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
Claim 1 has been amended.
Response to Arguments
Applicant's arguments, pages 6-8, filed 5/11/2026 have been fully considered but they are not
persuasive.
35 U.S.C. 101:
Regarding claim 1, applicant argues “a healthcare professional cannot electronically access each
of the plurality of the biosensor devices or the one or more environmental sensors to electronically obtain data therefrom using mental processes.” After further consideration, the examiner agrees that the step of using electronics to obtain data is not a mental process. However, the examiner argues that the electronic biosensor devices recite pre-solution activity to the step of data gathering and does not provide significantly more to the invention.
Furthermore, applicant argues “a general purpose computer is not capable of accessing these
devices/sensors without specialized one or more communication interfaces adapted to communicate with each of the plurality of biosensor devices.” Applicant respectfully argues these specialized
provisions provide significantly more than instructions to apply the alleged exception
using generic computer components. After further consideration, the examiner disagrees and argues that the addition of “eye-gazing sensing devices” are well-known in the art and that the combination of such devices with a processor does not provide significantly more than instructions to apply the alleged judicial exception.
Applicant is reminded that abstract ideas cannot provide a practical application or significantly
more (e.g., an improvement). Both Step 2A Prong 2 and Step 2B require an additional element, not an abstract idea, to provide a practical application or significantly more (e.g., an improvement). See Genetic Technologies Limited v. Merial LLC (Fed Cir 2016). Here, the additional elements of claims 1-26 are merely generically recited computer elements used as tools for executing the abstract ideas or insignificant extra-solution activity.
Applicant's arguments, pages 6-8, filed 5/11/2026 have been fully considered but they are not
persuasive.
35 U.S.C. 103:
Regarding claim 1, applicant has amended the claim to include subject “eye-gaze sensing
devices” as well as “the plurality of biosensor devices are synchronized including subject eye-gaze time- spatial data.” Applicant further argues that Bender, alone or in combination with the prior art, does not teach these amendments. After further search and consideration, the examiner will now rely on Simon to teach these amended limitations (paragraph 73 and 77). The placement of a camera can determine the position of each or both eyes as a function of time E_i(x,y,t), where E_i is the position of the ith eye (either left or right), (x,y) is the spatial position measured of the subject’s eye gaze by the eye tracker, and time t. There is synchronous motion between the two (e.g. the plot of head rotation on the x-axis and eye gaze on the y-axis) is smooth and continuous, then this would be evidence of a well-coordinated head rotation and eye gaze.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Bender to include an eye-gazing sensor from Simon for the benefit of identifying evidence for abnormal head rotation and gaze, thereby signaling a need for further evaluation.
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 1-26 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an
abstract idea without significantly more. Claims 1 recites a system with instructions for performing operations of the device comprising:
assign a timestamp to the received biodata;
store received biodata along with the assigned timestamp into a database and the environmental data;
analyze stored data along with the assigned timestamp to predict an evoked response to one or more stimuli and the environmental data;
provide a feedback to the subject or a healthcare worker based on the analysis.
To determine whether a claim satisfies the criteria for subject matter eligibility, the claim is
evaluated according to a stepwise process as described in MPEP 2106(III) and 2106.03-2106.05. The instant claims are evaluated according to such analysis.
Step 1: Is the claim to a process, machine, manufacture or composition of matter?
Claim 1 is directed to an apparatus/system and thus meet the requirements for step 1.
Step 2A (Prong 1): Does the claim recite an abstract idea, law of nature, or natural
phenomenon?
Claims 1 recites a system with instructions for performing operations of the device comprising:
assign a timestamp to the received biodata;
store received biodata along with the assigned timestamp into a database and the environmental data;
analyze stored data along with the assigned timestamp to predict an evoked response to one or more stimuli and the environmental data;
provide a feedback to the subject or a healthcare worker based on the analysis.
If a claim limitation, under its broadest reasonable interpretation, covers performance of the
limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Therefore, claim 1 recite an abstract idea of a mental process.
Claim 1 recite the abstract idea of a mental process. The limitations as drafted in the
claims, under its broadest reasonable interpretation, covers performance of the claimed steps in the mind, but for the recitation of a generic processor. Other than reciting a generic processing system and memory, nothing in the elements of the claims precludes the step from practically being performed in the mind or manually by a clinician. For example:
“Assign a timestamp to the received biodata;” A physician may assign a timestamp to biodata while performing the data gathering step.
“Store received biodata along with the assigned timestamp into a database and the environmental data;” A physician may store biodata along with their assigned timestamps using pen and paper. A physician may gather environmental data through observational analysis and manual sensors.
“Analyze stored data along with the assigned timestamp to predict an evoked response to one or more stimuli and the environmental data;” A physician may make analysis with equation using biodata, environmental data, and assigned timestamps.
“Provide a feedback to the subject or a healthcare worker based on the analysis.” A physician may give visual or auditory feedback to a patient based on their analysis.
Claim 3:
“Wherein the timestamp is generated based on a predetermined period divided by the sampling rate.” A physician may control the timestamp appearance based on a predetermined period divided by the sampling rate using simple division calculations after necessary data is collected.
Step 2A (Prong 2): Does the claim recite additional elements that integrate the judicial
exception into a practical application?
Claims 1, 4, 14, 17, and 19 recite the additional elements of a “subject eye-gaze sensing devices,” “a plurality of biosensor devices”, “one or more communication interfaces”, “a processor executing software on a non-transitory memory”, “a smartdevice”, “one or more of intelligent devices including virtual reality (VR) headsets, smart glasses, and artificial intelligent devices”, “a continuous glucose monitoring device”, “a muscle contraction measurement device,” which are being interpreted as a processor of a data gathering device.
Subject eye-gaze sensing devices and a plurality of biosensor devices, a continuous glucose monitoring device, and a muscle contraction measurement device are recited as pre-resolution activity for the step of data gathering. The examiner suggest amending claim 1 to recite a structural combination of these elements.
One or more of intelligent devices including virtual reality (VR) headsets, smart glasses, and artificial intelligent devices are computer implementation to perform the abstract idea of analysis of the biodata and providing feedback.
However, these elements are recited at a high level of generality performing the function of generic data processing such that they amount to no more than mere instructions to simply implement the abstract idea using generic computer components. See MPEP 2106.05(b) and (f).
Accordingly, the additional elements do not integrate the abstract idea into a practical
application.
Step 2B: Does the claim recite additional elements that amount to significantly more than the
judicial exception?
The additional elements when considered individually and in combination are not enough to
qualify as significantly more than the abstract idea.
Subject eye-gaze sensing devices and a plurality of biosensor devices, a continuous glucose monitoring device, and a muscle contraction measurement device are recited as pre-resolution activity for the step of data gathering. The examiner suggest amending claim 1 to recite a structural combination of these elements.
One or more of intelligent devices including virtual reality (VR) headsets, smart glasses, and artificial intelligent devices are computer implementation to perform the abstract idea of analysis of the biodata and providing feedback.
As discussed above with respect to integration of the abstract idea into a practical application, “subject eye-gaze sensing devices,” “a plurality of biosensor devices”, “one or more communication interfaces”, “a processor executing software on a non-transitory memory”, “a smartdevice”, “one or more of intelligent devices including virtual reality (VR) headsets, smart glasses, and artificial intelligent devices”, “a continuous glucose monitoring device”, “a muscle contraction measurement device,” which are being interpreted as a processor of a data gathering device as recited to perform the steps of:
receive biodata;
assign a timestamp to the received biodata;
store received biodata along with the assigned timestamp into a database and the environmental data;
analyze stored data along with the assigned timestamp to predict an evoked response to one or more stimuli and the environmental data;
provide a feedback to the subject or a healthcare worker based on the analysis.
amount to no more than mere instructions to apply the exception using generic computer
components. Mere instructions to apply an exception using generic components cannot provide an inventive concept. These additional elements are well‐understood, routine (For example Bender et al. US 20200126670 A1, hereinafter Bender) teaches a data gathering device with a processor and memory, and conventional limitations that amount to mere instructions or elements to implement the abstract idea. In addition, the end result of the system/method, the essence of the whole, is a patent-ineligible concept. Therefore, the claims are not patent eligible.
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.
Claims 1-14, 16, and 21-26 are rejected under 35 U.S.C. 103 as being unpatentable by
Bender et al. US Pub.: US 20200126670 A1, hereinafter Bender in view of SIMON et al. US Pub.: US 20170112427 A1, hereinafter Simon.
Regarding claim 1, Bender teaches a system for integrating a plurality of biosensor devices (27),
comprising: a plurality of biosensor devices (27) connected to a subject and configured to be electronically accessible (fig. 9; paragraph 130-135);
one or more communication interfaces (22) adapted to communicate with each of the plurality of biosensor devices (27) (fig. 9; paragraph 130-135);
a processor (16) executing software on a non-transitory memory (28), the execution of the software configures the processor to: establish an electronic communication link with each of the plurality of biosensor devices (27) each through the one or more communication interfaces (22) (fig. 9; paragraph 130-135 and 143);
receive biodata from each of the plurality of biosensor devices (27) through the one or more communication interfaces (22) at a sampling rate (27) (fig. 9; paragraph 27-31, 43, 130-135 and 143); The device takes biodata from a patient’s history and compares it to real-time data collected for stress classification. Real-time data collection of biosensors to monitor, detect, or analyze biological signals operate with a sampling rate.
assign a timestamp to the received biodata such that the received data from the plurality of biosensor devices are synchronized (fig. 9; paragraph 27-31 and 43); A client computer device incorporating a biometric sensor, at a time of output of biometric data by biometric sensor can tag output biometric data with a timestamp and geo-stamp specifying time and location of biometric data output.
Electronically receive environmental data via one or more environmental sensors (fig. 9; paragraph 135); One or more sensor device 27 can include a Global Positioning Sensor (GPS), which equates to an environmental sensor.
store received biodata along with the assigned timestamp into a database and the environmental data (fig. 9; paragraph 135);
analyze stored data along with the assigned timestamp to predict an evoked response to one or more stimuli and the environmental data (fig. 9; paragraph 27-31 and 43-48); The device takes into account assigned timestamped biodata and environmental data for the manager system 110 running machine learning process 117 can train one or more predictive model for use by manager system 110 in returning predictions e.g. such as the described prediction of a returned stress level of a user in response to a presented topic/stimuli.
and provide a feedback to the subject or a healthcare worker based on the analysis (fig. 9; paragraph 27-31 and 43-48); The device may provide feedback to a caregiver user so that the caregiver user interacts with a certain user in a manner that reduces a stress level of the certain user.
However, Bender does not teach an eye-gaze sensing devices and wherein the plurality of biosensor devices are synchronized including subject eye-gaze time- spatial data.
Simon teaches a health assessment system and further teaches an eye-gaze sensing devices and wherein the plurality of biosensor devices are synchronized including subject eye-gaze time- spatial data (paragraph 73 and 77). The placement of a camera can determine the position of each or both eyes as a function of time E_i(x,y,t), where E_i is the position of the ith eye (either left or right), (x,y) is the spatial position measured of the subject’s eye gaze by the eye tracker, and time t. There is synchronous motion between the two (e.g. the plot of head rotation on the x-axis and eye gaze on the y-axis) is smooth and continuous, then this would be evidence of a well-coordinated head rotation and eye gaze.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Bender to include an eye-gazing sensor from Simon for the benefit of identifying evidence for abnormal head rotation and gaze, thereby signaling a need for further evaluation.
Regarding claim 2, Bender in view of Simon teaches the claimed invention and Bender further
teaches wherein the timestamp is provided by the plurality of the biosensor devices (27) (fig. 9; paragraph 27-31 and 43).
Regarding claim 3, Bender in view of Simon teaches the claimed invention and Bender further
teaches wherein the timestamp is generated based on a predetermined period divided by the sampling rate (fig. 9; paragraph 27-31 and 43). A client computer device incorporating a biometric sensor, at a time of output of biometric data by biometric sensor can tag output biometric data with a timestamp and geo-stamp specifying time and location of biometric data output. An output biometric data is tagged; therefore, a division or separation of the sampling rate has occurred.
Regarding claim 4, Bender in view of Simon teaches the claimed invention and Bender further
teaches wherein the plurality of biosensor devices (27) includes a smartdevice (fig. 1; paragraph 23 and 107). The system includes a smart watch in communication with the biosensor device.
Regarding claim 5, Bender in view of Simon teaches the claimed invention and Bender further
teaches wherein the smartdevice provides heart rate biodata (fig. 9; paragraph 27 and 135).
Regarding claim 6, Bender in view of Simon teaches the claimed invention and Bender further
teaches wherein the smartdevice provides electrocardiogram biodata (fig. 9; paragraph 27 and 135).
Regarding claim 7, Bender in view of Simon teaches the claimed invention and Bender further
teaches wherein the smartdevice provides blood oxygen saturation biodata (fig. 9; paragraph 135). A pulse oximeter measures blood oxygen saturation of a patient.
Regarding claim 8, Bender in view of Simon teaches the claimed invention and Bender further
teaches wherein the smartdevice provides blood pressure biodata (fig. 9; paragraph 135).
Regarding claim 9, Bender in view of Simon teaches the claimed invention and Bender further
teaches wherein the smartdevice provides caloric expenditure Biodata (fig. 9; paragraph 27 and 135). Calorie expenditure may be measured using heart rate and motion data.
Regarding claim 10, Bender in view of Simon teaches the claimed invention and Bender further
teaches wherein the smartdevice provides sleep pattern biodata (fig. 9; paragraph 27 and 135). Heart rate and brain wave activity measure from EKG and EEG may determine sleep pattern biodata.
Regarding claim 11, Bender teaches, wherein the smartdevice provides perspiration biodata (fig. 9; paragraph 135). A humidity sensor detects a patient’s perspiration.
Regarding claim 12, Bender in view of Simon teaches the claimed invention and Bender further
teaches wherein the smartdevice provides position information of the subject (fig. 9; paragraph 135). A gyroscope detects a patient’s change in orientation. Therefore, the position of a patient is measured.
Regarding claim 13, Bender in view of Simon teaches the claimed invention and Bender further
teaches wherein the environmental data includes geographical locations (fig. 9; paragraph 135).
Regarding claim 14, Bender in view of Simon teaches the claimed invention and Bender further
teaches wherein the plurality of biosensor devices includes one or more of intelligent devices including virtual reality (VR) headsets, smart glasses, and artificial intelligent devices (fig. 9; paragraph 107). Artificial intelligent devices and platforms are used within the computer system for processing data.
Regarding claim 16, Bender in view of Simon teaches the claimed invention and Bender further
teaches wherein the one or more intelligent devices provide eye movement biodata (fig. 9; paragraph 27 and 135). A camera sensor for use in sensing facial expressions of a user, which includes eye movement data.
Regarding claim 21, Bender in view of Simon teaches the claimed invention and Bender further
teaches wherein the received data is based on a synchronous data transfer protocol (fig. 9; paragraph 27-31 and 43). A client computer device incorporating a biometric sensor, at a time of output of biometric data by biometric sensor can tag output biometric data with a timestamp and geo-stamp specifying time and location of biometric data output. The timestamp and biometric data are received and synchronized as a tag output.
Regarding claim 22, Bender in view of Simon teaches the claimed invention and Bender further
teaches wherein the storing of the data is based on using a direct memory access protocol (fig. 9; paragraph 130-135 and 143).
Regarding claim 23, Bender in view of Simon teaches the claimed invention and Bender further
teaches wherein the one or more communication interfaces include wireless channels (paragraph 30, 61, and 144).
Regarding claim 24, Bender in view of Simon teaches the claimed invention and Bender further
teaches wherein the one or more communication interfaces are wired (paragraph 143).
Regarding claim 25, Bender in view of Simon teaches the claimed invention and Bender further
teaches wherein the wireless channels are based on Bluetooth connectivity (paragraph 30, 50, 61, and 143).
Regarding claim 25, Bender in view of Simon teaches the claimed invention and Bender further
teaches wherein the wireless channels are based on Wi-Fi connectivity (paragraph 30, 61, and 144).
Claims 15 and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Bender in
view of Simon in view of Braido et al. US Pub.: US 20210369394 A1, hereinafter Braido.
Regarding claim 15, Bender in view of Simon does not teach wherein the one or more intelligent
devices provide heatmap biodata associated with where the subject is staring
Braido, in the same field of endeavor, teaches wherein the one or more intelligent devices provide heatmap biodata associated with where the subject is staring (paragraph 201).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the display system of Bender in view of Simon to generate a heatmap from Braido for the benefit of providing a gaze heatmap for the user allowing for instant attention towards warm or cold temperatures.
Regarding claim 17, Bender in view of Simon does not teach wherein the plurality of biosensors
includes a continuous glucose monitoring device.
Braido, in the same field of endeavor, teaches wherein the plurality of biosensors includes a continuous glucose monitoring device (paragraph 46, 63, 126, 155, 158, and 363).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the biosensors of Bender in view of Simon to add the glucose monitoring system from Braido for the benefit of providing continuous glucose data to the patient.
Regarding claim 18, Bender in view of Simon does not teach wherein the continuous glucose
monitoring device provides glucose biodata.
Braido, in the same field of endeavor, teaches wherein the continuous glucose monitoring
device provides glucose biodata (paragraph 46, 63, 126, 155, 158, and 363).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the biosensors of Bender in view of Simon to add the glucose monitoring system from Braido for the benefit of providing continuous glucose data to the patient.
Regarding claim 19, Bender in view of Simon does not teach wherein the plurality of biosensors
includes a muscle contraction measurement device.
Braido, in the same field of endeavor, teaches wherein the plurality of biosensors includes a muscle contraction measurement device (paragraph 44, 61, 77, 94, 111, 128, 174, 177, 346, 349, 422, 425, 471, 474, 532, and 536). EMG equates to a muscle contraction measurement device.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the biosensors of Bender in view of Simon to add the muscle contraction measurement device from Braido for the benefit of providing muscle contraction data to the patient.
Regarding claim 20, Bender in view of Simon does not wherein the muscle contraction
measurement device provides muscle contraction biodata.
Braido, in the same field of endeavor, teaches wherein the muscle contraction measurement
device provides muscle contraction biodata (paragraph 44, 61, 77, 94, 111, 128, 174, 177, 346, 349, 422, 425, 471, 474, 532, and 536). EMG equates to a muscle contraction measurement device.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the biosensors of Bender in view of Simon to add the muscle contraction measurement device from Braido for the benefit of providing muscle contraction data to the patient.
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 THIEN J TRAN whose telephone number is (571)272-0486. The examiner can normally be reached M-F. 8:30 am - 5:30 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at 571-270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/T.J.T./Examiner, Art Unit 3792
/MALLIKA D FAIRCHILD/Primary Examiner, Art Unit 3792
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