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 .
Response to Arguments
Applicant's arguments filed on November 19, 2025 have been fully considered but they are not fully persuasive.
In regard to the previous objections of claim 12, applicant has made appropriate corrections to the claim, therefore the previous objection of claim 12 is withdrawn.
In regard to applicant’s arguments regarding claim 18, applicant states that no disclosure in Koya states “determining, based on an analysis of multiple sensor inputs, 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.” The examiner respectfully disagrees.
As stated in paragraph 0085 of Koya, the system utilizes many sensors (such as blood glucose sensors, insulin sensors, sensors for detecting the amino acid concentration, activity sensors using accelerometer data, progesterone/estrogen sensors, etc.) in order to provide closed-loop control of the implantable neurostimulator. Furthermore, as stated in the last sentence of paragraph 0086-0087 and paragraph 0129, the therapy control can be based on the sensor inputs from multiple sensors as described in addition to the activity level of the patient (para 0086 - emphasis on the following sentence: “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.”).
In regards to the arguments of claim 1, like Koya, applicant states Waataja does not disclose the following, “determining, based on an analysis of multiple sensor inputs, 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.” Respectfully, the examiner partially disagrees.
As stated previously, Koya does disclose the previously disclosed subject matter. However, In regard to claim 1, although Waataja teaches utilizing a plurality of sensors (such as glucose sensors and/or other sensors that sense other biological molecules or hormones of interest) to tune stimulation (as stated in para 0090 and para 0145), they do not explicitly disclose utilizing glucose sensing, protein sensing, and hormone sensing upon predicting the activity level of a patient. Therefore, the rejections of claims 1-17 have been withdrawn. However, upon further search and consideration, a new ground(s) of rejection have been made in view of applicant’s amendments as can be further seen below.
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.
Claims 1-8 and 10-17 are rejected under 35 U.S.C. 103 as being unpatentable over US 2021/0146136 A1 to Waataja et al. (hereinafter “Waataja”) in view of US 2019/0125227 A1 to Koya et al. (hereinafter “Koya”).
Regarding claim 1, Waataja teaches a system (para 0009), comprising:
a first sensor that measures a glycemic level of a patient (para 0090 and para 0062: “In some embodiments the sensor is designed to measure the blood glucose 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 (para 0090 and para 0145: “In some embodiments, the sensor can be a sensing electrode, a glucose sensor, or sensor that senses other biological molecules or hormones of interest.”), a processor/controller that receives inputs from the first sensor and inputs from the second sensor/one or more sensors (para 0090 and para 0145),
and memory (para 0059 and 0061, line 1) comprising data/patient data (para 0059 and 0061, line 1) that, when executed by the processor/controller, enables the processor/controller to:
analyze the inputs (hormones or molecules) received from the first sensor and the second sensor (a sensor or a plurality of sensors)(para 0090 and para 0145),
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 (see para 0041, para 0071-0072, para 0120, para 0128, para 0160, and para 0163), and
cause the electrical treatment to be applied to the patient (para 0018 and para 0163-0164), but does not explicitly disclose wherein 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.
However, Koya teaches wherein an electrical treatment is to be applied to the patient on a basis of glucose sensing and on a combined basis of protein/amino acid sensing and hormone sensing (such as the progesterone/estrogen or cortisol levels) of the patient, both of which are predicated upon the activity level of the patient (see para 0085, para 0086- emphasis on the last sentence, para 0087, and para 0129).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Waataja with the activity sensor of Koya to arrive at the claimed invention, since such modification would improve the system by providing more accurate stimulation therapy, therefore reducing the likelihood of an error associated with the stimulation therapy when treating the patient.
Regarding claim 2, Waataja as modified teaches the system of claim 1, 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 a first portion of a nerve (see para 0071-0072, 0120, 0128, 0160, and 0163—emphasis on this paragraph),
and
application of a second electrical signal to the posterior sub diaphragmatic vagal trunk of the patient to up-regulate the neural activity thereof (see para 0071-0072, 0120, 0128, 0160, and 0163—emphasis on this paragraph), but does not explicitly disclose 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.
However, Koya teaches wherein the electrical treatment is applied to the patient to mute a glycemic response of the patient by lowering a post-prandial peak/post-meal peak (as taught in para 0059 of the specification) of the glycemic response as compared to a peak without the electrical treatment (see annotated fig. 2A-2B below, para 0043-0044, and para 0086).
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Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Waataja with the activity sensor of Koya to arrive at the claimed invention, since such modification would improve the system by providing a more accurate evaluation of how significantly the stimulation therapy is affecting the patient, ultimately allowing for more precise and accurate tuning of the neuromodulation therapy.
Regarding claim 3, Waataja as modified teaches the system of claim 2, wherein the first electrical signal comprises an ultralow frequency (such as a frequency in the range of 200Hz to 5000Hz), long pulse width stimulation (see para 0011 – the pulse width stimulation length can be modified)) of the anterior sub diaphragmatic hepatic vagal trunk of the patient (where the blocking signal is used for down-regulating as described in para 0055 of applicant’s specification -- see abstract, para 0018 – blocking signal applied to the hepatic branch of the anterior vagal nerve, para 0052, para 0075, para 0131, and para 0163 of Koya),
and,
wherein the second electrical signal comprises bursts of an alternative waveform applied to the posterior sub diaphragmatic vagal trunk of the patient (see para 0018, para 0133-0134 and para 0137-0138, and para 0163), but does not explicitly disclose wherein the second electrical signal comprises bursts of non-square stimulation pulses.
However, Waataja teaches wherein the first stimulation signal comprises pulses of square, sinusoidal, or other wave form shapes for the down regulating/blocking signal (see para 0131), and wherein the second signal’s (upregulating signal) waveform can be altered/modified (see para 0133-0134).
Therefore, It would have been obvious to one of ordinary skill in the art as of the filing date of Applicant' s invention to engage in routine experimentation to determine the optimal waveform structure/shape most suitable for the upregulating/second signal. 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”) (citing In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)).
Regarding claim 4, Waataja as modified teaches the system of claim 2, wherein the first electrical signal comprises a frequency of no more than/below about 5 kHz (para 0131).
Regarding claim 5, Waataja as modified teaches the system of claim 4, wherein the second electrical signal (the upregulating signal) has a frequency of between about 1 Hz and 10Hz (see para 0133).
Regarding claim 6, Waataja as modified teaches the system of claim 1, wherein the system can comprise one or more sensors used to initiate therapy to more than one electrode (see para 0090), and discloses wherein a sensor used in the device can be either a glucose sensor or another sensor that senses biological hormones of interest (see para 0145, lines 1-3), but does not explicitly disclose 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.
However, Koya teaches wherein multiple sensors are used (such as a sensor for detecting amino acids and sensors for detecting the hormone level) of the patient (see para 0085).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Waataja with the activity sensor of Koya to arrive at the claimed invention, since such modification would improve the system by providing more accurate stimulation therapy, therefore reducing the likelihood of an error associated with the stimulation therapy when treating the patient.
Regarding claim 7, Waataja as modified teaches the system of claim 6, but does not disclose 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.
However, Koya teaches analyzing inputs from the first sensor, the second sensor, and the third sensor ( or multiple sensors) and further enables the processor to determine, based on the analysis, that the electrical treatment is to be applied to the patient (see para 0085-0086).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Waataja with the activity sensor of Koya to arrive at the claimed invention, since such modification would improve the system by providing more accurate stimulation therapy, therefore reducing the likelihood of an error associated with the stimulation therapy when treating the patient.
Regarding claim 8, Waataja as modified teaches the system of claim 7, wherein the electrical treatment is applied by applying the following conditions:
for applying the electrical treatment on the basis of the glucose sensing, the measured glycemic level exceeds a predetermined glycemic threshold (see para 0090 and para 0135) OR
for applying the electrical treatment on the combined basis of the protein sensing and the hormone sensing, the measured protein level exceeds a predetermined protein threshold AND the measured hormone level exceeds a predetermined hormone threshold,
but does not explicitly disclose wherein the electrical treatment is applied on the basis of glucose sensing and on the combined basis of the protein sensing and the hormone sensing.
However, Koya teaches (as described above), the use of multiple sensors (such as glucose sensors, protein sensors, and hormone sensors (for cortisol and/or progesterone/estrogen levels)) to control electrical treatment through closed-loop control (see para 0085-0086).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Waataja with the activity sensor of Koya to arrive at the claimed invention, since such modification would improve the system by providing more accurate stimulation therapy, therefore reducing the likelihood of an error associated with the stimulation therapy when treating the patient.
Regarding claim 10, Waataja as modified teaches the system of claim 1, but does not explicitly disclose wherein the second sensor comprises an activity sensor that measures the activity level of the patient.
However, Koya teaches wherein the second sensor can comprise an activity sensor that measures the activity level of the patient (see para 0085, para 0086- emphasis on the last sentence, para 0087, and para 0129: “The system illustrated in FIG. 27 includes a diabetic therapy delivery system 2792 for graded glucose control, 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)…. 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.”).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified teachings of Waataja with the sensor of Koya to arrive at the claimed invention, since such modification would improve the system by providing proper stimulation treatment and regulation of a patient.
Regarding claim 11, Waataja as modified teaches the system of claim 10, but does not 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 (para 0089).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified teachings of Waataja with the sensor of Koya to arrive at the claimed invention, since such modification would improve the system by providing proper stimulation treatment and regulation of a patient.
Regarding claim 12, Waataja as modified teaches the system of claim 1, but does not explicitly disclose wherein the first sensor comprises a continuous glucose monitor.
However, Koya teaches a system and method for an implantable structure/device for providing glucose control therapy (see title and abstract). The system (fig. 1) contains a continuous glucose monitor (see para 0166).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified teachings/device of Waataja with a continuous glucose monitor of Koya to arrive at the claimed invention, since such modification would improve the system by ensuring the patient’s glucose levels are continuously regulated and remain within an acceptable range, ultimately reducing the likelihood of kidney damage or other long term health complications from occurring.
Regarding claim 13, Waataja teaches a device (para 0018) comprising:
a processor that receives a first input from a first sensor and a second input from a second sensor a first sensor that measures a glycemic level of a patient, wherein the first input describes a glycemic level of a patient (para 0090 and para 0062: “In some embodiments the sensor is designed to measure the blood glucose level of a patient”);
a second sensor that can measure at least one of a protein level of the patient, a hormone level of the patient, and an activity level of the patient (para 0090 and para 0145: “In some embodiments, the sensor can be a sensing electrode, a glucose sensor, or sensor that senses other biological molecules or hormones of interest.”),
and memory (para 0059 and 0061, line 1) comprising data/patient data (para 0059 and 0061, line 1) that, when executed by the processor/controller, enables the processor/controller to:
analyze the first input and the second input/analyze the inputs (hormones or molecules) received from the first sensor and the second sensor (a sensor or a plurality of sensors)(para 0090 and para 0145),
determine, based on the analysis, that an electrical treatment/electrical signal or blocking signal is to be applied to the patient (para 0145), and
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 (see para 0041, para 0071-0072, para 0120, para 0128, para 0160, and para 0163), and cause the electrical treatment to be applied to the patient (para 0018 and para 0163-0164), but does not explicitly disclose wherein 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.
However, Koya teaches wherein an electrical treatment is to be applied to the patient on a basis of glucose sensing and on a combined basis of protein/amino acid sensing and hormone sensing (such as the progesterone/estrogen or cortisol levels) of the patient, both of which are predicated upon the activity level of the patient (see para 0085, para 0086- emphasis on the last sentence, para 0087, and para 0129).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified teachings of Waataja with the activity sensor of Koya to arrive at the claimed invention, since such modification would improve the system by providing more accurate stimulation therapy, therefore reducing the likelihood of an error associated with the stimulation therapy when treating the patient.
Regarding claim 14, Waataja as modified teaches the device of claim 13, 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 a first portion of a nerve (see para 0071-0072, 0120, 0128, 0160, and 0163—emphasis on this paragraph),
and
application of a second electrical signal to the posterior sub diaphragmatic vagal trunk of the patient to up-regulate the neural activity thereof (see para 0071-0072, 0120, 0128, 0160, and 0163—emphasis on this paragraph), but does not explicitly disclose 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.
However, Koya teaches wherein the electrical treatment is applied to the patient to mute a glycemic response of the patient by lowering a post-prandial peak/post-meal peak (as taught in para 0059 of applicant’s specification) of the glycemic response as compared to a peak without the electrical treatment (see annotated fig. 2A-2B below, para 0043-0044, and para 0086).
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Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified teachings of Waataja with the activity sensor of Koya to arrive at the claimed invention, since such modification would improve the system by providing a more accurate evaluation of how significantly the stimulation therapy is affecting the patient, ultimately allowing for more precise and accurate tuning of the neuromodulation therapy.
Regarding claim 15, Waataja as modified teaches the device of claim 13, but does not explicitly disclose 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.
However, Koya teaches wherein the processor can receive a third input from a third sensor, wherein the second input describes the hormone level, wherein the third input can describe 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 (input from multiple sensors), then determine, based on the analysis, that the electrical treatment is to be applied to the patient (such as using the plurality of sensor inputs for closed-loop control of the neuromodulator - see para 0085-0087, para 0089, para 0111-0112, and para 0177-0178).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified teachings of Waataja with the teachings of Koya to arrive at the claimed invention. Such modification would improve the system by using three sensors to control the stimulation therapy, ultimately providing more accurate stimulation therapy/treatment for the patient.
Regarding claim 16, Waataja as modified teaches the device of claim 15, but does not 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 can describe 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 (multiple sensor inputs), then determine, based on the analysis, that the treatment is to be applied to the patient (such as using the plurality of sensor inputs for closed-loop control of the neuromodulator - see para 0085-0087, para 0089, para 0111-0112, and para 0177-0178).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified teachings of Waataja with the system of Koya to arrive at the claimed invention. Such modification would improve the system by using a fourth activity sensor to control the stimulation therapy, ultimately providing more accurate stimulation therapy/treatment for the patient.
Regarding claim 17, Waataja as modified teaches the device of claim 16, but does not 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 activity sensor (which could be the fourth input) could be an accelerometer (see para 0085 and para 0089).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified teachings of Waataja with the sensor of Koya to arrive at the claimed invention. Such modification would improve the system by using a fourth activity sensor to control the stimulation therapy, ultimately providing more accurate stimulation therapy/treatment for the patient.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Waataja in view of Koya, and further in view of US 2017/0164876 A1 to Hyde et al. (hereinafter “Hyde”).
Regarding claim 9, Waataja as modified teaches:
The system of claim 8, wherein the system detects an increase and/or decrease of blood glucose levels according to a threshold (see claim 15), but does not disclose wherein the electrical treatment is not applied on the basis of the glucose sensing or on the combined basis of the protein sensing and the hormone sensing when the measured activity level of the patient is above a predetermined activity threshold.
However, Hyde teaches systems and methods for monitoring an individuals and facilitating a motion regimen for the patient (see abstract, lines 1-2). The system (figs. 1A-1B and 9) teaches wherein the electrical stimulation treatment is not applied on the basis of the glucose sensing or on the combined basis of the protein sensing and the hormone sensing when the measured activity level of the patient is above a predetermined activity threshold (see para 0206: “In an embodiment, 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).”, para 0207, para 0209, para 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).”, para 0211 - first two sentences, para 0189 – first sentence and the following sentences: “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.”, para 0213, and para 0214, first two sentences and last two sentences). Since the glucose data, protein data, and hormone data can all be used to assess a patient’s pain level (in addition to the patient’s motion data), the stimulation treatment can be only applied when the patient’s motion data indicates that they are at rest (where the rest state is at or under a motion threshold), therefore preventing stimulation from being applied when the motion data exceeds a predetermined motion threshold (where exceeding the motion threshold is indicative of an active state of a patient).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified teachings of Waataja with the activity sensor of Hyde to arrive at the claimed invention, since such modification would improve the system by providing proper stimulation treatment and regulation of a patient.
Claims 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Koya in view of Waataja.
Regarding claim 18, Koya teaches a closed-loop system for providing therapy to a patient (abstract and para 0009-0010), the system comprising:
a plurality of sensors (para 0085 and para 0090), 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 (para 0085),
a processor (para 0087, para 0111, and para 0177),
and memory (para 0111-0112) comprising data that, when executed by the processor, enables the processor to;
receive inputs from the plurality of sensors,
and analyze the inputs received from the plurality of sensors (para 0111-0112),
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 (para 0085, para 0086- emphasis on the last sentence, para 0087, and para 0129), and wherein the system comprises stimulating the hepatic neural targets for neuromodulation therapy (see para 0092), and cause the electrical treatment to be applied to the patient (para 0005, para 0019-0020, para 0081, para 0084, para 0091, and para 0177),
but does not explicitly disclose 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.
However, Waataja teaches 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 (see para 0041, para 0052, para 0071-0072, para 0120, para 0128, para 0160, and para 0163), and
cause the electrical treatment to be applied to the patient (para 0018 and para 0163-0164).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Koya with the activity sensor of Waataja to arrive at the claimed invention, since such modification would improve the system by providing more accurate stimulation therapy, therefore reducing the likelihood of an error associated with the stimulation therapy when treating the patient.
Regarding claim 19, Koya as modified teaches the closed-loop system of claim 18, but does not explicitly disclose wherein the system further comprises:
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.
However, Waataja teaches wherein 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 (see abstract, para 0018 – blocking signal applied to the hepatic branch of the anterior vagal nerve, para 0052, para 0075, and para 0163, para 0052),
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 (wherein the second electrical signal comprises bursts of an alternative waveform applied to the posterior sub diaphragmatic vagal trunk of the patient (see para 0018, para 0052, para 0133-0134, para 0137-0138, and para 0163).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Koya with the teachings of Waataja to arrive at the claimed invention, since such modification would improve the system by providing more precise glucose regulation for the patient.
Regarding claim 20, Koya as modified teaches the closed-loop system of claim 18, wherein the processor/microcontroller and the memory are included in an implantable pulse generator/neuromodulator (para 0111-0112).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Tweden et al. (US 2009/0254143 A1) teaches a system and apparatus used to treat and regulate impaired glucose regulation through the use of stimulation to various nerves, such as different branches of the vagus nerve (see title and abstract).
THIS ACTION IS MADE FINAL. 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.
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/K.J.W./Examiner, Art Unit 3792
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792