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 .
Remarks
This action is in response to the remarks filed 12/29/2025.
Claims 1-3, 6-13, and 16-21 are pending.
Response to Arguments
Applicant’s arguments, see pages 11-19, filed 12/29/2025, with respect to the rejection of claims 1-3, 6-13, and 16-20 under 35 U.S.C. 103 have been fully considered and are persuasive. Independent claims 1, 11, and 20 have been amended to clarify that the second biometric sensor is selected based on the first suspected disease. New claim 21 has been added. Applicant argues that Wang or Wang in view of Davis does not disclose the amended limitation. Examiner agrees. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made, as explained in the office action below.
Applicant's arguments filed 12/29/2025, see pages 10-11, with regards to the rejection of the claims under 35 U.S.C. 101 have been fully considered but they are not persuasive.
Rejection of claims 1-3, 6-13, and 16-20 under 35 U.S.C. 101
Independent claims 1, 11, and 20 have been amended to clarify that the second biometric sensor is selected based on the first suspected disease. New claim 21 has been added. Applicant argues that the claimed invention is not drawn to an abstract idea, and that even if it were, the claimed features recite substantially more than an abstract idea. Further, Applicant argues that the claimed invention provides improvements in increasing the accuracy of biometric sensing information processing. However, this is not found to be persuasive.
While the claim recites additional features such as sensors, a display, memory, and one or more processors, these elements are simply being used as sensors for collecting data, a generic memory to store data, a generic processor configured to process and analyze the collected data, and a generic display to output the diagnosis. Any alleged improvement is within the abstract idea itself. As best understood, the invention is directed towards the data processing performed to identify disease information, and not the use of the additional elements. It is well known to use sensors to collect biometric data, process the data, and display the disease information (e.g. see rejection of the claims under 35 U.S.C. 103 below).
Therefore, there is no further description, in the claims or the specification, of any particular technology for performing the steps recited in the claim other than generic computer components used in their ordinary capacity as tools to apply the abstract idea. Nor does the claimed invention use a particular, or special, machine. In other words, the claims “are not tied to any particular novel machine or apparatus” capable of rescuing them from the realm of an abstract idea.
Therefore, the claims do not recite any additional elements that: (1) improve the functioning of a computer or other technology, (2) are applied with any particular machine, (3) effect a transformation of a particular article to a different state, and (4) are applied in any meaningful way beyond generally linking the use of the judicial exception to a particular technological environment or field of use. Please See MPEP § 2106.05(a)(c), (e)-(h). The rejection of the claims under 35 U.S.C. 101 is maintained. New claim 21 is addressed in the office action below.
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, 6-13, and 16-21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims recite an electronic device, method, and storage medium for determining a suspected disease. 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 2106.03-2106.04. 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 towards a device, claim 11 is directed towards a method, and claim 20 is directed towards a non-transitory computer-readable storage media. Claims 1 and 11 meet the requirements for step 1.
Step 2A (Prong 1): Does the claim recite an abstract idea, law of nature, or natural phenomenon?
Claim 1 is directed towards a device, claim 11 is directed towards a method, and claim 20 is directed towards a non-transitory computer-readable storage media for determining a suspected disease, comprising biometric sensors to acquire biometric data, identifying a parameter set associated with a plurality of suspected diseases based on the sensed electrocardiogram and a previously obtained electrocardiogram, selecting a second biometric sensor, obtaining second biometric sensing information based on second sensed biometric data, and displaying the suspected disease information based on the first and second biometric sensing information. The limitation of determining a suspected disease, as drafted in claims 1-3, 6-13, and 16-21, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind or using pen and paper, but for the recitation of generic sensing and processing components.
For example, determining a suspected disease in the context of this claim encompasses a user acquiring electrocardiogram data, identifying a suspected disease based on the sensed data, obtaining second biometric sensing information based on second sensed biometric data, and displaying the suspected disease information based on the second biometric sensing information.
The steps of acquiring electrocardiogram and biometric sensing data is considered to be a mere data gathering step (i.e. an insignificant extra-solution activity, see MPEP 2016.05(g)), and the steps of identifying a suspected disease based on the sensed electrocardiogram and a previously obtained electrocardiogram and the second biometric sensing information are considered to be a data analysis step. The step of displaying the suspected disease information is considered to be a data output step.
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. Accordingly, the claims recite an abstract idea.
Step 2A (Prong 2): Does the claim recite additional elements that integrate the judicial exception into a practical application?
The additional elements of a biometric sensors including electrodes, a sweat sensor, a blood flow sensor, a blood pressure sensor, or an iris sensor, a display, memory, and one or more processors are recited at a high level of generality (i.e., as generic computing elements performing the steps of gathering, analyzing, and displaying data) such that they amount to no more than mere instructions to apply the exception using a generic computer component.
Accordingly, these additional elements do no integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. See MPEP 2106.04(a)(2)(III)(C).
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 is not enough to qualify as significantly more than the abstract idea. As discussed above with respect to the integration of the abstract idea into a practical application, the additional elements of sensing and computing elements to gather data, perform the data analysis, and display the suspected disease amounts to no more than mere instructions to apply the exception using a generic data analysis model. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. Furthermore, the additional elements do not amount to more than generically linking the use of a judicial exception to a particular technological environment or field of use (see MPEP 2106.05(h)). Therefore, the claims are not patent eligible.
Claims 2, 3, 6-10, 12, 13, 16-19, and 21 depend on claims 1 and 11 and recite the same abstract idea as claims 1 and 11 from which they depend. Further, these claims only contain recitations that further limit the abstract idea (that is, the claims only recite limitations that further limit the mental process). For example, the additional limitations recited in claims 2, 3, 12, and 13 (i.e. identifying arrhythmia in the electrocardiogram) and claims 8-10 and 17-19 (i.e. describing the parameters used for identifying the suspected disease) are simply further data gathering and data analysis steps. The additional limitations recited in claim 21 (i.e. identifying different types of sensors) is simply a listing of types of sensors for the steps of data gathering. The additional elements individually do not amount to significantly more than the judicial exception explained above (the abstract idea). Looking at the limitations as a whole adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves any technology or includes a particular solution to a computer-based problem or a particular way to achieve a computer-based outcome. Rather, the collective functions of the claimed invention merely provides a conventional computer implementation, i.e. the computer (processor) is simply a tool to perform the claimed invention.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 6, 7, 11, 16, 20, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (US Patent Application Publication 2018/0192905, of record), hereinafter Wang, further in view of Davis et al. (US Patent 11,701,023), hereinafter Davis, and further in view of Jain et al. (US Patent 11,456,080), hereinafter Jain.
Regarding claims 1, 11, and 20, Wang discloses an electronic device, method, and non-transitory computer-readable storage medium (e.g. Abstract), comprising:
a first biometric sensor comprising a plurality of electrodes and a measurement sensor electrically connected with the plurality of electrodes, the first biometric sensor including an electrocardiogram sensor (e.g. Pars. [0017]-[0018]: electrodes and pulse oximeter);
a display (e.g. Par. [0020]: device includes a display);
memory storing one or more computer programs (e.g. Par. [0026]: memory 220 containing computer executable instructions); and
one or more processors communicatively coupled to the first biometric sensor, the display, and the memory (e.g. Par. [0025]: central processing units),
wherein the one or more computer programs include computer-executable instructions that, when executed by the one or more processors individually or collectively, cause the electronic device to (e.g. Par. [0026]: memory 220 containing computer executable instructions):
obtain, using the first biometric sensor, first biometric sensing information of a user wearing the electronic device, the first biometric sensing information including a first electrocardiogram waveform (e.g. Par. [0031]: biometric signals such as ECG are collected; Fig. 3: step 310, ECG signals are identified),
identify first parameter set among a plurality of parameter sets associated with a plurality of suspected diseases based on the first electrocardiogram waveform and a previously obtained second electrocardiogram waveform, the first parameter set including parameters associated with a first suspected disease suspected based on electrocardiogram factors by analyzing electrocardiogram factors of the first electrocardiogram waveform (e.g. Par. [0036]: disease diagnoses is made based on the biometric signals and historical data; Fig. 6: step 640, compare signal to historical data; Fig. 3: step 360, predicting an event; Fig. 5: analyzing and identifying wave features; Par. [0034]: explaining Fig. 5),
identify, from among a plurality of biometric sensors, a second biometric sensor associated with the first suspected disease among the plurality of suspected diseases (e.g. Par. [0018]: pulse oximeter is the second sensor),
obtain second biometric sensing information sensed by the second biometric sensor (e.g. Par. [0018]: pulse oximeter is the second sensor, and is used to obtain oxygen saturation; Par. [0036]: monitoring user to determine disease progression), and
display, on the display, disease information identified based on the first biometric sensing information and the second biometric sensing information (e.g. Par. [0028]: processed data is shown on the display; Fig. 3: data processing of both ECG and pulse oximetry data; Par. [0030]: describing Fig. 3).
However, Wang fails to specifically disclose wherein the suspected disease includes one of hypercalcemia, hyperkalemia, dehydration, or rehydration, wherein the second biometric sensor includes at least one of a sweat sensor, a blood sensor, a blood flow sensor, a blood pressure sensor, or an iris sensor, and specifically selecting the second biosensor based on the suspected disease. Davis, in a similar field of endeavor, is directed towards a wearable device for measuring a physiological condition of a user. Davis discloses wherein the disease could be dehydration (e.g. Col. 70, lines 5-7: “A condition of the body may include a heart condition, diabetes, a psychological condition, fatigue, dehydration, and so forth.”), and wherein one of the multiple sensors can comprise a blood pressure sensor (e.g. Col. 70, lines 34-44: the physiological sensors can include a blood pressure sensor).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Wang to include wherein the disease includes dehydration and the second sensor being a blood pressure sensor as taught by Davis, because doing so would result in the non-invasive monitoring of physiological parameters of the user.
However, Wang in view of Davis fails to specifically disclose selecting the second biosensor based on the suspected disease. Jain, in a similar field of endeavor, discloses methods and systems for adjusting data collection for disease management. Jain discloses selecting different sensors based on the suspected disease (e.g. Col. 5, lines 24-35: to improve detection of disease, the types of data collected can be changed based on the collected data).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Wang in view of Davis to include the selection of different sensors based on the suspected disease as taught by Jain, because doing so would improved detection of the disease that would allow earlier intervention and treatment.
Regarding claims 6 and 16, Wang further discloses communication circuitry, wherein the one or more computer programs further include computer-executable instructions that, when executed by the one or more processors individually or collectively, cause the electronic device to obtain the second biometric sensing information from an external device through communication with the external device by using the communication circuitry (e.g. Par. [0021]: communication component allows communication with external devices such as databases).
Regarding claim 7, Wang further discloses wherein the one or more computer programs further include computer-executable instructions that, when executed by the one or more processors individually or collectively, cause the electronic device to: obtain medical information from a medical information server through communication with the medical information server by using the communication circuitry, and obtain the second biometric sensing information from the medical information (e.g. Par. [0021]: communication component allows communication with external devices such as databases).
Regarding claim 21, Wang fails to specifically disclose wherein the plurality of biometric sensors, from which the second biometric sensor is selected, includes a photoplethysmography (PPG) sensor, a galvanic skin response sensor (GSR) sensor, an electrodermal activity (EDA) sensor capable of GSR sensing, a ballistocardiogram (BCG) sensor, a photo sensor, the sweat sensor for sensing hydration or dehydration, the blood sensor, the blood flow sensor, the blood pressure sensor, the iris sensor, and the body temperature sensor. Davis, in a similar field of endeavor, is directed towards a wearable device for measuring a physiological condition of a user. Davis discloses wherein one of the multiple sensors can comprise a blood pressure sensor (e.g. Col. 70, lines 34-44: the physiological sensors can include a blood pressure sensor).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Wang in view of Davis and Jain to include the second sensor being a blood pressure sensor as taught by Davis, because doing so would result in the non-invasive monitoring of physiological parameters of the user.
Claims 2, 3, 8-10, 12, 13, and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (US Patent Application Publication 2018/0192905, of record), hereinafter Wang, further in view of Davis et al. (US Patent 11,701,023), hereinafter Davis, and further in view of Jain et al. (US Patent 11,456,080), hereinafter Jain, as applied to claims 1 and 11 above, and further in view of Gopalakrishnan et al. (US Patent Application Publication 2015/0265164, of record), hereinafter Gopalakrishnan.
Regarding claims 2 and 12, Wang fails to specifically disclose wherein the one or more computer programs further include computer-executable instructions that, when executed by the one or more processors individually or collectively, cause the electronic device to: identify a presence or absence of an arrhythmia based on the first electrocardiogram waveform, and in response to identifying the presence of the arrhythmia, identify the suspected disease based on the first electrocardiogram waveform and the previously obtained second electrocardiogram waveform. Gopalakrishnan, in a similar field of endeavor, is directed towards tracking arrhythmia. Gopalakrishnan discloses identifying a presence or absence of an arrhythmia based on the first electrocardiogram waveform (e.g. Par. [0083]: arrhythmia is detected), and in response to identifying the presence of the arrhythmia, identifying the suspected disease based on the first electrocardiogram waveform and the previously obtained second electrocardiogram waveform (e.g. Pars. [0085]-[0086]: identifying heart health using obtained R-R intervals).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Wang in view of Davis and Jain to include identifying the presence of arrhythmia as taught by Gopalakrishnan, because doing so would result in the determination of the heart health of a user.
Regarding claims 3 and 13, Wang fails to specifically disclose wherein the one or more computer programs further include computer-executable instructions that, when executed by the one or more processors individually or collectively, cause the electronic device to: identify a presence or absence of an arrhythmia based on the first electrocardiogram waveform, identify a presence or absence of a symptom associated with the first electrocardiogram waveform, and in response to identifying the presence of the arrhythmia and the presence of the symptom, identify the suspected disease based on the first electrocardiogram waveform and the previously obtained second electrocardiogram waveform. Gopalakrishnan, in a similar field of endeavor, is directed towards tracking arrhythmia. Gopalakrishnan discloses identifying a presence or absence of an arrhythmia based on the first electrocardiogram waveform (e.g. Par. [0083]: arrhythmia is detected), identifying a presence or absence of a symptom associated with the first electrocardiogram waveform (e.g. Par. [0084]: determining heart rate variability), and in response to identifying the presence of the arrhythmia and the presence of the symptom, identify the suspected disease based on the first electrocardiogram waveform and the previously obtained second electrocardiogram waveform (e.g. Pars. [0085]-[0086]: identifying heart health using obtained R-R intervals).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Wang in view of Davis and Jain to include identifying the presence of arrhythmia and a symptom associated with the electrocardiogram as taught by Gopalakrishnan, because doing so would result in the determination of the heart health of a user.
Regarding claims 8 and 17, Wang fails to disclose wherein the electrocardiogram factors include at least one of a P wave, an RR interval, an R wave, a QRS complex, a PR interval, a PR segment, an ST segment, an ST interval, or a TP interval. Gopalakrishnan, in a similar field of endeavor, is directed towards tracking arrhythmia. Gopalakrishnan discloses wherein the electrocardiogram factors include at least one of a P wave, an RR interval, an R wave, a QRS complex, a PR interval, a PR segment, an ST segment, an ST interval, or a TP interval (e.g. Pars. [0070]-[0071]: ECG features such as P wave, T wave, etc. can be extracted and stored as subsets for later comparisons).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Wang in view of Davis and Jain to include the waveform factors as taught by Gopalakrishnan, because doing so would allow the user to determine change in ECG data over time to determine heart health.
Regarding claims 9 and 18, Wang fails to disclose wherein the one or more computer programs further include computer-executable instructions that, when executed by the one or more processors individually or collectively, cause the electronic device to: compare each of the electrocardiogram factors of the first electrocardiogram waveform with each of the electrocardiogram factors of the previously obtained second electrocardiogram waveform, identify, from among the electrocardiogram factors of the first electrocardiogram waveform, at least one electrocardiogram factor having a value changed by more than a specified threshold change value from a value of the electrocardiogram factors of the previously obtained second electrocardiogram waveform, and identify the first suspected disease corresponding to the at least one electrocardiogram factor. Gopalakrishnan, in a similar field of endeavor, is directed towards tracking arrhythmia. Gopalakrishnan discloses wherein the device is further configured to: compare each of the electrocardiogram factors of the first electrocardiogram waveform with each of the electrocardiogram factors of the previously obtained second electrocardiogram waveform, identify, from among the electrocardiogram factors of the first electrocardiogram waveform, at least one electrocardiogram factor having a value changed by more than a specified threshold change value from a value of the electrocardiogram factors of the previously obtained second electrocardiogram waveform, and identify the first suspected disease corresponding to the at least one electrocardiogram factor (e.g. Pars. [0070]-[0072]: ECG features such as P wave, T wave, etc. can be extracted and stored as subsets for later comparisons to draw conclusions about health conditions of the user).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Wang in view of Davis, Jain, and Gopalakrishnan to include the comparison of electrocardiogram factors and identification of a disease as taught by Gopalakrishnan, because doing so would allow a user to determine change in ECG data over time to determine heart health.
Regarding claims 10 and 19, Wang fails to disclose wherein the plurality of parameter sets include at least one of: the first parameter set associated with the hypercalcemia, a second parameter set associated with the dehydration, a third parameter set associated with the hyperkalemia, or a fourth parameter set associated with the rehydration. Davis, in a similar field of endeavor, is directed towards a wearable device for measuring a physiological condition of a user. Davis discloses wherein the disease could be dehydration, wherein the dataset is analyzed to determine a dehydration event occurring (e.g. Col. 70, lines 5-7: “A condition of the body may include a heart condition, diabetes, a psychological condition, fatigue, dehydration, and so forth.”; Col. 78, lines 48-61).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Wang in view of Davis, Jain, and Gopalakrishnan to include determining dehydration from the analysis of a dataset as taught by Davis, because doing so would provide an indication of a dehydration event occurring (e.g. Davis, col. 78, lines 48-61).
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 SHREYA P ANJARIA whose telephone number is (571)272-9083. The examiner can normally be reached M-F: 8:00-5:00 EST.
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/SHREYA ANJARIA/Examiner, Art Unit 3796
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792
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