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
Applicant's arguments, filed 04/22/2026, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 04/22/2026, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Applicants have amended claims 23-27 and 29-36.
Applicants have introduced new claims 38-46.
Applicants have canceled/previously canceled claims 1-22, 28, and 37.
Claims 23-27, 29-36, and 38-46 are the current claims hereby under examination.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/22/2026 is being considered by the examiner.
Claim Objections - Newly Applied Necessitated by Applicant’s Amendments
Claims 23, 25, 34, 38, 40, 43, and 45 are objected to because of the following informalities:
Regarding claim 23, lines 14-15 recite “wherein the ECG waveform obtained from the target patient, the target patient is the same person who is obtained the heart rate information”, however it appears it should read along the lines of --wherein the ECG waveform is obtained from the target patient--, and/or the limitation should be deleted because it reiterates what is previously recited.
Regarding claim 23, lines 28-29 recite “a prediction result indicating whether a thyroid function”, however it appears it should read --the prediction result indicating whether the thyroid function-- (emphasis added).
Regarding claim 23, line 33 recites “the thyroid function of the user”, however it appears it should read --the thyroid function of the target patient-- (emphasis added).
Regarding claim 25, line 2 recites “a wearable device”, however it appears it should read --the wearable device-- (emphasis added).
Regarding claim 34, lines 1-2 recite “the server further configured to:”, however it appears it should read --the server is further configured to:-- (emphasis added).
Regarding claim 38, line 2 recites “a first body part of the user”, however it appears it should read --the first body part of the target patient-- (emphasis added).
Regarding claim 38, lines 2-3 recite “a second body part of the user”, however it appears it should read --the second body part of the target patient-- (emphasis added).
Regarding claim 40, line 3 recites “ECG waveform”, however it appears it should read --the ECG waveform-- (emphasis added).
Regarding claim 43, lines 2-3 recite “the prediction result indicating whether the thyroid function of the target patient on a single screen”, however it appears it should read along the lines of --the prediction result indicating whether the thyroid function of the target patient is normal or abnormal on a single screen-- (emphasis added).
Regarding claim 45, lines 1-2 recite “the prediction result indicating whether the thyroid function of the target patient”, however it appears it should read along the lines of --the prediction result indicating whether the thyroid function of the target patient is normal or abnormal-- (emphasis added).
Claim Interpretation - 35 USC § 112(f) - Withdrawn
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
Response to Arguments
Applicant’s arguments, see page 8 of Remarks, filed 04/22/2026, with respect to claim 18 have been fully considered and are persuasive. Applicants have canceled claim 18, rendering the 112(f) claim interpretations of “an ECG waveform analyzer”, “a function monitor”, and “an event generator” moot. The 112(f) claim interpretations of the recited claim elements has been withdrawn.
Claim Rejections - 35 USC § 112 - Newly Applied Necessitated by Applicant’s Amendments
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Examiner’s note: Applicant has not shown support in the original disclosure for the new or amended claims. A review of the specification does not show support for the following limitations (see MPEP 2163, II, A).
Claims 23-27, 29-36, and 38-46 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 23, lines 7-8 recite “receive at least heart rate information which is obtained by the wearable device continuously” (emphasis added). A review of the specification does not show support for a server being configured to receive heart rate information which is obtained by the wearable device continuously. The only recitation of continuously monitoring heart rates appears in para. [0281], however this is in regards to a clinical study confirming the association between hypothyroidism and a heart rate, not in regards to the claimed invention.
The dependent claims of the above rejected claim are rejected due to their dependency.
Regarding claim 23, lines 36-37 recite “output, in response to the request for acquiring the ECG waveform, a guide for acquiring the ECG waveform to the target patient”. A review of the specification does not show support for this limitation. Para. [00380] recites “a user may be induced to bring his or her right finger into contact with the second electrode …”, however the specification does not disclose the wearable device outputs a guide for acquiring the ECG waveform and/or the “inducing” is a guide outputted by the wearable device.
The dependent claims of the above rejected claim are rejected due to their dependency.
Regarding claim 23, lines 40-42 recite “wherein the wearable device is configured to obtain the heart rate information without a request from the server for determining thyroid abnormality, while obtain the ECG waveform in response to the request from the server for determining thyroid abnormality” (emphasis added). A review of the specification does not show support for this limitation. The specification discloses monitoring a first factor (Fig. 20, para. [0355]) and requesting a second factor (Fig. 22, para. [0372]). However, the specification does not does not show support for the heart rate information being obtained by the wearable device without a request from the server.
Further, in regards to “without a request from the server …”, the mere absence of a positive recitation is not basis for an exclusion. See MPEP 2173.05(i). “Any negative limitation or exclusionary provision must have basis in the original disclosure. If alternative elements are positively recited in the specification, they may be explicitly excluded in the claims. See In re Johnson, 558 F.2d 1008, 1019, 194 USPQ 187, 196 (CCPA 1977)”.
The dependent claims of the above rejected claim are rejected due to their dependency.
Regarding claim 38, lines 1-3 recite “the guide includes information for guiding such that a first body part of the user contacts the first electrode of the wearable device, and a second body part of the user contacts the second electrode of the wearable device”. However, as recited above, a review of the specification does not show support for the wearable device outputting a guide, specifically a guide for guiding a first body part of the user to contact the first electrode and a second body part of the user to contact the second electrode. As recited above, para. [0380] recites a user may be induced to bring their finger into contact with the second electrode, however, the specification does not disclose the “inducing” is a guide that is output by the wearable device and/or the guide includes information for guiding a first body part and a second body part of the user to contact electrodes.
The dependent claims of the above rejected claim are rejected due to their dependency.
Claim Rejections - 35 USC § 101 - Withdrawn and Newly Applied Necessitated by Applicant’s Amendments
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.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 23-27, 29-36, and 38-46 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Regarding claim 23, lines 17-20 recite “wherein the ECG waveform of the target patient is generated as a physically electrical closed loop …”, which is directed to or encompasses a human organism. It is recommended to the Applicant to amend the claim to read along the lines of --wherein the ECG waveform is configured to be generated-- (emphasis added).
The dependent claims of the above rejected claim are rejected due to their dependency.
Regarding claim 38, lines 2-3 recite “such that a first body part of the user contacts the first electrode … a second body part of the user contacts the second electrode …”, which is directed to or encompasses a human organism. It is recommended to the Applicant to amend the claim to no longer encompass the user.
The dependent claims of the above rejected claim are rejected due to their dependency.
Regarding claim 39, lines 6-7 recite “the first body part of the target patient corresponds to a wrist of a right hand or a left hand, and the second body part of the target patient corresponds to a finger of the other hand”, which is directed to or encompasses a human organism. It is recommended to the Applicant to amend the claim to no longer encompass the target patient.
Response to Arguments
Applicant’s arguments, see pages 8-9 of Remarks, filed 04/22/2026, with respect to the 101 rejection of claims 18-20, 22-27, and 29-37 have been fully considered and are persuasive. Applicants have canceled/amended the claims to no longer be directed to a judicial exception without significantly more. The 101 rejection of claims 18-20, 22-27, and 29-37 has been withdrawn. However, Applicant’s amendments have necessitated new rejections.
Claim Rejections - 35 USC § 103 - Newly Applied Necessitated by Applicant’s Amendments
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 23-24, 27, 29-35, and 38-46 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (US 20180007983 A1) (previously cited), hereinafter referred to as Wang, in view of Wang et al. (US 20180279953 A1), hereinafter referred to as Wang2, in view of Baladi et al. (“ECG Changes in patients with primary hyperthyroidism”) (previously cited 04/17/2025), hereinafter referred to as Baladi, in view of Eom et al. (US 20160113578 A1), hereinafter referred to as Eom.
The claims are generally directed towards a system for determining a prediction result related to a thyroid function of a target patient, comprising: a wearable device configured to obtain heart rate information of the target patient and an electrocardiogram (ECG) waveform of the target patient; and a server; wherein the server is configured to: receive at least the heart rate information which is obtained by the wearable device continuously, determine a timing at which the wearable device obtains the ECG waveform additionally, transmit, based on the determination, a request for acquiring the ECG waveform to the wearable device, receive at least the ECG waveform obtained by the wearable device in response to the request, wherein the ECG waveform obtained from the target patient, the target patient is the same person who is obtained the heart rate information, wherein the ECG waveform of the target patient is generated as a physical electrical closed loop formed through a first electrode and a second electrode when a first body part of the target patient contacts with the first electrode and a second body part of the target patient contacts with the second electrode, wherein the ECG waveform is generated during a predetermined period, wherein the ECG waveform comprises multiple unit cycles, and wherein each of the unit cycles comprises a P wave, Q wave, R wave, and S wave, wherein the P wave, Q wave, R wave and S wave constituting the unit cycle are sequentially obtained; analyze the ECG waveform, wherein the analyzing the ECG waveform comprises analyzing at least the P wave or a relationship among the P wave, Q wave, R wave and S wave that constitute the unit cycle; and determine, based on a result of the analysis, a prediction result indicating whether a thyroid function of the target patient is normal or abnormal; wherein the analyzing the ECG waveform is configured to use pre-stored instructions that cause a first portion of the ECG waveform comprising the P wave preceding the Q wave within the unit cycle to have a greater influence than a second portion of the ECG waveform comprising the S wave following the Q wave in determining whether the thyroid function of the user is abnormal or normal, wherein the wearable device is configured to: output, in response to the request for acquiring the ECG waveform, a guide for acquiring the ECG waveform to the target patient, obtain the ECG waveform of the target patient during a predetermined time period, and transmit the obtained ECG waveform to the server, wherein the wearable device is configured to obtain the heart rate information without a request from the server for determining thyroid abnormality, while obtain the ECG waveform in response to the request from the server for determining thyroid abnormality.
Regarding claim 23, Wang discloses a system for determining a prediction result related to a thyroid function of a target patient (Abstract, para. [0019-0020], “systems for cardiac condition detection …”), comprising:
a wearable device configured to obtain heart rate information of the target patient and an electrocardiogram (ECG) waveform of the target patient (Fig. 1, elements 110, 111, 112, 120, 130, para. [0022], “ECG data collector … monitoring electrical activities of the heart of a wearer”, para. [0109], “heart rate of the wearer can be estimated based on ECG data”); and
a server (Fig. 3C, Fig. 3D, para. [0026], “remote server computer”);
wherein the server is configured to:
receive at least the heart rate information which is obtained by the wearable device continuously (para. [0026], “send … ECG data received … remote server computer”, para. [0088], “continuous monitoring …”, para. [0109], “heart rate of the wearer can be estimated based on ECG data”),
wherein the ECG waveform obtained from the target patient, the target patient is the same person who is obtained the heart rate information (para. [0022], “ECG data collector … monitoring electrical activities of the heart of a wearer”),
wherein the ECG waveform of the target patient is generated as a physical electrical closed loop formed through a first electrode and a second electrode when a first body part of the target patient contacts with the first electrode and a second body part of the target patient contacts with the second electrode (Fig. 1, elements 110, 111, 112, para. [0022], “monitoring electrical activities of the heart of a wearer (e.g., using an electrical potential difference between two body surfaces …)”, para. [0040], “two flexible electrodes of the at least two flexible electrodes can form an ECG lead …” - at least two electrodes contact two different portions of the target patients body, and the ECG waveform is inherently generated as a physical electrical closed loop because the potential difference between the two body surfaces is measured as an electrical current flows through the target patients body, through the ECG data collector, and back through the target patients body),
wherein the ECG waveform is generated during a predetermined period (para. [0025], “processor can determine a time interval for data collection …”, para. [0056]),
wherein the ECG waveform comprises multiple unit cycles (para. [0056], “collect the ECG data for half an hour … collect ECG data continuously in 24 hours …”, para. [0102], “R peak to R peak related features” - multiple cycles need to be detected to obtain R peak to R peak related features), and
wherein each of the unit cycles comprises a P wave, Q wave, R wave, and S wave (para. [0022], “ECG data collector can receive measurements from one or more sensors …”, para. [0102], “PQRST complex fiducial points …” - an ECG data collector that collects an ECG signal over a period of time inherently collects unit cycles that comprises P waves, Q waves, R waves, and S waves),
wherein the P wave, Q wave, R wave and S wave constituting the unit cycle are sequentially obtained (para. [0022], para. [0056], para. [0102], “PQRST complex fiducial points” - the PQRS waves are inherently sequentially obtained due to the electrical impulses of the heart);
analyze the ECG waveform (para. [0108], “detecting a cardiac condition …”),
wherein the analyzing the ECG waveform comprises analyzing at least the P wave or a relationship among the P wave, Q wave, R wave and S wave that constitute the unit cycle (Fig. 6, para. [0108], para. [0112], “P-wave and QRS complex within a time window for one or more leads are detected …”, para. [0113], “determined whether a P-wave and QRS complex condition is met …”);
wherein the analyzing the ECG waveform is configured to use pre-stored instructions (para. [0041-0042], para. [0067]),
wherein the wearable device is configured to:
transmit the obtained ECG waveform to the server (para. [0026], “send … ECG data received … remote server computer”, para. [0088], “continuous monitoring …”, para. [0109], “heart rate of the wearer can be estimated based on ECG data”),
wherein the wearable device is configured to obtain the heart rate information without a request from the server for determining thyroid abnormality (para. [0026], “send … ECG data received … remote server computer”, para. [0088], “continuous monitoring …”, para. [0109], “heart rate of the wearer can be estimated based on ECG data”).
However, Wang does not explicitly disclose the server is configured to determine a timing at which the wearable device obtains the ECG waveform additionally, transmit, based on the determination, a request for acquiring the ECG waveform to the wearable device, receive at least the ECG waveform obtained by the wearable device in response to the request, and wherein the wearable device is configured to obtain the ECG waveform in response to the request from the server for determining thyroid abnormality.
Wang2 teaches a system for monitoring heart data of a user (Abstract, para. [0002]), comprising a wearable device configured to obtain heart rate information of the user and an electrocardiogram (ECG) waveform of the user (para. [0029], para. [0039], para. [0044]). Wang2 further teaches a server is configured to determine a timing at which the wearable device obtains a sensor reading, additionally, transmit, based on the determination, a request for acquiring the sensor reading to the wearable device, receive at least the sensor reading obtained by the wearable device in response to the request, and wherein the wearable device is configured to obtain the sensor waveform in response to the request (Fig. 5C, para. [0071], para. [0093-0095]). 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 taught by modified Wang to additionally have the server be configured to determine a timing at which the wearable device obtains the ECG waveform additionally, transmit, based on the determination, a request for acquiring the ECG waveform to the wearable device, receive at least the ECG waveform obtained by the wearable device in response to the request, and wherein the wearable device is configured to obtain the ECG waveform in response to the request from the server for determining thyroid abnormality, as taught by Wang2. This is because Wang2 teaches utilizing heart rate information to determine if a threshold is met to output a request for further health related metrics allows for the best conditions to be met, allowing for higher quality data for the patient (para. [0072]).
Wang teaches the use of heart rate and the identification or lack of identified of certain portions of the ECG waveform are related to different cardiac conditions (para. [0113-0117]). Wang also teaches a heart rate can be detected from the ECG waveform based on R-R peaks (para. [0108]) and atrial fibrillation can be detected based on the P-wave (para. [0115]).
However, modified Wang does not explicitly disclose determine, based on a result of the analysis, a prediction result indicating whether a thyroid function of the target patient is normal or abnormal; wherein the pre-stored instructions cause a first portion of the ECG waveform comprising the P wave preceding the Q wave within the unit cycle to have a greater influence than a second portion of the ECG waveform comprising the S wave following the Q wave in determining whether the thyroid function of the user is abnormal or normal.
Baladi teaches the cardiovascular system is sensitive to the thyroid hormone (pg. 2, “Introduction”). Baladi further teaches changes in the ECG waveform for hyperthyroidism patients include sinus tachycardia and changes in the P-wave (pg. 2, “Methods”), and hyperthyroidism patients are more likely to have an increase in heart rate, with no detection of atrial fibrillation (Table 1, pg. 2, “Methods”, pg. 2, “Results”, pg. 3, “Results”, para. 2). 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 taught by modified Wang to additionally determine, based on a result of the analysis, a prediction result indicating whether a thyroid function of the target patient is normal or abnormal; wherein the pre-stored instructions cause a first portion of the ECG waveform comprising the P wave preceding the Q wave within the unit cycle to have a greater influence than a second portion of the ECG waveform comprising the S wave following the Q wave in determining whether the thyroid function of the user is abnormal or normal, as taught by Baladi. This is because Baladi teaches ECG changes occur within patients with hyperthyroidism, including an increase in heart rate while showing no signs of atrial fibrillation, which is detected by the P-wave, (Table 1, pg. 2, “Methods”) and these ECG changes allow cardiologists to better diagnose hyperthyroidism (pg. 3, “Conclusion”).
However, modified Wang does not explicitly disclose the wearable device is configured to: output, in response to the request for acquiring the ECG waveform, a guide for acquiring the ECG waveform to the target patient, and obtain the ECG waveform of the target patient during a predetermined time period.
Eom teaches a system comprising a wearable device configured to obtain heart rate information of a target patient and an electrocardiogram (ECG) waveform of the target patient, wherein the ECG waveform of the target patient is generated as a physical electrical closed loop formed through a first electrode and a second electrode when a first body part of the target patient contacts with the first electrode and a second body part of the target patient contacts with the second electrode (Abstract, Fig. 2, Fig. 3, para. [0047], para. [0059-0066]). Eom further teaches the wearable device is configured to: output, in response to a request for acquiring the ECG waveform, a guide for acquiring the ECG waveform to the target patient, and obtain the ECG waveform of the target patient during a predetermined time period (Fig. 8A-8B, para. [0081-0083]). 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 wearable device and first and second electrodes to additionally be configured to: output, in response to the request for acquiring the ECG waveform, a guide for acquiring the ECG waveform to the target patient, and obtain the ECG waveform of the target patient during a predetermined time period, as taught by Eom. This is because Eom teaches guidance screens allow for the user to be assisted to maintain a correct position to obtain accurate bio information, specifically when a wristwatch type ECG sensor is being utilized (para. [0057], para. [0083]).
Regarding claim 24, modified Wang discloses the system of Claim 23, wherein the analyze the ECG waveform comprises: determine whether the first portion of the ECG waveform is distinguishable (Fig. 6, para. [0113-0117], “lack of a detectable P-wave can be associated with … an atrial fibrillation condition …”), and wherein the determine the prediction result comprises: determine the prediction result as a second prediction result indicating a heart function of the target patient is abnormal when the first portion of the ECG waveform is determined to be indistinguishable (para. [0113-0117], “lack of a detectable P-wave can be associated with … an atrial fibrillation condition …”).
Wang teaches the use of heart rate and the identification or lack of identification of certain portions of the ECG waveform are related to different cardiac conditions (para. [0113-0117]). Wang also teaches a heart rate can be detected from the ECG waveform based on R-R peaks (para. [0108]) and atrial fibrillation can be detected based on the P-wave (para. [0115]). However, modified Wang does not explicitly disclose determining the prediction result as a first prediction result indicating the thyroid function of the target patient is abnormal when the first portion of the ECG waveform is determined to be distinguishable and determining the prediction result as a second prediction result indicating the thyroid function of the target patient is normal and a heart function of the target patient is abnormal when the first portion of the ECG waveform is determined to be indistinguishable.
Baladi further teaches that patients with primary hyperthyroidism are more likely to have an increase in heart rate, with no detection of atrial fibrillation (Table 1, pg. 2, “Methods”, pg. 2, “Results”, pg. 3, “Results”, para. 2). 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 taught by modified Wang to additionally include determining the prediction result as a first prediction result indicating the thyroid function of the target patient is abnormal when the first portion of the ECG waveform is determined to be distinguishable and determining the prediction result as a second prediction result indicating the thyroid function of the target patient is normal and a heart function of the target patient is abnormal when the first portion of the ECG waveform is determined to be indistinguishable, as taught by Baladi. This is because Baladi teaches ECG changes occur within patients with hyperthyroidism, including an increase in heart rate while showing no signs of atrial fibrillation (Table 1, pg. 2, “Methods”) and these ECG changes allow cardiologists to better diagnose hyperthyroidism (pg. 3, “Conclusion”).
Regarding claim 27, modified Wang discloses the system of Claim 23, wherein the analyze the ECG waveform comprises: analyze a portion of the ECG waveform related to at least the P wave (para. [0112], “P-wave and QRS complex within a time window for one or more leads are detected …”, para. [0113], “determined whether a P-wave and QRS complex condition is met …”, para. [0113-0117], “use the P-wave and/or QRS complex detected … to determine a cardiac condition (e.g., an abnormality type) for the wearer … lack of a detectable P-wave can be associated with … an atrial fibrillation condition”).
Regarding claim 29, modified Wang discloses the system of Claim 23, wherein the analyze the ECG waveform comprises: analyze the ECG waveform using an algorithm that considers the P wave more significantly compared to the Q wave, R wave, or S wave within the unit cycle (para. [0113-0117], “use the P-wave and/or QRS complex detected … to determine a cardiac condition (e.g., an abnormality type) for the wearer … lack of a detectable P-wave can be associated with … an atrial fibrillation condition” - the P-wave is only used to determine an association with an atrial fibrillation condition).
Regarding claim 30, modified Wang discloses the system of Claim 23, wherein the analyze the ECG waveform comprises: analyze intervals between peaks detected in the ECG waveform (Fig. 6, para. [0112], “P-wave and QRS complex within a time window for one or more leads are detected …”, para. [0114-0117], “lack of detectable P-wave …”).
Regarding claim 31, modified Wang discloses the system of Claim 30.
Wang teaches a heart rate can be detected from the ECG waveform based on R-R peaks (para. [0108]). However, modified Wang does not explicitly disclose wherein the determine the prediction result comprises: determine the prediction result as a first prediction result indicating the thyroid function of the target patient is abnormal when the intervals between the peaks detected in the ECG waveform indicate an increase in a heart rate of the target patient.
Baladi further teaches that patients with primary hyperthyroidism are more likely to have an increase in heart rate, with no detection of atrial fibrillation (Table 1, pg. 2, “Methods”, pg. 2, “Results”, pg. 3, “Results”, para. 2). 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 taught by modified Wang to additionally determine the prediction result as a first prediction result indicating the thyroid function of the target patient is abnormal when the intervals between the peaks detected in the ECG waveform indicate an increase in a heart rate of the target patient, as taught by Baladi. This is because Baladi teaches ECG changes occur within patients with hyperthyroidism, including an increase in heart rate while showing no signs of atrial fibrillation (Table 1, pg. 2, “Methods”) and these ECG changes allow cardiologists to better diagnose hyperthyroidism (pg. 3, “Conclusion”).
Regarding claim 32, modified Wang discloses the system of Claim 31, wherein the analyze the ECG waveform comprises: obtain the heart rate of the target patient based on the intervals between the peaks detected in the ECG waveform (para. [0102], “R peak to R peak related features (e.g., a heart rate)”, para. [0109]), wherein the determine the prediction result comprises determining the prediction result as the first prediction result when the heart rate of the target patient exceeds a pre-stored reference heart rate of the target patient by a predetermined range (para. [0084], “target range of ECG data … stored in the storage device”, para. [0110], “determine whether the estimated heart rate is out of the target range …”).
However, modified Wang does not explicitly disclose explicitly determining the prediction result as the first prediction result indicating the thyroid function of the target patient is abnormal when the heart rate of the target patient exceeds the pre-stored reference heart rate of the target patient by the predetermined range.
Baladi further teaches hyperthyroidism patients are more likely to have an increase in heart rate, with no detection of atrial fibrillation (Table 1, pg. 2, “Methods”, pg. 2, “Results”, pg. 3, “Results”, para. 2). 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 taught by modified Wang to additionally determine the prediction result as indicating the thyroid function of the target patient is abnormal when the heart rate of the target patient exceeds the pre-stored reference heart rate of the target patient by the predetermined range, as taught by Baladi. This is because Baladi teaches ECG changes occur within patients with hyperthyroidism, including an increase in heart rate while showing no signs of atrial fibrillation, which is detected by the P-wave, (Table 1, pg. 2, “Methods”) and these ECG changes allow cardiologists to better diagnose hyperthyroidism (pg. 3, “Conclusion”).
Regarding claim 33, modified Wang discloses the system of Claim 30.
Wang teaches the use of heart rate and the identification or lack of identification of certain portions of the ECG waveform are related to different cardiac conditions (para. [0113-0117]). Wang also teaches a heart rate can be detected from the ECG waveform based on R-R peaks (para. [0108]) and atrial fibrillation can be detected based on the P-wave (para. [0115]). However, modified Wang does not explicitly disclose wherein the determine the prediction result comprises determine the prediction result as a first prediction result indicating a risk of thyroid dysfunction is higher than a risk of atrial fibrillation when the intervals between peaks detected in the ECG waveform remain consistently below a predetermined threshold, and determine the prediction result as a second prediction result indicating the risk of atrial fibrillation is higher than the risk of thyroid dysfunction when the intervals between peaks detected in the ECG waveform change to exceed a predetermined threshold.
Baladi further teaches that patients with primary hyperthyroidism are more likely to have an increase in heart rate, with no detection of atrial fibrillation (Table 1, pg. 2, “Methods”, pg. 2, “Results”, pg. 3, “Results”, para. 2). 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 taught by modified Wang to additionally determine the prediction result as a first prediction result indicating a risk of thyroid dysfunction is higher than a risk of atrial fibrillation when the intervals between peaks detected in the ECG waveform remain consistently below a predetermined threshold, and determine the prediction result as a second prediction result indicating the risk of atrial fibrillation is higher than the risk of thyroid dysfunction when the intervals between peaks detected in the ECG waveform change to exceed a predetermined threshold, as taught by Baladi. This is because Baladi teaches ECG changes occur within patients with hyperthyroidism, including an increase in heart rate while showing no signs of atrial fibrillation (Table 1, pg. 2, “Methods”) and these ECG changes allow cardiologists to better diagnose hyperthyroidism (pg. 3, “Conclusion”). That is Wang and Baladi teach, and suggest, an increased heart rate, but the lack of determining the P-wave is abnormal can indicate a thyroid abnormality, while an increased heart rate, with a number of instances with non-distinguishable P-wave can indicate atrial fibrillation.
Regarding claim 34, modified Wang discloses the system of Claim 23, wherein the server further configured to: extract a portion of the ECG waveform corresponding to a predetermined period based on the ECG waveform (para. [0113], “use the P-wave and/or QRS complex to determine a cardiac condition …”), and generate a monitoring data based on the portion of the ECG waveform, wherein the analyze the ECG waveform comprises: analyze the monitoring data (para. [0113], “criteria can be compared against the detected P-wave and QRS complex …”).
Regarding claim 35, modified Wang discloses the system of Claim 34, wherein the predetermined period is selected as a period which satisfies time-related conditions (para. [0056], “collect the ECG data for half an hour once in every two hours … continuously in 24 hours …”).
Regarding claim 38, modified Wang discloses the system of Claim 23.
However, modified Wang does not explicitly disclose wherein the guide includes information for guiding such that a first body part of the user contacts the first electrode of the wearable device, and a second body part of the user contacts the second electrode of the wearable device.
Eom further teaches the guide includes information for guiding such that a first body part of the user contacts the first electrode of the wearable device, and a second body part of the user contacts the second electrode of the wearable device (Fig. 8A-8B, para. [0081-0083]). 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 guide taught by modified Wang to additionally include information for guiding such that a first body part of the user contacts the first electrode of the wearable device, and a second body part of the user contacts the second electrode of the wearable device, as taught by Eom. This is because Eom teaches guidance screens allow for the user to be assisted to maintain a correct position to obtain accurate bio information, specifically when a wristwatch type ECG sensor is being utilized (para. [0057], para. [0083]).
Regarding claim 39, modified Wang discloses the system of Claim 38.
However, modified Wang does not explicitly disclose wherein the wearable device includes a display panel on an upper surface, wherein the first electrode of the wearable device is disposed on a lower surface facing the upper surface on which the display panel is located, and the second electrode of the wearable device is disposed on a side surface of the wearable device, wherein the first body part of the target patient corresponds to a wrist of a right hand or a left hand, and the second body part of the target patient corresponds to a finger of the other hand.
Eom further teaches the wearable device includes a display panel on an upper surface (Fig. 1, Fig. 2, element MB, para. [0059]), wherein the first electrode of the wearable device is disposed on a lower surface facing the upper surface on which the display panel is located (para. [0065], “arranged on the main body …”), and the second electrode of the wearable device is disposed on a side surface of the wearable device (Fig. 2B, element 220, para. [0062]), wherein the first body part of the target patient corresponds to a wrist of a right hand or a left hand, and the second body part of the target patient corresponds to a finger of the other hand (Fig. 3, para. [0066]). 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 wearable device taught by modified Wang to additionally include a display panel and the locations of the first and second electrodes, as taught by Eom. This is because Eom teaches a wearable device with specific electrode locations is a known and suitable method for obtaining biometric information, such as ECG waveforms, and the display allows for guidance information to be presented to the patient (Fig. 8A-8B, para. [0047], para. [0066], para. [0083]).
Regarding claim 40, modified Wang discloses the system of Claim 23, wherein the prediction result is determined based on ECG waveform (para. [0108], “detecting a cardiac condition …” - further, see the rejection of claim 23).
However, modified Wang does not explicitly disclose wherein the timing at which the wearable device obtains the ECG waveform is determined based on the information on the heart rate.
Wang2 further teaches the timing at which the wearable device obtains the sensor reading is determined based on the information on the heart rate (para. [0093-0095]). 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 method taught by modified Wang to additionally have the timing at which the wearable device obtains the ECG waveform be determined based on the information on the heart rate, as taught by Wang2. This is because Wang2 teaches utilizing heart rate information to determine if a threshold is met to output a request for further health related metrics allows for the best conditions to be met, allowing for higher quality data for the patient (para. [0072]).
Regarding claim 41, modified Wang discloses the system of Claim 23, wherein the system further comprises a user terminal configured to display at least one of the heart rate information and the ECG waveform obtained by the wearable device (para. [0025], para. [0062], “a signal indicator on the user interface can be lighted to indicate the wearer of the garment that the current ECG data is abnormal …”, para. [0070]).
Regarding claim 42, modified Wang discloses the system of Claim 41, wherein the user terminal is configured to: receive the prediction result indicating whether the thyroid function of the target patient is normal or abnormal from the server, and output the prediction result (para. [0053], para. [0062], “a signal indicator on the user interface can be lighted to indicate the wearer of the garment that the current ECG data is abnormal …”).
Regarding claim 43, modified Wang discloses the system of Claim 42, wherein the user terminal is configured to output at least one of the heart rate information and the ECG waveform together with the prediction result indicating whether the thyroid function of the target patient on a single screen (para. [0025], para. [0062], “a signal indicator on the user interface can be lighted to indicate the wearer of the garment that the current ECG data is abnormal …”, para. [0070], “user interface can include a display … for presenting alerts or other messages to the wearer of the garment …”).
Regarding claim 44, modified Wang discloses the system of Claim 43, wherein at least one of the heart rate information and the ECG waveform is output so as to represent a pattern over time (para. [0025], para. [0062], “a signal indicator on the user interface can be lighted to indicate the wearer of the garment that the current ECG data is abnormal …”, para. [0070], “user interface can include a display … for presenting alerts or other messages to the wearer of the garment …”).
Regarding claim 45, modified Wang discloses the system of Claim 43, wherein the prediction result indicating whether the thyroid function of the target patient includes a risk level of thyroid dysfunction and information for inducing a hospital visit (para. [0025], para. [0062], “a signal indicator on the user interface can be lighted to indicate the wearer of the garment that the current ECG data is abnormal …”, para. [0070], “user interface can include a display … for presenting alerts or other messages to the wearer of the garment …”).
Regarding claim 46, modified Wang discloses the system of Claim 42, wherein the user terminal is configured to: receive at least one of the heart rate information and the ECG waveform from the wearable device or the server (para. [0025], para. [0062], “a signal indicator on the user interface can be lighted to indicate the wearer of the garment that the current ECG data is abnormal …”, para. [0070], “user interface can include a display … for presenting alerts or other messages to the wearer of the garment …”).
Claims 25, 26, and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (US 20180007983 A1) (previously cited), hereinafter referred to as Wang, in view of Wang et al. (US 20180279953 A1), hereinafter referred to as Wang2, in view of Baladi et al. (“ECG Changes in patients with primary hyperthyroidism”) (previously cited 04/17/2025), hereinafter referred to as Baladi, in view of Eom et al. (US 20160113578 A1), hereinafter referred to as Eom as applied to claims 23 and 35 above, and further in view of Joseph Wiesel (US 20150065891 A1) (previously cited), hereinafter referred to as Wiesel.
Regarding claim 25, modified Wang discloses the system of Claim 23.
However, modified Wang does not explicitly disclose wherein the ECG waveform of the target patient is obtained from a wearable device while the target patient is at a resting period.
Wiesel teaches an apparatus for measuring an ECG and pulse of a patient (Abstract, Fig. 2, para. [0021]). Wiesel further teaches the ECG waveform of the target patient is obtained from a wearable device while the target patient is at a resting period (para. [0043]). 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 taught by modified Wang to additionally obtain the ECG waveform while the target patient is at a resting period, as taught by Wiesel. This is because Wiesel teaches that obtaining the ECG waveform while the target patient is not moving allows for accurately determining if the heart rhythm is irregular (para. [0016]).
Regarding claim 26, modified Wang discloses the system of Claim 25.
However, modified Wang does not explicitly disclose wherein the wearable device comprises a motion sensor or an accelerometer for detecting a movement of the target patient, and wherein the resting period is determined using the motion sensor or the accelerometer.
Wiesel further teaches the wearable device comprises a motion sensor or an accelerometer for detecting a movement of the target patient, and wherein the resting period is determined using the motion sensor or the accelerometer (Fig. 2, element 20, para. [0038], para. [0043]). 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 taught by modified Wang to explicitly determine a resting period using a motion sensor or an accelerometer, as taught by Wiesel. This is because Wiesel teaches an accelerometer allows for precise motion measurements to be determined to determine a threshold if a patient is motionless to obtain more accurate results (para. [0016], para. [0038]).
Regarding claim 36, modified Wang discloses the system of Claim 35.
However, modified Wang does not explicitly disclose wherein the predetermined period is selected as a resting period during which no movement is detected from the target patient.
Wiesel teaches an apparatus for measuring an ECG and pulse of a patient (Abstract, Fig. 2, para. [0021]). Wiesel further teaches the ECG waveform of the target patient is obtained an analyzed only from the wearable device while the target patient is at resting period (para. [0043]). 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 taught by modified Wang to additionally have the predetermined period selected as a resting period during which no movement is detected from the target patient, as taught by Wiesel. This is because Wiesel teaches that obtaining the ECG waveform while the target patient is not moving allows for accurately determining if the heart rhythm is irregular (para. [0016]).
Response to Arguments
Applicant’s arguments, see pages 9-11 of Remarks, filed 04/22/2026, with respect to the rejection(s) of claim(s) 18-20, 22-27, and 29-37 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of at least Wang et al. (US 20180279953 A1), hereinafter referred to as Wang2 and Eom et al. (US 20160113578 A1), hereinafter referred to as Eom.
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.
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/K.W.K./Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791
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