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 .
Status of the Claims
Claims 1, 4-8, 10, 13, 15 and 18 are currently pending and have been considered below. Claims 1 and 10 have been amended and claims 2-3, 9, 11-12, 14, 16-17 and 19-20 have been cancelled.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on March 31, 2026 has been considered by the Examiner. An initialed copy of IDS form SB08 is enclosed herewith.
Response to Arguments
Applicant’s arguments, see page 8, filed May 27, 2026, with respect to USC 112 have been fully considered and are persuasive. The rejection of claims 1 and 10 have been withdrawn.
Applicant's arguments with respect to USC 101 has been fully considered but they are not persuasive. Applicant argues on pages 8-9 that amended claim 1 is directed to eligible subject matter because it recites a practical application, namely:
displaying a graph of an estimated subjective value of the physical or mental condition;
displaying a curve showing variation in the event score over time and a region of normal event scores; and
notifying the user at a time determined based on a probability of the user accepting an intervention measure.
Applicant further argues that these features improve the accuracy of introspection of notification contents and therefore amount to “significantly more” than an abstract idea.
Examiner disagrees. The additional limitations cited by Applicant amount to insignificant post-solution activity, presentation of information, and data analysis / decision-making based on information, none of which integrate the abstract idea into a practical application or amount to an inventive concept. The claim, even as amended, remains directed to the abstract idea of: obtaining and evaluating biological and situational data; generating a score or assessment regarding whether and when to notify a user; and making a notification decision based on that evaluation. The recited display of: a graph of an estimated subjective value of the physical or mental condition; a curve showing variation in the event score over time; and a region of normal event scores, is presentation of information. The U.S. Supreme Court has held that claims directed to displaying or organizing information, without more, do not constitute an eligible practical application. See, e.g., Electric Power Group, LLC v. Alstom S.A., 830 F.3d 1350 (Fed. Cir. 2016) (collecting, analyzing, and displaying information is abstract); Content Extraction & Transmission LLC v. Wells Fargo Bank, N.A., 776 F.3d 1343 (Fed. Cir. 2014).
Next, although Applicant asserts that the display helps the user understand why a situation differs from a usual situation, this asserted improvement is merely an improvement in the usefulness of the information presented, not an improvement to a computer or to another technology. The claim does not recite a new graphical display technique, improved sensor operation, improved processor performance, or a specific technical mechanism that changes how the computer functions. Rather, it recites displaying results of the analysis.
Regarding the notifying step being a practical application, Examiner disagrees. The limitation that the notification is output at a time determined based on a probability of the user accepting an intervention measure likewise does not add significantly more. This is another rule for deciding when to communicate information to the user. Selecting an optimal time to provide a notification based on user behavior or acceptance likelihood is an abstract scheduling/decision concept and does not itself integrate the abstract idea into a practical application. The claim does not recite a specific technical solution for determining such probability, nor does it recite any unconventional hardware or interaction with a particular machine that imposes a meaningful limit on the scope of the abstract idea. The recitation merely uses the calculated score to decide whether and when to notify the user.
Therefore, claims 1, 4-8, 10, 13, 15 and 18 remain directed to an abstract idea, and the additional limitations cited by Applicant do not amount to significantly more than the abstract idea. The claim is not tied to any particular machine in a meaningful way, does not effect a transformation, and does not recite an improvement to computer functionality or another technology. The rejection of claim 1 under § 101 is therefore maintained.
Applicant's arguments with respect to USC 103 has been fully considered but they are not persuasive. Applicant argues on pages 9-10 that Condie and Sundaram do not teach “output, based on a determination that the user is to be notified, the notification including a display on a screen including a graph of an estimated subjective value of the physical or mental condition, and a curve showing variation in the event score over time and showing a region of normal event scores, wherein the notification is output to the user at a time that is determined based on a probability of the user accepting an intervention measure.” Examiner disagrees. Figures 3 and 7 as seen below clearly show these features that Applicant is pointing to. Further, paragraphs 74-75 further describe these features. As seen below in Figure 3, an estimated value of physical or mental condition can be seen. Also, Figure 7 shows a graph showing variation in the event score over time and showing a region of normal event scores.
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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, 4-8, 10, 13, 15 and 18 rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1
In the instant case, claims 1 and 4-8 are directed to a device (i.e. a machine) while claims 10, 13, 15 and 18 are directed to a method (i.e. processes). Thus, each of the claims falls within one of the four statutory categories. Nevertheless, the claims fall within the judicial exception of an abstract idea.
Step 2A- Prong 1
Independent claims 1 and 10 recites steps that, under their broadest reasonable interpretations, cover Certain Methods of Organizing Human Activity, e.g. managing personal behavior, or relationships, or interactions between people. Specifically, claim 10 recites:
receiving, by a processor, biological measurement data of a user from a plurality of biological measurement sensors and situation expression data expressing a situation of the user;
evaluating, by the processor, based on the biological measurement data, an event score indicating a degree to which confirmation or an intervention behavior is to be performed by the user regarding an event that occurred with the user, the event including a change or an abnormality in a physical or mental condition of the user;
evaluating, by the processor, based on the situation expression data, a situation score indicating a degree of a situation in which the user easily performs a behavior regarding a notification;
calculating, by the processor, based on the event score and the situation score, a notification score indicating a degree to which a timing of the notification to the user of occurrence of the event is desirable to the user, and outputting the notification score;
determining, based on whether the notification score exceeds a threshold, whether to notify the user of the event; and
outputting, based on a determination that the user is to be notified, the notification including at least one of a display on a screen including a graph of an estimated subjective value of the physical or mental condition, and a curve showing variation in the event score over time and showing a region of normal event scores, wherein the notification is output to the user at a time that is determined based on a probability of the user accepting an intervention measure.
But for the recitation of generic computer components like a processor, biological measurement sensors, heartbeat sensor (claim 1), electrodermal sensor (claim 1) and movement sensor (claim 1) these functions, when considered as a whole, describe a medical diagnostic interaction that could take place between various human entities of a patient's care team, e.g. the patient and one or more medical professionals. For example, a patient could provide biological measurement data and situation expression data related to a medical condition to a clinician during an appointment or other interaction, and the clinician might analyze the received information and other known healthcare information to make a diagnostic decision such as a list of potential diagnoses for the patient with associated degrees of urgency, severity, risk, etc. They can then notify the patient based on the information a certain way to improve the chances of the patient accepting the intervention measure. Thus, claim 10 recites an abstract idea, as does claim 1 which recites substantially similar subject matter.
Dependent claims 4-8 inherit the limitations that recite an abstract idea from their dependence on claim 1, and dependent claims 13, 15 and 18 inherit the limitations that recite an abstract idea from their dependence on claim 10 and thus these claims also recite an abstract idea under the Step 2A - Prong 1 analysis.
Claim 8 specifies that based on a score, the clinician may or may not disclose to the patient information.
Claims 4 and 13 specify showing or displaying results to a patient.
Claims 5-7 specify the time frames being reviewed.
Claims 15 and 18 further limit a notification based on the probability of the user being able to respond to it.
However, recitation of an abstract idea is not the end of the analysis. Each of the claims must be analyzed for additional elements that indicate the abstract idea is integrated into a practical application to determine whether the claim is considered to be “directed to” an abstract idea.
Step 2A- Prong 2
The judicial exception is not integrated into a practical application. The additional elements of claims 1, 4-8, 10, 13, 15 and 18 include a processor, a memory storing a program, biological measurement sensors, heartbeat sensor, electrodermal sensor and movement sensor to perform the various functions/steps.
These additional elements, when considered in the context of each claim as a whole, merely serve to automate interactions and behavior that could occur between and by human actors (as described above), and thus amount to implementation of an abstract idea on generic computer components. For example, various entities of a patient care team can interact to share information, make diagnostic decisions, and output data. The processor, a memory storing a program, biological measurement sensors, heartbeat sensor, electrodermal sensor and movement sensor, merely digitizes these otherwise-abstract functions, and thus these generic computer elements amount to mere instructions to apply the abstract idea on a computer (see MPEP 2106.05(f)).
The judicial exception recited in dependent claims 4-8, 13, 15 and 18 are also not integrated into a practical application under a similar analysis as above. Although, additional elements processor, memory storing a program, and biological measurement sensors are seen in claims 4-8, 13, 15 and 18, they also amount to using generic computer elements to apply an abstract idea on a computer (see MPEP 2106.05(f)).
Accordingly, the additional elements of claims 1, 4-8, 10, 13, 15 and 18 do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Claims 1, 4-8, 10, 13, 15 and 18 are directed to an abstract idea.
Step 2B
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of the various units of the healthcare device used to perform the receiving, evaluating, calculating and outputting, etc. steps of the invention amount to no more than mere instructions to apply the exception using generic computer components (see MPEP 2106.05(f)). As evidence of the generic nature of the above recited additional elements, Examiner notes at least paragraphs 48 and 53 of Applicant’s specification, which describe the healthcare device and its associated components in terms of known types of computing devices such as a smart phone and smart watch. These disclosures do not indicate that the elements of the invention are particular machines and provide generic examples of computer hardware, such that one of ordinary skilled the art would understand that any generic computing device could be used to implement the healthcare device. Further, the combination of these additional elements is not expanded upon in the specification as a unique arrangement and as such relies on the knowledge of one of ordinary skill in the art to understand the combination of components within a computer system as a well-known and generic combination for automating an abstract idea that could otherwise be performed as a certain method of organizing human activity and thus do not provide an inventive concept.
Analyzing these additional elements as an ordered combination adds nothing that is not already present when considering the elements individually; the overall effect of the electronic implementation, the processor, a memory storing a program, biological measurement sensors, heartbeat sensor, electrodermal sensor and movement sensor in combination is to digitize and/or automate a health data sharing and medical diagnosis operation that could otherwise be achieved as a certain method of organizing human activity. Thus, when considered as a whole and in combination, claims 1, 4-8, 10, 13, 15 and 18 are not patent eligible.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1, 4-8, 10, 13, 15 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Condie et al., U.S. Patent Application Publication 2020/0090812 (see attached PTO-892, Ref. A) in view of Sundaram et al., U.S. Patent 11,672,477 (see attached PTO-892, Ref. F).
As per claim 1, Condie teaches a biological measurement data processing device comprising:
a plurality of biological measurement sensors configured to obtain biological measurements of a user including at least one of a heartbeat sensor, electrodermal sensor, or a movement sensor (see paragraph 49);
a memory storing a program (see Figure 11 and paragraphs 94-102); and
a processor configured to execute the program (see Figure 11 and paragraphs 94-102), which when executed causes the processor to
receive biological measurement data of the user and situation expression data expressing a situation of the user, including at least one of a heartbeat sensor, an electrodermal sensor, or a movement sensor (see paragraph 40, mental health module, 102 and paragraph 49, user's smart watch or other wearable sensor, and data from sensors such as sleep apnea devices);
evaluate, based on the biological measurement data, an event score indicating a degree to which confirmation or an intervention behavior is to be performed by the user regarding an event that occurred with the user, the event including a change or an abnormality in a physical or mental condition of the user (see paragraphs 41, heart rate data, bp data and paragraphs 64-66, 75 and 84);
evaluate, based on the situation expression data, a situation score indicating a degree of a situation in which the user easily performs a behavior regarding a notification (see paragraph 42, ratings); and
calculate, based on the event score and the situation score, a notification score expressing a degree to which a timing of the notification to the user of occurrence of the event is desirable for the user, and output the notification score (see paragraph 58, overall health score and paragraphs 63-66)
determine, based on whether the notification score exceeds a threshold, whether to notify the user of the event (see paragraphs 64-66); and
output, based on a determination that the user is to be notified, the notification including a display on a screen including a graph of an estimated subjective value of the physical or mental condition, and a curve showing variation in the event score over time and showing a region of normal event scores (see paragraphs 50 and 74-75 and Figures 3 and 7).
Examiner notes that although Condie discloses the above limitations, Condie does not use the same terminology as seen in claims 1, 4-8, 10, 13, 15 and 18 of instant application. Condie also discloses health data which is equivalent to biological measurement data of a user and rating that include metrics which is equivalent to situation expression data expressing a situation of the user. Also, an event score or situation score is similar to Condie’s rating while the notification score is equivalent to overall health score.
Therefore, it would be prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify Condie because simple substitution of one known element or term for another to obtain predictable results will help individuals control their overall health and wellbeing by recording data, seeing historical trends and receiving predictions and advice as taught by Condie (see paragraph 24).
Sundaram teaches wherein the notification is output to the user at a time that is determined based on a probability of the user accepting an intervention measure (see column 9, lines 64-67, column 10, lines 1-8 and 40-60 and column 22, lines 20-34).
Therefore, it would be prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to combine the teachings of Condie and Sundaram to determine the probability if a user confirms a notification and responds to it because it would help individuals control their overall health and wellbeing as taught Condie (see paragraph 6).
As per claim 4, Condie and Sundaram teach the device of claim 1. Condie further teaches wherein the program further causes the processor to display, on a terminal used by the user, at least one of the notification score calculated by the notification score evaluation unit and the event score evaluated by the event score evaluation unit as the notification indicating occurrence of the event (see Figure 7, “Overall Score”, and paragraph 74).
As per claim 5, Condie and Sundaram teach the device of claim 1. Condie further teaches wherein
the processor evaluates the event score up to a time point t (see paragraph 74-75, The user may request any suitable graph that may compare different metrics against each other, may compare metrics over time),
evaluates the situation score up to a time point (t + T) that is a time point after the time point t by a time T (see paragraph 74-75, The user may request any suitable graph that may compare different metrics against each other, may compare metrics over time), and
calculates the notification score up to the time point (t + T) based on the event score up to the time point t and the situation score up to the time point (t + T) (see paragraph 74-75, The user may request any suitable graph that may compare different metrics against each other, may compare metrics over time).
As per claim 6, Condie and Sundaram teach the device of claim 1. Condie further teaches wherein
among a plurality of the notification scores calculated at a plurality of time points, the processor sets the notification scores whose calculation time points are within a predetermined time range as a group of notification scores, and performs the notification determination based on the group of notification scores (see paragraph 74-75, The user may request any suitable graph that may compare different metrics against each other, may compare metrics over time…It should be appreciated that the system can generate any suitable reports or graphs that are beneficial to the user in different implementations… This allows the user to identify trends in their moods and emotions and allows the user to preemptively take actions that might be needed as the user experiences trials and stressful experiences), and
collectively outputs a plurality of notifications indicating occurrence of the event based on a result of the notification determination (see paragraph 74-75, The user may request any suitable graph that may compare different metrics against each other, may compare metrics over time…It should be appreciated that the system can generate any suitable reports or graphs that are beneficial to the user in different implementations… This allows the user to identify trends in their moods and emotions and allows the user to preemptively take actions that might be needed as the user experiences trials and stressful experiences).
As per claim 7, Condie and Sundaram teach the device of claim 1. Condie further teaches wherein the processor discretizes the situation expression data in any period of time by a predetermined time width, and stores the discretized situation expression data as a code string of a behavior pattern in the period of time (see paragraphs 74-75).
As per claim 8, Condie and Sundaram teach the device of claim 1. Condie further teaches wherein the processor determines at least one of an information amount to be presented and a response amount required for the user in the notification output based on predetermined setting (see paragraphs 65-66).
As per claim 10, Condie teaches:
receiving, by a processor, biological measurement data of a user from a plurality of biological measurement sensors and situation expression data expressing a situation of the user (see paragraphs 40-41, mental health module, 102);
evaluating, by the processor, based on the biological measurement data, an event score indicating a degree to which confirmation or an intervention behavior is to be performed by the user regarding an event that occurred with the user, the event including a change or an abnormality in a physical or mental condition of the user (see paragraphs 41, heart rate data, bp data and paragraphs 64-66, 75 and 84);
evaluating, by the processor, based on the situation expression data, a situation score indicating a degree of a situation in which the user easily performs a behavior regarding a notification (see paragraph 42, ratings); and
calculating, by the processor, based on the event score and the situation score, a notification score indicating a degree to which a timing of the notification to the user of occurrence of the event is desirable to the user, and outputting the notification score (see paragraph 58, overall health score and paragraphs 63-66);
determining, based on whether the notification score exceeds a threshold, whether to notify the user of the event (see paragraph 64-66); and
outputting, based on a determination that the user is to be notified, the notification including at least one of a display on a screen including a graph of an estimated subjective value of the physical or mental condition, and a curve showing variation in the event score over time and showing a region of normal event scores (see paragraphs 50 and 74-75 and Figures 3 and 7).
Examiner notes that although Condie discloses the above limitations, Condie does not use the same terminology as seen in claims 1, 4-8, 10, 13, 15 and 18 of instant application. Condie also discloses health data which is equivalent to biological measurement data of a user and rating that include metrics which is equivalent to situation expression data expressing a situation of the user. Also, an event score or situation score is similar to Condie’s rating while the notification score is equivalent to overall health score.
Therefore, it would be prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify Condie because simple substitution of one known element or term for another to obtain predictable results will help individuals control their overall health and wellbeing by recording data, seeing historical trends and receiving predictions and advice as taught by Condie (see paragraph 24).
Sundaram teaches wherein the notification is output to the user at a time that is determined based on a probability of the user accepting an intervention measure (see column 9, lines 64-67, column 10, lines 1-8 and 40-60 and column 22, lines 20-34).
Therefore, it would be prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to combine the teachings of Condie and Sundaram to determine the probability if a user confirms a notification and responds to it because it would help individuals control their overall health and wellbeing as taught Condie (see paragraph 6).
As per claim 13, Condie and Sundaram teach the method of claim 10. Condie further teaches a result display step of displaying, on a terminal used by the user, at least one of the notification score calculated in the notification score evaluation step and the event score evaluated in the event score evaluation step as the notification indicating occurrence of the event (see Figure 7, “Overall Score”, and paragraph 74).
As per claim 15, Condie and Sundaram teach the device of claim 1. Sundaram further teaches wherein the degree of the situation in which the user easily performs the behavior regarding the notification is a probability that the user can confirm the notification and respond to it.
Therefore, it would be prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to combine the teachings of Condie and Sundaram to determine the probability if a user confirms a notification and responds it because it would help individuals control their overall health and wellbeing as taught Condie (see paragraph 6).
As per claim 18, Condie teaches the method of claim 10. Sundaram further teaches wherein the degree of the situation in which the user easily performs the behavior regarding the notification is a probability that the user can confirm the notification and respond to it.
Therefore, it would be prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to combine the teachings of Condie and Sundaram to determine the probability if a user confirms a notification and responds it because it would help individuals control their overall health and wellbeing as taught Condie (see paragraph 6).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHAHID R MERCHANT whose telephone number is (571)270-1360. The examiner can normally be reached M-F 7:30-5.
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, Namrata Boveja can be reached at 571-272-8105. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Shahid Merchant/ Supervisory Patent Examiner, Art Unit 3684
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