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 § 103
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.
Claim(s) 1, 5-11, and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over US 2016/0135706 Sullivan et al., hereinafter “Sullivan” (cited previously), in view of US 2016/0022162 Ong et al., hereinafter “Ong”.
Regarding claim 1, Sullivan discloses a physiological information measurement device (Abstract) comprising: a risk level determination unit (Abstract; Para 16 and 279; the risk determination unit is the control unit 120) configured to analyze an electrocardiographic waveform (Para 127 and 279) measured by a measurement unit (Para 40; the ECG sensors) and to determine an occurrence risk of arrhythmia in a plurality of levels (Para 127; a risk sore of an occurrence of a potential arrhythmia is calculated as a time series and therefore in a plurality of levels); an arrhythmia monitoring unit configured to monitor a presence or absence of the arrhythmia (Para 127; the system with the one or more processors; see also Para 301, the display unit that displays the arrhythmia predictions for monitoring; see also Figure 4, element 430 that detects is an event is occurring, therefore whether or not it is present, see also Para 284), with a detection sensitivity corresponding to a level of the occurrence risk of the arrhythmia determined by the risk level determination unit (Para 127, see also Para 50 and 482 that disclose setting the sensitivity based on the occurrence risk), an electrocardiographic waveform analyzer configured to analyze the electrocardiographic waveform measured by the measurement unit (Figure 4, element 420 and Para 284, the control unit analyzes the ECG); a risk determination element storage unit in which a risk determination element for determining the occurrence risk of the arrhythmia is stored (Para 267 and 299); and a risk level calculator configured to calculate a risk level by using an analysis result of the electrocardiographic waveform by the electrocardiographic waveform analyzer and the risk determination element stored in the risk determination element storage unit (Figure 4, element 430; Para 284, see also Para 127 and 408),wherein the arrhythmia monitoring unit is configured to operate in a low-sensitivity monitoring mode in which the presence or absence of the arrhythmia is monitored with a predetermined monitoring criterion (Para 48, 50, 100, 466-467, and 481-482; see also Para 519; All the listed paragraphs discuss a less sensitive mode of operation. As made clear by Paras 48, 50, and 100 specifically, the processor functions under two sensitivities and two specificities which are modified based on a risk level of the subject. Para 482 specifically says “if a risk of the subject 104 having a medical event is relatively high, e.g., the risk of a cardiac arrest is relatively high, the sensitivity of an algorithm for determining the event estimation of risk score may be modified to be more sensitive to detecting the event” which directly translates, that if a risk is not high, then the mode is left on a first sensitivity level, i.e. the usual mode of operation), and a high-sensitivity monitoring mode in which the presence or absence of the arrhythmia is monitored with a monitoring criterion more sensitive than the predetermined monitoring criterion (Para 48, 50, 100, 466-467, and 481-482; see also Para 519; again kindly refer to Paras 48, 50, and 100 that show two different modes of operation, i.e. two different sensitivities, one higher than the other. Examiner is interpreting the second sensitivity level to be the “high-sensitivity monitoring mode”. Also again referring to para 481-482 it is clear that if the subject is at higher risk, then the system is modified to operate at a higher sensitivity for a more accurate detection), wherein when the level of the determined occurrence risk of the arrhythmia is less than the predetermined value, the risk level determination unit is configured to shift the arrhythmia monitoring unit to the low-sensitivity monitoring mode (Para 48, 50, 100, 466-467, and 481-482; see also Para 519; the monitoring mode is set based on the subjects risk level as made clear in the paragraphs listed, if the subject is not at high risk, then the system monitors at a lower sensitivity, i.e. the first sensitivity level), wherein when the level of the determined occurrence risk of the arrhythmia is equal to or greater than the predetermined value, the risk level determination unit is configured to shift the arrhythmia monitoring to the high-sensitivity monitoring mode (Para 50 and 482 disclose that when the risk is relatively high, above a risk threshold, then the sensitivity is modified to be higher to detect the event), wherein in the high-sensitivity monitoring mode, the monitoring criterion corresponds to the level of the determined occurrence risk of the arrhythmia (Para 48, 50, 100, 466-467, and 481-482; Para 482 specifically states “The early warning system 10 may be modified based on a risk of the subject 104 having a medical event” Therefore, the monitoring mode is shifted to the higher sensitivity level based on the risk level of having an arrhythmia occur), wherein the analysis result is: a prolongation of a QT interval corrected with a heart rate (QTe interval), an interval from a T wave peak to a T wave end point (TpTe interval),a prolongation of a JTp interval corrected with a heart rate (JTpc interval), a QT dispersion, an indication of whether a T wave alternans (TWA) is detected, an indication of whether a notched T wave is detected, an ST elevation in Coved or Saddle back pattern, an ST deviation, an extension of a QRS width, a premature ventricular contraction (PVC), or an index indicative of a magnitude of a deviation of a QT interval (QTVI) (Para 107 discloses a few of these analysis results).
Sullivan does not disclose wherein each of the risk determination elements is a normalized scalar occurrence risk based on a corresponding analysis result and the risk level is quantified as a sum of the risk determination elements.
However, Ong discloses a physiological measurement device that calculates a risk level for arrhythmia (Abstract, Para 1, and 90) and teaches wherein each of the risk determination elements (Para 27; weighted classifiers) is a normalized scalar occurrence risk based on a corresponding analysis result (Para 50) and the risk level is quantified as a sum of the risk determination elements (Para 51).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed a normalized scalar occurrence risk as taught by Ong, in the invention of Sullivan, in order to evaluate each risk determination element based on its importance (Ong; Para 49-51).
Regarding claim 5, Sullivan discloses the arrhythmia monitoring unit is configured to output an alarm when the arrhythmia is detected (Para 260; an alarm is outputted on the user interface/display; see also Para 475).
Regarding claim 6, Sullivan discloses the risk level determination unit is configured to output the level of the determined occurrence risk of the arrhythmia (Para 301; the estimated risk level is outputted on the display).
Regarding claim 7, Sullivan discloses the risk level determination unit comprises: an electrocardiographic waveform analyzer configured to analyze the electrocardiographic waveform measured by the measurement unit (Para 40, 127, 279; see also Para 107), a risk determination element storage unit in which a risk determination element for determining the occurrence risk of the arrhythmia is stored (Para 266-267 and 299), and a risk level calculator configured to calculate a risk level by using an analysis result of the electrocardiographic waveform by the electrocardiographic waveform analyzer and the risk determination element stored in the risk determination element storage unit (Para 127 and 266-267).
Regarding claim 8, Sullivan discloses the arrhythmia monitoring unit (Para 127) comprises: an electrocardiographic waveform analyzer configured to analyze the electrocardiographic waveform measured by the measurement unit (Para 40, 127, 279; see also Para 107), an arrhythmia determination element storage unit in which an arrhythmia determination element for monitoring the presence or absence of the arrhythmia in accordance with the level of the determined occurrence risk of the arrhythmia is stored (Para 127 this can be interpreted as the instructions stored on the computer readable storage medium to execute the estimation of risk of arrhythmia; see also Figure 4, element 430 that detects is an event is occurring, therefore whether or not it is present, see also Para 284), and an arrhythmia determination unit configured to determine the presence or absence of the arrhythmia in accordance with the level of the determined occurrence risk of the arrhythmia by using an analysis result of the electrocardiographic waveform by the electrocardiographic waveform analyzer and the arrhythmia determination element stored in the arrhythmia determination element storage unit (Para 127, 260, 281, and 514).
Regarding claim 9, Sullivan discloses a notification unit configured to output a risk score that is to be output from the risk level determination unit (Para 301), or an alarm that is to be output from the arrhythmia monitoring unit (Para 260).
Regarding claim 10, Sullivan discloses an arrhythmia analysis system (Abstract) comprising: a risk level determination unit (Abstract; Para 16 and 279; the risk determination unit is the control unit 120) configured to analyze an electrocardiographic waveform (Para 127 and 279) measured by a measurement unit (Para 40; the ECG sensors) and to determine an occurrence risk of arrhythmia in a plurality of levels (Para 127; a risk sore of an occurrence of a potential arrhythmia is calculated as a time series and therefore in a plurality of levels); an arrhythmia monitoring unit configured to monitor a presence or absence of the arrhythmia (Para 127; the system with the one or more processors; see also Para 301, the display unit that displays the arrhythmia predictions for monitoring; see also Figure 4, element 430 that detects is an event is occurring, therefore whether or not it is present, see also Para 284), with a detection sensitivity corresponding to a level of the occurrence risk of the arrhythmia determined by the risk level determination unit (Para 127, see also Para 50 and 482 that disclose setting the sensitivity based on the occurrence risk); an electrocardiographic waveform analyzer configured to analyze the electrocardiographic waveform measured by the measurement unit (Figure 4, element 420 and Para 284, the control unit analyzes the ECG); a risk determination element storage unit in which a risk determination element for determining the occurrence risk of the arrhythmia is stored (Para 267 and 299); and a risk level calculator configured to calculate a risk level by using an analysis result of the electrocardiographic waveform by the electrocardiographic waveform analyzer and the risk determination element stored in the risk determination element storage unit (Figure 4, element 430; Para 284, see also Para 127 and 408), wherein the arrhythmia monitoring unit is configured to operate in a low-sensitivity monitoring mode in which the presence or absence of the arrhythmia is monitored with a predetermined monitoring criterion (Para 48, 50, 100, 466-467, and 481-482; see also Para 519; All the listed paragraphs discuss a less sensitive mode of operation. As made clear by Paras 48, 50, and 100 specifically, the processor functions under two sensitivities and two specificities which are modified based on a risk level of the subject. Para 482 specifically says “if a risk of the subject 104 having a medical event is relatively high, e.g., the risk of a cardiac arrest is relatively high, the sensitivity of an algorithm for determining the event estimation of risk score may be modified to be more sensitive to detecting the event” which directly translates, that if a risk is not high, then the mode is left on a first sensitivity level, i.e. the usual mode of operation), and a high-sensitivity monitoring mode in which the presence or absence of the arrhythmia is monitored with a monitoring criterion more sensitive than the predetermined monitoring criterion (Para 48, 50, 100, 466-467, and 481-482; see also Para 519; again kindly refer to Paras 48, 50, and 100 that show two different modes of operation, i.e. two different sensitivities, one higher than the other. Examiner is interpreting the second sensitivity level to be the “high-sensitivity monitoring mode”. Also again referring to para 481-482 it is clear that if the subject is at higher risk, then the system is modified to operate at a higher sensitivity for a more accurate detection), wherein when the level of the determined occurrence risk of the arrhythmia is less than the predetermined value, the risk level determination unit is configured to shift the arrhythmia monitoring unit to the low-sensitivity monitoring mode (Para 48, 50, 100, 466-467, and 481-482; see also Para 519; the monitoring mode is set based on the subjects risk level as made clear in the paragraphs listed, if the subject is not at high risk, then the system monitors at a lower sensitivity, i.e. the first sensitivity level), wherein when the level of the determined occurrence risk of the arrhythmia is equal to or greater than the predetermined value, the risk level determination unit is configured to shift the arrhythmia monitoring to the high-sensitivity monitoring mode (Para 50 and 482 disclose that when the risk is relatively high, above a risk threshold, then the sensitivity is modified to be higher to detect the event), and wherein in the high-sensitivity monitoring mode, the monitoring criterion corresponds to the level of the determined occurrence risk of the arrhythmia (Para 48, 50, 100, 466-467, and 481-482; Para 482 specifically states “The early warning system 10 may be modified based on a risk of the subject 104 having a medical event” Therefore, the monitoring mode is shifted to the higher sensitivity level based on the risk level of having an arrhythmia occur), wherein the analysis result is: a prolongation of a QT interval corrected with a heart rate (QTe interval), an interval from a T wave peak to a T wave end point (TpTe interval),a prolongation of a JTp interval corrected with a heart rate (JTpc interval), a QT dispersion, an indication of whether a T wave alternans (TWA) is detected, an indication of whether a notched T wave is detected, an ST elevation in Coved or Saddle back pattern, an ST deviation, an extension of a QRS width, a premature ventricular contraction (PVC), or an index indicative of a magnitude of a deviation of a QT interval (QTVI) (Para 107 discloses a few of these analysis results).
Sullivan does not disclose wherein each of the risk determination elements is a normalized scalar occurrence risk based on a corresponding analysis result and the risk level is quantified as a sum of the risk determination elements.
However, Ong discloses a physiological measurement device that calculates a risk level for arrhythmia (Abstract, Para 1, and 90) and teaches wherein each of the risk determination elements (Para 27; weighted classifiers) is a normalized scalar occurrence risk based on a corresponding analysis result (Para 50) and the risk level is quantified as a sum of the risk determination elements (Para 51).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed a normalized scalar occurrence risk as taught by Ong, in the invention of Sullivan, in order to evaluate each risk determination element based on its importance (Ong; Para 49-51).
Regarding claim 11, Sullivan discloses an arrhythmia analysis method (Abstract) comprising: analyzing an electrocardiographic waveform (Para 127 and 279) measured by a measurement unit (Para 40; the ECG sensors) and determining an occurrence risk of arrhythmia in a plurality of levels (Para 127; a risk sore of an occurrence of a potential arrhythmia is calculated as a time series and therefore in a plurality of levels); monitoring a presence or absence of the arrhythmia (Para 127; the system with the one or more processors; see also Para 301, the display unit that displays the arrhythmia predictions for monitoring; see also Figure 4, element 430 that detects is an event is occurring, therefore whether or not it is present, see also Para 284), with a detection sensitivity corresponding to a level of the occurrence risk of the arrhythmia determined by the risk level determination (Para 127, see also Para 50 and 482 that disclose setting the sensitivity based on the occurrence risk); storing a risk determination element for determining the occurrence risk of the arrhythmia (Para 267 and 299); and calculating a risk level by using an analysis result of the electrocardiographic waveform and the risk determination element (Figure 4, element 430; Para 284, see also Para 127 and 408), wherein the presence or absence of the arrhythmia is monitored with a predetermined monitoring criterion when operating in a low-sensitivity monitoring mode (Para 48, 50, 100, 466-467, and 481-482; see also Para 519; All the listed paragraphs discuss a less sensitive mode of operation, which examiner is interpreting to read on “a usual monitoring mode”. As made clear by Paras 48, 50, and 100 specifically, the processor functions under two sensitivities and two specificities which are modified based on a risk level of the subject. Para 482 specifically says “if a risk of the subject 104 having a medical event is relatively high, e.g., the risk of a cardiac arrest is relatively high, the sensitivity of an algorithm for determining the event estimation of risk score may be modified to be more sensitive to detecting the event” which directly translates, that if a risk is not high, then the mode is left on a first sensitivity level, i.e. the usual mode of operation), and is monitored with a monitoring criterion more sensitive than the predetermined monitoring criterion when operating in a high-sensitivity monitoring mode (Para 48, 50, 100, 466-467, and 481-482; see also Para 519; again kindly refer to Paras 48, 50, and 100 that show two different modes of operation, i.e. two different sensitivities, one higher than the other. Examiner is interpreting the second sensitivity level to be the “high-sensitivity monitoring mode”. Also again referring to para 481-482 it is clear that if the subject is at higher risk, then the system is modified to operate at a higher sensitivity for a more accurate detection), wherein the method further comprises shifting operation to the low-sensitivity monitoring mode when the level of the determined occurrence risk of the arrhythmia is less than a predetermined value (Para 48, 50, 100, 466-467, and 481-482; see also Para 519; the monitoring mode is set based on the subjects risk level as made clear in the paragraphs listed, if the subject is not at high risk, then the system monitors at a lower sensitivity, i.e. the first sensitivity level), wherein the method further comprises shifting operation to the high-sensitivity mode when the level of the determined occurrence risk of the arrhythmia is equal to or greater than the predetermined value (Para 50 and 482 disclose that when the risk is relatively high, above a risk threshold, then the sensitivity is modified to be higher to detect the event), and wherein in the high-sensitivity monitoring mode, the monitoring criterion corresponds to the level of the determined occurrence risk of the arrhythmia (Para 48, 50, 100, 466-467, and 481-482; Para 482 specifically states “The early warning system 10 may be modified based on a risk of the subject 104 having a medical event” Therefore, the monitoring mode is shifted to the higher sensitivity level based on the risk level of having an arrhythmia occur), wherein the analysis result is: a prolongation of a QT interval corrected with a heart rate (QTe interval), an interval from a T wave peak to a T wave end point (TpTe interval),a prolongation of a JTp interval corrected with a heart rate (JTpc interval), a QT dispersion, an indication of whether a T wave alternans (TWA) is detected, an indication of whether a notched T wave is detected, an ST elevation in Coved or Saddle back pattern, an ST deviation, an extension of a QRS width, a premature ventricular contraction (PVC), or an index indicative of a magnitude of a deviation of a QT interval (QTVI) (Para 107 discloses a few of these analysis results).
Sullivan does not disclose wherein each of the risk determination elements is a normalized scalar occurrence risk based on a corresponding analysis result and the risk level is quantified as a sum of the risk determination elements.
However, Ong discloses a physiological measurement device that calculates a risk level for arrhythmia (Abstract, Para 1, and 90) and teaches wherein each of the risk determination elements (Para 27; weighted classifiers) is a normalized scalar occurrence risk based on a corresponding analysis result (Para 50) and the risk level is quantified as a sum of the risk determination elements (Para 51).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed a normalized scalar occurrence risk as taught by Ong, in the invention of Sullivan, in order to evaluate each risk determination element based on its importance (Ong; Para 49-51).
Regarding claim 13, Sullivan discloses all the limitations of claim 1.
Sullivan does not disclose each of the risk determination elements is a scalar value based on the correspondence analysis result.
However, Ong teaches each of the risk determination elements is a scalar value based on the correspondence analysis result (Para 49-51).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed a scalar value as taught by Ong, in the invention of Sullivan, in order to evaluate each risk determination element based on its importance (Ong; Para 49-51).
Regarding claim 14, Sullivan discloses all the limitations of claim 10.
Sullivan does not disclose each of the risk determination elements is a scalar value based on the correspondence analysis result.
However, Ong teaches each of the risk determination elements is a scalar value based on the correspondence analysis result (Para 49-51).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed a scalar value as taught by Ong, in the invention of Sullivan, in order to evaluate each risk determination element based on its importance (Ong; Para 49-51).
Regarding claim 15, Sullivan discloses all the limitations of claim 11.
Sullivan does not disclose each of the risk determination elements is a scalar value based on the correspondence analysis result.
However, Ong teaches each of the risk determination elements is a scalar value based on the correspondence analysis result (Para 49-51).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed a scalar value as taught by Ong, in the invention of Sullivan, in order to evaluate each risk determination element based on its importance (Ong; Para 49-51).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AYA ZIAD BAKKAR whose telephone number is (313)446-6659. The examiner can normally be reached on 7:30 am - 5:00 pm M-Th.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Carl Layno can be reached on (571) 272-4949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see https://ppair-my.uspto.gov/pair/PrivatePair. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/AYA ZIAD BAKKAR/
Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796