DETAILED ACTION
The present office action represents a nonfinal action on the merits.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on March 23, 2026 has been entered.
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 .
Priority
This application claims the priority date of provisional application 63/447,316 dated February 21, 2023.
Status of Claims
Claims 1, 3-4, 11, and 21-26 are amended and claims 1, 3-11, and 13-26 are 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, 3-11, and 13-26 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 and 3-10 are drawn to a method for analyzing objective health data and subject-conveyed health information for health information reporting, treatment planning, diagnoses, and treatment, which is within the four statutory categories (i.e., process). Claims 11 and 13-20 are drawn to a computing device for analyzing objective health data and subject-conveyed health information for health information reporting, treatment planning, diagnoses, and treatment, which is within the four statutory categories (i.e., machine). Claim 21 is drawn to a system for analyzing objective health data and subject-conveyed health information for health information reporting, treatment planning, diagnoses, and treatment, which is within the four statutory categories (i.e., machine). Claims 22-25 are drawn to a method for analyzing objective health data and subject-conveyed health information for health information reporting, treatment planning, diagnoses, and treatment, which is within the four statutory categories (i.e., process). Claim 26 is drawn to a computing device for analyzing objective health data and subject-conveyed health information for health information reporting, treatment planning, diagnoses, and treatment, which is within the four statutory categories (i.e., machine).
Claims 1 and 3-10 recite a method comprising:
at a computing device comprising a health data manager:
receiving a first set of information about a subject's health, wherein the first set of information was conveyed by the subject at a first time period;
using one or more physical sensors to acquire objective health data from a subject at a second time period after conveyance of the first set of information by the subject;
presenting, via a user interface, the acquired objective health data to the subject;
controlling receipt of, at a third time period subsequent to presentation of the acquired objective health data to the subject, a second set of information about the subject’s health, wherein the second set of information was conveyed by the subject;
analyzing the objective health data, the first set of information, and second the set of information to determine a discrepancy between the objective health data and at least one of the first set of information and the second set of information;
determining a treatment plan, diagnosis, and/or health information based on the discrepancy; and
presenting, via the user interface, the treatment plan, treatment, diagnosis, a therapeutic feedback intervention, and/or health information.
Claims 11 and 13-20 recite a computing device comprising:
one or more physical sensors configured to acquire objective health data from a subject:
a user interface; and
a health data manager configured to:
receive a first set of information about the subject's health, wherein the first set of information was conveyed by the subject at a first time period;
present, via the user interface, the acquired objective health data to the subject;
request, via the user interface, input from the subject about the subject's health;
control receipt of, at a third time period subsequent to presentation of the acquired objective health data to the subject, a second set of information about the subject’s health, wherein the second set of information was conveyed by the subject;
analyze the objective health data, the first set of information, and the second set of information to determine a discrepancy between the objective health data and at least one of the first set of information and the second set of information;
determine a treatment plan, diagnosis, and/or health information based on the discrepancy; and
present, via the user interface, the treatment plan, diagnosis, treatment, a therapeutic feedback intervention, and/or health information.
Claim 21 recites a system comprising:
one or more physical sensors configured to acquire objective health data from a subject; and
a computing device comprising:
a user interface; and
a health data manager configured to:
receive a first set of information about the subject's health, wherein the first set of information was conveyed by the subject at a first time period;
present, via the user interface, the acquired objective health data to the subject;
request, via the user interface, input from the subject about the subject's health;
control receipt of, at a third time period subsequent to presentation of the acquired objective health data to the subject, a second set of information about the subject’s health, wherein the second set of information was conveyed by the subject;
analyze the objective health data, the first set of information, and the second set of information to determine a discrepancy between the objective health data and at least one of the first set of information and the second set of information;
determine a treatment plan, diagnosis, and/or health information based on the discrepancy; and
present, via the user interface, the treatment plan, diagnosis, treatment, a therapeutic feedback intervention, and/or health information.
Claims 22-25 recite a method comprising:
at a computing device comprising a health data manager:
using one or more physical sensors to acquire objective health data from a subject;
receiving a first set of information about the subject's health, wherein the first set of information was conveyed by the subject at a first time period;
controlling receipt of, at a third time period subsequent to presentation of the acquired objective health data to the subject and via a user interface, input from the subject about the subject's health, wherein the acquired health data is not indicated in the request;
receiving, via the user interface, a set of information about the subject's health, wherein the set of information was conveyed by the subject;
controlling receipt of, at a third time period subsequent to presentation of the acquired objective health data to the subject, a second set of information about the subject's health, wherein the second set of information was conveyed by the subject;
analyzing a discrepancy between the objective health data and the set of information;
determining a treatment plan, diagnosis, and/or health information based on the discrepancy; and
presenting, via the user interface, the treatment plan, treatment, diagnosis, and/or health information.
Claim 26 recites a computing device comprising:
one or more physical sensors configured to acquire objective health data from a subject;
a user interface; and
a health data manager configured to:
receive a first set of information about the subject's health, wherein the first set of information was conveyed by the subject at a first time period;
controlling receipt of, at a third time period subsequent to presentation of the acquired objective health data to the subject and via the user interface, input from the subject about the subject's health, wherein the acquired health data is not indicated in the request;
receive, via the user interface, a set of information about the subject's health, wherein the set of information was conveyed by the subject;
control receipt of, at a third time period subsequent to presentation of the acquired objective health data to the subject, a second set of information about the subject's health, wherein the second set of information was conveyed by the subject;
analyze a discrepancy between the objective health data and the set of information;
determine a treatment plan, diagnosis, and/or health information based on the discrepancy; and
present, via the user interface, the treatment plan, treatment, diagnosis, and/or health information.
The bolded limitations, given the broadest reasonable interpretation, cover a certain method of organizing human activity, but for the recitation of generic computer components. The underlined limitations are not part of the identified abstract idea (the method of organizing human activity) and are deemed “additional elements,” and will be discussed in further detail below.
Dependent claims 3-10, 13-20, and 23-25 are similarly rejected because they either further define/narrow 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. These limitations only serve to further limit the abstract idea (or contain the same additional elements found in the independent claim), and hence are nonetheless directed towards fundamentally the same abstract idea as independent claims 1, 11, 21, 22, and 26.
The dependent claims contain additional limitations but these only serve to further limit the abstract idea, and hence are nonetheless directed towards fundamentally the same abstract idea as independent claims 1, 11, 21, 22, and 26.
The additional elements from claims 1, 11, 21, 22, and 26 include:
a computing device (apply it, MPEP 2106.05(f)).
a health data manager (apply it, MPEP 2106.05(f)).
a user interface (apply it, MPEP 2106.05(f)).
The additional elements from claims 21, 22, and 26 include:
one or more physical sensors (generally linking, MPEP 2106.05(h)).
The additional elements from claim 21 include:
a system (apply it, MPEP 2106.05(f)).
The dependent claims include other additional elements, including:
polysomnography equipment (generally linking, MPEP 2106.05(h)).
a wearable device (generally linking, MPEP 2106.05(h)).
an accelerometer (generally linking, MPEP 2106.05(h)).
a motion sensor (generally linking, MPEP 2106.05(h)).
These additional elements, in the independent claims are not integrated into a practical application because the additional elements (i.e., the limitations not identified as part of the abstract idea) amount to no more than limitations which:
Amount to mere instructions to apply an exception – for example, the recitation of “a computing device”, “a health data manager”, and “a user interface”, which amounts to merely invoking a computer as a tool to perform the abstract idea e.g., see Specification Paragraphs [0031] and [0034]-[0036] (See MPEP 2106.05(f)).
generally linking the use of the judicial exception to a particular technological environment or field of use, for example, the recitation of using sensors and wearable device, e.g., see Paragraphs [0032], [0034], [0041] of the Specification. A claim describing how the abstract idea of hedging could be used in the commodities and energy markets, as discussed in Bilski v. Kappos, 561 U.S. 593, 595, 95 USPQ2d 1001, 1010 (2010) or a claim limiting the use of a mathematical formula to the petrochemical and oil-refining fields, as discussed in Parker v. Flook, 437 U.S. 584, 588-90, 198 USPQ 193, 197-98 (1978) (MPEP 2106.05(h)).
Furthermore, the claims do not include additional elements that are sufficient to amount to “significantly more” than the judicial exception because, the additional elements (i.e., the elements other than the abstract idea) amount to no more than limitations which:
amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields, as demonstrated by:
The Specification discloses that the additional elements are well-understood, routine, and conventional in nature (i.e., the Specification Paragraphs [0031] and [0034]-[0036] disclose that the additional elements (i.e., a computing device, a health data manager, and a user interface) comprise a plurality of different types of generic computing systems that are configured to perform generic computer functions that are well understood routine, and conventional activities previously known to the pertinent industry (i.e., healthcare);
Relevant court decisions: The following example of court decision demonstrating well understood, routine and conventional activities, e.g., see MPEP 2106.05(d)(II): Receiving or transmitting data, e.g., see Intellectual Ventures v. Symantec; Storing and retrieving information in memory, Versata Dev. Group, Inc. v. SAP Am., Inc. – similarly, the current invention uses as input patient data.
Dependent claims 3-10, 13-20, and 23-25 include other limitations, but none of these functions are deemed significantly more than the abstract idea. Thus, taken alone, the additional elements do not amount to “significantly more” than the above identified abstract idea. Furthermore, looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually, and there is no indication that the combination of elements improves any other technology, and their collective functions merely provide conventional computer implementation.
The application, is an attempt to organize human activity, using methods, systems, and devices for analyzing objective health data and subject-conveyed health information for health information reporting, treatment planning, diagnoses, and treatment, which is not patentable. Therefore, whether taken individually or as an ordered combination, claims 1, 3-11, and 13-26 are nonetheless rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3-5, and 8-10 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Shouldice (U.S. Pub. No. 2025/0134451 A1).
Regarding claim 1, Shouldice discloses a method comprising (Paragraph [0019] discusses methods for facilitating sleep therapy.):
at a computing device comprising a health data manager (Paragraphs [0045] and [0049] discuss sleep management tools, memory device, user device, and devices.):
receiving a first set of information about a subject's health, wherein the first set of information was conveyed by the subject at a first time period (Examiner notes that the prior art does not specifically state “first”, “second”, “third”, etc., however, the art references the data can be updated at any time, daily, weekly, etc., and in realtime.) (Paragraphs [0019], [0050]-[0051], [0137], [0140], [0161], Claim 24 discuss receive data (e.g., physiological data, environmental data, pharmacological data, flow rate data, pressure data, motion data, acoustic data, etc.) from the one or more sensors, including from user smartphone app, and receiving sleep sensor data in realtime, information can be updated at any time, such as daily (e.g. between sleep sessions), weekly, monthly or yearly.);
using one or more physical sensors to acquire objective health data from a subject at a second time period after conveyance of the first set of information by the subject (Paragraphs [0007], [0019], [0050], and [0172]-[0174] discusses receive sensor data from one or more sensors associated with a user; receiving sleep sensor data in realtime, information can be updated at any time, such as daily (e.g. between sleep sessions), weekly, monthly or yearly.);
presenting, via a user interface, the acquired objective health data to the subject (Paragraphs [0050], [0106], [0108]-[0110] discuss a user device includes a display device or activity tracker that includes one or more sensors to display received physiological data; user profile information can be updated at any time, such as daily (e.g. between sleep sessions), weekly, monthly or yearly, the memory device stores media content that can be displayed on the display device.);
controlling receipt of, at a third time period subsequent to presentation of the acquired objective health data to the subject, a second set of information about the subject’s health, wherein the second set of information was conveyed by the subject (Paragraph [0050] discusses the user profile information, the self-reported user feedback can include information indicative of a self-reported subjective therapy score (e.g., poor, average, excellent), a self-reported subjective stress level of the user, a self-reported subjective fatigue level of the user, a self-reported subjective health status of the user, can be updated at any time, such as daily (e.g. between sleep sessions), weekly, monthly or yearly.);
analyzing the objective health data, the first set of information, and the second set of information to determine a discrepancy between the objective health data and at least one of the first set of information and the second set of information (Paragraphs [0051] and [0172] discuss the electronic interface is configured to receive data (e.g., physiological data, environmental data, pharmacological data, flow rate data, pressure data, motion data, acoustic data, etc.) from the one or more sensors such that the data can be stored in the memory device and/or analyzed by the processor; objective data obtain from sensor data can be used to confirm, refute, or adjust subjective data, use of objective data to compare with subjective data can help a user identify and become more aware of their objective data and its correlation to subjective data.);
determining a treatment plan, diagnosis, and/or health information based on the discrepancy (Paragraphs [0046]-[0048], [0172] and FIG. 7 discuss analyze data obtained and generate a sleep therapy plan, objective data obtain from sensor data can be used to confirm, refute, or adjust subjective data, if a gap between objective and subjective data is identified and does not converge as expected (e.g., for their demographic), the sleep therapy plan may be adjusted.); and
presenting, via the user interface, the treatment plan, treatment, diagnosis, a therapeutic feedback intervention, and/or health information (Paragraph [0047] discusses sleep therapy module can communicate with one or more user devices to present information (e.g., a sleep therapy plan recommendation or an updated therapy parameter) and/or automatically apply updates (e.g., automatically update a therapy parameter and/or otherwise automatically adjust a sleep therapy plan).).
Regarding claim 3, Shouldice discloses wherein the one or more physical sensors comprise polysomnography equipment, a wearable device, an accelerometer, and/or a motion sensor (Paragraphs [0050] and [0109]-[0110] discuss the activity tracker is a wearable device worn by a user includes one or more of the sensor described herein, such as, for example, the motion sensor (e.g., one or more accelerometers and/or gyroscopes), the PPG sensor, and/or the ECG sensor and the medical information data can include results from one or more of a polysomnography (PSG) test, a CPAP titration, or a home sleep test (HST), respiratory therapy system settings from one or more sleep sessions, sleep related respiratory events from one or more sleep sessions, or any combination thereof.).
Regarding claim 4, Shouldice discloses wherein the first set of information and the second set of information comprise total sleep time and/or confidence in a physical parameter (Paragraphs [0050], [0135], and [0172] discuss the self-reported user feedback can include information indicative of a self-reported subjective therapy score (e.g., poor, average, excellent), a self-reported subjective stress level of the user, a self-reported subjective fatigue level of the user, a self-reported subjective health status of the user, the user profile information can be updated at any time, such as daily (e.g. between sleep sessions), weekly, monthly or yearly; identify physiological parameters, such as anxiety and stress, which may be causing insomnia, via requesting subjective feedback (e.g., providing a questionnaire); further, examples of subjective data include an amount of restfulness felt by the user, a level of sleep quality perceived by the user, an in-bed time that the user believes is correct, or the like.).
Regarding claim 5 Shouldice discloses wherein the objective health data comprises sleep onset latency, total sleep time, wake after sleep onset, and/or sleep efficiency (Paragraphs [0073] and [0078]-[0079] discuss analysis of sleep quality based on processing of sensors and include information associated with sleep efficiency as well as other quality-related factors (e.g., time spent in certain sleep stages, total sleep time, and the like); parameters that can be determined for the user during the sleep session based on the sleep-wake signal include, for example, sleep quality metrics such as a total time in bed, a total sleep time, a sleep onset latency, a wake-after-sleep-onset parameter, a sleep efficiency, a fragmentation index, or any combination thereof.).
Regarding claim 8, Shouldice discloses wherein the received, objective health data of the subject includes data acquired about a predetermined health characteristic of the subject within a predetermined period of time, and wherein the first set of information about the subject’s health is associated with the subject’s conveyance of opinion about the predetermined health characteristic of the subject within the predetermined period of time (Paragraph [0172] discusses information can be stored in a log, including objective data (e.g., from one or more biological sensors) and subjective data (e.g., from user feedback). Examples of subjective data include an amount of restfulness felt by the user, a level of sleep quality perceived by the user, an in-bed time that the user believes is correct, or the like. In some cases, objective data obtain from sensor data can be used to confirm, refute, or adjust subjective data. Use of objective data to compare with subjective data can help a user identify and become more aware of their objective data and its correlation to subjective data.).
Regarding claim 9, Shouldice discloses further comprising:
comparing the data about the predetermined health characteristic with the subject’s conveyed opinion about the predetermined health characteristic (Paragraph [0172] and FIG. 5 discuss information can be stored in a log, including objective data (e.g., from one or more biological sensors) and subjective data (e.g., from user feedback). Examples of subjective data include an amount of restfulness felt by the user, a level of sleep quality perceived by the user, an in-bed time that the user believes is correct, or the like. In some cases, objective data obtain from sensor data can be used to confirm, refute, or adjust subjective data. Use of objective data to compare with subjective data can help a user identify and become more aware of their objective data and its correlation to subjective data.); and
presenting, via the user interface, the comparison of the data about the predetermined health characteristic with the subject’s conveyed opinion about the predetermined health characteristic (Paragraphs [0167], [0172] and FIG. 5 discuss information can be stored in a log, including objective data (e.g., from one or more biological sensors) and subjective data (e.g., from user feedback). Examples of subjective data include an amount of restfulness felt by the user, a level of sleep quality perceived by the user, an in-bed time that the user believes is correct, or the like. In some cases, objective data obtain from sensor data can be used to confirm, refute, or adjust subjective data. Use of objective data to compare with subjective data can help a user identify and become more aware of their objective data and its correlation to subjective data and visually presenting therapy parameter to user via a display device.).
Regarding claim 10, Shouldice discloses wherein the received, objective health data of the subject includes data acquired about a predetermined health characteristic of the subject within a plurality of different periods of time, wherein the first set of information about the subject’s health is associated with the subject’s conveyance of opinion about the predetermined health characteristic of the subject within the plurality of different periods of time, and wherein the method further comprises presenting, via the user interface, the data about the predetermined health characteristic and the subject’s conveyed opinion about the predetermined health characteristic (Paragraphs [0019], [0167], and [0172] discuss sensor data can be used to automatically update therapy parameters of an ongoing sleep therapy plan in real-time, information can be stored in a log, including objective data (e.g., from one or more biological sensors) and subjective data (e.g., from user feedback). Examples of subjective data include an amount of restfulness felt by the user, a level of sleep quality perceived by the user, an in-bed time that the user believes is correct, or the like. In some cases, objective data obtain from sensor data can be used to confirm, refute, or adjust subjective data. Use of objective data to compare with subjective data can help a user identify and become more aware of their objective data and its correlation to subjective data and visually presenting therapy parameter to user via a display device.).
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.
Claims 11, 13-15, and 18-26 are rejected under 35 U.S.C. 103 as being unpatentable over Shouldice in view of De Brouwer (U.S. Pub. No. 2020/0185073 B1).
Regarding claim 11, Shouldice discloses a computing device comprising (Paragraphs [0045] and [0049] discuss sleep management tools, memory device, user device, and devices.):
one or more physical sensors configured to acquire objective health data from a subject (Paragraph [0007] discusses receive sensor data from one or more sensors associated with a user.):
a user interface (Paragraphs [0106], [0108]-[0110] discuss a user device includes a display device or activity tracker that includes one or more sensors to display physiological data.); and
a health data manager configured to (Paragraph [0045] discusses sleep management tools and devices.):
receive a first set of information about the subject's health, wherein the first set of information was conveyed by the subject at a first time period (Paragraphs [0019], [0050]-[0051], [0137], [0140], [0161], Claim 24 discuss receive data (e.g., physiological data, environmental data, pharmacological data, flow rate data, pressure data, motion data, acoustic data, etc.) from the one or more sensors, including from user smartphone app, and receiving sleep sensor data in realtime, information can be updated at any time, such as daily (e.g. between sleep sessions), weekly, monthly or yearly.);
present, via the user interface, the acquired objective health data to the subject (Paragraphs [0050], [0106], [0108]-[0110] discuss a user device includes a display device or activity tracker that includes one or more sensors to display received physiological data; user profile information can be updated at any time, such as daily (e.g. between sleep sessions), weekly, monthly or yearly, the memory device stores media content that can be displayed on the display device.);
control receipt of, at a third time period subsequent to presentation of the acquired objective health data to the subject, a second set of information about the subject’s health, wherein the second set of information was conveyed by the subject (Paragraph [0050] discusses the user profile information, the self-reported user feedback can include information indicative of a self-reported subjective therapy score (e.g., poor, average, excellent), a self-reported subjective stress level of the user, a self-reported subjective fatigue level of the user, a self-reported subjective health status of the user, can be updated at any time, such as daily (e.g. between sleep sessions), weekly, monthly or yearly.);
analyze the objective health data, the first set of information, and the second set of information to determine a discrepancy between the objective health data and at least one of the first set of information and the second set of information (Paragraphs [0051] and [0172] discuss the electronic interface is configured to receive data (e.g., physiological data, environmental data, pharmacological data, flow rate data, pressure data, motion data, acoustic data, etc.) from the one or more sensors such that the data can be stored in the memory device and/or analyzed by the processor; objective data obtain from sensor data can be used to confirm, refute, or adjust subjective data, use of objective data to compare with subjective data can help a user identify and become more aware of their objective data and its correlation to subjective data.);
determine a treatment plan, diagnosis, and/or health information based on the discrepancy (Paragraphs [0046]-[0048], [0172] and FIG. 7 discuss analyze data obtained and generate a sleep therapy plan, objective data obtain from sensor data can be used to confirm, refute, or adjust subjective data, if a gap between objective and subjective data is identified and does not converge as expected (e.g., for their demographic), the sleep therapy plan may be adjusted.); and
present, via the user interface, the treatment plan, diagnosis, treatment, a therapeutic feedback intervention, and/or health information (Paragraph [0047] discusses sleep therapy module can communicate with one or more user devices to present information (e.g., a sleep therapy plan recommendation or an updated therapy parameter) and/or automatically apply updates (e.g., automatically update a therapy parameter and/or otherwise automatically adjust a sleep therapy plan).).
Shouldice does not explicitly disclose:
request, via the user interface, input from the subject about the subject's health.
De Brouwer teaches:
request, via the user interface, input from the subject about the subject's health (Paragraphs [0028], [0046] and FIGS. 3A-B and 4 discuss the remote device request and/or receive health/image data associated with the user.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Shouldice to include, request, via the user interface, input from the subject about the subject's health, as taught by De Brouwer, in order to improve the accuracy and precision of the blood test results and personalize the results to the user. (De Brouwer Paragraph [0006]).
Regarding claims 13 and 23, Shouldice discloses wherein the one or more physical sensors comprise polysomnography equipment, a wearable device, an accelerometer, and/or a motion sensor (Paragraphs [0050] and [0109]-[0110] discuss the activity tracker is a wearable device worn by a user includes one or more of the sensor described herein, such as, for example, the motion sensor (e.g., one or more accelerometers and/or gyroscopes), the PPG sensor, and/or the ECG sensor and the medical information data can include results from one or more of a polysomnography (PSG) test, a CPAP titration, or a home sleep test (HST), respiratory therapy system settings from one or more sleep sessions, sleep related respiratory events from one or more sleep sessions, or any combination thereof.).
Regarding claim 14, Shouldice discloses wherein the first set of information and the second set of information comprise total sleep time and/or confidence in a physical parameter (Paragraphs [0050], [0135], and [0172] discuss the self-reported user feedback can include information indicative of a self-reported subjective therapy score (e.g., poor, average, excellent), a self-reported subjective stress level of the user, a self-reported subjective fatigue level of the user, a self-reported subjective health status of the user, the user profile information can be updated at any time, such as daily (e.g. between sleep sessions), weekly, monthly or yearly; identify physiological parameters, such as anxiety and stress, which may be causing insomnia, via requesting subjective feedback (e.g., providing a questionnaire); further, examples of subjective data include an amount of restfulness felt by the user, a level of sleep quality perceived by the user, an in-bed time that the user believes is correct, or the like.).
Regarding claims 15 and 25, Shouldice discloses wherein the objective health data comprises sleep onset latency, total sleep time, wake after sleep onset, and/or sleep efficiency (Paragraphs [0073] and [0078]-[0079] discuss analysis of sleep quality based on processing of sensors and include information associated with sleep efficiency as well as other quality-related factors (e.g., time spent in certain sleep stages, total sleep time, and the like); parameters that can be determined for the user during the sleep session based on the sleep-wake signal include, for example, sleep quality metrics such as a total time in bed, a total sleep time, a sleep onset latency, a wake-after-sleep-onset parameter, a sleep efficiency, a fragmentation index, or any combination thereof.).
Regarding claim 18, Shouldice discloses wherein the received, objective health data of the subject includes data acquired about a predetermined health characteristic of the subject within a predetermined period of time, and wherein the first set of information about the subject’s health is associated with the subject’s conveyance of opinion about the predetermined health characteristic of the subject within the predetermined period of time (Paragraph [0172] discusses information can be stored in a log, including objective data (e.g., from one or more biological sensors) and subjective data (e.g., from user feedback). Examples of subjective data include an amount of restfulness felt by the user, a level of sleep quality perceived by the user, an in-bed time that the user believes is correct, or the like. In some cases, objective data obtain from sensor data can be used to confirm, refute, or adjust subjective data. Use of objective data to compare with subjective data can help a user identify and become more aware of their objective data and its correlation to subjective data.).
Regarding claim 19, Shouldice discloses wherein the health data manager is configured to (Paragraphs [0006], [0049]-[0050], and [0172] discuss the memory device is coupled toa user device, activity tracker, within a housing of the sensors, or any combination and obtains objective data from sensor data associated with a user.):
compare the data about the predetermined health characteristic with the subject’s conveyed opinion about the predetermined health characteristic (Paragraph [0172] and FIG. 5 discuss information can be stored in a log, including objective data (e.g., from one or more biological sensors) and subjective data (e.g., from user feedback). Examples of subjective data include an amount of restfulness felt by the user, a level of sleep quality perceived by the user, an in-bed time that the user believes is correct, or the like. In some cases, objective data obtain from sensor data can be used to confirm, refute, or adjust subjective data. Use of objective data to compare with subjective data can help a user identify and become more aware of their objective data and its correlation to subjective data.); and
utilize the user interface to present the comparison of the data about the predetermined health characteristic with the subject’s conveyed opinion about the predetermined health characteristic (Paragraphs [0167], [0172] and FIG. 5 discuss information can be stored in a log, including objective data (e.g., from one or more biological sensors) and subjective data (e.g., from user feedback). Examples of subjective data include an amount of restfulness felt by the user, a level of sleep quality perceived by the user, an in-bed time that the user believes is correct, or the like. In some cases, objective data obtain from sensor data can be used to confirm, refute, or adjust subjective data. Use of objective data to compare with subjective data can help a user identify and become more aware of their objective data and its correlation to subjective data and visually presenting therapy parameter to user via a display device.).
Regarding claim 20, Shouldice discloses wherein the received, objective health data of the subject includes data acquired about a predetermined health characteristic of the subject within a plurality of different periods of time, wherein the first set of information about the subject’s health is associated with the subject’s conveyance of opinion about the predetermined health characteristic of the subject within the plurality of different periods of time, and wherein the method further comprises presenting, via the user interface, the data about the predetermined health characteristic and the subject’s conveyed opinion about the predetermined health characteristic (Paragraphs [0019], [0167], and [0172] discuss sensor data can be used to automatically update therapy parameters of an ongoing sleep therapy plan in real-time, information can be stored in a log, including objective data (e.g., from one or more biological sensors) and subjective data (e.g., from user feedback). Examples of subjective data include an amount of restfulness felt by the user, a level of sleep quality perceived by the user, an in-bed time that the user believes is correct, or the like. In some cases, objective data obtain from sensor data can be used to confirm, refute, or adjust subjective data. Use of objective data to compare with subjective data can help a user identify and become more aware of their objective data and its correlation to subjective data and visually presenting therapy parameter to user via a display device.).
Regarding claim 21, Shouldice discloses a system comprising (Paragraph [0019] discusses systems for facilitating sleep therapy.):
one or more physical sensors configured to acquire objective health data from a subject (Paragraph [0019] discusses receive sensor data of sleep-related physiological parameters associated with a user engaging in a sleep therapy plan; and
a computing device comprising (Paragraphs [0045] and [0049] discuss sleep management tools, memory device, user device, and devices.):
a user interface (Paragraphs [0106] and [0108]-[0110] discuss a user device includes a display device or activity tracker that includes one or more sensors to display physiological data.); and
a health data manager configured to (Paragraph [0045] discusses sleep management tools and devices.):
receive a first set of information about the subject's health, wherein the first set of information was conveyed by the subject at a first time period (Paragraphs [0019], [0050]-[0051], [0137], [0140], [0161], Claim 24 discuss receive data (e.g., physiological data, environmental data, pharmacological data, flow rate data, pressure data, motion data, acoustic data, etc.) from the one or more sensors, including from user smartphone app, and receiving sleep sensor data in realtime, information can be updated at any time, such as daily (e.g. between sleep sessions), weekly, monthly or yearly.);
present, via the user interface, the acquired objective health data to the subject (Paragraphs [0050], [0106], [0108]-[0110] discuss a user device includes a display device or activity tracker that includes one or more sensors to display received physiological data; user profile information can be updated at any time, such as daily (e.g. between sleep sessions), weekly, monthly or yearly, the memory device stores media content that can be displayed on the display device.);
control receipt of, at a third time period subsequent to presentation of the acquired objective health data to the subject, a second set of information about the subject’s health, wherein the second set of information was conveyed by the subject (Paragraph [0050] discusses the user profile information, the self-reported user feedback can include information indicative of a self-reported subjective therapy score (e.g., poor, average, excellent), a self-reported subjective stress level of the user, a self-reported subjective fatigue level of the user, a self-reported subjective health status of the user, can be updated at any time, such as daily (e.g. between sleep sessions), weekly, monthly or yearly.);
analyze the objective health data, the first set of information, and the second set of information to determine a discrepancy between the objective health data and at least one of the first set of information and the second set of information (Paragraphs [0051] and [0172] discuss the electronic interface is configured to receive data (e.g., physiological data, environmental data, pharmacological data, flow rate data, pressure data, motion data, acoustic data, etc.) from the one or more sensors such that the data can be stored in the memory device and/or analyzed by the processor; objective data obtain from sensor data can be used to confirm, refute, or adjust subjective data, use of objective data to compare with subjective data can help a user identify and become more aware of their objective data and its correlation to subjective data.);
determine a treatment plan, diagnosis, and/or health information based on the discrepancy (Paragraphs [0046]-[0048], [0172] and FIG. 7 discuss analyze data obtained and generate a sleep therapy plan, objective data obtain from sensor data can be used to confirm, refute, or adjust subjective data, if a gap between objective and subjective data is identified and does not converge as expected (e.g., for their demographic), the sleep therapy plan may be adjusted.); and
present, via the user interface, the treatment plan, diagnosis, treatment, a therapeutic feedback intervention, and/or health information (Paragraph [0047] discusses sleep therapy module can communicate with one or more user devices to present information (e.g., a sleep therapy plan recommendation or an updated therapy parameter) and/or automatically apply updates (e.g., automatically update a therapy parameter and/or otherwise automatically adjust a sleep therapy plan).).
Shouldice does not explicitly disclose:
request, via the user interface, input from the subject about the subject's health.
De Brouwer teaches:
request, via the user interface, input from the subject about the subject's health (Paragraphs [0028], [0046] and FIGS. 3A-B and 4 discuss the remote device request and/or receive health/image data associated with the user.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Shouldice to include, request, via the user interface, input from the subject about the subject's health, as taught by De Brouwer, in order to improve the accuracy and precision of the blood test results and personalize the results to the user. (De Brouwer Paragraph [0006]).
Regarding claim 22, Shouldice discloses a method comprising:
at a computing device comprising a health data manager (Paragraphs [0045] and [0049] discuss sleep management tools, memory device, user device, and devices.):
using one or more physical sensors to acquire objective health data from a subject (Paragraph [0007] discusses receive sensor data from one or more sensors associated with a user.);
receiving a first set of information about the subject's health, wherein the first set of information was conveyed by the subject at a first time period (Paragraphs [0019], [0050]-[0051], [0137], [0140], [0161], Claim 24 discuss receive data (e.g., physiological data, environmental data, pharmacological data, flow rate data, pressure data, motion data, acoustic data, etc.) from the one or more sensors, including from user smartphone app, and receiving sleep sensor data in realtime, information can be updated at any time, such as daily (e.g. between sleep sessions), weekly, monthly or yearly.);
controlling receipt of, at a third time period subsequent to presentation of the acquired objective health data to the subject (Paragraph [0050] discusses the user profile information, the self-reported user feedback can include information indicative of a self-reported subjective therapy score (e.g., poor, average, excellent), a self-reported subjective stress level of the user, a self-reported subjective fatigue level of the user, a self-reported subjective health status of the user, can be updated at any time, such as daily (e.g. between sleep sessions), weekly, monthly or yearly.)
receiving, via the user interface, a set of information about the subject's health, wherein the set of information was conveyed by the subject (Paragraphs [0040]-[0041], [0050], and [0172] discuss clinician evaluates the patient subjective complaint using a checklist including insomnia symptoms, factors that influence insomnia symptoms, health factors, and social factors and information can be stored in a log including subjective data from user feedback, for example an amount of restfulness felt by the user, a level of sleep quality perceived by the user, an in-bed time that the user believes is correct, or the like; the self-reported user feedback can include information indicative of a self-reported subjective therapy score (e.g., poor, average, excellent), a self-reported subjective stress level of the user, a self-reported subjective fatigue level of the user, a self-reported subjective health status of the user, a recent life event experienced by the user, or any combination thereof.);
controlling receipt of, at a third time period subsequent to presentation of the acquired objective health data to the subject, a second set of information about the subject's health, wherein the second set of information was conveyed by the subject (Paragraph [0050] discusses the user profile information, the self-reported user feedback can include information indicative of a self-reported subjective therapy score (e.g., poor, average, excellent), a self-reported subjective stress level of the user, a self-reported subjective fatigue level of the user, a self-reported subjective health status of the user, can be updated at any time, such as daily (e.g. between sleep sessions), weekly, monthly or yearly.);
analyzing a discrepancy between the objective health data and the set of information (Paragraphs [0051] and [0172] discuss the electronic interface is configured to receive data (e.g., physiological data, environmental data, pharmacological data, flow rate data, pressure data, motion data, acoustic data, etc.) from the one or more sensors such that the data can be stored in the memory device and/or analyzed by the processor; objective data obtain from sensor data can be used to confirm, refute, or adjust subjective data, use of objective data to compare with subjective data can help a user identify and become more aware of their objective data and its correlation to subjective data.);
determining a treatment plan, diagnosis, and/or health information based on the discrepancy (Paragraphs [0046]-[0048], [0172] and FIG. 7 discuss analyze data obtained and generate a sleep therapy plan, objective data obtain from sensor data can be used to confirm, refute, or adjust subjective data, if a gap between objective and subjective data is identified and does not converge as expected (e.g., for their demographic), the sleep therapy plan may be adjusted.); and
presenting, via the user interface, the treatment plan, treatment, diagnosis, and/or health information (Paragraph [0047] discusses sleep therapy module can communicate with one or more user devices to present information (e.g., a sleep therapy plan recommendation or an updated therapy parameter) and/or automatically apply updates (e.g., automatically update a therapy parameter and/or otherwise automatically adjust a sleep therapy plan).).
Shouldice does not explicitly disclose:
via a user interface, input from the subject about the subject's health, wherein the acquired health data is not indicated in the request.
De Brouwer teaches:
via a user interface, input from the subject about the subject's health, wherein the acquired health data is not indicated in the request (Paragraphs [0006], [0028], [0044], [0046] and FIGS. 3A-B and 4 discuss the remote device request and/or receive health/image data associated with the user, there is a need to filter results based on certain parameters, so that the results can be parsed to provide personalized blood tests.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Shouldice to include, via a user interface, input from the subject about the subject's health, wherein the acquired health data is not indicated in the request, as taught by De Brouwer, in order to improve the accuracy and precision of the blood test results and personalize the results to the user. (De Brouwer Paragraph [0006]).
Regarding claim 24, Shouldice discloses wherein the set of information comprise total sleep time and/or confidence in a physical parameter (Paragraphs [0050], [0135], and [0172] discuss the self-reported user feedback can include information indicative of a self-reported subjective therapy score (e.g., poor, average, excellent), a self-reported subjective stress level of the user, a self-reported subjective fatigue level of the user, a self-reported subjective health status of the user, the user profile information can be updated at any time, such as daily (e.g. between sleep sessions), weekly, monthly or yearly; identify physiological parameters, such as anxiety and stress, which may be causing insomnia, via requesting subjective feedback (e.g., providing a questionnaire); further, examples of subjective data include an amount of restfulness felt by the user, a level of sleep quality perceived by the user, an in-bed time that the user believes is correct, or the like.).
Regarding claim 26, Shouldice discloses a computing device comprising (Paragraphs [0045] and [0049] discuss sleep management tools, memory device, user device, and devices.):
one or more physical sensors configured to acquire objective health data from a subject (Paragraph [0007] discusses receive sensor data from one or more sensors associated with a user.);
a user interface (Paragraphs [0106], [0108]-[0110] discuss a user device includes a display device or activity tracker that includes one or more sensors to display physiological data.); and
a health data manager configured to (Paragraph [0045] discusses sleep management tools and devices.):
receive a first set of information about the subject's health, wherein the first set of information was conveyed by the subject at a first time period (Paragraphs [0019], [0050]-[0051], [0137], [0140], [0161], Claim 24 discuss receive data (e.g., physiological data, environmental data, pharmacological data, flow rate data, pressure data, motion data, acoustic data, etc.) from the one or more sensors, including from user smartphone app, and receiving sleep sensor data in realtime, information can be updated at any time, such as daily (e.g. between sleep sessions), weekly, monthly or yearly.);
controlling receipt of, at a third time period subsequent to presentation of the acquired objective health data to the subject (Paragraph [0050] discusses the user profile information, the self-reported user feedback can include information indicative of a self-reported subjective therapy score (e.g., poor, average, excellent), a self-reported subjective stress level of the user, a self-reported subjective fatigue level of the user, a self-reported subjective health status of the user, can be updated at any time, such as daily (e.g. between sleep sessions), weekly, monthly or yearly.);
receive, via the user interface, a set of information about the subject's health, wherein the set of information was conveyed by the subject (Paragraph [0050] discusses the user profile information, the self-reported user feedback can include information indicative of a self-reported subjective therapy score (e.g., poor, average, excellent), a self-reported subjective stress level of the user, a self-reported subjective fatigue level of the user, a self-reported subjective health status of the user, can be updated at any time, such as daily (e.g. between sleep sessions), weekly, monthly or yearly.);
control receipt of, at a third time period subsequent to presentation of the acquired objective health data to the subject, a second set of information about the subject's health, wherein the second set of information was conveyed by the subject (Paragraph [0050] discusses the user profile information, the self-reported user feedback can include information indicative of a self-reported subjective therapy score (e.g., poor, average, excellent), a self-reported subjective stress level of the user, a self-reported subjective fatigue level of the user, a self-reported subjective health status of the user, can be updated at any time, such as daily (e.g. between sleep sessions), weekly, monthly or yearly.);
analyze a discrepancy between the objective health data and the set of information (Paragraphs [0051] and [0172] discuss the electronic interface is configured to receive data (e.g., physiological data, environmental data, pharmacological data, flow rate data, pressure data, motion data, acoustic data, etc.) from the one or more sensors such that the data can be stored in the memory device and/or analyzed by the processor; objective data obtain from sensor data can be used to confirm, refute, or adjust subjective data, use of objective data to compare with subjective data can help a user identify and become more aware of their objective data and its correlation to subjective data.);
determine a treatment plan, diagnosis, and/or health information based on the discrepancy (Paragraphs [0046]-[0048], [0172] and FIG. 7 discuss analyze data obtained and generate a sleep therapy plan, objective data obtain from sensor data can be used to confirm, refute, or adjust subjective data, if a gap between objective and subjective data is identified and does not converge as expected (e.g., for their demographic), the sleep therapy plan may be adjusted.); and
present, via the user interface, the treatment plan, treatment, diagnosis, and/or health information (Paragraph [0047] discusses sleep therapy module can communicate with one or more user devices to present information (e.g., a sleep therapy plan recommendation or an updated therapy parameter) and/or automatically apply updates (e.g., automatically update a therapy parameter and/or otherwise automatically adjust a sleep therapy plan).).
Shouldice does not explicitly disclose:
via the user interface, input from the subject about the subject's health, wherein the acquired health data is not indicated in the request.
De Brouwer teaches:
via the user interface, input from the subject about the subject's health, wherein the acquired health data is not indicated in the request (Paragraphs [0006], [0028], [0044], [0046] and FIGS. 3A-B and 4 discuss the remote device request and/or receive health/image data associated with the user, there is a need to filter results based on certain parameters, so that the results can be parsed to provide personalized blood tests.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Shouldice to include, via the user interface, input from the subject about the subject's health, wherein the acquired health data is not indicated in the request, as taught by De Brouwer, in order to improve the accuracy and precision of the blood test results and personalize the results to the user. (De Brouwer Paragraph [0006]).
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Shouldice in view of Jain (U.S. Pat. No. 12248384 B1).
Regarding claim 6, Shouldice discloses wherein analyzing the objective health data (Paragraphs [0048] discuss analyze data obtained (e.g., physiological data, environmental data, pharmacological data, flow rate data, pressure data, motion data, acoustic data, etc.) from the one or more sensors.).
Shouldice does not explicitly disclose:
comprises determining a variance and/or mean of the objective health data, the first set of information, and the second set of information.
Jain teaches:
comprises determining a variance and/or mean of the objective health data, the first set of information, and the second set of information (Column 18 lines 44-55 and Column 52 lines 22-29 discuss the study includes answers to survey questions and collection of sensor data and determine the aggregate measures for a monitoring group for each of different measured parameters (e.g., those in the first set of data specified by the first monitoring program). This can include determining averages (e.g., mean, median, etc.), characterizing a distribution of results (e.g., expected value, standard deviation, variance, etc.), determining a histogram for values, and so on.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Shouldice to include, comprises determining a variance and/or mean of the objective health data, the first set of information, and the second set of information, as taught by Jain, in order to improve the efficiency and effectiveness of monitoring programs. (Jain Column 1 lines 41-43).
Regarding claim 7, Shouldice discloses further comprising presenting, via the user interface (Paragraph [0047] discusses sleep therapy module can communicate with one or more user devices to present information (e.g., a sleep therapy plan recommendation or an updated therapy parameter) and/or automatically apply updates (e.g., automatically update a therapy parameter and/or otherwise automatically adjust a sleep therapy plan).).
Shouldice does not explicitly disclose:
the variance and/or mean.
Jain teaches:
the variance and/or mean (Column 18 lines 44-55 and Column 52 lines 22-29 discuss the study includes answers to survey questions and collection of sensor data and determine the aggregate measures for a monitoring group for each of different measured parameters (e.g., those in the first set of data specified by the first monitoring program). This can include determining averages (e.g., mean, median, etc.), characterizing a distribution of results (e.g., expected value, standard deviation, variance, etc.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Shouldice to include, the variance and/or mean, as taught by Jain, in order to improve the efficiency and effectiveness of monitoring programs. (Jain Column 1 lines 41-43).
Claims 6-7 and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Shouldice in view of De Brouwer and in further view of Jain (U.S. Pat. No. 12248384 B1).
Regarding claim 16, Shouldice discloses wherein the health data manager is configured to (Paragraphs [0006], [0049]-[0050], and [0172] discuss the memory device is coupled to a user device, activity tracker, within a housing of the sensors, or any combination and obtains objective data from sensor data associated with a user.).
Shouldice does not explicitly disclose:
to determine a variance and/or mean of the objective health data, the first set of information, and the second set of information subject.
Jain teaches:
to determine a variance and/or mean of the objective health data, the first set of information, and the second set of information subject (Column 18 lines 44-55 and Column 52 lines 22-29 discuss the study includes answers to survey questions and collection of sensor data and determine the aggregate measures for a monitoring group for each of different measured parameters (e.g., those in the first set of data specified by the first monitoring program). This can include determining averages (e.g., mean, median, etc.), characterizing a distribution of results (e.g., expected value, standard deviation, variance, etc.), determining a histogram for values, and so on.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Shouldice to include, to determine a variance and/or mean of the objective health data, the first set of information, and the second set of information subject, as taught by Jain, in order to improve the efficiency and effectiveness of monitoring programs. (Jain Column 1 lines 41-43).
Regarding claim 17, Shouldice discloses wherein the health data manager is configured to utilize the user interface to present (Paragraphs [0006], [0049]-[0050], and [0172] discuss the memory device is coupled toa user device, activity tracker, within a housing of the sensors, or any combination and obtains objective data from sensor data associated with a user.).
Shouldice does not explicitly disclose:
the variance and/or mean subject.
Jain teaches:
the variance and/or mean subject (Column 18 lines 44-55 and Column 52 lines 22-29 discuss the study includes answers to survey questions and collection of sensor data and determine the aggregate measures for a monitoring group for each of different measured parameters (e.g., those in the first set of data specified by the first monitoring program). This can include determining averages (e.g., mean, median, etc.), characterizing a distribution of results (e.g., expected value, standard deviation, variance, etc.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Shouldice to include, the variance and/or mean subject, as taught by Jain, in order to improve the efficiency and effectiveness of monitoring programs. (Jain Column 1 lines 41-43).
Response to Arguments
Applicant’s arguments filed 3/12/2026 have been fully considered.
Claim Objections:
Examiner withdraws the claim objections in light of Applicant’s amendments.
Claim Rejections under 35 USC § 112:
Examiner withdraws the claim rejection in light of Applicant’s amendments.
Rejections under 35 U.S.C. 101:
With respect to claim 1 and the 35 U.S.C. 101 rejection, Applicant’s amendment fails to overcome the previous rejection. Claim 1 as amended recites an abstract idea, a method of organizing human activity. See MPEP 2106.04(a)(2)(II)(C) Managing Personal Behavior or Relationships or Interactions Between People. Applicant states that regarding claim 1 as amended, “aforementioned ordered set of operations at different time periods is not merely advising a patient, and it cannot be performed as a mental process because it expressly requires operation of one or more physical sensors and a computing device that sequences objective measurement and subjective reporting in distinct time periods. Therefore, the claim is thus directed to a particular improvement in the way sensor-based health assessment is performed, particularly controlled objective-first measurement, controlled subsequent subject input, and machine computation of discrepancy, rather than to an abstract idea of simply "collecting and analyzing health information".” (Remarks, page 11). Examiner respectfully disagrees. Here, Applicant’s claims are managing personal behavior or relationships or interactions between people – the claims are directed to analyzing objective health data and subject-conveyed health information for health information reporting, treatment planning, diagnoses, and treatment. Further, there is no technical improvement, only an improvement to the abstract idea.
Step 2A. Prong Two -Integration into a Practical Application
While practical application is a way to overcome the Prong 2 35 U.S.C. 101 rejection, here, claim 1 fails to integrate the recited judicial exception into a practical application. Applicant states, “the additional elements, in combination, integrate any such exception into a practical application.” (Remarks, pages 11-12). Examiner respectfully disagrees. Here, using a sensor to acquire health data, requesting patient data, controlling when data is accepted, or analyzing the data to determine a discrepancy, does not result in a practical application as it is recited as part of the abstract idea – certain methods of organizing human activity , as stated above. The limitations in the Application, are part of the abstract idea and the abstract idea cannot be used to integrate itself into a practical application, and therefore, is not an additional element.
Step 2B - "Significantly More" than Well-Understood, Routine. Conventional Activity
All components in the claims are being used for their intended purpose and as written do not result in a practical application or significantly more than the abstract idea. Applicant states, “the rejection did not identify, and the prior art of record does not teach, the amended ordered combination.” (Remarks, page 12). Examiner respectfully disagrees. Here, the claims are directed to an abstract idea and as written, the inventive concept is using the computing device, sensors and these additional elements are not improved. Applicant further states, “Those features represent a non-conventional arrangement of otherwise known components that yields a new technical capability: automatically identifying and acting on inconsistency between a subject's reported status and sensor-measured status across time, to drive therapeutic interventions. Under the USPTO's guidance regarding inventive concept and Berkheimer-type issues, this specific ordered combination of elements, which is neither shown nor suggested in the cited art and is not characterized in the specification as routine, provides "significantly more" than any alleged abstract idea.” (Remarks, page 13). Examiner respectfully disagrees. Individually and in combination, the additional elements do not provide significantly more than the abstract idea. The claims recite features that are “well-understood, routine, conventional activities.” There is no technical improvement to any additional element. For the reasons stated above, claims 1, 11, 21, 22 and 26 similarly fail to overcome the 35 U.S.C. 101 rejection.
Rejections under 35 U.S.C. 103:
With respect to claim 1 and the 35 U.S.C. 103 rejection, Applicant’s amendment overcomes the previous 35 U.S.C. 103 rejection. Applicant states, “amendment to Claim 1 adds coordinated, time-sequenced subjective and objective data collection and discrepancy-based treatment selection that are neither taught nor suggested by Shouldice and De Brouwer. Therefore, it is believed that the § 103 rejection should be withdrawn.” (Remarks, page 14). Applicant further states, “Shouldice does not teach: obtaining a first subjective report at a first time period, subsequently, acquiring objective data only at a later, second time period, and subsequently, after presenting that acquired objective data, controlling receipt of a second subjective report at a distinct third time period.” (Remarks, page 15). Examiner respectfully disagrees, and under the BRI, the prior art reads on the limitations in the Application. In Shouldice, “objective data obtain from sensor data can be used to confirm, refute, or adjust subjective data. Use of objective data to compare with subjective data can help a user identify and become more aware of their objective data and its correlation to subjective data.” Shouldice Paragraph [0172]. Applicant’s arguments with respect to claim 1 have been considered and the Examiner’s rejection has been updated to address Applicant’s claim amendments and additions.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAWN TRINAH HAYNES whose telephone number is (571)270-5994. The examiner can normally be reached M-F 7:30-5:15PM.
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, Jason Dunham can be reached on (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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/DAWN T. HAYNES/
Art Unit 3686
/RACHELLE L REICHERT/Primary Examiner, Art Unit 3686