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 .
Claim Status: Claims 33, 35-42, and 44-52 are pending.
Response to Arguments
Applicant's arguments filed on March 18, 2026 have been fully considered but they are not persuasive.
1) Applicant made an argument that the claimed method is rooted in technology requiring a wearable device that is monitoring a user and determining and displaying a coronary heart disease probability of the user.
The data analysis and determining a coronary heart disease probability of the user is an abstract idea. Displaying the coronary heart disease probability is an insignificant extra-solution activity. A wearable device is an additional element that is a computer or computer component used as a tool to execute the abstract ideas (see MPEP 2106.05(f)) and well-understood, routine, conventional.
2) Applicant argued that the human mind is not equipped to handle ECG signals or perform signal reconstruction on ECG signals and that grouping of the pending claims into the “mental process” category is erroneous.
Examiner would like to note that there is no time limit in the claim and that a person can analyze ECG signal and perform signal reconstruction on ECG signal with pen and paper.
3) Applicant argued that the pending claims include an improvement to a manner in which a user’s coronary heart disease probability may be determined or estimated and informed to a user. Applicant’s statement of improvement is that a user can determine or estimate their coronary heart disease probability without requiring any invasive, expensive, and complex coronary angiography, and can be alerted that further diagnostic testing for coronary heart disease probability may be warranted.
Examiner notes that the determining and estimating coronary heart disease probability is an abstract idea and the abstract idea itself cannot be a practical application.
MPEP 2106.05(a):
It is important to note, the judicial exception alone cannot provide the improvement. The improvement can be provided by one or more additional elements. See the discussion of Diamond v. Diehr, 450 U.S. 175, 187 and 191-92, 209 USPQ 1, 10 (1981)) in subsection II, below. In addition, the improvement can be provided by the additional element(s) in combination with the recited judicial exception. See MPEP § 2106.04(d) (discussing Finjan, Inc. v. Blue Coat Sys., Inc., 879 F.3d 1299, 1303-04, 125 USPQ2d 1282, 1285-87 (Fed. Cir. 2018)). Thus, it is important for examiners to analyze the claim as a whole when determining whether the claim provides an improvement to the functioning of computers or an improvement to other technology or technical field.
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 33 and 35-41 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract idea without significantly more. The claim(s) recite(s) a method.
To determine whether a claim satisfies the criteria for subject matter eligibility, the claim is evaluated according to a stepwise process as described in MPEP 2106(III) and 2106.03-2106.04.
The instant claims are evaluated according to such analysis.
Step 1: Is the claim to a process, machine, manufacture or composition of matter?
Yes, Claim 33 is directed towards a method.
Step 2A (Prong 1): Does the claim recite an abstract idea, law of nature, or natural phenomenon?
Yes, the judicial exception relied upon by the instantly claimed invention is an abstract idea, and the limitation that sets forth or describes the abstract idea is: “determining, based on the ECG signals of the one or more leads, reconstructed signals respectively corresponding to the ECG signals of the one or more leads, wherein the ECG signals of the one or more leads comprise an ECG signal of a first lead, and a reconstructed signal corresponding to the ECG signal of the first lead is obtained by performing signal reconstruction based on a feature of the ECG signal of the first lead; determining an abnormal signal in the ECG signals of the one or more leads based on the ECG signals of the one or more leads and the reconstructed signals respectively corresponding to the ECG signals of the one or more leads; determining a coronary heart disease probability of the user based on the abnormal signal and a reconstructed signal corresponding to the abnormal signal.”The reason that the above limitations are abstract idea is because they are directed to mental process (observation, evaluation, judgment, opinion).
Please see the following analogous types of data manipulations that courts have found to be abstract ideas (all taken from MPEP § 2106.04):
collecting information, analyzing it, and displaying certain results of the collection and analysis, Electric Power Group, LLC v. Alstom, S.A., 830 F.3d 1350, 1351-52, 119 USPQ2d 1739, 1740 (Fed. Cir. 2016)
The steps of data collection and usage carried out in Applicant's claims are akin to a mental process because they are the type of calculations that could theoretically be carried out mentally, but are merely implemented using generic collection technology. The 2019 revised§ 101 guidance makes clear that the "mental process" category of abstract ideas does not only apply to steps actually carried out mentally; it also applies to the types of processes that could be carried out mentally, but are instead carried out using generic processing/collection technology.
Step 2A (Prong 2): Does the claim recite additional elements that integrate the judicial exception into a practical application?
No, the claim recites additional elements “obtaining electrocardiogram (ECG) signals of one or more leads corresponding to a user” and “displaying the coronary heart disease probability of the user”; however, these additional elements do not integrate the judicial exception into a practical application, because obtaining data amounts to insignificant extra-solution activity. The claim recites “a wearable device,” which is a computer or computer component used as a tool to execute the abstract ideas (see MPEP 2106.05(f)).
The following are relevant examples of similar limitations which courts have found not to constitute improvements to computers or improvements to other technology or technical field:
Gathering and analyzing information using conventional techniques and displaying the result, TIJ Communications, 823 F.3d at 612-13, 118 USPQ2d at 1747-48.
It is further noted that merely collecting the necessary data using known, generic sensors (or other data gathering components) only amounts to insignificant extrasolution activity; see MPEP § 2106.05(g). Applicant's claimed invention does not affect/change the functionality of the technology being used. Rather, Applicant's claimed invention uses the claimed technology for its standard, well-known purpose, e.g. known sensors are used to collect data which they are known to be capable of collecting, known generic processing circuitry is used to perform data calculations/ comparisons, etc. Applicant's invention does not result in improved performance of the sensors, the processing circuitry, etc.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
No, the claim recites additional elements “obtaining electrocardiogram (ECG) signals of one or more leads corresponding to a user” and “displaying the coronary heart disease probability of the user.” The additional elements do not amount to significantly more than the judicial exception, because it is simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception (See MPEP 2106.05(d)). Displaying information is general purpose computer operations.
The courts have recognized receiving or transmitting data over a network, e.g., using the Internet to gather data, as well-understood, routine, and conventional functions when they are claimed in a merely generic manner or as insignificant extra-solution activity: 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). See MPEP 2106.05(d)II.
Selecting information, based on types of information and availability of information in a power-grid environment, for collection, analysis and display, Electric Power Group, LLC v. Alstom S.A., 830 F.3d 1350, 1354-55, 119 USPQ2d 1739, 1742 (Fed. Cir. 2016).
The claim recites additional elements “a wearable device”, “a processor”, and “a memory”.
The wearable device is disclosed as a smartwatch in para. [0077] and [0079] of the instant specification, which shows that the wearable device is a commercially available product.
The processor and memory are discussed at a high level in para. [0185] and [0186] of the instant specification, which shows that they are well-understood, routine, conventional.
Therefore, the claim is not patent eligible.
With regards to the instantly rejected dependent claims 35-41, these claims when analyzed as a whole are also held to be patent ineligible under 35 U.S.C. 101 because the additional recited limitation(s) fail(s) to establish that the claim(s) is/are not directed to a judicial exception and/or do not add significantly more to the judicial exception. Therefore, the claim(s) is/are not patent eligible.
Claims 51 and 52 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract idea without significantly more. The claim(s) recite(s) a device.
To determine whether a claim satisfies the criteria for subject matter eligibility, the claim is evaluated according to a stepwise process as described in MPEP 2106(III) and 2106.03-2106.04.
The instant claims are evaluated according to such analysis.
Step 1: Is the claim to a process, machine, manufacture or composition of matter?
Yes, Claim 51 is directed towards a device.
Step 2A (Prong 1): Does the claim recite an abstract idea, law of nature, or natural phenomenon?
Yes, the judicial exception relied upon by the instantly claimed invention is an abstract idea, and the limitation that sets forth or describes the abstract idea is: “determining, based on the ECG signals of the one or more leads, reconstructed signals respectively corresponding to the ECG signals of the one or more leads, wherein the ECG signals of the one or more leads comprise an ECG signal of a first lead, and a reconstructed signal corresponding to the ECG signal of the first lead is obtained by performing signal reconstruction based on a feature of the ECG signal of the first lead; determining an abnormal signal from the reconstructed signals; determining a coronary heart disease probability of the user based on the abnormal signal and the reconstructed signals respectively corresponding to the ECG signals of the one or more leads.”
The reason that the above limitations are abstract idea is because they are directed to mental process (observation, evaluation, judgment, opinion).
Please see the following analogous types of data manipulations that courts have found to be abstract ideas (all taken from MPEP § 2106.04):
collecting information, analyzing it, and displaying certain results of the collection and analysis, Electric Power Group, LLC v. Alstom, S.A., 830 F.3d 1350, 1351-52, 119 USPQ2d 1739, 1740 (Fed. Cir. 2016)
The steps of data collection and usage carried out in Applicant's claims are akin to a mental process because they are the type of calculations that could theoretically be carried out mentally, but are merely implemented using generic collection technology. The 2019 revised§ 101 guidance makes clear that the "mental process" category of abstract ideas does not only apply to steps actually carried out mentally; it also applies to the types of processes that could be carried out mentally, but are instead carried out using generic processing/collection technology.
Step 2A (Prong 2): Does the claim recite additional elements that integrate the judicial exception into a practical application?
No, the claim recites additional elements “obtaining electrocardiogram (ECG) signals of one or more leads corresponding to a user” and “displaying the coronary heart disease probability of the user”; however, these additional elements do not integrate the judicial exception into a practical application, because obtaining data amounts to insignificant extra-solution activity. The claim recites “a wearable device,” “a processor” and “a memory” which are each a computer or computer component used as a tool to execute the abstract ideas (see MPEP 2106.05(f)).
The following are relevant examples of similar limitations which courts have found not to constitute improvements to computers or improvements to other technology or technical field:
Gathering and analyzing information using conventional techniques and displaying the result, TIJ Communications, 823 F.3d at 612-13, 118 USPQ2d at 1747-48.
It is further noted that merely collecting the necessary data using known, generic sensors (or other data gathering components) only amounts to insignificant extrasolution activity; see MPEP § 2106.05(g). Applicant's claimed invention does not affect/change the functionality of the technology being used. Rather, Applicant's claimed invention uses the claimed technology for its standard, well-known purpose, e.g. known sensors are used to collect data which they are known to be capable of collecting, known generic processing circuitry is used to perform data calculations/ comparisons, etc. Applicant's invention does not result in improved performance of the sensors, the processing circuitry, etc.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
No, the claim recites additional elements “obtaining electrocardiogram (ECG) signals of one or more leads corresponding to a user” and “displaying the coronary heart disease probability of the user.” The additional elements do not amount to significantly more than the judicial exception, because it is simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception (See MPEP 2106.05(d)). Displaying information is general purpose computer operations.
The courts have recognized receiving or transmitting data over a network, e.g., using the Internet to gather data, as well-understood, routine, and conventional functions when they are claimed in a merely generic manner or as insignificant extra-solution activity: 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). See MPEP 2106.05(d)II.
Selecting information, based on types of information and availability of information in a power-grid environment, for collection, analysis and display, Electric Power Group, LLC v. Alstom S.A., 830 F.3d 1350, 1354-55, 119 USPQ2d 1739, 1742 (Fed. Cir. 2016).
The claim recites additional elements “a wearable device”, “a processor”, and “a memory”.
The wearable device is disclosed as a smartwatch in para. [0077] and [0079] of the instant specification, which shows that the wearable device is a commercially available product.
The processor and memory are discussed at a high level in para. [0185] and [0186] of the instant specification, which shows that they are well-understood, routine, conventional. Therefore, the claim is not patent eligible.
With regards to the instantly rejected dependent claim 52, these claims when analyzed as a whole are also held to be patent ineligible under 35 U.S.C. 101 because the additional recited limitation(s) fail(s) to establish that the claim(s) is/are not directed to a judicial exception and/or do not add significantly more to the judicial exception. Therefore, the claim(s) is/are not patent eligible.
Claims 42 and 44-50 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract idea without significantly more. The claim(s) recite(s) a device.
To determine whether a claim satisfies the criteria for subject matter eligibility, the claim is evaluated according to a stepwise process as described in MPEP 2106(III) and 2106.03-2106.04.
The instant claims are evaluated according to such analysis.
Step 1: Is the claim to a process, machine, manufacture or composition of matter?
Yes, Claim 42 is directed towards a device.
Step 2A (Prong 1): Does the claim recite an abstract idea, law of nature, or natural phenomenon?
Yes, the judicial exception relied upon by the instantly claimed invention is an abstract idea, and the limitation that sets forth or describes the abstract idea is: “determining, based on the ECG signals of the one or more leads, reconstructed signals respectively corresponding to the ECG signals of the one or more leads, wherein the ECG signals of the one or more leads comprise an ECG signal of a first lead, and a reconstructed signal corresponding to the ECG signal of the first lead is obtained by performing signal reconstruction based on a feature of the ECG signal of the first lead; determining an abnormal signal in the ECG signals of the one or more leads based on the ECG signals of the one or more leads and the reconstructed signals corresponding to the ECG signals of the one or more leads; determining a coronary heart disease probability of the user based on the abnormal signal and a reconstructed signal corresponding to the abnormal signal.”
The reason that the above limitations are abstract idea is because they are directed to mental process (observation, evaluation, judgment, opinion).
Please see the following analogous types of data manipulations that courts have found to be abstract ideas (all taken from MPEP § 2106.04):
collecting information, analyzing it, and displaying certain results of the collection and analysis, Electric Power Group, LLC v. Alstom, S.A., 830 F.3d 1350, 1351-52, 119 USPQ2d 1739, 1740 (Fed. Cir. 2016)
The steps of data collection and usage carried out in Applicant's claims are akin to a mental process because they are the type of calculations that could theoretically be carried out mentally, but are merely implemented using generic collection technology. The 2019 revised§ 101 guidance makes clear that the "mental process" category of abstract ideas does not only apply to steps actually carried out mentally; it also applies to the types of processes that could be carried out mentally, but are instead carried out using generic processing/collection technology.
Step 2A (Prong 2): Does the claim recite additional elements that integrate the judicial exception into a practical application?
No, the claim recites additional elements “obtaining electrocardiogram (ECG) signals of one or more leads corresponding to a user” and “displaying the coronary heart disease probability of the user”; however, these additional elements do not integrate the judicial exception into a practical application, because obtaining data amounts to insignificant extra-solution activity. The claim recites “a wearable device,” “a processor” and “a memory” which are each a computer or computer component used as a tool to execute the abstract ideas (see MPEP 2106.05(f)).
The following are relevant examples of similar limitations which courts have found not to constitute improvements to computers or improvements to other technology or technical field:
Gathering and analyzing information using conventional techniques and displaying the result, TIJ Communications, 823 F.3d at 612-13, 118 USPQ2d at 1747-48.
It is further noted that merely collecting the necessary data using known, generic sensors (or other data gathering components) only amounts to insignificant extrasolution activity; see MPEP § 2106.05(g). Applicant's claimed invention does not affect/change the functionality of the technology being used. Rather, Applicant's claimed invention uses the claimed technology for its standard, well-known purpose, e.g. known sensors are used to collect data which they are known to be capable of collecting, known generic processing circuitry is used to perform data calculations/ comparisons, etc. Applicant's invention does not result in improved performance of the sensors, the processing circuitry, etc.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
No, the claim recites additional elements “obtaining electrocardiogram (ECG) signals of one or more leads corresponding to a user” and “displaying the coronary heart disease probability of the user.” The additional elements do not amount to significantly more than the judicial exception, because it is simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception (See MPEP 2106.05(d)). Displaying information is general purpose computer operations.
The courts have recognized receiving or transmitting data over a network, e.g., using the Internet to gather data, as well-understood, routine, and conventional functions when they are claimed in a merely generic manner or as insignificant extra-solution activity: 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). See MPEP 2106.05(d)II.
Selecting information, based on types of information and availability of information in a power-grid environment, for collection, analysis and display, Electric Power Group, LLC v. Alstom S.A., 830 F.3d 1350, 1354-55, 119 USPQ2d 1739, 1742 (Fed. Cir. 2016).
The claim recites additional elements “a wearable device”, “a processor”, and “a memory”.
The wearable device is disclosed as a smartwatch in para. [0077] and [0079] of the instant specification, which shows that the wearable device is a commercially available product.
The processor and memory are discussed at a high level in para. [0185] and [0186] of the instant specification, which shows that they are well-understood, routine, conventional.
Therefore, the claim is not patent eligible.
With regards to the instantly rejected dependent claims 44-50, these claims when analyzed as a whole are also held to be patent ineligible under 35 U.S.C. 101 because the additional recited limitation(s) fail(s) to establish that the claim(s) is/are not directed to a judicial exception and/or do not add significantly more to the judicial exception. Therefore, the claim(s) is/are not patent eligible.
Avoids Prior Art Rejection
The following is a statement of the ways that the application distinguishes over the closest prior art of record:
The closest prior art is Saba (US20090187097A1) discloses a method, applied to a wearable device (para. [0005], a traditional electrocardiogram (sEKG) derived from skin surface electrodes; para. [0071], implantable devices), the method comprising:
obtaining electrocardiogram (ECG) signals of one or more leads corresponding to a user (para. [0009], A properly placed array of skin surface electrodes connected to a conventional electrocardiograph device can result in the production of an sEKG.);
determining, based on the ECG signals of the one or more leads, reconstructed signals respectively corresponding to the ECG signals of the one or more leads (para. [0013], [0044], The term “reconstructed electrocardiogram” as used herein is abbreviated as “rEKG” and refers to the generation of a conventional P-Q-R-S-T heart waveform pattern by utilizing an algorithm based upon an EMG/sEKG correlation parameter and EMG data.),
wherein the ECG signals of the one or more leads comprise an ECG signal of a first lead, and a reconstructed signal corresponding to the ECG signal of the first lead is obtained by performing signal reconstruction based on a feature of the ECG signal of the first lead (para. [0009], [0013], [0042], fig. 6); determining a coronary heart disease probability of the user based on a reconstructed signal (para. [0071], Some advantages of using EKG reconstruction diagnostics instead of traditional EKG diagnostics is that it provides real-time continuous monitoring, which can be used for multiple purposes including but not limited to: i) ischemia detection; ii) myocardial Infarction detection; iii) electrolyte abnormalities detection; iv) assessment of effect of medications; or v) improved rhythm discrimination.).
Saba uses the traditional electrocardiogram (sEKG) in order to calculate EMG/sEKG correlations (EMG from an implanted device EMG recording) and once EMG/sEKG correlations are obtained in a subject, a subsequent rEKG does not require a paired sEKG for comparison (para. [0079]-[0081]).
Saba is silent regarding determining an abnormal signal in the ECG signals of the one or more leads based on the ECG signals of the one or more leads and the reconstructed signals respectively corresponding to the ECG signals of the one or more leads; and determining a coronary heart disease probability of the user based on the abnormal signal and a reconstructed signal corresponding to the abnormal signal.
Claim 33 and claims dependent thereon in the instant application have not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose, or suggest, in combination with other limitations of the claim, a method comprising: determining an abnormal signal in the ECG signals of the one or more leads based on the ECG signals of the one or more leads and the reconstructed signals respectively corresponding to the ECG signals of the one or more leads; and determining a coronary heart disease probability of the user based on the abnormal signal and a reconstructed signal corresponding to the abnormal signal.
Claim 42 and claims dependent thereon in the instant application have not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose, or suggest, in combination with other limitations of the claim, an electronic device comprising: determining an abnormal signal in the ECG signals of the one or more leads based on the ECG signals of the one or more leads and the reconstructed signals respectively corresponding to the ECG signals of the one or more leads; and determining a coronary heart disease probability of the user based on the abnormal signal and a reconstructed signal corresponding to the abnormal signal.
Claim 51 and claims dependent thereon in the instant application have not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose, or suggest, in combination with other limitations of the claim, an electronic device comprising: determining an abnormal signal from the reconstructed signals; determining a coronary heart disease probability of the user based on the abnormal signal and the reconstructed signals respectively corresponding to the ECG signals of the one or more leads.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VYNN V HUH whose telephone number is (571)272-4684. The examiner can normally be reached Monday to Friday from 9 am to 5 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at (571) 270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792
/V.V.H./
Vynn Huh, September 23, 2026Examiner, Art Unit 3792