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 .
Response to Arguments
Applicant's arguments filed 07/06/2026 have been fully considered but they are not persuasive.
Beginning on page 12, the applicant argues that the limitations recited in the claims are not practically performed in the human mind. This argument is fully considered but is not persuasive. As written, the claims merely recite obtaining data, identifying and extracting a portion of the data, to compare to a template, in order to make further determinations which are mere observation, evaluation, judgement and rending opinion which are concepts performed in the human mind. The claim does not provide any details regarding how many parameters, the timing, rate, etc., of the application of performing these steps which would prevent a person, when given a reasonable time, to perform these steps.
The applicant further argues that the claimed features constitute a meaningful application and demonstrates an improvement to the technical field. This argument is fully considered but is not persuasive. In order to have a technological improvement, the additional elements, either solely or in combination, need to reflect an improvement. Here, the alleged improvement is in the determination step (abstract idea of deciding which lead includes the highest signal to noise ratio) and not the computer/display itself. Neither the claims nor the specification, provide any limitations that would improve the computer system to work faster, or more accurately. As written, the claims only require the display to output the result of the determination step (i.e., output the result of an abstract idea).
It is noted that the claim does not provide any specific use for the determined ECG lead besides potentially displaying the result (which equates to simply outputting the result of the abstract idea on a display device).
The applicant provides similar arguments for all independent claims. For at least the reasons recited above, the applicant’s arguments are not persuasive and the 101 rejection is maintained and is now FINAL.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 recites “and determining, via the at least one processor, a signal-to-noise ratio for the lead based on the respective noise data; and determining []” which should be amended to “determining, via the at least one processor, a signal-to-noise ratio for the lead based on the respective noise data; and determining []”. Appropriate correction is required.
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 1-12, 15, 17-23 are rejected under 35 U.S.C. 101 because of the following analysis:
1 – statutory category: Claim 1-11 recite a series of steps and therefore, falls under the statutory category of being a process. See MPEP 2106.03.Claims 12, 15, 17-23 recite a system, and therefore, falls under the statutory category of being a thing or products. See MPEP 2106.03.
2A – Prong 1: The independent claims 1 recite a judicial exception by reciting the limitations of “obtaining, [], ECG data that includes a respective signal captured from a patient by each lead of a plurality of ECG leads; identifying, [], a heartbeat in the ECG data; for each lead: extracting, [], a portion of the respective signal corresponding to the identified heartbeat; identifying, [], a heartbeat template most likely to correspond to the identified heartbeat; determining, [], respective noise data for the extracted portion of the respective signal based on the identified heartbeat template based on a comparison between a respective signal remainder and a heartbeat template remainder; and determining, [], a signal-to-noise ratio for the lead based on the respective noise data; and determining, [], a lead from amongst the plurality of ECG leads having a highest signal-to-noise ratio”. These limitations, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in mind or by a person using a pen and paper. Therefore, an abstract idea is involved.
2A – Prong 2: The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements when considered both individually and as an ordered combination do not amount to significantly more than the abstract idea. The independent claims 1 recite the additional limitations of “at least one processor”, “a plurality of ECG leads”, etc. The mentioned limitations are recited at a high level of generality and are considered to be data gathering/processing which are mere extra-solution activity. The elements amount to mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea (see MPEP 2106.04(d) and 2106.05(f)). Accordingly, each of the additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limitations on practicing the abstract idea.
2B: The emphasized elements cited above do not amount to significantly more than the judicial exception because these limitations are simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’I, 110 USPQ2d 1976 (2014)).
In view of the above, the additional elements individually do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process. Simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry, as discussed in Alice Corp., 573 U.S. at 225, 110 USPQ2d at 1984 (see MPEP § 2106.05(d)).
Claims 2-12 depend on claim 1. The mentioned dependent claims recite the same abstract idea as the independent claims. Furthermore, 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 dependent claim recites the limitations “patient-specific heartbeat template library”, “graphical-user-interface of a display”, etc., are recited at a high level of generality and are mere extra-solution activity, and recited as performing generic computer functions. i.e., data processing. The elements amount to mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea (see MPEP 2106.04(d) and 2106.05(f)).
The additional elements individually do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
2A – Prong 1: The independent claims 12 recite a judicial exception by reciting the limitations of “receiving extracted portions of signals of electrocardiogram (ECG) data captured from a patient, the extracted portions corresponding to a heartbeat; for each of the one or more ECG leads: separating the extracted portions into one or more clusters, and generating a respective patient-specific heartbeat template based on the extracted portions included in each cluster, and storing the patient-specific heartbeat template []; identifying a patient-specific heartbeat template stored in the at least one memory that is specifically associated with one of the ECG leads, and that is most likely to correspond to the identified heartbeat; wherein identifying the patient-specific heartbeat template [] that is most likely to correspond to the heartbeat includes determining a cluster from amongst the one or more clusters that is a closest match to the extracted portions; and outputting the identified patient-specific heartbeat template.”. These limitations, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in mind or by a person using a pen and paper. Therefore, an abstract idea is involved.
2A – Prong 2: The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements when considered both individually and as an ordered combination do not amount to significantly more than the abstract idea. The independent claim 12 recite the additional limitations of “by one or more ECG leads”, “at least one memory”, etc. The mentioned limitations are recited at a high level of generality and are considered to be data gathering/processing which are mere extra-solution activity. The elements amount to mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea (see MPEP 2106.04(d) and 2106.05(f)). Accordingly, each of the additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limitations on practicing the abstract idea.
2B: The emphasized elements cited above do not amount to significantly more than the judicial exception because these limitations are simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’I, 110 USPQ2d 1976 (2014)).
In view of the above, the additional elements individually do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process. Simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry, as discussed in Alice Corp., 573 U.S. at 225, 110 USPQ2d at 1984 (see MPEP § 2106.05(d)).
Claims 15, 17-18 depend on claim 12. The mentioned dependent claims recite the same abstract idea as the independent claims. Furthermore, these claims only contain recitations that further limit the abstract idea (that is, the claims only recite limitations that further limit the mental process). Such signal processing steps are recited at a high level of generality and are mere extra-solution activity, and using a processor to perform such steps are recited as performing generic computer functions. i.e., data processing. The elements amount to mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea (see MPEP 2106.04(d) and 2106.05(f)).
The additional elements individually do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
2A – Prong 1: The independent claims 19 recite a judicial exception by reciting the limitations of “obtaining ECG data that includes a respective signal captured from a patient; identifying a heartbeat in the ECG data based on detection of a peak in the ECG data; for each lead: extracting a portion of the respective signal corresponding to the identified heartbeat; identifying a heartbeat template most likely to correspond to the identified heartbeat, by: accessing a patient-specific heartbeat template library; and comparing the extracted portion of the respective signal with any patient-specific heartbeat templates stored in the patient- specific heartbeat template library for the lead; and determining respective noise data for the extracted portion of the respective signal, by: removing a respective QRS complex from the extracted portion of the respective signal to form a respective signal remainder; obtaining a heartbeat template remainder in the form of the identified heartbeat template with a respective QRS complex removed; determining the respective noise data for the extracted portion of the respective signal based on a comparison between the respective signal remainder and the heartbeat template remainder; and determining a signal-to-noise ratio for the lead based on the respective noise data; and determining a lead from amongst the plurality of ECG leads having a highest signal-to-noise ratio.”. These limitations, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in mind or by a person using a pen and paper. Therefore, an abstract idea is involved.
2A – Prong 2: The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements when considered both individually and as an ordered combination do not amount to significantly more than the abstract idea. The independent claim 19 recite the additional limitations of “by each lead of a plurality of ECG leads”, “at least one memory”, etc. The mentioned limitations are recited at a high level of generality and are considered to be data gathering/processing which are mere extra-solution activity. The elements amount to mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea (see MPEP 2106.04(d) and 2106.05(f)). Accordingly, each of the additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limitations on practicing the abstract idea.
2B: The emphasized elements cited above do not amount to significantly more than the judicial exception because these limitations are simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’I, 110 USPQ2d 1976 (2014)).
In view of the above, the additional elements individually do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process. Simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry, as discussed in Alice Corp., 573 U.S. at 225, 110 USPQ2d at 1984 (see MPEP § 2106.05(d)).
Claims 20-23 depend on claim 19. The mentioned dependent claims recite the same abstract idea as the independent claims. Furthermore, these claims only contain recitations that further limit the abstract idea (that is, the claims only recite limitations that further limit the mental process). Such signal processing steps are recited at a high level of generality and are mere extra-solution activity, and using a processor to perform such steps are recited as performing generic computer functions. i.e., data processing. The elements amount to mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea (see MPEP 2106.04(d) and 2106.05(f)).
The additional elements individually do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
Thus, claims 1-12, 15, 17-23 are directed to an abstract idea and are therefore rejected.
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 SANA SAHAND whose telephone number is (571)272-6842. The examiner can normally be reached M-Th 8:30 am -5:30 pm; F 9 am-3 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer S McDonald can be reached at (571) 270- 3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SANA SAHAND/Examiner, Art Unit 3796
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