponding method claims, as a collection of executable instructions stored on machine readable media as opposed to a series of process steps. Since the teachings of Edwards disclose the underlying process steps that constitute the method of claims 1-18 it is respectfully submitted that they likewise disclose the executable instructions that perform the steps as well. As such, the limitations of claims 42-59 are rejected for the same reasons given above for claims 1-18.
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.
Claims 19, 40, and 60 are rejected under 35 U.S.C. 103 as being unpatentable over Edwards et. al (hereinafter Edwards) (US20200345955A1) in view of Manice et. al (hereinafter Manice) (US20240112782A1)
As per claim 19 and similarly claims 40 and 60, Edwards does not teach:
The method of claim 1, further comprising ordering additional medication for the patient through a medication supply system based on the recommendation.
However, Manice does teach:
The method of claim 1, further comprising ordering additional medication for the patient through a medication supply system based on the recommendation. ([0012] discloses, “The interactive tracking application is run on the smartphone to provide some analysis of the data and feedback to the user, but also other functions related to inhaler use, e.g., tracking and reminding of doctor's appointments, tracking and informing of the number of doses remaining in the inhaler and facilitating refill, making of emergency phone calls, storing treatment plan, displaying educational information and awarding of prizes as incentives for compliance.” And see [0069] discloses, “The upper right of the screen displays an inhaler icon, which provides information on how many doses are left in current inhaler cartridge. Optionally, this icon is a link so that touching this icon takes the user to another screen having prescription information including an icon which can be selected to electronically send a prescription refill request to a pharmacy. This could be implemented, e.g., by having the smartphone send a prescription request to the server 50 and for the server to then send a prescription refill request (an "e-prescription") to the pharmacy by facsimile or other electronic transmission. Add automaticAs before, a "!" near a faded inhaler icon can indicate that no tracking module is paired with the application, whereas a triple ")))" near the inhaler icon can indicate that a tracking module is synced, and clicking on the inhaler icon leads to an Order-Refill page.”)
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Edward’s teachings of preemptive care to improve action plans and provide opportunities for pre - emptive treatment , before the patient's condition requires , for example , unscheduled visits to or from a medical practitioner , hospital admission and administering of systemic steroids with Manice’s teachings of ordering additional medication for the patient through a medication supply system based on the recommendation as cited above, the motivation being that Manice’s addition of ordering additional medication would improve Edwards concerns of providing preemptive care and would be predictable as sensors of a use detection system e.g. 12B in Edwards can be used to also provide through the communication interface additional information which is a choice such as supply information.
Prior Art not cited but made of record
US20220280040A1 - JAVED, et. al
A system and method to determine symptoms of respiratory ailments is disclosed . The system includes a transceiver operable to receive data from a monitor attached to a patient . The monitor includes a plurality of sensors , each of the plurality of sensors outputting physiological data related to respiration of the patient . An analytics platform is coupled to the transceiver to analyze the physiological data to deter mine the occurrence of a symptom of a respiratory condi tion , disorder or ailment in the patient
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ashley Elizabeth Evans whose telephone number is (571) 270-0110. The examiner can normally be reached Monday – Friday 8:00 AM – 5:00 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mamon Obeid can be reached on (571) 270-1813. The fax phone number for the organization where this application or proceeding is assigned 571-273-8300.
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/ASHLEY ELIZABETH EVANS/Examiner, Art Unit 3687
/MAMON OBEID/Supervisory Patent Examiner, Art Unit 3687