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 Amendments to the Claims and Remarks on November 26, 2025 in response to the Examiner’s Non-Final Office Action, mailed August 26, 2025.
Amendments to the Claims
At this time, claims 1-7,9-15 and 17-19 are pending. Claims 1, 3, 6-7, 9-12, 15 and 17-18 have been amended. Claims 8, 16, and 20 have been cancelled. The Applicant asserts that no new matter is added. (Remarks, pg. 6)
Claim Rejections - 35 U.S.C. § 102 and 103
Claims 1-2, 7, 9-10, 12-13, and 15 were previously rejected under 35 U.S.C. 102(a)(2). Claims 3-6, 8, 11, 14, and 16-20 were previously rejected under 35 U.S.C. 103. (Remarks, pg. 6-9)
The Applicant has traversed each of these rejections, stating that the cited prior art references Rajguru, Campean, and Brown, either alone or in combination, fail to disclose, teach, or suggest, at least, the features of "a ratio of the on-time period to the off-time period is 4, and a length of the off-time period is not longer than 5 seconds", as recited in amended independent claim 1. The Applicant further states that, through such a limitation, “a more effective way for treating nerve/muscle injury is obtained”. (Remarks, pg. 7) Paragraphs [0101], [0106], and [0111] of the instant Specification, as well as in FIGS. 9- 10 and 12 were cited as support of this argument.
The Examiner respectfully disagrees with the Applicant’s arguments regarding the on- and off-time periods disclosed by Rajguru. (Remarks, pg. 8)
The Examiner has presented an overlapping range of on- and off-time periods, and thus established a prima facie case of obviousness via Rajguru. (See MPEP 2144.05(I).)
Further, the Applicant “submits that the features "a ratio of the on-time period to the off-time period is 4" and "a length of the off-time period is not longer than 5 seconds," as recited in amended claim 1 provide an unexpected synergistic effect that is not disclosed by Rajguru.” (Remarks, pg. 8) The instant Specification in para. [0108] states “…the results show that applying the electrical nerve stimulation with on/off ratio of 8:2 is a more effective way for treating nerve/muscle injury than the other on/off ratios including 5:5, 2:8, 1:9 for treating nerve/muscle injury.” However, the Examiner argues that describing the above ratio as “a more effective way for treating nerve/muscle injury than the other on/off ratios” does not equate to criticality of the on/off ratio of 8:2, or rather that "a ratio of the on-time period to the off-time period is 4, and a length of the off-time period is not longer than 5 seconds". The Specification does establish sufficient criticality to the ratio of the on-time period to the off-time period being 4. Because of this, the prior art discloses the claims. Per MPEP 2131.04, evidence of secondary considerations, such as unexpected results or commercial success, is irrelevant to 35 U.S.C. 102 rejections and thus cannot overcome a rejection so based. In re Wiggins, 488 F.2d 538, 543, 179 USPQ 421, 425 (CCPA 1973). (See also MPEP 716.01(d).)
In order to address the Amendments to the claims, Applicant’s arguments, see Remarks, pg. 6-9, with respect to the rejections of claims 1-20 under 35 U.S.C. § 102(a)(2) and 103 have been fully considered and have been withdrawn. However, upon further consideration, new grounds of rejection are made in view of Rajguru, Campean, and Brown.
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.
Claims 1-2, 7, 9-13, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Rajguru et al. (US 2017/0266443, hereinafter referred to as Rajguru) (cited previously).
Regarding amended, independent claim 1, Rajguru discloses an apparatus and methods for central and peripheral nerve and other tissue modulation or stimulation therapies. Rajguru further discloses a nerve stimulation system ([0101]: "In certain variations, various apparatus and methods may provide for central and peripheral nerve and other tissue modulation or stimulation therapies, including both excitation and blocking of nerve impulses"), comprising:
an electrode ([0012]: “…a stimulator electrode over a glabrous skin surface overlying a target nerve of a subject.”; [0194]: “In another variation, as shown in FIG. 23, percutaneous electrode needle 272 may be used in energy emitting system 260.”);
an electrode controlling device coupled to the electrode ([0152]: “As shown in FIG. 10, an electrical pulse controller 128 is electrically connected both to percutaneous needle 124 and to sensor 134, to provide the desired feedback and modulate the power to percutaneous needle 134. In the variation of FIG. 11, electrical pulse controller 130 is connected both to electrode 126 and to sensor 136, and performs a function similar to that of electrical pulse controller 128.”; [0297]: “. The electrical pulse generator may be coupled to the stimulator electrode.”; [0414]) and configured to control the electrode to electrically stimulate a peripheral nerve ([0101]: "In certain variations, various apparatus and methods may provide for central and peripheral nerve and other tissue modulation or stimulation therapies, including both excitation and blocking of nerve impulses"; [0304]: “Tissues that may be stimulated include but are not limited a central nerve, peripheral nerve, muscle, skin, or vasculature.”) based on a nerve stimulation signal ([0365]: “The devices typically comprise a pulse generating component that provides an electrical wave form as output. The electrical pulse comprises certain typical parameters, such as pulse width, frequency, number of pulses and amplitude among other parameters.”); and
a signal generating device coupled to the electrode controlling device and configured to generate the nerve stimulation signal ([0365]: “The devices typically comprise a pulse generating component that provides an electrical wave form as output.”),
wherein the nerve stimulation signal is a signal with a square envelope([0346]: “In certain variations, the electrical stimulation may have of a square wave electric signal at a frequency of about 5 Hz to about 60 Hz at the targeted tissue depth.”), the square envelope periodically comprises an on-time period with a pulse amplitude and an off-time period without the pulse amplitude ([0384]: “… the pulse energy applied to the electrodes may be at 100% amplitude for X pulses (for example, 5 pulses) and then at a lower amplitude (for example, 50% amplitude) for Y pulses (for example, 5 pulses). The pulse amplitude and length may vary, for example, there may be two amplitude levels, or 3 or more.”; The Examiner notes that “a lower amplitude” can be interpreted as an off-time without the pulse amplitude.), a ratio of the on-time period to the off-time period is 4 ([0351]: “For example, stimulation may be provided, e.g., continuously, for 10 minutes, where the stimulation is automatically paused or stopped for about a 30 second interval every 10 minutes.), and a length of the off-time period is not longer than 5 seconds ([0352]: “…the pause in stimulation may be for an interval ranging from 0 to 100 seconds…”).
Rajguru is of a similar pursuit to that of the instant application in being an electrical stimulation device that can be used to treat acute/chronic nerve injury such as carpal tunnel syndrome (CTS) ([0154]). Though Rajguru does not explicitly describe a ratio of the on-time period to the off-time period is 4, and a length of the off-time period is not longer than 5 seconds, the on- and off-time period ranges described by Rajguru can be set such that the ratio of the on-time period to the off-time period is 4. It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to establish in the invention of Rajguru that the ratio of the on-time period to the off-time period is 4, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980). (See also MPEP 2144.05 (II-B).)
Further, the Examiner has presented an overlapping range of on- and off-time periods, and thus established a prima facie case of obviousness via Rajguru. (See MPEP 2144.05(I).) It would also have been obvious to one having ordinary skill in the art at the time the invention was made to establish from Rajguru that length of the off-time period is not longer than 5 seconds, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. (See also MPEP 2144.05 (II-A).)
Regarding claim 2, Rajguru discloses that the electrode is to be implanted ([0194]: “Percutaneous electrode needle 272 includes a first end 276 for insertion into the patient's body in proximity to the preselected internal stimulation site or target nerve to be stimulated, and a second end 277.”) and aimed at a point between a lesion of the peripheral nerve and a muscle associated with the peripheral nerve ([0304]: “Tissues that may be stimulated include but are not limited a central nerve, peripheral nerve, muscle, skin, or vasculature.”).
Regarding amended claim 7, Rajguru discloses that the length of the off-time period is within 0.5 second to 5 seconds ([0352]: “In certain variations, for example, the pause in stimulation may be for an interval ranging from 0 to 100 seconds…”).
Regarding amended claim 9, Rajguru discloses that the length of the on-time period is within 3 second to 9 seconds ([0352]: “In other variations, the treatment parameters may vary, e.g., stimulation may be applied for an interval ranging from 0 to 100 minutes or greater or as necessary to treat symptoms.”).
Regarding amended claim 10, Rajguru discloses that a frequency of the nerve stimulation signal in the on-time period is within 5 Hz to 500 Hz ([0022]: “In some embodiments, the electrical stimulation is delivered at a frequency of about 5 Hz to about 60 Hz…”; [0346]: “In certain variations, the electrical stimulation may have of a square wave electric signal at a frequency of about 5 Hz to about 60 Hz at the targeted tissue depth.”).
Regarding amended claim 11, Rajguru discloses that a duty cycle of the on-time period and the off-time period is within 60% to 80% ([0357]: “Electrical energy may be applied or delivered using any of the devices, applicators or electrodes described herein at specified frequencies and/or parameters or using various duty cycles.”; [0352]: “In other variations, the treatment parameters may vary, e.g., stimulation may be applied for an interval ranging from 0 to 100 minutes or greater or as necessary to treat symptoms. In certain variations, for example, stimulation may be applied or provided for 20, 40, 50 or 60 minutes. In certain variations, for example, the pause in stimulation may be for an interval ranging from 0 to 100 seconds…”).
As a duty cycle percentage is understood as the on-time period divided by the sum of the on-time period and the off-time period, it would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to interpret that the on-time period of “0 to 100 minutes or greater or as necessary to treat symptoms” and the off-time period (or “pause in stimulation”) of “0 to 100 seconds” disclosed by Rajguru ([0352]) would meet the instant requirements of the duty cycle of the on-time period and the off-time period being within 60% to 80%. Within these disclosed on- and off-period intervals, any on-time period of 0 to 400 seconds and off-time period of 0 to 100 seconds could be calculated to meet the instant duty cycle of 60% to 80% (e.g. an on-time period of 8 seconds of stimulation and an off-time period of 2 seconds with no stimulation to the patient would calculate to a duty cycle of 80%).
Regarding amended, independent claim 12, Rajguru discloses a signal generating device ([0365]: “The devices typically comprise a pulse generating component that provides an electrical wave form as output.”; [0414]), comprising:
a transceiver coupled to an electrode controlling device ([0414]: “The generator/controller is a 9-volt battery powered, microprocessor controlled, electrical-neural stimulator with embedded software that delivers pulses of DC energy to the patient via the stimulation and return electrodes. The device simultaneously reads electromyographical signals from the patient via the EMG electrodes and displays them on a display screen.”; The Examiner notes that in reading and displaying electromyographical (EMG) signals, the device is functioning as a transceiver.); and
a processor ([0414]: “The generator/controller is a 9-volt battery powered, microprocessor controlled, electrical-neural stimulator with embedded software that delivers pulses of DC energy to the patient via the stimulation and return electrodes.”) coupled to the transceiver and configured to:
generate a nerve stimulation signal ([0414]: “The generator/controller …delivers pulses of DC energy to the patient via the stimulation and return electrodes.”); and
transmit, using the transceiver, the nerve stimulation signal to the electrode controlling device (electrical pulse controller 128 in Fig. 10; electrical pulse controller 130 in Fig. 11; [0414]: “The device simultaneously reads electromyographical signals from the patient via the EMG electrodes and displays them on a display screen.”) such that the electrode controlling device controls an electrode to electrically stimulate a peripheral nerve ([0101]: "In certain variations, various apparatus and methods may provide for central and peripheral nerve and other tissue modulation or stimulation therapies, including both excitation and blocking of nerve impulses"; [0304]: “Tissues that may be stimulated include but are not limited a central nerve, peripheral nerve, muscle, skin, or vasculature.”) based on the nerve stimulation signal ([0365]: “The devices typically comprise a pulse generating component that provides an electrical wave form as output. The electrical pulse comprises certain typical parameters, such as pulse width, frequency, number of pulses and amplitude among other parameters.”),
wherein the nerve stimulation signal is a signal with a square envelope ([0346]: “In certain variations, the electrical stimulation may have of a square wave electric signal at a frequency of about 5 Hz to about 60 Hz at the targeted tissue depth.”), the square envelope periodically comprises an on-time period with a pulse amplitude and an off-time period without the pulse amplitude ([0384]: “… the pulse energy applied to the electrodes may be at 100% amplitude for X pulses (for example, 5 pulses) and then at a lower amplitude (for example, 50% amplitude) for Y pulses (for example, 5 pulses). The pulse amplitude and length may vary, for example, there may be two amplitude levels, or 3 or more.”; The Examiner notes that “a lower amplitude” can be interpreted as an off-time without the pulse amplitude.), a ratio of the on-time period to the off-time period is 4 ([0351]: “For example, stimulation may be provided, e.g., continuously, for 10 minutes, where the stimulation is automatically paused or stopped for about a 30 second interval every 10 minutes.”), and a length of the off-time period is not longer than 5 seconds ([0352]: “…the pause in stimulation may be for an interval ranging from 0 to 100 seconds….”).
Though Rajguru does not explicitly describe that a ratio of the on-time period to the off-time period is 4, and a length of the off-time period is not longer than 5 seconds, the on- and off-time period ranges described by Rajguru can be set such that the ratio of the on-time period to the off-time period is 4. It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to establish in the invention of Rajguru that the ratio of the on-time period to the off-time period is 4, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980). (See also MPEP 2144.05 (II-B).)
Further, the Examiner has presented an overlapping range of on- and off-time periods, and thus established a prima facie case of obviousness via Rajguru. (See MPEP 2144.05(I).) It would also have been obvious to one having ordinary skill in the art at the time the invention was made to establish from Rajguru that length of the off-time period is not longer than 5 seconds, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. (See also MPEP 2144.05 (II-A).)
Regarding claim 13, Rajguru discloses that the electrode is to be implanted ([0194]: “Percutaneous electrode needle 272 includes a first end 276 for insertion into the patient's body in proximity to the preselected internal stimulation site or target nerve to be stimulated, and a second end 277.”) and aiming at a point between a lesion of the peripheral nerve and a muscle associated with the peripheral nerve ([0304]: “Tissues that may be stimulated include but are not limited a central nerve, peripheral nerve, muscle, skin, or vasculature.”).
Regarding amended claim 15, Rajguru discloses that a frequency of the nerve stimulation signal in the on-time period is within 5 Hz to 500 Hz ([0022]: “In some embodiments, the electrical stimulation is delivered at a frequency of about 5 Hz to about 60 Hz…”; [0346]: “In certain variations, the electrical stimulation may have of a square wave electric signal at a frequency of about 5 Hz to about 60 Hz at the targeted tissue depth.”).
Claims 3, 5-6, 14, and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Rajguru in view of Campean et al. (WO2021/055716, hereinafter referred to as Campean) (cited previously).
Regarding amended claim 3, Rajguru discloses the nerve stimulation system further comprising:
an electromyography (EMG) monitoring device ([0412]: “The generator/controller housing is a plastic enclosure with an on/off switch, adjustable current control, mode switch button, and LCD screen facing the operator. The generator/controller has connections for a stimulation electrode (output), return electrode (input) and two electromyographic (EMG) capture electrodes (input).”) coupled to the signal generating device ([0365]: “The devices typically comprise a pulse generating component that provides an electrical wave form as output.”) and configured to acquire an EMG signal ([0243]: “FIG. 33 shows a system including a corded back applicator 340, a sensor 342 and a logic controller 344. Various sensors may be utilized, e.g., a three lead EMG, other EMG electrode, a microneedle electrode, or any sensor for detecting physiologic changes associated with nerve firing and/or muscle contraction. The sensor 342 provides feedback which may be used to monitor and/or control therapy.”) associated with a muscle, wherein:
a voltage of the EMG signal ([0234]: “In certain variations described herein, sensors may detect voltage or current…”) and [controlling] an amplitude of the nerve stimulation signal for electrically stimulating the peripheral nerve ([0365]: “The electrical pulse comprises certain typical parameters, such as pulse width, frequency, number of pulses and amplitude among other parameters.”).
While Rajguru defines a maximum threshold of the EMG signal ([0164]), Rajguru is silent to:
in a case that a voltage of the EMG signal is greater than a maximum threshold, the signal generating device is further configured to decrease an amplitude of the nerve stimulation signal for electrically stimulating the peripheral nerve, and
in a case that the voltage of the EMG signal is less than a minimum threshold, the signal generating device is further configured to increase the amplitude of the nerve stimulation signal for electrically stimulating the peripheral nerve.
However, Campean teaches a system for treating a medical condition by applying electrical stimulation to a target peripheral nerve of a subject. Campean further teaches that:
in a case that a voltage of the EMG signal is greater than a maximum threshold, the signal generating device is further configured to decrease an amplitude of the nerve stimulation signal for electrically stimulating the peripheral nerve (see Fig. 9: step 450 “EMG/MMG above window?” and step 452 “Decrease stim parameters for next pulse if allowed”; [0027]: “…adjusting the stimulation parameters in response to the recorded EMG responses under closed loop control can include: …decreasing the amplitude and/or pulse width of subsequent stimulation pulses in response to the recorded EMG responses being above the predetermined EMG window, and maintaining the amplitude and/or pulse width of subsequent stimulation pulses in response to the recorded EMG responses being within the predetermined EMG window.”), and
in a case that the voltage of the EMG signal is less than a minimum threshold, the signal generating device is further configured to increase the amplitude of the nerve stimulation signal for electrically stimulating the peripheral nerve (see Fig. 9: step 444 “EMG/MMG below window?” and step 446 “Increase stim parameters for next pulse if allowed” [0027]: “…adjusting the stimulation parameters in response to the recorded EMG responses under closed loop control can include: increasing the amplitude and/or pulse width of subsequent stimulation pulses in response to the recorded EMG responses being below a predetermined EMG window…”).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the nerve stimulation system of Rajguru to include a maximum and minimum threshold of the monitored EMG signal to utilize as a control for adjusting the nerve stimulation signal amplitude, as taught by Campean, to stay within a safe and effective range of therapy to a patient.
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Regarding claim 5, in view of the Rajguru/Campean combination, Rajguru discloses that the minimum threshold is 200 µV ([0208]: “In certain variations, typical voltage sensed at the skin and detectable or conductible by a microneedle patch or microneedle array may range from about 1 to 400 microvolts or about 10 to 300 microvolts.”).
Rajguru is silent to a minimum threshold of an EMG voltage range.
However, Campean teaches a minimum threshold (see Fig. 9: step 444 “EMG/MMG below window?”; [0027]: “…adjusting the stimulation parameters in response to the recorded EMG responses under closed loop control can include: increasing the amplitude and/or pulse width of subsequent stimulation pulses in response to the recorded EMG responses being below a predetermined EMG window…”).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the nerve stimulation system of Rajguru to include a minimum threshold of the EMG signal voltage to utilize as a control for adjusting the nerve stimulation signal amplitude, as taught by Campean, to stay within a safe and effective range of therapy to a patient.
Regarding amended claim 6, in view of the Rajguru/Campean combination, Rajguru discloses the nerve stimulation system further comprising:
a prompt device coupled to an electromyography (EMG) monitoring device ([0231]: “In certain variations, as shown in FIGS. 29a-29d, energy emitting device may include a controller 289… One or more EMG plugs 295 are provided… A display screen 296 may also be provided along with power cord 298. The display screen 296 can display a variety of information to the user and/or practitioner such as the level of power or current applied, treatment time, temperature of the cradle device, detected current levels and/or physiological parameters, etc., to facilitate effective and efficient therapeutic treatment. The information can be used to vary or adjust the controller to ensure that adequate conduction of a target nerve, e.g., posterior tibial nerve 220 or muscle stimulation occurs and an adequate and accurate dosage of treatment is being received. Controls may also be included to affect the following: power, field strength, frequency, pulse, start/pause and cancellation of therapy (as shown) or other parameters one of skill in the art would find necessary or useful to control or monitor.”), wherein:
in a case that a voltage of an EMG signal is greater than a maximum threshold ([0164]), the prompt device is configured to provide a prompt indicating an excessive current ([0231]: “The display screen 296 can display a variety of information to the user and/or practitioner such as the level of power or current applied, treatment time, temperature of the cradle device, detected current levels and/or physiological parameters, etc., to facilitate effective and efficient therapeutic treatment.”; [0122]: “…providing an accurate assessment of the efficiency of the applied therapy on the patient. …provide an indication to the patient or to a healthcare provider as to whether stimulation has been applied at an excessive level in view of the anatomical and physiological characteristics of the patient.”);
the prompt device is configured to provide another prompt indicating an efficient stimulation ([0297]: “An applicator may include one or more sensor electrodes configured to detect nerve stimulation and/or provide feedback about the efficacy of the applied electrical stimulation therapy. Such feedback may allow the therapy to be adjusted, modulated and/or optimized.”); and
the prompt device is configured to provide another prompt indicating an insufficient current ([0231]: “The display screen 296 can display a variety of information to the user and/or practitioner such as the level of power or current applied, treatment time, temperature of the cradle device, detected current levels and/or physiological parameters, etc., to facilitate effective and efficient therapeutic treatment.”; [0297]: “An applicator may include one or more sensor electrodes configured to detect nerve stimulation and/or provide feedback about the efficacy of the applied electrical stimulation therapy. Such feedback may allow the therapy to be adjusted, modulated and/or optimized.”).
Rajguru is silent to a case that the voltage of the EMG signal falls within a voltage range defined by the maximum threshold and a minimum threshold and a case that the voltage of the EMG signal is less than the minimum threshold.
Campean teaches a case that the voltage of the EMG signal falls within a voltage range defined by the maximum threshold and a minimum threshold ([0027]: “…adjusting the stimulation parameters in response to the recorded EMG responses under closed loop control can include: … maintaining the amplitude and/or pulse width of subsequent stimulation pulses in response to the recorded EMG responses being within the predetermined EMG window.”); and
a case that the voltage of the EMG signal is less than the minimum threshold (see Fig. 9: step 444 “EMG/MMG below window?” and step 446 “Increase stim parameters for next pulse if allowed” [0027]: “…adjusting the stimulation parameters in response to the recorded EMG responses under closed loop control can include: increasing the amplitude and/or pulse width of subsequent stimulation pulses in response to the recorded EMG responses being below a predetermined EMG window…”).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the nerve stimulation system of Rajguru to include a maximum and minimum threshold of the monitored EMG signal to utilize as a control for adjusting the nerve stimulation signal amplitude, as taught by Campean, and prompt a user via a prompt device to provide the best care to a patient.
Regarding claim 14, in view of the Rajguru/Campean combination, Rajguru discloses that the processor ([0414]: “The generator/controller is a 9-volt battery powered, microprocessor controlled, electrical-neural stimulator…”) is further configured to:
receive an electromyography (EMG) signal associated with a muscle from an EMG monitoring device ([0412]: “The generator/controller housing is a plastic enclosure with an on/off switch, adjustable current control, mode switch button, and LCD screen facing the operator. The generator/controller has connections for a stimulation electrode (output), return electrode (input) and two electromyographic (EMG) capture electrodes (input).”) by using the transceiver ([0414]: “The device simultaneously reads electromyographical signals from the patient via the EMG electrodes and displays them on a display screen.”; The Examiner notes that in reading and displaying electromyographical (EMG) signals, the device is functioning as a transceiver.).
Rajguru is silent to determining whether a voltage of the EMG signal falls within a voltage range defined by a maximum threshold and a minimum threshold;
in a case of determining that the voltage of the EMG signal is greater than the maximum threshold, decrease an amplitude of the nerve stimulation signal; and
in a case of determining that the voltage of the EMG signal is less than the minimum threshold, increase the amplitude of the nerve stimulation signal.
However, Campean teaches determining whether a voltage of the EMG signal falls within a voltage range defined by a maximum threshold and a minimum threshold ([0027]: “…adjusting the stimulation parameters in response to the recorded EMG responses under closed loop control can include: … maintaining the amplitude and/or pulse width of subsequent stimulation pulses in response to the recorded EMG responses being within the predetermined EMG window.”);
in a case of determining that the voltage of the EMG signal is greater than the maximum threshold, decrease an amplitude of the nerve stimulation signal (see Fig. 9: step 450 “EMG/MMG above window?” and step 452 “Decrease stim parameters for next pulse if allowed”; [0027]: “…adjusting the stimulation parameters in response to the recorded EMG responses under closed loop control can include: …decreasing the amplitude and/or pulse width of subsequent stimulation pulses in response to the recorded EMG responses being above the predetermined EMG window, and maintaining the amplitude and/or pulse width of subsequent stimulation pulses in response to the recorded EMG responses being within the predetermined EMG window.”); and
in a case of determining that the voltage of the EMG signal is less than the minimum threshold, increase the amplitude of the nerve stimulation signal (see Fig. 9: step 444 “EMG/MMG below window?” and step 446 “Increase stim parameters for next pulse if allowed” [0027]: “…adjusting the stimulation parameters in response to the recorded EMG responses under closed loop control can include: increasing the amplitude and/or pulse width of subsequent stimulation pulses in response to the recorded EMG responses being below a predetermined EMG window…”).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the nerve stimulation system of Rajguru to include a maximum and minimum threshold of the monitored EMG signal to utilize as a control for adjusting the nerve stimulation signal amplitude, as taught by Campean, to stay within a safe and effective range of therapy to a patient.
Regarding amended, independent claim 17, Rajguru discloses an operation method performed by a nerve stimulation system ([0101]: "In certain variations, various apparatus and methods may provide for central and peripheral nerve and other tissue modulation or stimulation therapies, including both excitation and blocking of nerve impulses"), the method comprising:
generating a nerve stimulation signal ([0365]: “The devices typically comprise a pulse generating component that provides an electrical wave form as output. The electrical pulse comprises certain typical parameters, such as pulse width, frequency, number of pulses and amplitude among other parameters.”) by a signal generating device of the nerve stimulation system ([0365]: “The devices typically comprise a pulse generating component that provides an electrical wave form as output.”; [0414]);
providing an electrical stimulation, based on the nerve stimulation signal, via an electrode of the nerve stimulation system ([0012]: “…a stimulator electrode over a glabrous skin surface overlying a target nerve of a subject.”; [0194]: “In another variation, as shown in FIG. 23, percutaneous electrode needle 272 may be used in energy emitting system 260.”);
acquiring an electromyography (EMG) signal associated with a subject ([0243]: “FIG. 33 shows a system including a corded back applicator 340, a sensor 342 and a logic controller 344. Various sensors may be utilized, e.g., a three lead EMG, other EMG electrode, a microneedle electrode, or any sensor for detecting physiologic changes associated with nerve firing and/or muscle contraction. The sensor 342 provides feedback which may be used to monitor and/or control therapy.”) by an EMG monitoring device of the nerve stimulation system ([0412]: “The generator/controller housing is a plastic enclosure with an on/off switch, adjustable current control, mode switch button, and LCD screen facing the operator. The generator/controller has connections for a stimulation electrode (output), return electrode (input) and two electromyographic (EMG) capture electrodes (input).”); and
wherein the nerve stimulation signal is a signal with a square envelope ([0346]: “In certain variations, the electrical stimulation may have of a square wave electric signal at a frequency of about 5 Hz to about 60 Hz at the targeted tissue depth.”), the square envelope periodically comprises an on-time period with a pulse amplitude and an off-time period without the pulse amplitude ([0384]: “… the pulse energy applied to the electrodes may be at 100% amplitude for X pulses (for example, 5 pulses) and then at a lower amplitude (for example, 50% amplitude) for Y pulses (for example, 5 pulses). The pulse amplitude and length may vary, for example, there may be two amplitude levels, or 3 or more.”; The Examiner notes that “a lower amplitude” can be interpreted as an off-time without the pulse amplitude.), a ratio of the on-time period to the off-time period is 4 ([0351]: “For example, stimulation may be provided, e.g., continuously, for 10 minutes, where the stimulation is automatically paused or stopped for about a 30 second interval every 10 minutes.), and a length of the off-time period is not longer than 5 seconds ([0352]: “…the pause in stimulation may be for an interval ranging from 0 to 100 seconds…”).
Rajguru is of a similar pursuit to that of the instant application in being an electrical stimulation device that can be used to treat acute/chronic nerve injury such as carpal tunnel syndrome (CTS) ([0154]). Though Rajguru does not explicitly describe a ratio of the on-time period to the off-time period is 4, and a length of the off-time period is not longer than 5 seconds, the on- and off-time period ranges described by Rajguru can be set such that the ratio of the on-time period to the off-time period is 4. It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to establish in the invention of Rajguru that the ratio of the on-time period to the off-time period is 4, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980). (See also MPEP 2144.05 (II-B).)
Further, the Examiner has presented an overlapping range of on- and off-time periods, and thus established a prima facie case of obviousness via Rajguru. (See MPEP 2144.05(I).) It would also have been obvious to one having ordinary skill in the art at the time the invention was made to establish from Rajguru that length of the off-time period is not longer than 5 seconds, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. (See also MPEP 2144.05 (II-A).)
Rajguru is silent determining whether a voltage of the EMG signal falls within a voltage range defined by a maximum threshold and a minimum threshold.
Campean teaches determining whether a voltage of the EMG signal falls within a voltage range defined by a maximum threshold and a minimum threshold ([0027]: “…adjusting the stimulation parameters in response to the recorded EMG responses under closed loop control can include: … maintaining the amplitude and/or pulse width of subsequent stimulation pulses in response to the recorded EMG responses being within the predetermined EMG window.”).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the nerve stimulation system of Rajguru to include a maximum and minimum threshold of the monitored EMG signal to utilize as a control for adjusting the nerve stimulation signal amplitude, as taught by Campean, and prompt a user via a prompt device to provide the best care to a patient.
Regarding amended claim 18, in view of the Rajguru/Campean combination, Rajguru discloses that the length of the off-time period is within 0.5 second to 5 seconds ([0352]: “In certain variations, for example, the pause in stimulation may be for an interval ranging from 0 to 100 seconds…”).
Regarding claim 19, in view of the Rajguru/Campean combination, Rajguru discloses that the length of the off-time period is 2 seconds ([0352]: “In certain variations, for example, the pause in stimulation may be for an interval ranging from 0 to 100 seconds…”).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over the Rajguru/Campean combination and further in view of Brown (US 4807642) (cited previously).
Regarding claim 4, in view of the Rajguru/Campean combination, Rajguru defines a maximum threshold of the EMG signal ([0164]), but Rajguru is silent to the maximum threshold being 800 µV.
Campean teaches a maximum threshold (see Fig. 9: step 450 “EMG/MMG above window?”; [0027]: “…adjusting the stimulation parameters in response to the recorded EMG responses under closed loop control can include: …decreasing the amplitude and/or pulse width of subsequent stimulation pulses in response to the recorded EMG responses being above the predetermined EMG window, and maintaining the amplitude and/or pulse width of subsequent stimulation pulses in response to the recorded EMG responses being within the predetermined EMG window.”).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the nerve stimulation system of Rajguru to include a maximum threshold of the EMG signal voltage to utilize as a control for adjusting the nerve stimulation signal amplitude, as taught by Campean, to stay within a safe and effective range of therapy to a patient.
However, the Rajguru/Campean combination is silent to the maximum threshold being 800 µV.
Brown teaches a monitoring device for detecting muscle strain, which might lead to repetitive strain injury includes EMG sensors which generate an EMG signal. Brown further teaches a maximum threshold being 800 µV ([col. 1, li. 47-63]: “The EMG waveform is a rapidly fluctuating bipolar signal with an amplitude in the range of 1 to 1000 microvolts … Most biofeedback EMG instruments process this signal further by comparing it to an adjustable threshold”).
The device of Brown uses EMG measuring for diagnostic purposes ([col. 1, li. 30-36]), therefore it would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to combine the nerve stimulation system of the Rajguru/Campean combination with the EMG monitoring system voltage range taught by Brown, as a control for adjusting the nerve stimulation signal amplitude, to stay within a safe and effective range of therapy to a patient.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/M.G.S./Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796