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 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.
Claim(s) 1-21 is/are rejected under 35 U.S.C. 101 because the claimed invention, considering all claim elements both individually and in combination as a whole, do not amount to significantly more than a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea).
Claim 1 is a claim to a process, machine, manufacture, or composition of matter and therefore meets one of the categorical limitations of 35 U.S.C. 101. However, claim 1 meets the first prong of the step 2A analysis because it is directed to a/an abstract idea, as evidenced by the claim language of “independently, for each of the plurality of ECG leads: repeatedly sampling the ECG signal on the lead for a predetermined time interval to obtain a plurality of sample ECG waveforms;”, “applying each sample waveform to a low-pass filter to obtain a plurality of low-band filter (“LBF”) energy values;”, “applying each sample waveform to a high-pass filter to obtain a plurality of high-band filter (“HBF”) energy values;”, “saving a predetermined number of consecutive LBF energy values and a predetermined number of consecutive HBF energy values for the ECG lead;”, “calculating a running average of saved LBF energy values and a running average of saved HBF energy values for the ECG lead;”, “measuring a peak-to-peak amplitude value of a QRS complex in the ECG signals from the ECG lead;”, “and calculating a signal-to-noise (“S/N”) ratio of the ECG lead as a function of the peak-to-peak QRS complex amplitude value divided by the sum of the running average of saved LBF energy values and the running average of HBF energy values;”, “selecting two of the plurality of ECG leads based on a comparison of the calculated S/N ratio for each of the plurality of ECG leads;”, and “and executing an ECG signal processing algorithm on the ECG signals from the selected leads.”. This claim language, under the broadest, reasonable interpretation, encompasses subject matter that may be performed by a human using mental steps or with pen and paper that can involve basic critical thinking, which are types of activities that have been found by the courts to represents abstract ideas (i.e., the mental comparison in Ambry Genetics, or the diagnosing an abnormal condition by performing clinical tests and thinking about the results in Grams). The claim language also meets prong 2 of the step 2A analysis because the above-recited claim language does not integrate the abstract idea into a practical application. The disclosed technologies do not improve a technical field (see MPEP 2106.05(a)), affect a particular treatment for a disease or medical condition (see MPEP 2106.04(d)(2)), effect a transformation or reduction of a particular article to a different state or thing (see MPEP 2106.04(d)(2)), apply the judicial exception with, or by use of, a particular machine (see MPEP 2106.05(b)), or apply the judicial exception in some meaningful way beyond generally linking the use of the abstract idea to a particular technological environment (MPEP 2106.04(d)(2) and 2106.05(e)). As a result, step 2A is satisfied and the second step, step 2B, must be considered.
With regard to the second step, the claim does not appear to recite additional elements that amount to significantly more. The additional elements are “a plurality of ECG leads connected to a patient”. However, these elements are not “significantly more” because they are well-known, routine, and/or conventional as evidenced by para [0005]: “standard 12-lead ECG is conventionally created or produced using ten electrodes connected to the electrocardiograph and placed at predefined positions on the body surface” of Ugander et al. (US 20230363684 A1).
Additionally, the ordered combination of elements do not add anything significantly more to the claimed subject matter. Specifically, the ordered combination of elements do not have any function that is not already supplied by each element individually. That is, the whole is not greater than the sum of its parts.
In view of the above, independent claim 1 fails to recite patent-eligible subject matter under 35 U.S.C. 101. Dependent claim(s) 2-7 fail to cure the deficiencies of independent claim 1 by merely reciting additional abstract ideas, further limitations on abstract ideas already recited, and/or additional elements that are not significantly more. Thus, claim(s) 1-7 is/are rejected under 35 U.S.C. 101.
Claim 8 is a claim to a process, machine, manufacture, or composition of matter and therefore meets one of the categorical limitations of 35 U.S.C. 101. However, claim 8 meets the first prong of the step 2A analysis because it is directed to a/an abstract idea, as evidenced by the claim language of “receive the ECG signals and independently perform ECG signal processing on the ECG signals for each of the plurality of leads”, “applying each sample waveform to a low-pass filter to obtain a plurality of low-band filter (“LBF”) energy values;”, “repeatedly sampling the ECG signal of the lead over a plurality of predetermined intervals to produce a plurality of sample waveforms;”, “low-pass filtering each sample waveform to obtain a plurality of low-band filter (“LBF”) energy values;”, “high-pass filtering each sample waveform to obtain a plurality of high-band filter (“HBF”) energy values;”, “saving a predetermined number of the LBF energy values and a predetermined number of consecutive HBF energy values;”, “calculating a running average of saved LBF energy values and a running average of saved HBF energy values for the ECG lead;”, “measuring a peak-to-peak amplitude value of a QRS complex in the ECG signals from the ECG lead;”, “and calculating a signal-to-noise (“S/N”) ratio of the ECG lead as a function of the peak-to-peak QRS complex amplitude value divided by the sum of the running average of saved LBF energy values and the running average of HBF energy values;”, “select two of the plurality of ECG leads based on a comparison of the calculated S/N ratio for each of the plurality of ECG leads;”, and “and execute an ECG signal processing algorithm on the ECG signals from the selected leads.”. This claim language, under the broadest, reasonable interpretation, encompasses subject matter that may be performed by a human using mental steps or with pen and paper that can involve basic critical thinking, which are types of activities that have been found by the courts to represents abstract ideas (i.e., the mental comparison in Ambry Genetics, or the diagnosing an abnormal condition by performing clinical tests and thinking about the results in Grams). The claim language also meets prong 2 of the step 2A analysis because the above-recited claim language does not integrate the abstract idea into a practical application. The disclosed technologies do not improve a technical field (see MPEP 2106.05(a)), affect a particular treatment for a disease or medical condition (see MPEP 2106.04(d)(2)), effect a transformation or reduction of a particular article to a different state or thing (see MPEP 2106.04(d)(2)), apply the judicial exception with, or by use of, a particular machine (see MPEP 2106.05(b)), or apply the judicial exception in some meaningful way beyond generally linking the use of the abstract idea to a particular technological environment (MPEP 2106.04(d)(2) and 2106.05(e)). As a result, step 2A is satisfied and the second step, step 2B, must be considered.
With regard to the second step, the claim does not appear to recite additional elements that amount to significantly more. The additional elements are “a sensor interface configured to receive electrocardiogram (“ECG”) signal” and “a plurality of ECG leads connected to a patient”. However, these elements are not “significantly more” because they are well-known, routine, and/or conventional as evidenced by para [0007]: “A typical patient monitoring system ECG sensor interface (or “front end”) is designed to receive an ECG signal” of Risher-Kelly et al. (WO 2024042356 A1) and para [0005]: “standard 12-lead ECG is conventionally created or produced using ten electrodes connected to the electrocardiograph and placed at predefined positions on the body surface” of Ugander et al. (US 20230363684 A1). Regarding claim 8, a generic computer structure such as “a processor” is not significantly more according to Alice v. CLS. Therefore, these elements do not add significantly more and thus the claim as a whole does not amount to significantly more than a judicial exception.
Additionally, the ordered combination of elements do not add anything significantly more to the claimed subject matter. Specifically, the ordered combination of elements do not have any function that is not already supplied by each element individually. That is, the whole is not greater than the sum of its parts.
In view of the above, independent claim 8 fails to recite patent-eligible subject matter under 35 U.S.C. 101. Dependent claim(s) 9-14 fail to cure the deficiencies of independent claim 8 by merely reciting additional abstract ideas, further limitations on abstract ideas already recited, and/or additional elements that are not significantly more. Thus, claim(s) 9-14 is/are rejected under 35 U.S.C. 101.
Claim 15 is a claim to a process, machine, manufacture, or composition of matter and therefore meets one of the categorical limitations of 35 U.S.C. 101. However, claim 15 meets the first prong of the step 2A analysis because it is directed to a/an abstract idea, as evidenced by the claim language of “repeatedly sampling the ECG signal on the lead for a predetermined time interval to obtain a plurality of sample ECG waveforms;”, “applying each sample waveform to a low-pass filter to obtain a plurality of low-band filter (“LBF”) energy values;”, “applying each sample waveform to a high-pass filter to obtain a plurality of high-band filter (“HBF”) energy values;”, “saving a predetermined number of consecutive LBF energy values and a predetermined number of consecutive HBF energy values for the ECG lead;”, “calculating a running average of saved LBF energy values and a running average of saved HBF energy values for the ECG lead;”, “measuring a peak-to-peak amplitude value of a QRS complex in the ECG signals from the ECG lead;”, “and calculating a signal-to-noise (“S/N”) ratio of the ECG lead as a function of the peak-to-peak QRS complex amplitude value divided by the sum of the running average of saved LBF energy values and the running average of HBF energy values;”, “selecting two of the plurality of ECG leads based on a comparison of the calculated S/N ratio for each of the plurality of ECG leads;”, and “and executing an ECG signal processing algorithm on the ECG signals from the selected leads.”. This claim language, under the broadest, reasonable interpretation, encompasses subject matter that may be performed by a human using mental steps or with pen and paper that can involve basic critical thinking, which are types of activities that have been found by the courts to represents abstract ideas (i.e., the mental comparison in Ambry Genetics, or the diagnosing an abnormal condition by performing clinical tests and thinking about the results in Grams). The claim language also meets prong 2 of the step 2A analysis because the above-recited claim language does not integrate the abstract idea into a practical application. The disclosed technologies do not improve a technical field (see MPEP 2106.05(a)), affect a particular treatment for a disease or medical condition (see MPEP 2106.04(d)(2)), effect a transformation or reduction of a particular article to a different state or thing (see MPEP 2106.04(d)(2)), apply the judicial exception with, or by use of, a particular machine (see MPEP 2106.05(b)), or apply the judicial exception in some meaningful way beyond generally linking the use of the abstract idea to a particular technological environment (MPEP 2106.04(d)(2) and 2106.05(e)). As a result, step 2A is satisfied and the second step, step 2B, must be considered.
With regard to the second step, the claim does not appear to recite additional elements that amount to significantly more. The additional elements are “a plurality of ECG leads connected to a patient”. However, these elements are not “significantly more” because they are well-known, routine, and/or conventional as evidenced by para [0005]: “standard 12-lead ECG is conventionally created or produced using ten electrodes connected to the electrocardiograph and placed at predefined positions on the body surface” of Ugander et al. (US 20230363684 A1). Regarding claim 15, a generic computer structure such as “a computer-readable medium” and “a processor” is not significantly more according to Alice v. CLS. Therefore, these elements do not add significantly more and thus the claim as a whole does not amount to significantly more than a judicial exception.
Additionally, the ordered combination of elements do not add anything significantly more to the claimed subject matter. Specifically, the ordered combination of elements do not have any function that is not already supplied by each element individually. That is, the whole is not greater than the sum of its parts.
In view of the above, independent claim 15 fails to recite patent-eligible subject matter under 35 U.S.C. 101. Dependent claim(s) 16-21 fail to cure the deficiencies of independent claim 15 by merely reciting additional abstract ideas, further limitations on abstract ideas already recited, and/or additional elements that are not significantly more. Thus, claim(s) 15-21 is/are rejected under 35 U.S.C. 101.
Allowable Subject Matter
Claims 1-21 contain allowable subject matter over the prior art. The following is a statement of reasons for the indication of allowable subject matter: A search of relevant prior art yielded the following results:
Botzer (US 20210196139 A1), which discloses a method of processing of electrocardiogram (“ECG”) signals from a plurality of ECG leads connected to a patient ([0013]: "a number of leads… placed on the patient's limbs and on the surface of the chest"), comprising: independently, for each of the plurality of ECG leads ([0043]: “the noise level may be estimated for each catheter (where more than one catheter is used)”): repeatedly sampling the ECG signal on the lead for a predetermined time interval to obtain a plurality of sample ECG waveforms ([0016]: "the ECG signal is segmented into short segments (e.g., 40 to 50 millisecond windows)."); applying each sample waveform to a low-pass filter to obtain a plurality of low-band filter (“LBF”) energy values ([0037]); applying each sample waveform to a high-pass filter to obtain a plurality of high-band filter (“HBF”) energy values ([0037]); saving a predetermined number of consecutive LBF energy values and a predetermined number of consecutive HBF energy values for the ECG lead (Fig 2 step 210); calculating a running average of saved LBF energy values and a running average of saved HBF energy values for the ECG lead (Fig 2 element 210, [0033]: "and the estimated average noise level of the ECG data is calculated by taking the average of the estimated noise levels of the selected subset of ECG segments"); measuring a peak-to-peak amplitude value of a QRS complex in the ECG signals from the ECG lead ([0016]: “peak-to-peak amplitude”), selecting two of the plurality of ECG leads based on a comparison of the calculated noise energy for each of the plurality of ECG leads ([0005]: "The estimated noise energy may be used in a variety of applications, for example to compare and select diagnostic equipment (e.g., catheters, electrodes) with minimal noise"); and executing an ECG signal processing algorithm on the ECG signals from the selected leads ([0027]: “and algorithms that take account the noise level, and/or for reporting the resulting residual noise level estimate to a monitor station (user) to be used for example for correction, analysis, and/or big data.”).
However, Botzer fails to disclose calculating a signal-to-noise (“S/N”) ratio of the ECG lead as a function of the peak-to-peak QRS complex amplitude value divided by the sum of the running average of saved LBF energy values and the running average of HBF energy values.
Zhang et al. (CN 114601437 A), discloses calculating a signal-to-noise (“S/N”) ratio of the ECG leads ([0133]: “the ratio of the energy of the highest peak and the energy sum of other peaks is the signal-to-noise ratio, the signal-to-noise ratio can be used as the confidence level of the highest peak”), but fails to specifically disclose calculating a signal-to-noise (“S/N”) ratio of the ECG lead as a function of the peak-to-peak QRS complex amplitude value divided by the sum of the running average of saved LBF energy values and the running average of HBF energy values.
Greenhut et al. (US 20080269813 A1) disclsoes comparing a first parameter and second parameter for each of the selected leads to a predetermined threshold ([0090]: “a tiered threshold scheme” claim 5: “vectors of the subset is acceptable further includes comparing a second signal quality parameter value to a second threshold”), and if the LFB and HFB energy values for one of the selected leads exceeds the second predetermined threshold, terminating the ECG signal processing algorithm, but does not disclose calculating a signal-to-noise (“S/N”) ratio.
Ishikawa et al. (WO 2024062919 A1) – discloses stopping a process after a threshold has been exceeded but additionally fails to disclose calculating a signal-to-noise (“S/N”) ratio.
Based on the above, calculation of a signal-to-noise (“S/N”) ratio of the ECG lead as a function of the peak-to-peak QRS complex amplitude value divided by the sum of the running average of saved LBF energy values and the running average of HBF energy values is novel over the prior art, thus the claims contain allowable subject matter.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
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/KAVYA SHOBANA BALAJI/Examiner, Art Unit 3791
/DANIEL L CERIONI/Primary Examiner, Art Unit 3791