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 .
Election/Restrictions
Applicant’s election with traverse of Group I in the reply filed on 06/21/2024 is acknowledged. Due to amendments in which claim 9 depends from claim 1, the restriction is withdrawn.
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.
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Claims 1, 3-6, 8-13 and 15-20 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 5-7, 10 and 12 of U.S. Patent No. 11,497,918 in view of Sanghera et al. (Pub No. US 2016/0144192 A1).
Regarding claims 1 and 16, the patent claims recite a system and method, comprising:
a memory configured to store a plurality sets of stimulation parameters for different postures, each set of stimulation parameters corresponding to a plurality of stored heart rates or heart rate ranges (patent claim 1) with respect to a corresponding stored posture ; and
a stimulation control circuit (patent claim 1) configured to:
receive a detected heart rate (patent claim 1);
select, from the plurality of stored sets of stimulation parameters in the memory, a stimulation parameter in accordance with the detected heart rate (patent claim 1);
control delivery of cardiac stimulation according to the selected stimulation parameter (patent claim 1); and
update at least a portion of the plurality of stored sets of stimulation parameters using an atrioventricular conduction characteristic of the patient (claim 1).
However, claim 1 of the patent does not disclose a plurality sets of stimulation parameters for different postures;
receive a detected posture; and
select, from the plurality of stored sets of stimulation parameters in the memory, a stimulation parameter in accordance with the received posture information of the patient.
Sanghera anticipates the instant claims by disclosing that the atrial template signal can be collected by a…programmer 320…and fed into a controller, the template can be stored within electronic storage of the pulse generator, templates can be obtained that reflect the signal template when the patient is in different postures, has different heart rates (par. [0244]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, to modify the system of the patent claims to include stimulation parameters that are set to posture information and corresponding heart rates as taught by Sanghera in order to adjust proper cardiac capture energy levels according to assessed mechanical movement of the heart (par. [0289]).
Regarding claim 3, the patent claims recite the patent claim recites the stimulation control circuit is configured to receive the posture information from a posture sensor associated with the patient (patent claim 7).
Regarding claims 4 and 18, the patent claim recites the system of claim 1 and the method of claim 16 respectively, wherein the plurality of stored sets of stimulation parameters include stimulation timing parameters including atrioventricular delay values (patent claim 3), or interventricular delay values (patent claim 5).
Regarding claims 5 and 19, the patent claims recite the system of claim 1 and the method of claim 16 respectively, wherein the plurality of stored sets of stimulation parameters include stimulation site parameters including at least one of: an indication of left ventricular-only pacing; an indication of biventricular pacing; an indication of single site left- ventricular pacing; or an indication of multisite left-ventricular pacing (patent claim 12).
Regarding claims 6 and 20, the patent claims recite the system of claim 1 and the method of claim 16 respectively, wherein the plurality of stored sets of stimulation parameters further correspond to stored atrial sensed (AS) events and atrial paced (AP) events, and the stimulation control circuit is configured to select the stimulation parameter further according to a detected AS event or a detected AP event (patent claim 1).
Regarding claim 8, the patent claims recite the system of claim 1, wherein the stimulation control circuit is configured to update at least the portion of the plurality of stored sets of stimulation parameters further using a cardiac or hemodynamic response of the patient to cardiac stimulation (patent claim 10).
Regarding claim 9, the patent claims recite the system of claim 1, wherein the stimulation control circuit is further configured to:
receive time of a day information corresponding to the detected heart rate; and
select, from the plurality of stored sets of stimulation parameters in the memory, the stimulation parameter further in accordance with the received time of the day information (patent claim 6).
The patent claim does not disclose receive time of a day information corresponding to the posture information.
Sanghera discloses the atrial template signal can be collected by a programmer, such as programmer 320 of FIG. 3, and fed into a controller, such as controller 302 of FIG. 3….the template can be stored within electronic storage of the pulse generator, such as electronic storage 308 of FIG. 3…multiple templates can be obtained that reflect the signal template when the patient is in different postures, has different heart rates (par. [0244]); selection of the appropriate template … can be automatically updated based upon factors including…heart rate, posture, time of day (par. [0258]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, to modify the system of the patent claims to include stimulation parameters that are set to posture information and corresponding heart rates as taught by Sanghera in order to adjust proper cardiac capture energy levels according to assessed mechanical movement of the heart (par. [0289]).
Regarding claim 11, the patent claims recite the system of claim 9, wherein the plurality of stored sets of stimulation parameters include stimulation timing parameters including atrioventricular delay values or interventricular delay values (patent claim 5).
Regarding claim 12, the patent claims recite the system of claim 9, wherein the plurality of stored sets of stimulation parameters include stimulation site parameters including at least one of: an indication of left ventricular-only pacing; an indication of biventricular pacing; an indication of single site left- ventricular pacing; or an indication of multisite left-ventricular pacing (patent claim 12).
Regarding claim 13, the patent claims recite the system of claim 9, wherein the plurality of stored sets of stimulation parameters further correspond to stored atrial sensed (AS) events and atrial paced (AP) events, and the stimulation control circuit is configured to select the stimulation parameter further according to a detected AS event or a detected AP event (patent claim 1).
Regarding claim 15, the patent claims recite the system of claim 9, wherein the stimulation control circuit is configured to update at least the portion of the plurality of stored sets of stimulation parameters further using a cardiac or hemodynamic response of the patient to cardiac stimulation (patent claim 10).
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.
Claim(s) 1-4, 7-11 and 14-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sanghera et al. (US 2016/0144192 A1 hereinafter, “Sanghera”) in view of Koh et al. (Pub. No. US 2011/0196440 A1, hereinafter “Koh”).
Regarding claim 1, Sanghera discloses a system, comprising:
a memory (Fig. 3 (308)) configured to store a plurality sets of stimulation parameters for different postures (par. [0013]: The second sensor can be a multi-axis accelerometer configured to monitor a posture of the patient), each set of stimulation parameters corresponding to a plurality of stored heart rates or heart rate ranges (par. [0013]: The first sensor can be an electrode…configured to sense heart rate) with respect to a corresponding stored posture (Fig. 3 and par. [0244]: multiple templates can be obtained that reflect the signal template when the patient is in different postures, has different heart rates…measured, [0257]: the template can be …stored within electronic storage of the pulse generator, such as electronic storage 308, [0285]: factors analyzed in multiple postures and across varying degrees of activity and heartrates); and
a stimulation control circuit (Fig. 3 (302) and par. [0064] Controller electronic storage 308 can store instructions configured to be implemented by the controller to control the functions of pulse generator 102) configured to:
receive a detected heart rate (pars. [0008], [0013]: The first sensor can be an electrode…configured to sense heart rate. The controller can be configured to modify pacing characteristics based on variables including a signal received from the first sensor) and posture information (pars. [0011]: The controller can be configured to modify pacing characteristics based on variables including a signal received from the second sensor) of the patient;
select, from the plurality of stored sets of stimulation parameters in the memory, a stimulation parameter in accordance with the detected heart rate and the received posture information of the patient (par. [0244]: The atrial template signal can be collected by a…programmer 320…and fed into a controller, such as 302…the template can be stored within electronic storage of the pulse generator, such as electronic storage 308…templates can be obtained that reflect the signal template when the patient is in different postures, has different heart rates);
control delivery of cardiac stimulation according to the selected stimulation parameter (par. [0011]: The cardiac pacing system can include a first sensor configured to monitor a characteristic of a patient. The cardiac pacing system can include a second sensor configured to monitor a second characteristic of a patient. The cardiac pacing system… The controller can be configured to cause the pulse generator to deliver the therapeutic electrical pulses according to the determined modified pacing characteristics).
Sanghera does not expressly disclose updating at least a portion of the plurality of stored sets of stimulation parameters using an atrioventricular conduction characteristic of the patient
However, Koh, in the same field of endeavor: adaptively creating a table of optimal AV delays, discloses a stimulation control circuit (Fig. 1 (10)) configured to:
update at least a portion of the plurality of stored sets of stimulation parameters using an atrioventricular conduction characteristic of the patient (par. [0052]: the IMD adaptively performs tests at different AV delays as the patient reaches each target heart rate in the table. The IMD selects the best of the tested AV delays…This selected optimal AV delay is then stored in the AV delay table associated with the particular target heart rate…an optimal AV delay is selected for each of the target heart rates within the patient's range…the IMD will perform updates of the optimal delays) to provide the benefit of a customized operation of the stimulation device to suit the needs of a particular patient (par. [0043]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, to modify the cardiac pacing system that stimulates with parameters from a stored posture and heart rate of Sanghera to include stimulation parameters based on AV delay as taught by Koh in order to customize the operation of the stimulation device to suit the needs of a particular patient.
Regarding claim 2, the Sanghera and Koh combination discloses the system of claim 1, wherein the plurality of stored sets of stimulation parameters include at least one of a first set of stimulation parameters for a supine posture, a second set of stimulation parameters for a sitting posture, or a third set of stimulation parameters for a standing posture (Sanghera, pars. [0224]: detected events…algorithm can monitor include signal amplitude, heart rate, posture, pace/sense modes… the manner in which signals travel through the body can change if the patient's posture changes from supine to standing, [0244]: the template can be stored within electronic storage of the pulse generator, such as electronic storage 308 of FIG. 3…multiple templates can be obtained that reflect the signal template when the patient is in different postures, has different heart rates, for different sense vectors, and other like parameters; templates obtained reflect different postures; postures noted are supine and standing).
Regarding claim 3, the Sanghera and Koh combination discloses the system of claim 1, wherein the stimulation control circuit is configured to receive the posture information from a posture sensor associated with the patient (Sanghera, Fig. 3 (322) and par. [0304] A multi-axis accelerometer, or other posture sensor, can be used by the cardiac pacing system to analyze the patient's position).
Regarding claim 4, Sanghera discloses the system of claim 1, except wherein the plurality of stored sets of stimulation parameters include stimulation timing parameters including atrioventricular delay values or interventricular delay values.
Koh discloses the plurality of stored sets of stimulation parameters include stimulation timing parameters including atrioventricular delay values (par. [0051]: a table is defined that stores the optimal AV delay associated with each particular target heart rate within the range) to provide the benefit of a customized operation of the stimulation device to suit the needs of a particular patient (par. [0043]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, to modify the stored set of stimulation parameters of Sanghera to include AV delay timing parameters as taught by Koh in order to customize the operation of the stimulation device to suit the needs of a particular patient.
Regarding claim 7, Sanghera discloses the system of claim 1, wherein the stimulation control circuit (Fig. 3 (302)) is configured to store in memory (Fig. 3 (308)) a stimulation parameter that includes the plurality of stored sets of stimulation parameters respectively determined for the different postures and corresponding to the plurality of stored heart rates or heart rate ranges (Fig. 3 and par. [0244]: multiple templates can be obtained that reflect the signal template when the patient is in different postures, has different heart rates…measured, [0257]: the template can be …stored within electronic storage of the pulse generator, such as electronic storage 308).
Sanghera does not disclose the stimulation control circuit is configured to store in the memory a stimulation parameter table.
Koh discloses the stimulation control circuit (Fig. 2A (60)) is configured to store in the memory a stimulation parameter table (Fig. 2A (123)) that includes the plurality of stored sets of stimulation parameters (par. [0043]: The programmable operating parameters used by the microcontroller 60 are stored and modified…The memory 94 includes software modules, such as the AV optimization feature module 124 and the optimal AV delay table 123, which, when executed or used by the microcontroller 60, provide the operational functions of the implantable stimulation device 10) for the purpose of customizing the operation of the stimulation device 10 to suit the needs of a particular patient (par. [0043]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, to modify the cardiac pacing system that stimulates with parameters from a stored posture and heart rate of Sanghera to have the parameters stored in a table as taught by Koh in order to customize the operation of the stimulation device to suit the needs of a particular patient.
Regarding claim 8, Sanghera discloses the system of claim 1 except wherein the stimulation control circuit is configured to update at least the portion of the plurality of stored sets of stimulation parameters further using a cardiac or hemodynamic response of the patient to cardiac stimulation.
Koh discloses the stimulation control circuit is configured to update at least the portion of the plurality of stored sets of stimulation parameters further using a cardiac or hemodynamic response of the patient to cardiac stimulation (par. [0052]: In order to fill this table with the optimal AV delays, the IMD adaptively performs tests at different AV delays as the patient reaches each target heart rate in the table. The IMD selects the best of the tested AV delays based on a measurement of cardiac output during each of the tested AV delays. This selected optimal AV delay is then stored in the AV delay table associated with the particular target heart rate) to provide the benefit of maintaining an accurate set of delays for a patient, whose heart function may be deteriorating or improving (par. [0052).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, to modify the cardiac pacing system that stimulates with parameters from a stored posture and heart rate of Sanghera to have the parameters stored in a table as taught by Koh in order to maintain an accurate set of delays for a patient, whose heart function may be deteriorating or improving.
Regarding claim 9, the Sanghera and Koh combination discloses the system of claim 1, wherein the stimulation control circuit is further configured to:
receive time of a day information corresponding to the detected heart rate and the posture information; and
select, from the plurality of stored sets of stimulation parameters in the memory (Sanghera, Fig. 3 (308)), the stimulation parameter further in accordance with the received time of the day information (Sanghera, Fig. 3 (308) and par. [0244]: The atrial template signal can be collected by a programmer, such as programmer 320 of FIG. 3, and fed into a controller, such as controller 302 of FIG. 3….the template can be stored within electronic storage of the pulse generator, such as electronic storage 308 of FIG. 3…multiple templates can be obtained that reflect the signal template when the patient is in different postures, has different heart rates, [0258]: Furthermore, the selection of the appropriate template for comparison can be automatically updated based upon factors including pacing mode, heart rate, posture, time of day).
Regarding claim 10, the Sanghera and Koh combination discloses the system of claim 9, wherein the plurality of stored sets of stimulation parameters include at least one of a first set of stimulation parameters for daytime of the day, a second set of stimulation parameters for nighttime of the day, or a third set of stimulation parameters for a pre-determined time period in the day (Sanghera, pars. [0258]: the selection of the appropriate template for comparison can be automatically updated based upon factors including…heart rate, posture, time of day…several measured …templates can be stored by the cardiac pacing system and used for the morphology detection algorithms where [0294]: algorithm can operate…in a periodic fashion, such as once per hour, day, week, or the like).
Regarding claim 11, Sanghera discloses the system of claim 9, except wherein the plurality of stored sets of stimulation parameters include stimulation timing parameters including atrioventricular delay values.
Koh discloses the plurality of stored sets of stimulation parameters include stimulation timing parameters including atrioventricular delay values (Fig. 10 and par. [0073]: The optimal AV delay table 123 maintains a target heart rate list 1000 that includes each of the heart rates that fall within the target rate boundary generated for the individual patient. As the AV delay optimization process unfolds, the AV optimization feature stores selected optimal AV delay rates in an optimal AV delay list 1001. The optimal AV delay table 123 is configured as a relational data structure in which the AV delay stored in the optimal AV delay list 1001 corresponds to a particular heart rate in the target heart rate list 1000) to provide the benefit of a customized operation of the stimulation device to suit the needs of a particular patient (par. [0043]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, to modify the cardiac pacing system that stimulates with parameters from a stored posture and heart rate of Sanghera to include stimulation timing parameters AV delay values as taught by Koh in order to customize the operation of the stimulation device to suit the needs of a particular patient.
Regarding claim 14, Sanghera discloses the system of claim 9, wherein the stimulation control circuit (Fig. 3 (302)) is configured to store in the memory (Fig. 3 (308)) a stimulation parameter that includes the plurality of stored sets of stimulation parameters respectively determined for the different times of the day and corresponding to the plurality of stored heart rates or heart rate ranges (Sanghera, Fig. 3 (308) and par. [0244]: The atrial template signal can be collected by a programmer, such as programmer 320 of FIG. 3, and fed into a controller, such as controller 302 of FIG. 3….the template can be stored within electronic storage of the pulse generator, such as electronic storage 308 of FIG. 3…multiple templates can be obtained that reflect the signal template when the patient is in different postures, has different heart rates, [0258]: Furthermore, the selection of the appropriate template for comparison can be automatically updated based upon factors including pacing mode, heart rate, posture, time of day).
Sanghera does not disclose the stimulation control circuit is configured to store in the memory a stimulation parameter table that includes the plurality of stored sets of stimulation parameters.
Koh discloses the stimulation control circuit (Fig. 2A (60)) is configured to store in the memory a stimulation parameter table (Koh, Fig. 10 (1000) and Abstract and para. [0043]: The memory 94 includes… the optimal AV delay table 123, …executed or used by the microcontroller 60) to provide the benefit of optimal patient-specific operational functions to the stimulation device (par. [0050]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, to modify the cardiac pacing system that stimulates with parameters from a stored for different times of day and corresponding heart rates of Sanghera to have the parameters stored in a table as taught by Koh in order to optimize patient-specific operational functions to the stimulation device.
Regarding claim 15, Sanghera discloses the system of claim 9 except wherein the stimulation control circuit is configured to update at least the portion of the plurality of stored sets of stimulation parameters further using a cardiac or hemodynamic response of the patient to cardiac stimulation.
Koh discloses the stimulation control circuit is configured to update at least the portion of the plurality of stored sets of stimulation parameters further using a cardiac or hemodynamic response of the patient to cardiac stimulation (par. [0052]: In order to fill this table with the optimal AV delays, the IMD adaptively performs tests at different AV delays as the patient reaches each target heart rate in the table. The IMD selects the best of the tested AV delays based on a measurement of cardiac output during each of the tested AV delays. This selected optimal AV delay is then stored in the AV delay table associated with the particular target heart rate) to provide the benefit of maintaining an accurate set of delays for a patient, whose heart function may be deteriorating or improving (par. [0052).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, to modify the cardiac pacing system that stimulates with parameters from a stored posture and heart rate of S to have the parameters stored in a table as taught by Koh in order to maintain an accurate set of delays for a patient, whose heart function may be deteriorating or improving.
Regarding claim 16, Sanghera discloses a system, comprising:
storing in a memory (Fig. 3 (308)) a plurality sets of stimulation parameters for different postures (par. [0013]: The second sensor can be a multi-axis accelerometer configured to monitor a posture of the patient), each set of stimulation parameters corresponding to a plurality of stored heart rates or heart rate ranges (par. [0013]: The first sensor can be an electrode…configured to sense heart rate) with respect to a corresponding stored posture (Fig. 3 and par. [0244]: multiple templates can be obtained that reflect the signal template when the patient is in different postures, has different heart rates…measured, [0257]: the template can be …stored within electronic storage of the pulse generator, such as electronic storage 308); and
receiving a detected heart rate (pars. [0008], [0013]: The first sensor can be an electrode…configured to sense heart rate. The controller can be configured to modify pacing characteristics based on variables including a signal received from the first sensor) and posture information (pars. [0011]: The controller can be configured to modify pacing characteristics based on variables including a signal received from the second sensor where [0013]: The second sensor can be a multi-axis accelerometer configured to monitor a posture of the patient. The controller can be configured to modify pacing characteristics in a manner proportional to a change in posture.) of the patient;
selecting, from the plurality of stored sets of stimulation parameters in the memory, a stimulation parameter in accordance with the detected heart rate and the received posture information of the patient (par. [0244]: The atrial template signal can be collected by a…programmer 320…and fed into a controller, such as 302…the template can be stored within electronic storage of the pulse generator, such as electronic storage 308…templates can be obtained that reflect the signal template when the patient is in different postures, has different heart rates) using a stimulation control circuit (Fig. 3 (302) and par. [0064] Controller electronic storage 308 can store instructions configured to be implemented by the controller to control the functions of pulse generator 102);
control delivery of cardiac stimulation according to the selected stimulation parameter (par. [0011]: The cardiac pacing system can include a first sensor configured to monitor a characteristic of a patient. The cardiac pacing system can include a second sensor configured to monitor a second characteristic of a patient. The cardiac pacing system… The controller can be configured to cause the pulse generator to deliver the therapeutic electrical pulses according to the determined modified pacing characteristics).
Sanghera does not expressly disclose updating at least a portion of the plurality of stored sets of stimulation parameters using an atrioventricular conduction characteristic of the patient.
However, Koh, in the same field of endeavor: adaptively creating a table of optimal AV delays, discloses a stimulation control circuit (Fig. 1 (10)) configured to:
updating at least a portion of the plurality of stored sets of stimulation parameters using an atrioventricular conduction characteristic of the patient (par. [0052]: the IMD adaptively performs tests at different AV delays as the patient reaches each target heart rate in the table. The IMD selects the best of the tested AV delays…This selected optimal AV delay is then stored in the AV delay table associated with the particular target heart rate…an optimal AV delay is selected for each of the target heart rates within the patient's range…the IMD will perform updates of the optimal delays) to provide the benefit of a customized operation of the stimulation device to suit the needs of a particular patient (par. [0043]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, to modify the cardiac pacing system that stimulates with parameters from a stored posture and heart rate of S to include stimulation parameters based on AV delay as taught by Koh in order to customize the operation of the stimulation device to suit the needs of a particular patient.
Regarding claim 17, the Sanghera and Koh combination discloses the system of claim 16, wherein the plurality of stored sets of stimulation parameters include at least one of a first set of stimulation parameters for a supine posture, a second set of stimulation parameters for a sitting posture, or a third set of stimulation parameters for a standing posture (Sanghera, pars. [0224]: detected events…algorithm can monitor include signal amplitude, heart rate, posture, pace/sense modes… the manner in which signals travel through the body can change if the patient's posture changes from supine to standing, [0244]: the template can be stored within electronic storage of the pulse generator, such as electronic storage 308 of FIG. 3…multiple templates can be obtained that reflect the signal template when the patient is in different postures, has different heart rates, for different sense vectors, and other like parameters; templates obtained reflect different postures; postures noted are supine and standing).
Regarding claim 18, Sanghera discloses the method of claim 16, except wherein the plurality of stored sets of stimulation parameters include stimulation timing parameters including atrioventricular delay values or interventricular delay values.
Koh discloses the plurality of stored sets of stimulation parameters include stimulation timing parameters including atrioventricular delay values (Fig. 10 and par. [0073]: The optimal AV delay table 123 maintains a target heart rate list 1000 that includes each of the heart rates that fall within the target rate boundary generated for the individual patient. As the AV delay optimization process unfolds, the AV optimization feature stores selected optimal AV delay rates in an optimal AV delay list 1001. The optimal AV delay table 123 is configured as a relational data structure in which the AV delay stored in the optimal AV delay list 1001 corresponds to a particular heart rate in the target heart rate list 1000) to provide the benefit of a customized operation of the stimulation device to suit the needs of a particular patient (par. [0043]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, to modify the cardiac pacing system that stimulates with parameters from a stored posture and heart rate of S to include stimulation timing parameters AV delay values as taught by Koh in order to customize the operation of the stimulation device to suit the needs of a particular patient.
Claim(s) 5, 12 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sanghera et al. (US 2016/0144192 A1 hereinafter, “Sanghera”) in view of Koh et al. (Pub. No. US 2011/0196440 A1, hereinafter “Koh”) as applied to claims 1-4, 7-11 and 14-18 above, and further in view of Zhang et al. (US 2013/0268017 A1 hereinafter, “Zhang”).
Regarding claim 5, the Sanghera and Koh combination discloses the system of claim 1, except wherein the plurality of stored sets of stimulation parameters include stimulation site parameters including at least one of: an indication of left ventricular-only pacing; an indication of biventricular pacing; an indication of single site left- ventricular pacing
However, Zhang in the same field of endeavor: adaptive cardiac resynchronization therapy timing parameter optimization, discloses the plurality of stored sets of stimulation parameters include stimulation site parameters including at least one of: an indication of left ventricular-only pacing; an indication of biventricular pacing; an indication of single site left- ventricular pacing (Figs. 5-7 and pars. [0014], [0015], [0020]: pacing pulses are selectively delivered in both the right and left ventricle (biventricular pacing) or only in the left ventricle (LV-only pacing or single ventricle pacing), A system and associated method for controlling CRT therapy delivery parameters… during both biventricular and LV-only pacing modes, [0040]: the CRT control parameter being optimized is…an AV delay for use during LV-only pacing and an AV delay and a VV delay for use during biventricular pacing.…The parameter selected at block 204 may depend in part on the status of AV conduction and the biventricular or LV pacing mode selected at the time the process is being performed) to provide the benefit of patient-specific optimized CRT control parameters without requiring hemodynamic measurements every time the control parameter is adjusted (par. [0015]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, to modify the stored set of stimulation parameters of Sanghera and Koh to include biventricular or LV-only pacing indications as taught by Zhang in order to provide the benefit of patient-specific optimized CRT control parameters without requiring hemodynamic measurements every time the control parameter is adjusted.
Regarding claim 12, the Sanghera and Koh combination discloses the system of claim 9, except wherein the plurality of stored sets of stimulation parameters include stimulation site parameters including at least one of:
an indication of left ventricular-only pacing; an indication of biventricular pacing; or an indication of single site left- ventricular pacing (Figs. 5-7 and pars. [0014], [0015], [0020]: pacing pulses are selectively delivered in both the right and left ventricle (biventricular pacing) or only in the left ventricle (LV-only pacing or single ventricle pacing), A system and associated method for controlling CRT therapy delivery parameters… during both biventricular and LV-only pacing modes, [0040]: the CRT control parameter being optimized is…an AV delay for use during LV-only pacing and an AV delay and a VV delay for use during biventricular pacing.…The parameter selected at block 204 may depend in part on the status of AV conduction and the biventricular or LV pacing mode selected at the time the process is being performed) to provide the benefit of patient-specific optimized CRT control parameters without requiring hemodynamic measurements every time the control parameter is adjusted (par. [0015]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, to modify the stored set of stimulation parameters of Sanghera and Koh to include biventricular or LV-only pacing indications as taught by Zhang in order to provide the benefit of patient-specific optimized CRT control parameters without requiring hemodynamic measurements every time the control parameter is adjusted.
Regarding claim 19, the Sanghera and Koh combination discloses the method of claim 16, except wherein the plurality of stored sets of stimulation parameters include stimulation site parameters including at least one of: an indication of left ventricular-only pacing; an indication of biventricular pacing; an indication of single site left- ventricular pacing.
However, Zhang in the same field of endeavor: adaptive cardiac resynchronization therapy timing parameter optimization, discloses the plurality of stored sets of stimulation parameters include stimulation site parameters including at least one of: an indication of left ventricular-only pacing; an indication of biventricular pacing; an indication of single site left- ventricular pacing (Figs. 5-7 and pars. [0014], [0015], [0020]: pacing pulses are selectively delivered in both the right and left ventricle (biventricular pacing) or only in the left ventricle (LV-only pacing or single ventricle pacing), A system and associated method for controlling CRT therapy delivery parameters… during both biventricular and LV-only pacing modes, [0040]: the CRT control parameter being optimized is…an AV delay for use during LV-only pacing and an AV delay and a VV delay for use during biventricular pacing.…The parameter selected at block 204 may depend in part on the status of AV conduction and the biventricular or LV pacing mode selected at the time the process is being performed) to provide the benefit of patient-specific optimized CRT control parameters without requiring hemodynamic measurements every time the control parameter is adjusted (par. [0015]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, to modify the stored set of stimulation parameters of Sanghera and Koh to include biventricular or LV-only pacing indications as taught by Zhang in order to provide the benefit of patient-specific optimized CRT control parameters without requiring hemodynamic measurements every time the control parameter is adjusted.
Conclusion
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