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
The Applicant filed Amendment and Response After Final on November 25, 2025 in response to the Examiner’s Final Office Action, mailed September 22, 2025. The Applicant filed a Request for Continued Examination was filed December 17, 2025.
Amendments to the Claims
At this time, claims 1-20 are pending. Claims 1, 17, and 20 have been amended. The Applicant asserts that no new matter is added. (Remarks, pg. 6)
Double Patenting
Claims 1-20 were provisionally rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-9, 12-13 and 15-20 of copending Application No. 18/137,378.
Applicant’s arguments with respect to claims 1-20 have been fully considered and are persuasive. The non-statutory double patenting rejection of September 22, 2025 has been withdrawn.
Claim Rejections - 35 U.S.C. § 103
Claims 1-20 were previously rejected under 35 U.S.C. 103. The Applicant argues that the cited art does not disclose or suggest amended claim 1. (Remarks, pg. 6-8) Such amendments have been made to further emphasize that an amount of time between incremental current increases gets shorter over a selected time period.
Applicant’s arguments, see Remarks, pg. 6-8, with respect to the rejections of claim 1-20 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Baldoni, Perryman, Dobak, Kramer, and Jiang (cited in the Claim Rejections section below).
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on September 22, 2025 has been entered.
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, 3-5, 7, 9-17, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Baldoni et al. (US 2019/0321641, hereinafter referred to as Baldoni) in view of Perryman (EP 2651431) (both cited previously) and further in view of Dobak (US 2005/0065575).
Regarding amended, independent claim 1, Baldoni discloses systems and methods for treating a patient having a blood glucose abnormality, such as type 2 diabetes (T2D), using an electrical signal. Baldoni further discloses a system for treating metabolic syndrome ([0028]: “The present technology is directed generally to spinal cord modulation and associated systems and methods for treating blood glucose abnormalities, including metabolic syndrome, type 2 diabetes (T2D)… via waveforms with therapeutic electrical signal elements or components that provide therapeutic results.”), comprising:
a device (system 100 in Fig. 1A) comprising:
a signal generator configured to generate an electrical signal ([0046]: “The signal generator 101 can transmit signals (e.g., electrical signals) to the signal delivery elements 110 that excite and/or suppress target nerves (e.g., sympathetic nerves).”); and
at least one processor (one or more processor(s) 107 in Fig. 1A; [0115]: “…the patient can use a constant glucose monitor that continuously monitors the patient's blood glucose level and communicates the measurements to an internal or external processor (e.g., an implanted pulse generator, or a phone-based app or other external device).”) configured to:
monitor a value of at least one parameter of a patient that is associated with diabetes ([0028]: “…systems and methods for treating blood glucose abnormalities, including… type 2 diabetes (T2D)…”); and
one or more electrodes (first and second leads 111a, 111b in FIG. 1A) coupled to the signal generator ([0044]: “...the signal delivery devices 110 can include one or more elongated lead(s) or lead body or bodies 111 (identified individually as a first lead 111a and a second lead 111b). As used herein, the terms signal delivery device, lead, and/or lead body include any of a number of suitable substrates and/or supporting members that carry electrodes/devices for providing therapy signals to the patient 190. For example, the lead or leads 111 can include one or more electrodes or electrical contacts that direct electrical signals into the patient's tissue, e.g., to provide for therapeutic relief.”) to stimulate at least one dorsal root ganglion ([0034]: “…therapeutic modulation signals are directed to the target location that generally includes the patient's spinal cord, e.g., the dorsal column of the patient's spinal cord. The modulation signals can be directed to the …dorsal root ganglion...”) of at least one spinal nerve ([0031]: “… a target neural population in the thoracic region of the patient's spinal column (e.g., T2-T12)…”) based on the electrical signal which causes a response by at least one anatomical element of the patient ([0031]: “…inhibiting at least a portion of the patient's sympathetic nervous system, such as one or more sympathetic nerves corresponding to one or more of the patient's …pancreas, …may result in the therapeutic effect by … altering insulin production...”) that changes the value of the at least one parameter of the patient ([0095]: “…if a change in the patient's blood glucose level is detected, the systems, devices, and methods described herein can automatically deliver therapeutic electrical signals. Representative systems and methods described herein can include one or more sensors configured to monitor the patient's blood glucose levels by detecting an amount of glucose in the patient's blood.”).
Baldoni is silent to the at least one processor being configured to: control, when the value of the at least one parameter exceeds a threshold value, the signal generator to generate, over a selected time period, the electrical signal with incremented current values up to a maximum current value until either the value of the at least one parameter drops below the threshold value or the selected time period expires, wherein an amount of time between each current value increment becomes shorter over the selected time period; and
…wherein the maximum current value is set based on a current value known to stimulate a part of the at least one spinal nerve other than the at least one dorsal root ganglion.
However, Perryman teaches a system and apparatus for control of pancreatic beta cell function to improve glucose homeostatis and insulin production. Perryman further teaches to control, when the value of the at least one parameter exceeds a threshold value, the signal generator to generate the electrical signal ([0065]: “If outside the desired or threshold range, the feedback controller can initiate adjustments to parameter settings of the electrical stimulation.”; [0075]: “The controller can send the signals to increase or decrease stimulation until glucose homeostasis is achieved… The controller can include a microprocessor that can instruct the system to produce an exciting or inhibiting stimulation signal or to cease electrical stimulation.”) until the value of the at least one parameter drops below the threshold value ([0075]: “The controller can send the signals to increase or decrease stimulation until glucose homeostasis is achieved… The controller can include a microprocessor that can instruct the system to produce an exciting or inhibiting stimulation signal or to cease electrical stimulation.”) until the value of the at least one parameter drops below the threshold value.
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to combine the above-described teachings of Perryman, which teaches controlling the signal generator based on a threshold value, with the invention of Baldoni due to the similar areas of pursuit. Further, it would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the stimulation system of Baldoni to include a threshold limitation case for controlling the start of electrostimulation in order to keep the patient’s blood glucose levels from rising above a normal, healthy range (see Perryman [0058], where "the Cafferent sensory nerve fibers innervating pancreatic beta cells are either excited or inhibited to promote glucose homeostasis in response to abnormal biomarker levels"). Continuing, it would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the stimulation system of Baldoni to include a case to stop electrostimulation when the blood glucose parameter is below the threshold, as taught by Perryman, in order to prevent the patient’s blood glucose levels from falling below a normal, healthy range.
The Baldoni/Perryman combination is silent to controlling the signal generator to generate, over a selected time period, the electrical signal with incremented current values up to a maximum current value until the selected time period expires, wherein an amount of time between each current value increment becomes shorter over the selected time period; and
…wherein the maximum current value is set based on a current value known to stimulate a part of the at least one spinal nerve other than the at least one dorsal root ganglion.
However, Dobak teaches dynamic nerve stimulation for treatment of disorders. Dobak further teaches controlling the signal generator (such as that in Fig. 5) to generate, over a selected time period ([0127]: “Optimal intermittent therapy may be, for example, 18 hours on and 6 hours off, 12 hours on and 12 hours off, 3 days on and 1 day off, 3 weeks on and one week off or another combination of daily or weekly cycling. Alternatively, treatment can be delivered at a higher interval rate, say, about every three hours, for shorter durations, such as about 2-30 minutes. The treatment duration and frequency can be tailored to achieve the desired result. The treatment duration can last for as little as a few minutes to as long as several hours.”), the electrical signal with incremented current values up to a maximum current value ([0130]: “The muscle-twitching phenomenon can also be used to help guide the stimulation intensity used for the therapy. Once the threshold of muscle twitching is reached, activation of at least the A fibers has occurred. Increasing the current amplitude beyond the threshold increases the severity of the muscle contraction and can increase discomfort. Delivering the therapy at about the threshold for muscle twitching, and not substantially higher, helps ensure that the comfort of the patient is maintained, particularly at higher frequencies. …It should be noted that patient comfort can be achieved at current amplitudes slightly higher than the muscle twitch threshold, or that effective therapy can be delivered at current amplitudes slightly below the muscle twitch threshold, particularly at longer pulse widths.”) until the selected time period expires, wherein an amount of time between each current value increment becomes shorter over the selected time period ([0157]: “A single cycle of ramp-cycling therapy comprises a stimulation time period and a no-stimulation time period. … In other embodiments the treatment parameters, and/or the duty cycle parameters and/or the signal parameters may be changed from cycle to cycle.”; [0191]: “…the changes in the stimulation duty cycle may be accomplished by fixing the signal-on time to a certain duration (e.g. about 15 seconds to about 60 seconds), and the signal-off time may be varied from about 15 about 5 minutes). This can be accomplished randomly or through a preset pattern such as 50%, 33%, 25%, 20%, 10% that repeats upward and/or downward indefinitely.”; Figs. 27-31; The Examiner notes that Figs. 31 and para. [0191] show the electric signal can be controlled such that shorter duration than the immediately preceding iteration.); and
…wherein the maximum current value is set based on a current value known to stimulate a part of the at least one spinal nerve other than the at least one dorsal root ganglion ([0026]: “A dynamic stimulation technique using ramp-cycling can be used on cranial nerves, the spinal cord, and/or other peripheral nerves, including those in the autonomic system and other motor and sensory nerves.”; [0130]).
Dobak is of a similar pursuit to that of the Baldoni/Perryman combination and the instant application in teaching electrotherapy through spinal or peripheral nerve electrodes. Dobak additionally teaches treatment of Type II diabetes ([0214]: “In obesity, insulin levels are often elevated, and insulin resistant diabetes (Type II) is common. Down-regulation of insulin secretion by splanchnic nerve activation may help correct insulin resistant diabetes.”) Therefore, it would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the feedback system of the Baldoni/Perryman combination to include control of the time period, current, and time between each current value of electric signal, as a shorter duration than the immediately preceding iteration, which may result in faster treatment of type 2 diabetes and/or the condition of metabolic syndrome such as a high blood glucose level because higher current levels are implemented more quickly.
Regarding claim 3, in view of the Baldoni/Perryman/Dobak/Kramer combination, Baldoni discloses that the signal generator (signal generator 101 and signal delivery elements 110 in Fig. 1A) is controlled to generate the electrical signal ([0095]: “…if a change in the patient's blood glucose level is detected, the systems, devices, and methods described herein can automatically deliver therapeutic electrical signals.”).
Baldoni does not teach generating the electrical signal in a manner that keeps the value of the at least one parameter above a second threshold value that is less than the threshold value.
However, Perryman teaches second threshold value ([0033]: “The method is performed in which the biomarker is glucose and the level is below about 100 mg/dL, and the electrical stimulation is carried out to inhibit said C-afferent sensory nerve fibers innervating pancreatic beta cells.”; Note: 120 mg/dL is equivalent to 5.55 mmol/L.) that is less than the threshold value ([0033]: “The method is performed in which the biomarker is glucose and the level is above about 120 mg/dL, and the electrical stimulation is carried out to excite the C-afferent sensory nerve fibers innervating pancreatic beta cells.”; Note: 120 mg/dL is equivalent to 6.67 mmol/L.).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the stimulation system of Baldoni (and further the Baldoni/Perryman/Dobak combination) to include a first and second threshold limitation case for controlling the start and stop of electrostimulation in order to keep the patient’s blood glucose levels from falling outside of a normal, healthy range.
Regarding claim 4, in view of the Baldoni/Perryman/Dobak combination, Baldoni discloses that the at least one parameter comprises a blood glucose level of the patient ([0113]: “In block 806, the effects of the therapy on the patient are detected. For example, block 806 can include detecting a serum blood glucose level, at a particular point in time.”; [0117]: “By selecting and manipulating the parameters described herein, the disclosed techniques can affect both insulin levels and the patient's glucose storage rates. By controlling both variables, these techniques can more accurately control the patient's blood sugar levels, and therefore more accurately control the patient's T2D.”).
Regarding claim 5, in view of the Baldoni/Perryman/Dobak combination, although Baldoni discloses a threshold value between 100 mg/dL and about 175 mg/dL ([0091]: “Delivering one or more therapeutic modulation signals described herein to a patient having T2D can maintain the T2D patient's blood glucose levels between about 75 mg/dL and about 200 mg/dL, and more specifically, between about 100 mg/dL and about 175 mg/dL.”; Note: 7 mmol/L is equivalent to 126 mg/dL.), it does not explicitly teach a threshold of 7mmol/L.
However, Perryman teaches that the threshold value is 7mmol/L ([0033]: “The method is performed in which the biomarker is glucose and the level is above about 120 mg/dL, and the electrical stimulation is carried out to excite the C-afferent sensory nerve fibers innervating pancreatic beta cells.”; Note: 120 mg/dL is equivalent to 6.67 mmol/L.). While 6.67 mmol/L is slightly less than 7mmol/L, 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 discover the optimal threshold value. 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)).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the stimulation system of Baldoni (and further the Baldoni/Perryman/Dobak combination) to include this limitation case for controlling the start of electrostimulation in order to keep the patient’s blood glucose levels from falling outside of a normal, healthy range (Perryman [0058]: “…the C-afferent sensory nerve fibers innervating pancreatic beta cells are either excited or inhibited to promote glucose homeostasis in response to abnormal biomarker levels.”).
Regarding claim 7, in view of the Baldoni/Perryman/Dobak combination, Baldoni discloses the signal generator (signal generator 101 and signal delivery elements 110 in Fig. 1A; ([0095]: “…if a change in the patient's blood glucose level is detected, the systems, devices, and methods described herein can automatically deliver therapeutic electrical signals.”).
Baldoni does not disclose that when the value of the at least one parameter drops below the threshold value, the signal generator to cease generating the electrical signal.
However, Perryman teaches that when the value of the at least one parameter drops below the threshold value, the signal generator to cease generating the electrical signal ([0075]: “The controller can send the signals to increase or decrease stimulation until glucose homeostasis is achieved… The controller can include a microprocessor that can instruct the system to produce an exciting or inhibiting stimulation signal or to cease electrical stimulation.”).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the stimulation system of Baldoni (and further the Baldoni/Perryman/Dobak combination) to include a case to stop electrostimulation when the blood glucose parameter is below the threshold, as taught by Perryman, in order to prevent the patient’s blood glucose levels from falling below a normal, healthy range.
Regarding claim 9, in view of the Baldoni/Perryman/Dobak combination, Baldoni discloses that the signal generator (signal generator 101 and signal delivery elements 110 in Fig. 1A) is controlled to adjust a pulse width of the electrical signal ([0053]: “In response to the patient feedback, one or more signal parameters can be adjusted, such as frequency, pulse width, amplitude or delivery location.”).
Regarding claim 10, in view of the Baldoni/Perryman/Dobak combination, Baldoni discloses that the at least one anatomical element of the patient comprises the patient's pancreas ([0031]: “…inhibiting at least a portion of the patient's sympathetic nervous system, such as one or more sympathetic nerves corresponding to one or more of the patient's …pancreas, …may result in the therapeutic effect by increasing glycogen production (e.g., hepatic glycogenesis), increasing insulin sensitivity, increasing the patient's gastrointestinal contraction rate which, without intending to be bound by any particular theory, may induce release of glucagon-like peptide-1 (GLP-1) from the patient's intestine, and/or otherwise altering insulin production...”).
Regarding claim 11, in view of the Baldoni/Perryman/Dobak combination, Baldoni discloses that the response by the patient's pancreas comprises an increase in insulin production ([0031]: “The therapeutic effect can be produced by inhibiting, suppressing, downregulating, blocking, preventing, and/or otherwise modulating the activity of the affected and/or target neural population, such as a target neural population in the thoracic region of the patient's spinal column (e.g., T2-T12). In representative systems and methods, the affected neural population is located within, proximate to, or otherwise corresponds to the patient's sympathetic nervous system, which modulates glycogen production and regulates the patient's production and/or response to insulin.”; [0117]: “By selecting and manipulating the parameters described herein, the disclosed techniques can affect both insulin levels and the patient's glucose storage rates.”).
Regarding claim 12, in view of the Baldoni/Perryman/Dobak combination, Baldoni discloses that the at least one dorsal root ganglion of the at least one spinal nerve ([0031]) comprises multiple dorsal root ganglions ([0034]: “In representative systems and methods, therapeutic modulation signals are directed to the target location that generally includes the patient's spinal cord, e.g., the dorsal column of the patient's spinal cord. The modulation signals can be directed to the …dorsal root ganglion…”) of different spinal nerves ([0031]: “The therapeutic effect can be produced by inhibiting, suppressing, downregulating, blocking, preventing, and/or otherwise modulating the activity of the affected and/or target neural population, such as a target neural population in the thoracic region of the patient's spinal column (e.g., T2-T12)… In representative systems and methods, the therapeutic effect may be produced by inhibiting one or more sympathetic nerves corresponding to one or more thoracic vertebrae in the range of T2 to T12.”).
Regarding claim 13, in view of the Baldoni/Perryman/Dobak combination, Baldoni discloses that the multiple dorsal root ganglion nerves are at one or more of thoracic levels T7, T8, T9, T10, T11, and/or T12 of the patient ([0080]: “In representative systems and methods, one or more therapeutic modulation signals can be delivered to a target location proximate to or at one or more of T7 to T12.”).
Baldoni does not disclose that the multiple dorsal root ganglion nerves are at one or more of lumbar levels L1 and/or L2 of the patient.
However, Perryman teaches that the multiple dorsal root ganglion nerves are at one or more of lumbar levels L1 and/or L2 of the patient ([0014]: “FIG. 4 is a diagram of a cross sectional pathway overview of a spinal column segment 201 at which an electrode lead 202 is placed to stimulate the dorsal root ganglia 203 and/or spinal nerves 210 from in the dermatome regions from spinal segments T7 to L1, which are sensory nerve fibers 204 that lead to the pancreas 206.”).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the Baldoni stimulation locations to further include the lumbar levels taught by Perryman in order to cause the pancreas to increase insulin and/or glucagon production to lower the patient's blood glucose level, thereby providing an effective treatment for type 2 diabetes.
Regarding claim 14, in view of the Baldoni/Perryman/Dobak combination, Baldoni discloses a monitoring device configured to continuously provide data ([0104]: “Monitoring a patient's blood glucose level can be performed on a continuous basis using one or more sensing elements (referred to herein as a “sensing element”) for detecting neural signals, neural responses, and/or other physiological parameters of the patient before, during and/or after the application of electrical stimulation signals to the patient.”; [0105]: “The neural response(s) can be detected frequently enough such that an upward or downward trend of the data corresponding to the blood glucose levels can be determined, or at least estimated.”) that enables the at least one processor (one or more processor(s) 107 in Fig. 1A) to monitor the value of the at least one parameter ([0104] discloses that the sensing element monitors the value of the patient’s blood glucose level on a continuous basis.).
Regarding claim 15, in view of the Baldoni/Perryman/Dobak combination, Baldoni discloses that the data comprises the value of the at least one parameter ([0104]: “Monitoring a patient's blood glucose level can be performed on a continuous basis using one or more sensing elements … for detecting neural signals, neural responses, and/or other physiological parameters of the patient…”).
Regarding claim 16, in view of the Baldoni/Perryman/Dobak combination, Baldoni discloses that the at least one processor (one or more processor(s) 107 in Fig. 1A) processes the data to determine the value of the at least one parameter ([0115]: “…the patient can use a constant glucose monitor that continuously monitors the patient's blood glucose level and communicates the measurements to an internal or external processor (e.g., an implanted pulse generator, or a phone-based app or other external device). …In any of these representative systems and methods, the system can automatically determine whether or not to change the signal parameters at block 808, and can automatically establish proposed updates at block 810.”; In Fig. 8: Step 808 “Can the therapy be improved?” and Step 810 “Establish updates”).
Regarding amended, independent claim 17, Baldoni discloses an implantable device for treating metabolic syndrome ([0044]: “FIG. 1A schematically illustrates a representative patient therapy system 100 for treating a patient's blood glucose abnormalities (e.g., T2D or metabolic syndrome), arranged relative to the general anatomy of the patient's spinal column 191. The system 100 can include a signal generator 101 (e.g., an implanted or implantable pulse generator or IPG), which may be implanted subcutaneously within a patient 190 and coupled to one or more signal delivery elements or devices 110.”), comprising:
a signal generator configured to generate an electrical signal (signal generator 101 and signal delivery elements 110 in Fig. 1A; [0046]: “The signal generator 101 can transmit signals (e.g., electrical signals) to the signal delivery elements 110 that excite and/or suppress target nerves (e.g., sympathetic nerves).”); and
at least one processor (one or more processor(s) 107 in Fig. 1A; [0115]: “…the patient can use a constant glucose monitor that continuously monitors the patient's blood glucose level and communicates the measurements to an internal or external processor…”) configured to:
monitor a value of at least one parameter of a patient that is associated with type 2 diabetes ([0028]: “…spinal cord modulation and associated systems and methods for treating blood glucose abnormalities, including metabolic syndrome, type 2 diabetes (T2D)…”; [0095]: “one or more sensors configured to monitor the patient's blood glucose levels by detecting an amount of glucose in the patient's blood.”); and
control the signal generator to output the electrical signal to one or more electrodes (first and second leads 111a, 111b in FIG. 1A) to stimulate at least one dorsal root ganglion ([0034]: “…therapeutic modulation signals are directed to the target location that generally includes the patient's spinal cord, e.g., the dorsal column of the patient's spinal cord. The modulation signals can be directed to the …dorsal root ganglion...”) of at least one spinal nerve of the patient ([0031]: “The therapeutic effect can be produced by inhibiting, suppressing, downregulating, blocking, preventing, and/or otherwise modulating the activity of the affected and/or target neural population, such as a target neural population in the thoracic region of the patient's spinal column (e.g., T2-T12)… In representative systems and methods, the therapeutic effect may be produced by inhibiting one or more sympathetic nerves corresponding to one or more thoracic vertebrae in the range of T2 to T12.”) which causes a response by at least one anatomical element of the patient that changes the value of the at least one parameter ([0031]: “…inhibiting at least a portion of the patient's sympathetic nervous system, such as one or more sympathetic nerves corresponding to one or more of the patient's …pancreas, …may result in the therapeutic effect by … altering insulin production...”).
Baldoni is silent to controlling, when the value of the at least one parameter exceeds a threshold value, the signal generator to output the electrical signal over a selected time period to one or more electrodes to stimulate at least one dorsal root ganglion of at least one spinal nerve of the patient which causes a response by at least one anatomical element of the patient that changes the value of the at least one parameter, wherein the signal generator is controlled to output the electrical signal with incremented current values up to a maximum current value until either the value of the at least one parameter drops below the threshold value or the selected time period expires, wherein an amount of time between each current value increment becomes shorter over the selected time period,
wherein the maximum current value is set based on a current value known to stimulate at least one ventral root of the at least one spinal nerve.
However, Perryman teaches control of the signal generator being based on when the value of the at least one parameter exceeds a threshold value and wherein the signal generator is controlled to output the electrical signal ([0065]: “If outside the desired or threshold range, the feedback controller can initiate adjustments to parameter settings of the electrical stimulation.”; [0075]: “The controller can send the signals to increase or decrease stimulation until glucose homeostasis is achieved… The controller can include a microprocessor that can instruct the system to produce an exciting or inhibiting stimulation signal or to cease electrical stimulation.”) until the value of the at least one parameter drops below the threshold value ([0075]: “The controller can send the signals to increase or decrease stimulation until glucose homeostasis is achieved… The controller can include a microprocessor that can instruct the system to produce an exciting or inhibiting stimulation signal or to cease electrical stimulation.”).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to combine the above-described teachings of Perryman, which teaches controlling the signal generator based on a threshold value, with the invention of Baldoni due to the similar areas of pursuit. Further, it would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the stimulation system of Baldoni to include a threshold limitation case for controlling the start of electrostimulation in order to keep the patient’s blood glucose levels from rising above a normal, healthy range (see Perryman [0058], where "the Cafferent sensory nerve fibers innervating pancreatic beta cells are either excited or inhibited to promote glucose homeostasis in response to abnormal biomarker levels"). Continuing, it would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the stimulation system of Baldoni to include a case to stop electrostimulation when the blood glucose parameter is below the threshold, as taught by Perryman, in order to prevent the patient’s blood glucose levels from falling below a normal, healthy range.
The Baldoni/Perryman combination is silent to controlling the signal generator to output the electrical signal over a selected time period, wherein the signal generator is controlled to output the electrical signal with incremented current values up to a maximum current value until the selected time period expires, wherein an amount of time between each current value increment becomes shorter over the selected time period,
wherein the maximum current value is set based on a current value known to stimulate at least one ventral root of the at least one spinal nerve.
However, Dobak teaches controlling the signal generator (such as that in Fig. 5) to output the electrical signal over a selected time period ([0127] discussing treatment duration), wherein the signal generator is controlled to output the electrical signal with incremented current values up to a maximum current value ([0130]: “The muscle-twitching phenomenon can also be used to help guide the stimulation intensity used for the therapy. Once the threshold of muscle twitching is reached, activation of at least the A fibers has occurred. Increasing the current amplitude beyond the threshold increases the severity of the muscle contraction and can increase discomfort. Delivering the therapy at about the threshold for muscle twitching, and not substantially higher, helps ensure that the comfort of the patient is maintained, particularly at higher frequencies. …It should be noted that patient comfort can be achieved at current amplitudes slightly higher than the muscle twitch threshold, or that effective therapy can be delivered at current amplitudes slightly below the muscle twitch threshold, particularly at longer pulse widths.”) until the selected time period expires, wherein an amount of time between each current value increment becomes shorter over the selected time period ([0157]: “A single cycle of ramp-cycling therapy comprises a stimulation time period and a no-stimulation time period. … In other embodiments the treatment parameters, and/or the duty cycle parameters and/or the signal parameters may be changed from cycle to cycle.”; [0191]: “…the changes in the stimulation duty cycle may be accomplished by fixing the signal-on time to a certain duration (e.g. about 15 seconds to about 60 seconds), and the signal-off time may be varied from about 15 about 5 minutes). This can be accomplished randomly or through a preset pattern such as 50%, 33%, 25%, 20%, 10% that repeats upward and/or downward indefinitely.”; Figs. 27-31),
wherein the maximum current value is set based on a current value known to stimulate at least one ventral root of the at least one spinal nerve([0026]: “A dynamic stimulation technique using ramp-cycling can be used on cranial nerves, the spinal cord, and/or other peripheral nerves, including those in the autonomic system and other motor and sensory nerves.”; [0130]).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the feedback system of the Baldoni/Perryman combination to include control of the time period, current, and time between each current value of electric signal, as a shorter duration than the immediately preceding iteration, which may result in faster treatment of type 2 diabetes and/or the condition of metabolic syndrome such as a high blood glucose level because higher current levels are implemented more quickly.
Regarding claim 19, in view of the Baldoni/Perryman/Dobak combination, Baldoni discloses that the at least one dorsal root ganglion nerve comprises multiple dorsal root ganglion nerves at one or more of thoracic levels T7, T8, T9, T10, T11, and/or T12 of the patient ([0080]: “In representative systems and methods, one or more therapeutic modulation signals can be delivered to a target , location proximate to or at one or more of T7 to T12.”), and wherein the at least one anatomical element comprises the patient's pancreas ([0031]: “…inhibiting at least a portion of the patient's sympathetic nervous system, such as one or more sympathetic nerves corresponding to one or more of the patient's …pancreas, …may result in the therapeutic effect by increasing glycogen production (e.g., hepatic glycogenesis), increasing insulin sensitivity, increasing the patient's gastrointestinal contraction rate which, without intending to be bound by any particular theory, may induce release of glucagon-like peptide-1 (GLP-1) from the patient's intestine, and/or otherwise altering insulin production...”).
Baldoni does not disclose that the at least one dorsal root ganglion nerve comprises multiple dorsal root ganglion nerves at one or more of lumbar levels L1 and/or L2 of the patient.
However, Perryman teaches that the at least one dorsal root ganglion nerve comprises multiple dorsal root ganglion nerves at one or more of lumbar levels L1 and/or L2 of the patient ([0014]: “FIG. 4 is a diagram of a cross sectional pathway overview of a spinal column segment 201 at which an electrode lead 202 is placed to stimulate the dorsal root ganglia 203 and/or spinal nerves 210 from in the dermatome regions from spinal segments T7 to L1, which are sensory nerve fibers 204 that lead to the pancreas 206.”).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the Baldoni stimulation locations to further include the lumbar levels taught by Perryman in order to cause the pancreas to increase insulin and/or glucagon production to lower the patient's blood glucose level, thereby providing an effective treatment for type 2 diabetes.
Regarding amended, independent claim 20, Baldoni discloses a method for treating metabolic syndrome ([0002]: “…methods and systems for treating treat blood glucose abnormalities, including metabolic syndrome, type 2 diabetes (T2D), …by applying electrical stimulation to a target neural population located within the patient's spinal cord.”), comprising:
monitoring a blood glucose level of a patient ([0104]: “Monitoring a patient's blood glucose level can be performed on a continuous basis using one or more sensing elements … for detecting neural signals, neural responses, and/or other physiological parameters of the patient…”); and
generating an electrical signal for one or more electrodes to stimulate a dorsal root ganglion ([0034]: “…therapeutic modulation signals are directed to the target location that generally includes the patient's spinal cord, e.g., the dorsal column of the patient's spinal cord. The modulation signals can be directed to the …dorsal root ganglion...”) of a spinal nerve ([0031]) of the patient to cause a response by a pancreas of the patient that reduces the blood glucose level of the patient to within a healthy range ([0031]: “…inhibiting at least a portion of the patient's sympathetic nervous system, such as one or more sympathetic nerves corresponding to one or more of the patient's …pancreas, …may result in the therapeutic effect by … altering insulin production...”; [0117]: “By selecting and manipulating the parameters described herein, the disclosed techniques can affect both insulin levels and the patient's glucose storage rates. By controlling both variables, these techniques can more accurately control the patient's blood sugar levels, and therefore more accurately control the patient's T2D.”).
Baldoni is silent to determining the blood glucose level exceeds an upper limit threshold value; and generating, over a selected time period, an electrical signal, wherein the electrical signal is generated in response to determining that the blood glucose level exceeds the upper limit threshold value, and wherein the electrical signal is generated with incremented current values up to a maximum current value until either the blood glucose level drops below the upper limit threshold value or the selected time period expires, wherein an amount of time between each current value increment becomes shorter over the selected time period, wherein the maximum current value is set based on a current value known to stimulate a ventral root of the spinal nerve.
However Perryman teaches determining that the blood glucose level exceeds the upper limit threshold value ([0065]; [0075]); and wherein the electrical signal is generated in response to determining that the blood glucose level exceeds the upper limit threshold value ([0065]: “If outside the desired or threshold range, the feedback controller can initiate adjustments to parameter settings of the electrical stimulation.”; [0075]: “The controller can send the signals to increase or decrease stimulation until glucose homeostasis is achieved… The controller can include a microprocessor that can instruct the system to produce an exciting or inhibiting stimulation signal or to cease electrical stimulation.”), and wherein the electrical signal is generated until the blood glucose level drops below the upper limit threshold value ([0075]: “The controller can send the signals to increase or decrease stimulation until glucose homeostasis is achieved… The controller can include a microprocessor that can instruct the system to produce an exciting or inhibiting stimulation signal or to cease electrical stimulation.”).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to combine the above-described teachings of Perryman, which teaches controlling the signal generator based on a threshold value, with the invention of Baldoni due to the similar areas of pursuit. Further, it would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the stimulation system of Baldoni to include a threshold limitation case for controlling the start of electrostimulation in order to keep the patient’s blood glucose levels from rising above a normal, healthy range (see Perryman [0058], where "the Cafferent sensory nerve fibers innervating pancreatic beta cells are either excited or inhibited to promote glucose homeostasis in response to abnormal biomarker levels"). Continuing, it would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the stimulation system of Baldoni to include a case to stop electrostimulation when the blood glucose parameter is below the threshold, as taught by Perryman, in order to prevent the patient’s blood glucose levels from falling below a normal, healthy range.
The Perryman/Baldoni combination is silent to generating, over a selected time period, an electrical signal, and wherein the electrical signal is generated with incremented current values up to a maximum current value until either the selected time period expires, wherein an amount of time between each current value increment becomes shorter over the selected time period, wherein the maximum current value is set based on a current value known to stimulate a ventral root of the spinal nerve.
However, Dobak teaches generating, over a selected time period ([0127] discussing treatment duration), an electrical signal, and wherein the electrical signal is generated with incremented current values up to a maximum current value ([0130]: “The muscle-twitching phenomenon can also be used to help guide the stimulation intensity used for the therapy. Once the threshold of muscle twitching is reached, activation of at least the A fibers has occurred. Increasing the current amplitude beyond the threshold increases the severity of the muscle contraction and can increase discomfort. Delivering the therapy at about the threshold for muscle twitching, and not substantially higher, helps ensure that the comfort of the patient is maintained, particularly at higher frequencies. …It should be noted that patient comfort can be achieved at current amplitudes slightly higher than the muscle twitch threshold, or that effective therapy can be delivered at current amplitudes slightly below the muscle twitch threshold, particularly at longer pulse widths.”) until either the selected time period expires, wherein an amount of time between each current value increment becomes shorter over the selected time period ([0157]: “A single cycle of ramp-cycling therapy comprises a stimulation time period and a no-stimulation time period. … In other embodiments the treatment parameters, and/or the duty cycle parameters and/or the signal parameters may be changed from cycle to cycle.”; [0191]: “…the changes in the stimulation duty cycle may be accomplished by fixing the signal-on time to a certain duration (e.g. about 15 seconds to about 60 seconds), and the signal-off time may be varied from about 15 about 5 minutes). This can be accomplished randomly or through a preset pattern such as 50%, 33%, 25%, 20%, 10% that repeats upward and/or downward indefinitely.”; Figs. 27-31), wherein the maximum current value is set based on a current value known to stimulate a ventral root of the spinal nerve ([0026]: “A dynamic stimulation technique using ramp-cycling can be used on cranial nerves, the spinal cord, and/or other peripheral nerves, including those in the autonomic system and other motor and sensory nerves.”; [0130]).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the feedback system of the Baldoni/Perryman combination to include control of the time period, current, and time between each current value of electric signal, as a shorter duration than the immediately preceding iteration, which may result in faster treatment of type 2 diabetes and/or the condition of metabolic syndrome such as a high blood glucose level because higher current levels are implemented more quickly.
Claims 2, 6, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over the Baldoni/Perryman/Dobak combination as applied to claims above, and further in view of Kramer et al. (US 2012/0277839, hereinafter referred to as Kramer) (cited previously).
Regarding claim 2, in view of the Baldoni/Perryman/Dobak combination, while Baldoni mentions the ventral root ([0055]), the Baldoni/Perryman/Dobak combination does not disclose that the part of the at least one spinal nerve corresponds to a ventral root.
However, Kramer teaches targeted treatment of a variety of medical conditions by directly neuromodulating a target anatomy associated with the condition while minimizing or excluding undesired neuromodulation of other anatomies. Kramer further teaches that the part of the at least one spinal nerve corresponds to a ventral root ([0045]: “In particular, selective stimulation of tissues, such as the dorsal root, DRG, or portions thereof, exclude stimulation of the ventral root wherein the stimulation signal has an energy below an energy threshold for stimulating a ventral root associated with the target dorsal root while the lead is so positioned.”).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to combine the above-described teachings Kramer with the system of the Baldoni/Perryman/Dobak combination in order to exclude stimulating the patient's ventral root, as accidental stimulation of the ventral root may induce side effects for the patient (instant Specification [0095]; see also Kramer [0045]: “It may be appreciated that indiscriminant stimulation of the ventral root, such as from an electrode which emits stimulation energy which directly stimulates the ventral root, typically causes unpleasant sensations for the patient, such as tingling, buzzing or undesired motions or movements.”).
Regarding claim 6, in view of the Baldoni/Perryman/Dobak/Kramer combination, while Baldoni mentions the ventral root ([0055]), the Baldoni/Perryman/Dobak combination does not disclose that the maximum current value is set to be below the current value known to stimulate the ventral root.
However, Kramer teaches that the maximum current value is set to be below the current value known to stimulate the ventral root ([0045]: “In particular, selective stimulation of tissues, such as the dorsal root, DRG, or portions thereof, exclude stimulation of the ventral root wherein the stimulation signal has an energy below an energy threshold for stimulating a ventral root associated with the target dorsal root while the lead is so positioned.”).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to combine the above-described maximum current value of Kramer with the system of the Baldoni/Perryman/Dobak combination in order to keep the maximum current below a level that is known to stimulate the patient's ventral root, as accidental stimulation of the ventral root may induce side effects for the patient (instant Specification [0095]; see also Kramer [0045]: “It may be appreciated that indiscriminant stimulation of the ventral root, such as from an electrode which emits stimulation energy which directly stimulates the ventral root, typically causes unpleasant sensations for the patient, such as tingling, buzzing or undesired motions or movements.”).
Regarding claim 18, in view of the Baldoni/Perryman/Dobak combination, while Baldoni discloses mentions the ventral root ([0055]), the Baldoni/Perryman/Dobak combination does not disclose that the maximum current value is set to be below the current value known to stimulate the at least one ventral root.
However, Kramer teaches that the maximum current value is set to be below the current value known to stimulate the at least one ventral root ([0045]: “In particular, selective stimulation of tissues, such as the dorsal root, DRG, or portions thereof, exclude stimulation of the ventral root wherein the stimulation signal has an energy below an energy threshold for stimulating a ventral root associated with the target dorsal root while the lead is so positioned.”).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to combine the above-described maximum current value of Kramer with the system of the Baldoni/Perryman/Dobak combination in order to keep the maximum current below a level that is known to stimulate the patient's ventral root, as accidental stimulation of the ventral root may induce side effects for the patient (instant Specification [0095]; see also Kramer [0045]: “It may be appreciated that indiscriminant stimulation of the ventral root, such as from an electrode which emits stimulation energy which directly stimulates the ventral root, typically causes unpleasant sensations for the patient, such as tingling, buzzing or undesired motions or movements.”).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over the Baldoni/Perryman/Dobak/Kramer combination as applied to claims above, and further in view of Jiang et al. (CN 106,999,709, hereinafter referred to as Jiang).
Regarding claim 8, in view of the Baldoni/Perryman/Dobak/Kramer combination, the Baldoni/Perryman combination is silent to that each current value 0.05mA larger than a previous current value up to the maximum current value.
However, Dobak teaches the maximum current value ([0130]: “… effective therapy can be delivered at current amplitudes slightly below the muscle twitch threshold, particularly at longer pulse widths.”).
The Baldoni/Perryman/Dobak combination does not disclose that each current value 0.05mA larger than a previous current value.
However, Jiang teaches a clinician programmer that is interoperable with implantable neurostimulators. Jiang further teaches that that each current value 0.05mA larger than a previous current value (pg. 4, li. 52-53 of the translated Specification document: “Automatic adjustment can include: for test stimuli less than or equal to 1mA, increase the stimulus amplitude in increments of 0.05 mA…”; Increasing the stimulus amplitude of 0.05 mA would cause the current value to increase by the same amount.).
While Jiang does not teach a blood glucose control parameter, it does teach a similar pursuit of nerve stimulation in order to treat a disorder of condition of a patient. It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the stimulation system of the Baldoni/Perryman/Dobak/Kramer combination to include an incremental current adjustment in order to gradually control current values until the blood glucose parameter drops below the threshold value.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Esteller et al. (US 2020/0398057).
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/M.G.S./Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796