larityDETAILED 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 Amendment
The amendment filed December 29, 2025 has been entered. Claims 1-18 and 21-22 remain pending in the application. Claims 19-20 have been cancelled. Applicant’s amendments to the specification and claims have overcome the objections previously set forth in the Non-Final Office Action mailed October 01, 2025.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-6 and 13-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhang et al. (US 2015/0157260).
Regarding claim 1, Zhang discloses a system (medical device system 300) for adjusting a therapy delivered to a patient (“the system 300 includes a therapy circuit 350 to control delivery of drug therapy to the HF subject.” [0033]), the system comprising:
a physiological event detector circuit (sensing circuit 310 and processor 315) configured to:
generate a composite signal metric (via parameter module 320) using a plurality of physiological signals sensed from the patient (“the processor 315 can include a parameter module 320 and a trending module 325. The parameter module 320 extracts values of at least one physiological parameter indicative of health status of the HF subject using the sensed physiological signal.” [0020]); and
trend the composite signal metric over time to create a trended composite signal metric (via trending module 325; “The trending module 325 trends extracted values of the physiological parameter and detects an effect of the dosing of the medication on the HF subject using the trending of the extracted values of the at least one physiological parameter.” [0020]); and
a therapy control circuit (therapy circuit 350) configured to adjust a therapy parameter in response to the trended composite signal metric satisfying a predetermined trend condition (“The trending module detects the side effect when detecting that the integral of values of the physiological parameter exceeds a specified threshold integral value of the physiological parameter…the system 300 includes a therapy circuit 350 to control delivery of drug therapy to the HF subject. The processor 315 may initiate at least one of delivery of drug therapy or a change in a parameter of the drug therapy in response to detection of the effect of the dosing of the medication on the HF subject.” [0032-0033]).
Regarding claim 2, Zhang discloses the system of claim 1, wherein the therapy delivered to the patient includes an electrostimulation therapy, wherein to adjust the therapy parameter includes to adjust an electrostimulation parameter in response to the trended composite signal metric satisfying the predetermined trend condition (“the system 300 includes a therapy circuit 350 to control delivery of drug therapy to the HF subject…the therapy circuit 350 provides electrical cardiac therapy to the HF subject. The processor 315 initiates at least one of the electrical cardiac therapy or a change in a parameter of the electrical cardiac therapy in response to detection of a side effect of the dosing of the medication on the HF subject.” [0033]).
Regarding claim 3, Zhang discloses the system of claim 1, wherein the therapy delivered to the patient includes a drug therapy, wherein to adjust the therapy parameter includes to adjust a drug dosage in response to the trended composite signal metric satisfying the predetermined trend condition (“In some examples, the system 300 includes a therapy circuit 350 to control delivery of drug therapy to the HF subject. The processor 315 may initiate at least one of delivery of drug therapy or a change in a parameter of the drug therapy in response to detection of the effect of the dosing of the medication on the HF subject.” [0033]).
Regarding claim 4, Zhang discloses the system of claim 1, wherein the physiological event detector circuit is configured to detect a worsening heart failure (WHF) event using the trended composite signal metric (“Worsening of HF of the subject can be detected by sensing one or both of sensing thoracic impedance (e.g., to monitor congestion and hyperinflation breathing patterns due to COPD) and the amplitude of the S3 heart sound (e.g., to monitor elevated filling pressure due to HF).” [0039]), wherein the therapy control circuit is configured to adjust the therapy parameter further in response to the detection of the WHF event (“The trending module 325 may trend values of the heart sound parameter to detect a side effect of the dosing, such as an increase in the amplitude of the S1 that may indicate higher contractility, or an increase in amplitude of the S3 heart sound that may indicate fluid retention.” [0030]; “the system 300 includes a therapy circuit 350 to control delivery of drug therapy to the HF subject. The processor 315 may initiate at least one of delivery of drug therapy or a change in a parameter of the drug therapy in response to detection of the effect of the dosing of the medication on the HF subject. In some examples, the therapy circuit 350 provides electrical cardiac therapy to the HF subject. The processor 315 initiates at least one of the electrical cardiac therapy or a change in a parameter of the electrical cardiac therapy in response to detection of a side effect of the dosing of the medication on the HF subject.” [0033]).
Regarding claim 5, Zhang discloses the system of claim 1, wherein the therapy control circuit is configured to generate a therapy titration protocol including values of the therapy parameter varied over time relative to a target therapy parameter value (“it may be desirable to use a relatively low dosage of medication for the HF patient that is still effective to treat the pulmonary condition with minimal adverse side effects. Device-based monitoring of the respiratory and cardiac function of a patient with HF may be useful in determining the effective dosage of medication for the patient.” [0012]; “the system 300 includes a therapy circuit 350 to control delivery of drug therapy to the HF subject. The processor 315 may initiate at least one of delivery of drug therapy or a change in a parameter of the drug therapy in response to detection of the effect of the dosing of the medication on the HF subject. In some examples, the therapy circuit 350 provides electrical cardiac therapy to the HF subject. The processor 315 initiates at least one of the electrical cardiac therapy or a change in a parameter of the electrical cardiac therapy in response to detection of a side effect of the dosing of the medication on the HF subject.” [0033]).
Regarding claim 6, Zhang discloses the system of claim 5, wherein the values of the therapy parameter are varied in accordance with the trended composite signal metric (“The trending module 325 may trend values of the heart sound parameter to detect a side effect of the dosing, such as an increase in the amplitude of the S1 that may indicate higher contractility, or an increase in amplitude of the S3 heart sound that may indicate fluid retention.” [0030]; “the system 300 includes a therapy circuit 350 to control delivery of drug therapy to the HF subject. The processor 315 may initiate at least one of delivery of drug therapy or a change in a parameter of the drug therapy in response to detection of the effect of the dosing of the medication on the HF subject. In some examples, the therapy circuit 350 provides electrical cardiac therapy to the HF subject. The processor 315 initiates at least one of the electrical cardiac therapy or a change in a parameter of the electrical cardiac therapy in response to detection of a side effect of the dosing of the medication on the HF subject.” [0033]).
Regarding claim 13, Zhang discloses a method (method 100 using medical device system 300) for adjusting a therapy delivered to a patient (“method 100 of operating a medical device to monitor effects of dosing of a heart failure (HF) patient or subject.” [0013];“the system 300 includes a therapy circuit 350 to control delivery of drug therapy to the HF subject.” [0033]), the method comprising:
receiving a plurality of physiological signals (via sensing circuit 310) sensed from a patient (“The system includes at least one sensing circuit 310 and at least one processor 315. The sensing circuit 310 senses at least one physiological signal that includes physiological information of the HF subject.” [0019]);
generating a composite signal metric (via parameter module 320) of the received plurality of physiological signals using a physiological event detector circuit (processor 315 having sensing circuit 310; “the processor 315 can include a parameter module 320 and a trending module 325. The parameter module 320 extracts values of at least one physiological parameter indicative of health status of the HF subject using the sensed physiological signal.” [0020]));
trending the composite signal metric over time to create a trended composite signal metric using the physiological event detector circuit (via trending module 325 of processor 315; “The trending module 325 trends extracted values of the physiological parameter and detects an effect of the dosing of the medication on the HF subject using the trending of the extracted values of the at least one physiological parameter.” [0020]); and
adjusting a therapy parameter in response to the trended composite signal metric satisfying a predetermined trend condition (“The trending module detects the side effect when detecting that the integral of values of the physiological parameter exceeds a specified threshold integral value of the physiological parameter…the system 300 includes a therapy circuit 350 to control delivery of drug therapy to the HF subject. The processor 315 may initiate at least one of delivery of drug therapy or a change in a parameter of the drug therapy in response to detection of the effect of the dosing of the medication on the HF subject.” [0032-0033]).
Regarding claim 14, Zhang discloses the method of claim 13, wherein the therapy delivered to the patient includes an electrostimulation therapy, wherein adjusting the therapy parameter includes adjusting an electrostimulation parameter in response to the trended composite signal metric satisfying the predetermined trend condition (“the system 300 includes a therapy circuit 350 to control delivery of drug therapy to the HF subject…the therapy circuit 350 provides electrical cardiac therapy to the HF subject. The processor 315 initiates at least one of the electrical cardiac therapy or a change in a parameter of the electrical cardiac therapy in response to detection of a side effect of the dosing of the medication on the HF subject.” [0033]).
Regarding claim 15, Zhang discloses the method of claim 13, wherein the therapy delivered to the patient includes a drug therapy, wherein adjusting the therapy parameter includes adjusting a drug dosage in response to the trended composite signal metric satisfying the predetermined trend condition (“In some examples, the system 300 includes a therapy circuit 350 to control delivery of drug therapy to the HF subject. The processor 315 may initiate at least one of delivery of drug therapy or a change in a parameter of the drug therapy in response to detection of the effect of the dosing of the medication on the HF subject.” [0033]).
Regarding claim 16, Zhang discloses the method of claim 13, comprising generating a therapy titration protocol including values of the therapy parameter varied over time relative to a target therapy parameter value (“it may be desirable to use a relatively low dosage of medication for the HF patient that is still effective to treat the pulmonary condition with minimal adverse side effects. Device-based monitoring of the respiratory and cardiac function of a patient with HF may be useful in determining the effective dosage of medication for the patient.” [0012]; “the system 300 includes a therapy circuit 350 to control delivery of drug therapy to the HF subject. The processor 315 may initiate at least one of delivery of drug therapy or a change in a parameter of the drug therapy in response to detection of the effect of the dosing of the medication on the HF subject. In some examples, the therapy circuit 350 provides electrical cardiac therapy to the HF subject. The processor 315 initiates at least one of the electrical cardiac therapy or a change in a parameter of the electrical cardiac therapy in response to detection of a side effect of the dosing of the medication on the HF subject.” [0033]).
Regarding claim 17, Zhang discloses the method of claim 16, wherein the values of the therapy parameter are varied in accordance with the trended composite signal metric (“The trending module 325 may trend values of the heart sound parameter to detect a side effect of the dosing, such as an increase in the amplitude of the S1 that may indicate higher contractility, or an increase in amplitude of the S3 heart sound that may indicate fluid retention.” [0030]; “the system 300 includes a therapy circuit 350 to control delivery of drug therapy to the HF subject. The processor 315 may initiate at least one of delivery of drug therapy or a change in a parameter of the drug therapy in response to detection of the effect of the dosing of the medication on the HF subject. In some examples, the therapy circuit 350 provides electrical cardiac therapy to the HF subject. The processor 315 initiates at least one of the electrical cardiac therapy or a change in a parameter of the electrical cardiac therapy in response to detection of a side effect of the dosing of the medication on the HF subject.” [0033]).
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 7-10 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. (US 20150157260) in view of Schmitz et al. (US 20150032053).
Regarding claim 7, Zhang discloses the system of claim 6.
Zhang fails to explicitly disclose the therapy titration protocol includes a stepwise change in the values of the therapy parameter in accordance with the trended composite signal metric.
Schmitz teaches a system for adjusting a therapy delivered to a patient (Figure 1; “Referring now to FIGS. 2-6, some examples of methods for carrying out titration schemes” [0057]), the system comprising generating a therapy titration protocol including values of a therapy parameter varied over time relative to a target therapy parameter value, wherein the therapy titration protocol includes a stepwise change in the values of the therapy parameter in accordance with a composite signal metric (step-wise dose escalation scheme 20A; Figure 1; see all of [0051-0052]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the therapy titration protocol of Zhang to include a stepwise change in the values of the therapy parameter in accordance with the trended composite signal metric based on the teachings of Schmitz to allow for fine tuning of the titration to determine the ideal effective dose of the patient while limiting side effects (Schmitz [0052]).
Regarding claim 8, Zhang discloses the system of claim 5.
Zhang fails to explicitly disclose the target therapy parameter includes a baseline electrostimulation parameter value for an electrostimulation therapy, or a baseline drug dosage for a drug therapy.
Schmitz teaches a system for adjusting a therapy delivered to a patient (Figure 3) including a target therapy parameter including a baseline drug dosage for a drug therapy a (initial rate 100; “an infusion device may be configured to deliver a liquid composition at an initial rate (100), which corresponds to an initial dose of the medicament.” [0057]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the target therapy parameter of the system of Zhang to include a baseline drug dosage for a drug therapy based on the teaching of Schmitz to maximize the effectiveness of the dosage while limiting side effects for the patient (Schmitz [0003], [0058]).
Regarding claim 9, Zhang discloses the system of claim 5.
Zhang fails to explicitly disclose wherein the therapy control circuit is further configured to, when the values of the therapy parameter are above the target therapy parameter value for a predetermined time period, increase the target therapy parameter value to a level corresponding to a lowest therapy parameter value during the predetermined time period.
Schmitz teaches a system for adjusting a therapy delivered to a patient (Figure 3), wherein a therapy control circuit ([0068]) is configured to, when the values of the therapy parameter are above a target therapy value (initial rate 100, see initial rate on graph in Figure 1) for a predetermined time period (“At predetermined points in time the dose is escalated by a predetermined amount; the dose is held constant for a predetermined period of time before the next escalation; and so on.” [0050]), increase the target therapy parameter value to a level corresponding to a lowest therapy parameter value during the predetermined time period (“a time at which a patient may experience a side effect is depicted by the arrow with the * above the arrow in FIG. 1. Once input is received by an infusion device that the patient is experiencing a side effect, the dose is decreased. By way of example, the dose may be decreased to the immediately preceding dose at which the patient did not experience the side effect (indicated by arrow with "A" over the arrow) or may be decreased to the dose two time periods prior to the dose at which the side effect occurred (indicated by the arrow with the "B" over the arrow)” [0051]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the system of Zhang to include the therapy control circuit is further configured to, when the values of the therapy parameter are above the target therapy parameter value for a predetermined time period, increase the target therapy parameter value to a level corresponding to a lowest therapy parameter value during the predetermined time period based on the teaching of Schmitz to maximize the effectiveness of the dosage while limiting side effects for the patient (Schmitz [0003], [0058]).
Regarding claim 10, Zhang discloses the system of claim 5.
Zhang fails to explicitly disclose the therapy control circuit is further configured to: evaluate a patient response to a therapy delivered over a monitoring time period in accordance with a lower therapy parameter value than the target therapy parameter value; and change the target therapy parameter value to the lower therapy parameter value if the patient response indicates no worsening of the physiological condition during the monitoring time period.
Schmitz teaches a system for adjusting a therapy delivered to a patient (Figure 3), the system comprising a therapy control circuit ([0068]) configured to: evaluate a patient response to a therapy delivered over a monitoring time period in accordance with a lower therapy parameter value (“If the infusion device received input indicative of a patient side effect, the infusion device may deliver the composition comprising the medicament at a predetermined rate decreased relative to the rate at which the side effect occurred (160).” [0058]) than a target therapy parameter value (“As further shown in FIG. 3, it may also be desirable to continue to monitor side effects even after the dosage has been decreased to a dose that previously did not result in a side effect. That is, a determination may be made as to whether the infusion device has received input indicative of a patient side effect (120'') after the pump has decreased the rate of medicament delivery (160).” [0058]); and change the target therapy parameter value to the lower therapy parameter value if the patient response indicates no worsening of the physiological condition during the monitoring time period (“If no indication is received regarding a patient side effect at the decreased rate, the pump may continue to deliver at the decreased rate (160).” [0058]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the therapy control circuit of Zhang to be configured to evaluate a patient response to a therapy delivered over a monitoring time period in accordance with a lower therapy parameter value than the target therapy parameter value; and change the target therapy parameter value to the lower therapy parameter value if the patient response indicates no worsening of the physiological condition during the monitoring time period based on the teaching of Schmitz to maximize the effectiveness of the dosage while limiting side effects for the patient (Schmitz [0003], [0058]).
Regarding claim 18, Zhang discloses the method of claim 16.
Zhang fails to explicitly disclose wherein the values of the therapy parameter are above the target therapy parameter value for a predetermined time period, increasing the target therapy parameter value to a level corresponding to a lowest therapy parameter value during the predetermined time period.
Schmitz teaches a method for adjusting a therapy dosage in a patient (Figure 3), comprising when the values of a therapy parameter are above a target therapy parameter value (initial rate 100, see initial rate on graph in Figure 1) for a predetermined time period (“At predetermined points in time the dose is escalated by a predetermined amount; the dose is held constant for a predetermined period of time before the next escalation; and so on.” [0050]), increase the target therapy parameter value to a level corresponding to a lowest therapy parameter value during the predetermined time period (“a time at which a patient may experience a side effect is depicted by the arrow with the * above the arrow in FIG. 1. Once input is received by an infusion device that the patient is experiencing a side effect, the dose is decreased. By way of example, the dose may be decreased to the immediately preceding dose at which the patient did not experience the side effect (indicated by arrow with "A" over the arrow) or may be decreased to the dose two time periods prior to the dose at which the side effect occurred (indicated by the arrow with the "B" over the arrow)” [0051]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the method of Zhang to when the values of the therapy parameter are above the target therapy parameter value for a predetermined time period, increase the target therapy parameter value to a level corresponding to a lowest therapy parameter value during the predetermined time period based on the teaching of Schmitz to maximize the effectiveness of the dosage while limiting side effects for the patient (Schmitz [0003], [0058]).
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. (US 20150157260) in view of An et al. (US 20150351660).
Regarding claim 11, Zhang discloses the system of claim 1, wherein to adjust the therapy parameter, the therapy control circuit is configured to: maintain or decrease the electrostimulation energy or the drug dosage in response to the trended composite signal metric indicating a decreasing trend (“The trending module 325 trends values of the respiration parameter and generates an indication of effectiveness of the dosing of the medication using the trend of values of the respiration parameter. For example, the trending module 325 may generate an indication that the treatment is effective when the respiration rate of the HF subject decreases to satisfy a specified (e.g., programmed) respiration rate threshold.” [0023]; “Therefore in some situations it may be desirable to use a relatively low dosage of medication for the HF patient that is still effective to treat the pulmonary condition with minimal adverse side effects.” [0012]).
Zhang fails to explicitly disclose wherein to adjust the therapy parameter, the therapy control circuit is configured to: increase an electrostimulation energy or a drug dosage in response to the trended composite signal metric indicating an increasing trend.
An discloses a system for adjusting a therapy delivered to a patient ([0046]), the system comprising a therapy control circuit (controller circuit 415) configured to increase a drug dosage in response to a trended composite signal metric indicating an increasing trend (“The risk circuit 525 generates a recommended change in titration of medication according to the quantified risk of WHF…A change in a medication regimen may be recommended to reduce lung fluid (as indicated by absolute thoracic impedance), such as by up-titration of dose diuretics to lower fluid and increase impedance away from the risk detection threshold impedance.” [0046]; “The trend circuit 430 may generate a respiratory rate trend (RRT), such as a trend of at least one of a daily respiratory rate maximum value, minimum value, or median value, for example. The risk circuit 425 quantifies the risk of WHF using the deter measure of absolute thoracic impedance and the generated respiratory rate trend. By combining RRT and absolute thoracic impedance (Z), a very small group of patients with extremely high risk of WHF can be identified (e.g., a group defined as RRT≧22 breaths per minute and Z≦30 ohms).” [0040]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the therapy control circuit of the system of Zhang to be configured to increase an electrostimulation energy or a drug dosage in response to the trended composite signal metric indicating an increasing trend based on the teachings of An to more accurately assess the risk of a patient having worsening heart failure within a specified period of time and treating the patient to lower that risk (An [0025], [0046]).
Regarding claim 12, Zhang discloses the system of claim 1, wherein to adjust the therapy parameter, the therapy control circuit is configured to: maintain or decrease the electrostimulation energy or the drug dosage in response to the trended composite signal metric falling below a composite signal metric threshold value (“The trending module 325 trends values of the respiration parameter and generates an indication of effectiveness of the dosing of the medication using the trend of values of the respiration parameter. For example, the trending module 325 may generate an indication that the treatment is effective when the respiration rate of the HF subject decreases to satisfy a specified (e.g., programmed) respiration rate threshold.” [0023]; “Therefore in some situations it may be desirable to use a relatively low dosage of medication for the HF patient that is still effective to treat the pulmonary condition with minimal adverse side effects.” [0012]).
Zhang fails to explicitly disclose wherein to adjust the therapy parameter, the therapy control circuit is configured to: increase an electrostimulation energy or a drug dosage in response to the trended composite signal metric exceeding a composite signal metric threshold value.
An discloses a system for adjusting a therapy delivered to a patient ([0046]), the system comprising a therapy control circuit (controller circuit 415) configured to increase a drug dosage in response to a trended composite signal metric exceeding a composite signal metric threshold value (“The risk circuit 525 generates a recommended change in titration of medication according to the quantified risk of WHF…A change in a medication regimen may be recommended to reduce lung fluid (as indicated by absolute thoracic impedance), such as by up-titration of dose diuretics to lower fluid and increase impedance away from the risk detection threshold impedance.” [0046]; “The trend circuit 430 may generate a respiratory rate trend (RRT), such as a trend of at least one of a daily respiratory rate maximum value, minimum value, or median value, for example. The risk circuit 425 quantifies the risk of WHF using the deter measure of absolute thoracic impedance and the generated respiratory rate trend. By combining RRT and absolute thoracic impedance (Z), a very small group of patients with extremely high risk of WHF can be identified (e.g., a group defined as RRT≧22 breaths per minute and Z≦30 ohms).” [0040]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the therapy control circuit of the system of Zhang to be configured to increase an electrostimulation energy or a drug dosage in response to the trended composite signal metric exceeding a composite signal metric threshold value based on the teachings of An to more accurately assess the risk of a patient having worsening heart failure within a specified period of time and treating the patient to lower that risk (An [0025], [0046]).
Claims 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. (US 20150157260), hereinafter Zhang 2015, in view of Zhang et al. (US 20140236026), hereinafter Zhang 2014.
Regarding claim 21, Zhang 2015 discloses the system of claim 1.
Zhang 2015 fails to explicitly disclose wherein to generate the composite signal metric, the physiological event detector circuit is configured to combine at least two physiological signal metrics into a unified metric value, the at least two physiologic signal metrics including at least two of thoracic impedance, a heart sound intensity, a heart sound signal energy, a respiration rate, a tidal volume, or a cardiac timing interval.
Zhang 2014 discloses a system (CRM system 100) for adjusting a therapy delivered to a patient (“the ambulatory or implantable medical devices can be configured to sense electrical activity and mechanical function of the heart, and to optionally deliver therapy such as electrical stimulation pulses to a target area, such as to restore or improve the cardiac function.” [0005]), the system comprising: a physiological event detector circuit (signal sensing circuit 202) configured to: generate a composite signal metric using a plurality of physiological signals sensed from the patient, the physiological event detector circuit is configured to combine at least two physiological signal metrics into a unified metric value, the at least two physiologic signal metrics including at least two of thoracic impedance, a heart sound intensity, a heart sound signal energy, a respiration rate, a tidal volume, or a cardiac timing interval (“The sensing circuit 202 can be configured to sense a physiological signal, such as can be indicative of HF decompensation status. Examples of such a physiological signal can include…intrathoracic impedance… one or more heart sounds, one or more respiration signals such as a respiration rate signal or a tidal volume signal…the signal sensing circuit can sense two or more physiological signals and can generate a composite signal parameter set such as using the two or more physiological signals.” [0035]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the system of Zhang 2015 to include wherein to generate the composite signal metric, the physiological event detector circuit is configured to combine at least two physiological signal metrics into a unified metric value, the at least two physiologic signal metrics including at least two of thoracic impedance, a heart sound intensity, a heart sound signal energy, a respiration rate, a tidal volume, or a cardiac timing interval based on the teachings of Zhang 2014 to accurately detect heart failure decompensation to preventing worsening heart failure (Zhang 2014 [0035], [0006]).
Regarding claim 22, Zhang 2015 discloses the system of claim 1.
Zhang 2015 fails to explicitly disclose wherein the physiologic event detector circuit is configured to generate the composite signal metric as a function of at least two physiological signal metrics, the at least two physiologic signal metrics including at least two of thoracic impedance, a heart sound intensity, a heart sound signal energy, a respiration rate, a tidal volume, or a cardiac timing interval.
Zhang 2014 discloses a system (CRM system 100) for adjusting a therapy delivered to a patient (“the ambulatory or implantable medical devices can be configured to sense electrical activity and mechanical function of the heart, and to optionally deliver therapy such as electrical stimulation pulses to a target area, such as to restore or improve the cardiac function.” [0005]), the system comprising: a physiological event detector circuit (signal sensing circuit 202) configured to: generate a composite signal metric using a plurality of physiological signals sensed from the patient, wherein the physiologic event detector circuit is configured to generate the composite signal metric as a function of at least two physiological signal metrics, the at least two physiologic signal metrics including at least two of thoracic impedance, a heart sound intensity, a heart sound signal energy, a respiration rate, a tidal volume, or a cardiac timing interval (“The sensing circuit 202 can be configured to sense a physiological signal, such as can be indicative of HF decompensation status. Examples of such a physiological signal can include…intrathoracic impedance… one or more heart sounds, one or more respiration signals such as a respiration rate signal or a tidal volume signal…the signal sensing circuit can sense two or more physiological signals and can generate a composite signal parameter set such as using the two or more physiological signals.” [0035]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the system of Zhang 2015 to include the physiologic event detector circuit is configured to generate the composite signal metric as a function of at least two physiological signal metrics, the at least two physiologic signal metrics including at least two of thoracic impedance, a heart sound intensity, a heart sound signal energy, a respiration rate, a tidal volume, or a cardiac timing interval based on the teachings of Zhang 2014 to accurately detect heart failure decompensation to preventing worsening heart failure (Zhang 2014 [0035], [0006]).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 3-6, 9-12, and 21-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-5, 7-8, and 10-12 of U.S. Patent No. 11534107. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1, 3-5, 7-8, and 10-12 of USPN 11534107 disclose all of the limitations of claims 1, 3-6, 9-12, and 21-22 (see Table below); and therefore claims 1, 3-6, 9-12, and 21-22 are anticipated by claims 1, 3-5, 7-8, and 10-12 of USPN 11534107.
Claim 2 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11534107 in view of Zhang et al. (US 2015/0157260). Claim 1 of USPN 11534107 discloses all of the limitations of claim 2, except for the therapy delivered to the patient includes an electrostimulation therapy, wherein to adjust the therapy parameter includes to adjust an electrostimulation parameter in response to the trended composite signal metric satisfying the predetermined trend condition. As detailed above, Zhang discloses a system (300) comprising: a therapy control circuit (350) configured to adjust a therapy parameter in response to the trended composite signal metric satisfying a predetermined trend condition ([0032-0033]), wherein the therapy delivered to the patient includes an electrostimulation therapy, wherein to adjust the therapy parameter includes to adjust an electrostimulation parameter in response to the trended composite signal metric satisfying the predetermined trend condition (“the system 300 includes a therapy circuit 350 to control delivery of drug therapy to the HF subject…the therapy circuit 350 provides electrical cardiac therapy to the HF subject. The processor 315 initiates at least one of the electrical cardiac therapy or a change in a parameter of the electrical cardiac therapy in response to detection of a side effect of the dosing of the medication on the HF subject.” [0033]). Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the system of USPN 11534107 to include that the therapy delivered includes an electrostimulation therapy based on the teachings of Zhang to provide electoral cortical therapy for a heart failure patient (Zhang [0033]).
Claims 7 and 8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11534107 in view of Schmitz et al. (US 20150032053).
Regarding claim 7, Claim 1 of USPN 11534107 discloses all of the limitations of claim 7, except for the therapy titration protocol includes a stepwise change in the values of the therapy parameter in accordance with the trended composite signal metric. Schmitz teaches a system for adjusting a therapy delivered to a patient (Figure 1; [0057]), comprising generating a therapy titration protocol including values of a therapy parameter varied over time relative to a target therapy parameter value, wherein the therapy titration protocol includes a stepwise change in the values of the therapy parameter in accordance with a composite signal metric (step-wise dose escalation scheme 20A; Figure 1; see all of [0051-0052]). Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the therapy titration protocol of USPN 11534107 to include a stepwise change in the values of the therapy parameter in accordance with the trended composite signal metric based on the teachings of Schmitz to allow for fine tuning of the titration to determine the ideal effective dose of the patient while limiting side effects (Schmitz [0052]).
Regarding claim 8, Claim 1 of USPN 11534107 discloses all of the limitations of claim 8, except for the target therapy parameter includes a baseline electrostimulation parameter value for an electrostimulation therapy, or a baseline drug dosage for a drug therapy. Schmitz teaches a system for adjusting a therapy delivered to a patient (Figure 3) including a target therapy parameter including a baseline drug dosage for a drug therapy a (initial rate 100; [0057]). Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the target therapy parameter of the system of USPN 11534107 to include a baseline drug dosage for a drug therapy based on the teaching of Schmitz to maximize the effectiveness of the dosage while limiting side effects for the patient (Schmitz [0003], [0058]).
Present Claims
USPN 11534107
1
1
2
1 in view of Zhang
3
1 and 3-4
4
1 and 3-4
5
1
6
1
7
1 in view of Schmitz
8
1 in view of Schmitz
9
7
10
8
11
1 and 5
12
1 and 5
21
1 and 10-12
22
1 and 10-12
Response to Arguments
Applicant's arguments filed December 29, 2025 have been fully considered but they are not persuasive.
Regarding the argument that Zhang does not disclose “a physiological event detector circuit configured to: generate a composite signal metric using a plurality of physiological signals sensed from the patient; and trend the composite signal metric over time to create a trended composite signal metric” as required by claim 1 and similarly recited by claim 13 (Remarks, page 7), the examiner respectfully disagrees. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “generating a composite metric from multiple parameters” (Remarks Page 7) and “algorithmically combining these parameters” (Remarks Page 8)) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Independent claim 1 as currently presented states “generate a composite signal metric using a plurality of physiological signals sensed from the patient”. This limitation does not require that the “plurality of physiological signals” are signals representative of different types physiological signals (such as stated in dependent claims 21 and 22). The claim language additionally does not require any specific way or algorithm by which the “plurality of physiological signals” are used to generate a “composite signal metric”. As detailed above, Zhang discloses a physiological event detector circuit (310 and 315) configured to: generate a composite signal metric using a plurality of physiological signals sensed from the patient (“The parameter module 320 extracts values of at least one physiological parameter indicative of health status of the HF subject using the sensed physiological signal.” [0020]); and trend the composite signal metric over time to create a trended composite signal metric (“The trending module 325 trends extracted values of the physiological parameter and detects an effect of the dosing of the medication on the HF subject using the trending of the extracted values of the at least one physiological parameter.” [0020]). The parameter module 310 uses a plurality of values from of at least one physiological parameter, therefore can be considered to generate a composite signal metric from a plurality of physiological signals. This signal is then used by the trending module 325 to create a trended composite signal metric, as detailed in [0020].
Regarding the argument that Zhang fails to teach “adjust a therapy parameter in response to the trended composite signal metric satisfying a predetermined trend condition” (Remarks, page 8), the examiner respectfully disagrees. As detailed above, Zhang discloses a therapy control circuit (350) configured to adjust a therapy parameter in response to the trended composite signal metric satisfying a predetermined trend condition (“The trending module detects the side effect when detecting that the integral of values of the physiological parameter exceeds a specified threshold integral value of the physiological parameter…the system 300 includes a therapy circuit 350 to control delivery of drug therapy to the HF subject. The processor 315 may initiate at least one of delivery of drug therapy or a change in a parameter of the drug therapy in response to detection of the effect of the dosing of the medication on the HF subject.” [0032-0033]). The features upon which applicant relies (i.e., “the therapy control circuit may "dynamically up-titrate or down-titrate the therapy dosage in accordance with the growth trend or a decay trend of the signal metric or the composite signal metric."” (Remarks, page 8) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Regarding the argument that Zhang does not disclose “the values of the therapy parameter are varied in accordance with the trended composite signal metric” as required by claim 6 and similarly recited in claim 17 (Remarks Page 8), the examiner respectfully disagrees. As detailed above, Zhang discloses the values of the therapy parameter are varied in accordance with the trended composite signal metric (“The trending module 325 may trend values of the heart sound parameter to detect a side effect of the dosing, such as an increase in the amplitude of the S1 that may indicate higher contractility, or an increase in amplitude of the S3 heart sound that may indicate fluid retention.” [0030]; “the system 300 includes a therapy circuit 350 to control delivery of drug therapy to the HF subject. The processor 315 may initiate at least one of delivery of drug therapy or a change in a parameter of the drug therapy in response to detection of the effect of the dosing of the medication on the HF subject.” [0033]). The language of claim 6 as currently presented does not specify how or by what algorithm the values of the therapy parameter of varied in accordance with the trended composite signal.
The features upon which applicant relies (i.e., “therapy variation…that is proportionally related to or tracks the composite metric trend as required by said claims…Applicant's claims provide graduated, trend-responsive therapy adjustments where therapy changes track the trend pattern itself, as illustrated in FIGS. 4A-B and described at [0089]-[0090].” (Remarks, page 8) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Regarding the argument that Zhang in view of Schmitz fails to render obvious “the therapy titration protocol includes a stepwise change in the values of the therapy parameter in accordance with the trended composite signal metric” as required by claim 7 (Remarks, page 9), the examiner respectfully disagrees. Schmitz teaches a system for adjusting a therapy delivered to a patient (Figure 1; [0057]) comprising generating a therapy titration protocol including values of a therapy parameter varied over time relative to a target therapy parameter value, wherein the therapy titration protocol includes a stepwise change in the values of the therapy parameter in accordance with a composite signal metric (step-wise dose escalation scheme 20A; Figure 1; see all of [0051-0052]). As detailed in [0050-0052], Schmitz discloses that the stepwise titration occurs when a time period has elapsed (“At predetermined points in time the dose is escalated by a predetermined amount; the dose is held constant for a predetermined period of time before the next escalation; and so on.” [0050]), unless the system receives input regarding a patient side effect in which case there is a stepwise change based on the received signal (“For purposes of illustration, a time at which a patient may experience a side effect is depicted by the arrow with the * above the arrow in FIG. 1. Once input is received by an infusion device that the patient is experiencing a side effect, the dose is decreased…The amount by which the dose is decreased may be based on the severity of the side effect, the medical judgment or experience of a health care provider regarding the particular patient, or the like.” [0051]). This is illustrated in Figure 1, and is additionally described throughout the specification. For example, “If the infusion device received input indicative of a patient side effect, the infusion device may deliver the composition comprising the medicament at a predetermined rate decreased relative to the rate at which the side effect occurred (160).” [0057]. Based on this disclosure of Schmitz, it is maintained that it would have been obvious to one having ordinary skill in the art to modify the therapy titration protocol of Zhang to include a stepwise change in the values of the therapy parameter in accordance with the trended composite signal metric based on the teachings of Schmitz to allow for fine tuning of the titration to determine the ideal effective dose of the patient while limiting side effects (Schmitz [0052]).
Regarding the argument that Zhang in view of An fails to render obvious the limitations of claims 11 and 12 (Remarks, page 10), the examiner respectfully disagrees. Specifically, applicant argues that “neither teaches nor does the combination result in the proportional dynamic therapy adjustment based on composite signal metric trends as required by claims 11 and 12.”. However, the features upon which applicant relies (i.e., “proportional dynamic therapy adjustment” (Remarks, page 10) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). As detailed above with respect to the rejections of claims 11 and 12, Zhang discloses a therapy control circuit is configured to: maintain or decrease the electrostimulation energy or the drug dosage in response to the trended composite signal metric indicating a decreasing trend or falling below a composite signal metric threshold value ([0023]; [0012]). An discloses a therapy control circuit (415) configured to increase a drug dosage in response to a trended composite signal metric indicating an increasing trend or exceeding a composite signal metric threshold value ([0046]; [0040]). It is maintained that it would have been obvious to one having ordinary skill in the art to modify the therapy control circuit of the system of Zhang to be configured to increase an electrostimulation energy or a drug dosage in response to the trended composite signal metric indicating an increasing trend or exceeding a composite signal metric threshold value based on the teachings of An to more accurately assess the risk of a patient having worsening heart failure within a specified period of time and treating the patient to lower that risk (An [0025], [0046]).
Regarding the argument that Zhang in view of Schmitz fails to render obvious the limitations of claims 9 and similarly recited claim 18 (Remarks, page 10), the examiner respectfully disagrees. As detailed above with respect to the rejections of claims 9 and 18, Schmitz teaches a therapy control circuit ([0068]) configured to, when the values of the therapy parameter are above a target therapy value (initial rate 100, see initial rate on graph in Figure 1) for a predetermined time period ([0050]), increase the target therapy parameter value to a level corresponding to a lowest therapy parameter value during the predetermined time period ([0051]). As described about with respect to the arguments of claim 7, Schmitz discloses a time-based titration, unless a signal indicative of a side effect is received. The “target therapy parameter value” of Schmitz is considered to be the initial delivery rate 100 as shown in Figure 1. The therapy parameter increases at predetermined time periods, up until the side effect signal is received, at time “*” as described in [0051]. At that point, the “target therapy parameter” or the baseline delivery rate increases from the initial rate to either the rate at point A or point B and stepwise titration can continue, as described in [0051-0050] and shown in Figure 1. Therefore, it is maintained that it would have been obvious to one having ordinary skill in the art to modify the system of Zhang to include the therapy control circuit is further configured to, when the values of the therapy parameter are above the target therapy parameter value for a predetermined time period, increase the target therapy parameter value to a level corresponding to a lowest therapy parameter value during the predetermined time period based on the teaching of Schmitz to maximize the effectiveness of the dosage while limiting side effects for the patient (Schmitz [0003], [0058]).
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 LEAH J SWANSON whose telephone number is (571)270-0394. The examiner can normally be reached M-F 9 AM- 5 PM ET.
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, Kevin Sirmons can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LEAH J SWANSON/Examiner, Art Unit 3783
/LOAN B JIMENEZ/Supervisory Patent Examiner, Art Unit 3784