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 Claims
This action is in reply to the claims filed on 16 March 2026. Claims 1 and 4 were amended. Claims 1-6 are currently pending and have been examined.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 4-6 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 4 recites the limitation “the clean data” in line 8. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, this element will be considered to state “the data.” Appropriate correction is required. Claims 5-6 inherit this deficiency.
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 and claims 4-6 will be analyzed in separate sections)
Claims 1-3 are rejected under 35 USC § 101
Step 1: Is the claim to a process, machine, manufacture, or composition of matter?
Claims 1-3 fall within one or more statutory categories. Claims 1-3 fall within the category of a machine.
Step 2A Prong One: Does the claim recite an abstract idea, law of nature, or natural phenomenon?
Claims 1-3 recite an abstract idea. Representative claim 1 recites:
… receiving heart rhythm data acquired in real time from the participant and processing the heart rhythm data received to generate clean data;
… receiving and analyzing the clean data at predetermined intervals to generate primary metrics by analysis of the clean data for neurochemical response associated with the participant quantitatively associated with the participant over time;
… receiving and analyzing external contextual data;
… receiving and analyzing the clean data, the primary metrics, and the external contextual data to generate secondary metrics;
wherein the primary metric is one or more of psychological safety and immersion levels.
Therefore, the claim as a whole is directed to “analyzing patient data,” which is an abstract idea because it is a method of organizing human activity. “Analyzing patient data” is considered to be a method of organizing human activity because it is an example of managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions). The broadest reasonable interpretation of the claims include the interaction between a healthcare provider and a patient.
Alternatively, the claims recite a mental process because they include concepts capable of being performed in the human mind (including an observation, evaluation, judgment, opinion) with the aid of pen and paper.
Step 2A Prong Two: Does the claim recite additional elements that integrate the judicial exception into a practical application?
This judicial exception is not integrated into a practical application. In particular, claim 1 recites the following additional element(s):
one or more processors; and
memory containing executable instructions which, when executed by the one or more processors, cause the processor to at least implement:
an ingestion data hub;
a neuroscience processing unit;
a contextual analysis unit;
a behavior analysis unit; and
a workflow management unit for controlling the ingestion data hub, the neuroscience processing unit, the contextual analysis unit, and the behavior analysis unit.
The additional elements individually or in combination do not integrate the exception into a practical application. These additional elements amount to merely reciting the words ‘‘apply it’’ (or an equivalent) with the judicial exception, or merely including instructions to implement an abstract idea on a computer, or merely using a computer as a tool to perform an abstract idea (see MPEP 2106.05(f)). Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Claim 1 is directed to an abstract idea.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
Claim 1 does not include additional elements, considered individually or in combination, 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 element(s), individually and in combination, amount to merely reciting the words ‘‘apply it’’ (or an equivalent) with the judicial exception, or merely including instructions to implement an abstract idea on a computer, or merely using a computer as a tool to perform an abstract idea (see MPEP 2106.05(f)). Accordingly, claim 1 is ineligible.
Dependent claim 2 recites the system of claim 1, wherein:
the secondary metrics include at least one of emotional wellbeing, energy, mood, and peak immersion value for a given time frame.
This merely further limits the abstract idea of claim 1 discussed above and does not provide further additional elements. Therefore, claim 2 is considered to be ineligible.
Dependent claim 3 recites the system of claim 1, wherein:
the external contextual data include at least one of location, proximity of related persons, time of day, day of a week, weather conditions, traffic conditions, measured activity levels, calendar events, biofeedback, survey results and information provided by the participant, tracked usage of software applications, engagement with social media, and sleep patterns.
This merely further limits the abstract idea of claim 1 discussed above and does not provide further additional elements. Therefore, claim 3 is considered to be ineligible.
Claims 4-6 are rejected under 35 USC § 101
Step 1: Is the claim to a process, machine, manufacture, or composition of matter?
Claims 4-6 fall within one or more statutory categories. Claims 4-6 fall within the category of a process.
Step 2A Prong One: Does the claim recite an abstract idea, law of nature, or natural phenomenon?
Claims 4-6 recite an abstract idea. Representative claim 4 recites:
collecting at a photoplethysmographic (PPG) sensor, data related to the individual, wherein the data include neurophysiologic measurements and contextual information in real time;
pre-processing the data;
calculating primary metrics by analysis of the clean data neurochemical response associated with the participant; and
calculating secondary metrics associated with the participant over time,
wherein collecting data includes collecting neurophysiologic measurements in at least 1 Hz intervals,
wherein calculating primary metrics includes using the neurophysiological measurements to calculate at least one of immersion and psychological safety, and
wherein calculating secondary metrics includes combining the primary metrics so calculated with contextual information to generate the secondary metrics.
Therefore, the claim as a whole is directed to “analyzing patient data,” which is an abstract idea because it is a method of organizing human activity. “Analyzing patient data” is considered to be a method of organizing human activity because it is an example of managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions). The broadest reasonable interpretation of the claims include the interaction between a healthcare provider and a patient.
Alternatively, the claims recite a mental process because they include concepts capable of being performed in the human mind (including an observation, evaluation, judgment, opinion) with the aid of pen and paper.
Step 2A Prong Two: Does the claim recite additional elements that integrate the judicial exception into a practical application?
This judicial exception is not integrated into a practical application. In particular, claim recites the following additional element(s):
transmitting the data to an assessment system.
The additional elements individually or in combination do not integrate the exception into a practical application. These additional element amounts to merely reciting the words ‘‘apply it’’ (or an equivalent) with the judicial exception, or merely including instructions to implement an abstract idea on a computer, or merely using a computer as a tool to perform an abstract idea (see MPEP 2106.05(f)). Further, transmitting data between systems is considered to be insignificant extra-solution activity (see MPEP 2106.05(g)). Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Claim 1 is directed to an abstract idea.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
Claim 1 does not include additional elements, considered individually or in combination, 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 element, individually and in combination, amounts to merely reciting the words ‘‘apply it’’ (or an equivalent) with the judicial exception, or merely including instructions to implement an abstract idea on a computer, or merely using a computer as a tool to perform an abstract idea (see MPEP 2106.05(f)). Further, transmitting data over a network is considered to be well-understood, routine, and conventional (see MPEP 2106.05(d)(II)(i); “Receiving or transmitting data over a network” listed as an example of a well‐understood, routine, and conventional function). Accordingly, claim 1 is ineligible.
Dependent claim 5 recites the method of claim 4, wherein:
calculating secondary metrics further includes generating a predicted value of at least one primary metric and a secondary metric at a future time point.
This merely further limits the abstract idea of claim 1 discussed above and does not provide further additional elements. Therefore, claim 5 is considered to be ineligible.
Dependent claim 6 recites the method of claim 4, wherein:
calculating secondary metrics includes calculating at least one of emotional wellbeing, energy, mood, and a peak immersion value for a given time frame.
This merely further limits the abstract idea of claim 1 discussed above and does not provide further additional elements. Therefore, claim 6 is considered to be ineligible.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over Rothman et al. U.S. (2018/0301220), hereinafter “Rothman,” in view of Söhne et al. (U.S. 2020/0035337), hereinafter “Sohne.”
Regarding claim 1, Rothman discloses a neurophysiologic assessment system for assessing primary metrics of a participant and extracting secondary metrics over time, the system comprising:
one or more processors (See Rothman [0191] the system can include the use of processors and memory.); and
memory containing executable instructions which, when executed by the one or more processors (See Rothman [0191] the system can include the use of processors and memory.), cause the processor to at least implement:
an ingestion data hub for receiving heart rhythm data acquired in real time from the participant (See Rothman [0030] system collects heart rate, heart rate variability. [0043] system may provide something like an EKG trace from the patient. [0057] a heart rate signal from a wearable sensor device may be almost continuously updated. This is understood to mean that the heart rate data is collected in real-time. See also [0041] for system use of a real-time operating system. [0105] system can collect heart rhythm data. See also [0178].) and processing the heart rhythm data received to generate clean data (See Rothman [0070] the system can receive incoming patient data and convert (transform) the data into a usable format.);
a neuroscience processing unit for receiving and analyzing the clean data at predetermined intervals to generate primary metrics … (See Rothman [0070] the system can convert raw patient data into scaled numbers (i.e. “primary metrics)” based on various derived transformation functions. See also [0071]. [0057] different types of data received at different intervals.);
a contextual analysis unit for receiving and analyzing external contextual data (See Rothman [0072] the system can apply contextual data to the received/calculated metrics (i.e. the “primary metrics”). [0073] the system can support a rich contextual approach to health score analysis by having the context information of the patient's state or actions at the time of sensors measurement provide an opportunity to derive meaning from the context.);
a behavior analysis unit for receiving and analyzing the clean data, the primary metrics, and the external contextual data to generate secondary metrics quantitatively associated with the participant over time (See Rothman [0072] the system can apply contextual data to the received/calculated metrics (i.e. the “primary metrics”). [0073] the system can support a rich contextual approach to health score analysis by having the context information of the patient's state or actions at the time of sensors measurement provide an opportunity to derive meaning from the context. See also [0070].); and
a workflow management unit for controlling the ingestion data hub, the neuroscience processing unit, the contextual analysis unit, and the behavior analysis unit (See Rothman [0193] the system includes the use of a processor that can execute code or instructions to perform the operations and functionality described herein, manage request flow and address mappings, and to perform calculations and generate commands. [0065] this paragraph lists various modules used to perform the various tasks disclosed by the system.);
wherein the primary metric is one or more of psychological safety and immersion levels (See Rothman [0045] system can determine state of mind, mental acuity, attention (i.e. “immersion”), alertness, other psychological or other emotional qualities of the patient. [0047] system can use data connected to patient query responses about socializing. [0110] a determination of patient health level can be connected to social wellbeing. These metrics connected to socializing meets the broadest reasonable interpretation of psychological safety.”).
Rothman does not disclose:
[generate the primary metrics] by analysis of the clean data for neurochemical response associated with the participant.
Sohne teaches:
[generate the primary metrics] by analysis of the clean data for neurochemical response associated with the participant (See Sohne [0035] system can use heart rate and heart rate variability to indirectly determine flow and emotional state of a user, which is also reflected in the balance between the sympathetic and parasympathetic portions of the autonomic nervous system of the user. This is understood to be a neurochemical response because it relates the heart rate measurement to the function and balance of the autonomic nervous system.).
The system of Sohne is applicable to the disclosure of Rothman as they both share characteristics and capabilities, namely, they are directed to analyzing heart rate for health assessment. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Rothman to include HRV/nervous system correlation as taught by Sohne. One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Rothman in order to provide quantified information regarding the users' balance which is easily used and does not require extensive biofeedback equipment (see Sohne [0021]).
Regarding claim 2, Rothman in view of Sohne discloses the system of claim 1 as discussed above. Rothman further discloses a system, wherein:
the secondary metrics include at least one of emotional wellbeing, energy, mood, and peak immersion value for a given time frame (See Rothman [0060] collected patient data can include mood. [0110] health of a patient may relate to the patient's overall physical, mental, spiritual and social wellbeing [0135] system may include patient query responses to health and wellness related patient queries. The patient queries may seek to ascertain how the patient feels subjectively, how energetic or vital the patient is, the patients quality of life, how the patient is eating and sleeping, how the patient is complying with medications and/or therapies, how the patient rates their perception of pain or discomfort, and so forth.).
Regarding claim 3, Rothman in view of Sohne discloses the system of claim 1 as discussed above. Rothman further discloses a system, wherein:
the external contextual data include at least one of location, proximity of related persons, time of day, day of a week, weather conditions, traffic conditions, measured activity levels, calendar events, biofeedback, survey results and information provided by the participant, tracked usage of software applications, engagement with social media, and sleep patterns (See Rothman [0072] Context may include information such as time since moving, activity levels, calories consumed, sleep state, sleep hygiene, other such contexts, changes in such contexts, and transitions between states associated with contexts. The collected data may be more meaningful to a health score when put in the context of what the patient is doing while the heart rate is measured. See also [0074].).
Regarding Claim 4, Rothman discloses a method for quantifying emotional well-being of an individual, the method comprising:
collecting at a photoplethysmographic (PPG) sensor, data related to the individual (See Rothman [0022]-[0023] the system can use a photoplethysmogram (PPG) sensor as pulse oximeter.), wherein the data include neurophysiologic measurements (See Rothman [0030] system collects heart rate, heart rate variability. [0043] system may provide something like an EKG trace from the patient. [0105] the system can collect data using a food assessment, a neurological assessment, a psychiatric assessment, a safety assessment, a skin assessment, a genitourinary assessment, a muscular-skeletal assessment, a respiratory assessment, a cardiac assessment, a peripheral vascular assessment, a gastrointestinal assessment, a Braden scale assessment and a pain assessment. See also [0178].) and contextual information (See Rothman [0072] the system can apply contextual data to the received/calculated metrics (i.e. the “primary metrics”). [0073] the system can support a rich contextual approach to health score analysis by having the context information of the patient's state or actions at the time of sensors measurement provide an opportunity to derive meaning from the context.), in real time (See Rothman [0057] a heart rate signal from a wearable sensor device may be almost continuously updated. This is understood to mean that the heart rate data is collected in real-time. See also [0041] for system use of a real-time operating system.);
transmitting the data to an assessment system (See Rothman [0049] various examples of patient data may be transmitted to the health score system.);
pre-processing the data (See Rothman [0070] the system can receive incoming patient data and convert (transform) the data into a usable format.);
calculating primary metrics … (See Rothman [0070] the system can convert raw patient data into scaled numbers (i.e. “primary metrics)” based on various derived transformation functions. See also [0071].); and
calculating secondary metrics associated with the participant over time (See Rothman [0072] the system can apply contextual data to the received/calculated metrics (i.e. the “primary metrics”). [0073] the system can support a rich contextual approach to health score analysis by having the context information of the patient's state or actions at the time of sensors measurement provide an opportunity to derive meaning from the context. See also [0070].),
wherein calculating primary metrics includes using the neurophysiological measurements to calculate at least one of immersion and psychological safety (See Rothman [0045] system can determine state of mind, mental acuity, attention (i.e. “immersion”), alertness, other psychological or other emotional qualities of the patient. [0047] system can use data connected to patient query responses about socializing. [0110] a determination of patient health level can be connected to social wellbeing. These metrics connected to socializing meets the broadest reasonable interpretation of psychological safety.”), and
wherein calculating secondary metrics includes combining the primary metrics so calculated with contextual information to generate the secondary metrics (See Rothman [0072] the system can apply contextual data to the received/calculated metrics (i.e. the “primary metrics”). [0073] the system can support a rich contextual approach to health score analysis by having the context information of the patient's state or actions at the time of sensors measurement provide an opportunity to derive meaning from the context. See also [0070].).
Rothman does not disclose:
[calculating the primary metrics] by analysis of the clean data neurochemical response associated with the participant;
wherein collecting data includes collecting neurophysiologic measurements in at least 1 Hz intervals.
Sohne teaches:
[calculating the primary metrics] by analysis of the clean data neurochemical response associated with the participant (See Sohne [0035] system can use heart rate and heart rate variability to indirectly determine flow and emotional state of a user, which is also reflected in the balance between the sympathetic and parasympathetic portions of the autonomic nervous system of the user. This is understood to be a neurochemical response because it relates the heart rate measurement to the function and balance of the autonomic nervous system.);
wherein collecting data includes collecting neurophysiologic measurements in at least 1 Hz intervals (The system collects heart rate variability data at a rate of at least 100Hz. Because 100HZ is at least 1Hz, this meets the broadest reasonable interpretation of this claim element.).
The system of Sohne is applicable to the disclosure of Rothman as they both share characteristics and capabilities, namely, they are directed to analyzing heart rate for health assessment. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Rothman to include HRV/nervous system correlation as taught by Sohne. One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Rothman in order to provide quantified information regarding the users' balance which is easily used and does not require extensive biofeedback equipment (see Sohne [0021]).
Regarding claim 5, Rothman in view of Sohne discloses the method of claim 4 as discussed above. Rothman further discloses a system, wherein:
calculating secondary metrics further includes generating a predicted value of at least one primary metric and a secondary metric at a future time point (See Rothman [0052] system can make recommendations about future care of patient based on the collected patient data. [0092] use metrics as predictive indicators of a decline in health. [0095] system can be used to make predictions about medical emergencies. [0113] system can predict crisis by comparing patient health scores to a standard recovery or wellness curve. This meets the broadest reasonable interpretation of “metric at a future time point.”).
Regarding claim 6, Rothman in view of Sohne discloses the method of claim 4 as discussed above. Rothman further discloses a system, wherein:
calculating secondary metrics includes calculating at least one of emotional wellbeing, energy, mood, and a peak immersion value for a given time frame (See Rothman [0060] collected patient data can include mood. [0110] health of a patient may relate to the patient's overall physical, mental, spiritual and social wellbeing [0135] system may include patient query responses to health and wellness related patient queries. The patient queries may seek to ascertain how the patient feels subjectively, how energetic or vital the patient is, the patients quality of life, how the patient is eating and sleeping, how the patient is complying with medications and/or therapies, how the patient rates their perception of pain or discomfort, and so forth.).
Response to Arguments
Applicant's arguments filed 16 March 2026, with respect to the 35 U.S.C. §101 rejection of the claims, have been fully considered but they are not persuasive. First, Applicant argues that the claims cannot recite a method of organizing human activity because the specification does not recite a healthcare provider (see Applicant Remarks pages 6-8). This is not persuasive. Simple stating that the method is performed by a computer, with no healthcare provider required, does not mean the activity recited is not activity typically performed by a healthcare provider. In the present claims, the system receives heart rhythm data and uses that to make a determination on the user’s (i.e. the patient’s) mental or emotional state (in the form of psychological safety or immersion). This is reasonably interpreted to be activity that can be carried out between a healthcare provider and a patient.
Next, Applicant argues that the claims are integrated into a practical application under Step 2A Prong Two (see Applicant Remarks page 8). This is not persuasive. The recited additional elements amount to merely reciting the words ‘‘apply it’’ (or an equivalent) with the judicial exception, or merely including instructions to implement an abstract idea on a computer, or merely using a computer as a tool to perform an abstract idea (see MPEP 2106.05(f)). This is not enough to integrate the abstract idea into a practical application.
Finally, Applicant argues that the claims amount to significantly more than the judicial exception under step 2B (see Applicant Remarks pages 8-9). This is not persuasive. The recited additional elements amount to merely reciting the words ‘‘apply it’’ (or an equivalent) with the judicial exception, or merely including instructions to implement an abstract idea on a computer, or merely using a computer as a tool to perform an abstract idea (see MPEP 2106.05(f)). This is not enough to amount to significantly more than the judicial exception. Accordingly, the claims remain rejected for being directed to ineligible subject matter.
Applicant's arguments filed 16 March 2026, with respect to the 35 U.S.C. §103 rejection of the claims, have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new grounds of rejection is made in view of the newly cited Sohne reference.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Iliffe-Moon et al. U.S. (2021/0257080) discloses a system and method using rhythm data to measure level of immersion or engagement.
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 BENJAMIN L HANKS whose telephone number is (571)270-5080. The examiner can normally be reached Monday-Friday 8am-5pm.
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, Shahid Merchant can be reached at (571) 270-1360. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/B.L.H./Examiner, Art Unit 3684
/Shahid Merchant/Supervisory Patent Examiner, Art Unit 3684
Prosecution Insights