DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim 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 30-49 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., an abstract idea) without significantly more.
Step 1 of the Alice/Mayo Test
Claims 30-45 are drawn to a non-transitory computer-readable storage media, which is within the four statutory categories (i.e. manufacture). Claims 46-47 are drawn to a method, which is within the four statutory categories (i.e. process). Claims 48-49 are drawn to a user device, which is within the four statutory categories (i.e. apparatus).
Step 2A of the Alice/Mayo Test - Prong One
The independent claims recite an abstract idea. For example, claim 30 (and substantially similar with independent claim 46, 48) recites:
One or more non-transitory computer-readable storage media storing instructions that, when executed by a computer, cause the computer to:
execute a program for tracking a medical condition of a user;
obtain environmental information or user specific health information, wherein the obtained environmental information or user-specific health information is indicative of a possible exacerbation of the medical condition of the user;
determine that a trigger condition is met based on the obtained environmental information or user specific health information; and
in response to determining that the trigger condition is met, generate a notification to be displayed on a user device prompting the user to input data into a medical journal within the program.
These underlined elements recite an abstract idea that can be categorized, under its broadest reasonable interpretation, to cover the management of personal behavior or interactions (i.e., following rules or instructions), but for the recitation of generic computer components. For example, but for the non-transitory computer-readable storage media, computer, user device, processors, the limitations in the context of this claim encompass following rules or instructions to track a user’s medical condition and report condition triggers. If a claim limitation, under its broadest reasonable interpretation, covers management of personal behavior or interactions but for the recitation of generic computer components, then the limitations fall within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. See MPEP § 2106.04(a).
Dependent claims recite additional subject matter which further narrows or defines the abstract idea embodied in the claims (such as claims 31-45, 47, 49 reciting particular aspects of the abstract idea).
Step 2A of the Alice/Mayo Test - Prong Two
For example, claim 30 (and substantially similar with independent claim 46, 48) recites:
One or more non-transitory computer-readable storage media storing instructions that, when executed by a computer, cause the computer to: (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f))
execute a program for tracking a medical condition of a user;
obtain environmental information or user specific health information, wherein the obtained environmental information or user-specific health information is indicative of a possible exacerbation of the medical condition of the user;
determine that a trigger condition is met based on the obtained environmental information or user specific health information; and
in response to determining that the trigger condition is met, generate a notification to be displayed on a user device(merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f)) and (merely insignificant extrasolution activity steps as noted below, see MPEP 2106.05(g)) prompting the user to input data into a medical journal within the program.
The judicial exception is not integrated into a practical application. In particular, the additional elements do not integrate the abstract idea into a practical application, other than the abstract idea per se, because the additional elements amount to no more than limitations, which:
amount to mere instructions to apply an exception (such as recitations of the non-transitory computer-readable storage media, computer, user device, processors, thereby invoking computers as a tool to perform the abstract idea, see applicant’s specification pgs. 1-2, 5, 22-23, see MPEP 2106.05(f))
add insignificant extra-solution activity to the abstract idea (such as recitation of displaying a notification on a user’s device amounts to insignificant extrasolution activity, see MPEP 2106.05(g))
Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims (such as claims 31-45, 47, 49 recite additional limitations which amount to invoking computers as a tool to perform the abstract idea, and claims 31-45, 47, 49 additional limitations which generally link the abstract idea to a particular technological environment or field of use). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation and do not impose a meaningful limit to integrate the abstract idea into a practical application.
Step 2B of the Alice/Mayo Test for Claims
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 discussion of integration of the abstract idea into a practical application, the additional elements amount to no more than mere instructions to apply an exception and add insignificant extra-solution activity to the abstract idea. Additionally, the additional elements, other than the abstract idea per se, amount to no more than elements which:
amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields (such as using the non-transitory computer-readable storage media, computer, user device, processors, e.g., Applicant’s spec describes the computer system with it being well-understood, routine, and conventional because it describes in a manner that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such elements to satisfy 112a. (See Applicant’s Spec. pgs. 1-2, 5, 22-23); using the non-transitory computer-readable storage media, computer, user device, processors, e.g., merely adding a generic computer, generic computer components, or a programmed computer to perform generic computer functions, Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 134 S. Ct. 2347, 2358-59, 110 USPQ2d 1976, 1983-84 (2014).
adding insignificant extrasolution activity to the abstract idea, for example mere data gathering, selecting a particular data source or type of data to be manipulated, and/or insignificant application. The following represent examples that courts have identified as insignificant extrasolution activities (e.g. see MPEP 2106.05(g)): displaying a notification on a user’s device, e.g., outputting or providing access to the information, MPEP 2106.05(g)(3).
Dependent claims recite additional subject matter which, as discussed above with respect to integration of the abstract idea into a practical application, amount to invoking computers as a tool to perform the abstract idea and are generally linking the abstract idea to a particular field of environment. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation. Therefore, the claims are not patent eligible, and are rejected under 35 U.S.C. § 101.
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.
Claim 30-49 are rejected under 35 U.S.C. 103 as being unpatentable over Zikria (US 2022/0218290) in view of Shouldice (WO 2017/032873).
Regarding claim 30, Zikria discloses one or more non-transitory computer-readable storage media storing instructions that, when executed by a computer, cause the computer to:
execute a program for tracking a medical condition of a user; (Zikria [0018] FIG. 3A-D illustrate example implementations of the system configured to provide asthma-related information of subjects based on environmental conditions and/or subject condition information, in accordance with one or more implementations.
obtain environmental information or user specific health information, wherein the obtained environmental information or user-specific health information is indicative of a possible exacerbation of the medical condition of the user; (Zikria [0053] FIG. 3B illustrates GUI 300b on smartphone 50, the same as smartphone 50 in FIG. 3A. GUI 300b may present the environmental conditions obtained including values to pollen, dust and dander, weather, and air quality index at the physical location (e.g., zip code 90210) of subject 301 (same as FIG. 3A) [0054] FIG. 3C illustrates GUI 300c on smartphone 50, the same as smartphone 50 in FIG. 3A-B. GUI 300c may present the subject condition information of subject 301. The subject condition information, as described in FIG. 1A-B, may include information related to asthma and general health of the subject. GUI 300c may include results 304a to a remote FeNO test, results 304b to a remote spirometry test, and results 304c to a remote peak flow test that the subject conducted themselves.)
determine that a trigger condition is met based on the obtained environmental information or user specific health information; and (Zikria [0040] In some implementations, notification providing component 120 may be configured to determine increases or otherwise changes in the environmental conditions. The changes (e.g., increases) in the environmental conditions may indicate asthma triggers of the subject. Asthma triggers may cause activation of asthma symptoms or flare-ups of the subject. By way of non-limiting example, the changes to the environmental conditions may include increases in the pollen levels, the elevation, the mold, the dust and dander, the air quality index, and/or other environmental conditions reaching particular values indicative of the asthma triggers. In some implementations, to indicate the asthma triggers, the changes in the environmental conditions may including all the environmental conditions reaching specific threshold values for the respective environmental condition, all the environmental conditions reaching specific threshold values for the respective environmental condition within a particular amount of time [0041] Responsive to changes in the environmental conditions, notification providing component 120 may be configured to generate notifications. A notification may include the changes in the environmental conditions determined. For example, the notification may be generated responsive to the value of the tree pollen increasing to 18 past a threshold value of 15 and include information related to the increase past the threshold value of 15)
in response to determining that the trigger condition is met, generate a notification to be displayed on a user device (Zikria [0039] In some implementations, subject condition component 112 may be configured to obtain new results of the FeNO test, the remote spirometry test, the remote peak flow test, the digital inhaler, the physician-administered FeNO test, the physician-administered spirometry test, and the physician-administered peak flow test, and/or other remote diagnostic information, and/or other physician-supervised diagnostic information. The new results may refer to most recently obtained/measured results. In some implementations, subject condition component 112 may be configured to update the remote diagnostic information and physician-supervised diagnostic information with the respective new results. Updating the remote diagnostic information and physician-supervised diagnostic information may include adding the new results, replacing the results with the respective new results, and/or other updates. Thus, the remote diagnostic information and physician-supervised diagnostic information conveyed by the graphical user interface may include their results and the respective new results. [0041] Responsive to changes in the environmental conditions, notification providing component 120 may be configured to generate notifications. A notification may include the changes in the environmental conditions determined. For example, the notification may be generated responsive to the value of the tree pollen increasing to 18 past a threshold value of 15 and include information related to the increase past the threshold value of 15)
Zikria does not appear to explicitly teach the following however Shouldice teaches it is old and well known in the art of healthcare data processing to:
prompting the user to input data into a medical journal within the program (Shouldice [134] The portable device may also include an output interface 316 (e.g., a display, vibrator, speaker, LED or other light, etc.) capable of providing information and instructions to the user, and an input interface 318 (e.g., keyboard, buttons, microphone, infra-red scanner, accelerometer, etc.) capable of receiving data and commands from the user. As in the example system of FIG. 2, the portable device 310 of FIG. 3, may, for example, be a smart-device, such as a smart-phone or smart-watch. [152] Other environmental data (e.g., information relating to air particulates and pollen counts) may similarly be estimated or gauged based on subjective input of a user).
Therefore, it would have been obvious to one of ordinary skill in the art of healthcare data processing, before the effective filing date of the claimed invention, to modify Zikria, to incorporate prompting the user to input data into a medical journal within the program, as taught by Shouldice, to gather data from the user at any given time and monitor conditions remotely. See Shouldice [28]-[29].
Regarding claim 31, Zikria-Shouldice teaches the one or more non-transitory computer-readable storage media of claim 30, and Shouldice further teaches wherein the program is configured to track a plurality of different medical conditions of the user. (Shouldice [80] The methods, systems, devices and apparatus described herein can provide improved functioning in a processor, such as of a processor of a specific purpose computer when implemented with one or more functions of the disclosed algorithm(s), and/or in monitoring devices for a respiratory and/or a cardiac monitoring apparatus, such as for monitoring a chronic respiratory and/or cardiac condition (e.g. cardio-pulmonary condition)… for example, asthma, chronic obstructive pulmonary disease (COPD) and/or congestive heart failure (CHF), so that potentially problematic or dangerous respiratory or cardiac related events may be discovered and/or treated more readily). The motivation to combine the references is discussed above and incorporated herein.
Regarding claim 32, Zikria-Shouldice teaches the one or more non-transitory computer-readable storage media of claim 30, and Shouldice further teaches wherein the computer is part of the user device and wherein the instructions are further configured to cause the computer to perform at least one of the following: obtaining the environmental information using one or more first sensors forming part of the user device; obtaining the environmental information from a weather application running on the user device; obtaining the user specific health information from one or more second sensors of the user device; or displaying the generated notification on the user device as a push notification to a locked screen of the user device. (Shouldice [149] In some cases, environmental data may also be accessed without a network (such as if the device 201 has a built-in thermometer). The motivation to combine the references is discussed above and incorporated herein.
Regarding claim 33, Zikria-Shouldice teaches the one or more non-transitory computer-readable storage media of claim 32, and Shouldice further teaches wherein the one or more first sensors comprise one or more of a thermometer, a barometer, or a hygrometer. (Shouldice [149] In some cases, environmental data may also be accessed without a network (such as if the device 201 has a built-in thermometer). The motivation to combine the references is discussed above and incorporated herein.
Regarding claim 34, Zikria-Shouldice teaches the one or more non-transitory computer-readable storage media of claim 30, and Zikria further teaches wherein the environmental information comprises one or more of: a temperature; a humidity; an air pressure; a pollen count; a pollution index; an NO2 count; an air quality index; a UV index; a weather condition; or a weather prediction. (Zikria [0053] FIG. 3B illustrates GUI 300b on smartphone 50, the same as smartphone 50 in FIG. 3A. GUI 300b may present the environmental conditions obtained including values to pollen, dust and dander, weather, and air quality index at the physical location (e.g., zip code 90210) of subject 301 (same as FIG. 3A)).
Regarding claim 35, Zikria-Shouldice teaches the one or more non-transitory computer-readable storage media of claim 30, and Zikria further teaches wherein the trigger condition comprises one or more of: an upper temperature threshold; a lower temperature threshold; an upper humidity threshold; an upper pollen count threshold; an upper NO2 count threshold; a threshold air quality index score; or one or more sets of predefined weather conditions. (Zikria [0040] In some implementations, notification providing component 120 may be configured to determine increases or otherwise changes in the environmental conditions. The changes (e.g., increases) in the environmental conditions may indicate asthma triggers of the subject. Asthma triggers may cause activation of asthma symptoms or flare-ups of the subject. By way of non-limiting example, the changes to the environmental conditions may include increases in the pollen levels, the elevation, the mold, the dust and dander, the air quality index, and/or other environmental conditions reaching particular values indicative of the asthma triggers. In some implementations, to indicate the asthma triggers, the changes in the environmental conditions may including all the environmental conditions reaching specific threshold values for the respective environmental condition, all the environmental conditions reaching specific threshold values for the respective environmental condition within a particular amount of time).
Regarding claim 36, Zikria-Shouldice teaches the one or more non-transitory computer-readable storage media of claim 32, and Shouldice further teaches wherein the one or more second sensors comprise an optical sensor. (Shouldice [73] contactless sensing can be performed from the case using active RF methods (e.g., an RF chip module), or via the phone's inbuilt sensors/transducers; e.g., heart rate measurement using an optical sensor, sonar using the phone's loudspeaker and microphone, a custom microphone/speaker assembly in the smart case, etc.). The motivation to combine the references is discussed above and incorporated herein.
Regarding claim 37, Zikria-Shouldice teaches the one or more non-transitory computer-readable storage media of claim 30, and Zikria further teaches wherein the instructions are further configured to cause the computer to obtain the user specific health information from one or more external devices. (Zikria [0054] FIG. 3C illustrates GUI 300c on smartphone 50, the same as smartphone 50 in FIG. 3A-B. GUI 300c may present the subject condition information of subject 301. The subject condition information, as described in FIG. 1A-B, may include information related to asthma and general health of the subject. GUI 300c may include results 304a to a remote FeNO test, results 304b to a remote spirometry test, and results 304c to a remote peak flow test that the subject conducted themselves. [0033] Some of the subject health information may be obtained from one or more wearable devices worn by the subject. For example, the wearable devices may include an orientation sensor, a location sensor, a pressure sensor, a temperature sensor, a light sensor, an audio sensor, cardiovascular sensors, and/or other sensors).
Regarding claim 38, Zikria-Shouldice teaches the one or more non-transitory computer-readable storage media of claim 37, and Zikria further teaches wherein the one or more external devices comprises a wearable device selected from a list of devices comprising a smart watch, a step meter, a glucose meter, and a pulse oximeter. (Zikria [0033] Some of the subject health information may be obtained from one or more wearable devices worn by the subject. For example, the wearable devices may include an orientation sensor…).
Regarding claim 39, Zikria-Shouldice teaches the one or more non-transitory computer-readable storage media of claim 30, and Zikria further teaches wherein the user specific health information comprises one or more of: a heart rate, a breathing rate, a temperature, a blood pressure, a blood oxygen level, a number of steps taken in a specific time period, an amount of sleep, or a sleep pattern. (Zikria [0032] The subject health information may include values for one or more of cardiovascular parameters, sleep parameters, activity parameters, diet parameters, and/or other parameters [0033] By way of non-limiting example, the cardiovascular parameters may include a heart rate, a resting heart rate of the subject, a respiratory rate of the subject, blood pressure of the subject, oxygen saturation of the subject, heart variability, heartbeat strength, heartbeat rhythm, and/or other cardiovascular parameters).
Regarding claim 40, Zikria-Shouldice teaches the one or more non-transitory computer-readable storage media of claim 39, and Shouldice further teaches wherein the trigger condition comprises one or more of: an upper and/or lower threshold for a heartrate, an upper/lower threshold for a blood pressure, a lower threshold for a blood oxygen level, an upper/lower temperature threshold, an upper/lower breathing rate threshold, a lower threshold for a number of steps taken in a specific time period, or a deviation from an established or predefined sleep pattern. (Shouldice [49] The method may include, in the processor, tracking a baseline threshold of the first physiological parameter. [75] The apparatus may include a sensor configured to derive at least one parameter from a physiological characteristic of the user. The apparatus may include a processor for predicting the status of the chronic respiratory and/or cardiac condition based on at the at least one derived parameter. The apparatus may include a user interface for alerting the user concerning the chronic respiratory and/or cardiac condition based on the predicted status of the chronic respiratory condition. [78] derived one or more physiological parameters and the environmental signals may include varying rule thresholds based on adaptive probabilistic weightings from one or both of user specific and population based demographic data. Optionally, at least one of the derived one or more physiological parameters may be one of breathing rate, heart rate, blood pressure, cough signature, wheeze, snore, sleep disordered breathing, Cheyne- Stokes Respiration, sleep condition and electrodermal response). The motivation to combine the references is discussed above and incorporated herein.
Regarding claim 41, Zikria-Shouldice teaches the one or more non-transitory computer-readable storage media of claim 30, and Zikria further teaches wherein the user specific health information comprises one or more of: calorie intake, fat intake, or salt intake. (Zikria [0033] By way of non-limiting example, diet parameters may include caloric intake, weight, weight goal, height, body mass index (BMI), various vitamin intake, food restrictions, food intake, liquid intake, substance intake, and/or other diet parameters).
Regarding claim 42, Zikria-Shouldice teaches the one or more non-transitory computer-readable storage media of claim 30, and Zikria further teaches wherein the generated notification provides a warning about the environmental information or the user specific health information that triggered the generation of the notification. (Zikria [0041] Responsive to changes in the environmental conditions, notification providing component 120 may be configured to generate notifications. A notification may include the changes in the environmental conditions determined).
Regarding claim 43, Zikria-Shouldice teaches the one or more non-transitory computer-readable storage media of claim 30, and Shouldice further teaches wherein the instructions are further configured to cause the computer to create a journal entry within the program comprising information regarding symptoms of the user's medical condition reported by the user. (Shouldice [134] The portable device may also include an output interface 316 (e.g., a display, vibrator, speaker, LED or other light, etc.) capable of providing information and instructions to the user, and an input interface 318 (e.g., keyboard, buttons, microphone, infra-red scanner, accelerometer, etc.) capable of receiving data and commands from the user. As in the example system of FIG. 2, the portable device 310 of FIG. 3, may, for example, be a smart-device, such as a smart-phone or smart-watch. [152] Other environmental data (e.g., information relating to air particulates and pollen counts) may similarly be estimated or gauged based on subjective input of a user). The motivation to combine the references is discussed above and incorporated herein.
Regarding claim 44, Zikria-Shouldice teaches the one or more non-transitory computer-readable storage media of claim 43, and Zikria further teaches wherein the information regarding symptoms of the user's medical condition comprises information regarding symptoms of a plurality of different medical conditions. (Zikria [0054] FIG. 3C illustrates GUI 300c on smartphone 50, the same as smartphone 50 in FIG. 3A-B. GUI 300c may present the subject condition information of subject 301. The subject condition information, as described in FIG. 1A-B, may include information related to asthma and general health of the subject {where asthma and general health is construed to read on symptoms of a plurality of different medical conditions}).
Regarding claim 45, Zikria-Shouldice teaches the one or more non-transitory computer-readable storage media of claim 43, and Zikria further teaches wherein the instructions are further configured to cause the computer to:
compare the information regarding symptoms of the user's medical condition reported by the user with contemporary environmental information or user specific health information to identify one or more correlations; (Zikria [0042] In some implementations, subject condition component 112 may be configured to determine correlations between at least the subject condition information and the environmental conditions and/or between other information related to the subject and their asthma)
based on the identified one or more correlations, identify that current environmental information or user specific health information is indicative of a risk factor for the user's medical condition; and (Zikria [0042] The determination of negative correlations may be made in cases where values of low humidity (i.e., very dry conditions) cause a high result to the remote FeNO test indicative of extreme lung inflammation)
in response, generate a notification to be displayed on the user device to alert the user to the current environmental information or user specific health information and/or to the risk factor. (Zikria [0042]The determined correlations may be conveyed to the subject via the graphical user interface).
Regarding claim 46, the claim recites substantially similar limitations as those recited in the rejection of claim 30, and, as such, is rejected for similar reasons as give above.
Regarding claim 47, the claim recites substantially similar limitations as those recited in the rejection of claim 32, and, as such, is rejected for similar reasons as give above.
Regarding claim 48, the claim recites substantially similar limitations as those recited in the rejection of claim 30, and, as such, is rejected for similar reasons as give above.
Regarding claim 49, the claim recites substantially similar limitations as those recited in the rejection of claim 32, and, as such, is rejected for similar reasons as give above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Dias et al. (US 2018/0060494) is pertinent for teaching monitoring patients with chronic illnesses and considering exogeneous information, such as, information from a patient’s environment conditions.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMANDA R COVINGTON whose telephone number is (303)297-4604. The examiner can normally be reached Monday - Friday, 10 - 5 MT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jason B. Dunham can be reached at (571) 272-8109. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMANDA R. COVINGTON/Examiner, Art Unit 3686
/RACHELLE L REICHERT/Primary Examiner, Art Unit 3686
