DETAILED ACTION
Notice to Applicant
This communication is in response to the amendment submitted May 8, 2026. The present application claims priority to European Application No. 22188148.5, filed on August 1, 2022. Claims 1, 3, 8, 11, and 15 are amended. Claims 1 – 20 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 .
Claim Objections
Claim 3 is objected to because of the following informalities: Claim 3 is identified as “Currently Amended”, however, the claim is “Original”. Each amendment document that includes a change to an existing claim, including the deletion of an existing claim, or submission of a new claim, must include a complete listing of all claims ever presented (including previously canceled and non-entered claims) in the application. After each claim number, the status identifier of the claim must be presented in a parenthetical expression, and the text of each claim under examination as well as all withdrawn claims (each with markings if any, to show current changes) must be presented. The listing will serve to replace all prior versions of the claims in the application. Status is indicated in a parenthetical expression following the claim number by one of the following status identifiers: (original), (currently amended), (previously presented), (canceled), (withdrawn), (new), or (not entered). The status identifier (withdrawn – currently amended) is also acceptable for a withdrawn claim that is being currently amended. See paragraph (E) below for acceptable alternative status identifiers. Claims added by a preliminary amendment must have the status identifier (new) instead of (original), even when the preliminary amendment is present on the filing date of the application and such claim is treated as part of the original disclosure. If applicant files a subsequent amendment, applicant must use the status identifier (previously presented) if the claims are not being amended, or (currently amended) if the claims are being amended, in the subsequent amendment. Claims that are canceled by a preliminary amendment that is present on the filing date of the application are required to be listed and must have the status identifier (canceled) in the preliminary amendment and in any subsequent amendment. Appropriate correction is required.
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 – 20 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.
Step One
Claims 1 – 20 are drawn to a method, system, device, and computer-readable medium, which is/are statutory categories of invention (Step 1: YES).
Step 2A Prong One
Independent claim 1 recites monitoring spray delivery of drug-containing liquid for remedying a discomfort, the method comprising: a) the first input data comprising a number of delivered puffs as detected by a counter of a spray device during an intake period, b) user state data representative of self-reported perceived discomfort level and/or self-reported perceived side effect severity during the intake period, the user state data being obtained from a user input, c) determining, based at least on the first input data and the second input data, a suggested number of delivered puffs for an upcoming intake period, wherein the determining comprises comparing the self-reported perceived discomfort level to a baseline discomfort level provided by the user prior to the intake period, and determining whether to increase or decrease the suggested number of delivered puffs relative to the number of delivered puffs detected during the intake period based on the comparison and the self- reported perceived side effect severity and d) outputting user instructions indicating the suggested number of delivered puffs.
The recited limitations, as drafted, under their broadest reasonable interpretation, cover certain methods of organizing human activity, as reflected in the specification, which states a “method for monitoring spray delivery, and optionally puff sequences, of drug-containing liquid for remedying a discomfort” (paragraph 8 of the published specification). If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or relationships or interactions between people, then it falls within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas by providing to the patient instructions indicating the suggested number of “puffs” needed to ease discomfort. The present claims cover certain methods of organizing human activity because they address a need for monitoring spray delivery of drug containing liquids, which is dependent on the proper handling of the user of the spray device (paragraph 3 of the published specification). Accordingly, the claims recite an abstract idea(s) (Step 2A Prong One: YES).”
Step 2A Prong Two
This judicial exception is not integrated into a practical application. The claims are abstract but for the inclusion of the additional elements including:
Claim 1: “computer implemented method”, “computing system”, “sensor”, “receiving first input data”, “receiving second input data”, “user interface”
Claim 6: “automatic or semi-automatically”
Claim 7: “transmitting”
Claim 8: “computing system”, “wired or wireless data connection”
Claim 9: “computing system”
Claim 10: “data processing system”, “a computing system configured to communicate with a spray device data processing device via a data connection”
Claim 11: “spray device”, “data processing device”
Claim 12: “spray device”
Claim 13: “monitoring system”, “spray device”, “computing system”
Claim 15: “non-transitory computer-readable medium, having stored thereon instructions which, when executed by a computer, cause the computer to carry out and/or control the steps of the method”
Claim 20: “spray device”, “computing system”
These features are additional elements that are recited at a high level of generality such that they amount to no more than mere instruction to apply the exception using generic computer components. See: MPEP 2106.05(f).
The additional elements are merely incidental or token additions to the claim that do not alter or affect how the process steps or functions in the abstract idea are performed. Therefore, the claimed additional elements do not add meaningful limitations to the indicated claims beyond a general linking to a technological environment. See: MPEP 2106.05(h).
The combination of these additional elements is no more than mere instructions to apply the exception using generic computer components. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea.
Hence, the additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Accordingly, the claims are directed to an abstract idea (Step 2A Prong Two: NO).
Step 2B
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, using the additional elements to perform the abstract idea amounts to no more than mere instructions to apply the exception using generic components. Mere instructions to apply an exception using a generic components cannot provide an inventive concept. See MPEP 2106.05(f).
Further, the claimed additional elements, identified above, are not sufficient to amount to significantly more than the judicial exception because they are generic components that are not integrated into the claim because they are merely incidental or token additions to the claim that do not alter or affect how the process steps or functions in the abstract idea are performed. Therefore, the claimed additional elements do not add meaningful limitations to the indicated claims beyond a general linking to a technological environment. See: MPEP 2106.05(h).
Further, the claimed additional elements, identified above, are not sufficient to amount to significantly more than the judicial exception because they are generic components that are configured to perform well-understood, routine, and conventional activities previously known to the industry. See: MPEP 2106.05(d). Said additional elements are recited at a high level of generality and provide conventional functions that do not add meaningful limits to practicing the abstract idea. The published specification supports this conclusion as follows:
[0078] The present disclosure also provides a computer program comprising instructions which, when the program is executed by a computer, cause the computer to carry out and/or control the steps of any of the methods of the present disclosure.
[0079] The present disclosure also provides a computer readable medium having stored thereon instructions which, when executed by a computer, cause the computer to carry out and/or control the steps of any of the methods of the present disclosure.
Viewing the limitations as an ordered combination, the claims simply instruct the additional elements to implement the concept described above in the identification of abstract idea with routine, conventional activity specified at a high level of generality in a particular technological environment.
Hence, the claims as a whole, considering the additional elements individually and as an ordered combination, do not amount to significantly more than the abstract idea (Step 2B: NO).
Dependent claim(s) 2 – 20 when analyzed as a whole, considering the additional elements individually and/or as an ordered combination, are held to be patent ineligible under 35 U.S.C. 101 because the additional recited limitation(s) fail(s) to establish that the claim(s) is/are not directed to an abstract idea without significantly more. These claims fail to remedy the deficiencies of their parent claims above, and are therefore rejected for at least the same rationale as applied to their parent claims above, and incorporated herein.
The rejection of Claim 15 under 35 U.S.C. 101 for being directed to non-statutory subject matter is withdrawn based upon the amendment submitted May 8, 2026.
Claim Rejections - 35 USC § 102
The rejection of Claim(s) 1 – 10, 16 – 17, and 19 under 35 U.S.C. 102(a)(1) as being anticipated by Davidson et al., herein after Davidson (U.S. Publication Number 2019/0015382 A1) are withdrawn based upon the amendment submitted May 8, 2026.
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.
Claim(s) 1 – 11, 16 – 17, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Davidson et al., herein after Davidson (U.S. Publication Number 2019/0015382 A1) in view of Deaton et al., herein after Deaton (WO 2005/009325 A2).
Claim 1 (Currently Amended). Davidson teaches a computer-implemented method for monitoring spray delivery of drug-containing liquid for remedying a discomfort (Figures 1 and 2; paragraph 51 discloses the pharmaceutically active agent can be in a solid or a liquid form, and further noted that the agent is contained in a solid form of a substance; paragraph 136 discloses a symptom includes a form of discomfort (for example pain or nausea)), the method comprising:
a) receiving at a computing device first input data, the first input data (paragraphs 321 and 322 discloses a physician interface and a patient interface which comprise a controller, memory, and/or communication module configured on a computer device; paragraph 328 discloses data from various interactions between patients and the MDI device is collected in the central database, continuously learning individual usage patterns of patients and recommending dose and/or regimen; paragraph 415 discloses a "single delivery event" refers to an event over which a single low dose is delivered to the patient through inhalation; paragraph 418 discloses a number of inhalations takes place within 5-30 minutes or within under 15 minutes or even within under 5-10 minutes; paragraph 424 discloses no more than 8 delivery events, 6 delivery events, 4 delivery events or intermediate, or lower number of delivery events are provided over a day, wherein in each event 2 mg THC or less are delivered to the patient),
b) receiving second input data comprising user state data representative of self-reported perceived discomfort level and/or self-reported perceived side effect severity during the intake period, the user state data being obtained from a user input via a user interface of an application executed on a computer system (Figure 2; paragraph 134 discloses a "personally perceived therapeutic effect" which is a subjective assessment of a patient pertaining to a beneficial (desired) effect of a given agent in the patient's body; paragraph 135 discloses the patient may perceive a change in the perceived level of the symptom, and when the symptom of the medical condition is alleviated, the person perceives this change as a therapeutic effect of agent delivered during the treatment; paragraphs 321 and 322 discloses a physician interface and a patient interface which comprise a controller, memory, and/or communication module configured on a computer device; paragraph 379 discloses questions to the patient relating their current state are displayed on a screen, and the patient answers the questions, where the question may be presented in the form of a bar indicating a pain level, for example, which the patient raises and/or lowers),
c) determining, based at least on the first input data and the second input data, a suggested number of delivered puffs for an upcoming intake period (Figure 2; paragraph 352 discloses once one or more personal PD (pharmacodynamic) effects are obtained, the dose and/or regimen may be modified accordingly. In some embodiments, the dose and/or regimen is modified, on one hand, to improve or otherwise change a condition of the patient based on the provided indication, and, on the other hand, to achieve a pre-selected pharmacodynamic profile, such as maintaining the patient within the therapeutic window-between a lower limit of a therapeutic effect that provides symptom relief, and a higher limit of an adverse effect in which the adverse effect level is still tolerable. In some embodiments, the MDI device can be configured such that when below a minimal therapeutic effect, input by the patient may increase the dose and/or adjust the regimen in frequency and/or in quantity; paragraph 328 discloses data from various interactions between patients and the MDI (metered dose inhaler) device is collected in the central database, continuously learning individual usage patterns of patients and recommending dose and/or regimen), wherein the determining comprises comparing the self-reported perceived discomfort level to a baseline discomfort level provided by the user prior to the intake period (paragraph 401 discloses one or more baseline values, which may indicate for example an improvement or a decline in wellbeing (e.g. as manifested by strength and/or pain that may affect the inhalation properties/patterns for the user) and/or concentration or attention; Figure 10 and paragraph 450 discloses the x-axis represents the time of day, and the y-axis represents an arbitrary scale for indicating symptom severity and level of psychoactivity. The scale represents, based on user reports, a grade of the symptoms and a grade of the psychoactive effects, for example compared to a baseline report collected from the patient before treatment), and
determining whether to increase or decrease the suggested number of delivered puffs relative to the number of delivered puffs detected during the intake period based on the comparison and the self- reported perceived side effect severity (paragraph 352 discloses the MDI device can be configured such that when below a minimal therapeutic effect, input by the patient may increase the dose and/or adjust the regimen in frequency and/or in quantity. Optionally, the dose and/or regimen is modified to obtain a level above a minimal therapeutic effect. Additionally or alternatively, the dose and/or regimen is modified as much as the maximal level of an adverse effect permits), and
d) outputting, via the user interface, user instructions indicating the suggested number of delivered puffs (paragraph 226 discloses a dose display meter for providing visual output of the vaporization of the pharmaceutically active agent; paragraph 326 discloses the patient interface and/or MDI device are configured to notify the patient every time a pulmonary delivery (an inhalation) is due).
Davidson fails to explicitly teach the following limitations met by Deaton as cited:
comprising a number of delivered puffs as detected by a counter of a spray device during an intake period (page 10, paragraph 3 discloses the counter operates in a three function mode (time elapsed since last dose, number of doses in last twenty-four (24) hours, and doses remaining). The third mode indicates the number of doses delivered in the preceding twenty-four hour period. Upon an initial depression of the canister, a continual clock twenty-four hour is started. The clock registers the number of times during the twenty-four hour period the canister has been depressed. the number of doses delivered over that time period is registered by the device and displayed for the user),
wherein the counter is configured to process sensor data indicative of movement of a trigger element of the spray device to detect each delivered puff (page 10, paragraph 3 discloses the counter operates in a three function mode (time elapsed since last dose, number of doses in last twenty-four (24) hours, and doses remaining). Upon an initial depression of the canister, a continual clock twenty-four hour is started. The clock registers the number of times during the twenty-four hour period the canister has been depressed. the number of doses delivered over that time period is registered by the device and displayed for the user).
It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to expand the method of Davidson to further include the electronic monitoring and counting of medication dosages, and in particular to a metered dose inhaler that includes an electronic counter module as disclosed by Deaton.
One of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to expand the method of Davidson in this way to provide information to the user regarding the dosage administration to reduce the possibility of overdosing (Deaton: page 3, paragraphs 1 and 2).
Claim 2 (Original). Davidson and Deaton teach the method of claim 1. Davidson teaches a method comprising repeating a) to d) for each of a plurality of intake periods (paragraph 380 discloses the dose and/or regimen is iteratively modified by the patient interface. Modifications may take place a plurality of times, for example during, between or after one or more pulmonary deliveries, and/or over a total treatment time period ( days, weeks, months, years) over which the patient is treated).
Claim 3 (Currently Amended). Davidson and Deaton teach the method of claim 1. Davidson teaches a method wherein the determining is further based on third input data, the third input data comprising a set of historical data comprising, for each of a plurality of intake periods, a sub-set of historical data comprising the first input data and the second input data associated with the intake period and optionally, the suggested number of puffs for the intake period (paragraph 386 discloses patient data also includes PK/PD data from one or more previous uses of an inhaler for the same active agent(s) and possibly also for the same indication and may also include providing patient data includes a correlation or set of correlations between a dose and the PK (pharmacokinetic) profile and/or PD profile of the patient over a period of time as recorded in one or more previous deliveries of the same one or more pharmaceutically active substances, which indicates historical use and recordation of the drug delivery); and/or wherein the determining is further based on fourth input data, the fourth input data representative of one or more dosage regimens.
Claim 4 (Original). Davidson and Deaton teach the method of claim 1. Davidson teaches a method wherein the first input data comprises, for each puff, a time stamp indicative of the time of delivery of the puff, and/or wherein the method comprises determining, for at least one of a plurality of intake periods, the number of delivered puffs during the intake period (paragraph 386 discloses providing patient data includes a correlation or set of correlations between a dose and the PK (pharmacokinetic) profile and/or PD profile of the patient over a period of time as recorded in one or more previous deliveries of the same one or more pharmaceutically active substances, which indicates historical use and recordation of the drug delivery).
Claim 5 (Original). Davidson and Deaton teach the method of claim 1. Davidson teaches a method comprising determining, based on a sequence and/or frequency of delivered puffs, and/or based on a totaled number of delivered puffs within a predetermined period of time, that there is an increased risk of misuse and/or abuse and transmitting data indicative of the increased risk to a third-party (paragraph 329 discloses the pre-determined vaporized amount (dose and/or regimen) is automatically modified by controller of the patient interface and/or by controller of the MDI device to compensate for inadequate settings or misuse of the MDI device, for example in a situation in which the patient does not use the MDI device when instructed to, and/or use the MDI device is carried out at a timing different than the preset regimen).
Claim 6 (Original). Davidson and Deaton teach the method of claim 3. Davidson teaches a method comprising automatically or semi-automatically creating and/or updating a dosage regimen based on at least one of the first input data, the second input data, the third input data, and the fourth input data (paragraph 380 discloses the dose and/or regimen is iteratively modified by the patient interface. Modifications may take place a plurality of times, for example during, between or after one or more pulmonary deliveries, and/or over a total treatment time period ( days, weeks, months, years) over which the patient is treated), and optionally based on an adherence score.
Claim 7 (Original). Davidson and Deaton teach the method of claim 3. Davidson teaches a method comprising transmitting reporting data to a third party, wherein the reporting data comprises at least one of the first input data, the second input data, the third input data, and the fourth input data (Figure 1; paragraph 225 discloses a communication interface for communicating to one or more external computers and/or systems and/or patient/physician interfaces; paragraph 317 discloses MDI device is configured to send output to one or both of the interfaces), and/or an adherence score, and/or data indicative of the increased risk of misuse and/or abuse.
Claim 8 (Currently Amended). Davidson and Deaton teach the method of claim 1. Davidson teaches a method wherein the first input data is received said computing system, from the spray device via a wired or wireless data connection (Figure 1; paragraph 214 discloses the MDI device is further configured for communication with a patient interface circuitry and be integrated in a system designed to allow PK/PD data acquisition and input, patient records' storage, automatic or manual calibration, adjustment, resetting and re-determination of the initial presetting of the device by the patient and/or by a practitioner; paragraph 318 discloses communication between the system components is performed via one or more data transfer means such as a USB connection, a cable connection, a wireless connection, and/or any suitable wired and/or wireless communication protocol; paragraph 324 discloses the display is an interactive display, for example a touch screen of a smartphone, a handheld device, a wearable device, a wrist device or an integrated eyewear device).
Claim 9 (Original). Davidson and Deaton teach the method of claim 1. Davidson teaches a method further comprising the counter of the spray device detecting the number of delivered puffs and the spray device transmitting the number of delivered puffs as detected by the counter to the computing system (paragraph 328 discloses Data from various interactions between patients and the MDI device is collected in the central database, continuously learning individual usage patterns of patients and recommending dose and/or regimen; paragraph 415 discloses a "single delivery event" refers to an event over which a single low dose is delivered to the patient through inhalation; paragraph 418 discloses a number of inhalations takes place within 5-30 minutes or within under 15 minutes or even within under 5-10 minutes; paragraph 424 discloses no more than 8 delivery events, 6 delivery events, 4 delivery events or intermediate, or lower number of delivery events are provided over a day, wherein in each event 2 mg THC or less are delivered to the patient).
Claim 10 (Original). Davidson and Deaton teach a data processing system, comprising:
a computing system configured to communicate with a spray device data processing device via a data connection (paragraph 214 discloses the MDI device is further configured for communication with a patient interface circuitry and be integrated in a system designed to allow PK/PD data acquisition and input, patient records' storage, automatic or manual calibration, adjustment, resetting and re-determination of the initial presetting of the device by the patient and/or by a practitioner; paragraph 318 discloses communication between the system components is performed via one or more data transfer means such as a USB connection, a cable connection, a wireless connection, and/or any suitable wired and/or wireless communication protocol, and optionally, the spray device data processing device),
wherein the data processing system is configured to carry out and/or control steps of the method according to claim 1 (refer to the rejection of claim 1 above).
Claim 11 (Currently Amended). Davidson and Deaton teach a spray device, configured for use in the method according to claim 1 (refer to the rejection of claim 1 above), the spray device comprising:
a spray device data processing device, the spray device data processing device configured to transmit the number of delivered puffs to a computing system external to the spray device (paragraph 214 discloses the MDI device is further configured for communication with a patient interface circuitry and be integrated in a system designed to allow PK/PD data acquisition and input, patient records' storage, automatic or manual calibration, adjustment, resetting and re-determination of the initial presetting of the device by the patient and/or by a practitioner; paragraph 318 discloses communication between the system components is performed via one or more data transfer means such as a USB connection, a cable connection, a wireless connection, and/or any suitable wired and/or wireless communication protocol, and optionally, the spray device data processing device).
Claim 16 (Original). Davidson and Deaton teach the method of claim 3. Davidson discloses wherein the method comprises creating and/or updating the set of historical data (paragraph 386 discloses patient data also includes PK/PD data from one or more previous uses of an inhaler for the same active agent(s) and possibly also for the same indication and may also include providing patient data includes a correlation or set of correlations between a dose and the PK (pharmacokinetic) profile and/or PD profile of the patient over a period of time as recorded in one or more previous deliveries of the same one or more pharmaceutically active substances, which indicates historical use and recordation of the drug delivery).
Claim 17 (Original). Davidson and Deaton teach the method of claim 3. Davidson discloses a method wherein the suggested number of delivered puffs is determined by selecting and optionally, adjusting, one of the one or more dosage regimens based on the first input data and the second input data, and optionally, the third input data (Figure 2; paragraph 352 discloses once one or more personal PD (pharmacodynamic) effects are obtained, the dose and/or regimen may be modified accordingly. In some embodiments, the dose and/or regimen is modified, on one hand, to improve or otherwise change a condition of the patient based on the provided indication, and, on the other hand, to achieve a pre-selected pharmacodynamic profile, such as maintaining the patient within the therapeutic window-between a lower limit of a therapeutic effect that provides symptom relief, and a higher limit of an adverse effect in which the adverse effect level is still tolerable. In some embodiments, the MDI device can be configured such that when below a minimal therapeutic effect, input by the patient may increase the dose and/or adjust the regimen in frequency and/or in quantity; paragraph 328 discloses data from various interactions between patients and the MDI (metered dose inhaler) device is collected in the central database, continuously learning individual usage patterns of patients and recommending dose and/or regimen).
Claim 19 (Original). Davidson and Deaton teach the method of claim 7. Davidson discloses a method wherein the method comprises reporting the data at predetermined times and/or predetermined intervals, and/or whenever a data connection is established (Figure 1; paragraph 225 discloses a communication interface for communicating to one or more external computers and/or systems and/or patient/physician interfaces; paragraph 317 discloses MDI device is configured to send output to one or both of the interfaces).
Claim(s) 12 – 15, 18, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Davidson et al., herein after Davidson (U.S. Publication Number 2019/0015382 A1) in view of Deaton et al., herein after Deaton (WO 2005/009325 A2) further in view of Shouldice (U.S. Publication Number 2020/0297955 A1).
Claim 12 (Original). Davidson and Deaton teach the spray device of claim 11.
Davidson and Deaton fail to explicitly teach the following limitations met by Shouldice as cited:
wherein the counter is configured such that each delivered puff is counted and/or such that only full puffs are counted (paragraph 104 discloses the treatment device is an inhaler or other portable therapy device, and the device may optionally pre-set an inhaler over the wireless interface based on detected patterns, as well as counting puffs (uses of the inhaler), and communicate such data to a remote system, e.g., via the network); and/or wherein the counter is configured to prevent incomplete delivery of a puff; and/or wherein the counter is configured to receive a bottle of liquid to be delivered as a puff.
It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to expand the method of Davidson and Deaton to further include a lifestyle management method for managing a chronic respiratory and/or cardiac condition of a user. The method may be implemented in a management device, including a processor, such that the device may be configured for communication with a physiological monitor, and the physiological monitor may be adapted to be carried by the user and operative to sense a physiological parameter of the user. as disclosed by Shouldice.
One of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to expand the method of Davidson and Deaton in this way to provide medical and/or lifestyle devices used in the diagnosis, amelioration, treatment, or prevention of respiratory disorders having one or more of improved comfort, cost, efficacy, ease of use and manufacturability (Shouldice: paragraph 45).
Claim 13 (Original). Davidson and Deaton teach a monitoring system, comprising the spray device of claim 11 (refer to the rejection of claim 11 above).
Davidson and Deaton fail to explicitly teach the following limitations met by Shouldice as cited:
a computing system external to the spray device, wherein the monitoring system is configured to carry out steps of the method (paragraph 266 discloses a remote external device is one or more computers, for example a cluster of networked computers).
The motivation to combine the teachings of Davidson, Deaton, and Shouldice is discussed in the rejection of claim 12, and incorporated herein.
Claim 14 (Original). Davidson and Deaton teach the method for monitoring spray delivery of a drug-containing liquid.
Davidson and Deaton fail to explicitly teach the following limitations met by Shouldice as cited:
the method comprising: delivering sprays with the spray device according to claim 11 (refer to the rejection of claim 11 above).
The motivation to combine the teachings of Davidson, Deaton, and Shouldice is discussed in the rejection of claim 12, and incorporated herein.
Claim 15 (Currently Amended). Davidson and Deaton teach instructions which, when executed by a computer, cause the computer to carry out and/or control the steps of the method of claim 1. Davidson teaches the method steps of claim 1 (see rejection of claim 1 above).
Davidson and Deaton fail to explicitly teach the following limitations met by Shouldice as cited:
A non-transitory computer readable medium (paragraph 244 discloses a non-transitory computer readable storage medium).
The motivation to combine the teachings of Davidson, Deaton, and Shouldice is discussed in the rejection of claim 12, and incorporated herein.
Claim 18 (Original). Davidson and Deaton teach the method of claim 4.
Davidson and Deaton fail to explicitly teach the following limitations met by Shouldice as cited:
wherein the method comprises determining an adherence score indicative of adherence to the dosage regimen, based on a difference between the actual number of delivered puffs and the suggested number of delivered puffs for the intake period (paragraph 52 discloses the determined treatment dosage may be one or more of: a number of puffs from an inhaler; and a quantity on a metered inhaler; paragraph 105 discloses a smart inhaler or smart drug delivery mechanism via a mask, it may also track user compliance, e.g., detecting the expected resistance to puff of a person correctly taking the dose on an inspiration, and may interface with the device to notify whether medication was taken correctly or incorrectly; paragraph 191 discloses treatment dosage may involve either of a number of puffs from the inhaler, or an amount of dosage on a metered inhaler).
The motivation to combine the teachings of Davidson, Deaton, and Shouldice is discussed in the rejection of claim 12, and incorporated herein.
Claim 20 (Original). Davidson, Deaton, and Shouldice teach the spray device of claim 12. Davidson teaches wherein the counter is configured to prevent unauthorized removal of the bottle from the counter, and comprises a locking ring configured to lock the bottle in place (paragraph 486 discloses the device is locked to prevent or reduce the hazard of unauthorized use, for example by a non-patient) and optionally configured such that a special tool is required to unlock the locking ring so as to release the bottle, and/or wherein the counter is configured to detect removal of the bottle from the counter and/or insertion of the bottle into the counter, and optionally, the spray device configured to transmit an indication and/or count of removal and/or insertion to the computing system.
Response to Arguments
Applicant's arguments filed May 8, 2026 have been fully considered but they are not persuasive. The Applicant’s arguments have been addressed in the order in which they were presented.
Claim Rejections under 35 USC § 101
The Applicant argues the claimed method is directed to a specific technical implementation, an improvement in the reliability and objectivity of drug delivery monitoring, rather than a mere method of organizing human activity. The Examiner disagrees. Under its broadest reasonable interpretation, the Applicant’s claims are an abstract idea that falls into the grouping of “Certain Methods of Organizing Human Activity” which covers fundamental economic principles or practices, commercial or legal interactions, or managing personal behavior or relationships or interactions between people. The Examiner respectfully submits that the PEG (Patent Eligibility Guidelines) of January 2019 recite that “Certain Methods of Organizing Human Activity” include managing personal behavior or relationships or interactions between people, including social activities, teaching, and following rules or instructions. The present claims recite the abstract idea of instructing a patient on the recommended number of puffs to deliver. The present claims recite monitoring spray delivery of drug-containing liquid for remedying a discomfort, the method comprising: a) the first input data comprising a number of delivered puffs as detected by a counter of a spray device during an intake period, b) user state data representative of self-reported perceived discomfort level and/or self-reported perceived side effect severity during the intake period, the user state data being obtained from a user input, c) determining, based at least on the first input data and the second input data, a suggested number of delivered puffs for an upcoming intake period, wherein the determining comprises comparing the self-reported perceived discomfort level to a baseline discomfort level provided by the user prior to the intake period, and determining whether to increase or decrease the suggested number of delivered puffs relative to the number of delivered puffs detected during the intake period based on the comparison and the self- reported perceived side effect severity and d) outputting user instructions indicating the suggested number of delivered puffs. These features describe interactions with people, thus “Certain Methods of Organizing Human Activity”. Thus, if a claim limitation, under its broadest reasonable interpretation, covers interactions with people, but for the recitation of generic components, then it is still in the “Certain Methods of Organizing Human Activity” grouping.
Claim Rejections under 35 USC § 102 and 35 USC § 103
The Applicant argues Davidson fails to disclose comparing the current self-reported discomfort level against a patient-specific baseline discomfort level provided by the user prior to the intake period, and then determining to increase or decrease puffs based on both that comparison and the self-reported side effect severity. The Examiner submits the limitation was not in the previously submitted claims, and has been addressed in the Office Action above.
Conclusion
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 KRISTINE K RAPILLO whose telephone number is (571)270-3325. The examiner can normally be reached Monday - Friday 7:30 - 4 pm.
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, Fonya Long can be reached at 571-270-5096. 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 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/docx 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.
/K.K.R/Examiner, Art Unit 3682 /ROBERT A SOREY/Primary Examiner, Art Unit 3682
Prosecution Insights