DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-4, 6-20 are rejected under 35 U.S.C. 103 as being unpatentable by Gelfand(US 10207110 B1) in view of Sommer(US 20130006332 A1).
Regarding claim 1, Gelfand discloses a therapeutic system, comprising: an implantable pulse generator configured to generate a current; a plurality of electrodes configured to apply the current to one or more splanchnic nerves of a patient(The pulse generator 178 for electrical nerve stimulation in an embodiment is implantable and programmable. Programmable pulse generators can employ conventional microprocessors and other standard electrical components(Detailed description, paragraph 35). In the context of this disclosure the GSN can mean right or left greater splanchnic nerve and electrical block and stimulation can be performed via an implanted nerve cuff electrode(s) or a bilateral treatment can be performed from nerve cuff electrodes implanted to access both right and left greater splanchnic nerves(Detailed Description, paragraph 9)), wherein each of the plurality of electrodes comprises at least one of an anode or a cathode; a processor(In this example, the high frequency block therapy is delivered via electrodes 3, 4, and 5 in a tripolar configuration with electrode 4 acting as a cathode(Detailed description, paragraph 29). In addition, although the reference electrode is located remotely, there is always a virtual anode 134 at each end of the cuff because the current always flows into the nerve at the cuff ends(Detailed description, paragraph 13). In a further embodiment, said device may be configured to receive signals from sensors including fluid or blood pressure (BP) sensor and adjust accordingly to modulate and deliver modified therapy, as needed or desired.(Detailed Description, paragraph 50)); and a memory storing data for processing by the processor, the data, when processed, causes the processor to: receive first sensor information describing subcutaneous nerve activity of the patient; and adjust one or more parameters of the implantable pulse generator based on the subcutaneous nerve activity(The case further includes a connector (not shown, e.g., a header or a connector block, made of polyurethane or other suitable material), having a plurality of terminals shown schematically with the names of the leads to which they are connected shown next to the terminals, including: a nerve lead terminal 216, a cardiac lead terminal 217, and a physiological sensor terminal 218 for physiological sensors(Detailed Description, paragraph 38)(Fig. 16). The operating parameters of the implantable device may be non-invasively programmed into the memory 225 through a telemetry circuit 226 in telemetric communication via a communication link with the external device, such as a clinician programmer or a patient interface 227(Detailed Description, Paragraph 44)). Gelfand fails to discloses “receiving second sensor information describing physical activity of the patient different from the subcutaneous nerve activity”.
However, Sommer teaches “Therapy system 10 may also include at least one sensor 17 in addition to or instead of sense electrodes and sensors on the leads 14, 16. Sensor 17 may be configured to detect an activity level, motion, posture, intracardiac, intravascular or other pressure within the patient, or another physiological parameter of patient 18. For example, sensor 17 may comprise an accelerometer. Sensor 17 may generate a signal that varies as a function of at least one physiological parameter of patient 18[0040]”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the splanchnic nerve modulation device of Gelfand with the multiple sensors of the therapeutic stimulation of Sommer. Doing so would clearly state multiple sensors in the system to sense different physiological parameters to obtain a comprehensive view of the patient during stimulation.
Regarding claim 2, Gelfand in view of Sommer teaches the system of claim 1, but Gelfand fails to disclose wherein the second sensor information further comprises signals indicating patient activity including consumption of food at different times of day.
However, Sommer teaches “ The accelerator may be an external sensor 17 placed on the stomach of patient 18. Alternatively, the accelerator may be implanted within patient 18, e.g., implanted on lead body 132 of lead 130. Movement of lead body 132 may indicate phrenic nerve stimulation. As another example, processor 40 may receive feedback from a user via user interface 44 indicating the occurrence of a hiccup[0106]”. An accelerometer placed on the stomach will movements occurring in the stomach as well as hiccups, both of which signify digestion(food consumption). Therefore, it is an obvious assumption that the sensor of Sommer can signify when food has been consumed.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the splanchnic nerve modulation device of Gelfand with the multiple sensors of the therapeutic stimulation of Sommer. Doing so would clearly state multiple sensors in the system to sense different physiological parameters to obtain a comprehensive view of the patient during stimulation.
Regarding claim 3, Gelfand in view of Sommer teaches the system of claim 2, wherein first and second sensor information is received from one or more sensors provided on or implanted in the patient that comprise at least one of a wearable sensor, an implantable sensor, and an environmental sensor, and wherein the sensor information is received via a wireless communication signal from the one or more sensors(Communication between the device and external devices (clinician programmer, patient interface, sensors, etc.) may also be performed wirelessly using RF communication protocols(Detailed Description, paragraph 45)). Gelfand fails to explicitly state a first and second sensor.
However, Sommer teaches “Therapy system 10 may also include at least one sensor 17 in addition to or instead of sense electrodes and sensors on the leads 14, 16. Sensor 17 may be configured to detect an activity level, motion, posture, intracardiac, intravascular or other pressure within the patient, or another physiological parameter of patient 18. For example, sensor 17 may comprise an accelerometer. Sensor 17 may generate a signal that varies as a function of at least one physiological parameter of patient 18[0040]. Wireless communication in programmer 19, IMD 12 and sensors 17 may be accomplished by radio frequency (RF) communication or proximal inductive interaction of between such devices[0057]”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the splanchnic nerve modulation device of Gelfand with the multiple sensors of the therapeutic stimulation of Sommer. Doing so would clearly state multiple sensors in the system to sense different physiological parameters to obtain a comprehensive view of the patient during stimulation.
Regarding claim 4, Gelfand in view of Sommer teaches the system of claim 1, wherein the one or more parameters of the implantable pulse generator comprise at least one of frequency, peak current, duty cycle, and application duration(and at least one lead for delivering stimulus to the at least one greater splanchnic nerve through the tripolar nerve cuff, wherein the delivered stimulus has a frequency of at least 6 kHz and an amplitude of at least 10 mA to cause a reversible blockage to conduction along the at least one greater splanchnic nerve(claim 1). The pulse generator 178 for electrical nerve stimulation in an embodiment is implantable and programmable. Programmable pulse generators can employ conventional microprocessors and other standard electrical components. The pulse generators envisioned for use in the present embodiments are able to generate charge balanced, biphasic pulses. The biphasic pulse is repeated continuously to produce the blocking stimulus waveform(Detailed Description, paragraph 35)).
Regarding claim 6, Gelfand in view of Sommer teaches the system of claim 1, further comprising: a user interface that allows at least one of the patient and a clinician to provide inputs to describe an aspect of the subcutaneous nerve activity(In a further embodiment, it is envisioned that the device and IPG can both receive and transmit signals. For example, it is envisioned that signals could be transmitted from the device to an external programmer or display. Likewise, it is envisioned in a further embodiment that patient or clinician input could be received by the device to modulate the generated pulse, as needed(Detailed Description, paragraph 46). Once blocking therapy is initiated 236, the effectiveness of the block may be determined (see FIGS. 12A and 12B). If block is not effective, parameters will be changed until successful blocking is confirmed. Once the blocking is confirmed, physiological sensors will be monitored to determine therapy effectiveness 234(Detailed Description, paragraph 68)).
Regarding claim 7, Gelfand in view of Sommer teaches the system of claim 1, wherein the one or more splanchnic nerves comprises at least one of a greater splanchnic nerve, a lesser splanchnic nerve, and a least splanchnic nerve(The method of claim 1, wherein the at least one greater splanchnic nerve is at least one of a left greater splanchnic nerve and a right greater splanchnic nerve(claim 2)).
Regarding claim 8, Gelfand in view of Sommer teaches the system of claim 1, wherein the one or more parameters of the implantable pulse generator are adjusted to increase a nerve blocking applied at the one or more splanchnic nerves(After therapy is initiated 240, blocking effectiveness is assessed 241. If blocking is not successful, high frequency blocking parameters will be adjusted until blocking is successful(Detailed Description, Paragraph 51). In the context of this disclosure, modulation describes not only stimulation to increase nerve activity, but also, more notably, stimulation to create a nerve block(Summary of the Disclosure, paragraph 19)).
Regarding claim 9, Gelfand in view of Sommer teaches the system of claim 1, wherein the one or more parameters of the implantable pulse generator are adjusted to decrease a nerve blocking applied at the one or more splanchnic nerves(Conversely, as illustrated by FIG. 4, decreased sympathetic nervous system activity or a splanchnic bed normalized with GSN blocking 120 may result in the compliance of the splanchnic bed, which may be relaxed or normalized from the “stiff” or contracted state(Detailed Description, paragraph 11)).
Regarding claim 10, Gelfand in view of Sommer teaches the system of claim 1, wherein the one or more parameters of the implantable pulse generator are adjusted to increase a nerve stimulation applied at the one or more splanchnic nerves(After therapy is initiated 240, blocking effectiveness is assessed 241. If blocking is not successful, high frequency blocking parameters will be adjusted until blocking is successful(Detailed Description, Paragraph 51). In the context of this disclosure, modulation describes not only stimulation to increase nerve activity, but also, more notably, stimulation to create a nerve block(Summary of the Disclosure, paragraph 19)).
Regarding claim 11, Gelfand in view of Sommer teaches the system of claim 1, wherein the one or more parameters of the implantable pulse generator are adjusted to decrease a nerve stimulation applied at the one or more splanchnic nerves(Conversely, as illustrated by FIG. 4, decreased sympathetic nervous system activity or a splanchnic bed normalized with GSN blocking 120 may result in the compliance of the splanchnic bed, which may be relaxed or normalized from the “stiff” or contracted state(Detailed Description, paragraph 11)).
Regarding claim 12, Gelfand in view of Sommer teaches the system of claim 1, wherein the sensor information is received from at least one of the plurality of electrodes(The case 215 may further be used as a return electrode alone, or in combination with, one or more electrodes for stimulating or blocking purposes. The case may also be used as one of the sensors in determination of lead impedance, for example.(Detailed Description, paragraph 37)).
Regarding claim 13, Gelfand discloses a control subsystem for use in a therapeutic system, the control subsystem comprising: a processor; and a memory storing data for processing by the processor, the data, when processed, causes the processor to: receive sensor information describing subcutaneous nerve activity of a patient; and determine an electrical signal applied by an implantable pulse generator to a splanchnic nerve of the patient is to be adjusted based on the subcutaneous nerve activity; and transmit a control signal to the implantable pulse generator thereby causing the implantable pulse generator to adjust the electrical signal applied to the splanchnic nerve(The pulse generator 178 for electrical nerve stimulation in an embodiment is implantable and programmable. Programmable pulse generators can employ conventional microprocessors and other standard electrical components(Detailed description, paragraph 35). In the context of this disclosure the GSN can mean right or left greater splanchnic nerve and electrical block and stimulation can be performed via an implanted nerve cuff electrode(s) or a bilateral treatment can be performed from nerve cuff electrodes implanted to access both right and left greater splanchnic nerves(Detailed Description, paragraph 9). In another exemplary embodiment, a nerve cuff 195 has 5 active electrodes (FIG. 12B). In this example, the high frequency block therapy is delivered via electrodes 3, 4, and 5 in a tripolar configuration with electrode 4 acting as a cathode(Detailed description, paragraph 29). In addition, although the reference electrode is located remotely, there is always a virtual anode 134 at each end of the cuff because the current always flows into the nerve at the cuff ends(Detailed description, paragraph 13). In a further embodiment, said device may be configured to receive signals from sensors including fluid or blood pressure (BP) sensor and adjust accordingly to modulate and deliver modified therapy, as needed or desired.(Detailed Description, paragraph 50). The case further includes a connector (not shown, e.g., a header or a connector block, made of polyurethane or other suitable material), having a plurality of terminals shown schematically with the names of the leads to which they are connected shown next to the terminals, including: a nerve lead terminal 216, a cardiac lead terminal 217, and a physiological sensor terminal 218 for physiological sensors(Detailed Description, paragraph 38)(Fig. 16). The operating parameters of the implantable device may be non-invasively programmed into the memory 225 through a telemetry circuit 226 in telemetric communication via a communication link with the external device, such as a clinician programmer or a patient interface 227(Detailed Description, Paragraph 44)). Gelfand fails to discloses “receiving second sensor information describing physical activity of the patient different from the subcutaneous nerve activity”.
However, Sommer teaches “Therapy system 10 may also include at least one sensor 17 in addition to or instead of sense electrodes and sensors on the leads 14, 16. Sensor 17 may be configured to detect an activity level, motion, posture, intracardiac, intravascular or other pressure within the patient, or another physiological parameter of patient 18. For example, sensor 17 may comprise an accelerometer. Sensor 17 may generate a signal that varies as a function of at least one physiological parameter of patient 18[0040]”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the splanchnic nerve modulation device of Gelfand with the multiple sensors of the therapeutic stimulation of Sommer. Doing so would clearly state multiple sensors in the system to sense different physiological parameters to obtain a comprehensive view of the patient during stimulation.
Regarding claim 14, Gelfand in view of Sommer teaches the system of claim 13, wherein the electrical signal comprises at least one of a blocking signal that provides a nerve block and a stimulation signal that provides a nerve stimulation to the splanchnic nerve(In the context of this disclosure, modulation describes not only stimulation to increase nerve activity, but also, more notably, stimulation to create a nerve block. Conduction of the blocking signal can be performed by a number of preferred embodiments, as described in the examples, including single, multiple, or multipole cuff electrodes that can be spiral or other cuff configurations(Summary of the Disclosure, paragraph 19)).
Regarding claim 15, Gelfand in view of Sommer teaches the system of claim 14, wherein the splanchnic nerve comprises at least one of a greater splanchnic nerve, a lesser splanchnic nerve, and a least splanchnic nerve(The method of claim 1, wherein the at least one greater splanchnic nerve is at least one of a left greater splanchnic nerve and a right greater splanchnic nerve(claim 2)).
Regarding claim 16, Gelfand in view of Sommer teaches the system of claim 13, wherein the first and second sensor information is received from one or more sensors provided on or implanted in the patient(Once the blocking is confirmed, physiological sensors will be monitored to determine therapy effectiveness 234. The signal conditioning and DAQ 230 modules in the IPG (FIG. 16) will be used to acquire the physiological signal 238 used to determine therapy effectiveness (Physiological Sensor Module, FIG. 16). High frequency block parameters may be adjusted based on detection from physiological sensors(Detailed Description, paragraph 48)).
Regarding claim 17, Gelfand in view of Sommer teaches the system of claim 13, wherein one or more parameters of the electrical signal are adjusted and wherein the one or more parameters include at least one of frequency, peak current, duty cycle, and application duration(and at least one lead for delivering stimulus to the at least one greater splanchnic nerve through the tripolar nerve cuff, wherein the delivered stimulus has a frequency of at least 6 kHz and an amplitude of at least 10 mA to cause a reversible blockage to conduction along the at least one greater splanchnic nerve(claim 1)).
Regarding claim 18, Gelfand discloses a method, comprising: determining a first state of a therapy for a patient, wherein the first state of the therapy includes providing electrical signals to one or more splanchnic nerves of the patient; receiving first sensor information from one or more first sensors; based on the received sensor information, determining a subcutaneous nerve activity associated with the patient; and based on the subcutaneous nerve activity, adjusting one or more parameters of the electrical signals to change the therapy from the first state to a second state(The pulse generator 178 for electrical nerve stimulation in an embodiment is implantable and programmable. Programmable pulse generators can employ conventional microprocessors and other standard electrical components(Detailed description, paragraph 35). In the context of this disclosure the GSN can mean right or left greater splanchnic nerve and electrical block and stimulation can be performed via an implanted nerve cuff electrode(s) or a bilateral treatment can be performed from nerve cuff electrodes implanted to access both right and left greater splanchnic nerves(Detailed Description, paragraph 9). In another exemplary embodiment, a nerve cuff 195 has 5 active electrodes (FIG. 12B). In this example, the high frequency block therapy is delivered via electrodes 3, 4, and 5 in a tripolar configuration with electrode 4 acting as a cathode(Detailed description, paragraph 29). In addition, although the reference electrode is located remotely, there is always a virtual anode 134 at each end of the cuff because the current always flows into the nerve at the cuff ends(Detailed description, paragraph 13). In a further embodiment, said device may be configured to receive signals from sensors including fluid or blood pressure (BP) sensor and adjust accordingly to modulate and deliver modified therapy, as needed or desired.(Detailed Description, paragraph 50). The case further includes a connector (not shown, e.g., a header or a connector block, made of polyurethane or other suitable material), having a plurality of terminals shown schematically with the names of the leads to which they are connected shown next to the terminals, including: a nerve lead terminal 216, a cardiac lead terminal 217, and a physiological sensor terminal 218 for physiological sensors(Detailed Description, paragraph 38)(Fig. 16). The operating parameters of the implantable device may be non-invasively programmed into the memory 225 through a telemetry circuit 226 in telemetric communication via a communication link with the external device, such as a clinician programmer or a patient interface 227(Detailed Description, Paragraph 44)). Gelfand fails to discloses “ receiving second sensor information from one or more second sensors; patient and physical activity if the patient different from the subcutaneous nerve activity”.
However, Sommer teaches “Therapy system 10 may also include at least one sensor 17 in addition to or instead of sense electrodes and sensors on the leads 14, 16. Sensor 17 may be configured to detect an activity level, motion, posture, intracardiac, intravascular or other pressure within the patient, or another physiological parameter of patient 18. For example, sensor 17 may comprise an accelerometer. Sensor 17 may generate a signal that varies as a function of at least one physiological parameter of patient 18[0040]. Processor 20 may also receive physiological signals sensed by selected electrodes on leads 14, 16 or other leads via switch device 29. In some examples, processor 20 may receive physiological signals sensed by at least one electrode (not shown) located on housing 13 (FIG. 1) of IMD 12, which may be used alone or in combination with lead-borne electrodes for delivery of stimulation or sensing. Furthermore, processor 20 may additionally or alternatively receive at least one signal generated by one or more other sensors 17 that are on or within housing 13, or coupled to processor 20 via a lead or wirelessly, e.g. via communication module 26[0049]”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the splanchnic nerve modulation device of Gelfand with the multiple sensors of the therapeutic stimulation of Sommer. Doing so would clearly state multiple sensors in the system to sense different physiological parameters to obtain a comprehensive view of the patient during stimulation.
Regarding claim 19, Gelfand in view of Sommer teaches the method of claim 18, wherein the first state of the therapy further comprises a unilateral ablation of at least a portion of the splanchnic nerve(The splanchnic venous vascular bed serves as the major blood reservoir and can be affected by activation (e.g., stimulation) or deactivation (e.g., blocking or ablation) of splanchnic nerves and particularly of the greater splanchnic nerve (GSN) causing relaxation of veins, mobilization, release or uptake of venous blood from or to splanchnic vascular beds, respectively, and important changes in circulating blood volume.(Detailed Description, paragraph 8)).
Regarding claim 20, Gelfand in view of Sommer teaches the method of claim 18, wherein the electrical signals are applied bilaterally to the one or more splanchnic nerves and wherein adjusting the one or more parameters comprises changing at least one of a frequency, peak current, duty cycle, and application duration for the electrical signals(In the context of this disclosure the GSN can mean right or left greater splanchnic nerve and electrical block and stimulation can be performed via an implanted nerve cuff electrode(s) or a bilateral treatment can be performed from nerve cuff electrodes implanted to access both right and left greater splanchnic nerves(Detailed Description, paragraph 9)).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Gelfand in view of Sommer and further in view of Chen(20190374121).
Regarding claim 5, Gelfand in view of Sommer teaches the system of claim 1, but fails to explicitly disclose wherein memory further stores data that, when processed by the processor, causes the processor to: estimate a sympathetic tone based on the first sensor information describing the subcutaneous nerve activity. However, Chen teaches “In some aspects, the processor 102 of system 100 may perform a number of signal processing steps to identify nerve activity in data samples received from the signal detector 108. Specifically, the processor 102 may be configured to estimate a sympathetic nerve activity[0049]. As described herein, it is a discovery of the present disclosure that controlling sympathetic tone may depend upon the specific stimulation parameters selected[0060]”.
It would be obvious to one of ordinary skill in the art before the effective date to configure the electrical modulation device of Gelfand with the nerve electrical stimulation of Chen. Doing so would specify the processors ability to estimate sympathetic nerve activity in order to evaluate the effectiveness of the stimulation.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. New art Sommer has been added with combination with Gelfand to disclose claimed material. Sommer teaches multiple sensors, one with the ability to measure physical activity in the system and the feedback from said sensors is used to alter therapy and change configurations if necessary, as shown in [0040],[0049], [FIG. 9], and[ FIG. 10]. The combination of Sommer and Gelfand and further combined with Chen discloses all claimed material. Therefore 103 rejections stand for all claims.
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 MARIA CATHERINE ANTHONY whose telephone number is (703)756-4514. The examiner can normally be reached 7:30 am - 4:30 pm, EST, M-F.
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/MARIA CATHERINE ANTHONY/Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796