Detailed Noticed
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
Claims 35-42 are currently pending.
Claim 35 is amended.
Claims 1-34 are canceled.
Claims 35-42 are rejected.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 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.
Step 1:
In the instant case, claims 35-42 are directed toward a method (i.e. a process). Thus, each of the claims falls within one of the four statutory categories. Nevertheless, the claims fall within the judicial exception of an abstract idea.
Step 2A—Prong 1:
Independent claim 35 recite steps that, under their broadest reasonable interpretations, cover performance of the limitations of a certain method of organizing human activity and mathematical concepts, but for the recitation of generic computer components.
Claim 1 recites: “A method for predicting thyroid dysfunction for a subject performed by one or more processors, comprising: obtaining a heart rate signal from a wearable device comprising a heart rate measurement sensor; specifying a plurality of time interval, wherein each of the plurality of time interval representing a resting period comprising i) a period where movement of user is below a reference value or ii) a sleep period of user; determining a target date; specifying a first set of days for the target date; extracting, from the heart rate signal, a first set of interval heart rates for the first set of days using the plurality of time interval, wherein the first set of interval heart rates comprises heart rates corresponding to the plurality of time intervals within the first set of days; determining a reference date, wherein the reference date is selected among one or more test dates on which the subject takes a hormone test regardless of whether the subject's thyroid function is normal or abnormal; specifying a second set of days for the reference date; extracting, from the heart rate signal, a second set interval heart rates for the second set of days using the plurality of time interval, wherein the second set of interval heart rates comprises heart rates corresponding to the plurality of time intervals within the second set of days; obtaining at least one of hormone concentration related to a thyroid corresponding to the reference date; identifying, based on the first set of interval heart rates, the second set of interval heart rates and the at least one of hormone concentration, a set of parameters to be used in determining whether a thyroid function of a subject is normal or abnormal, wherein the set of parameters comprises : (i) a first parameter = (an average of the first set of interval heart rates - an average of the second set of interval heart rates) / the average of the second set of interval heart rates,(ii) a second parameter = (a standard deviation of the first set of interval heart rates / the average of the first set of interval heart rates) - (a standard deviation of the second set of interval heart rates / the average of the second set of interval heart rates),(iii) a third parameter = a value indicating a free T4 concentration corresponding to the reference date,(iv) a fourth parameter = a value indicating a TSH concentration corresponding to the reference date; determining whether the thyroid function of the subject is normal or abnormal by considering all of the set of parameters comprising the first to fourth parameter, wherein all of the first to fourth parameter is considered by a trained thyroid abnormality prediction model; and continuously monitoring, using the trained thyroid abnormality prediction model, the thyroid dysfunction without a doctor's help and a hospital visit in person”.
The limitations of obtaining a heart rate signal; specifying a plurality of time interval, wherein each of the plurality of time interval representing a resting period comprising i) a period where movement of user is below a reference value or ii) a sleep period of user; determining a target date; specifying a first set of days for the target date; extracting, a first set of interval heart rates for the first set of days using the plurality of time interval, wherein the first set of interval heart rates comprises heart rates corresponding to the plurality of time intervals within the first set of days; determining a reference date, wherein the reference date is selected among one or more test dates on which the subject takes a hormone test regardless of whether the subject's thyroid function is normal or abnormal; specifying a second set of days for the reference date; extracting, a second set interval heart rates for the second set of days using the plurality of time interval, wherein the second set of interval heart rates comprises heart rates corresponding to the plurality of time intervals within the second set of days; obtaining at least one of hormone concentration related to a thyroid corresponding to the reference date; identifying, based on the first set of interval heart rates, the second set of interval heart rates and the at least one of hormone concentration, a set of parameters to be used in determining whether a thyroid function of a subject is normal or abnormal, wherein the set of parameters comprises: determining whether the thyroid function of the subject is normal or abnormal by considering all of the set of parameters comprising the first to fourth parameter; and continuously monitoring, the thyroid dysfunction without a doctor's help and a hospital visit in person, given the broadest reasonable interpretation, cover the abstract idea of a certain method of organizing human activity because they recite managing personal behavior or relationships or interactions between people (i.e. social activities, teaching, and following rules or instructions—in this case the aforementioned steps recite a process of obtaining, specifying, determining, extracting, determining, and identifying, which is properly interpreted as a “personal behavior”), but instead automates the process via a computer model, e.g. see MPEP 2106.04(a)(2).
Furthermore, the limitations of (i) a first parameter = (an average of the first set of interval heart rates - an average of the second set of interval heart rates) / the average of the second set of interval heart rates, (ii) a second parameter = (a standard deviation of the first set of interval heart rates / the average of the first set of interval heart rates) - (a standard deviation of the second set of interval heart rates / the average of the second set of interval heart rates), (iii) a third parameter - a value indicating a free T4 concentration corresponding to the reference date, (iv) a fourth parameter = a value indicating a TSH concentration corresponding to the reference date, given their broadest interpretation amount to mathematical concepts but instead automates the process via a computer model, e.g. see MPEP 2106.04(a)(2). Any limitations not identified above as part of the abstract idea are deemed “additional elements”, and will be discussed in further detail below.
Dependent claims 36-42 include other limitations, for example , as well as specific step of data to be processed, received, and applied, but these only serve to further limit the abstract idea and do not add and additional elements, and hence are nonetheless directed towards fundamentally the same abstract idea as independent claim 35. However, recitation of an abstract idea is not the end of the 35 U.S.C. 101 analysis. Each of the claims must be analyzed for additional elements that indicate the abstract idea is integrated into a practical application to determine whether the claim is considered to be “directed to” an abstract idea.
Step 2A—Prong 2:
Claims 35-42 are not integrated into a practical application because the additional elements (i.e. any limitations that are not identified as part of the abstract idea) amount to no more than limitations which:
Amount to mere instructions to apply an exception—for example, the recitation of “wearable device”, “heart rate signal”, “thyroid abnormality prediction model”, and “processors”, which amount to merely invoking a computer as a tool to perform the abstract idea, e.g. see FIG. 1, FIG. 4, [0014]-[0015, [0023], and [0336], of the present specification, and see further MPEP 2106.05(f);
Generally linking the abstract idea to a particular technological environment or field of use, for example, “from a wearable device”, “heart rate signal”, “wherein all of the first to fourth parameter is considered by a trained thyroid abnormality prediction model”, and “using the trained thyroid abnormality prediction model”, which amounts to limiting the abstract idea to the field of technology/the environment of computers, see MPEP 2106.05(h); and/or
Merely acquiring information for further analysis by the system and the particular manner of acquisition is not described or shown to be important, for example, “obtaining a heart rate signal from a wearable device comprising a heart rate measurement sensor” and “obtaining at least one of hormone concentration related to a thyroid corresponding to the reference date”, which amounts to insignificant extra-solution activity in the form of mere data gathering because it merely functions tangentially to the main idea of the invention and serves only to bring in the data necessary for the inventions main analysis, see MPEP 2106.05(g).
Additionally, dependent claims 36-42 include other limitations, but as stated above, the limitations recited by these claims do not include any additional elements beyond those already recited in independent claim 35, and hence also do not integrate the aforementioned abstract idea into a practical application.
Step 2B:
The claims do not include additional elements that are sufficient to amount to “significantly more” than the judicial exception because the additional elements (i.e. the elements other than the abstract idea), as stated above, are directed towards no more than limitations that amount to mere instructions to apply the exception, and/or generally link the abstract idea to a particular technological environment or field of use, which even when reevaluated under the considerations of Step 2B of the analysis, do not amount to “significantly more” than the abstract idea.
Dependent claims 36-42 include other limitations, but none of these limitations are deemed significantly more than the abstract idea because, as stated above, the aforementioned dependent claims do not recite any additional elements not already recited in independent claim 35, and hence do not amount to “significantly more” than the abstract idea.
Additionally, the additional elements (i.e., “obtaining a heart rate signal from a wearable device comprising a heart rate measurement sensor” and “obtaining at least one of hormone concentration related to a thyroid corresponding to the reference date”), add extra solution activity, which comprises limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in a particular field as demonstrated by:
Relevant court decisions (See MPEP 2106.05(d)(II)):
Receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 610, 118 USPQ2d 1744, 1745 (Fed. Cir. 2016) (using a telephone for image transmission); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network); but see DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245, 1258, 113 USPQ2d 1097, 1106 (Fed. Cir. 2014) (“Unlike the claims in Ultramercial, the claims at issue here specify how interactions with the Internet are manipulated to yield a desired result‐‐a result that overrides the routine and conventional sequence of events ordinarily triggered by the click of a hyperlink.” (emphasis added)).
Thus, taken alone, the additional elements do not amount to significantly more than the abstract idea identified above. Furthermore, looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually, and there is no indication that the combination of elements improves the functioning of a computer or improves any other technology, and their collective functions merely provide conventional computer implementation.
Therefore, whether taken individually or as an ordered combination, claims 35-42 are nonetheless rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Response to Arguments
Applicant's arguments filed 01/22/2026 have been fully considered but they are not persuasive.
Regarding the 35 U.S.C. 101 Rejection, Applicant argues the claimed subject matter is not directed to an abstract idea of a mathematical concept, a certain method of organizing human activity, or a mental process. Examiner respectfully disagrees. The limitations of obtaining a heart rate signal, specifying a plurality of time interval, determining a target date, extracting… a first set of interval hear rates, determining a reference date, specifying a second set of days for the reference date, extracting… a second set interval heart rates, obtaining at least one or hormone concentrations, identifying the second set of interval heart rates, determining whether the thyroid function of the subject is normal or abnormal, and monitoring… the thyroid dysfunction without a doctor’s help and a hospital visit in person are abstract ideas that amount to a certain method of organizing human activity. MPEP 2106.04(a)(2) states “the sub-groupings encompass both activity of a single person (for example, a person following a set of instructions or a person signing a contract online) and activity that involves multiple people (such as a commercial interaction), and thus, certain activity between a person and a computer (for example a method of anonymous loan shopping that a person conducts using a mobile phone) may fall within the “certain methods of organizing human activity” grouping” and see further “a claim to “collecting information, analyzing it, and displaying certain results of the collection and analysis,” where the data analysis steps are recited at a high level of generality such that they could practically be performed in the human mind, Electric Power Group v. Alstom, S.A., 830 F.3d 1350, 1353-54, 119 USPQ2d 1739, 1741-42 (Fed. Cir. 2016)” and “a claim to collecting and comparing known information (claim 1), which are steps that can be practically performed in the human mind, Classen Immunotherapies, Inc. v. Biogen IDEC, 659 F.3d 1057, 1067, 100 USPQ2d 1492, 1500 (Fed. Cir. 2011)”.
The limitations of “(i) a first parameter = (an average of the first set of interval heart rates - an average of the second set of interval heart rates) / the average of the second set of interval heart rates,(ii) a second parameter = (a standard deviation of the first set of interval heart rates / the average of the first set of interval heart rates) - (a standard deviation of the second set of interval heart rates / the average of the second set of interval heart rates),(iii) a third parameter = a value indicating a free T4 concentration corresponding to the reference date,(iv) a fourth parameter = a value indicating a TSH concentration corresponding to the reference date” falls under the abstract idea of a mathematical concepts. See MPEP 2106.04(a)(2) states “A claim that recites a numerical formula or equation will be considered as falling within the “mathematical concepts” grouping. In addition, there are instances where a formula or equation is written in text format that should also be considered as falling within this grouping. For example, the phrase “determining a ratio of A to B” is merely using a textual replacement for the particular equation (ratio = A/B). Additionally, the phrase “calculating the force of the object by multiplying its mass by its acceleration” is using a textual replacement for the particular equation (F= ma)… A claim that recites a mathematical calculation, when the claim is given its broadest reasonable interpretation in light of the specification, will be considered as falling within the “mathematical concepts” grouping. A mathematical calculation is a mathematical operation (such as multiplication) or an act of calculating using mathematical methods to determine a variable or number, e.g., performing an arithmetic operation such as exponentiation. There is no particular word or set of words that indicates a claim recites a mathematical calculation. That is, a claim does not have to recite the word “calculating” in order to be considered a mathematical calculation. For example, a step of “determining” a variable or number using mathematical methods or “performing” a mathematical operation may also be considered mathematical calculations when the broadest reasonable interpretation of the claim in light of the specification encompasses a mathematical calculation.” Therefore, the claims recite two abstract ideas: certain method of organizing human activity and mathematical concepts.
Applicant argues the claims are similar to Example #39. Examiner respectfully disagrees. Example #39 is directed to a method of training a neural network for facial detection, which is not the same as predicting thyroid dysfunction. Example #39 also recites limitations that cannot practically be performed in the human mind. The limitations of transforming digital facial images cannot be performed mentally; Example #39 is eligible because there is no abstract idea recited in the claims. However, the current claims are not directed to any such similar features, and also does recite an abstract idea.
Applicant alleges the amendments of “continuously monitoring, using the trained thyroid abnormality prediction model, the thyroid dysfunction without a doctor’s help and a hospital visit in person” was agreed upon in the interview to integrate the abstract idea into a practical application. Examiner respectfully disagrees. The previous interview, no agreement was reached. It was noted that, if the claims were written in such a way that could not involve a person to practically perform the claims in the mind or with pen and paper, then the claims may be eligible. However, the claims do not reflect such methods, even with the amendment of “without a doctor’s help and a hospital visit in person”, which is still vague and broad.
Applicant argues Technical Features 1-4 improve the technology. Examiner respectfully disagrees. The recited Technical Features are not technological improvements, but merely part of the abstract idea that a model or computer is being tasked to perform. An abstract idea cannot integrate itself into a practical application. Only the additional elements (i.e., computer, processor, model, etc.) can integrate the abstract idea into a practical application. See MPEP 2106.05(a) states “If it is asserted that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes, a technical explanation as to how to implement the invention should be present in the specification. That is, the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. The specification need not explicitly set forth the improvement, but it must describe the invention such that the improvement would be apparent to one of ordinary skill in the art. Conversely, if the specification explicitly sets forth an improvement but in a conclusory manner (i.e., a bare assertion of an improvement without the detail necessary to be apparent to a person of ordinary skill in the art), the examiner should not determine the claim improves technology”, “It is important to note that in order for a method claim to improve computer functionality, the broadest reasonable interpretation of the claim must be limited to computer implementation. That is, a claim whose entire scope can be performed mentally, cannot be said to improve computer technology. Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d 1138, 120 USPQ2d 1473 (Fed. Cir. 2016) (a method of translating a logic circuit into a hardware component description of a logic circuit was found to be ineligible because the method did not employ a computer and a skilled artisan could perform all the steps mentally). Similarly, a claimed process covering embodiments that can be performed on a computer, as well as embodiments that can be practiced verbally or with a telephone, cannot improve computer technology. See RecogniCorp, LLC v. Nintendo Co., 855 F.3d 1322, 1328, 122 USPQ2d 1377, 1381 (Fed. Cir. 2017) (process for encoding/decoding facial data using image codes assigned to particular facial features held ineligible because the process did not require a computer)”, and “Merely adding generic computer components to perform the method is not sufficient. Thus, the claim must include more than mere instructions to perform the method on a generic component or machinery to qualify as an improvement to an existing technology.” Additionally, implementing the Technical Features via a model amount to “apply it”. See MPEP 2106.05(f) states “Use of a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general-purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not integrate a judicial exception into a practical application or provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Similarly, “claiming the improved speed or efficiency inherent with applying the abstract idea on a computer” does not integrate a judicial exception into a practical application or provide an inventive concept. Intellectual Ventures I LLC v. Capital One Bank (USA), 792 F.3d 1363, 1367, 115 USPQ2d 1636, 1639 (Fed. Cir. 2015)”.
Applicant argues an artificial intelligence model is present to perform the conditions of the technology disclosed in D1 (the amount of change between the heart rate of the reference date when the thyroid function is normal and the heart rate on the target day). Examiner respectfully disagrees. The specification and claims do not recite the use of any artificial intelligence (AI) model, but a “thyroid abnormality prediction model”, which is not the same.
Applicant argues the application reflects sensitivity improvements in Example #1 and Example #7, which is similar to the improvement in CARDIONET. Examiner respectfully disagrees. CARDIONET is directed to cardiac monitoring device which contains a beat detector, ventricular beat detector, as well as using variability determination logic, relevance determination logic, and event generator. The Federal Circuit stated that the claims clearly recited improved technical features of a specific detector components in combination of particular processing logic, and a defined interaction between those elements. The current claims do not have such similar features.
Applicant argues the claims provide a specific means or method that considers deviations in heart rate due to patient lifestyle. Additionally, Applicant shows Experiment 1, Experiment 2, and Experiment 3 comparison for providing improvement to the technology. Examiner respectfully disagrees. The concepts in Experiment 1, Experiment 2, and Experiment 3 and the means or method that considers deviations in heart rate due to patient lifestyle, is very high level and are, again, a part of the abstract idea of a mathematical concepts/formulas/equation. The abstract idea cannot integrate itself into a practical application. See MPEP 2106.04(d) states “the Court in Gottschalk v. Benson “held that simply implementing a mathematical principle on a physical machine, namely a computer, was not a patentable application of that principle)” and MPEP 2106.05(f) states “The Court found that the claimed process had no meaningful practical application except in connection with a computer. Benson, 409 U.S. at 71-72, 175 USPQ at 676. The claim simply stated a judicial exception (e.g., law of nature or abstract idea) while effectively adding words that “apply it” in a computer”.
Applicant argues the claimed subject matter does not simply automate known technology similar to McRO and CARDIONET. Examiner respectfully disagrees. McRO was eligible because was directed to obtaining phoneme timing data from speech, applying a set of rules, generating morph weight sets, and producing synchronized face animation, which is not similar to the features of the current application. The claimed rules of McRO are limited to rules with specific characteristics of lip-synchronization and facial animation. Again, current claims do not have such similar features. As stated above, CARDIONET is directed to cardiac monitoring device which contains a beat detector, ventricular beat detector, as well as using variability determination logic, relevance determination logic, and event generator. The Federal Circuit stated that the claims clearly recited improved technical features of a specific detector components in combination of particular processing logic, and a defined interaction between those elements. Again, the current claims do not have such similar features.
Applicant argues the previous office action did not substantiate the rejection under Step 2B as required under the Berkheimer Memo. Examiner respectfully disagrees. The previous office action cited the relevant court decision “Receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 610, 118 USPQ2d 1744, 1745 (Fed. Cir. 2016) (using a telephone for image transmission); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network); but see DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245, 1258, 113 USPQ2d 1097, 1106 (Fed. Cir. 2014) (“Unlike the claims in Ultramercial, the claims at issue here specify how interactions with the Internet are manipulated to yield a desired result‐‐a result that overrides the routine and conventional sequence of events ordinarily triggered by the click of a hyperlink.” (emphasis added))” (see MPEP 2106.05(d) “(b) A citation to one or more of the court decisions discussed in Subsection II below as noting the well-understood, routine, conventional nature of the additional element(s)”).
Applicant argues the features in claim 35 is not well-understood, routine, or conventional similar to Thales Visionix Inc. v. United States, 850 F.3d 1343 (Fed. Cir. 2017), hereinafter Thales Visionix. Applicant also argues the present application specifies a particular non-conventional configuration, a particular method of using data from the particular configuration, and provides a method that are more improved that a previous system. Applicant alleges the independent claim 35 is directed to a method using interval heart rates in a non-conventional manner and non-conventional configuration of input values to increase accuracy in predicting thyroid abnormality. Examiner respectfully disagrees. Thales Visionix was eligible because “the particular configuration of inertial sensors and the particular method of using the raw data from the sensors was more than simply applying a law of nature. The court found that the claims provided a system and method that “eliminate[d] many ‘complications’ inherent in previous solutions for determining position and orientation of an object on a moving platform.” In other words, the claim recited a technological solution to a technological problem”. The present application is not similar specific sensor (other than a generic heart rate measurement sensor), which is not similar to the sensor and its features of Thales Visionix. Therefore, the 35 U.S.C. 101 Rejection is maintained.
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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/R.S.S./Examiner, Art Unit 3681
/PETER H CHOI/Supervisory Patent Examiner, Art Unit 3681
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