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 .
Information Disclosure Statement
The information disclosure statements (IDS) were submitted on 11/04/2024, 11/07/2025, and 02/04/2026. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The disclosure is objected to because of the following informalities:
In [0072] “protein s1ensor” should read “protein sensor”.
Appropriate correction is required.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 14, and 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Perez et al. (US 2018/0085580 A1), hereinafter Perez.
Regarding claim 1, Perez discloses a system (Figure 1A: system 100), comprising:
a first sensor (Figure 1A: sensors 135) that measures a glycemic level of a patient ([0487] “stimulation device includes at least one sensor…The sensor may include any one or combination of a glucose sensor, a neural sensor, an accelerometer, an impedance sensor, and a bio-impedance sensor.”, [1264], Table 1);
a second sensor (Figure 1A: sensors 135) that measures at least one of a protein level of the patient, a hormone level of the patient, and an activity level of the patient ([0487] “stimulation device includes at least one sensor…The sensor may include any one or combination of a glucose sensor, a neural sensor, an accelerometer, an impedance sensor, and a bio-impedance sensor.”, [1235], Table 1);
a processor (microprocessor 112) that receives inputs from the first sensor and inputs from the second sensor ([0767] “the microprocessor 112 is in electronic communication with one or more sensors 135 to generate data representative of various physiological parameters of an individual, such as the individual's heart rate, pulse rate, beat-to-beat heart variability, EKG or ECG, respiration rate, skin temperature, core body temperature, heat flow off the body, galvanic skin response or GSR, EMG, EEG, EOG, blood pressure, body fat, hydration level, activity level, oxygen consumption, glucose or blood sugar level, body position, pressure on muscles or bones, and/or UV radiation exposure and absorption”); and
memory comprising data that (microcontroller 112, [0769] “The microprocessor 112 is programmed to summarize and analyze the data representative of the physiological parameters of the individual.”), when executed by the processor, enables the processor to:
analyze the inputs received from the first sensor and the second sensor ([0767], [0769] “The microprocessor 112 is programmed to summarize and analyze the data representative of the physiological parameters of the individual”);
determine, based on the analysis, that an electrical treatment is to be applied to the patient ([0487] “Optionally, said stimulation device includes at least one sensor and said control device is configured to modify said stimulation parameters based on data received from said at least one sensor. The sensor may include any one or combination of a glucose sensor, a neural sensor, an accelerometer, an impedance sensor, and a bio-impedance sensor.”, [1258] “the HMA generates a modulation signal (to titrate stimulation protocols and/or parameters) based on any one or a combination of the acquired or received glucose status data”), wherein the electrical treatment comprises application of at least one electrical signal to a nervous system of the patient; and cause the electrical treatment to be applied to the nervous system of the patient ([0761] “FIG. 1A is a block diagram illustration of a system 100 for stimulating or modulating nerves and nerve endings in body tissues, in accordance with an embodiment of the present specification.”, [1002]-[1003]).
Regarding claim 14, Perez discloses a device (Figure 1A: electrodermal patch (EDP) device 110), comprising:
A processor (microcontroller 112) that receives a first input from a first sensor and second input from a second sensor (Figure 1A: sensors 135), wherein the first input describes a glycemic level of a patient ([0487] “stimulation device includes at least one sensor…The sensor may include any one or combination of a glucose sensor, a neural sensor, an accelerometer, an impedance sensor, and a bio-impedance sensor.”, [1264], Table 1), and wherein the second input describes at least one of a hormone level, a protein level, and an activity level of the patient ([0487] “stimulation device includes at least one sensor…The sensor may include any one or combination of a glucose sensor, a neural sensor, an accelerometer, an impedance sensor, and a bio-impedance sensor.”, [1235], Table 1);
memory comprising data that (microcontroller 112, [0769] “The microprocessor 112 is programmed to summarize and analyze the data representative of the physiological parameters of the individual.”), when executed by the processor, enables the processor to:
analyze the inputs received from the first sensor and the second sensor ([0767] “the microprocessor 112 is in electronic communication with one or more sensors 135 to generate data representative of various physiological parameters of an individual, such as the individual's heart rate, pulse rate, beat-to-beat heart variability, EKG or ECG, respiration rate, skin temperature, core body temperature, heat flow off the body, galvanic skin response or GSR, EMG, EEG, EOG, blood pressure, body fat, hydration level, activity level, oxygen consumption, glucose or blood sugar level, body position, pressure on muscles or bones, and/or UV radiation exposure and absorption”, [0769] “The microprocessor 112 is programmed to summarize and analyze the data representative of the physiological parameters of the individual”);
determine, based on the analysis, that an electrical treatment is to be applied to the patient ([0487] “Optionally, said stimulation device includes at least one sensor and said control device is configured to modify said stimulation parameters based on data received from said at least one sensor. The sensor may include any one or combination of a glucose sensor, a neural sensor, an accelerometer, an impedance sensor, and a bio-impedance sensor.”, [1258] “the HMA generates a modulation signal (to titrate stimulation protocols and/or parameters) based on any one or a combination of the acquired or received glucose status data”), wherein the electrical treatment comprises application of at least one electrical signal to a nervous system of the patient; and cause the electrical treatment to be applied to the nervous system of the patient ([0761] “FIG. 1A is a block diagram illustration of a system 100 for stimulating or modulating nerves and nerve endings in body tissues, in accordance with an embodiment of the present specification.”, [1002]-[1003]).
Regarding claim 19, Perez discloses a closed-loop system for providing therapy to a patient, (Figure 1A: system 100, [0494]), the system comprising:
A plurality of sensors (Figure 1A: sensors 135) wherein the plurality of sensors measure two or more of a glycemic level of a patient, a hormone level of the patient, a protein level of the patient, and an activity level of the patient ([0487] “stimulation device includes at least one sensor…The sensor may include any one or combination of a glucose sensor, a neural sensor, an accelerometer, an impedance sensor, and a bio-impedance sensor.”, [1264], Table 1, [01235]);
a processor; and memory comprising data that (microcontroller 112, [0769] “The microprocessor 112 is programmed to summarize and analyze the data representative of the physiological parameters of the individual.”), when executed by the processor, enables the processor to:
receives inputs from the plurality of sensors ([0767] “the microprocessor 112 is in electronic communication with one or more sensors 135 to generate data representative of various physiological parameters of an individual, such as the individual's heart rate, pulse rate, beat-to-beat heart variability, EKG or ECG, respiration rate, skin temperature, core body temperature, heat flow off the body, galvanic skin response or GSR, EMG, EEG, EOG, blood pressure, body fat, hydration level, activity level, oxygen consumption, glucose or blood sugar level, body position, pressure on muscles or bones, and/or UV radiation exposure and absorption”); and
analyze the inputs received from the first sensor and the second sensor ([0767], [0769] “The microprocessor 112 is programmed to summarize and analyze the data representative of the physiological parameters of the individual”);
determine, based on the analysis, that an electrical treatment is to be applied to the patient ([0487] “Optionally, said stimulation device includes at least one sensor and said control device is configured to modify said stimulation parameters based on data received from said at least one sensor. The sensor may include any one or combination of a glucose sensor, a neural sensor, an accelerometer, an impedance sensor, and a bio-impedance sensor.”, [1258] “the HMA generates a modulation signal (to titrate stimulation protocols and/or parameters) based on any one or a combination of the acquired or received glucose status data”), wherein the electrical treatment comprises application of at least one electrical signal to a nervous system of the patient; and cause the electrical treatment to be applied to the nervous system of the patient ([0761] “FIG. 1A is a block diagram illustration of a system 100 for stimulating or modulating nerves and nerve endings in body tissues, in accordance with an embodiment of the present specification.”, [1002]-[1003]).
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) 1-5, 7-9, and 11-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Waataja et al. (US 2021/0146136 A1), hereinafter Waataja in view of Koya et al. (US 2019/0125227 A1), hereinafter Koya.
Regarding claim 1, Waataja discloses a system ([0009] “methods and systems for treating impaired glucose regulation in a subject”), comprising:
A first sensor that measures a glycemic level of a patient ([0090] “the system may include one or more sensors that may provide for signals to initiate therapy signals to one or more electrodes. For example, a sensor may measure the amount of glucose in the blood”);
A second sensor that measures at least one of a protein level of the patient, a hormone level of the patient, and an activity level of the patient ([0145] “the sensor can be a sensing electrode, a glucose sensor, or sensor that senses other biological molecules or hormones of interest.”);
A processor that receives inputs from the first sensor and inputs from the second sensor ([0090] “the system may include one or more sensors that may provide for signals to initiate therapy signals to one or more electrodes”, [0145] “controller 102 (FIG. 3), controller with the additive function of receiving a signal from sensing electrode can be remotely programmed as to parameters of blocking duration and no blocking duration as well as targets for initiating a blocking signal or upregulating signal”)
Memory comprising data that ([0061] “The neuroregulatory 104 also may include memory in which treatment instructions and/or patient data can be stored”), when executed by the processor, enables the processor to:
Analyze the inputs received from the first sensor and the second sensor ([0090] “the system may include one or more sensors that may provide for signals to initiate therapy signals to one or more electrodes. For example, a sensor may measure the amount of glucose in the blood and initiate an upregulating signal to a nerve or organ if the amount of blood glucose exceeds a certain threshold.”, [0145] “As described with reference to controller 102 (FIG. 3), controller with the additive function of receiving a signal from sensing electrode can be remotely programmed as to parameters of blocking duration and no blocking duration as well as targets for initiating a blocking signal or upregulating signal.”, [0090]);
an electrical treatment is to be applied to the patient, wherein the electrical treatment comprises application of at least one electrical signal to a nervous system of the patient ([0041]); and
Cause the electrical treatment to be applied to the nervous system of the patient ([0018] “A blocking or HFAC signal is applied to the hepatic branch of the anterior or ventral vagal nerve and the a stimulating signal is applied to the celiac branch of the posterior or dorsal vagal nerve.”)
Waataja fails to explicitly disclose determine, based on the analysis, that an electrical treatment is applied to the patient, wherein the electrical treatment comprises at least one electrical signal to a nervous system of the patient
However, Koya et al. (US 2019/0125227 A1) teaches a system (Abstract: “A system may include an implantable structure with a plurality of electrodes attached thereto, where the implantable structure is configured to be implanted proximate to a nerve that innervates and is proximate to an organ involved with glucose control.”), comprising a plurality of sensors ([0085]) and determine, based on the analysis, that an electrical treatment is applied to the patient, wherein the electrical treatment comprises at least one electrical signal to a nervous system of the patient ([0086] “As will also be evident to one of ordinary skill in the art upon reading and comprehending this disclosure, the therapy control may be based, at least in part, on other inputs such as activity, diet, etc.”, [0129] “a control system 2793 configured for controlling the diabetic therapy delivery system, and therapy inputs 2794 to the control system 2793 used by the control system 2793 to control the diabetic therapy delivery system 2792. In some embodiments, the diabetic therapy delivery system 2792 is configured to control the modulation target 2795 (e.g. whether the targeted neural tissue is a parasympathetic target and/or a sympathetic target and/or whether the modulation target is a hepatic neuromodulation target or a pancreatic neuromodulation target). In some embodiments, the diabetic therapy delivery system 2792 is configured to control the type of modulation 2796 that is delivered to the modulation target… The therapy inputs 2794 may include a glucose monitor, a neural activity sensor (e.g. a sensor to detect neural activity on the parasympathetic or detect neural activity on the sympathetic nerves), a timer such as may be used to determine a time of day for a circadian rhythm, a posture sensor, an activity sensor, or another physiological sensor. Therapy inputs may include user inputs, such as diet, patient factor (e.g. patient specific parameters such as pregnancy status, lactation, comorbidities, use of other medications capable of altering glucose levels, dietary intake, time elapsed after eating, or other), anticipated activity, glucose levels, therapy start and/or stop, therapy scheduling (e.g. calendar-based scheduling), event (e.g. calendar-based events), location (e.g. location services on personal device, or apps on person device to monitor patient condition)”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Waataja to incorporate the teachings of Koya to determine, based on the analysis, that an electrical treatment is applied to the patient, wherein the electrical treatment comprises at least one electrical signal to a nervous system of the patient, as these prior art references are directed to monitoring glucose levels and providing stimulation. One would be motivated to incorporate a multi-sensor control of the electrical stimulation to as this information can help determine the efficacy of the modulation, side effects to the modulation, or energy ise for modulation which may in turn may be used to determine the desired modulation parameters to modulate the targeted location, as recognized by Koya ([0127]).
Regarding claim 2, Waataja in view of Koya teaches the system of claim 1 (as shown above). Waataja further discloses wherein the electrical treatment comprises application of a first electrical signal to a first portion of a nerve and application of a second electrical signal to a second portion of the nerve ([0075] “In some therapeutic application an electrode connected to a blocking electrical signal is placed on the hepatic branch of the vagal nerve. In other therapeutic applications an electrode connected to an upregulating signal is placed on the celiac branch.”, [0120] “a stimulation signal is applied to the celiac branch of the vagus nerve when a monitor detects low blood glucose levels. In other embodiments a downregulating signal is continuously delivered to the hepatic branch of the vagus nerve, or the ventral vagal trunk above the branching point of the hepatic nerve, along with stimulation of the celiac branch, or the dorsal vagal trunk above the branching point of the celiac nerve.”).
Regarding claim 3, Waataja in view of Koya discloses the system of claim 2 (as shown above). Waataja further discloses wherein the first electrical signal comprises a low frequency stimulation of a celiac branch of the nerve ([0117] “In embodiments, an up-regulating signal may be applied to a celiac nerve or splanchnic nerve.”, [0133] “Upregulating signals typically comprise signals of a frequency of less than 200 Hz, more preferably between 0.01 to 200 Hz, more preferably 10 to 50 Hz, more preferably 5 to 20 Hz, more preferably 5 to 10 Hz, more preferably 1 to 5 Hz, preferably 0.1 to 2 Hz, most preferably 1 Hz”) and wherein the second electrical signal comprises a high frequency blockade of a hepatic branch of the nerve ([0117] “In other embodiments, an up-regulating or downregulating signal may be applied to a hepatic branch of the vagus nerve or the signal may be applied to decrease the amount of glucose secreted from the liver.”, [0120] “In other embodiments a downregulating signal is continuously delivered to the hepatic branch of the vagus nerve, or the ventral vagal trunk above the branching point of the hepatic nerve, along with stimulation of the celiac branch, or the dorsal vagal trunk above the branching point of the celiac nerve.”, [0131] “downregulating signal has a frequency of at least 200 Hz and up to 5000 Hz. In other embodiments, the signal is applied at a frequency of about 500 to 5000 Hz. Applicant has determined a most preferred blocking signal has a frequency of 3,000 Hz to 5,000 Hz or greater applied by two or more bi-polar electrodes.”).
Regarding claim 4, Waataja in view of Koya discloses the system of claim 2 (as shown above). Waataja further discloses wherein the first electrical signal comprises a frequency of no more than about 5kHZ ([0133] “Upregulating signals typically comprise signals of a frequency of less than 200 Hz, more preferably between 0.01 to 200 Hz, more preferably 10 to 50 Hz, more preferably 5 to 20 Hz, more preferably 5 to 10 Hz, more preferably 1 to 5 Hz, preferably 0.1 to 2 Hz, most preferably 1 Hz.”, [0120] “a stimulation signal is applied to the celiac branch of the vagus nerve when a monitor detects low blood glucose levels.”, [0131] “In some embodiments, a downregulating signal has a frequency of at least 200 Hz and up to 5000 Hz. In other embodiments, the signal is applied at a frequency of about 500 to 5000 Hz”).
Regarding claim 5, Waataja in view of Koya teaches the system of claim 2 (as shown above). Waataja further discloses wherein the second electrical signal comprises a square wave having a frequency of between 1-10 Hz ([0117] “In embodiments, an up-regulating signal may be applied to a celiac nerve or splanchnic nerve.”, [0133] “Upregulating signals typically comprise signals of a frequency of less than 200 Hz, more preferably between 0.01 to 200 Hz, more preferably 10 to 50 Hz, more preferably 5 to 20 Hz, more preferably 5 to 10 Hz, more preferably 1 to 5 Hz, preferably 0.1 to 2 Hz, most preferably 1 Hz”, Examiner would like to note that [0054] of specification recites these electrical signal parameters are applied to a celiac branch.)
Although, Waataja does not explicitly state a square wave it would have been obvious to one having ordinary skill in the art to engage in routine experimentation to determine the optimal waveform and shape for the second electrical signal to comprise of a square wave as Waataja teaches that “Other signal attributes can be varied to reduce the likelihood of accommodation by the nerve or an organ. These include altering the power, waveform or pulse width” ([0133]) and teaches different waveforms such as square, sinusoidal, etc. ([0131]). See MPEP 2144.05 (II)(A) (“[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation”) In re Aller, 2020 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)).
Regarding claim 7, Waataja in view of Koya teaches the system of claim 1 (as shown above). Waataja further discloses “the sensor can be a sensing electrode, a glucose sensor, or sensor that senses other biological molecules or hormones of interest.”, however, Waataja fails to explicitly teach wherein the second sensor measures the protein level of the patient, the system further comprising: a third sensor that measures the hormone level of the patient.
However, Koya teaches wherein the second sensor measures the protein level of the patient ([0085] “The system 100 may include sensor(s), such as but not limited to an activity sensor 103 or a physiological sensor 104 such as glucose sensor. A number of sensors may be used, as disclosed throughout this disclosure. One or more sensors (implantable or non-invasive) may be integrated with or otherwise in communication with the neuromodulator. Examples of sensors may include…insulin sensors…Other sensors may be used, such as sensors to detect amino acid concentration, glucagon”), the system further comprising: a third sensor that measures the hormone level of the patient ([0085] “The system 100 may include sensor(s), such as but not limited to an activity sensor 103 or a physiological sensor 104 such as glucose sensor. A number of sensors may be used, as disclosed throughout this disclosure. One or more sensors (implantable or non-invasive) may be integrated with or otherwise in communication with the neuromodulator…Other sensors may be used, such as sensors to detect…cortisol, progesterone/estrogen, norepinephrine/epinephrine”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Waataja to incorporate the teachings of Koya to havethe second sensor measures the protein level of the patient, the system further comprising: a third sensor that measures the hormone level of the patient, as these prior art references are directed to monitoring glucose levels and providing stimulation. One would be motivated to incorporate a multi-sensor control of the electrical stimulation as this information can help determine the efficacy of the modulation, side effects to the modulation, or energy use for modulation which may in turn may be used to determine the desired modulation parameters to modulate the targeted location, as recognized by Koya ([0127]).
Regarding claim 8, Waataja in view of Koya teaches the system of claim 7 (as shown above). Waataja fails to disclose wherein the memory further comprises data that, when executed by the processor, enables the processor to analyze the inputs received from the first sensor, the second sensor, and the third sensor and further enables the processor to determine based on the analysis, that the electrical treatment is applied to the patient.
However, Koya teaches wherein the memory further comprises data that, when executed by the processor, enables the processor to analyze the inputs received from the first sensor, the second sensor, and the third sensor and further enables the processor to determine based on the analysis, that the electrical treatment is applied to the patient ([0085] “The system 100 may include sensor(s), such as but not limited to an activity sensor 103 or a physiological sensor 104 such as glucose sensor. A number of sensors may be used, as disclosed throughout this disclosure. One or more sensors (implantable or non-invasive) may be integrated with or otherwise in communication with the neuromodulator. Examples of sensors may include…insulin sensor. Other sensors may be used, such as sensors to detect amino acid concentration, glucagon”, [0085] “These sensors may be used for closed-loop control”, [0087] “The patient device may also include a patient-facing interface for use by the patient to input data such as glucose levels, activity, or other information. The patient-facing interface may be used by a patient to provide inputs such as meal start time and carbohydrates in meal. Other inputs may include exercise time, sleep time, medication intake and time, alcohol intake, or menstruation information. A processor may use one or more of these input signals as an input to control stimulation parameters.”, [0164], [0171]-[0178]).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Waataja to incorporate the teachings of Koya have the memory further comprises data that, when executed by the processor, enables the processor to analyze the inputs received from the first sensor, the second sensor, and the third sensor and further enables the processor to determine based on the analysis, that the electrical treatment is applied to the patient, as these prior art references are directed to monitoring glucose levels and providing stimulation. One would be motivated to incorporate a multi-sensor control of the electrical stimulation to as this information can help determine the efficacy of the modulation, side effects to the modulation, or energy ise for modulation which may in turn may be used to determine the desired modulation parameters to modulate the targeted location, as recognized by Koya ([0127]).
Regarding claim 9, Waataja in view of Koya teaches the system of claim 8 (as shown above). Waataja further discloses wherein the electrical treatment is applied when the following conditions are met: (i) the measured glycemic level exceeds a predetermined glycemic threshold ([0090] “a sensor may measure the amount of glucose in the blood and initiate an upregulating signal to a nerve or organ if the amount of blood glucose exceeds a certain threshold.”).
Regarding claim 11, Waataja in view of Koya teaches the system of claim 1 (as shown above). Waataja fails to disclose wherein the second sensor comprises an activity sensor that measures the activity level of the patient.
However, Koya teaches wherein the second sensor comprises an activity sensor that measures the activity level of the patient ([0085] “The system 100 may include sensor(s), such as but not limited to an activity sensor 103 or a physiological sensor 104 such as glucose sensor. A number of sensors may be used, as disclosed throughout this disclosure”, [0086] “As will also be evident to one of ordinary skill in the art upon reading and comprehending this disclosure, the therapy control may be based, at least in part, on other inputs such as activity, diet, etc.”)
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Waataja to incorporate the teachings of Koya to have the second sensor comprise an activity sensor that measures the activity level of the patient, as these prior art references are directed to monitoring glucose levels and providing stimulation. One would be motivated to incorporate a multi-sensor control of the electrical stimulation as this information can help determine the efficacy of the modulation, side effects to the modulation, or energy use for modulation which may in turn may be used to determine the desired modulation parameters to modulate the targeted location, as recognized by Koya ([0127]).
Regarding claim 12, Waataja in view of Koya teaches the system of claim 11 (as shown above). Waataja fails to explicitly disclose wherein the activity sensor comprises at least one of a heart rate sensor, an accelerometer, a gyroscope, and a motion sensor.
However, Koya teaches wherein the activity sensor comprises at least one of a heart rate sensor, an accelerometer, a gyroscope, and a motion sensor ([0089] “Examples of activity sensors 103 may include an accelerometer, a gyroscope, a GPS sensor, a cardiovascular activity sensor, a respiratory sensor, or any other activity tracker or combination thereof.”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Waataja to incorporate the teachings of Koya to have the activity sensor comprises at least one of a heart rate sensor, an accelerometer, a gyroscope, and a motion sensor, as these prior art references are directed to monitoring glucose levels and other physiological levels for providing stimulation. One would be motivated to do this to utilize this information to adjust or update stimulation therapy parameters, as recognized by Koya ([0129]).
Regarding claim 13, Waataja in view of Koya discloses the system of claim 1 (as shown above). Although Waataja discloses a glucose sensor ([0145]) but fails to explicitly disclose wherein first sensor comprises a continuous glucose monitor.
However, Koya teaches wherein the first sensor comprises a continuous glucose monitor ([0166] “The system may further include a continuous glucose monitor 4047, which may be external or implantable…In some embodiments, the glucose monitor sends an alert to the patient's mobile device 4048 and the patient accepts the notice enabling the external device 4045 to initiate, terminate or adjust the therapy”, [0181]).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Waataja to incorporate the teachings of Koya to have the first sensor comprise a continuous glucose monitor, as these prior art references are directed to monitoring glucose levels and delivering electrical stimulation based on the physiological signals. One would be motivated to do this to ensure that the patient’s glucose levels are continuously regulated and remain within acceptable range reducing the likelihood of kidney damage or other long term health complications.
Regarding claim 14, Waataja discloses a device ([0048] “The disclosure provides systems and devices for treating a condition associated with impaired glucose regulation comprising a pulse generator that provides signals to modulate neural activity on a target nerve or organ.”), comprising:
A processor that receives a first input from a first sensor and a second input from a second sensor ([0090] “the system may include one or more sensors that may provide for signals to initiate therapy signals to one or more electrodes”, [0145] “controller 102 (FIG. 3), controller with the additive function of receiving a signal from sensing electrode can be remotely programmed as to parameters of blocking duration and no blocking duration as well as targets for initiating a blocking signal or upregulating signal”), wherein the first input describes a glycemic level of a patient ([0090] “the system may include one or more sensors that may provide for signals to initiate therapy signals to one or more electrodes. For example, a sensor may measure the amount of glucose in the blood”), and wherein the second input describes at least one of a hormone level, a protein level, and an activity level of the patient ([0145] “the sensor can be a sensing electrode, a glucose sensor, or sensor that senses other biological molecules or hormones of interest.”);and
Memory comprising data that ([0061] “The neuroregulatory 104 also may include memory in which treatment instructions and/or patient data can be stored”), when executed by the processor, enables the processor to:
Analyze the inputs received from the first sensor and the second sensor ([0090] “the system may include one or more sensors that may provide for signals to initiate therapy signals to one or more electrodes. For example, a sensor may measure the amount of glucose in the blood and initiate an upregulating signal to a nerve or organ if the amount of blood glucose exceeds a certain threshold.”, [0145] “As described with reference to controller 102 (FIG. 3), controller with the additive function of receiving a signal from sensing electrode can be remotely programmed as to parameters of blocking duration and no blocking duration as well as targets for initiating a blocking signal or upregulating signal.”, [0090]);
A treatment is to be applied to the patient, wherein the treatment comprises application of at least one electrical signal to a nervous system of the patient ([0041]); and
Cause the electrical treatment to be applied to the nervous system of the patient ([0018] “A blocking or HFAC signal is applied to the hepatic branch of the anterior or ventral vagal nerve and the a stimulating signal is applied to the celiac branch of the posterior or dorsal vagal nerve.”)
Waataja fails to explicitly disclose determine, based on the analysis, that a treatment is applied to the patient, wherein the treatment comprises application of at least one electrical signal to a nervous system of the patient
However, Koya teaches a system (Abstract: “A system may include an implantable structure with a plurality of electrodes attached thereto, where the implantable structure is configured to be implanted proximate to a nerve that innervates and is proximate to an organ involved with glucose control.”), comprising a plurality of sensors ([0085]) and determine, based on the analysis, that a treatment is applied to the patient, wherein the treatment comprises application of at least one electrical signal to a nervous system of the patient ([0086] “As will also be evident to one of ordinary skill in the art upon reading and comprehending this disclosure, the therapy control may be based, at least in part, on other inputs such as activity, diet, etc.”, [0129] “a control system 2793 configured for controlling the diabetic therapy delivery system, and therapy inputs 2794 to the control system 2793 used by the control system 2793 to control the diabetic therapy delivery system 2792. In some embodiments, the diabetic therapy delivery system 2792 is configured to control the modulation target 2795 (e.g. whether the targeted neural tissue is a parasympathetic target and/or a sympathetic target and/or whether the modulation target is a hepatic neuromodulation target or a pancreatic neuromodulation target). In some embodiments, the diabetic therapy delivery system 2792 is configured to control the type of modulation 2796 that is delivered to the modulation target… The therapy inputs 2794 may include a glucose monitor, a neural activity sensor (e.g. a sensor to detect neural activity on the parasympathetic or detect neural activity on the sympathetic nerves), a timer such as may be used to determine a time of day for a circadian rhythm, a posture sensor, an activity sensor, or another physiological sensor. Therapy inputs may include user inputs, such as diet, patient factor (e.g. patient specific parameters such as pregnancy status, lactation, comorbidities, use of other medications capable of altering glucose levels, dietary intake, time elapsed after eating, or other), anticipated activity, glucose levels, therapy start and/or stop, therapy scheduling (e.g. calendar-based scheduling), event (e.g. calendar-based events), location (e.g. location services on personal device, or apps on person device to monitor patient condition)”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Waataja to incorporate the teachings of Koya to determine, based on the analysis, that a treatment is applied to the patient, wherein the treatment comprises application of at least one electrical signal to a nervous system of the patient, as these prior art references are directed to monitoring glucose levels and providing stimulation. One would be motivated to incorporate a multi-sensor control of the electrical stimulation to as this information can help determine the efficacy of the modulation, side effects to the modulation, or energy ise for modulation which may in turn may be used to determine the desired modulation parameters to modulate the targeted location, as recognized by Koya ([0127]).
Regarding claim 15, Waataja in view of Koya discloses the device of claim 14 (as shown above). Waataja further discloses wherein the electrical treatment comprises application of a first electrical signal to a first portion of a nerve and application of a second electrical signal to a second portion of the nerve ([0075] “In some therapeutic application an electrode connected to a blocking electrical signal is placed on the hepatic branch of the vagal nerve. In other therapeutic applications an electrode connected to an upregulating signal is placed on the celiac branch.”, [0120] “a stimulation signal is applied to the celiac branch of the vagus nerve when a monitor detects low blood glucose levels. In other embodiments a downregulating signal is continuously delivered to the hepatic branch of the vagus nerve, or the ventral vagal trunk above the branching point of the hepatic nerve, along with stimulation of the celiac branch, or the dorsal vagal trunk above the branching point of the celiac nerve.”), wherein the first electrical signal comprises a low frequency stimulation of a celiac branch of the nerve ([0117] “In embodiments, an up-regulating signal may be applied to a celiac nerve or splanchnic nerve.”, [0133] “Upregulating signals typically comprise signals of a frequency of less than 200 Hz, more preferably between 0.01 to 200 Hz, more preferably 10 to 50 Hz, more preferably 5 to 20 Hz, more preferably 5 to 10 Hz, more preferably 1 to 5 Hz, preferably 0.1 to 2 Hz, most preferably 1 Hz”) and wherein the second electrical signal comprises a high frequency blockade of a hepatic branch of the nerve ([0117] “In other embodiments, an up-regulating or downregulating signal may be applied to a hepatic branch of the vagus nerve or the signal may be applied to decrease the amount of glucose secreted from the liver.”, [0120] “In other embodiments a downregulating signal is continuously delivered to the hepatic branch of the vagus nerve, or the ventral vagal trunk above the branching point of the hepatic nerve, along with stimulation of the celiac branch, or the dorsal vagal trunk above the branching point of the celiac nerve.”, [0131] “downregulating signal has a frequency of at least 200 Hz and up to 5000 Hz. In other embodiments, the signal is applied at a frequency of about 500 to 5000 Hz. Applicant has determined a most preferred blocking signal has a frequency of 3,000 Hz to 5,000 Hz or greater applied by two or more bi-polar electrodes.”).
Regarding claim 16, Waataja in view of Koya teaches the device of claim 14 (as shown above). Waataja fails to explicitly disclose wherein the second input describes the hormone level, wherein the third input describes the protein level, and wherein the memory further comprises data that, when executed by the processor, enables the processor to analyze the third input along with the first input and the second input, then determine, based on the analysis, that the treatment is to be applied to the patient.
However, Koya teaches wherein the processor receives a third input from a third sensor, wherein the second input describes the hormone level, wherein the third input describes the protein level ([0085] “The system 100 may include sensor(s), such as but not limited to an activity sensor 103 or a physiological sensor 104 such as glucose sensor. A number of sensors may be used, as disclosed throughout this disclosure. One or more sensors (implantable or non-invasive) may be integrated with or otherwise in communication with the neuromodulator. Examples of sensors may include…insulin sensor. Other sensors may be used, such as sensors to detect amino acid concentration, glucagon”), and wherein the memory further comprises data that, when executed by the processor, enables the processor to analyze the third input along with the first input and the second input, then determine, based on the analysis, that the treatment is to be applied to the patient ([0085] “These sensors may be used for closed-loop control”, [0087] “The patient device may also include a patient-facing interface for use by the patient to input data such as glucose levels, activity, or other information. The patient-facing interface may be used by a patient to provide inputs such as meal start time and carbohydrates in meal. Other inputs may include exercise time, sleep time, medication intake and time, alcohol intake, or menstruation information. A processor may use one or more of these input signals as an input to control stimulation parameters.”, [0164], [0171]-[0178])
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Waataja to incorporate the teachings of Koya to wherein the second input describes the hormone level, wherein the third input describes the protein level, and wherein the memory further comprises data that, when executed by the processor, enables the processor to analyze the third input along with the first input and the second input, then determine, based on the analysis, that the treatment is to be applied to the patient, as these prior art references are directed to monitoring glucose levels and providing stimulation. One would be motivated to incorporate a multi-sensor control of the electrical stimulation to as this information can help determine the efficacy of the modulation, side effects to the modulation, or energy ise for modulation which may in turn may be used to determine the desired modulation parameters to modulate the targeted location, as recognized by Koya ([0127]).
Regarding claim 17, Waataja in view of Koya teaches the device of claim 16 (as shown above). Waataja fails to explicitly disclose wherein the processor receives a fourth input from a fourth sensor, wherein the fourth input describes the activity level, and wherein the memory further comprises data that, when executed by the processor, enables the processor to analyze the fourth input along with the first input, the second input, and the third input, then determine, based on the analysis, that the treatment is to be applied to the patient.
However, Koya teaches wherein the processor receives a fourth input from a fourth sensor, wherein the fourth input describes the activity level ([0085] “The system 100 may include sensor(s), such as but not limited to an activity sensor 103 or a physiological sensor 104 such as glucose sensor. A number of sensors may be used, as disclosed throughout this disclosure”, [0086] “As will also be evident to one of ordinary skill in the art upon reading and comprehending this disclosure, the therapy control may be based, at least in part, on other inputs such as activity, diet, etc.”, [0175] “Various embodiments include an activity sensor for use to detect exercise levels, and automatically, semi-automatically or manually control therapy delivery using the detected exercise levels.”) and wherein the memory further comprises data that, when executed by the processor, enables the processor to analyze the fourth input along with the first input, the second input, and the third input, then determine, based on the analysis, that the treatment is to be applied to the patient ([0164], [0086], [0087] “The patient device 105 may function as a monitor, a remote control to control the therapy initiation, therapy termination, or therapy scheduling as discussed in more detail below. The patient device may also include a patient-facing interface for use by the patient to input data such as glucose levels, activity, or other information. The patient-facing interface may be used by a patient to provide inputs such as meal start time and carbohydrates in meal. Other inputs may include exercise time, sleep time, medication intake and time, alcohol intake, or menstruation information. A processor may use one or more of these input signals as an input to control stimulation parameters. The processor may use the time of day to determine normal daily patient trends as an input to control stimulation parameters.”, [0129], [0177], [0173] “Various embodiments may modulate glucose levels for a medical condition in a patient by implanting a medical device containing at least one electrode in proximity to one or more nerves innervating the liver, sensing at least one parameter from the patient indicative of a glucose level, delivering non-thermal energy to the at least one electrode in response to the at least one sensed parameter, and increasing or decreasing neural activity in the at least one nerve innervating the liver to modulate glucose levels in response to the at least one sensed parameter…The at least one sensed parameter includes at least one of a glucose metric, insulin level, glucose-regulating hormone level, or glucose-regulating enzyme level. The at least one of a plurality electrodes and therapy settings may be selected based on measured individual patient responses to electrical energy delivered to parasympathetic and sympathetic targets. The individual patient response may include a sensed parameter indicative of at least one of an intrinsic neural activity, evoked compound action potential, autonomic measure, glucose metric, insulin level, glucose-regulating hormone level, or glucose-regulating enzyme level.”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Waataja to incorporate the teachings of Koya to have the processor receives a fourth input from a fourth sensor, wherein the fourth input describes the activity level, and wherein the memory further comprises data that, when executed by the processor, enables the processor to analyze the fourth input along with the first input, the second input, and the third input, then determine, based on the analysis, that the treatment is to be applied to the patient, as these prior art references are directed to monitoring glucose levels and providing stimulation. One would be motivated to incorporate a multi-sensor control of the electrical stimulation to as this information can help determine the efficacy of the modulation, side effects to the modulation, or energy use for modulation which may in turn may be used to determine the desired modulation parameters to modulate the targeted location, as recognized by Koya ([0127]).
Regarding claim 18, Waataja in view of Koya teaches the device of claim 17 (as shown above). Waataja fails to explicitly disclose wherein the fourth sensor comprises at least one of a heart rate sensor, an accelerometer, a gyroscope, and a motion sensor.
However, Koya teaches wherein the fourth sensor comprises at least one of a heart rate sensor, an accelerometer, a gyroscope, and a motion sensor ([0089] “Examples of activity sensors 103 may include an accelerometer, a gyroscope, a GPS sensor, a cardiovascular activity sensor, a respiratory sensor, or any other activity tracker or combination thereof.”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Waataja to incorporate the teachings of Koya to have the fourth sensor comprises at least one of a heart rate sensor, an accelerometer, a gyroscope, and a motion sensor, as these prior art references are directed to monitoring glucose levels and other physiological levels for providing stimulation. One would be motivated to do this to utilize this information to adjust or update stimulation therapy parameters, as recognized by Koya ([0129]).
Regarding claim 19, Waataja discloses a closed-loop system for providing therapy to a patient ([0009] “methods and systems for treating impaired glucose regulation in a subject”), the system comprising:
A plurality of sensors, wherein the plurality of sensors measure two or more of a glycemic level pf the patient, a hormone level of the patient, a protein level of the patient, a protein level of the patient, and an activity level of the ([0090] “the system may include one or more sensors that may provide for signals to initiate therapy signals to one or more electrodes. For example, a sensor may measure the amount of glucose in the blood”,[0145] “the sensor can be a sensing electrode, a glucose sensor, or sensor that senses other biological molecules or hormones of interest.”);
A processor (controller 102); and
Memory comprising data that ([0061] “The neuroregulatory 104 also may include memory in which treatment instructions and/or patient data can be stored”), when executed by the processor, enables the processor to:
Receive inputs from the plurality of sensors ([0090] “the system may include one or more sensors that may provide for signals to initiate therapy signals to one or more electrodes”, [0145] “controller 102 (FIG. 3), controller with the additive function of receiving a signal from sensing electrode can be remotely programmed as to parameters of blocking duration and no blocking duration as well as targets for initiating a blocking signal or upregulating signal”)
Analyze the inputs received from the plurality of sensors ([0090] “the system may include one or more sensors that may provide for signals to initiate therapy signals to one or more electrodes. For example, a sensor may measure the amount of glucose in the blood and initiate an upregulating signal to a nerve or organ if the amount of blood glucose exceeds a certain threshold.”, [0145] “As described with reference to controller 102 (FIG. 3), controller with the additive function of receiving a signal from sensing electrode can be remotely programmed as to parameters of blocking duration and no blocking duration as well as targets for initiating a blocking signal or upregulating signal.”, [0090]);
A treatment is to be applied to the patient, wherein the treatment comprises application of at least one electrical signal to a nervous system of the patient ([0041]); and
Cause the electrical treatment to be applied to the nervous system of the patient ([0018] “A blocking or HFAC signal is applied to the hepatic branch of the anterior or ventral vagal nerve and the a stimulating signal is applied to the celiac branch of the posterior or dorsal vagal nerve.”)
Waataja fails to explicitly disclose determine, based on the analysis, that a treatment is applied to the patient, wherein the treatment comprises application of at least one electrical signal to a nervous system of the patient.
However, Koya et al. (US 2019/0125227 A1) teaches a closed-loop system for providing therapy to a patient (Abstract: “A system may include an implantable structure with a plurality of electrodes attached thereto, where the implantable structure is configured to be implanted proximate to a nerve that innervates and is proximate to an organ involved with glucose control.”, [0089] “the system may deliver closed-loop therapy based on sensor data”), comprising a plurality of sensors ([0085]) and determine, based on the analysis, that a treatment is applied to the patient, wherein the treatment comprises application of at least one electrical signal to a nervous system of the patient ([0086] “As will also be evident to one of ordinary skill in the art upon reading and comprehending this disclosure, the therapy control may be based, at least in part, on other inputs such as activity, diet, etc.”, [0129] “a control system 2793 configured for controlling the diabetic therapy delivery system, and therapy inputs 2794 to the control system 2793 used by the control system 2793 to control the diabetic therapy delivery system 2792. In some embodiments, the diabetic therapy delivery system 2792 is configured to control the modulation target 2795 (e.g. whether the targeted neural tissue is a parasympathetic target and/or a sympathetic target and/or whether the modulation target is a hepatic neuromodulation target or a pancreatic neuromodulation target). In some embodiments, the diabetic therapy delivery system 2792 is configured to control the type of modulation 2796 that is delivered to the modulation target… The therapy inputs 2794 may include a glucose monitor, a neural activity sensor (e.g. a sensor to detect neural activity on the parasympathetic or detect neural activity on the sympathetic nerves), a timer such as may be used to determine a time of day for a circadian rhythm, a posture sensor, an activity sensor, or another physiological sensor. Therapy inputs may include user inputs, such as diet, patient factor (e.g. patient specific parameters such as pregnancy status, lactation, comorbidities, use of other medications capable of altering glucose levels, dietary intake, time elapsed after eating, or other), anticipated activity, glucose levels, therapy start and/or stop, therapy scheduling (e.g. calendar-based scheduling), event (e.g. calendar-based events), location (e.g. location services on personal device, or apps on person device to monitor patient condition)”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Waataja to incorporate the teachings of Koya to determine, based on the analysis, that a treatment is applied to the patient, wherein the treatment comprises application of at least one electrical signal to a nervous system of the patient, as these prior art references are directed to monitoring glucose levels and providing stimulation. One would be motivated to incorporate a multi-sensor control of the electrical stimulation to as this information can help determine the efficacy of the modulation, side effects to the modulation, or energy ise for modulation which may in turn may be used to determine the desired modulation parameters to modulate the targeted location, as recognized by Koya ([0127]).
Regarding claim 20, Waataja in view of Koya teaches the closed-loop system of claim 19 (as shown above). Waataja further discloses a first electrode that delivers a first electrical signal to a first portion of a nerve; and a second electrode that delivers a second electrical signal to a second portion of the nerve ([0075] “In some therapeutic application an electrode connected to a blocking electrical signal is placed on the hepatic branch of the vagal nerve. In other therapeutic applications an electrode connected to an upregulating signal is placed on the celiac branch.”, [0120] “a stimulation signal is applied to the celiac branch of the vagus nerve when a monitor detects low blood glucose levels. In other embodiments a downregulating signal is continuously delivered to the hepatic branch of the vagus nerve, or the ventral vagal trunk above the branching point of the hepatic nerve, along with stimulation of the celiac branch, or the dorsal vagal trunk above the branching point of the celiac nerve.”).
Regarding claim 21, Waataja in view of Koya teaches the closed-loop system of claim 19 (as shown above). Waataja further discloses wherein the processor ([0081] “The pulse generator utilizes a conventional microprocessor and other standard electrical and electronic components, and communicates with an external programmer and/or monitor by asynchronous serial communication for controlling or indicating states of the device.”) and the memory ([0061] “The neuroregulator 104 also may include memory in which treatment instructions and/or patient data can be stored.”) are included in an implantable pulse generator (pulse generator 104).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Waataja in view of Koya as applied to claim 2 above, and further in view of Cakmak (US Patent 10,850,100 B2), hereinafter Cakmak.
Regrading claim 6, Waataja in view of Koya teaches the system of claim 2 (as shown above). Waataja and Koya, alone or in combination, fail to teach wherein the second electrical signal comprises an ultralow frequency blockade of hepatic branch of the nerve.
However, Cakmak teaches a blood glucose level decrease system that decreases blood glucose level of a patient (Abstract) using at least one stimulator for sending electrical signals to said electrodes in order to block the sympathetic nerve innervation to smooth muscles of hepatic artery proper, liver and pancreas wherein the signal has a frequency of 1-60 Hz or 10 Hz (Claims 1-4, Column 2, line 45 -Column 3, line 10).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Waataja and Koya to incorporate the teachings of Cakmak to have wherein the second electrical signal comprises an ultralow frequency blockade of hepatic branch of the nerve, as these prior art references are directed to controlling blood glucose levels. One would be motivated to do this to prevent damage to the nerves, as recognized by Cakmak (Column 2, lines 7-12).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Waataja in view of Koya as applied to claim 9 above, and further in view of Hyde et al. (US 2017/0164876 A1), hereinafter Hyde.
Regarding claim 10, Waataja in view of Koya teaches the system of claim 9 (as shown above). Waataja and Koya, alone or in combination, fail to explicitly teach wherein the electrical treatment is applied when the measured activity lelvel of the patient is below a predetermined activity threshold.
However, Hyde teaches wherein the electrical treatment is applied when the measured activity level of the patient is below a predetermined activity threshold ([0206] “the physiological sensor 1012 includes the near infrared sensor 3300 configured to measure a physiological characteristic of the body portion such as, but not limited to, tissue oxygenation, a blood analyte, such as oxygen, carbon monoxide, methemoglobin, total hemoglobin, glucose, a protein, or a lipid, or to measure brain activity (prefrontal cortex activity associated with nociception)”, [0207], [0209], [0210] “In an embodiment, the physiological sensor 1012 includes the chemical sensor 3340 configured to measure an analyte, where such analyte can be indicative of a pain state of the individual subject. In an embodiment, the chemical sensor 3340 can include a sensor for detecting an analyte in sweat. For example, the chemical sensor 3340 can include a sensor for detecting increased levels in sweat of a saccharide such as glucose, of a salt such as lactate or glutamate. For example, the chemical sensor 3340 can include a sensor for detecting a hormone (e.g., cortisol or adrenaline).”, [0211], [0189] “In an embodiment, the motion sensor 1010 is configured to transmit one or more sense signals to the processor 1006 indicative of a motion state of the individual subject, a rest state of the individual subject, or a duration of a rest state of the individual subject. For example, the motion state of the individual subject can indicate that the individual subject (or body portions thereof) is currently moving, whereas the rest state of the individual subject can indicate that the individual subject (or body portions thereof) are not moving, or are moving at a rate or between orientations that does not exceed a threshold rate. In an embodiment, the processor 1006 determines a rest state of the individual based on the sense signals from the motion sensor 1010. For example, the processor 1006 can compare the sense signals from the motion sensor 1010 to reference data indicative of a body portion at rest to determine whether the body portion of the individual subject is experiencing a rest state (e.g., at or under a motion threshold relative to the reference data) or an active state (e.g., exceeding a motion threshold relative to the reference data). In an embodiment, the processor 1006 is configured to activate the effector 1008 to affect the body portion (e.g., via ultrasound, electric, magnetic, optical, or thermal stimulation, as described further herein) only when the body portion is at rest. For example, the processor 1006 can instruct the effector 1008 (e.g., via one or more electric control signals) to activate to affect the body portion when the sense signals from the motion sensor 1010 indicate that the body portion is experiencing a rest state. As an example, the effector 1008 may operate only when the individual subject, or the particular body portion to treat, is at rest, such as when the individual subject is asleep, resting on furniture, driving or riding in a vehicle, or the like.”).
It would have been prima facie obvious for one of ordinary skill of the art before the effective filing date of the claimed invention to have modified Waataja and Koya to incorporate the teachings of Hyde to have the electrical treatment be applied when the measures activity level of the patient is below a predetermined activity threshold, as these prior art references are directed to controlling electrical stimulation based on physiological signals. One would be motivated to do this to provide an effective and safe stimulation to the user.
Double Patenting
Claims 1-2, 4-5, 7-8, 11-14, and 16-21 of this application is patentably indistinct from claims 1-2, 4-7, 10-13, and 15-20 (respectively) of Application No.18/132186. Pursuant to 37 CFR 1.78(f), when two or more applications filed by the same applicant or assignee contain patentably indistinct claims, elimination of such claims from all but one application may be required in the absence of good and sufficient reason for their retention during pendency in more than one application. Applicant is required to either cancel the patentably indistinct claims from all but one application or maintain a clear line of demarcation between the applications. See MPEP § 822.
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 1-2, 4-5, 7-8, 11-14, and 16-21 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-7, 10-13, and 15-20 (respectively) of copending Application No. 18/132186 (reference application), hereinafter Shrivastav. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of Shrivastav recite the entire scope of the respective claims of the instant application (as shown in detail below). Since the instant application’s claims are fully encompassed by Shirvastav, the difference between the application claims and Shrivastav’s claim lies in the fact that Shrivastav’s claim includes more elements and is thus more specific. Accordingly, the invention of Shrivastav is a “species” of the “generic” invention of the application claims. It has been held that the generic invention is “anticipated” by the “species”. Since the application claims are anticipated by Shrivastav’s claims, it is not patentably distinct from the patent claim (view Table below).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
INSTANT APPLICATION CLAIMS
APPLICATION NO. 18/132186 - (filed 05/04/2026)
1.A system, comprising: a first sensor that measures a glycemic level of a patient; a second sensor that measures at least one of a protein level of the patient, a hormone level of the patient, and an activity level of the patient; a processor that receives inputs from the first sensor and inputs from the second sensor; and memory comprising data that, when executed by the processor, enables the processor to: analyze the inputs received from the first sensor and the second sensor; determine, based on the analysis, that an electrical treatment is to be applied to the patient, wherein the electrical treatment comprises application of at least one electrical signal to a nervous system of the patient; and cause the electrical treatment to be applied to the nervous system of the patient.
1. A system, comprising: a first sensor that measures a glycemic level of a patient; a second sensor that measures at least one of a protein level of the patient, a hormone level of the patient, and an activity level of the patient; a processor that receives inputs from the first sensor and inputs from the second sensor; and memory comprising data that, when executed by the processor, enables the processor to; analyze the inputs received from the first sensor and the second sensor; determine, based on the analysis, that an electrical treatment is to be applied to the patient on a basis of glucose sensing and on a combined basis of protein sensing and hormone sensing, both of which are predicated upon the activity level of the patient, wherein the electrical treatment comprises application of at least one electrical signal to an anterior sub diaphragmatic hepatic vagal trunk of the patient to down-regulate neural activity thereof and/or to a posterior sub diaphragmatic vagal trunk of the patient to up-regulate neural activity thereof; and cause the electrical treatment to be applied to the patient based on the combined basis of the measured protein level exceeding a predetermined protein threshold and the measured hormone level exceeding a predetermined hormone threshold.
2. The system of claim 1, wherein the electrical treatment comprises application of a first electrical signal to a first portion of a nerve and application of a second electrical signal to a second portion of the nerve
2. The system of claim 1, wherein the electrical treatment is applied to the patient to mute a glycemic response of the patient by lowering a post-prandial peak of the glycemic response as compared to a peak without the electrical treatment and wherein the electrical treatment comprises application of a first electrical signal to the anterior sub diaphragmatic hepatic vagal trunk of the patient to down-regulate the neural activity thereof and application of a second electrical signal to the posterior sub diaphragmatic vagal trunk of the patient to up-regulate the neural activity thereof.
4. The system of claim 2, wherein the first electrical signal comprises a frequency of no more than about 5 kHz.
4. The system of claim 2, wherein the first electrical signal comprises a frequency of no more than about 5 kHz.
5. The system of claim 4, wherein the second electrical signal comprises a square wave having a frequency of between about 1-10 Hz.
5. (Original) The system of claim 4, wherein the second electrical signal comprises a square wave having a frequency of between about 1 Hz and 10Hz.
7.The system of claim 1, wherein the second sensor measures the protein level of the patient, and the system further comprising: a third sensor that measures the hormone level of the patient.
6. The system of claim 1, wherein the second sensor measures the protein level of the patient, and the system further comprising: a third sensor that measures the hormone level of the patient.
8. The system of claim 7, wherein the memory further comprises data that, when executed by the processor, enables the processor to analyze the inputs received from the first sensor, the second sensor, and the third sensor and further enables the processor to determine, based on the analysis, that the electrical treatment is to be applied to the patient.
7. The system of claim 6, wherein the memory further comprises data that, when executed by the processor, enables the processor to simultaneously analyze the inputs received from the first sensor, the second sensor, and the third sensor and further enables the processor to determine, based on the analysis, that the electrical treatment is to be applied to the patient.
11. The system of claim 1, wherein the second sensor comprises an activity sensor that measures the activity level of the patient.
10. The system of claim 1, wherein the second sensor comprises an activity sensor that measures the activity level of the patient.
12. The system of claim 11, wherein the activity sensor comprises at least one of a heart rate sensor, an accelerometer, a gyroscope, and a motion sensor.
11. The system of claim 10, wherein the activity sensor comprises at least one of a heart rate sensor, an accelerometer, a gyroscope, and a motion sensor.
13. The system of claim 1, wherein first sensor comprises a continuous glucose monitor.
12. The system of claim 1, wherein the first sensor comprises a continuous glucose monitor.
14. A device comprising:a processor that receives a first input from a first sensor and a second input from a second sensor, wherein the first input describes a glycemic level of a patient, and wherein the second input describes at least one of a hormone level, a protein level, and an activity level of the patient; and memory comprising data that, when executed by the processor, enables the processor to; analyze the first input and the second input; determine, based on the analysis, that a treatment is to be applied to the patient, wherein the treatment comprises application of at least one electrical signal to a nervous system of the patient; and cause the treatment to be applied to the patient.
13. A device comprising:a processor that receives a first input from a first sensor and a second input from a second sensor, wherein the first input describes a glycemic level of a patient, and wherein the second input describes at least one of a hormone level, a protein level, and an activity level of the patient; andmemory comprising data that, when executed by the processor, enables the processor to;analyze the first input and the second input;determine, based on the analysis, that an electrical treatment is to be applied to the patient on a basis of glucose sensing and on a combined basis of protein sensing and hormone sensing, both of which are predicated upon the activity level of the patient, wherein the electrical treatment comprises application of at least one electrical signal to an anterior sub diaphragmatic hepatic vagal trunk of the patient to down-regulate neural activity thereof and/or to a posterior sub diaphragmatic vagal trunk of the patient to up-regulate neural activity thereof; and cause the electrical treatment to be applied to the patient based on the combined basis of the measured protein level exceeding a predetermined protein threshold and the measured hormone level exceeding a predetermined hormone threshold.
16. The device of claim 14, wherein the processor receives a third input from a third sensor, wherein the second input describes the hormone level, wherein the third input describes the protein level, and wherein the memory further comprises data that, when executed by the processor, enables the processor to analyze the third input along with the first input and the second input, then determine, based on the analysis, that the treatment is to be applied to the patient.
15. The device of claim 13, wherein the processor receives a third input from a third sensor, wherein the second input describes the hormone level, wherein the third input describes the protein level, and wherein the memory further comprises data that, when executed by the processor, enables the processor to simultaneously analyze the third input along with the first input and the second input, then determine, based on the analysis, that the electrical treatment is to be applied to the patient.
17. The device of claim 16, wherein the processor receives a fourth input from a fourth sensor, wherein the fourth input describes the activity level, and wherein the memory further comprises data that, when executed by the processor, enables the processor to analyze the fourth input along with the first input, the second input, and the third input, then determine, based on the analysis, that the treatment is to be applied to the patient.
16. The device of claim 15, wherein the processor receives a fourth input from a fourth sensor, wherein the fourth input describes the activity level, and wherein the memory further comprises data that, when executed by the processor, enables the processor to analyze the fourth input along with the first input, the second input, and the third input, then determine, based on the analysis, that the electrical treatment is to be applied to the patient on the basis of the glucose sensing or on the combined basis of the protein sensing and the hormone sensing as long as the activity level of the patient is below a predetermined activity threshold.
18. The device of claim 17, wherein the fourth sensor comprises at least one of a heart rate sensor, an accelerometer, a gyroscope, and a motion sensor.
17. The device of claim 16, wherein the fourth sensor comprises at least one of a heart rate sensor, an accelerometer, a gyroscope, and a motion sensor.
19. A closed-loop system for providing therapy to a patient, the system comprising: a plurality of sensors, wherein the plurality of sensors measure two or more of a glycemic level of the patient, a hormone level of the patient, a protein level of the patient, and an activity level of the patient; a processor; and memory comprising data that, when executed by the processor, enables the processor to; receive inputs from the plurality of sensors; analyze the inputs received from the plurality of sensors; determine, based on the analysis, that a treatment is to be applied to the patient, wherein the treatment comprises application of at least one electrical signal to a nervous system of the patient; and cause the treatment to be applied to the patient.
18. A closed-loop system for providing therapy to a patient, the system comprising: a plurality of sensors, wherein the plurality of sensors measure two or more of a glycemic level of the patient, a hormone level of the patient, a protein level of the patient, and an activity level of the patient; a processor; and memory comprising data that, when executed by the processor, enables the processor to; receive inputs from the plurality of sensors; analyze the inputs received from the plurality of sensors; determine, based on the analysis, that an electrical treatment is to be applied to the patient on a basis of glucose sensing and on a combined basis of protein sensing and hormone sensing, both of which are predicated upon the activity level of the patient, wherein the electrical treatment comprises application of at least one electrical signal to an anterior sub diaphragmatic hepatic vagal trunk of the patient to down-regulate neural activity thereof and/or to a posterior sub diaphragmatic vagal trunk of the patient to up-regulate neural activity thereof; and cause the electrical treatment to be applied to the patient based on the combined basis of the measured protein level exceeding a predetermined protein threshold and the measured hormone level exceeding a predetermined hormone threshold.
20. The closed-loop system of claim 19, further comprising: a first electrode that delivers a first electrical signal to a first portion of a nerve; and a second electrode that delivers a second electrical signal to a second portion of the nerve.
19. The closed-loop system of claim 18, further comprising:a first electrode that delivers a first electrical signal to the anterior sub diaphragmatic hepatic vagal trunk of the patient to down-regulate the neural activity thereof; and a second electrode that delivers a second electrical signal to the posterior sub diaphragmatic vagal trunk of the patient to up-regulate the neural activity thereof.
21. The closed-loop system of claim 19, wherein the processor and the memory are included in an implantable pulse generator.
20. The closed-loop system of claim 18, wherein the processor and the memory are included in an implantable pulse generator.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ATTIYA SAYYADA HUSSAINI whose telephone number is (703)756-5921. The examiner can normally be reached Monday-Friday 8:00 am - 5:00 pm.
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, Niketa Patel can be reached at 5712724156. 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.
/ATTIYA SAYYADA HUSSAINI/Examiner, Art Unit 3792
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792
Prosecution Insights