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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on April 17, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Claim Objections
Claim 2 is objected to because of the following informality: “the group” should read “a group” in lines 1-2. 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 1-15 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. Claims 1-15 are directed to a system and method for analyzing physiologic signal using a computational algorithm, which is an abstract idea. Claims 1-15 do not include additional elements that integrate the exception into a practical application or that are sufficient to amount to significantly more than the judicial exception for the reasons provided below which are in line with the 2014 Interim Guidance on Patent Subject Matter Eligibility (Federal Register, Vol. 79, No. 241, p 74618, December 16, 2014), the July 2015 Update on Subject Matter Eligibility (Federal Register, Vol. 80, No. 146, p. 45429, July 30, 2015), the May 2016 Subject Matter Eligibility Update (Federal Register, Vol. 81, No. 88, p. 27381, May 6, 2016), and the 2019 Revised Patent Subject Matter Eligibility Guidance (Federal Register, Vol. 84, No. 4, page 50, January 7, 2019).
The analysis of claim 1 is as follows:
Step 1: Claim 1 is drawn to a machine.
Step 2A – Prong One: Claim 1 recites an abstract idea. In particular, claim 1 recites the following limitations:
[A1] - compare a sign associated with a present sample value of the physiologic signal to a sign associated with a previous sample value of the physiologic signal;
[B1] - determine a presence of a fiducial event if the sign associated with the present sample value is different from the sign associated with the previous sample value;
[C1] - count samples of the physiologic signal in intervals defined between fiducial events to obtain a respective sample count for each of the intervals; and
[D1] - determine at least one physiologic parameter based on the sample counts.
These elements [A1]-[D1] of claim 1 are drawn to an abstract idea since they involve a mental process that can be practically performed in the human mind including observation, evaluation, judgment, and opinion and using pen and paper.
Step 2A – Prong Two: Claim 1 recites the following limitations that are beyond the judicial exception:
[A2] – “an input configured to receive a discrete-time physiologic signal”; and
[B2] – “at least one processor module”.
These elements [A2]-[B2] of claim 1 do not integrate the exception into a practical application of the exception. In particular, the element [A2] is merely adding insignificant extra-solution activity to the judicial exception, i.e., mere data gathering at a higher level of generality - see MPEP 2106.04(d) and MPEP 2106.05(g). Furthermore, the element [B2] is merely an instruction 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 MPEP 2106.05(f).
Step 2B: Claim 1 does not recite additional elements that amount to significantly more than the judicial exception itself. The element [B2] does not qualify as significantly more because this limitation is simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014)) and/or a claim to an abstract idea requiring no more than being stored on a computer readable medium which is a well-understood, routine and conventional activity previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014); SAP Am. v. InvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
Claims 2-13 depend from claim 1, and recite the same abstract idea as claim 1. Furthermore, these claims only contain recitations that further limit the abstract idea (that is, the claims only recite limitations that further limit the algorithm), with the following exceptions:
Claim 13: “an implantable medical device”.
This claim limitation does not integrate the exception into a practical application. Also, claim 13 does not recite additional elements that amount to significantly more than the judicial exception itself because they are merely insignificant extrasolution activity to the judicial exception, e.g., mere data gathering in conjunction with the abstract idea that uses conventional, routine, and well known elements or simply displaying the results of the algorithm that uses conventional, routine, and well known elements. In particular, the implantable medical device is merely a device comprising sensors and processing circuitry that is capable of being implanted. Such medical devices are conventional as evidenced by:
U.S. Patent Publication No. US 20110021887 A1 (Crivelli et al.) discloses that implant devices are conventional and capable of performing operations independently ([0017-0018]; [0036]).
Also, this limitation from claim 13 is simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions (that is, one of display) that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int'l, 110 USPQ2d 1976 (2014); SAP Am. v. InvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations of each claim as an ordered combination in conjunction with the claims from which they depend (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.
The analysis of claim 14 is as follows:
Step 1: Claim 14 is drawn to a process.
Step 2A – Prong One: Claim 14 recites an abstract idea. In particular, claim 4 recites the following limitations:
[A1] – comparing a sign associated with a present sample value of the physiologic signal to a sign associated with a previous sample value of the physiologic signal;
[B1] - determining a presence of a fiducial event if the sign associated with the present sample value is different from the sign associated with the previous sample value;
[C1] - counting samples of the physiologic signal in intervals defined between fiducial events to obtain a respective sample count for each of the intervals; and
[D1] - determining at least one physiologic parameter based on the sample counts.
These elements [A1]-[D1] of claim 14 are drawn to an abstract idea since they involve a mental process that can be practically performed in the human mind including observation, evaluation, judgment, and opinion and using pen and paper.
Step 2A – Prong Two: Claim 14 recites the following limitations that are beyond the judicial exception:
[A2] – “receiving a discrete-time physiologic signal”.
The element [A2] of claim 14 does not integrate the exception into a practical application of the exception. In particular, the element [A2] is merely adding insignificant extra-solution activity to the judicial exception, i.e., mere data gathering at a higher level of generality - see MPEP 2106.04(d) and MPEP 2106.05(g).
Step 2B: Claim 14 does not recite additional elements that amount to significantly more than the judicial exception itself. In particular, the limitation [A2] does not qualify as significantly more because this limitation merely describes the nature of the signal data and does not incorporate the any particular machine as part of the claimed invention.
Claim 15 depends from claim 14, and recite the same abstract idea as claim 14. Furthermore, these claims only contain recitations that further limit the abstract idea (that is, the claims only recite limitations that further limit the algorithm), with the following exceptions:
Claim 15: “a machine-readable storage medium having computer-executable instructions stored, that, when executed, cause one or more processors to perform the method of claim 14”.
This claim limitation does not integrate the exception into a practical application. In particular, the elements of claim 15 is merely adding insignificant extra-solution activity to the judicial exception, i.e., mere data gathering at a higher level of generality - see MPEP 2106.04(d) and MPEP 2106.05(g).
Also, each of these limitations does not recite additional elements that amount to significantly more than the judicial exception itself because they are merely insignificant extrasolution activity to the judicial exception, e.g., mere data gathering in conjunction with the abstract idea that uses conventional, routine, and well known elements or simply displaying the results of the algorithm that uses conventional, routine, and well known elements. In particular, this limitation is simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions (that is, one of display) that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int'l, 110 USPQ2d 1976 (2014); SAP Am. v. InvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations of each claim as an ordered combination in conjunction with the claims from which they depend (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.
Claim 15 recites “machine-readable storage medium having computer-executable instructions stored”, which is directed to non-patent eligible subject matter. Transitory forms of signal transmission are not directed to any of the statutory categories. In order to overcome this rejection, the claim should be amended to recite “non-transitory machine-readable storage medium having computer-executable instructions stored” in lines 1-2.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20210307669 A1 (Rajagopal et al.).
Regarding claim 1, Rajagopal teaches a system for analyzing physiologic signals, comprising:
- an input configured to receive a discrete-time physiologic signal ([0034] “acquisition of the ECG recording”; [0049] “physiological signals recorded by ICM 10”; [0053]); and
- at least one processor module ([0052] “Processing circuitry 50”) configured to:
- compare a sign associated with a present sample value of the physiologic signal to a sign associated with a previous sample value of the physiologic signal ([0109] “Processing circuitry 50 may determine whether there is a sign change (e.g., from positive to negative, or from negative to positive) between each of the plurality of first differences and the respective next difference of the plurality of first differences.”; Fig. 7);
- determine a presence of a fiducial event if the sign associated with the present sample value is different from the sign associated with the previous sample value ([0117] “For each determined sign change, processing circuitry 50 may determine whether a magnitude of a respective corresponding fourth difference value is greater than a positive third predetermined noise threshold or lower than a negative third predetermined noise threshold.”; [0142] “Processing circuitry 50 may determine a noise count by counting the number of samples in the window where there is a sign change of greater than a first threshold (e.g., 50) or a sign change of less than a second threshold (e.g., −50). If this noise count is greater than or equal to a threshold (e.g., 5) then processing circuitry 50 may determine the beat is noisy…. Processing circuitry 50 may determine whether the segment between the current R wave and the next R wave is noisy in a similar manner.”);
- count samples of the physiologic signal in intervals defined between fiducial events to obtain a respective sample count for each of the intervals ([0142] “processing circuitry may determine whether the current R wave is noisy by defining a window of a few samples before the R wave peak and a few samples after the R wave peak. Processing circuitry 50 may determine a noise count by counting the number of samples in the window where there is a sign change of greater than a first threshold (e.g., 50) or a sign change of less than a second threshold (e.g., −50)”; [0135] “Processing circuitry 50 may determine the search window to start at a number of samples after an R-wave peak and end a different number of samples after the R-wave peak. These numbers of samples may be based on the length of the current RR interval or the previous RR interval.”); and
- determine at least one physiologic parameter based on the sample counts (Fig. 19A; [0030] “techniques for identifying one or more parameters of a cardiac signal, such as QT intervals. The parameters may be used to, for example, detect or predict arrhythmias, to evaluate other conditions of the patient such as change in electrolytes, change in diabetic status, fluid overload or dehydration, or to configure and/or evaluate therapies, such as pharmacological therapies.”; [0110] “if the result of the counting is higher than the second predetermined noise threshold, processing circuitry 50 may consider the R-wave to be noisy. In such a case, the beat associated with the noisy R-wave may not be used to determine a QT or QTc interval. If the result of the counting is equal to or lower than the second predetermined noise threshold, processing circuitry 50 may consider the R-wave to not be noisy.”).
Regarding claim 2, Rajagopal teaches the system of claim 1, wherein the physiologic signal is selected from the group consisting of an electrocardiogram, oxygen saturation, blood pressure, impedance, activity, accelerometry, fluid status, inspiration and/or expiration efforts, and respiration ([0034] “acquisition of the ECG recording”).
Regarding claim 3, Rajagopal teaches the system of claim 1 wherein the fiducial event is a zero-crossing or an extremum of the physiologic signal ([0102] “ICM 10 may analyze zero crossings and a rate of change (e.g., slope) of the cardiac signal to determine whether the cardiac signal is noisy. For example, if zero crossings have a high rate of change, that may be indicative of a noisy cardiac signal.”; [0133] “Processing circuitry 50 may determine the previous RR interval to be the time between the two consecutive peak R values, peak_current_sample and peak_previous_sample. In some examples, processing circuitry 50 may take a first predetermined number of samples before the sensed R-wave and a second predetermined number of samples after the sensed R-wave at a predetermined frequency and determine the sample with the maximum amplitude is the R-wave peak sample.”).
Regarding claim 4, Rajagopal teaches the system of claim 1, wherein the fiducial event includes, or is, a zero-crossing, and wherein the at least one processor module is configured to identify the zero-crossing if the sign associated with the present sample value differs from the sign associated with the previous sample value ([0102] “ICM 10 may analyze zero crossings and a rate of change (e.g., slope) of the cardiac signal to determine whether the cardiac signal is noisy. For example, if zero crossings have a high rate of change, that may be indicative of a noisy cardiac signal.”; [0109] “Processing circuitry 50 may determine whether there is a sign change (e.g., from positive to negative, or from negative to positive)”)).
Regarding claim 5, Rajagopal teaches the system of claim 4, wherein the sample count of an interval between two successive zero-crossings corresponds to counts of an unbroken run of a positive sign or a negative sign of the sample values in the interval ([0150] “determine whether there is a sign change between each of the plurality of first differences and the respective next difference of the plurality of first differences; for each determined sign change, determine whether a magnitude of a respective corresponding second difference value is greater than a first positive predetermined noise threshold or lower than a first negative predetermined noise threshold; calculate a total number of the corresponding second difference values having the magnitude greater than the positive first predetermined noise threshold or lower than the negative first predetermined noise threshold; and determine whether the calculated total number is greater than a second predetermined noise threshold”).
Regarding claim 6, Rajagopal teaches the system of claim 1, wherein the fiducial event includes, or is, an extremum, and wherein the at least one processor module is configured to identify the extremum if the sign associated with a slope the present sample value differs from the sign associated with a slope of the previous sample value ([0125] “processing circuitry 50 may determine the degree of flatness based on area under the curve between points selected on either side of the determined T-wave, amplitude of samples around the T-wave, slope analysis, or other techniques that would be indicative of a degree of flatness of the cardiac signal around the determined T-wave.”).
Regarding claim 7, Rajagopal teaches the system of claim 6, wherein the extremum is a peak or a trough ([0126] “processing circuitry 50 may determine a maximum amplitude and a minimum amplitude of amplitudes of a fourth plurality of samples of the cardiac signal”).
Regarding claim 8, Rajagopal teaches the system of claim 6, wherein the intervals for the sample count are defined between two successive extrema of the same type ([0142] “processing circuitry 50 may determine whether a beat is noisy by determining whether the current R wave is noisy or the ECG segment between the current R wave and the next R wave is noisy or both”; Figs. 7-9 depict measuring the intervals from peak to peak.).
Regarding claim 9, Rajagopal teaches the system of claim 1, wherein the at least one processor module is configured to reject one or more fiducial events if one or more rejection criteria are met ([0122] “processing circuitry 50 may determine whether the beats are noisy by employing the noise detection techniques discussed above with respect to each of the beats. If the number of noisy beats exceeds the predetermined noisy beats threshold, processing circuitry 50 may exclude the current beat from the QT interval analysis”).
Regarding claim 10, Rajagopal teaches the system of claim 9, wherein the one or more rejection criteria relate to at least one of a patient's motion, an operating limit of at least one signal processing element of the system, non-monotonicity, and noise ([0122] “noise detection”; [0026]).
Regarding claim 11, Rajagopal teaches the system of claim 1, wherein the system is configured to determine the at least one physiologic parameter using sample counts associated with two or more fiducial events of different types ([0110] “Processing circuitry 50 may calculate a total number of sign changes in the first difference value with a corresponding second difference value greater than the positive first predetermined noise threshold or lower than the negative first predetermined noise threshold.”; “if the result of the counting is higher than the second predetermined noise threshold, processing circuitry 50 may consider the R-wave to be noisy. In such a case, the beat associated with the noisy R-wave may not be used to determine a QT or QTc interval. If the result of the counting is equal to or lower than the second predetermined noise threshold, processing circuitry 50 may consider the R-wave to not be noisy.”).
Regarding claim 12, Rajagopal teaches the system of claim 1, wherein the system is configured to determine the at least one physiologic parameter for one or more observation windows, wherein a length of each observation window is based on at least one of a set minimum number of samples and a maximum processing time ([0133] “processing circuitry 50 may take a first predetermined number of samples before the sensed R-wave and a second predetermined number of samples after the sensed R-wave at a predetermined frequency and determine the sample with the maximum amplitude is the R-wave peak sample.”).
Regarding claim 13, Rajagopal teaches the system of claim 1, further including an implantable medical device, wherein the implantable medical device is configured to perform at least the aspects of comparing signs, determining a presence of a fiducial event, and count samples ([0045] “Some implantable medical devices (IMDs) also sense and monitor cardiac EGMs”; [0050] “described in the context of examples in which ICM 10 that senses the cardiac EGM comprises an insertable cardiac monitor, example systems including one or more implantable or external devices of any type configured to sense a cardiac EGM may be configured to implement the techniques of this disclosure.”).
Regarding claim 14, Rajagopal teaches a method for analyzing physiologic signals (Abstract), comprising:
- receiving a discrete-time physiologic signal ([0034] “acquisition of the ECG recording”; [0049] “physiological signals recorded by ICM 10”; [0053]);
- comparing a sign associated with a present sample value of the physiologic signal to a sign associated with a previous sample value of the physiologic signal ([0109] “Processing circuitry 50 may determine whether there is a sign change (e.g., from positive to negative, or from negative to positive) between each of the plurality of first differences and the respective next difference of the plurality of first differences.”; Fig. 7);
- determining a presence of a fiducial event if the sign associated with the present sample value is different from the sign associated with the previous sample value ([0117] “For each determined sign change, processing circuitry 50 may determine whether a magnitude of a respective corresponding fourth difference value is greater than a positive third predetermined noise threshold or lower than a negative third predetermined noise threshold.”; [0142] “Processing circuitry 50 may determine a noise count by counting the number of samples in the window where there is a sign change of greater than a first threshold (e.g., 50) or a sign change of less than a second threshold (e.g., −50). If this noise count is greater than or equal to a threshold (e.g., 5) then processing circuitry 50 may determine the beat is noisy…. Processing circuitry 50 may determine whether the segment between the current R wave and the next R wave is noisy in a similar manner.”);
- counting samples of the physiologic signal in intervals defined between fiducial events to obtain a respective sample count for each of the intervals ([0142] “processing circuitry may determine whether the current R wave is noisy by defining a window of a few samples before the R wave peak and a few samples after the R wave peak. Processing circuitry 50 may determine a noise count by counting the number of samples in the window where there is a sign change of greater than a first threshold (e.g., 50) or a sign change of less than a second threshold (e.g., −50)”; [0135] “Processing circuitry 50 may determine the search window to start at a number of samples after an R-wave peak and end a different number of samples after the R-wave peak. These numbers of samples may be based on the length of the current RR interval or the previous RR interval.”); and
- determining at least one physiologic parameter based on the sample counts (Fig. 19A; [0030] “techniques for identifying one or more parameters of a cardiac signal, such as QT intervals. The parameters may be used to, for example, detect or predict arrhythmias, to evaluate other conditions of the patient such as change in electrolytes, change in diabetic status, fluid overload or dehydration, or to configure and/or evaluate therapies, such as pharmacological therapies.”; [0110] “if the result of the counting is higher than the second predetermined noise threshold, processing circuitry 50 may consider the R-wave to be noisy. In such a case, the beat associated with the noisy R-wave may not be used to determine a QT or QTc interval. If the result of the counting is equal to or lower than the second predetermined noise threshold, processing circuitry 50 may consider the R-wave to not be noisy.”).
Regarding claim 15, Rajagopal teaches a machine-readable storage medium having computer-executable instructions stored, that, when executed, cause one or more processors to perform the method of claim 14 ([0007] “a non-transitory, computer-readable storage medium storing a set of instructions that, when executed, cause a system to: determine an R-wave of the cardiac signal; determine whether the R-wave is noisy; based on the R-wave not being noisy, determine whether the cardiac signal around a determined T-wave is noisy; and based on the cardiac signal around the determined T-wave not being noisy, determine a QT interval or a corrected QT interval based on the determined T-wave and the determined R-wave”; [0057]).
Conclusion
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/EVELYN GRACE PARK/Examiner, Art Unit 3791 /TSE W CHEN/Supervisory Patent Examiner, Art Unit 3791