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.
Claims 1-2, 4-7, 10-13, and 15-20 are rejected under 35 U.S.C. 103 as being unpatentable over US 2022/0000421 by Ippolito in view of US 20120253207 by Sarkar.
Regarding Claim 1, Ippolito teaches a system (e.g. title, abstract, ¶¶ 2,24: system to determine efficacy of a treatment) comprising:
an implantable medical device comprising one or more sensors, and configured to receive one or more signals from the sensors, to determine a plurality of detected patient metrics based at least in part on the received signals (e.g. abstract, ¶¶ 3,25-27,53, Fig. 1: IMD 10 with multiple sensors measuring multiple metrics, such as heart rate and temperature);
processing circuitry configured to:
initiate a period of time based on an intervention being provided to the patient [e.g. ¶ 4: “processing circuitry to receive data indicative of a time (e.g., a day, an hour, or a second) in which a treatment program administered to the patient begins”; ¶ 37: “processing circuitry 14 may determine the efficacy of the treatment program by determining a time in which the treatment program is administered (e.g., including a time in which the treatment program begins and/or a time in which the treatment program ends) and analyzing values of any one or combination of the set of parameters relative to the time in which the treatment program is administered”; It is also noted here that the “based on an intervention being provided to the patient” is directed to an intended use, and all that is required in this product claim is that the processing circuitry initiates a period, nevertheless Ippolito explicitly discloses that the initiation is based on an intervention];
generate a different resolution diagnostic information based on one of the plurality of patient metrics during the initiated period of time, wherein the higher resolution diagnostic information comprises one of the plurality of patient metrics and is indicative of heart recovery, and wherein, to generate the different resolution diagnostic information, the processing circuitry is configured to cause the implantable medical device to sample the one of the plurality of patient metrics at a sampling rate that is different than a sampling rate of the one of the plurality of patient metrics before the initiated period of time (e.g. ¶90: “the resolution of periodic measurements may change automatically or change manually from daily to hourly or every minute depending on the data measured prior or the interventions that the patient receives”; abstract, ¶¶ 4,37,41,43, 51,105: all of the metrics tracked are tracked to determine heart recovery during administration of a treatment);
generate an average of each of the plurality of detected patient metrics detected over the initiated period of time (e.g. ¶90: “the measured value of the parameter for a period, such as a day, may represent a plurality of values determined during the period, such as being a mean, median, or other statistical representation of values determined the period”; ¶¶24,37,42,51,99,123: reference to “the parameter” includes multiple of the parameters, “each parameter” being evaluated for improvement or worsening of the patient’s heart in response to the administered treatment);
compare each of the averages to a respective detected patient metric detected at a beginning of the initiated period of time (e.g. ¶¶4-5: “the processing circuitry may arrive at a more accurate determination of whether an improvement or a worsening has occurred in the respective physiological parameter based on the plurality of parameter values measured by the IMD and the time in which the treatment program begins as compared with techniques in which a determination of a patient status is made without an indication of a time in which the treatment program begins… determine, based on the parameter change value, whether an improvement or a worsening of the patient has occurred responsive to a treatment administered beginning at the reference time…”; abstract, ¶42-43,91-92,96, Fig. 7-8,12: change is tracked and includes change from day 0/points 720E/820E;¶¶24,37,42,51,99: reference to “the parameter” includes multiple of the parameters, “each parameter” being evaluated for improvement or worsening of the patient’s heart in response to the administered treatment); and
automatically generate a degree of heart recovery based on the comparison, wherein the degree of heart recovery is indicative of an amount the heart recovered over the initiated period of time (e.g. ¶97-98: the change which is expressed as a ratio, e.g. 0.5,0.7, 0.9, is a degree of heart recovery), and
communication circuitry configured to transmit the different resolution diagnostic information and the indication of heart recovery (e.g. ¶¶ 83-84,118,121, Fig. 1,3,5-6: all of the data is transmitted, and the system is capable of transmitting, through communication circuits within the system and to external computers).
Ippolito does not explicitly disclose that the difference in sampling is that it is higher than before the initiated period of time.
However, in the teaching of changing sampling resolution based on the beginning of a treatment, Ippolito inherently teaches two available options. The change must either be higher or lower. Sarkar teaches an analogous IMD system, which increases the sampling frequency to monitor a patient undergoing an intervention (e.g. hospitalization) as compared to a baseline period (e.g. at home) to “aid the evaluation of heart failure treatment” [e.g. abstract, ¶¶ 5-6]. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to incorporate an increase in the sampling frequency during an intervention in a system according to the teachings of Ippolito, as taught by Sarkar, as: a) this would only amount to a selection among limited option that would have been obvious to try, b) this would more accurately track the changes during the intervention to “aid the evaluation of heart failure treatment”, as suggested by Sarkar, and c) in order to conserve power during uneventful everyday monitoring.
Regarding Claim 2, Ippolitio as modified in Claim 1 teaches the system of claim 1, wherein the at least one patient metric comprises temperature (e.g. ¶ 27).
Regarding Claim 4, Ippolitio as modified in Claim 1 teaches the system of claim 1, wherein the processing circuitry is further configured to: generate lower resolution diagnostic information based on at least one of the plurality of patient metrics before the initiated period of time; and switch from generating lower resolution diagnostic information to generating of higher resolution diagnostic information during the initiated period of time in response to receiving an indication the intervention is provided to the patient (e.g. as modified in Claim 1 in view of Sarkar, abstract, ¶5-6: the sampling frequency is changed from low frequency to high frequency between periods of normal monitoring to periods of intervention).
Regarding Claim 5, Ippolitio as modified in Claim 1 teaches the system of claim 4, wherein the processing circuitry is further configured to switch from generating higher resolution diagnostic information during the initiated period of time to generating lower resolution diagnostic information in response to receiving an indication the initiated period of time ends (e.g. as modified in Claim 1 in view of Sarkar, abstract, ¶5-6: the sampling frequency is changed from low frequency to high frequency between periods of normal monitoring to periods of intervention; Ippolito, ¶37: the end of the period of treatment is also set).
Regarding Claims 6-7, Ippolitio as modified in Claim 1 teaches the system of claim 4, wherein the higher resolution diagnostic information is generated at least at a ten times greater sampling rate than the lower resolution diagnostic information is generated (e.g. Shakar, abstract, ¶ 55: once every ten minutes vs. once per day).
Regarding Claim 10, Ippolitio as modified in Claim 1 teaches the system of claim 1, wherein the processing circuitry is further configured to: generate an average of each of the plurality of detected patient metrics detected over a second period of time, the second period of time beginning after the initiated period of time is initiated; compare each of the averages to a respective detected patient metric detected at a beginning of the initiated period of time; and automatically generate the degree of heart recovery based on the comparison (e.g. ¶¶4-5,42-43,91-92,96, Fig. 7-8,12: change is tracked over time after the start of treatment; ¶ 97-98: the change which is expressed as a ratio, e.g. 0.5,0.7, 0.9, is a degree of heart recovery; ¶¶ 24,37,42,51,99: reference to “the parameter” includes multiple of the parameters, “each parameter” being evaluated for improvement or worsening of the patient’s heart in response to the administered treatment).
Regarding Claim 11, Ippolitio as modified in Claim 1 teaches the system of claim 1, wherein the processing circuitry is further configured to: generate a change metric of each of the plurality of detected patient metrics detected over the initiated period of time; compare each of the change metrics to a respective threshold level; and automatically generating a degree of patient metric recovery of each of the plurality of automatically detected patient metrics based on the comparison, wherein the degree of patient metric recovery is indicative of an amount each parameter recovered over the initiated period of time (e.g. ¶¶4-5,42-43,91-92,96, Fig. 7-8,12: change is tracked over time after the start of treatment; ¶ 97-98: the change which is expressed as a ratio, e.g. 0.5,0.7, 0.9, is a degree of heart recovery; ¶¶ 24,37,42,51,99: reference to “the parameter” includes multiple of the parameters, “each parameter” being evaluated for improvement or worsening of the patient’s heart in response to the administered treatment), yet does not explicitly disclose that the change metric is a rate of change. However, Shakar teaches an analogous IMD system, wherein a rate of change of metrics are tracked in order to determine a degree of heart recovery (e.g. ¶ 61). Therefore, it would have been obvious to a person having ordinary skill in the art to incorporate a rate of change metric in the metrics in a system according to the teachings of Ippolito, as taught by Shakar, in order to predictably determine the degree of heart recovery, and this would capture transient changes that may otherwise be overlooked.
Regarding Claim 12, Ippolitio as modified in Claim 11 teaches the system of claim 11, wherein the processing circuitry is further configured to: automatically generate the degree of heart recovery based on the generated degrees of patient metric recovery (e.g. Shakar, ¶157).
Regarding Claim 13, Ippolitio as modified in Claim 1 teaches the system of claim 1, yet does not explicitly disclose wherein the processing circuitry is further configured to generate a treatment recommendation based on the degree of heart recovery. However, Shakar teaches an analogous IMD system, wherein the processing circuitry is further configured to generate a treatment recommendation based on the degree of heart recovery (e.g. ¶ 136: “present the alert to the healthcare professional regarding the risk level or present an instruction to patient 14 to seek medical treatment”). Therefore, it would have been obvious to a person having ordinary skill in the art to incorporate a recommendation to seek medical treatment in a system according to the teachings of Ippolito, as taught by Shakar, in order to predictably inform the user or clinician of a health risk and respective appropriate action.
Regarding Claim 15, Ippolitio as modified in Claim 13 teaches the system of claim 13, wherein the treatment recommendation includes a change in activity recommendation (see discussion in Claim 13, recommendation to seek medical treatment).
Regarding Claim 16, Ippolitio as modified in Claim 1 teaches the system of claim 1, wherein the patient metric comprises night heart rate (e.g. ¶53).
Regarding Claim 17, Ippolitio teaches a method (e.g. title, abstract, ¶¶ 2,24: method to determine efficacy of a treatment) comprising:
obtaining a plurality of detected patient metrics by an implantable medical device of a patient (e.g. abstract, ¶¶ 3,25-27,53, Fig. 1: IMD 10 with multiple sensors measuring multiple metrics, such as heart rate and temperature);
initiating a period of time based on an intervention being provided to the patient [e.g. ¶ 4: “processing circuitry to receive data indicative of a time (e.g., a day, an hour, or a second) in which a treatment program administered to the patient begins”; ¶ 37: “processing circuitry 14 may determine the efficacy of the treatment program by determining a time in which the treatment program is administered (e.g., including a time in which the treatment program begins and/or a time in which the treatment program ends) and analyzing values of any one or combination of the set of parameters relative to the time in which the treatment program is administered”];
causing the implantable medical device to sample at least one of the plurality of patient metrics at a sampling rate that is higher than a sampling rate of the at least one of the plurality of patient metrics before the initiated period of time to generate higher resolution diagnostic information of the patient during the initiated period of time, wherein the higher resolution diagnostic information comprises the at least one of the plurality of patient metrics and is indicative of heart recovery (e.g. ¶90: “the resolution of periodic measurements may change automatically or change manually from daily to hourly or every minute depending on the data measured prior or the interventions that the patient receives”; abstract, ¶¶ 4,37,41,43, 51,105: all of the metrics tracked are tracked to determine heart recovery during administration of a treatment);
generating an average of each of the plurality of detected patient metrics detected over the initiated period of time (e.g. ¶90: “the measured value of the parameter for a period, such as a day, may represent a plurality of values determined during the period, such as being a mean, median, or other statistical representation of values determined the period”; ¶¶24,37,42,51,99,123: reference to “the parameter” includes multiple of the parameters, “each parameter” being evaluated for improvement or worsening of the patient’s heart in response to the administered treatment);
comparing each of the averages to a respective detected patient metric detected at a beginning of the initiated period of time (e.g. ¶¶4-5: “the processing circuitry may arrive at a more accurate determination of whether an improvement or a worsening has occurred in the respective physiological parameter based on the plurality of parameter values measured by the IMD and the time in which the treatment program begins as compared with techniques in which a determination of a patient status is made without an indication of a time in which the treatment program begins… determine, based on the parameter change value, whether an improvement or a worsening of the patient has occurred responsive to a treatment administered beginning at the reference time…”; abstract, ¶42-43,91-92,96, Fig. 7-8,12: change is tracked and includes change from day 0/points 720E/820E;¶¶24,37,42,51,99: reference to “the parameter” includes multiple of the parameters, “each parameter” being evaluated for improvement or worsening of the patient’s heart in response to the administered treatment);
automatically generating a degree of heart recovery based on the comparison, wherein the degree of heart recovery is indicative of an amount the heart recovered over the initiated period of time (e.g. ¶97-98: the change which is expressed as a ratio, e.g. 0.5,0.7, 0.9, is a degree of heart recovery), and
transmitting the generated higher resolution diagnostic information to indicate a degree of recovery for one or more patient metrics indicative of heart recovery (e.g. ¶¶ 83-84,118,121, Fig. 1,3,5-6: all of the data is transmitted through communication circuits within the system and to external computers).
Ippolito does not explicitly disclose that the difference in sampling is that it is higher than before the initiated period of time.
However, in the teaching of changing sampling resolution based on the beginning of a treatment, Ippolito inherently teaches two available options. The change must either be higher or lower. Sarkar teaches an analogous IMD system, which increases the sampling frequency to monitor a patient undergoing an intervention (e.g. hospitalization) as compared to a baseline period (e.g. at home) to “aid the evaluation of heart failure treatment” [e.g. abstract, ¶¶ 5-6]. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to incorporate an increase in the sampling frequency during an intervention in a method according to the teachings of Ippolito, as taught by Sarkar, as: a) this would only amount to a selection among limited option that would have been obvious to try, b) this would more accurately track the changes during the intervention to “aid the evaluation of heart failure treatment”, as suggested by Sarkar, and c) in order to conserve power during uneventful everyday monitoring.
Regarding Claim 18, Ippolitio as modified in Claim 17 teaches the system of claim 17, wherein the at least one patient metric comprises temperature (e.g. ¶ 27).
Regarding Claim 19, Ippolitio as modified in Claim 17 teaches the system of claim 17, further comprising: generating lower resolution diagnostic information based on at least one of the plurality of patient metrics before the initiated period of time; and switching from generating lower resolution diagnostic information to the generating of higher resolution diagnostic information during the initiated period of time in response to receiving an indication the intervention is provided to the patient (e.g. as modified in Claim 1 in view of Sarkar, abstract, ¶5-6: the sampling frequency is changed from low frequency to high frequency between periods of normal monitoring to periods of intervention).
Regarding Claim 20, Ippolitio as modified in Claim 17 teaches the system of claim 17, further comprising: comparing each of the plurality of detected patient metrics detected at an end of the initiated period of time to a respective detected patient metric detected at a beginning of the initiated period of time; and automatically generating the degree of heart recovery based on the comparison (e.g. ¶¶4-5,42-43,91-92,96, Fig. 7-8,12: change is tracked over time after the start of treatment; ¶ 97-98: the change which is expressed as a ratio, e.g. 0.5,0.7, 0.9, is a degree of heart recovery; ¶¶ 24,37,42,51, 99: reference to “the parameter” includes multiple of the parameters, “each parameter” being evaluated for improvement or worsening of the patient’s heart in response to the administered treatment).
Claims 3 and 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Ippolito/Sarkar, as applied to Claims 1 and 4, and further in view of US 2022/0095953 by Wen.
Regarding Claim 3, Ippolitio as modified in Claim 1 teaches the system of Claim 1, yet does not explicitly disclose wherein the higher resolution diagnostic information is sampled with a quantity of sensors by the implantable medical device that is greater than a quantity of sensors of the implantable medical device before the initiated period of time is initiated. However, Wen teaches an analogous health monitoring device, wherein a higher resolution diagnostic information is sampled with a quantity of sensors by the implantable medical device that is greater than a quantity of sensors of the implantable medical device before the increase in resolution (e.g. ¶ 53, 56, 95: increasing the number of sensors during a period of interest). Therefore, it would have been obvious to a person having ordinary skill in the art to incorporate higher resolution by sampling more sensors during the treatment period, than during a non-treatment period, in a system according to the teachings of Ippolito, as taught by Wen, in order to predictably determine the effectiveness of the treatment, and furthermore increase the accuracy of the detection by assessing multiple physiologic parameters indicative of heart recovery, Shakar suggesting that the number of different parameters is taken into account in determining heart recovery in order to reduce false positives (e.g. ¶44,46,49).
Regarding Claim 8, Ippolitio as modified in Claim 1 teaches the system of Claim 4, yet does not explicitly disclose wherein the higher resolution diagnostic information is generated from at least two times more sensors than the lower resolution diagnostic information is generated. However, Wen teaches an analogous health monitoring device, wherein the higher resolution diagnostic information is generated from at least two times more sensors than the lower resolution diagnostic information is generated. (e.g. ¶ 53, 56, 75, 95: at least doubling the number of sensors during a period of interest). Therefore, it would have been obvious to a person having ordinary skill in the art to incorporate higher resolution by sampling at least two times more sensors during the treatment period, than during a non-treatment period, in a system according to the teachings of Ippolito, as taught by Wen, in order to predictably determine the effectiveness of the treatment, and furthermore increase the accuracy of the detection by assessing multiple physiologic parameters indicative of heart recovery, Shakar suggesting that the number of different parameters is taken into account in determining heart recovery in order to reduce false positives (e.g. ¶44,46,49).
Regarding Claim 9, Ippolitio as modified in Claim 8, teaches the system of claim 8, wherein the processing circuitry is further configured to: compare each of the plurality of detected patient metrics detected at an end of the initiated period of time to a respective detected patient metric detected at a beginning of the initiated period of time; and automatically generate the degree of heart recovery based on the comparison (as discussed in Claim 1).
Allowable Subject Matter
Claim 14 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Ippolito does not teach Claim 14, as a whole.
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/MANOLIS PAHAKIS/Examiner, Art Unit 3796
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