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 .
Remarks
This action is in response to the supplemental response filed 04/09/2026.
Claims 1-6, 8-15, 17-22 are pending.
Response to Arguments
Applicant’s arguments, see pages 12-15, filed 04/09/2026, with respect to the rejection of claims 1-6, 8-15, 17-22 under 35 U.S.C. 103 have been fully considered and are persuasive. Independent claims 1 and 10 have been amended to recite “activating an artificial neural network module wherein the artificial neural network module comprises a first input, the first input being a pre-trained database and a second input, the second input being the plurality of sample signals collected from two or more ECG leads”, “determining an initial set of weight factors and bias factors from the pre-trained database”, and further clarified the onset and offset point determination. Applicant argues that Henry or Henry in view of Amirim, Chen, and Zhao fail to disclose the amended limitation. Examiner agrees. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made, as explained in the office action below.
Applicant’s arguments, see pages 9-12, filed 04/09/2026, with respect to the rejection of claims 1-6, 8-15, 17-22 under 35 U.S.C. 101 have been fully considered
Rejection of claims 1-6, 8-15, 17-20 under 35 U.S.C. 101
Independent claims 1 and 10 have been amended to recite “activating an artificial neural network module wherein the artificial neural network module comprises a first input, the first input being a pre-trained database and a second input, the second input being the plurality of sample signals collected from two or more ECG leads”, “determining an initial set of weight factors and bias factors from the pre-trained database”, and further clarified the onset and offset point determination. Applicant argues that the claims do not recite an abstract idea because the claims are not practically performable in the human mind, and that the claims integrate the alleged abstract idea into a practical application.
The argument that the claims do not recite an abstract idea is not found to be persuasive. As recited, the claims require determining artifact signals from sample signals, comprising activating an artificial neural network module, determining initial weight and bias factors for the neural network from a pre-trained database, selecting a plurality of sample points, extracting features from the sample points, generating a probability of existence of artifact signals as an output from the neural network, identifying QRS complexes, extracting features related to the QRS complexes, generating a signal quality index (SQI) by clustering the QRS complexes into first and second clusters and comparing the extracted features corresponding to each QRS complex within the second cluster, determining artifact signals based on the SQI and probability, and when the SQI is below a threshold, determining an onset and offset point of the QRS complex, determining an area of the QRS complex, and determining the QRS complex as valid when an overlap in area between the QRS complex measured from each of the ECG leads exceeds a threshold. It would be possible to perform the recited features in the human mind using generic computer components.
For example, a user could use a generic computer and processing equipment to activate a neural network module, select a plurality of sample points, extract features from the sample points, generate a probability of existence of artifact signals, identify QRS complexes, extract features related to the QRS complexes, generate a signal quality index (SQI) by clustering the QRS complexes into first and second clusters and comparing the extracted features corresponding to each QRS complex within the second cluster, determine artifact signals based on the SQI and probability, and determine a QRS complex as valid based on area comparison. See MPEP 2106.04(a)(2)(III)(C), explaining that claims encompassing a computer can still be an abstract idea.
The claimed limitations are directed towards data collection and analysis. The step of selecting a plurality of sample points is considered to be a mere data gathering step, and the steps of activating a neural network, extracting features from the sample points, generating a probability of existence of artifact signals, identifying QRS complexes, extracting features related to the QRS complexes, generating a signal quality index (SQI), determining artifact signals based on the SQI and probability, and determining a QRS complex as valid based on area comparison are considered to be a data analysis step.
The argument that the claimed features are integrated into a practical application are not found to be persuasive. As explained above, the crux of the invention is the data processing performed to determine the signal quality index, which is considered to be the abstract idea of data processing. Any alleged improvement is within the abstract idea itself.
Therefore, there is no further description, in the claims or the specification, of any particular technology for performing the steps recited in the claim other than generic computer components used in their ordinary capacity as tools to apply the abstract idea. Nor does the claimed invention use a particular, or special, machine. In other words, the claims “are not tied to any particular novel machine or apparatus” capable of rescuing them from the realm of an abstract idea.
Therefore, the claims do not recite any additional elements that: (1) improve the functioning of a computer or other technology, (2) are applied with any particular machine, (3) effect a transformation of a particular article to a different state, and (4) are applied in any meaningful way beyond generally linking the use of the judicial exception to a particular technological environment or field of use. Please See MPEP § 2106.05(a)(c), (e)-(h). The rejection of the claims under 35 U.S.C. 101 is maintained.
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 1-6, 8-15, 17-22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims recite a system and method for determining artifact signals from sample signals. 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?
Claim 1 is directed towards an apparatus, and claim 10 is directed towards a method, and meet the requirements for step 1.
Step 2A (Prong 1): Does the claim recite an abstract idea, law of nature, or natural phenomenon?
Claim 1 is directed towards an apparatus and claim 10 is directed towards a method for determining artifact signals from sample signals, comprising activating an artificial neural network module, determining initial weight and bias factors for the neural network from a pre-trained database, selecting a plurality of sample points, extracting features from the sample points, generating a probability of existence of artifact signals as an output from the neural network, identifying QRS complexes, extracting features related to the QRS complexes, generating a signal quality index (SQI) by clustering the QRS complexes into first and second clusters and comparing the extracted features corresponding to each QRS complex within the second cluster, determining artifact signals based on the SQI and probability, and when the SQI is below a threshold, determining an onset and offset point of the QRS complex, determining an area of the QRS complex, and determining the QRS complex as valid when an overlap in area between the QRS complex measured from each of the ECG leads exceeds a threshold. The limitation of an apparatus and method for determining artifact signals from sample signals, as drafted in claims 1-6, 8-15, and 17-20, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind or using pen and paper or generic computer components.
For example, a user could use a generic computer and processing equipment to activate an artificial neural network module, select a plurality of sample points, extract features from the sample points, generate a probability of existence of artifact signals based on the neural network, identify QRS complexes, extract features related to the QRS complexes, generate a signal quality index (SQI) by clustering the QRS complexes into first and second clusters and comparing the extracted features corresponding to each QRS complex within the second cluster, determine artifact signals based on the SQI and probability, and determine a QRS complex as valid based on area comparison. See MPEP 2106.04(a)(2)(III)(B) and (C), explaining that claims encompassing a human performing the steps with a physical aid or using a computer is still an abstract idea.
Further, the claims can be described as a mathematical concept. These claims simply require generating weights from a database and calculating a probability. The steps of generating weights and calculating probability are mathematical concepts. Therefore, this falls under the abstract idea of a mathematical concept. Please see MPEP 2106.04(a)(2).
Therefore, claims 1 and 10 recite the abstract idea of both a mental process and a mathematical concept.
Step 2A (Prong 2): Does the claim recite additional elements that integrate the judicial exception into a practical application?
As claimed and understood, the crux of the invention is the data processing performed to determine the signal quality index. The step of selecting a plurality of sample points is considered to be a mere data gathering step, and the steps of activating the neural network module, extracting features from the sample points, generating a probability of existence of artifact signals, identifying QRS complexes, extracting features related to the QRS complexes, generating a signal quality index (SQI), determining artifact signals based on the SQI and probability, and determining a QRS complex as valid based on area comparison are considered to be a data analysis step.
The additional elements of at least one electrocardiogram lead, one or more processors, and a display (claim 21) are recited at a high level of generality (i.e., as generic computing elements performing the steps of gathering and analyzing data) such that they amount to no more than mere instructions to apply the exception using a generic computer component. The electrocardiogram lead and display provides generic structure for the insignificant, extra-solution activity of data gathering and output.
Accordingly, these additional elements do no integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. See MPEP 2106.04(a)(2)(III)(C).
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
The additional elements when considered individually and in combination is not enough to qualify as significantly more than the abstract idea. As discussed above with respect to the integration of the abstract idea into a practical application, the additional elements of at least one electrocardiogram lead, one or more processors, and a display (claim 21) amounts to no more than mere instructions to apply the exception using generic data analysis. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. Furthermore, the additional elements do not amount to more than generically linking the use of a judicial exception to a particular technological environment or field of use (see MPEP 2106.05(h)). Therefore, the claims are not patent eligible.
Claims 2-6, 8, 9, 11-15, and 17-20 depend on claims 1 and 10 and recite the same abstract idea as claims 1 and 10 from which they depend. Further, these claims only contain recitations that further limit the abstract idea (that is, the claims only recite limitations that further limit the mental process). For example, the additional limitations recited in claims 2-6, 8, 9, 11-15, and 17-20 (i.e. providing details about the feature extraction and data analysis performed) are further data analysis steps. The additional limitations recited in claims 21 and 22 (i.e. displaying the QRS complexes) are simply a data output step. The additional elements individually do not amount to significantly more than the judicial exception explained above (the abstract idea). Looking at the limitations as a whole adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves any technology or includes a particular solution to a computer-based problem or a particular way to achieve a computer-based outcome. Rather, the collective functions of the claimed invention merely provides a conventional computer implementation, i.e. the computer (processor) is simply a tool to perform the claimed invention.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-6, 8, 10-15, 17, 19, 21, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Henry et al. (US Patent Application Publication 2020/0093389 – of record), hereinafter Henry, further in view of Amirim (US Patent Application Publication 2015/0164359 – of record), further in view of Chen et al. (US Patent Application Publication 2013/0338519 – of record), hereinafter Chen, further in view of Zhao et al. (US Patent Application Publication 2016/0278656 – of record), hereinafter Zhao, and further in view of Cascella et al. (US Patent Application Publication 2022/0032075), hereinafter Cascella.
Regarding claims 1 and 10, Henry discloses an apparatus and method for determining artifact signals from a plurality of sample signals collected during a pre-determined time window from at least one electrocardiogram ("ECG") lead configured to be affixed to a patient (e.g. Abstract; Fig. 1), the apparatus comprising:
one or more processors (e.g. Par. [0072]: microprocessor part of the device); and
a non-transitory computer-readable medium storing instructions that (e.g. Par. [0072]: software used with the microprocessor), when executed by the one or more processors, perform operations comprising:
selecting a plurality of sample points from the plurality of sample signals, extracting a plurality of features from the selected plurality of sample points, generating a probability of existence of the artifact signals in the plurality of sample signals, by applying a transformation process to at least two of the plurality of features (e.g. Pars. [0024]-[0029]: selecting ECG waveforms and extracting features; Pars. [0133]-[0137]: determining probability of cardiac events),
identifying a plurality of QRS-complexes from the plurality of sample signals, extracting one or more features corresponding to the identified plurality of QRS-complexes (e.g. Pars. [0010]-[0016]: identifying QRS complex and determining features such as occurrence of asystole),
generating a signal quality index ("SQI") by comparing the one or more features corresponding to the identified plurality of QRS-complexes, and determining the artifact signals based on the SQl and the probability (e.g. Pars. [0079]-[0082]: determining whether a QRS signal is usable or not to determine cardiac events),
the determination of the SQl by comparing the one or more features corresponding to the plurality of QRS-complexes further comprises: determining the SQl by comparing the one or more extracted features corresponding to each of the plurality of QRS-complexes (e.g. Par. [0082]).
However, Henry fails to disclose clustering the plurality of QRS-complexes into a first cluster and a second cluster, the second cluster having a larger number of QRS-complexes than the first cluster, and when the SQI is below a predetermined threshold, determining an onset point and an offset point of the same QRS-complex measured from two or more ECG leads; based on the onset point and the offset point, determining an area of the same QRS-complex measured from each of the two or more ECG leads; and determining the same QRS-complex as a valid QRS-complex when an overlap in the area of the same QRS-complex measured from each of the two or more ECG leads exceeds a pre-determined threshold.
Amirim is directed towards QRS complex classification. Amirim discloses clustering the plurality of QRS-complexes into a first cluster and a second cluster, the second cluster having a larger number of QRS-complexes than the first cluster (e.g. Par. [0007]: calculating QRS complexes; Fig. 3: first node with 48 complexes and second node with 80 complexes; Par. [0068]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Henry to include clustering the plurality of QRS-complexes into a first cluster and a second cluster, the second cluster having a larger number of QRS-complexes than the first cluster as taught by Amirim because doing so would classify the QRS complexes in an efficient manner. These classified QRS complexes can then be analyzed to determine heart conditions (e.g. Amirim, pars. [0003]-[0004]).
However, Henry in view of Amirim fails to disclose when the SQI is below a predetermined threshold, determining an onset point and an offset point of the same QRS-complex measured from two or more ECG leads, wherein the onset point and the offset point are determined based on a morphology of the same QRS-complex; based on the onset point and the offset point, determining an area of the same QRS-complex measured from each of the two or more ECG leads; and determining the same QRS-complex as a valid QRS-complex when an overlap in the area of the same QRS-complex measured from each of the two or more ECG leads exceeds a pre-determined threshold.
Chen, in a similar field of endeavor, is directed towards measuring physiological signal quality. Chen discloses determining an onset point and an offset point of the QRS-complex measured from two or more ECG leads, wherein the onset point and the offset point are determined based on a morphology of the same QRS-complex (e.g. Par. [0036]: fixed time period window; Par. [0037]; Par. [0039]; Par. [0044]), based on the onset point and the offset point, determining an area of the QRS-complex measured from each of the two or more ECG leads, and determining the QRS-complex as a valid QRS-complex when an overlap in the area of the QRS-complex measured from each of the two or more ECG leads exceeds a pre-determined threshold (e.g. Par. [0044]: determining QRS complexes by comparing the areas).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Henry in view of Amirim to include determining an onset point and an offset point of the QRS-complex measured from two or more ECG leads, based on the onset point and the offset point, determining an area of the QRS-complex measured from each of the two or more ECG leads, and determining the QRS-complex as a valid QRS-complex when an overlap in the area of the QRS-complex measured from each of the two or more ECG leads exceeds a pre-determined threshold as taught by Chen because doing so would improve signal quality detection (e.g. Chen, Par. [0079]).
However, Henry in view of Chen fails to disclose using the same QRS complex. Zhao is directed towards determining the occurrence of a QRS complex in ECG data. Zhao discloses using the same QRS complex (e.g. Par. [0012]: the QRS detection occurs in the same time window from 3 ECG leads).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Henry in view of Amirim and Chen to include using the same QRS complex as taught by Zhao because doing so would allow detection of QRS complexes in the ECG data to aid in cardiac diagnostics.
However, Henry in view of Amirim, Chen, and Zhao fails to disclose activating an artificial neural network module wherein the artificial neural network module comprises a first input, the first input being a pre-trained database and a second input, the second input being the plurality of sample signals collected from two or more ECG leads and determining an initial set of weight factors and bias factors from the pre-trained database.
Cascella is directed towards an automatic defibrillator. Cascella discloses using an artificial neural network module that comprises a first input, the first input being a pre-trained database and a second input, the second input being the plurality of sample signals collected (e.g. Par. [0090]: the input can take both data collected and training data) and determining an initial set of weight factors and bias factors from the pre-trained database (e.g. Par. [0083]: weights and biases are determined from the training of the model).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Henry in view of Amirim, Chen, and Zhao to include the artificial neural network module as taught by Cascella because doing so would allow faster data analysis.
Regarding claims 2 and 11, Henry fails to disclose wherein the selected plurality of sample points comprises at least one of: a sample point with a maximum amplitude, a sample point with a minimum amplitude, and a sample point exceeding a pre-determined threshold. Chen, in a similar field of endeavor, is directed towards measuring physiological signal quality. Chen discloses wherein the selected plurality of sample points comprises a sample point exceeding a pre-determined threshold (e.g. Par. [0064]: signal compared to a threshold to ensure the signal is of sufficient strength).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Henry in view of Amirim, Chen, Zhao, and Cascella to include the sample points comprises a sample point exceeding a pre-determined threshold as taught by Chen because doing so would allow determination of if a signal is usable for additional data analysis.
Regarding claims 3 and 12, Henry fails to disclose wherein the plurality of features extracted from the selected plurality of sample points comprises: an amplitude difference between a sample point with a maximum amplitude and a sample point with a minimum amplitude, a medium amplitude of the selected plurality of sample points, a standard deviation of the selected plurality of sample points, an amplitude difference between two consecutive sample points, or a number of two consecutive sample points when the amplitude difference between the two consecutive sample points exceeds a pre-determined threshold. Chen, in a similar field of endeavor, is directed towards measuring physiological signal quality. Chen discloses wherein the extracted feature comprises a medium amplitude of the selected plurality of sample points (e.g. Pars. [0077]-[0079]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Henry in view of Amirim, Chen, Zhao, and Cascella to include the extracted feature comprises a medium amplitude of the selected plurality of sample points as taught by Chen to improve signal quality detection (e.g. Chen, Par. [0079]).
Regarding claims 4 and 13, Henry further discloses wherein the one or more extracted features corresponding to the plurality of QRS-complexes comprise: an amplitude of an R-peak in each of the plurality of QRS-complexes, a width of the R-peak in each of the plurality of QRS-complexes, an R-R interval of consecutive R-peaks included in the plurality of QRS-complexes, an area of each of the plurality of QRS-complexes, or an area of an S region in each of the plurality of QRS-complexes (e.g. Par. [0113]: RR intervals are measured).
Regarding claims 5 and 14, Henry further discloses wherein the SQI is calculated by comparing the similarities in the one or more extracted features in the plurality of QRS-complexes (e.g. Par. [0082]: signals that are below the threshold are used, and therefore the signal quality is proportional to the kurtosis of the signals).
Regarding claims 6 and 15, Henry further discloses wherein, when the SQI is below a pre-determined threshold, the sample signals are determined to have the artifact signals (e.g. Par. [0082]).
Regarding claims 8 and 17, Henry further discloses determining one or more fiducial points corresponding to the QRS-complex measured from two or more ECG leads, and determining the same QRS-complex as a valid QRS-complex when a difference between the one or more fiducial points measured from the two or more ECG leads is below a pre-determined threshold (e.g. Pars. [0012]-[0015]: determining valid QRS complexes; Pars. [0019]-[0023]: using the valid QRS complexes to determine valid intervals to determine cardiac events). However, Henry fails to specifically disclose using the same QRS complex. Zhao is directed towards determining the occurrence of a QRS complex in ECG data. Zhao discloses using the same QRS complex (e.g. Par. [0012]: the QRS detection occurs in the same time window from 3 ECG leads).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Henry in view of Amirim, Chen, Zhao, and Cascella to include using the same QRS complex as taught by Zhao to detect QRS complexes in the ECG data.
Regarding claim 19, Henry further discloses determining a plurality of heart rate values based on R-R intervals measured from the plurality of QRS-complexes; ranking the plurality of heart rate values; comparing a new heart rate calculated based on the valid QRS-complex with a medium heart rate of the ranked plurality of heart rate values; and calculating an output heart rate based on the new heart rate and the medium heart rate value (e.g. Par. [0124]: calculating heart rate based on RR intervals).
Regarding claims 21 and 22, while Henry discloses a display that displays alarms (e.g. Par. [0016]), Henry fails to specifically disclose a display, the display configured to update the QRS-complexes in real time. Chen, in a similar field of endeavor, is directed towards measuring physiological signal quality. Chen discloses a display for showing the monitored patient parameter data (e.g. Par. [0034]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Henry in view of Amirim, Chen, Zhao, and Cascella to include the display as taught by Chen because doing so would allow the user to monitor the patient data.
Claims 9 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Henry et al. (US Patent Application Publication 2020/0093389 – of record), hereinafter Henry, further in view of Amirim (US Patent Application Publication 2015/0164359 – of record), further in view of Chen et al. (US Patent Application Publication 2013/0338519 – of record), hereinafter Chen, further in view of Zhao et al. (US Patent Application Publication 2016/0278656 – of record), hereinafter Zhao, and further in view of Cascella et al. (US Patent Application Publication 2022/0032075), hereinafter Cascella, as applied to claims 1 and 10 above, and further in view of Ghosh et al. (US Patent Application Publication 2019/0231274), hereinafter Ghosh.
Regarding claims 9 and 18, Henry, Amirim, Chen, and Zhao in combination discloses all of the claimed elements as described above, but fails to explicitly disclose a feedback loop is provided to adjust a threshold for approving the valid QRS-complexes added into a template database. Ghosh, in a similar field of endeavor, is directed towards template-based analysis and matching of cardiovascular waveforms. Ghosh discloses updating the threshold for approving data entering a template database (e.g. Par. [0049]: adjusting the threshold for template database).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Henry in view of Amirim, Chen, Zhao, and Cascella to include updating the threshold for approving data entering a template database as taught by Ghosh because an updated threshold would allow closer template matches (e.g. Ghosh, par. [0049]).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Henry et al. (US Patent Application Publication 2020/0093389 – of record), hereinafter Henry, further in view of Amirim (US Patent Application Publication 2015/0164359 – of record), further in view of Chen et al. (US Patent Application Publication 2013/0338519 – of record), hereinafter Chen, further in view of Zhao et al. (US Patent Application Publication 2016/0278656 – of record), hereinafter Zhao, and further in view of Cascella et al. (US Patent Application Publication 2022/0032075), hereinafter Cascella, as applied to claim 10 above, further in view of Dai et al. (US Patent Application Publication 2021/0128048 – of record), hereinafter Dai.
Regarding claim 20, Henry further discloses extracting one or more features of the valid QRS-complex, the one or more features including an R-R interval, an amplitude of an R-wave, a width of the R-wave, an amplitude of a P-wave, a polarity of an ST-segment (e.g. Par. [0113]: extracting RR intervals). However, Henry, Amirim, Chen, and Zhao in combination fails to disclose establishing an adjusted threshold corresponding to the one or more features of the valid QRS-complex, and when the one or more features of the valid QRS-complex exceed the adjusted threshold, storing the valid QRS-complex into a QRS-complex template database. Dai is directed towards analyzing arrhythmia. Dai discloses establishing an adjusted threshold corresponding to the one or more features of the valid QRS-complex, and when the one or more features of the valid QRS-complex exceed the adjusted threshold, storing the valid QRS-complex into a QRS-complex template database (e.g. Fig. 5: creating a new threshold template if there is not current matching template; Par. [0116]: describing Fig. 5).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Henry in view of Amirim, Chen, Zhao, and Cascella to include establishing an adjusted threshold corresponding to the one or more features of the valid QRS-complex, and when the one or more features of the valid QRS-complex exceed the adjusted threshold, storing the valid QRS-complex into a QRS-complex template database as taught by Dai because doing so would allow determination of cardiac events.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Kim (US 2021/0052180 – of record) is directed towards a cardiac monitoring system.
Ghosh et al. (US 2018/0263522 – of record) is directed towards QRS onset and offset determination.
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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/SHREYA ANJARIA/Examiner, Art Unit 3796
/ALLEN PORTER/Primary Examiner, Art Unit 3796
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