CTNF 18/802,762 CTNF 101859 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia 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 07-29-01 AIA Claim 1, 11, and 13 objected to because of the following informalities: In claim 1, 11, and 13, “pairing a selected steering instruction set” should instead recite “ the/said selected steering instruction” as it was previously recited In claim 1-5, and 12, “a portion” lacks proper antecedent basis. Only the first introduction should be “a/an” and later should refer as “the/said” Appropriate correction is required. Claim Rejections - 35 USC § 103 07-06 AIA 15-10-15 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. 07-20-aia AIA 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. 07-23-aia AIA The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness. 07-21-aia AIA Claim s 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over US 7769462 B2 to Meadows et al. (hereinafter “ Meadows ”) in view of US 20180071515 A1 to Weiss et al. (hereinafter “ Weiss ”) . Regarding Claim 1, 11, and 13, Meadows teaches an implantable medical device (see Para 13: “an implantable stimulator device”) comprising: a housing (see Para 34: “an implantable pulse generator (IPG) 100 … housed in a rounded titanium case”) containing a power source (see Para 35: “a power source”) , a controller (see Para 72: “the IPG includes a microcontroller 160”), and stimulation circuitry (see Para 35: “The IPG 100 contains stimulating electrical circuitry”); and a lead (see Para 13: “one or more stimulation electrode leads”; and Para 36: “the lead extension 120”) having a plurality of electrodes (see Para 37: “a multiplicity of electrodes, e.g., sixteen electrodes, included within the electrode array 110”) thereon, the lead coupled to the housing (see Para 36: “the IPG 100 is connected to a lead system”) such that the stimulation circuitry can issue stimulus pulse patterns to a patient via the electrodes (see Para 42: “an important feature of the SCS system of the present invention is the ability to support more than one lead with two or more channels. Here, a "channel" is defined as a specified electrode, or group of electrodes, that receive a specified pattern or sequence of stimulus pulses … each channel may be programmed to provide its own specified pattern or sequence of stimulus pulses to its defined electrode or group of electrodes. In operation, all of the stimulus patterns applied through all of the channels of such multi-channel system thus combine to provide an overall stimulation pattern that is applied to the tissue exposed to the individual electrodes of the electrode array(s)”); wherein the controller comprises: a memory (see Para 72: “memory circuitry 162 … operating program and stimulation parameters are typically programmably stored within the memory 162”) including steering memory, aggregate memory, pulse memory, and configuration memory; a plurality of pulse definition circuits (see Para 78: “a plurality m of independent current source pairs”) each including steering logic, aggregate logic, and pulse logic (see Para 72: “The .mu.C 160 typically comprises … associated logic circuitry, which in combination with control logic circuits 166, timer logic 168, and an oscillator and clock circuit 164, generate the necessary control and status signals which allow the .mu.C to control the operation of the IPG in accordance with a selected operating program and stimulation parameters”); wherein: the steering memory contains steering instruction sets for a plurality of steering programs, each steering program determining which of the electrodes receive a fraction of a total stimulus output, (see Para 56: “the IPG has, … sixteen electrode contacts, each of which is independently programmable relative to stimulus polarity and amplitude for each of up to four different programmable channel assignments (groups or phase generators). In operation, each channel identifies which electrodes among the sixteen electrodes, E1, E2, E3, . . . E16 and the IPG case electrode (reference electrode), are to output stimulation pulses in order to create an electric current field. All electrodes assigned to a given channel deliver their stimulation pulses simultaneously with the same pulse width and at the same pulse rate”) and the steering logic is configured to implement a selected steering instruction set (see Para 80-81: “each of the n programmable electrode contacts can be programmed to have a positive (sourcing current), negative (sinking current), or off (no current) polarity in any of the k channels. Moreover, it is seen that each of the n electrode contacts can operate in a bipolar mode or multipolar mode, e.g., where two or more electrode contacts are grouped to source/sink current at the same time); the pulse memory contains pulse programs, each having a one or more pulse instructions defining pulse components each having a pulse type and one or more determining characteristics for the pulse type (see Para 60: “For each channel, the first phase period (pulse width) is programmable from 10 to 1000 microseconds (.mu.s) in 10 .mu.s steps. The inter-phase period between the First (Pulse Width) and Second (Recharge) phases is 100 .mu.s. The Second (Recharge) phase period is programmable from 10 to 1500 .mu.s in 10 .mu.s increments. The Second (Recharge) phase type is programmable as either Passive or Active. The pulse rate is programmable in either a Normal or a High rate range”) ; the aggregate memory contains aggregate instructions each defining one or more aggregated outputs, each aggregated output pairing a selected steering instruction set with a selected pulse program and defining a number of repetitions for the selected pulse program to execute with the selected steering instruction set (see Para 100: “Included as part of the digital ASIC 191' is a matrix of counters 760 that function as a digital pulse generator. This matrix of counters 760 include four delay and burst counters 764, four slow start/stop counters 765, and four phase counters 766. There is thus one counter of each type for each channel. In combination, the counters 760 define the parameters (timing and amplitude) associated with the stimulation pulses that are generated by the output current DACs 186' included within the analog ASIC chip 190' (see FIGS. 4B and 4C). Any combination of timing generators can drive any electrode through the analog ASIC chip 190'. An arbitrator circuit 768 monitors the various pulses being defined by the counters 760 in order to control overlap between pulses”) ; the configuration memory contains a plurality of therapy configuration instruction sets each having a defined total stimulus output amplitude, an arbitration mode, a holdoff setting, and identifying a one or more aggregate instructions to be executed for each therapy configuration (see Para 56: “The amplitude is programmable from -12.7 mA to +12.7 mA in 0.1 mA steps”, and Para 61: “To prevent more than one channel from producing a stimulus current at the same time, i.e., to prevent current pulses from different channels that overlap, an overlap arbitration circuit may be employed (that is, the arbitration feature may be programmed ON or OFF for each channel) that determines which channel has priority”, also Para 62: “Once a non-overlapping channel begins a pulse, the start of pulses from any other non-overlapping channel is delayed until the ongoing pulse phase one is completed and a Hold-Off has been completed. The Hold-Off period is timed from the end of the first phase of the pulse … The Hold-Off period is programmable from 1 to 64 milliseconds in 1 millisecond increments”) ; the arbitration mode defined in the configuration memory for each therapy configuration instruction set determines whether the therapy configuration instruction sets will wait for completion of portions of other therapy configuration instruction sets before initiating (see Para 62: “Once a non-overlapping channel begins a pulse, the start of pulses from any other non-overlapping channel is delayed until the ongoing pulse phase one is completed and a Hold-Off has been completed. The Hold-Off period is timed from the end of the first phase of the pulse. If the start of two or more non-overlapping channels are delayed by an ongoing pulse and Hold-Off, the pending channels are started in the order they would have occurred without arbitration. If two non-overlapping channels are scheduled to start simultaneously, the lower number channel takes priority and starts first (i.e., channel 1 before channel 2, channel 2 before channel 3, and channel 3 before channel 4). The Hold-Off period is programmable from 1 to 64 milliseconds in 1 millisecond increments”) , and the holdoff setting determines whether the therapy configuration instruction set can be interrupted by another therapy configuration instruction set (see Para 62: “Current from any stimulus pulse (First phase) or active recharge (active second phase) is prevented from passing through any electrode undergoing passive recharge. the delivery of an active first phase or active second phase on any electrode takes precedence over all ongoing passive recharge phases. Electrodes undergoing passive recharge have their passive recharge phases temporarily interrupted during the active phase(s). If the electrode is not part of the active phase, it remains in a high impedance state (i.e., turned OFF) until the active phase is completed”) ; and the controller is configured to execute the plurality of therapy configurations to generate output pulses using the stimulation circuity (see Para 90: “Controlling the current sources and switching matrix 188 using the microcontroller 160, in combination with the control logic 166 and timer logic 168, thereby allows each electrode contact to be paired or grouped with other electrode contacts, including the monopolar case electrode, in order to control the polarity, amplitude, rate, pulse width and channel through which the current stimulus pulses are provided”, and Para 113: “The ASIC has a standard bus interface to the microcontroller allowing simple, direct and efficient access to all of its control and stimulation parameter registers. Triggering and timing control circuitry allow the simultaneous activation of any of the channels”) by: initiating execution of a first therapy configuration instruction set (see Fig 3B and Para 64: “Channel 1 firing at time T1 … two events begin: (1) an inter-phase period 3B11, and (2) a hold-off period 3B12 …”) ; while executing the first therapy configuration instruction set, receiving a request to execute a second therapy configuration instruction set (see Para 64: Channel 1 firing at time T1, Channel 3 firing at time T2 … at time T2, when Channel 3 would normally fire, it is prevented from doing so. Rather, it must wait a time period Td3 until the Channel 1 Hold-Off Period 3B12 concludes …”) ; determining whether the arbitration mode for the second therapy configuration instruction set allows the second therapy configuration instruction set to wait for completion of portions of other therapy configuration instruction sets and, if not, initiating execution of the second therapy configuration instruction set while the first therapy configuration instruction set is executing (see Para 64 – 67: “the normal sequence of Channel firings without arbitration, would be as follows: Channel 1 firing at time T1, Channel 3 firing at time T2 … at time T2, when Channel 3 would normally fire, it is prevented from doing so. Rather, it must wait a time period Td3 until the Channel 1 Hold-Off Period 3B12 concludes … During the firing of channels 1 and 4, Channel 2 is still experiencing a Second Phase passive recharge 3B20. Hence, this passive recharge is temporarily interrupted for electrodes E16 and the common (case) electrode during the active phase of Channels 1 and 4”), or else: determining whether the holdoff setting for the first therapy configuration instruction set allows interruption of the first therapy configuration instruction set by the second therapy configuration instruction set (see Para 63 - 67, and Fig. 3B) and: if so, completing an ongoing execution of at least a portion of the first therapy configuration instruction set, and then starting execution of the second therapy configuration instruction set (see Para 63 - 67, and Fig. 3B) ; or if not, completing execution of the first therapy configuration instruction set before allowing the second therapy configuration instruction set to be started (see Para 63 - 67, and Fig. 3B). Additional contents of claim 11 : determining whether the aggregate holdoff setting for an ongoing aggregate instruction being executed allows interruption of the ongoing aggregate instruction by the second therapy configuration instruction set (see Para 63 - 67, and Fig. 3B) and: if so, completing execution of a pulse program of the ongoing aggregate instruction set of the first therapy configuration instruction set and then starting execution of at least a first aggregate instruction set of the second therapy configuration instruction set (see Para 63 - 67, and Fig. 3B) ; or if not, completing execution of the ongoing aggregate instruction set of the first therapy configuration instruction set and then initiating execution of at least the first aggregate instruction of the second therapy configuration to be executed (see Para 63 - 67, and Fig. 3B) . Additional contents of claim 13 : further wherein the pulse holdoff setting of each pulse instruction determines whether the pulse instruction allows concurrent execution of another therapy configuration during execution of the pulse instruction (see Para 61-69: “To prevent more than one channel from producing a stimulus current at the same time, i.e., to prevent current pulses from different channels that overlap … no electrodes are shared between Channels 1 and 4, and thus simultaneous firing is permitted if the timing is such that simultaneous firing is called for …”) ; in response to the request to start the second therapy configuration, checking a pulse holdoff setting for a next pulse instruction to be executed in the pulse program (see Para 61-69: “To prevent more than one channel from producing a stimulus current at the same time, i.e., to prevent current pulses from different channels that overlap … Channel 1 firing at time T1, Channel 3 firing at time T2 … During the Hold-Off Period 3B12, no other channel is permitted to generate a stimulus pulse. Thus, at time T2, when Channel 3 would normally fire, it is prevented from doing so. Rather, it must wait a time period Td3 until the Channel 1 Hold-Off Period 3B12 concludes …”) and: if the pulse holdoff setting of the next pulse instruction allows concurrent therapy by another therapy configuration, starting the second therapy configuration when starting execution of the next pulse instruction ( see Para 61-69: “To prevent more than one channel from producing a stimulus current at the same time … Channels 1 and 4, and thus simultaneous firing is permitted if the timing is such that simultaneous firing is called for …”) ; or else waiting at least until completion of execution of the next pulse instruction before starting execution of the second therapy configuration ( see Para 61-69: “To prevent more than one channel from producing a stimulus current at the same time … During the Hold-Off Period 3B12, no other channel is permitted to generate a stimulus pulse. Thus, at time T2, when Channel 3 would normally fire, it is prevented from doing so. Rather, it must wait a time period Td3 until the Channel 1 Hold-Off Period 3B12 concludes …”) . Meadows teaches that the implantable pulse generator includes a microcontroller connected to memory circuitry and plurality of pulse definition circuits. However, does not specifically teach that the memory including steering memory, aggregate memory, pulse memory, and configuration memory and all the different logics in detail. Another reference, Weiss , teaches a similar implantable medical device (see Para 2) wherein a memory (see Para 63: “memory circuits”) including steering memory, aggregate memory, pulse memory, and configuration memory (see Para 63: “The memory circuits include a steering memory 502 … a pulse memory 504 … an aggregate memory 506 … additionally includes a configuration memory 508”); a plurality of pulse definition circuits (see Para 63: “one or more pulse definition circuits (PDCs) 171”) each including steering logic, aggregate logic, and pulse logic (see Para 64: “The microcode and configuration parameters that are stored in the memory circuitry are processed by logic blocks in the PDCs 171 … These logic blocks include a steering logic block 512, a pulse logic block 514, and an aggregate logic block 516”); the steering memory contains steering instruction sets for a plurality of steering programs (see Para 63: “a steering memory 502 that contains steering microcode that defines electrode steering programs”, and 66: “a single steering program is shown, multiple steering programs may be stored within the steering memory 502”) , each steering program determining which of the electrodes receive a fraction of a total stimulus output (see Para 65: “a steering program that defines the polarity and current allocation for 33 electrodes (e.g., 32 lead electrodes and a case electrode). In the illustrated arrangement, each memory location includes 32 bits, and a steering program is defined by nine consecutive memory locations. For each electrode, the polarity and the allocation of current of the specified polarity is defined by one byte within one of the memory locations, and the bytes are arranged in consecutive order of the electrodes across the nine memory locations”) , and the steering logic is configured to implement a selected steering instruction set (see Para 111: the active steering program is referenced by the address parameter of the steering logic block 512”) ; the pulse memory contains pulse programs (see Para 63: “a pulse memory 504 that contains pulse microcode that defines pulse programs”) , each having a one or more pulse instructions defining pulse components each having a pulse type and one or more determining characteristics for the pulse type (see Para 67: “the pulse memory 504 to define a pulse program, which example is illustrated with reference to FIGS. 7-9. In the example arrangement, each 32-bit memory location stores a pulse instruction that defines the properties of a single phase of the pulse. The arrangement of parameters for the different types of instructions (which define different types of phases) is illustrated in FIG. 7”) ; the aggregate memory contains aggregate instructions each defining one or more aggregated outputs (see Para 82: “aggregate memory 506 stores a library of aggregate instructions. One or more aggregate instructions define an aggregate program”) , each aggregated output pairing a selected steering instruction set with a selected pulse program (see Para 63: “an aggregate memory 506 that contains aggregate microcode that links pulse programs and steering programs to create a desired pulse therapy program”) and defining a number of repetitions for the selected pulse program to execute with the selected steering instruction set (see Para 81: “Bits 12-19 enable specification of the number of times that the selected pulse is to be repeated. The eight bits in this repeat range enable the specification of up to 255 repeats”) ; the configuration memory contains a plurality of therapy configuration instruction sets (see Para 63: “configuration memory 508 that stores configuration parameters some of which are global (apply across multiple PDCs 171) and some of which are specific to a particular PDC 171”) each having a defined total stimulus output amplitude (see Para 95: “configuration parameters include adjustment parameters that adjust the timing or amplitude parameters”) , an arbitration mode (see Para 95: “an arbitration mode bit (bit 2)”) , a holdoff setting (see Para 98: “an arbitration holdoff value (bits 0-15)” , and identifying a one or more aggregate instructions to be executed for each therapy configuration (see Para 98: “additionally includes a start delay value (bits 16-31), which specifies the number of clock cycles after the PDC 171's enable bit is set that the execution of the specified aggregate instruction is initiated”) ; the arbitration mode defined in the configuration memory for each therapy configuration instruction set determines whether the therapy configuration instruction sets will wait for completion of portions of other therapy configuration instruction sets before initiating, and the holdoff setting determines whether the therapy configuration instruction set can be interrupted by another therapy configuration instruction set (see Para 101: “the stimulation request from the PDC 171 is dependent upon the selected arbitration mode. In the aggregate arbitration mode, the PDC 171 requests approval prior to executing an aggregate instruction. Upon the grant of approval, the PDC 171 executes the full aggregate instruction. This is illustrated in the aggregate mode portion of FIG. 16”, also and Para 103: “The pulse arbitration mode functions similarly to the aggregate arbitration mode except that each PDC 171 requests approval from the arbitration manager block 1602 prior to the execution of a single pulse. This is illustrated in the pulse mode portion of FIG. 16. Like the aggregate arbitration mode example, at t0, PDC 171(1) communicates a request to the arbitration manager block 1602, and, because there is no active holdoff timer, the arbitration manager block 1602 communicates the grant to PDC 171(1) at t1 and starts accumulating the holdoff timer … arbitration can also be implemented with different PDCs operating in different arbitration modes”) ; It would have been obvious to one of ordinary skill in the art as of the time of Applicant’s effective filing date of invention to combine Weiss teaching to modify the invention of Meadows in order to improve the stimulation circuitry for creating pulses and improved measurement circuitry for measuring values in an implantable medical device (see Para 02). Regarding Claim 2 , Meadows further teaches the modified implantable medical device of claim above, wherein, if the holdoff setting for the first therapy configuration instruction set allows interruption of the first therapy configuration instruction set by the second therapy configuration instruction set, the controller is configured, while the second therapy configuration instruction set is being executed, to determine whether the holdoff setting of the second therapy configuration instruction set allows interruption of the second therapy configuration instruction set and, if so, interrupting the second therapy configuration instruction set after completing execution of a portion thereof to execute a portion of the first therapy configuration instruction set (see Para 61-69: “To prevent more than one channel from producing a stimulus current at the same time, i.e., to prevent current pulses from different channels that overlap, an overlap arbitration circuit may be employed (that is, the arbitration feature may be programmed ON or OFF for each channel) that determines which channel has priority … Once a non-overlapping channel begins a pulse … Channels 1, 2 and 3 have arbitration (a hold-off period) programmed ON, while Channel 4 does not … Channel 1 firing at time T1, Channel 3 firing at time T2 … During the Hold-Off Period 3B12, no other channel is permitted to generate a stimulus pulse. Thus, at time T2, when Channel 3 would normally fire, it is prevented from doing so. Rather, it must wait a time period Td3 until the Channel 1 Hold-Off Period 3B12 concludes … Recall that Channel 4 does not have its arbitration feature programmed ON, hence, it fires just as soon as it can after the preceding Hold-Off period 3B19 terminates, which just happens to be at the same time that Channel 1 fires. Note that no electrodes are shared between Channels 1 and 4, and thus simultaneous firing is permitted if the timing is such that simultaneous firing is called for. During the firing of channels 1 and 4, Channel 2 is still experiencing a Second Phase passive recharge 3B20. Hence, this passive recharge is temporarily interrupted for electrodes E16 and the common (case) electrode during the active phase of Channels 1 and 4 … During the firing of channels 1 and 4, Channel 2 is still experiencing a Second Phase passive recharge 3B20. Hence, this passive recharge is temporarily interrupted for electrodes E16 and the common (case) electrode during the active phase of Channels 1 and 4 …”) . Regarding Claim 3 , Meadows further teaches the modified implantable medical device of claim above, wherein, if the holdoff settings of the first and second therapy configuration instruction sets allow interruption of each of the first and second therapy configuration instruction sets, the controller is configured to alternate between execution of a portion of the first therapy configuration instruction set and execution of a portion of the second therapy configuration instruction set until completion of all aggregate instructions of one of the first and second therapy configuration instruction sets (see Para 61- 69: “Once a non-overlapping channel begins a pulse … Channels 1, 2 and 3 have arbitration (a hold-off period) programmed ON, while Channel 4 does not … Channel 4 does not have its arbitration feature programmed ON, hence, it fires just as soon as it can after the preceding Hold-Off period 3B19 terminates, which just happens to be at the same time that Channel 1 fires. Note that no electrodes are shared between Channels 1 and 4, and thus simultaneous firing is permitted if the timing is such that simultaneous firing is called for. During the firing of channels 1 and 4, Channel 2 is still experiencing a Second Phase passive recharge 3B20. Hence, this passive recharge is temporarily interrupted for electrodes E16 and the common (case) electrode during the active phase of Channels 1 and 4 … During the firing of channels 1 and 4, Channel 2 is still experiencing a Second Phase passive recharge 3B20. Hence, this passive recharge is temporarily interrupted for electrodes E16 and the common (case) electrode during the active phase of Channels 1 and 4 … the next channel to fire is Channel 3, which channel fires at its programmed rate, f3, as determined from its last firing (i.e., at a time interval 1/f3 from its prior firing) … the second phase period for each channel or group need not be a passive recharge period. Rather, as shown in FIG. 3C, the second phase can also be an active phase, i.e., a phase when one or more current sources are turned ON …”) . Regarding Claim 4 , Meadows further teaches the modified implantable medical device of claim above, wherein each aggregate instruction includes an aggregate holdoff setting, and the controller is configured to determine, using aggregate holdoff settings of the aggregate instructions, the portion the first configuration instruction set to execute before switching to execute a portion of the second therapy configuration instruction set (see Fig. 3B and Para 61-69: “The interpulse interval (1/Rate) is programmed such that it is greater than the sum of the first phase period plus the inter-phase period plus the second phase period for each channel. When passive recharge is programmed, the total second phase period available to complete recharge (not including interruptions for active phases) is at least 7 milliseconds for every pulse delivered … at the conclusion of the Channel 1 Hold-Off period 3B12, Channel 3 fires, which means a First Phase period 3B14 for Channel 3 begins. At this time, which is still during the Channel 1 Second Phase Period 3B13, the passive recharge which is taking place in electrodes E1, E2 and E3 is interrupted temporarily (e.g., for the duration of the active first phase period 3B14) … Channel 2 inter-phase period 3B18 and a Channel 2 Hold-Off period 3B19. A Channel 2 Second Phase period 3B20 begins at the conclusion of the Channel 2 inter-phase period 3B18 … At the conclusion of the Channel 2 hold-off period 3B19, as seen in FIG. 3B, two events occur: (1) Channel 1 fires, which means a channel 1 First Phase period 3B21 begins; and (2) Channel 4 fires, which means a Channel 4 First Phase period 3B22 begins”) . Regarding Claim 5 and 12 , Meadows further teaches the modified implantable medical device of claim above, wherein each pulse component includes a pulse component holdoff setting, and the controller is configured to determine, using pulse component holdoff settings of the pulse components, the portion the first therapy configuration instruction set to execute before switching to execute a portion of the second therapy configuration instruction set (see Para 61-69: “Once a non-overlapping channel begins a pulse, the start of pulses from any other non-overlapping channel is delayed until the ongoing pulse phase one is completed and a Hold-Off has been completed … The Hold-Off period is programmable from 1 to 64 milliseconds in 1 millisecond increments. Current from any stimulus pulse (First phase) or active recharge (active second phase) is prevented from passing through any electrode undergoing passive recharge. the delivery of an active first phase or active second phase on any electrode takes precedence over all ongoing passive recharge phases … Channel 2 inter-phase period 3B18 and a Channel 2 Hold-Off period 3B19. A Channel 2 Second Phase period 3B20 begins at the conclusion of the Channel 2 inter-phase period 3B18 … At the conclusion of the Channel 2 hold-off period 3B19, as seen in FIG. 3B, two events occur: (1) Channel 1 fires, which means a channel 1 First Phase period 3B21 begins; and (2) Channel 4 fires, which means a Channel 4 First Phase period 3B22 begins …”) . Regarding Claim 6 and 17 , Meadows further teaches the modified implantable medical device of claim above, wherein the stimulation circuitry comprises a plurality of digital-to-analog converter circuits including selectable current mirrors, and the total output amplitude is defined in terms of total output current, such that the implantable medical device is configured to deliver current controlled neural stimulation (see Para 96: “The analog IC (AIC) 190' comprises an ASIC that functions as the main integrated circuit that performs several tasks necessary for the functionality of the IPG 100', including providing power regulation, stimulus output, and impedance measurement and monitoring. Electronic circuitry 194' performs the impedance measurement and monitoring function. The main area of the analog 190' is devoted to the current stimulus generators 186'. These generators 186' may be realized using the circuitry described in the previously-referenced PCT application, Serial No. PCT/US99/14190, or similar circuitry. These generators 186' are designed to deliver up to 20 mA aggregate and up to 12.7 mA on a single channel in 0.1 mA steps, which resolution requires that a seven (7) bit digital-to-analog (DAC) circuit be employed at the output current DAC 186'. Regulators for the IPG 100' supply the processor and the digital sequencer with a voltage of 2.7 V.+-.10%. Digital interface circuits residing on the AIC 190' are similarly supplied with a voltage of 2.7 V.+-.10%. A regulator programmable from 5V to 18V supplies the operating voltage for the output current DACs 186”, also Para 98: “the analog IC 186' includes a multiplicity of output current sources 4C06, e.g., sixteen bi-directional output current sources, each configured to operate as a DAC current source. Each DAC output current source 4C06 may source or sink current, i.e., each DAC output current source is bi-directional. Each DAC output current source is connected to an electrode node 4C11”) . Regarding Claim 7 and 18 , Meadows further teaches the modified implantable medical device of claim above, wherein the pulse definition circuit is coupled to the plurality of digital-to-analog converter circuits and is configured to instruct a selected one of the plurality of digital-to-analog converter circuits to use the total output current, and divide the total output current using the selected steering instruction set (see Para 97: “a data bus 4C01 from the digital IC 191' couples data received from the digital IC to AIC sequencer circuits 4C02. Such data includes odd and even amplitude data, odd and even mode data, and odd and even change data, where "odd" and "even" refer to the electrode number (with electrodes E1, E3, E5, etc. being "odd" electrodes; and electrodes E2, E4, E6, etc., comprising "even" electrodes). A multiplicity of latch circuits 4C03 are connected to the AIC sequencer 4C02, one latch circuit for each electrode”) . Regarding Claim 8 and 19 , Meadows further teaches the modified implantable medical device of claim above, wherein the stimulation circuitry comprises a plurality of switches configured to control which electrodes receive current from the plurality of digital to analog converter circuits, and the pulse definition circuit is coupled to the plurality of switches and is configured to control the plurality of switches using the selected steering instruction set (see Para 78: “The output of the positive current source and the negative current source of each pair of current sources 186 is connected to a common node 187. This common node 187, in turn, is connected through a low impedance switching matrix 188 to any of n electrode nodes E1, E2, E3, . . . En, through respective coupling capacitors C1, C2, C3, . . . Cn. (Note: a second embodiment of the IPG, see FIGS. 4B and 4C, discussed below, does not use a low impedance switching matrix 188. Rather, there is an independent bi-directional current source for each of the sixteen electrodes.) Through appropriate control of the switching matrix 188, when used (FIG. 4A), or through operation of the independent bi-directional current sources, when used (FIGS. 4B and 4C), any of the m current source nodes 187 may be connected to any of the electrode nodes E1, E2, E3, . . . En”, also Para 97: “A PDAC circuit 4C05 is enabled by a signal on the S1 line when a current having the amplitude specified on the amplitude bus 4C04 is to be sourced from a current source 4C06 through a coupling capacitor Cn, where n is an integer from 1 to 16. Similarly, an NDAC circuit 4C07 is enabled by a signal on the S2 line when a current having the amplitude specified on the amplitude bus 4C04 is to be sunk into the current source 4C06 through the coupling capacitor Cn. A recharge switch 4C08 is enabled by the signal on the S3 line when it is desired to remove the charge from the coupling capacitor Cn. Another switch 4C09 allows an indifferent electrode 4C11, e.g., the case of the IPG, to be turned on upon receipt of an SC1 signal. Similarly, a recharge switch 4C10 allows the indifferent electrode 4C11 to be selectively connected to ground, or another voltage source, upon receipt of an SC2 signal”) . Regarding Claim 9 and 20 , Meadows further teaches the modified implantable medical device of claim above, and a clinician programmer adapted to communicate with the implantable medical device and program each of the arbitration mode and holdoff settings stored in the implantable medical device (see Para 127: “the clinician programming system will be described. This system includes, as seen in FIG. 1, a clinician programmer 204 coupled to a directional device 206. The clinician programmer 204 typically interfaces with the patient hand-held programmer 202 in communicating with the implanted pulse generator (IPG) 100. As described above, the clinician programmer 204 may also be selectively coupled to the external trial stimulator 140 … The clinician's programming system is used to optimize the programming of the implant for the patient. In a preferred implementation, such system comprises software, referred to as Clinician's Programmer Software (referred to as "ClinPro" software) with operates on a 32 bit Windows operating system. The function of the ClinPro software is to program the IPG. Programming the IPG involves setting the pulse width, amplitude, and rate through which electrical stimuli are to be applied to the patient through the selected combinations or groups of electrodes on the electrode array 110”) ; wherein the lead is adapted for placement in the brain of a patient. Meadows teaches that a clinician programmer adapted to communicate with the implantable medical device and program each of the arbitration mode and holdoff settings stored in the implantable medical device. However, does not teach that the lead of the implantable pulse generator is adapted for placement in the brain of a patient. Weiss, teaches the improved implantable medical device above wherein the lead is adapted for placement in the brain of a patient (see Para 3: “Implantable stimulation devices are devices that generate and deliver electrical stimuli to body nerves and tissues for the therapy of various biological disorders … spinal cord stimulators to treat chronic pain, cortical and deep brain stimulators to treat motor and psychological disorders … the present invention may find applicability in any implantable medical device system, including a Deep Brain Stimulation (DBS) system”) . It would have been obvious to one of ordinary skill in the art as of the time of Applicant’s effective filing date of invention to combine Weiss teaching to modify the invention of Meadows in order to provide therapy for various biological disorders including to treat motor and psychological disorders (see Para 3) . Regarding Claim 10 , Meadows further teaches the modified implantable medical device of claim above, and a clinician programmer adapted to communicate with the implantable medical device and program each of the arbitration mode and holdoff settings stored in the implantable medical device (see Para 127-128: “the clinician programming system will be described. This system includes, as seen in FIG. 1, a clinician programmer 204 coupled to a directional device 206. The clinician programmer 204 typically interfaces with the patient hand-held programmer 202 in communicating with the implanted pulse generator (IPG) 100. As described above, the clinician programmer 204 may also be selectively coupled to the external trial stimulator 140 … The clinician's programming system is used to optimize the programming of the implant for the patient. In a preferred implementation, such system comprises software, referred to as Clinician's Programmer Software (referred to as "ClinPro" software) with operates on a 32 bit Windows operating system. The function of the ClinPro software is to program the IPG. Programming the IPG involves setting the pulse width, amplitude, and rate through which electrical stimuli are to be applied to the patient through the selected combinations or groups of electrodes on the electrode array 110”) ; wherein the lead is adapted for placement in the spinal column of a patient (see Para 1-4: “a spinal cord stimulation system for stimulating nerves in the spinal cord … implanted along the dura of the spinal cord”) . Regarding Claim 14 , Meadows further teaches the modified implantable medical device of claim above, wherein, in response to the request to start the second therapy configuration, the controller is configured to prevent initiation of the second therapy configuration until either: a subsequent pulse instruction has a holdoff setting allowing concurrent therapy by another therapy configuration; or the controller completes execution of at least the pulse program that is executing at the time the request to start the second therapy configuration is received (see Para 61-69: “To prevent more than one channel from producing a stimulus current at the same time, i.e., to prevent current pulses from different channels that overlap … the Channel 2 hold-off period 3B19, as seen in FIG. 3B, two events occur: (1) Channel 1 fires, which means a channel 1 First Phase period 3B21 begins; and (2) Channel 4 fires, which means a Channel 4 First Phase period 3B22 begins … During the firing of channels 1 and 4, Channel 2 is still experiencing a Second Phase passive recharge 3B20. Hence, this passive recharge is temporarily interrupted for electrodes E16 and the common (case) electrode during the active phase of Channels 1 and 4 …”) . Regarding Claim 15 , Meadows further teaches the modified implantable medical device of claim above, wherein, in response to the request to start the second therapy configuration, the controller is configured to prevent initiation of the second therapy configuration until either: a subsequent pulse instruction has a holdoff setting allowing concurrent therapy by another therapy configuration; or the controller completes execution of at least the aggregate instruction set that is executing at the time the request to start the second therapy configuration is received (see Para 61-69: “… Channel 1 firing at time T1, Channel 3 firing at time T2, and Channels 2 and 4 both firing at time T3. However, with arbitration ON, the respective channel firings are ordered as follows: The First phase period for Channel 1, 3B10, comprises the time when electrode E1 and E2 function as anodes, and electrodes E3 and E4 function as cathodes … During the Hold-Off Period 3B12, no other channel is permitted to generate a stimulus pulse. Thus, at time T2, when Channel 3 would normally fire, it is prevented from doing so. Rather, it must wait a time period Td3 until the Channel 1 Hold-Off Period 3B12 concludes …”) . Regarding Claim 16 , Meadows further teaches the modified implantable medical device of claim above, The implantable medical device of claim 13, wherein, in response to the request to start the second therapy configuration, the controller is configured to prevent initiation of the second therapy configuration until either: a subsequent pulse instruction has a holdoff setting allowing concurrent therapy by another therapy configuration; or the controller completes execution of the first therapy configuration (see Para 61-69: “… Channel 1 firing at time T1, Channel 3 firing at time T2, and Channels 2 and 4 both firing at time T3 … the conclusion of the Channel 1 Hold-Off period 3B12, Channel 3 fires, which means a First Phase period 3B14 for Channel 3 begins. At this time, which is still during the Channel 1 Second Phase Period 3B13 …”) . Conclusion 07-96 AIA The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 20170281944 A1 - An implantable pulse generator (IPG) that generates spinal cord stimulation signals. US 20190209850 A1 - a system for delivering neurostimulation. US 20250213866 A1 - A multi-active-implantable-medical-device therapy system. US 20180071514 A1 - Improved circuitry for measuring analog values in an implantable pulse generator. US 20180071513 A1 - Improved stimulation circuitry for controlling the stimulation delivered by an implantable stimulator. US 20180071516 A1 - Improved stimulation circuitry for controlling the stimulation delivered by an implantable stimulator. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ISRAT JAHAN whose telephone number is (571)272-8895. The examiner can normally be reached Mon-Fri: 8am-5pm. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Patel Niketa can be reached at (571) 272-4156. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /I.J./ Examiner, Art Unit 3792 /NIKETA PATEL/ Supervisory Patent Examiner, Art Unit 3792 Application/Control Number: 18/802,762 Page 2 Art Unit: 3792 Application/Control Number: 18/802,762 Page 3 Art Unit: 3792 Application/Control Number: 18/802,762 Page 4 Art Unit: 3792 Application/Control Number: 18/802,762 Page 5 Art Unit: 3792 Application/Control Number: 18/802,762 Page 6 Art Unit: 3792 Application/Control Number: 18/802,762 Page 7 Art Unit: 3792 Application/Control Number: 18/802,762 Page 8 Art Unit: 3792 Application/Control Number: 18/802,762 Page 9 Art Unit: 3792 Application/Control Number: 18/802,762 Page 10 Art Unit: 3792 Application/Control Number: 18/802,762 Page 11 Art Unit: 3792 Application/Control Number: 18/802,762 Page 12 Art Unit: 3792 Application/Control Number: 18/802,762 Page 13 Art Unit: 3792 Application/Control Number: 18/802,762 Page 14 Art Unit: 3792 Application/Control Number: 18/802,762 Page 15 Art Unit: 3792 Application/Control Number: 18/802,762 Page 16 Art Unit: 3792 Application/Control Number: 18/802,762 Page 17 Art Unit: 3792 Application/Control Number: 18/802,762 Page 18 Art Unit: 3792 Application/Control Number: 18/802,762 Page 19 Art Unit: 3792 Application/Control Number: 18/802,762 Page 20 Art Unit: 3792 Application/Control Number: 18/802,762 Page 21 Art Unit: 3792 Application/Control Number: 18/802,762 Page 22 Art Unit: 3792 Application/Control Number: 18/802,762 Page 23 Art Unit: 3792 Application/Control Number: 18/802,762 Page 24 Art Unit: 3792 Application/Control Number: 18/802,762 Page 25 Art Unit: 3792 Application/Control Number: 18/802,762 Page 26 Art Unit: 3792 Application/Control Number: 18/802,762 Page 27 Art Unit: 3792
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