DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claims 1-22 are objected to because of the following informalities: The numbers of the elements in the drawings should be removed from the claims. Appropriate correction is required.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mishra et al. (Pub. No.: US 2019/0001139 A1); hereinafter referred to as “Mishra”, in view of Bojeva et al. (Pub. No.: US 2007/0067004 A1); hereinafter referred to as “Bojeva”.
Regarding claim 1, Mishra discloses an implantable pulse generator (e.g. see figure 1 element 250, [0250]) comprising: an Rx antenna (e.g. see figure 1 elements 230, 240) configured to receive a radio frequency (RF) signal (e.g. see [0229], [0246], [0259], [0280]); a rectifier (e.g. see figure 1 element 232, [0259]) coupled to the Rx antenna and configured to rectify the RF signal to generate an output voltage; an energy storage capacitor (e.g. see figure 1 element 270, [0243]) coupled to the rectifier and configured to be charged by the output voltage; and a demodulator (e.g. see figure 1 element 231, [0258]) coupled to the Rx antenna, the rectifier, and a source (e.g. see [0246], [0259]. The examiner understands the “source” to be the power signal (RF signal) from external device 500).
Mishra discloses the demodulator (e.g. see figure 1 element 231, [0258]) and delivering pulse trains (e.g. see [0368]) but is silent as to the demodulator configured to control an output of a train of mini-pulses based on the RF signal, each mini-pulse having a voltage amplitude and a pulse width (on-portion) smaller than a pulse width. Bojeva teaches it is known to use such a modification as set forth in [0294], figure 30 element 416 (for the demodulator that receives the RF signal) and [0286], figure 26A (for the mini-pulses) to provide pulses and pulse trains that give physicians a lot of flexibility for trying various different neuromodulation algorithms for providing and optimizing therapy for neurologic and neuropsychiatric disorders (e.g. see [0294]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use the demodulator function as taught by Bojeva in the system/method of Mishra, since said modification would provide the predictable results of pulses and pulse trains that give physicians a lot of flexibility for trying various different neuromodulation algorithms for providing and optimizing therapy for neurologic and neuropsychiatric disorders.
Mishra discloses delivering pulse trains (e.g. see [0368]) but is silent as to stimulation circuitry coupled to receive the train of mini-pulses and deliver the train of mini-pulse to an electrode, the stimulation circuitry configured such that delivery of the train of mini-pulses to the electrode effectively corresponds to a stimulation pulse having the pulse width and an amplitude that is a function of the pulse widths of the mini-pulses included in the train of mini-pulses. Bojeva teaches it is known to use such a modification as set forth in [0298], [0286] to provide pulses and pulse trains that give physicians a lot of flexibility for trying various different neuromodulation algorithms for providing and optimizing therapy for neurologic and neuropsychiatric disorders (e.g. see [0294]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use the stimulation circuitry configuration as taught by Bojeva in the system/method of Mishra, since said modification would provide the predictable results of pulses and pulse trains that give physicians a lot of flexibility for trying various different neuromodulation algorithms for providing and optimizing therapy for neurologic and neuropsychiatric disorders.
Regarding claim 2, Mishra discloses the invention but is silent as to the RF signal is amplitude modulated to include a plurality of notches, and the demodulator is configured to detect the plurality of notches and, for each notch, to enable the output of a mini-pulse in the train of mini-pulses. Bojeva teaches it is known to use such a modification as set forth in [0298] (“The physician or medical technician programs programming unit 450 via keyboard 432. This program regarding the frequency, pulse width, modulation program, ON time etc. is stored in programming circuit 438. The programming unit 450 must be placed relatively close to the implanted stimulator 490 in order to transfer the commands and programming information from antenna 440 to antenna 418. Upon receipt of this programming data, modulator/demodulator and decoder 416 decodes and conditions these signals, and the digital programming information is captured by memory 414”) (Thus, the notches are the periods the On time is not On, which is translated/decoded by the demodulator) to provide pulses and pulse trains that give physicians a lot of flexibility for trying various different neuromodulation algorithms for providing and optimizing therapy for neurologic and neuropsychiatric disorders (e.g. see [0294]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use the stimulation circuitry configuration as taught by Bojeva in the system/method of Mishra, since said modification would provide the predictable results of pulses and pulse trains that give physicians a lot of flexibility for trying various different neuromodulation algorithms for providing and optimizing therapy for neurologic and neuropsychiatric disorders.
Regarding claim 3, Mishra discloses the demodulator (e.g. see figure 1 element 231, [0258]) but is silent as to the demodulator is configured to control a release of energy stored in an energy storage capacitor to output the train of mini-pulses. Bojeva teaches it is known to use such a modification as set forth in [0298], [0286] to provide pulses and pulse trains that give physicians a lot of flexibility for trying various different neuromodulation algorithms for providing and optimizing therapy for neurologic and neuropsychiatric disorders (e.g. see [0294]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use the stimulation circuitry configuration as taught by Bojeva in the system/method of Mishra, since said modification would provide the predictable results of pulses and pulse trains that give physicians a lot of flexibility for trying various different neuromodulation algorithms for providing and optimizing therapy for neurologic and neuropsychiatric disorders.
Regarding claim 4, Mishra discloses the demodulator (e.g. see figure 1 element 231, [0258]) but is silent as to the demodulator is configured to control the coupling of the output voltage to output the train of mini-pulses. Bojeva teaches it is known to use such a modification as set forth in [0295]-[0296] to provide pulses and pulse trains that give physicians a lot of flexibility for trying various different neuromodulation algorithms for providing and optimizing therapy for neurologic and neuropsychiatric disorders (e.g. see [0294]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use the stimulation circuitry configuration as taught by Bojeva in the system/method of Mishra, since said modification would provide the predictable results of pulses and pulse trains that give physicians a lot of flexibility for trying various different neuromodulation algorithms for providing and optimizing therapy for neurologic and neuropsychiatric disorders.
Regarding claims 5 and 6, Mishra discloses the circuitry (see rejection for claim 1) but is silent as to the stimulation circuitry comprises a low pass filter and the low pass filter comprises a resistor and a capacitor that are added. Bojeva teaches it is known to use such a modification as set forth in [0295], figure 30 element 406 to provide pulses and pulse trains that give physicians a lot of flexibility for trying various different neuromodulation algorithms for providing and optimizing therapy for neurologic and neuropsychiatric disorders (e.g. see [0294]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use the stimulation circuitry configuration as taught by Bojeva in the system/method of Mishra, since said modification would provide the predictable results of pulses and pulse trains that give physicians a lot of flexibility for trying various different neuromodulation algorithms for providing and optimizing therapy for neurologic and neuropsychiatric disorders.
Regarding claim 7, Mishra discloses the circuitry (see rejection for claim 1) but is silent as to the stimulation circuitry comprises a DC-block capacitor coupled to the output of the low pass filter, wherein the DC-block capacitor prevents release of DC charge. Bojeva teaches it is known to use such a modification as set forth in [0381] to provide pulses and pulse trains that give physicians a lot of flexibility for trying various different neuromodulation algorithms for providing and optimizing therapy for neurologic and neuropsychiatric disorders (e.g. see [0294]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use the stimulation circuitry configuration as taught by Bojeva in the system/method of Mishra, since said modification would provide the predictable results of pulses and pulse trains that give physicians a lot of flexibility for trying various different neuromodulation algorithms for providing and optimizing therapy for neurologic and neuropsychiatric disorders.
Regarding claims 8-10, Mishra discloses the circuitry (see rejection for claim 1) but is silent as to each mini-pulse comprises an on portion and an off portion, the on portion corresponding to the pulse width of the mini-pulse; and the pulse width of the stimulation pulse is greater than a summation of the on portions of the mini-pulses in the train of mini-pulses, each mini-pulse comprises an on portion and an off portion, the on portion corresponding to the pulse width of the mini-pulse; and the pulse width of the stimulation pulse is substantially equal to a summation of the on portion and the off portion of each mini-pulse in the train of mini-pulses, and each mini-pulse comprises an on portion and an off portion, the on portion corresponding to the pulse width of the mini-pulse; and the amplitude of the stimulation pulse is proportional to a summation of the pulse widths of the mini-pulses in the train of mini-pulses. Bojeva teaches it is known to use such a modification as set forth in [0298], [0286] to provide pulses and pulse trains that give physicians a lot of flexibility for trying various different neuromodulation algorithms for providing and optimizing therapy for neurologic and neuropsychiatric disorders (e.g. see [0294]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use the stimulation circuitry configuration as taught by Bojeva in the system/method of Mishra, since said modification would provide the predictable results of pulses and pulse trains that give physicians a lot of flexibility for trying various different neuromodulation algorithms for providing and optimizing therapy for neurologic and neuropsychiatric disorders.
Regarding claim 11, Mishra discloses the circuitry (see rejection for claim 1) but is silent as to the voltage amplitudes of the mini-pulses in the train of mini-pulses are constant. Bojeva teaches it is known to use such a modification as set forth in [0381] to provide pulses and pulse trains that give physicians a lot of flexibility for trying various different neuromodulation algorithms for providing and optimizing therapy for neurologic and neuropsychiatric disorders (e.g. see [0294]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use the stimulation circuitry configuration as taught by Bojeva in the system/method of Mishra, since said modification would provide the predictable results of pulses and pulse trains that give physicians a lot of flexibility for trying various different neuromodulation algorithms for providing and optimizing therapy for neurologic and neuropsychiatric disorders.
Regarding claim 12, Mishra discloses the pulse widths of the mini-pulses in the train of mini-pulses are constant (e.g. see [0368]).
Regarding claim 13, Mishra discloses the pulse widths of the mini-pulses in the train of mini-pulses vary (e.g. see [0368]).
Regarding claims 14 and 15, Mishra discloses the circuitry (see rejection for claim 1) but is silent as to the pulse widths of the mini-pulses in the train of mini-pulses alternate between a first pulse width and a second pulse width and a first subset of the mini-pulses in the train of mini-pulses have a first pulse width and a second subset of the mini-pulses in the train of mini-pulses have a second pulse width different from the first pulse width. Bojeva teaches it is known to use such a modification as set forth in [0303]-[0306], [0319]-[0321] to provide pulses and pulse trains that give physicians a lot of flexibility for trying various different neuromodulation algorithms for providing and optimizing therapy for neurologic and neuropsychiatric disorders (e.g. see [0294]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use the stimulation circuitry configuration as taught by Bojeva in the system/method of Mishra, since said modification would provide the predictable results of pulses and pulse trains that give physicians a lot of flexibility for trying various different neuromodulation algorithms for providing and optimizing therapy for neurologic and neuropsychiatric disorders.
Regarding claim 16, Mishra discloses the circuitry (see rejection for claim 1) but is silent as to the train of mini-pulses is configurable to provide different spectrums in the frequency domain, wherein a spectrum of a train of mini-pulses in the frequency domain changes based on a configuration of the train of mini-pulses. Bojeva teaches it is known to use such a modification as set forth in [0304]-[0307], [0319]-[0322] to provide pulses and pulse trains that give physicians a lot of flexibility for trying various different neuromodulation algorithms for providing and optimizing therapy for neurologic and neuropsychiatric disorders (e.g. see [0294]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use the stimulation circuitry configuration as taught by Bojeva in the system/method of Mishra, since said modification would provide the predictable results of pulses and pulse trains that give physicians a lot of flexibility for trying various different neuromodulation algorithms for providing and optimizing therapy for neurologic and neuropsychiatric disorders.
Regarding claim 17, Mishra discloses the circuitry (see rejection for claim 1) but is silent as to the train of mini-pulses is configurable to provide different spectrums in the frequency domain, wherein a spectrum of a train of mini-pulses in the frequency domain changes based on a configuration of the train of mini-pulses. Bojeva teaches it is known to use such a modification as set forth in [0286], [0292] to provide pulses and pulse trains that give physicians a lot of flexibility for trying various different neuromodulation algorithms for providing and optimizing therapy for neurologic and neuropsychiatric disorders (e.g. see [0294]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use the stimulation circuitry configuration as taught by Bojeva in the system/method of Mishra, since said modification would provide the predictable results of pulses and pulse trains that give physicians a lot of flexibility for trying various different neuromodulation algorithms for providing and optimizing therapy for neurologic and neuropsychiatric disorders.
Regarding claim 18, Mishra discloses the stimulation circuitry is coupled to receive different trains of mini-pulses in the frequency domain and generate a same stimulation pulse having the pulse width and an amplitude that is a function of the pulse widths of the mini-pulses included in the different trains of mini-pulses (e.g. see [0365], [0358]).
Regarding claim 19, see the rejection for claims 1 and 2 above.
Regarding claim 20, Mishra discloses the invention (see rejection for claim 1) an implantable pulse generator having at least one electrode; and an external apparatus comprising a transmitter configured to generate and transmit the RF signal received by the implantable pulse generator as recited in claim 1. Bojeva teaches it is known to use such a modification as set forth in [0328] to provide pulses and pulse trains that give physicians a lot of flexibility for trying various different neuromodulation algorithms for providing and optimizing therapy for neurologic and neuropsychiatric disorders (e.g. see [0294]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use the stimulation circuitry configuration as taught by Bojeva in the system/method of Mishra, since said modification would provide the predictable results of pulses and pulse trains that give physicians a lot of flexibility for trying various different neuromodulation algorithms for providing and optimizing therapy for neurologic and neuropsychiatric disorders.
Regarding claim 21, Mishra discloses the circuitry (see rejection for claim 1) but is silent as to the transmitter is configured to be programmed to control the configuration of the RF signal to thereby control the amplitude of the stimulation pulse. Bojeva teaches it is known to use such a modification as set forth in [0286] to provide pulses and pulse trains that give physicians a lot of flexibility for trying various different neuromodulation algorithms for providing and optimizing therapy for neurologic and neuropsychiatric disorders (e.g. see [0294]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use the stimulation circuitry configuration as taught by Bojeva in the system/method of Mishra, since said modification would provide the predictable results of pulses and pulse trains that give physicians a lot of flexibility for trying various different neuromodulation algorithms for providing and optimizing therapy for neurologic and neuropsychiatric disorders.
Regarding claim 22, Mishra discloses the invention but is silent as to the amplitude of the stimulation pulse is controlled by a number and duration of the notches in the RF signal, which duration controls the pulse widths of the mini-pulses in the train of mini-pulses. Bojeva teaches it is known to use such a modification as set forth in [0298] (“The physician or medical technician programs programming unit 450 via keyboard 432. This program regarding the frequency, pulse width, modulation program, ON time etc. is stored in programming circuit 438. The programming unit 450 must be placed relatively close to the implanted stimulator 490 in order to transfer the commands and programming information from antenna 440 to antenna 418. Upon receipt of this programming data, modulator/demodulator and decoder 416 decodes and conditions these signals, and the digital programming information is captured by memory 414”) (Thus, the notches are the periods the On time is not On, which is translated/decoded by the demodulator) to provide pulses and pulse trains that give physicians a lot of flexibility for trying various different neuromodulation algorithms for providing and optimizing therapy for neurologic and neuropsychiatric disorders (e.g. see [0294]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use the stimulation circuitry configuration as taught by Bojeva in the system/method of Mishra, since said modification would provide the predictable results of pulses and pulse trains that give physicians a lot of flexibility for trying various different neuromodulation algorithms for providing and optimizing therapy for neurologic and neuropsychiatric disorders.
Conclusion
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/P.C.E/Examiner, Art Unit 3792
/AMANDA L STEINBERG/Examiner, Art Unit 3792
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