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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/21/2025 has been entered.
Status of Claims
Applicant's arguments, filed 11/21/2025, 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 11/21/2025, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Applicants have amended claims 18, 23, 25, 34, and 36-37.
Applicants have left claims 19-20, 22, 24, 26-27, 29-33, and 35 as originally filed/previously presented.
Applicants have canceled/previously canceled claims 1-17, 21, and 28.
Claims 18-20, 22-27, and 29-37 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 10/22/2025 is being considered by the examiner.
Claim Objections - Withdrawn
Response to Arguments
Applicant’s arguments, see pages 8-10 of Remarks, filed 11/21/2025, with respect to the objections of claims 18, 23, 25, 34, 36, and 37 have been fully considered and are persuasive. Applicants have amended the claims, rendering the objections moot. The objections of claims 18, 23, 25, 34, 36, and 37 have been withdrawn.
Claim Interpretation - 35 USC § 112(f) - Maintained
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.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
Claim 18: The claim limitation “an ECG waveform analyzer configured to analyze …” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “analyzer” coupled with functional language “configured to analyze …” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “analyzer”.
Claim 18: The claim limitation “a function monitor configured to determine …” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “monitor” coupled with functional language “configured to determine …” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “monitor”.
Claim 18: The claim limitation “an event generator configured to generate an event …” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “generator” coupled with functional language “configured to generate an event …” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “generator”.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation:
“monitoring server 3000 may analyze the waveform of the additional data …” and “monitoring server 3000 may include a server communication unit 3100, a server database 3200, and a server control unit 3300 … monitoring server 3000 may be physically included in one server or may be a distributed server … monitoring server 3000 … may include computer hardware in which a thyroid function program is executed or a computer program that provides a service to another program and/or an electronic device …”, or equivalents thereof, as described in para. [0169-0184] and para. [0381] of the disclosure filed on 01/30/2025.
“monitoring server 3000 may determine that the risk of atrial fibrillation is greater than the risk of thyroid dysfunction …” and “monitoring server 3000 may include a server communication unit 3100, a server database 3200, and a server control unit 3300 … monitoring server 3000 may be physically included in one server or may be a distributed server … monitoring server 3000 … may include computer hardware in which a thyroid function program is executed or a computer program that provides a service to another program and/or an electronic device …”, or equivalents thereof, as described para. [0169-0184] and para. [0384-0385] of the disclosure filed on 01/30/2025.
“monitoring server 3000 may transmit an alert to the user terminal 2000 on the basis of the result of the thyroid function monitoring …” and “monitoring server 3000 may include a server communication unit 3100, a server database 3200, and a server control unit 3300 … monitoring server 3000 may be physically included in one server or may be a distributed server … monitoring server 3000 … may include computer hardware in which a thyroid function program is executed or a computer program that provides a service to another program and/or an electronic device …”, or equivalents thereof, as described in para. [0120] and para. [0169-0184] of the disclosure filed on 01/30/2025.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 101 - Maintained and Modified 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.
Claims 18-20, 22-27, and 29-37 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Analysis of independent claims 18, 23, and 37:
Step 1 of the subject matter eligibility test (see MPEP 2106.03).
Claim 18 is directed to a device, which describes one of the four statutory categories of patentable subject matter, i.e., a machine. Claim 23 is directed to a method, which describes one of the four statutory categories of patentable subject matter, i.e., a process. Claim 37 is directed to an article comprising one or more machine-readable media, which describes one of the four statutory categories of patentable subject matter, i.e., a product. Therefore, further consideration is necessary.
Step 2A of the subject matter eligibility test (see MPEP 2106.04).
Prong One: Claim 18 recites an abstract idea. In particular, the claim recites the following:
Analyze at least the P wave or a relationship among the P wave, Q wave, R wave and S wave that constitute the unit cycle of the ECG waveform and output a result of analysis;
Determine, based on the result of analysis, a prediction result indicating whether a thyroid function of the target patient is normal or abnormal; and
Wherein a first portion of the ECG waveform comprising the P wave preceding the Q wave within the unit cycle has 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.
Prong One: Claim 23 recites an abstract idea. In particular, the claim recites the following:
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;
Determining, based on a result of the analysis, a prediction result indicating whether a thyroid function of the target patient is normal or abnormal; and
Wherein the analyzing the ECG waveform causes 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.
Prong One: Claim 37 recites an abstract idea. In particular, the claim recites the following:
Analyzing 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;
Determining, based on a result of the analysis, a prediction result indicating whether a thyroid function of the target patient is normal or abnormal; and
Wherein the analyzing the ECG waveform causes 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.
These elements recited in claims 18, 23, and 37 are drawn to an abstract idea since (1) they involve a mental process that can be practically performed in the human mind including observation, evaluation, judgment, and opinion and using pen and paper.
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 is drawn to a mental process. A person with ordinary skill in the art can reasonably view an ECG waveform on a piece of paper and analyze different sections of the ECG waveform by visually seeing if the P wave is normal/abnormal and/or visually seeing if the P wave, Q wave, R wave and S wave are normal/abnormal. There is currently nothing to suggest an undue level of complexity in the analyzing step.
Determining/predicting, based on the result of analysis, a prediction result indicating whether a thyroid function of the target patient is normal or abnormal, specifically by giving the P wave a greater influence than the S wave, is drawn to a mental process. A person with ordinary skill in the art can reasonably make a mental determination and/or prediction if a thyroid function is normal or abnormal based on an analysis of the P wave or a relationship among the P wave, Q wave, R wave, and S wave, and specifically by giving the P wave a greater influence than the S wave. For example, a person can reasonably identify or predict if a thyroid abnormality is present when the P wave is distinguishable and determine or predict if a thyroid normality is present when the P wave is indistinguishable. There is currently nothing to suggest an undue level of complexity in the identifying and/or predicting steps.
Prong Two: Claims 18, 23, and 37 do not recite additional elements that integrate the exception into a practical application. Therefore, the claims are “directed to” the abstract idea. The additional elements merely:
Recite the words “apply it” or an equivalent with the judicial exception, or include instructions to implement the abstract idea on a computer, or merely use the computer as a tool to perform the abstract idea (e.g., “an ECG waveform analyzer” (claim 18), “a function monitor” (claim 18), “pre-stored instructions …” (claim 18), “pre-stored instructions …” (claim 23), “An article comprising one or more machine-readable media storing instructions operable to cause one or more machines …” (claim 37), “pre-stored instructions …” (claim 37)), and
Add insignificant extra-solution activity (the pre-solution activity of: using generic data-gathering components (e.g. “a heartbeat detector configured to detect the heartbeat of the target patient as an electrocardiogram (ECG) waveform, wherein the heartbeat detector comprises a first electrode and a second electrode, wherein the ECG waveform is generated as a physical electrical closed loop through the first electrode and the 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” (claim 18), “obtaining 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, 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” (claim 23), “obtaining 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, 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” (claim 37)); the post-solution activity of: (e.g. “an event generator configured to generate an event when the ECG waveform is identified as being relevant to the thyroid function of the target patient” (claim 18); using generic data-outputting components (e.g. “an event generator” (claim 18))).
As a whole, the additional elements merely serve to gather information to be used by the abstract idea, while generically implementing it on a computer. There is no practical application because the abstract idea is not applied, relied on, or used in a meaningful way. The processing performed remains in the abstract realm, i.e., the result is not used for a treatment. No improvement to the technology is evident. Therefore, the additional elements, alone or in combination, do not integrate the abstract idea into a practical application.
Per the Berkheimer requirement, the additional elements are well-understood, routine, and conventional. For example, a first electrode and a second electrode to obtain an ECG waveform of a patient through a physical electrical closed loop is well-understood, routine, and conventional, as disclosed by Wang et al. (US 20180007983 A1) - Fig. 1, para. [0022].
Further, “an ECG waveform analyzer”, “a function monitor”, “an event generator”, as interrupted under 112(f) as generic servers, processors, computers, and non-transitory computer medica, and “machine-readable media” and “pre-stored instructions” does not qualify as significantly more because this limitation is simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014)) and/or a claim to an abstract idea requiring no more than being stored on a computer readable medium which is a well-understood, routine and conventional activity previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014); SAP Am. v. InvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
Step 2B of the subject matter eligibility test (see MPEP 2106.05).
Claims 18, 23, and 37 do not include additional elements, alone or in combination, that are sufficient to amount to significantly more than the judicial exception (i.e., an inventive concept) for the same reasons as described above. E.g., all elements are directed to pre-solution data gathering steps/elements, and generic, post-solution steps/elements, which merely facilitate the abstract idea.
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taking individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
Analysis of the dependent claims:
Claims 19-20, 22, 24-27, and 29-36 depend from the independent claims. The dependent claims merely further define the abstract idea and are, therefore, directed to an abstract idea for similar reasons: they merely
Further describe the abstract idea (“determine whether the first portion of the ECG waveform is distinguishable, and wherein the function monitor is configured to: identify the ECG waveform is relevant to the abnormality of the thyroid function when the first portion of the ECG waveform is determined to be distinguishable, identify the ECG waveform is relevant to a normality of the thyroid function and the abnormality of the heart function when the first portion of the ECG waveform is determined to be indistinguishable” (claim 19), “analyze the first portion of the ECG waveform related to at least the P wave” (claim 20), “determining whether the first portion of the ECG waveform is distinguishable, and wherein the determining the prediction result comprises 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” (claim 24), “analyzing a portion of the ECG waveform related to at least the P wave” (claim 27), “analyzing intervals between peaks detected in the ECG waveform” (claim 30), “determining 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” (claim 31), “obtaining the heart rate of the target patient based on the intervals between the peaks detected in the ECG waveform, wherein the determining the prediction result comprises 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 a pre-stored reference heart rate of the target patient by a predetermined range” (claim 32), “determining 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 determining 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” (claim 33), “extracting a portion of the ECG waveform corresponding to a predetermined period based on the ECG waveform, and generating a monitoring data based on the portion of the ECG waveform, wherein the analyzing the ECG waveform comprises: analyzing the monitoring data” (claim 34), “the predetermined period is selected as a period which satisfies time-related conditions” (claim 35), “the predetermined period is selected as a resting period during which no movement is detected from the target patient” (claim 36)),
Further describe the pre-solution activity (or the structure used for such activity) (“wherein the ECG waveform of the target patient is obtained from a wearable device while the target patient is at a resting period” (claim 25), “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” (claim 26)),
Further describe the computer implementation (“the ECG waveform analyzer is configured to 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” (claim 22), “analyzing 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” (claim 29)), and
Per the Berkheimer requirement, the additional elements are well-understood, routine, and conventional. For example, a motion sensor or an accelerometer for detecting a movement of the patient to determine a resting period is well-understood, routine, and conventional, as disclosed by Joseph Wiesel (US 20150065891 A1) - Fig. 2, para. [0038].
Taken alone or in combination, the additional elements do not integrate the judicial exception into a practical application at least because the abstract idea is not applied, relied on, or used in a meaningful way. The additional elements do not add anything significantly more than the abstract idea. The collective functions of the additional elements merely provide computer/electronic implementation and processing, and no additional elements beyond those of the abstract idea. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements improves the functioning of a computer, output device, improves technology other than the technical field of the claimed invention, etc. Therefore, the claims are rejected as being directed to non-statutory subjection matter. Claims 18-20, 22-27, and 29-37 are rejected.
Response to Arguments
Applicant's arguments filed 11/21/2025 have been fully considered but they are not persuasive.
Applicants have argued on page 10 of Remarks, filed 11/21/2025, that the claims “recite specific features … that cannot be performed in the human mind … obtaining an electrocardiogram (ECG) waveform of the target patient, analyzing the ECG waveform, determining, based on a result of the analysis, a prediction result indicating whether a thyroid function of the target patient is normal or abnormal and wherein the ECG waveform analyzer 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”, and the amended independent claims recite additional elements “wherein the ECG waveform analyzer 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”.
The Examiner respectfully disagrees. As reiterated above, as currently claimed “analyzing the ECG waveform and determining, based on a result of the analysis, a prediction result indicating whether a thyroid function of the target patient is normal or abnormal, and causing 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” are all directed towards a mental process that can be practically performed in the human mind including observation, evaluation, judgment, and opinion and using pen and paper. There is nothing to suggest an undue level of complexity. See the rejection above.
Further, the use of obtaining an ECG, specifically through electrodes, and using an ECG waveform analyzer, a function monitor, and pre-stored instructions, are directed to additional elements that are well-understood, routine, and conventional. There is no indication that the combination of elements improves the functioning of a computer, output device, improves technology other than the technical field of the claimed invention, etc. See the rejection above.
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 18-20, 22-24, 27, and 29-35, and 37 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 Baladi et al. (“ECG Changes in patients with primary hyperthyroidism”) (previously cited), hereinafter referred to as Baladi.
The claims are generally directed towards a device for generating a prediction result related to a thyroid function of a target patient, comprising: a heartbeat detector configured to detect the heartbeat of the target patient as an electrocardiogram (ECG) waveform, wherein the heartbeat detector comprises a first electrode and a second electrode, wherein the ECG waveform is generated as a physical electrical closed loop through the first electrode and the 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; an ECG waveform analyzer configured to analyze at least the P wave or a relationship among the P wave, Q wave, R wave and S wave that constitute the unit cycle of the ECG waveform and output a result of analysis; a function monitor configured to determine, based on the result of analysis, a prediction result indicating whether a thyroid function of the target patient is normal or abnormal; and an event generator configured to generate an event when the ECG waveform is identified as being relevant to an abnormality of the thyroid function of the target patient; wherein the ECG waveform analyzer 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.
Regarding claim 18, Wang discloses a device for generating a prediction result related to a thyroid function of a target patient (Abstract, para. [0019-0020], “systems for cardiac condition detection …”), comprising:
a heartbeat detector (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”) configured to detect the heartbeat of the target patient as an electrocardiogram (ECG) waveform (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”),
wherein the heartbeat detector comprises a first electrode and a second electrode (Fig. 1, elements 110, 111, and 112, “flexible electrodes”, para. [0022]),
wherein the ECG waveform is generated as a physical electrical closed loop through the first electrode and the 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);
an ECG waveform analyzer (Fig. 3B, element 310, Fig. 3C, element 300D, Fig. 3D, element 300D, para. [0065], para. [0071]) configured to analyze at least the P wave or a relationship among the P wave, Q wave, R wave and S wave that constitute the unit cycle of the ECG waveform and output a result of analysis (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 …”);
a function monitor (Fig. 3B, element 310, Fig. 3C, element 300D, Fig. 3D, element 300D, para. [0065], para. [0071]); and
an event generator (Fig. 3C, Fig. 3D) configured to generate an event when the ECG waveform is identified as being relevant to an abnormality (para. [0052], para. [0062], para. [0067-0070], para. [0073]);
wherein the ECG waveform analyzer is configured to use pre-stored instructions (para. [0041-0042], para. [0067]).
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, Wang does not explicitly disclose the function monitor is configured to determine, based on the analysis, a prediction result indicating whether a thyroid function of the target patient is normal or abnormal; the event generator is configured to generate an event when the ECG waveform is identified as being relevant to an abnormality of the thyroid function of the target patient, and 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 device disclosed by Wang to additionally determine, based on the analysis, a prediction result indicating whether a thyroid function of the target patient is normal or abnormal; the event generator is configured to generate an event when the ECG waveform is identified as being relevant to an abnormality of the thyroid function of the target patient, and 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”).
Regarding claim 19, modified Wang discloses the device of Claim 18, wherein the ECG waveform analyzer is configured to: 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 …”), wherein the function monitor is configured to identify the ECG waveform is relevant to the abnormality of the heart function 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, Wang does not explicitly disclose wherein the function monitor is configured to: identify the ECG waveform is relevant to the abnormality of the thyroid function when the first portion of the ECG waveform is determined to be distinguishable, and identify the ECG waveform is relevant to a normality of the thyroid function and the abnormality of the heart function 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 function monitor disclosed by modified Wang to additionally be configured to: identify the ECG waveform is relevant to the abnormality of the thyroid function when the first portion of the ECG waveform is determined to be distinguishable, and identify the ECG waveform is relevant to a normality of the thyroid function and the abnormality of the heart function 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 20, modified Wang discloses the device of Claim 18, wherein the ECG waveform analyzer is configured to analyze the first 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 22, modified Wang discloses the device of Claim 18, wherein the ECG waveform analyzer is configured to 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 23, Wang discloses a method for determining a prediction result related to a thyroid function of a target patient (Abstract, “method …”, para. [0019-0020], “systems for cardiac condition detection …”), performed by a server (Fig. 3C, Fig. 3D, para. [0026], “remote server computer”), comprising:
obtaining 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”),
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);
analyzing 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]).
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, Wang does not explicitly disclose determining, 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 method disclosed by 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”).
Regarding claim 24, modified Wang discloses the method of Claim 23, wherein the analyzing the ECG waveform comprises: determining 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 determining the prediction result comprises: determining 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 method disclosed 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 method of Claim 23, wherein the analyzing the ECG waveform comprises analyzing 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 method of Claim 23, wherein the analyzing the ECG waveform comprises: analyzing 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 method of Claim 23, wherein the analyzing the ECG waveform comprises: analyzing 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 method 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 determining the prediction result comprises: determining 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 method disclosed 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 method of Claim 31, wherein the analyzing the ECG waveform comprises: obtaining 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 determining 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 method disclosed 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 method 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 determining the prediction result comprises determining 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 determining 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 method disclosed by modified Wang to additionally determining 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 determining 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 method of Claim 23, wherein the method further comprises: extracting 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 generating a monitoring data based on the portion of the ECG waveform, wherein the analyzing the ECG waveform comprises: analyzing the monitoring data (para. [0113], “criteria can be compared against the detected P-wave and QRS complex …”).
Regarding claim 35, modified Wang discloses the method 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 37, Wang discloses an article comprising one or more machine-readable media storing instructions operable to cause one or more machines to perform operations (Abstract, para. [0008], “non-transitory computer-readable medium …”, Fig. 3B, Fig. 3C, Fig. 3D), the operations comprising:
obtaining an electrocardiogram (ECG) waveform of a 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”),
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);
analyzing 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]).
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, Wang does not explicitly disclose determining, 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 article/method disclosed by 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”).
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 Baladi et al. (“ECG Changes in patients with primary hyperthyroidism”) (previously cited), hereinafter referred to as Baladi 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 method 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 method disclosed 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 method 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 method disclosed 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 method 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 method disclosed 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 filed 11/21/2025 have been fully considered but they are not persuasive.
Applicants have argued on pages 11-12 of Remarks, filed 11/21/2025, that “Wang fails to disclose or suggest, at least, “wherein the ECG waveform analyzer is configured to use pre-stored instructions …””.
The Examiner respectfully disagrees. As recited in the newly applied rejection above, Wang discloses using pre-stored instructions for analyzing the ECG waveforms (para. [0041-0042], para. [0067]).
Applicants have further argued on pages 11-12 of Remarks, filed 11/21/2025, that Baladi does not disclose or suggest “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” and “Baladi does not provide any teaching or motivation to design an algorithm in which the P-wave region has a greater influence than the S-wave region in determining thyroid function status.
The Examiner respectfully disagrees. As recited in the rejection above, Baladi teaches hyperthyroidism patients are more likely to have an increase in heart rate, with no change in the P-wave (Table 1, pg. 2, “Methods”, pg. 2, “Results”, pg. 3, “Results, para. 2). That is, Baladi teaches when monitoring patients with thyroid abnormalities, the P-wave can be used with greater influence over the S wave when detecting atrial fibrillation to determine if the patient has 1) an increased heart rate with atrial fibrillation, meaning a heart function is abnormal, or 2) an increased heart rate without atrial fibrillation, meaning there is a thyroid dysfunction, and one of ordinary skill in the art would have been motivated in view of Baladi to modify the pre-stored instructions of Wang to additionally determine a prediction results of thyroid function based at least on the P wave.
Applicants have further argued on pages 11-12 of Remarks, filed 11/21/2025, that Baladi does not disclose or suggest certain elements, which are essential to derive the claimed configuration.
Applicants arguments are not commensurate in scope with the claimed invention. The claims do not require specifics regarding how the thyroid function is determination as normal or abnormal, as argued.
Conclusion
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/K.W.K./Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791