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
Regarding 35 U.S.C. 112(b)
New 35 U.S.C. 112(b) rejections are necessitated by amendments.
Examiner notes that although claims 12-13 are cancelled and claim 1 is amended to incorporate similar features that amendments to claim 1 do not clarify the nature of the PPG sensor and activation thereof based on the heart rate variability metric. For at least these reasons, the 112(b) rejection with respect to activation of a second one or more sensors (comprising a PPG sensor) is maintained/updated in view of the amendments to the claims.
Regarding prior art
Applicant’s arguments with respect to claims 1, 14, and 20 have been considered but are moot in view of the new grounds of rejection necessitated by amendment.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-2, 4-5, 7-11, 14-15, 17-18, and 20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1, 14, and 20 recite the limitation “based on the heart rate variability metric being below the heart rate variability threshold, activate/activating a second one or more sensors configured to sense a second one or more physiological characteristics, the second one or more sensors comprising a photoplethysmography (PPG) sensor”. Examiner notes that it is unclear if the second one or more physiological sensors is the same as or included in the first one or more sensors or if this is a different/distinct one or more sensors. Specifically, this makes the limitation unclear as the heart rate variability metric is previously recited as being the one or more patient attributes that is defined using the one or more first output signals from the one or more first sensors and it is noted that heart rate variability is a patient attribute which may be defined using signals from a PPG sensor. Thus in an instance where the first and second sensor(s) are the same, it is unclear how the heart rate variability is defined and determined to be below a threshold if the PPG sensor has not been activated.. For examination purposes, it has been interpreted that the second one or more sensors may be the same as the first one or more sensors and is activated in any case including a case in which the heart rate variability is below the heart rate variability threshold, thus based thereon. Clarification is required.
Claims 1, 14, and 20 recite the limitation “indicative of a second one or more physiological characteristics”. It is unclear if the second one or more physiological characteristics is the same as the previously recited second one or more physiological characteristics or if this is a different one or more physiological characteristics. For examination purposes, it has been interpreted to be either the same or different, however, clarification is required.
Claims 1, 14, and 20 recite the limitation “define a second one or more patient attributes using the second one or more output signals”. It is unclear if the second one or more patient attributes are the same as the first one or more patient attributes and/or heart rate variability metrics as it is noted that PPG is capable of being used to define heart rate variability metrics and thus may read on the first one or more patient attributes. For examination purposes, it has been interpreted that they may be the same or different, however, clarification is required.
Claim 4 recites the limitation “the one or more output signals”. There is insufficient antecedent basis for the limitation in the claim. It is unclear if the limitation is intending to refer to the first one or more output signals, the second one or more output signals, or a different/distinct one or more output signals due to the lack of modifier. For examination purposes, it has been interpreted to mean any one or more output signals, however, clarification is required.
Claim 11 recites the imitation “the PPG signal”. There is insufficient antecedent basis of the limitation in the claim. It is unclear if the PPG signal is one of the second one or more physiological characteristics, one of the second one or more output signals or if this is a different/distinct signal. For examination purposes, it has been interpreted to mean any PPG signal, however, clarification is required.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-2, 4, 9, 11, 14-15, 17 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Ben Ishay et al. (US 20220369936 A1), hereinafter Ben Ishay in view of Sarkar et al. (US 20210093220 A1), hereinafter
Regarding claims 1, 14, and 20,
Ben Ishay teaches a system (at least fig. 1 (100) and fig. 2A/B (200) and corresponding disclosure n at least [0045]), comprising:
A medical device (100 and 200) comprising:
A first one or more sensors (at least fig. 2A/B (212 and/or 210/214) and corresponding disclosure in at least [0046]) configured to continuously sense a first one or more physiological characteristics of a body ([0045] which discloses electrogram sensor, having one or more electrodes for outputting tissue electrical activity values) of a maternal patient (examiner notes that a person having ordinary skill in the art would have recognized the system would function on any patient including a maternal patient); and
Sensing circuitry operably connected to the first one or more sensors and configured to issue a first one or more output signals indicative of the first one or more physiological characteristics ([0045] which discloses one or more electrodes for outputting tissue electrical activity values. Examiner notes that such electrodes/electrogram sensor would necessarily comprise sensing circuitry in order to output such values/signals accordingly. See also [0047] which discloses wired connection between computing unit 110 and electrogram sensor 210 where such a wire is considered to be a sensing circuitry which would output signals to the computing unit 110) ; and
processing circuitry (at least fig. 1 (110) and corresponding disclosure in at least [0033]) configured to:
Define a first one or more patient attributes using first one or more output signals from a first one or more sensors ([0047] which discloses In some embodiments, computing unit 110 includes electrical activity functionality for calculating tissue electrical activity values in parallel to calculating the BP values. [0055] which discloses BP device 100/200/300 includes one or more control units to control the operation of BP device 100 (e.g. PPG sensor 102, electrogram 210, computing unit 110, sampling circuit 114, and output unit 118, in some embodiments control units are configured to trigger BP measuring during specific conditions evaluated based on signals received by electrogram sensor 210), the one or more patient attributes comprising one or more heart rate variability metrics ([0061] which discloses an example of such a condition is HR below or above a set threshold, HRV below or above a set threshold (e.g. lower than 40-60));
Determine that the heart rate variability metric is below a heart rate variability threshold ([0061] which discloses an example of such a condition is HR below or above a set threshold, HRV below or above a set threshold (e.g. lower than 40-60));
Based on the heart rate variability metric being below the heart rate variability threshold, activating a second one or more sensors configured to sense a second one or more physiological characteristics ([0055] which discloses BP device 100/200/300 includes one or more control units to control the operation of BP device 100 (e.g. PPG sensor 102, electrogram 210, computing unit 110, sampling circuit 114, and output unit 118, in some embodiments control units are configured to trigger BP measuring during specific conditions evaluated based on signals received by electrogram sensor 210), the second one or more sensors comprising a photoplethysmography (PPG) sensor (at least fig. 2 ( and being configured to issue a second one or more output signals indicative of a second one or more physiological characteristics ([0014] which discloses measuring blood pressure using a BP measuring device having a PPG sensor and a computing unit, the method including receiving PPG signals from the PPG sensors, sampling by the computing unit the received PPG signals into PPG signals samples at a rate higher than 120 Hz, processing the PPG signals samples into BP values by the computing unit, repeating the sampling for at least 100 cycles, and outputting the BP values);
Define a second one or more patient attributes using the second one or more output signals ([0033] which discloses computing unit 110 comprises a processor 116 having a BP calculation functionality, for processing the PPG signals samples into a BP profile. The BP profile may include BP parameters such as sequential BP values, BP change rate, diastolic pressure values, systolic pressure values, maximum BP, and minimum BP), and
Generate an output based on the first one or more patient attributes and the second one or more patient attributes ([0035] which discloses computing unit 110 further comprises a BP output unit 118, for outputting the calculated values of the BP profile. Examiner notes that the BP profile is based on both the second one or more patient attributes (i.e. BP profile or values thereof) and the first one or more patient attributes including HRV in that the system functions to measure the BP values based on HRV values being within a certain range), the output configured to cause a computing device to provide an indication of preeclampsia of the maternal patient to a user ([0051] which discloses BP device 200 further comprises a display unit which can show values related to the measured BP profiled, e.g. values provided by output unit 118. Examiner first notes that an indication of preeclampsia of the maternal patient is broad and encompasses merely the BP values/profile themselves in that the BP values/profile would indicate to a user whether preeclampsia is occurring or not and further notes that the computing device is not a part of the claimed invention and is merely intended to be used with the claimed invention, where it is noted that the output must merely be capable of causing a computing device to provide an indication. It is noted that the output of BP values as taught by Ben Ishay would therefore be capable of being used to cause a computing device to provide an indication of preeclampsia of the maternal patient to a user and therefore reads on the claimed invention).
While Ben Ishay teaches that the device is a wearable device and in some cases is attachable to a tissue or body organ in [0011], it is not made explicitly clear if the medical device is implantable.
Sarkar, in a similar field of endeavor involving heart monitoring, teaches a system comprising:
An implantable medical device (at least fig. 3 (10) and corresponding disclosure in at least [0068]) comprising:
One or more sensors (at least fig. 3 (16) and corresponding disclosure in at least [0068]) configured to continuously sense one or more physiological characteristics of a body of a maternal patient ([0160] which discloses For instance, IMD 10 may identify a high and a low risk level for preeclampsia that may correspond to variable risk thresholds that differ at various stages of a pregnancy, for example. Thus is configured to sense one or more physiological characteristics of a body of a maternal (e.g. pregnant) patient); and
Sensing circuitry (at least fig. 3 (52) and corresponding disclosure in at least [0068]) operably connected to the one or more sensors and configured to issue one or more output signals indicative of the one or more physiological characteristics ([0070] which discloses Sensing circuitry 52 may be selectively coupled to electrodes 16 via switching circuitry 58, e.g., to select the electrodes 16 and polarity, referred to as the sensing vector, used to sense impedance and/or cardiac signals, as controlled by processing circuitry 50 sensing circuitry 52 may sense signals from electrodes 16, e.g., to produce a cardiac EGM or subcutaneous electrocardiogram (ECG), in order to facilitate monitoring the electrical activity of the heart. See also [0073] which discloses processing circuitry 50 may receive a plurality of signals using electrodes 16 where the signals include at least one ECGT and/or one or more subcutaneous tissue impedance, thus it is noted that the sensing circuitry 52 necessarily outputs such signals for the processing circuitry to receive it);
And processing circuitry (at least fig. 3 (50) and corresponding disclosure in at least [0046]) configured to :
Define one or more first patient attributes using the one or more output signals ([0088] which discloses processing circuitry 50 of IMD 10, and/or processing circuitry of another device that retrieves data from IMD 10, may analyze the impedance values to determine a cardiac condition of patient 4 according to the techniques of this disclosure); and
Generate an output based on the one or more first patient attributes ([0098] which discloses Using the impedance analysis techniques disclosed herein, processing circuitry 80 may then determine a heart condition status of patient 4 and/or generate an alert based on the heart condition status), the output configured to cause a computing device to provide an indication of preeclampsia of the maternal patient to a user ([0164] which discloses IMD 10 or external device 12 may determine a health or heart status in accordance with fig. 6, transmit a health or heart status. See also at least fig. 10 depicting the heart condition status of the patient is received by the external device as disclosed in [0222] and transmits instructions to user interface which [0222] discloses may be an alert, such as a text- or graphics-based notification, a visual notification, etc. al and finally [0160] which discloses IMD 10 determine status levels for other health conditions such as edema, preeclampsia, hypertension, etc. and may identify a high and a low risk level for preeclampsia that may correspond to variable risk thresholds that differ at various stages of a pregnancy, for example. Therefore a person having ordinary skill in the art would have recognized that an output including a health condition such as disclosed in [0164] would include an indication of preeclampsia or a level thereof as disclosed in [0160] and cause a computing device to provide the indication of preeclampsia accordingly).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Ben Ishay to be an implantable device as taught by Sarkar in order to facilitate relatively longer-term monitoring of patients during normal daily activities (Sarker [0045]).
Examiner notes that the modified system would perform the method 14 having corresponding method steps and would comprise the non-transitory computer-readable medium of claim 20 having corresponding functions accordingly.
Regarding claims 2 and 15,
Ben Ishay further teaches wherein the first one or more sensors comprise a plurality of electrodes (212/214), and the first one or more output signals comprise an electrocardiogram ([0046])
Regarding claims 4 and 17,
Ben Ishay further teaches wherein the one or more heart rate variability metrics comprise at least one of a time-domain metric or a frequency-domain metric of a set of cardiac lengths determined based on at least one of the one or more output signals (HR or HRV is considered a time-domain or a frequency domain metric of a set of cardiac lengths determined based on at least one of the first one or more output signals)
Regarding claim 9,
Ben Ishay further teaches wherein the one or more sensors comprises a plurality of electrodes, the one or more signals comprise an impedance signal ([0046] which discloses impedance electrodes are of ECG and [0046] which discloses electrical activity can be for example heart rate, EEG/EMG amplitude, impedance).
Ben Ishay, as currently modified, fails to explicitly teach wherein the processing circuitry is configured to generate the output based on a determination that the patient impedance is below a threshold.
Nonetheless, Sarkar further teaches generating the output based on a determination that the patient impedance is below a threshold ([0132]-[0133] which discloses comparing the impedance values to the reference impedance value to determined whether it is greater than or equal to the reference impedance values. See also In another example, IMD 10 determine status levels for other health conditions, such as edema, preeclampsia, hypertension, etc., based on the impedance score. In such examples, IMD 10 may identify various risk thresholds for each health monitoring situation. For example, the risk thresholds for heart failure decompensation may be different from other heart-related conditions. In some instances, the number of risk categories may differ as well. For instance, IMD 10 may identify a high and a low risk level for preeclampsia that may correspond to variable risk thresholds that differ at various stages of a pregnancy, for example. In any event, the impedance score may indicate conditions that appear to alter impedance levels within subcutaneous space 22 prior to warranting medical intervention)
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Ben Ishay to include generating the output based on a determination that the patient impedance is below a threshold as taught by Sarkar in order to provide additional health monitoring data which takes into account the impedance value of the subject accordingly.
Regarding claim 11,
Ben Ishay further teaches wherein the second one or more patient attributes comprise a blood pressure determined based on the PPG signal ([0033] which discloses The BP profile may include BP parameters such as sequential BP values, BP change rate, diastolic pressure values, systolic pressure values, maximum BP, and minimum BP).
Claims 5 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Ben Ishay and Sarkar, as applied to claims 4 and 17 above, and further in view of WIPO Pastore et al. (WO 2006078519 A2), hereinafter Pastore.
Regarding claims 5 and 18,
Ben Ishay, as modified, teaches the elements of claims 4 and 17. Ben Ishay, as modified, fails to explicitly teach wherein frequency domain metric of a set of cardiac cycle lengths comprises at least a magnitude of cardiac cycle length differences in a first frequency band, or a ratio of magnitudes of cardiac cycle length differences in the first frequency band and a second frequency band different than the first frequency band.
Pastore, in a similar field of endeavor involving health monitoring, teaches wherein frequency domain metric of a set of cardiac cycle lengths comprises at least a magnitude of cardiac cycle length differences in a first frequency band, or a ratio of magnitudes of cardiac cycle length differences in the first frequency band and a second frequency band different than the first frequency band (pg. 6 line 20-pg. 7 line 2 which discloses the HRV parameter is the time differences between successive cardiac cycle lengths averaged over a predetermined period of time, hi one specific embodiment, the cardiac cycle lengths are ventricular cycle lengths, i.e., V-V intervals, or R-R intervals, which are time intervals between successive ventricular depolarizations (R waves), hi an alternative specific embodiment, the cardiac cycle lengths are atrial cycle lengths, i.e., A-A intervals, or P-P intervals, which are time intervals between successive atrial depolarizations (P waves), hi various specific embodiments, the HRV parameters includes, but are not limited to, Standard Deviation of Normal-to-Normal intervals (SDNN), Standard Deviation of Averages of Normal-to-Normal intervals (SDANN), ratio of Low-Frequency (LF) HRV to High-Frequency (HF) HRV (LF/HF ratio), HRV footprint, and Root-Mean-Square of Successive Differences (RMSSD)).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Ben Ishay, as modified, to include a frequency domain metric as taught by Pastor in order to provide alternative HRV parameters. Such an HRV parameter as taught by Pastor would allow for monitoring substantial changes in the LF/HF ratio which would indicate the degree to which the sympathetic nervous system is over-stimulated (Pastor pg. 7 lines 15-20). Furthermore, such a modification amounts to merely a simple substitution of one known HRV parameter for another yielding predictable results with respect to HRV monitoring thereby rendering the claim obvious MPEP 2143.
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Ben Ishay and Sarkar, as applied to claim 1 above, and further in view of Thigpen et al. (US 20220313148 A1), hereinafter Thigpen.
Regarding claim 7,
Ben Ishay, as modified, teaches the elements of claim 1 as previously stated. Ben Ishay further teaches wherein the heart rate variability metric is a current heart rate variability metric.
Ben Ishay fails to explicitly teach wherein the processing circuitry is configured to determine the heart rate variability threshold based on a plurality of prior heart rate variability metrics.
Thigpen, as applied to claim 6 above further teaches wherein the heart rate variability metric is a current heart rate variability metric, and the processing circuitry is configured to determine the heart rate variability threshold based on a plurality of prior heart rate variability metrics ( [0158] which discloses the system may identify and/or predict the indication of the one or more pregnancy complications by observing a user’s relative HRV for many days and marking the decrease in HRV values 445 relative to a pregnancy baseline (e.g., pregnancy baseline of HRV values 440), which may indicate a pregnancy complication. See also claim 5 which recites wherein detecting the indication of the one or more pregnancy complications is based at least in part on determining that the received heart rate variability data is less than the pregnancy baseline heart rate variability for the user. [0219] which discloses the one or more pregnancy complications comprise pre existing chronic hypertension, gestational hypertension, preeclampsia, eclampsia, cardiometabolic disorders, gestational diabetes, infections, or a combination thereof and abstract which discloses The system may generate a message for display on a graphical user interface on a user device that indicates the indication of the one or more pregnancy complications and [0127] which discloses the historical user data may include historical data 360. The historical data 360 may include historical temperature patterns of the user, historical heart rate patterns of the user, historical respiratory rate patterns of the user, historical HRV patterns of the user, historical blood oxygen saturation of the user, historical pregnancy events (e.g., conception date, due date, etc.) of the user, or a combination thereof. The historical data 360 may be selected from the last few months. The historical data 360 may be used (e.g., by the user device 310 or server 315) to determine a threshold (e.g., pregnancy baseline) for the user ).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Ben Ishay, as modified, to include determining the heart rate variability threshold based on a plurality of prior heart rate variability thresholds as taught by Thigpen in order to provide a personalized threshold for a user. Such a modification would therefore provide a more appropriate baseline HRV for a user such that the threshold and comparison thereto is more accurate.
Regarding claim 8,
Ben Ishay fails to explicitly teach wherein the processing circuitry is configured to determine the heart rate variability threshold based on a duration of pregnancy of the maternal patient.
Thigpen, as applied to claim 6 above further teaches wherein the heart rate variability metric is a current heart rate variability metric, and the processing circuitry is configured to determine the heart rate variability threshold based on a duration of pregnancy of the maternal patient ( [0158] which discloses the system may identify and/or predict the indication of the one or more pregnancy complications by observing a user’s relative HRV for many days and marking the decrease in HRV values 445 relative to a pregnancy baseline (e.g., pregnancy baseline of HRV values 440), which may indicate a pregnancy complication. See also claim 5 which recites wherein detecting the indication of the one or more pregnancy complications is based at least in part on determining that the received heart rate variability data is less than the pregnancy baseline heart rate variability for the user. [0219] which discloses the one or more pregnancy complications comprise pre existing chronic hypertension, gestational hypertension, preeclampsia, eclampsia, cardiometabolic disorders, gestational diabetes, infections, or a combination thereof and abstract which discloses The system may generate a message for display on a graphical user interface on a user device that indicates the indication of the one or more pregnancy complications and [0127] which discloses the historical user data may include historical data 360. The historical data 360 may include historical temperature patterns of the user, historical heart rate patterns of the user, historical respiratory rate patterns of the user, historical HRV patterns of the user, historical blood oxygen saturation of the user, historical pregnancy events (e.g., conception date, due date, etc.) of the user, or a combination thereof. The historical data 360 may be selected from the last few months. The historical data 360 may be used (e.g., by the user device 310 or server 315) to determine a threshold (e.g., pregnancy baseline) for the user ).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Ben Ishay, as modified, to include determining the heart rate variability threshold based on a plurality of prior heart rate variability thresholds as taught by Thigpen in order to provide a personalized threshold for a user (especially in the case of a maternal patient). Such a modification would therefore provide a more appropriate baseline HRV for a maternal patient such that the threshold and comparison thereto is more accurate.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Ben Ishay and Sarkar, as applied to claim 1 above, and further in view of Su et al. (US 20160113618 A1), hereinafter Su.
Regarding claim 10,
Sarkar teaches the elements of claim 1 as previously stated. Sarkar fails to explicitly teach wherein the first one or more signals comprises a heart sounds signal, and the first one or more patient attributes comprise one or more of a heart sound morphological metric, a cardiac electromechanically activation interval.
Su, in a similar field of endeavor involving health monitoring, teaches wherein one or more signals from sensors of an implantable device comprise a heart sounds signal ([0027] which discloses IMD 20 is used to detect one or more acoustic signals while implanted within patient 12. The location of IMD 20 within patient 12 may be selected based on a patient prescription defined by a physician or other caregiver. For example, IMD 20 may be implanted near the heart 24 if the patient prescription requires detection of heart sounds. See also [0052]), and processing circuitry is configured to define one or more patient attributes comprising a heart sound morphological metric ([0073] which discloses feature module may extract information regarding morphology of the A2 or P2 heart sound).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Ben Ishay, as currently modified, to include heart sounds signals and defining one or more patient attributes including a heart sound morphological metric as taught by Su in order to provide additional monitoring data of the subject such as systemic blood pressure and pulmonary blood pressure (Su [0036]).
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 BROOKE L KLEIN whose telephone number is (571)270-5204. The examiner can normally be reached Mon-Fri 7:30-4.
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/BROOKE LYN KLEIN/Primary Examiner, Art Unit 3797
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