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 11/07/2025, 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 11/07/2025, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Applicants have amended claim 18.
Applicants have left claims 19 and 22-26 as originally filed/previously presented.
Applicants have canceled/previously canceled claims 1-17, 20-21, and 27-34.
Claims 18-19 and 22-26 are the current claims hereby under examination.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Objections - Withdrawn
Response to Arguments
Applicant’s arguments, see page 5 of Remarks, filed 11/07/2025, with respect to claim 18 have been fully considered and are persuasive. Applicants have amended the claims, rendering the objections moot. The objections of claim 18 have been withdrawn.
Claim Rejections - 35 USC § 112 - Withdrawn and Newly Applied Necessitated by Applicant’s Amendments
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 18-19 and 22-26 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 18, the claim recites the limitation "the resting heart rate" in line 13. There is insufficient antecedent basis for this limitation in the claim. In light of the specification, it is currently unclear if “the resting heart rate” is the same as, related to, or different from “the reference heart rate”. For the purposes of examination, “the resting heart rate” is being interpreted as “the reference heart rate”. It is recommended to the Applicant to amend the claims to clearly recite what “the resting heart rate” is referring to.
The dependent claims of the above rejected claim are rejected due to their dependency.
Response to Arguments
Applicant’s arguments, see page 5 of Remarks, filed 11/07/2025, with respect to claims 18-19 and 22-26 have been fully considered and are persuasive. Applicants have amended claim 18, rendering the 112(b) rejections moot. The 112(b) rejections of claims 18-19 and 22-26 have been withdrawn. However, Applicant’s amendments necessitated new grounds for rejection.
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 18-19 and 22-24 are rejected under 35 U.S.C. 103 as being unpatentable over Jaehoon Moon (WO 2019054553 A1) (previously cited), hereinafter referred to as Moon - for the purposes of English Translation, citations below reference US 20200214644 A1, which is the US national phase entry of WO 2019054553 A1, in view of Shinar et al. (US 20110282216 A1), hereinafter referred to as Shinar, in view of Udovcic et al. (“Hypothyroidism and the Heart”) (previously cited 11/19/2024), hereinafter referred to as Udovcic.
The claims are generally directed towards a method of treating a hypothyroidism of a person, the method comprising: acquiring, using a wearable device worn by the person, a first set of data comprising heart rates of the person; assessing if a thyroid function is normal based on at least one thyroid hormone measurements test; computing, on a monitoring server, a reference heart rate of the person using the first set of data acquired in a first set of consecutive days in which the person's thyroid function is assessed normal, wherein the reference heart rate of the person is computed using heart rates belonging to a predetermined night section in the first set of consecutive days, thereby, even if the person moves within the predetermined night section in the first set of consecutive days, the heart rates at that time are used to calculate the resting heart rate; subsequent to computing the reference heart rate of the person, acquiring a second set of data comprising heart rates of the person using the wearable device or another wearable device worn by the person; computing, on the monitoring server, a monitoring heart rate using the second set of data acquired in a second set of consecutive days, wherein an earliest day of the second set of consecutive days is later than an earliest day of the first set of consecutive days, wherein the monitoring heart rate of the person is computed using heart rates belonging to a predetermined night section in the second set of consecutive days, thereby, even if the person moves within the predetermined night section in the second set of consecutive days, the heart rates at that time are used to calculate the monitoring heart rate; comparing, on the monitoring server, the monitoring heart rate against the reference heart rate of the person; and outputting an alert to the person, for whom the monitoring heart rate is smaller than the reference heart rate by a predetermined value or more, whereby the person conducts a blood test on the person in a hospital in response to the alert.
Regarding claims 18, Moon discloses a method of treating a hypothyroidism of a person (Abstract, “system … predicting thyrotoxicosis … warning alarm”), the method comprising:
acquiring, using a wearable device worn by the person, a first set of data comprising heart rates of the person (Fig. 1, element 20, “wearable device”, para. [0027-0028], “wearable device 20 for measuring bio-signals of a patient … measures bio-signals of a patient 10, for example, a heart rate and the number of steps”);
assessing if a thyroid function is normal based on at least one thyroid hormone measurements test (Fig. 4, Fig. 5, Fig. 6, Fig. 7, para. [0049-0054], “confirm the association between a thyroid function and heart rates … thyroid hormone concentration measured at the time of a patient’s visit to a clinic … decreased to be within a normal range (0.8-1.8 ng/dL) …”);
computing, on a monitoring server, a reference heart rate of the person using the first set of data acquired in a first set of consecutive days in which the person's thyroid function is assessed normal (Fig. 4, para. [0029], para. [0033], “computing unit 33 defines a reference heart rate … reference heart rate may be defined as an average value of resting heart rates measured for a predetermined number of days during which a patient is in a normal state (that is, when a thyroid function is normal) …”, para. [0047], “defines an average value of resting heart rates measured for a predetermined number of days during which a patient’s thyroid function is in a normal state as a ‘reference heart rate’”),
subsequent to computing the reference heart rate of the person, acquiring a second set of data comprising heart rates of the person using the wearable device or another wearable device worn by the person (para. [0044-0046], “receives heart rates … computes a resting heart rate …”);
computing, on the monitoring server, a monitoring heart rate using the second set of data acquired in a second set of consecutive days (para. [0035], “computing unit may calculate the resting heart rate … section calculated for one day, para. [0044-0046], “computes a resting heart rate … computing device 30 calculates a median value …”),
wherein an earliest day of the second set of consecutive days is later than an earliest day of the first set of consecutive days (Fig. 4, para. [0049-0054], - the first set of consecutive days for computing the reference heart rate is over the course of the months of the study, the second set of consecutive days is the use of the device after the study, and after the reference heart rate has been determined),
comparing, on the monitoring server, the monitoring heart rate against the reference heart rate of the person (Fig. 3, para. [0048], “computing device compares values of the resting heart rate and the reference heart rate …”); and
outputting an alert to the person, for whom the monitoring heart rate is different than the reference heart rate by a predetermined value or more (Fig. 3, para. [0048], “outputs a warning alarm … when resting heart rate is greater than the reference heart rate …”), whereby the person conducts a blood test on the person in a hospital in response to the alert (para. [0055], “when a resting heart rate increases abnormally compared with a reference heart rate, the prediction system may alert the patient to receive a blood test by warning the patient of thyroid function abnormalities”, para. [0050-0051], “visit to a clinic … free T4, which is measured …” - a hospital/clinic is known to be capable of performing the blood test).
However, Moon does not explicitly disclose wherein the reference heart rate of the person is computed using heart rates belonging to a predetermined night section in the first set of consecutive days, thereby, even if the person moves within the predetermined night section in the first set of consecutive days, the heart rates at that time are used to calculate the resting heart rate; and wherein the monitoring heart rate of the person is computed using heart rates belonging to a predetermined night section in the second set of consecutive days, thereby, even if the person moves within the predetermined night section in the second set of consecutive days, the heart rates at that time are used to calculate the monitoring heart rate.
Shinar teaches an analogous method for monitoring and treating a condition of a person (Abstract, para. [0008], para. [0010]). Shinar teaches acquiring a first set of data and a second set of data comprising heart rates of the person (Fig. 6, para. [0159]), and computing a reference rate heart and a monitoring heart rate (para. [0172], para. [0198]). Shinar further teaches wherein the reference heart rate of the person is computed using heart rates belonging to a predetermined night section in the first set of consecutive days, thereby, even if the person moves within the predetermined night section in the first set of consecutive days, the heart rates at that time are used to calculate the resting heart rate; and wherein the monitoring heart rate of the person is computed using heart rates belonging to a predetermined night section in the second set of consecutive days, thereby, even if the person moves within the predetermined night section in the second set of consecutive days, the heart rates at that time are used to calculate the monitoring heart rate (Fig. 6, para. [0150], para. [0198], para. [0205], para. [0208]). 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 disclosed by Moon to explicitly have the reference heart rate of the person is computed using heart rates belonging to a predetermined night section in the first set of consecutive days, thereby, even if the person moves within the predetermined night section in the first set of consecutive days, the heart rates at that time are used to calculate the resting heart rate and the monitoring heart rate of the person is computed using heart rates belonging to a predetermined night section in the second set of consecutive days, thereby, even if the person moves within the predetermined night section in the second set of consecutive days, the heart rates at that time are used to calculate the monitoring heart rate, as taught by Shinar. This is because Shinar teaches it is most effective to monitor a patients heart rate for conditions during sleep at night to minimize the effects of physical and mental activities of the subject on the heart rate (para. [0150]).
However, modified Moon does not explicitly disclose outputting an alert to the person, for whom the monitoring heart rate is smaller than the reference heart rate by a predetermined value or more.
Udovcic teaches that thyroid hormones have a variety of effects on the cardiovascular system that impact cardiac function (Fig. 1, pg. 55, “Cardiometabolic Changes in Hypothyroidism”, left col., para. 1). Udovcic further teaches that hypothyroidism effects cardiac contractility, which results in a state of low cardiac output with decreased heart rate (pg. 56, “Heart Failure and Hypothyroidism”, pg. 58, “Key Points”). 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 disclosed by modified Moon to explicitly output the alert to the person for whom the monitoring heart rate is smaller than the reference heart rate by a predetermined value or more, as taught by Udovcic. This is because Udovcic teaches that an increase or decrease in thyroid hormones effect the cardiovascular system, and explicitly that hypothyroidism causes a decrease in heart rate (pg. 56, “Heart Failure and Hypothyroidism”, pg. 58, “Key Points”). One of ordinary skill in the art would have been motivated to additionally monitor a decrease in heart rate to treat hypothyroidism of the person.
Regarding claim 19, modified Moon discloses the method of claim 18.
However, modified Moon does not explicitly disclose wherein the predetermined night section in the first set of consecutive days represents at least one of sections between 2 AM to 6 AM on each day of the first set of consecutive days and wherein the predetermined night section in the second set of consecutive days represents at least one of sections between 2 AM to 6 AM on each day of the second set of consecutive days.
Shinar further teaches that a predetermined night section in the first set of consecutive days represents at least one of sections between 2 AM to 6 AM on each day of the first set of consecutive days and wherein the predetermined night section in the second set of consecutive days represents at least one of sections between 2 AM to 6 AM on each day of the second set of consecutive days (Fig. 6, para. [0205], para. [0208]). 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 disclosed by modified Moon to additionally have the predetermined night section in the first set of consecutive days represents at least one of sections between 2 AM to 6 AM on each day of the first set of consecutive days and wherein the predetermined night section in the second set of consecutive days represents at least one of sections between 2 AM to 6 AM on each day of the second set of consecutive days, as taught by Shinar. This is because Shinar teaches night sections, including 2 AM to 6 AM, minimizes the effects of physical and mental activities of the subject on the heart rate (para. [0150]).
Regarding claims 22, modified Moon discloses the method of claim 18, wherein a number of days belonging to the first set of consecutive days is the same as a number of days belonging to the second set of consecutive days (para. [0037-0038], para. [0047-0048], “defines an average of resting heart rates measured for a predetermined number of days … as ‘reference heart rate’ … average value of resting heart rates of a predetermined number of consecutive days … greater than the reference heart rate by a predetermined value …”).
Regarding claims 23, modified Moon discloses the method of claim 22, wherein the number of days belonging to the first set of consecutive days is more than 5 (para. [0038], para. [0048], “predetermined number of consecutive days … for example, 5 consecutive days or more …”).
Regarding claim 24, modified Moon discloses the method of claim 18, wherein the wearable device and the monitoring server are physically separate devices (Fig. 1, element 20, element 30, para. [0028], “wearable device communicates with the bio-signal computing device through a network … wireless communication …”, para. [0030]).
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Jaehoon Moon (WO 2019054553 A1) (previously cited), hereinafter referred to as Moon - for the purposes of English Translation, citations below reference US 20200214644 A1, which is the US national phase entry of WO 2019054553 A1, in view of Shinar et al. (US 20110282216 A1), hereinafter referred to as Shinar, in view of Udovcic et al. (“Hypothyroidism and the Heart”) (previously cited 11/19/2024), hereinafter referred to as Udovcic as applied to claim 18 above, and further in view of Conry et al. (US 20060074713 A1) (previously cited), hereinafter referred to as Conry.
Regarding claims 25, modified Moon discloses the method of claim 18.
However, modified Moon does not explicitly disclose wherein the assessing if the thyroid function is normal comprises: receiving a result of the thyroid hormone measurements test from the wearable device or a mobile device, and determining the thyroid function is normal or not by comparing a threshold hormone level stored on the monitoring server.
Conry teaches an analogous method of patient care (Abstract, para. [0011]). Conry further teaches receiving a result of the thyroid hormone measurement test from the wearable device or a mobile device (Fig. 1, element 120, para. [0026-0029], [0076]), and determining the thyroid function is normal or not by comparing a threshold hormone level stored on the monitoring server (para. [0076]). 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 disclosed by modified Moon to additionally include receiving a result of the thyroid hormone measurements test from the wearable device or a mobile device, and determining the thyroid function is normal or not by comparing a threshold hormone level stored on the monitoring server, as taught by Conry. This is because Conry teaches blood tests can be obtained from a network in order to generate a notification if a result deviates from a normal range (para. [0076]).
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Jaehoon Moon (WO 2019054553 A1) (previously cited), hereinafter referred to as Moon - for the purposes of English Translation, citations below reference US 20200214644 A1, which is the US national phase entry of WO 2019054553 A1, in view of Shinar et al. (US 20110282216 A1), hereinafter referred to as Shinar, in view of Udovcic et al. (“Hypothyroidism and the Heart”) (previously cited 11/19/2024), hereinafter referred to as Udovcic as applied to claim 18 above, and further in view of Sipe et al. (US 20200305713 A1) (previously cited), hereinafter referred to as Sipe.
Regarding claims 26, modified Moon discloses the method of claim 18.
However, modified Moon does not explicitly disclose wherein outputting the alert comprises: outputting a risk level of hypothyroidism, and outputting a trend of monitoring heart rates and the reference heart rate, which makes the person confirm worsening of the hypothyroidism.
Sipe teaches an analogous method of monitoring and treating a patient (Abstract, para. [0005]). Sipe further teaches outputting a risk level of an assessment (para. [0286]), and outputting a trend of monitoring heart rates and the reference heart rate, which makes the person confirm worsening of a condition (Fig. 6A-6F, Fig. 13, para. [0197-0198], [0206-0208]). 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 outputting disclosed by modified Moon to additionally include outputting a risk level of hypothyroidism, and outputting a trend of monitoring heart rates and the reference heart rate, which makes the person confirm worsening of the hypothyroidism, as taught by Sipe. This is because Sipe teaches outputting a risk level and a trend of monitoring heart rates allows a user or health care practitioner to quickly and reliably determine a patient’s heart rate over a period of time (para. [0197-0198], [0206-0208]).
Response to Arguments
Applicant’s arguments, see pages 5-8 of Remarks, filed 11/07/2025, with respect to the rejection of independent claim 18 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 Shinar et al. (US 20110282216 A1), hereinafter referred to as Shinar.
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