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Patent Application 17997500 - SYSTEM AND METHOD TO IDENTIFY SUITABLE PATIENT - Rejection

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Patent Application 17997500 - SYSTEM AND METHOD TO IDENTIFY SUITABLE PATIENT

Title: SYSTEM AND METHOD TO IDENTIFY SUITABLE PATIENT SUBGROUPS FOR BIOLOGICS

Application Information

  • Invention Title: SYSTEM AND METHOD TO IDENTIFY SUITABLE PATIENT SUBGROUPS FOR BIOLOGICS
  • Application Number: 17997500
  • Submission Date: 2025-05-12T00:00:00.000Z
  • Effective Filing Date: 2022-10-28T00:00:00.000Z
  • Filing Date: 2022-10-28T00:00:00.000Z
  • National Class: 705
  • National Sub-Class: 002000
  • Examiner Employee Number: 95618
  • Art Unit: 3683
  • Tech Center: 3600

Rejection Summary

  • 102 Rejections: 0
  • 103 Rejections: 1

Cited Patents

The following patents were cited in the rejection:

Office Action Text


    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 .

DETAILED ACTION
Response to Amendment
In the amendment dated 03/13/2025, the following occurred: Claims 1, 4-6, 9, 12-14, 17-18, 24 and 29 have been amended. Claims 7-8, 10, 20-21, 23, 25 and 27-28 were canceled. 
In the preliminary amendment dated 10/28/2022, the following occurred: Claims 3-6, 9, 11, 13, 16-19, 22 and 24, 26 were amended. Claims 7-8, 10, 20-21, 23, 25 and 27-28 were canceled. Claim 29 is new. The specification at paragraph [0001] has been amended.
Claims 1-6, 9, 11-19, 22, 24, 26 and 29 are currently pending. 

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 1-6, 9, 11-19, 22, 24, 26 and 29 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. 

Claims 1, 14 and 29 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim recites a system, method and a non-transitory computer readable medium for identifying suitable patient subgroups for biologics. 
Regarding claims 1, 14 and 29, the limitation of (claim 1 being representative) to determine suitability for enhanced treatment for a respiratory ailment: to collect use data to deliver controller or rescue respiration medicament to a patient; storing the collected use data comprising injection data; based on the collected use data, determining whether the patient is over a first threshold level of adherence in use of based on the collected use data, determining whether the patient has a rescue respiration medicament use over a second threshold level and providing a notification of recommendation of the enhanced treatment if the patient is over the first threshold level and the second threshold level and an injection interface configured to graphically provide: regions on the patient to inject and/or receive the respiration medicament associated with the recommendation, regions on the patient comprising previous treatment sites, and a responsive confirmation of a treatment as Crafted, is are processes that, under the broadest reasonable interpretation, covers certain methods of organizing human activity (i.e., managing personal behavior including following rules or instructions) but for recitation of generic computer components. That is other than reciting a communication interface, a memory and one or more processors (in claim 1) a communication interface and a storage device (in claim 14) and a non-transitory computer readable medium, a processor, a communication interface and a storage device (in claim 29), the claimed invention amounts to managing personal behavior or interaction between people (i.e., rules or instructions). For example, but for the non-transitory computer readable medium, the processor, the communication interface, the storage device, the memory and one or more processors, the claims encompass identifying suitable patient subgroups for biologics in the manner described in the identified abstract idea, supra. The Examiner notes that certain “method[s] of organizing human activity” includes a person’s interaction with a computer (see MPEP 2106.04(a)(2)(II)). If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or interactions between people, but for the recitation of generic computer components, then it falls within the “Certain Methods of Organizing Human Activity – Managing Personal Behavior Relationships, Interactions Between People (e.g. social activities, teaching, following rules or instructions)” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, claim 1 recite the additional elements of a communication interface, a memory and one or more processors. Claim 14 recites the additional elements of a communication interface and a storage device and a data analysis module. Claim 29 recites the additional element of a non-transitory computer readable medium, a processor, a communication interface, a storage device, a memory and one or more processors. These additional elements are not exclusively defined by the applicant and are recited at a high-level of generality (i.e., a generic computer components for enabling access to medical information or for performing generic computer functions) such that they amounts to no more than mere instructions to apply the exception using a generic computer component. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea. 
Claims 1, 14 and 29 further recite the additional element of a respiration medicament device and an injection interface. These additional element are recited at a high level of generality (i.e. a general means to output/receive/transmit data) and amount to extra solution activity. MPEP 2106.04(d)(I) indicates that extra-solution data gathering activity cannot provide a practical application. Accordingly, even in combination, this additional element does not integrate the abstract idea into a practical application.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of the non-transitory computer readable medium, the processor, the communication interface, the storage device, the memory and processor to perform the noted steps amount to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept (“significantly more”). 
Also as discussed above with respect to integration of the abstract idea into a practical application, the additional element of a respiration medicament device and an injection interface were considered extra-solution activity. This has been re-evaluated under “significantly more” analysis and determined to be well-understood, routine and conventional activity in the field. MPEP 2016.05(d)(II) indicates that receiving and/or transmitting data over a network has been held by the courts to be well-understood, routine and conventional activity (citing Symantec, TLI Communications, OIP Techs., and buySAFE). Well-understood, routine and conventional activity cannot provide an inventive concept (“significantly more”). Therefore when considering the additional elements alone, and in combination, there is no inventive concept in the claim, and thus the claim is not patent eligible.
The examiner notes that: A well-known, general-purpose computer has been determined by the courts to be a well-understood, routine and conventional element (see, e.g., Alice Corp. v. CLS Bank; see also MPEP 2106.05(d)); Receiving and/or transmitting data over a network (“a communications network”) has also been recognized by the courts as a well - understood, routine and conventional function (see, e.g., buySAFE v. Google; MPEP 2016(d)(II)); and Performing repetitive calculations is/are also well-understood, routine and conventional computer functions when they are claimed in a merely generic manner (see, e.g., Parker v. Flook; MPEP 2016.05(d)).
Claims 2-6, 9, 11-13, 15-19, 22, 24 and 26 are similarly rejected because they either further define the abstract idea and/or do not further limit the claim to a practical application or provide as inventive concept such that the claims are subject matter eligible even when considered individually or as an ordered combination. Dependent claim 2 further defines the respiratory ailment. Dependent claim 3 further defines the enhanced treatment. Dependent claim 4 defines the first threshold level. Dependent claim 5 further defines the second threshold level. Dependent claim 6 defines a mobile computing device. Claim 6 further recites the additional element of a mobile computing device which is analyzed as above and does not provide practical application or significantly more. Dependent claim 9 further defines an enhanced treatment module engine. Claim 9 further recites the additional element of an enhanced treatment module engine which is analyzed as above and does not provide practical application or significantly more. Dependent claim 11 further defines the enhanced treatment. Dependent claim 12 further defines the interface. Claims 11, 12 and 24 further recite the additional element of an interface which is analyzed as above and does not provide practical application or significantly more. Dependent claim 13 further defines a health monitor. Dependent claim 15 further defines the respiratory ailment. Dependent claim 16 further defines the enhanced treatment. Dependent claim 17 further defines the first threshold level. Dependent claim 18 further defines the second threshold level. Dependent claim 19 further defines establishing communication. Dependent claim 22 further defines tracking a use. Dependent claim 24 further defines the enhanced treatment. Dependent claim 26 further defines monitoring the patient.

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 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) are summarized as follows:
i.   Determining the scope and contents of the prior art. 
ii.   Ascertaining the differences between the prior art and the claims at issue.
iii.   Resolving the level of ordinary skill in the pertinent art. 
iv.   Considering objective evidence present in the application indicating obviousness or nonobviousness.  

Claims 1-6, 9, 11-19, 22, 24, 26 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Barrett (US 2020/0058403) and in further view of Anquetil (US 2018/0147351). 

REGARDING CLAIM 1
	Barrett discloses a system to determine suitability for enhanced treatment for a respiratory ailment, the system comprising: a communication interface to collect use data of a respiration medicament device to deliver controller or rescue respiration medicament to a patient (Barrett at [0037] teaches the patient may have a rescue medicament device that dispenses rescue medication, and a controller medicament device that dispenses controller medication (interpreted by examiner as a respiration medicament device to deliver controller or rescue respiration medicament to a patient) and that each patient may be associated with more than one sensor, each chosen to operate with one of the patient's medicament devices. [0039] teaches sensor includes network adapter and [0041] teaches the sensor captures data about usage of the medicament device (interpreted by examiner as the communication interface to collect use data of a respiration medicament device)); a memory comprising instructions stored thereon, which when executed by one or more processors, causes the one or more processors to perform: storing the collected use data (Barrett at [0064] teaches the use of a memory and one or more processors. [0042] teaches all sensors will include an onboard processor, persistent memory, and the network adapter mentioned above that together function to record, store, and report medication event information and [0046] teaches storage on application server), based on the collected use data, determining whether the patient is over a first threshold level of adherence in use of the respiration medicament device based on the collected use data (Barrett at [Claim 4] teaches an adherence of the patient comparing the frequency per day with which the patient uses the controller medication to the frequency with which the patient is instructed to take the controller medication. [claim 6] teaches wherein a trigger describes a threshold indicating one or more of the following: a presence of a measurable quantity indicative of increased usage of the rescue medication; and an absence of a measurable quantity indicative of increased usage of the rescue medication. [0052] teaches data analysis module executes routines to access asthma event data as well as other data including a patient's profile, analyze the data, and output the results of its analysis to both patients and providers. [0053] teaches adherence changes over time (interpreted by examiner to imply threshold based on previous adherence level) [0102] teaches an adherence regimen comparing the frequency per day with which the patient takes the rescue medication to the frequency with which the prescription is instructed to take the rescue medication (the examiner interprets the prescribed frequency thus constituting a threshold) and [0104] teaches the frequency with which a data store is updated with new rescue usage events 550 may vary depending on a number of factors not limited to the patient's circumstances, their adherence regimen to a controller medication, environmental conditions, and so on (interpreted by examiner as means to determine whether the patient is over a first threshold level of adherence in use of the respiration medicament device based on the collected use data)), determining whether the patient has a rescue respiration medicament use over a second threshold level and providing a notification of recommendation of the enhanced treatment if the patient is over the first threshold level and the second threshold level (Barrett at [claim 6] teaches a trigger describes a threshold indicating one or more of the following: a presence of a measurable quantity indicative of increased usage of the rescue medication; and an absence of a measurable quantity indicative of increased usage of the rescue medication and [0117] teaches a patient has been determined to be sensitive to a trigger by the data analysis module (this implies that rescue respiration medicament use is at least over a threshold of 0 and interpreted by examiner as means to determine whether the patient has a rescue respiration medicament use over a second threshold level), the notification module generates a risk score notification including any one or more of the following: a list of labeled triggers, a list of triggers still being analyzed, information characterizing the trigger, the relative risk score and confidence interval of the trigger, and options that the patient may take to prevent the occurrence of another rescue usage event in the presence of the trigger (interpreted by examiner as a notification of recommendation of the enhanced treatment if the patient is over the first threshold level and the second threshold level, since avoiding rescue usage events is an enhancement with regard to the health of the patient)).

Barrett does not disclose, however Anquetil discloses:
the collected use data comprising injection data (Anquetil at [0053] teaches receiving injection information (interpreted by examiner as the collected use data of Barrett that comprises injection data)); and an injection interface configured to graphically provide: regions on the patient to inject and/or receive the respiration medicament associated with the recommendation, regions on the patient comprising previous treatment sites, and a responsive confirmation of a treatment (Anquetil at [0056] and [0057] teach a user interface with a display screen and/or visual display (interpreted by examiner as the injection interface) [0043] teaches a “heat map” may be displayed, with locations that have received the full amount of treatment in one color (e.g., red), and with locations that require further injections of treatment displayed in another color (e.g., green) (interpreted by examiner as configured to graphically provide: regions on the patient to inject and/or receive the respiration medicament associated with the recommendation and regions on the patient comprising previous treatment sites) [0057] teaches the user interface can indicate that the user may move the nozzle 120 again after the treatment is delivered (interpreted by examiner as a responsive confirmation of a treatment)). 

It would have been obvious for one of the ordinary skill in the art before the effective filling date of the claimed invention to have modified the medicament device monitoring of Barrett to include the injection interface as taught by Anquetil, with the motivation of visually directing the user to move the injector to apply treatments to regions where it is necessary (see Anquetil at [0043]).

REGARDING CLAIM 2
Barrett and Anquetil disclose the limitation of claim 1.
Anquetil does not explicitly disclose, however Barrett further discloses:
The system of claim 1, wherein the respiratory ailment is asthma (Barrett at [0005] teaches medicament devices allow patients to manage respiratory symptoms, such as asthma).

REGARDING CLAIM 3
Barrett and Anquetil disclose the limitation of claim 1.
Anquetil does not explicitly disclose, however Barrett further discloses:
The system of claim 1, wherein the enhanced treatment is prescription of a biologic-based treatment or therapy (Barrett at [0163] teaches the trigger identification notifications provided to patient, providers, and users more generally convey many benefits. Patients are informed of their causes of a respiratory related event in real time or near real time as rescue usage events occur and can take actions to address or avoid those triggers, for example by adding or altering their prescribed medication regimen (such as an adjustment of dosage or the introduction of antibiotics or systemic corticosteroids) or by avoiding geographic areas with adverse condition (e.g., air pollution concentrations) (interpreted by examiner as the enhanced treatment is prescription of a biologic-based treatment or therapy)).

REGARDING CLAIM 4
Barrett and Anquetil disclose the limitation of claim 1.
Anquetil does not explicitly disclose, however Barrett further discloses:
The system of claim 1, wherein the first threshold level is a percentage adherence value of at least about 65% adherence (Barrett at [0113] teaches relative exacerbation when a trigger is present is 90% (interpreted by examiner as a percentage adherence value of at least about 65% adherence)).

REGARDING CLAIM 5
Barrett and Anquetil disclose the limitation of claim 1.
Anquetil does not explicitly disclose, however Barrett further discloses:
The system of claim 1, wherein the second threshold level is over at least about fifteen uses of rescue medicament over one week (Barrett at [0149] teaches first, the total number of rescue usage events from a preceding seven day period may be summed and recorded, for example for a total of 30 events. Second the baseline threshold is determined as the number of events equal to a fraction of the total, for example 5% of the total or 1.5 events. To label a day as an exacerbation day, the model 560 assigns a label if the number of rescue inhaler usage events in a given day is greater than the threshold, for example greater than 5% of the 30 events tallied over the last seven days (interpreted by examiner as means for the second threshold level over at least about fifteen uses of rescue medicament over one week)).

REGARDING CLAIM 6
Barrett and Anquetil disclose the limitation of claim 1.
Anquetil does not explicitly disclose, however Barrett further discloses:
The system of claim 1, further comprising a mobile computing device, the mobile computing device in communication with the one or more processors and the communication interface, wherein the mobile computing device includes an application to assist the patient in applying the enhanced treatment (Barrett at [0011] teaches a client application and [0030] teaches in addition to communicating with the application server, client devices connected wirelessly to the asthma analytics system may also exchange information with other connected client devices. For example, through a client software application. [0032] teaches event data sent through the network is received by the application server where it is analyzed and processed for storage and retrieval in conjunction with database server. The application server may direct retrieval and storage request to the database system as required by the client application (interpreted by examiner as the mobile computing device in communication with the one or more processors and the communication interface, wherein the mobile computing device includes an application to assist the patient in applying the enhanced treatment)).

REGARDING CLAIM 9
Barrett and Anquetil disclose the limitation of claim 1.
Anquetil does not explicitly disclose, however Barrett further discloses:
The system of claim 6 wherein the instructions are further configured to track a use of the enhanced treatment by the patient (Barrett at [0006] teaches an asthma analytics system is described that is a unified platform for treating, monitoring, and managing rescue events resulting from asthma. The asthma analytics system tracks asthma rescue medication events by receiving event notifications from a sensor attached to a medicament device (e.g., inhaler) used by a patient who has authorized the asthma analytics system to help manage their asthma (interpreted by examiner as means to track a use of the enhanced treatment by the patient)).

REGARDING CLAIM 11
Barrett and Anquetil disclose the limitation of claim 1.
Anquetil does not explicitly disclose, however Barrett further discloses:
The system of claim 6, wherein the enhanced treatment is prescription of an injectable biologic, and wherein the application includes an interface to coach the patient on at least one injection technique (Barrett at [0036] teaches in one embodiment, medicine is delivered in aerosol form through a medicament device such as a metered dose inhaler. Metered dose inhalers included a pressured propellant canister of aerosol medicine, a metering valve for delivering a regulated medicine dosage amount, and a plastic holder that holds the pressurized canister and also forms a mouthpiece for delivery of the medicine. In another embodiment, medicine is delivered in dry powder form through a medicament device such as a dry powder inhaler (interpreted by the examiner as the enhanced treatment is prescription of an injectable biologic). [0160] teaches deliver a notification to the primary patient informing them and including instructions for how best to handle the change in conditions while maintaining their health. [0077] teaches an education card includes information meant to educate the recipient. Education cards provide general disease information and tips for patients to reduce their risk of rescue events (interpreted by the examiner as an interface to coach the patient on at least one injection technique)).

REGARDING CLAIM 12
Barrett and Anquetil disclose the limitation of claim 1.
Anquetil does not explicitly disclose, however Barrett further discloses:
The system of claim 11, wherein the interface includes an interface to record an area of an injection of the biologic (Barrett at [0051] teaches gathering data such as geographic area (interpreted by examiner as an interface to record the area of an injection)).

REGARDING CLAIM 13
Barrett and Anquetil disclose the limitation of claim 1.
Anquetil does not explicitly disclose, however Barrett further discloses:
The system of claim 1, further comprising a health monitor to monitor the patient, wherein the communication interface is configured to collect data from the health monitor to determine the response of the patient to the enhanced treatment (Barrett at [0009] and FIG. 1 teach an asthma analytics system for monitoring accurate, real-time medicament device usage, performing analytics on that data, and providing asthma rescue event risk notifications, according to one embodiment. [0075] teaches an input response area for the recipient to add triggers for the rescue usage event and [0086] teaches interfaces may present an event summary for a rescue usage event to the user (interpreted by examiner as to collect data from the health monitor to determine the response of the patient to the enhanced treatment)).

REGARDING CLAIMS 14-19, 22, 24, 26 and 29
Claims 14-19, 22, 24, 26 and 29 are analogous to Claims 1-6, 9, 11-13 thus Claims 14-19, 22, 24, 26 and 29 are similarly analyzed and rejected in a manner consistent with the rejection of Claims 1-6, 9, 11-13.

Response to Arguments
Rejection under 35 U.S.C. § 112(f)
Regarding the 112f interpretation, the Applicant has amended the claims to overcome the 112f interpretation. 

Rejection under 35 U.S.C. § 112(a)
Regarding the written description rejection of claims 1-6, 9, 11-19, 22, 24, 26 and 29, the Applicant has amended the claims to overcome the bases of rejection. 

Rejection under 35 U.S.C. § 112(b)
Regarding the indefinite rejection of claims 1-6, 9, 11-19, 22, 24, 26 and 29, the Applicant has amended the claims to overcome the bases of rejection.

Rejection under 35 U.S.C. § 101
Regarding the rejection of claims 1-6, 9, 11-19, 22, 24, 26 and 29, the Examiner has considered the Applicant’s arguments, but does not find them persuasive. Applicant argues:  
Assuming arguendo, the claims contain an abstract idea (which Applicant does not concede), under Prong Two of the Revised Step 2A procedure requires the additional claim elements integrate the alleged abstract idea into a practical application, which renders the claims as a whole patent eligible… As cited in the MPEP, Classen Immunotherapies Inc. v. Biogen IDEC provides another example of claims that recited meaningful limitations. 659 F.3d 1057, 100 USPQ2d 1492 (Fed. Cir. 2011). the claims recited methods that gathered and analyzed the effects of particular immunization schedules on the later development of chronic immune- mediated disorders to identify a lower risk immunization schedule, and then immunized mammalian subjects in accordance with the identified lower risk schedule (thereby lowering the risk that the immunized subject would later develop chronic immune-mediated diseases). Similar to Classen, the current invention receives medical data, wherein the data is analyzed to determine a diagnosis… In particular, Applicant claims "an injection interface configured to graphically provide: regions on the patient to inject and/or receive the respiration medicament associated with the recommendation, regions on the patient comprising previous treatment sites, and a responsive confirmation of a treatment." Referring back to Classen, although the analysis step was an abstract mental process that collected and compared known information, the immunization step was meaningful because it integrated the results of the analysis into a specific and tangible method that resulted in the method "moving from abstract scientific principle to specific application." 659 F.3d at 1066-68. Similar to Classen, the disclosure provides a practical application wherein a treatment is provided. For example, another source of data may include a data connection to a smart-syringe. Such smart syringes are known in the art, and could be connected to the current system to confirm use of the biologic, time and date of use, quantity of drug, batch of drug, etc. per paragraph [0079]. Accordingly Applicant asserts there is patentable subject matter and requests the rejection to be removed.
Regarding 1, The Examiner would like to clarify that the claims were analyzed to falls within the “Certain Methods of Organizing Human Activity – Managing Personal Behavior Relationships, Interactions Between People (e.g. social activities, teaching, following rules or instructions)” grouping of abstract ideas, not a mental process grouping of abstract ideas. 
Moreover, the Examiner respectfully disagrees that the claims integrate the abstract idea into a practical application. The injection interface is analyzed as an additional element and does not provide a practical application as it graphically provides information (i.e., display data). Displaying data is an abstract idea and the additional element if an injection is recited at a high level of generality and amount to extra solution activity. MPEP 2106.04(d)(I) indicates that extra-solution data gathering activity cannot provide a practical application. Accordingly, even in combination, this additional element does not integrate the abstract idea into a practical application. Furthermore, graphically providing information is not the same as a smart syringe. 

Rejection under 35 U.S.C. § 102
Regarding the rejection of claims 1-6, 9, 11-19, 22, 24, 26 and 29, the Examiner has considered the Applicant’s arguments, but does not find them persuasive. Applicant argues:  
Without conceding the correctness of the rejection, independent claim 1, as amended, recites: providing a notification of recommendation of the enhanced treatment if the patient is over the first threshold level and the second threshold level, and an injection interface configured to graphically provide: regions on the patient to inject and/or receive the respiration medicament associated with the recommendation, and regions on the patient comprising previous treatment sites. Amended Claims 14 and 29 each include a similar recitation. For at least the reasons discussed during the above-referenced interview with the Examiner, the applied references, whether alone or in combination, in view of what was known to those of ordinary skill in the art at the time the invention was made, do not teach or suggest at least the above-referenced limitations of the amended independent claims, which are believed to be in condition for allowance..
Regarding 1, The Examiner has cited new art to teach the newly amended limitation. Given the broadest reasonable interpretation the cited references in combination teach the claimed features. 
Conclusion
Applicant’s amendment necessitated the new grounds of rejection presented in this Office action. 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.
The prior art made of record though not relied upon in the present basis of rejection are noted in the attached PTO 892 and include: 
Barrett (US 2019/0102522) teaches pre-emptive asthma risk notification based on medicament device monitoring. 
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LIZA TONY KANAAN whose telephone number is (571)272-4664. The examiner can normally be reached on Mon-Thu 9:00am-6:00pm ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. 
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Morgan can be reached on 571-272-6773. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from the Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docs for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. 

/L.T.K./Examiner, Art Unit 3683                                                                                                                                                                                                        
/ROBERT W MORGAN/Supervisory Patent Examiner, Art Unit 3683                                                                                                                                                                                                        

  


    
        
            
        
            
        
            
    


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