DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant’s arguments filed with respect to the rejection of Independent Claim 1 under 35 U.S.C. 103 as being unpatentable over US 2014/0058480 A1 to Perryman et al. (“Perryman”) in view of Non-Patent Literature E. Khansalee et al., "High Frequency Rectifier for RF Energy Harvesting Systems," 2015 7th International Conference on Information Technology and Electrical Engineering (ICITEE), Chiang Mai, Thailand, 2015, pp. 304-308 (“Khansalee”) and Non-Patent Literature J. Thelin et al., "Implant Size and Fixation Mode Strongly Influence Tissue Reactions in the CNS;" PLoS ONE 6(1): e16267, January 2011 (“Thelin”) have been fully considered and but are not persuasive.
Applicant argues that “the combination of cited references does not teach or suggest the main control chip as claimed” (Applicant’s Remarks at Pg. 8 of 13). Applicant provides three reasons for this argument: (i) “Thelin's discussion of implant dimensions and tethering is not a teaching or suggestion of integrating the claimed functions into a single main control chip;” (ii) Perryman cannot feasibly be adapted to use a single “main control chip” because “the RF pulse generator module 106 and the implanted lead module 114 are designed as separate modules;” and (iii) Perryman cannot feasibly be adapted to use a single “main control chip” because Perryman’s “RF pulse generator module 106 includes a power supply battery subsystem 210 that includes a battery” and “[i]f RF pulse generator module 106 is implanted subcutaneously, replacing the battery requires surgery.” Applicant’s arguments are not persuasive.
Regarding Applicant’s first argument, Applicant’s argument is not persuasive because it is based on a reading of Thelin that is inaccurately narrow. Applicant does not point to any particular portion of Thelin’s disclosure in support of Applicant’s position, and is it not clear what particularly in Thelin Applicant’s conclusion is based upon. Thelin assesses the physiological impact of various implant structures, concluding that “combined small diameter, un-tethered implants cause the smallest tissue reactions” (Thelin at Abstract). In other words, Thelin concludes that a smaller device with less parts minimizes tissue reaction relative to a larger device with more parts. Relevantly, by the proposed modification there are two options: use a single part containing all elements, or use multiple parts across which elements are dispersed. By the teachings of Thelin, the former is superior. Thelin thus does indeed teach such a main control chip as claimed.
It is noted that such a modification may additionally be considered to entail making integral in the sense contemplated by MPEP 2144.04(v)(B).
The Examiner additionally notes the relevance of L. H. Jung et al., "Towards a chip scale neurostimulator: System architecture of a current-driven 98 channel neurostimulator via a two-wire interface," 2011 Annual International Conference of the IEEE Engineering in Medicine and Biology Society, Boston, MA, USA, 2011, pp. 6737-6740, which depicts a configuration similar to that of Claim 1 at Fig. 2 and notes at both its Abstract and Pg. 6737, Right Col., First Paragraph the “split” design is a solution to certain problems of the more typical single-piece approach.
Regarding Applicant’s second argument, Applicant’s argument is not persuasive. As the Examiner best understands Applicant’s second argument, Applicant argues that Perryman’s dual chip design is not amenable to modification such that a single main chip is used because there is a benefit to Perryman’s separate modules. Applicant does not appear to be of the position that the benefit of separate modules would be lost by the proposed modification.
Although Perryman’s RF pulse generator module 106 and implanted lead module 114 may indeed be designed as separate modules, the proposed modification entails altering both such that they are separate modules no longer. The same benefit as Applicant highlights (i.e., compliance with “strict limitations on available implant space”) would be achieved by using a single, smaller “main chip” in place of Perryman’s dual chip structure. Such is the proposed modification, and such is the teaching of Thelin.
Regarding Applicant’s third argument, Applicant’s arguments are not persuasive because they rely on an interpretation that is narrower than the broadest reasonable interpretation. Applicant argues that “[i]f RF pulse generator module 106 is implanted subcutaneously, replacing the battery requires surgery,” and “[f]requent surgical removal of the wireless neurostimulator 114 would be unacceptable to patients.” However, Claim 1 does not require any particular battery placement (or for that matter, require a battery at all). Accordingly, Claim 1 includes such devices as would require surgery for battery replacement, regardless of whether “[f]requent surgical removal … would be unacceptable to patients.” Were Claim 1 to recite such battery placement as Applicant’s arguments rely upon, the Examiner’s position may merit reconsideration.
Applicant’s arguments regarding the rejection of Claim 2 under 35 USC 103 as unpatentable over Perryman, Khansalee, Thelin and US 20020077673 A1 to Penner et al. (“Penner”) have been fully considered but are not persuasive. Applicant argues that “the teaching given by Penner is that the memory in the extracorporeal energy controller can be a non-volatile memory,” and that Penner thus “does not teach that the main memory of the implantable neurostimulator is non-volatile memory. Applicant’s arguments are not persuasive because they attack Penner individually when the rejection is based on a combination of references. See MPEP 2145(IV). Penner teaches non-volatile memory and explained the benefit thereof (see Penner at Para. [0042]). As explained at Para. 38-39 of the Non-Final Office Action dated 10/1/2025, the Examiner’s position is that in view of Penner’s teachings, it would have been obvious to modify the device of combined Perryman, Khansalee and Thelin such that the unspecified (though likely non-volatile, given the context) memory of combined Perryman, Khansalee and Thelin’s “main memory” is such non-volatile memory as taught by Perryman. Citing Penner at Para. [0042], the Examiner states at Para. 39 of the Non-Final Office Action dated 10/1/2025 that the benefit of so-doing is “to allow for permanent data storage.” Applicant’s argument regarding where in Penner’s device the non-volatile memory is placed does not dissuade from the proposed combination.
Applicant’s arguments regarding the rejection of Claims 8-10 and 12 under 35 USC 103 as unpatentable over Perryman, Khansalee, Thelin and Penner have been fully considered but are not persuasive. Applicant’s arguments regarding Claims 8-10 and 12 are similar to Applicant’s arguments regarding Claim 2, and are not persuasive for the same reasons.
Applicant makes additional arguments regarding dependent Claims 2-14 based on Applicant’s arguments regarding Independent Claim 1. Applicant’s arguments have been fully considered but are not persuasive for the same reasons as explained above.
Applicant’s arguments with respect to the objection to Claims 1 and 12 for minor informalities have been fully considered and are persuasive. The Examiner agrees that the amendments to Claims 1 and 12 have resolved the cited informalities.
Applicant’s arguments regarding the rejection of Claims 1, 3, 5, 8, 10, 11, 13 and 14 and Claims 2, 4, 6-7, 9, and 12 by dependency, under 35 USC 112(b) have been fully considered and are persuasive. The Examiner agrees that Applicant’s amendments have resolved the indefiniteness issues cited in the Non-Final Office Action dated 10/1/2025. Therefore, the rejection has been withdrawn. However, Applicant’s amendments have raised new indefiniteness issues under 35 USC 112(b), the particulars of which are addressed below.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 3, 5 and Claims 2, 4, and 6-14 by dependency, are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding Independent Claim 1, Claim 1 recites “and the control information comprises combinations of clinical stimulation parameters, the clinical stimulation parameters are a combination of parameters including polarity assignment information parameters, pulse width parameters, pulse amplitude parameters and pulse frequency parameters.” It is grammatically unclear what the recited “control information” is contemplated to comprise. More specifically, it is unclear what a combination of clinical stimulation parameters which reads on the claim is envisioned to entail.
For purposes of this Office Action, Claim 1 is being interpreted to open-endedly recite the claimed combinations.
Regarding Claim 3, Claim 3 recites “wherein the combinations of clinical stimulation parameters comprise a plurality of groups of the clinical stimulation parameters stored in the main memory, each group of clinical stimulation parameters being associated with a respective code, and the control information further comprises one or more group-selection codes that correspond to the codes of the groups of the clinical stimulation parameters stored in the main memory.”
It is grammatically unclear what is “stored in the main memory.”
It is unclear in what sense the “plurality of groups of the clinical stimulation parameters” further limits the “combination of parameters including polarity assignment information parameters, pulse width parameters, pulse amplitude parameters and pulse frequency parameters” that Claim 1 recites the combinations of Claim 3 to include.
In view of the ambiguity addressed above with respect to Claim 1, it is unclear what a “group” is envisioned to entail.
For purposes of this Office Action, this limitation is being interpreted to mean that stimulation parameters are stored digitally in the main memory in a manner that facilitates their identification at a later time.
Regarding Claim 5, Claim 5 recites “wherein the control information further comprises a data read instruction, in response to the control information the main control CPU is configured to send corresponding data stored in the main memory to the extracorporeal energy controller.” It is grammatically unclear what “the main control CPU is configured to send corresponding data stored in the main memory to the extracorporeal energy controller” in response to, particularly in view of the manner in which the term “control information” is used in Claim 1.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 3-5 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over previously cited US 2014/0058480 A1 to Perryman et al. (“Perryman”) in view of previously cited Non-Patent Literature E. Khansalee et al., "High Frequency Rectifier for RF Energy Harvesting Systems," 2015 7th International Conference on Information Technology and Electrical Engineering (ICITEE), Chiang Mai, Thailand, 2015, pp. 304-308 (“Khansalee”), previously cited Non-Patent Literature J. Thelin et al., "Implant Size and Fixation Mode Strongly Influence Tissue Reactions in the CNS;" PLoS ONE 6(1): e16267, January 2011 (“Thelin”). The rejection is maintained.
Regarding Independent Claim 1, Perryman teaches:
An implantable neurostimulator which communicates with and receives electrical energy from an extracorporeal energy controller through radio frequency, comprising: (Abstract, “A system, including: an implantable neural stimulator including electrodes, at least one antenna and an electrode interface; a radio-frequency (RF) pulse generator module comprising an antenna module configured to send an input signal to the antenna in the implantable neural stimulator through electrical radiative coupling, the input signal containing electrical energy and polarity assignment information…”);
It is noted that “An implantable neurostimulator which communicates with and receives electrical energy from an extracorporeal energy controller through radio frequency, comprising” is being interpreted to mean that the “implantable neurostimulator” (e.g., as opposed to the extracorporeal energy source, or the combination of both the extracorporeal energy source and the implantable neurostimulator) comprises the claim elements which follow, and that – accordingly – the subsequently recited claim elements are required to be implanted rather than extracorporeal. This interpretation is supported by Figs. 3 and 4 of the Present Drawings.
Perryman differs from the Present Invention in that Perryman uses two chips which collectively contain Perryman’s components rather than a single chip as required by Claim 1. This deficiency is addressed below.
Perryman contemplates Perryman’s two chips being either external or implanted (see Perryman at Para. [0043], “The RF pulse generator module 106 can be implanted subcutaneously, or it can be worn external to the body.”). The instance wherein both of Perryman’s chips (i.e., “RF pulse generator module 106” and “implanted lead module 114”) are implanted is used as the basis of this rejection.
Perryman’s “implanted neural stimulator 114” (see Perryman Fig. 2; Annotated Fig. 2, below) is such an “implantable neurostimulator” as claimed.
Perryman’s “programmer module 102” (see Perryman Fig. 2; Annotated Fig. 2, below) is such an “extracorporeal energy controller” as claimed.
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a main control chip (Fig. 2, “RF Pulse Generator Module 106;” see Annotated Fig. 2, above);
comprising a main CPU, a main memory, and a digital to analog conversion current source circuit; (Para. [0051], “The controller subsystem 214 may include a CPU 230 to handle data processing, a memory subsystem 228 such as a local memory, communication subsystem 234 to communicate with programmer module 102 (including receiving stimulation parameters from programmer module), pulse generator circuitry 236, and digital/analog (D/A) converters 232;” Fig. 2; see Annotated Fig. 2, above);
a stimulator antenna (Fig. 2, “RX Antenna 238;” see Annotated Fig. 2, above);
and its impedance matching circuit, (Para. [0061], “In order to sense impedance mismatch conditions, the controller subsystem 214 can measure the reflected-power ratio in real time, and according to preset thresholds for this measurement, the controller subsystem 214 can modify the level of RF power generated by the RF pulse generator 106;” see Annotated Fig. 2, above);
which are radio-frequency coupled with the extracorporeal energy controller to receive input signals containing electrical energy and control information from the extracorporeal energy controller, (Para. [0043], “ In either event, receiver circuit(s) internal to the neural stimulator module 114 can capture the energy radiated by the TX antenna 110 and convert this energy to an electrical waveform;” Para. [0046], “For instance, the programmer module 102, which can be utilized for multiple users, such as a patient's control unit or clinician's programmer unit, can be used to send stimulation parameters to the RF pulse generator module 106.”);
Perryman’s “extracorporeal controller” (i.e., “Programmer Module 102” in Fig. 2) is “radio-frequency coupled” (Fig. 1, “RF 112”) with Perryman’s “implanted neural stimulator 114.”
Perryman’s “extracorporeal controller” (i.e., “Programmer Module 102” in Fig. 2) “send[s] stimulation parameters” to Perryman’s “stimulation antenna” (i.e., “RX Antenna 238” in Fig. 2). Perryman’s “stimulation parameters” are such “control information” as claimed.
Perryman’s “stimulation antenna” (i.e., “RX Antenna 238” in Fig. 2) thus “receive[s] input signals containing … control information from the extracorporeal energy controller” in the manner claimed.
Perryman’s “receiver antenna 238” is one such “receiver circuit” which can “capture the energy radiated by the TX antenna 110,” and is thus “receive[s] input signals containing electrical energy” in the manner claimed.
and are capable of sending data to the extracorporeal energy controller; (Para. [0051], “The controller subsystem 214 may include a CPU 230 to handle data processing, a memory subsystem 228 such as a local memory, communication subsystem 234 to communicate with programmer module 102 (including receiving stimulation parameters from programmer module), pulse generator circuitry 236, and digital/analog (D/A) converters 232.”);
a rectification energy storage circuit connected to … the main control chip respectively, so as to extract electrical energy from the received input signal and store electrical energy, and supply power to the main control chip; (Para. [0066]; Fig. 2, “Rectification 244;” see Annotated Fig. 2, above);
It is noted that Perryman’s “impedance matching circuitry” is positioned on a different chip than Perryman’s “rectification energy storage circuit,” and is only connected indirectly thereto. This difference is remedied by the proposed modification with Khansalee, as explained below.
a modulation/demodulation circuit (Fig. 2, “Feedback Subsystem 212;” see Annotated Fig. 2, above);
connected to the impedance matching circuit and the main control chip to extract control information from the received input signal and transmit the control information to the main control chip, (Para. [0064], “In the feedback subsystem 212, the telemetry signal can be down modulated using demodulator 222 and digitized by being processed through an analog to digital (A/D) converter 220. The digital telemetry signal may then be routed to a CPU 230 with embedded code, with the option to reprogram, to translate the signal into a corresponding current measurement in the tissue based on the amplitude of the received signal. The CPU 230 of the controller subsystem 214 can compare the reported stimulus parameters to those held in local memory 228 to verify the stimulator(s) 114 delivered the specified stimuli to tissue.”);
Perryman’s “modulation/demodulation circuitry” (i.e., “Feedback Subsystem 212”) is connected to Perryman’s “impedance matching circuit” (i.e., “controller subsystem 214”) and Perryman’s “main control chip” (i.e., “RF Pulse Generator Module 106”).
and configured to modulate the data from the main control chip, and transmit the data as modulated to the impedance matching circuit, the impedance matching circuit is configured to send the data as modulated to the extracorporeal energy controller through the stimulator antenna; (Para. [0064], “In the feedback subsystem 212, the telemetry signal can be down modulated using demodulator 222 and digitized by being processed through an analog to digital (A/D) converter 220. The digital telemetry signal may then be routed to a CPU 230 with embedded code, with the option to reprogram, to translate the signal into a corresponding current measurement in the tissue based on the amplitude of the received signal. The CPU 230 of the controller subsystem 214 can compare the reported stimulus parameters to those held in local memory 228 to verify the stimulator(s) 114 delivered the specified stimuli to tissue. For example, if the stimulator reports a lower current than was specified, the power level from the RF pulse generator module 106 can be increased so that the implanted neural stimulator 114 will have more available power for stimulation;” Para. [0061]);
an electrode interface connected to the main control chip and configured to receive polarity assignment information from the main control chip and receive stimulation pulse sequences from the digital to analog conversion current source circuit; (Para. [0104], “The stimulator includes an electrode array 254 in which the polarity of the electrodes can be assigned as cathodic or anodic, and for which the electrodes can be alternatively not powered with any energy. … The electrode array 254 is controlled through an on-board controller circuit 242 that sends the appropriate bit information to the electrode interface 252 in order to set the polarity of each electrode in the array, as well as power to each individual electrode.”);
one or more stimulation electrodes connected to the electrode interface (Fig. 2, “Electrodes 254;” see Annotated Fig. 2, above);
which assigns the stimulation pulse sequences to each corresponding stimulation electrode based on the polarity assignment information; (Para. [0104], “ The stimulator includes an electrode array 254 in which the polarity of the electrodes can be assigned as cathodic or anodic, and for which the electrodes can be alternatively not powered with any energy.”);
wherein the main memory stores a control program and the received control information, (Para. [0053], “The controller subsystem 214 may store received parameter settings in the local memory subsystem 228… The CPU 206 may use the parameters stored in the local memory to control the pulse generator circuitry 236 to generate a stimulus waveform…” );
the main control CPU runs the control program to control the digital to analog conversion current source circuit to generate the stimulation pulse sequences based on the control information, (Para. [0053], “The controller subsystem 214 may store received parameter settings in the local memory subsystem 228… The CPU 206 may use the parameters stored in the local memory to control the pulse generator circuitry 236 to generate a stimulus waveform…”);
and the control information comprises combinations of clinical stimulation parameters, the clinical stimulation parameters are a combination of parameters including polarity assignment information parameters, pulse width parameters, pulse amplitude parameters and pulse frequency parameters. (Para. [0053], “The controller subsystem 214 may store received parameter settings in the local memory subsystem 228… The CPU 206 may use the parameters stored in the local memory to control the pulse generator circuitry 236 to generate a stimulus waveform…;” Para. [0085], “The telemetry signal may contain information about parameters of the electrical pulses applied to the electrodes, such as the impedance of the electrodes, whether the safe current limit has been reached, or the amplitude of the current that is presented to the tissue from the electrodes;” Para. [0100], “ A table can be displayed to the user, as shown in block 908 and each row displays a program's codename and lists its basic parameter settings, as shown in block 910, which includes but is not limited to: pulse width, frequency, cycle timing, pulse shape, duration, feedback sensitivity, as shown in block 912;” Para. [0104], “The controller current, polarity and power state parameter data, shown as the controller output, is be sent back to the antenna(s) 238 for telemetry transmission back to the pulse generator module 106;” ).
As explained above, Claim 1 is being interpreted to open-endedly recite the claimed combinations.
Perryman does not disclose:
an antenna and its impedance matching circuit which are radio-frequency coupled with the extracorporeal energy controller to receive input signals containing electrical energy and control information from the extracorporeal energy controller, and are capable of sending data to the extracorporeal energy controller;
That is, Perryman teaches similar impedance circuitry that claimed at Para. [0061], but Perryman’s impedance matching circuitry is on a different chip than Perryman’s antenna, and as such is not “radio-frequency coupled with the extracorporeal controller” in the manner claimed.
a rectification energy storage circuit connected to the impedance matching circuit and the main control chip respectively, so as to extract electrical energy from the received input signal and store electrical energy, and supply power to the main control chip;
As noted above, Perryman uses two “control chips” (i.e., RF pulse generator module 106” and “implanted lead module 114”) rather than a single “main control chip.”
Khansalee describes a “High frequency rectifier for RF energy harvesting systems” (Title). Khansalee is analogous art.
Khansalee teaches:
an antenna and its impedance matching circuit which are radio-frequency coupled with the extracorporeal energy controller to receive input signals containing electrical energy and control information from the extracorporeal energy controller, and are capable of sending data to the extracorporeal energy controller; (Pg. 304, Right Column, Third Paragraph, “The RF energy harvesting system consists of the antenna, the impedance matching RF rectifier circuit, DC filter circuit and Load. The RF energy is received by the antenna, and then the receiving signal is sent through the impedance matching that is designed by source-pull technique to match between the receiving antenna and the RF rectifier circuit that converts the RF signal to be DC output power.;” Pg. 305, Figs. 1 and 3 depict impedance matching circuitry labeled “Impedance Matching” connected to an antenna);
a rectification energy storage circuit connected to the impedance matching circuit and the main control chip respectively, so as to extract electrical energy from the received input signal and store electrical energy, and supply power to the main control chip; (Pg. Pg. 305, Figs. 1 and 3 depict such a rectification energy storage circuit labeled “RF Rectifier Circuit” connected to impedance matching circuitry labeled “Impedance Matching;” Pg. 304, Right Column, Fourth Paragraph through Pg. 305, Left Column, First Paragraph describe the function of the “RF Rectifier Circuit,” confirming its function is equivalent to that claimed).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Perryman with the teachings of Khansalee (i.e., to employ such an high frequency rectifier for RF energy harvesting as taught by Khansalee in Perryman’s “implanted lead module 114,” for example in the manner illustrated below in Proposed Modification of Perryman with Khansalee, thereby powering the device via Khansalee’s methodology) in order to wirelessly supply energy to Perryman’s “implanted lead module 114” (Khansalee at Pg. 304, Abstract; Pg. 304, Left Column, First Paragraph; Pg. 304, Right Column, First Paragraph).
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The combination of Perryman and Khansalee does not disclose such a single “main control chip” as claimed.
Instead, as explained above, Perryman uses two “control chips” (i.e., RF pulse generator module 106” and “implanted lead module 114”), both of which are implanted.
Thelin describes the influence of implant size and fixation mode on tissue reactions in the central nervous system (Title). Thelin is analogous art.
Thelin teaches such a single “main control chip” as claimed (Thelin at Abstract, “Our findings therefore clearly indicate that the combined small diameter, un-tethered implants cause the smallest tissue reactions.”)
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Perryman and Khansalee with the teachings of Thelin (i.e., to modify Perryman’s two “control chip” design with separate chips for “RF pulse generator module 106” and “implanted lead module 114” such that both are contained on a single “main” chip) in order to minimize tissue reaction to the implant (Thelin at Abstract).
Regarding Claim 3, the combination of Perryman, Khansalee and Thelin renders obvious the entirety of Claim 1 as explained above.
Perryman additionally teaches:
wherein the combinations of clinical stimulation parameters comprise a plurality of groups of the clinical stimulation parameters stored in the main memory, each group of clinical stimulation parameters being associated with a respective code, and the control information further comprises one or more group-selection codes that correspond to the codes of the groups of the clinical stimulation parameters stored in the main memory (Para. [0100] (not quoted for brevity); see also Paras. [0143]-[0145]).
As explained above, this limitation is being interpreted to mean that stimulation parameters are stored digitally in the main memory in a manner that facilitates their identification at a later time.
Perryman’s Para. [0100] details such digital storage.
Perryman’s “register file” of Paras. [0143]-[0145] is additionally such digital storage.
Regarding Claim 4, the combination of Perryman, Khanaslee and Thelin renders obvious the entirety of Claim 1 as explained above.
Perryman additionally teaches:
wherein the control information further comprises adding/subtracting instructions, in response to which the main control chip adjusts pulse intensity of the stimulation pulse sequence in a step-by-step manner (Para. [0040], “The application can enable the user to view the system status and diagnostics, change various parameters, increase/decrease the desired stimulus amplitude of the electrode pulses, and adjust feedback sensitivity of the RF pulse generator module 106, among other functions;” Para. [0090], “If after one cycle the data burst has stopped, the RF pulse generator 106 may slowly ramp up the transmission power in increments, for example from 5% to 75% of previous current amplitude levels, as shown in block 428. The user can then manually adjust current amplitude level to go higher at the user's own risk;” Paras. [0098]-[0099]).
Regarding Claim 5, the combination of Perryman, Khanaslee and Thelin renders obvious the entirety of Claim 1 as explained above.
Perryman additionally teaches:
wherein the control information further comprises a data read instruction, in response to the control information the main control CPU is configured to send corresponding data stored in the main memory to the extracorporeal energy controller (Para. [0062], “The controller 242 of the stimulator 114 may transmit informational signals, such as a telemetry signal, through the antenna 238 to communicate with the RF pulse generator module 106 during its receive cycle. For example, the telemetry signal from the stimulator 114 may be coupled to the modulated signal on the dipole antenna(s) 238, during the on and off state of the transistor circuit to enable or disable a waveform that produces the corresponding RF bursts necessary to transmit to the external (or remotely implanted) pulse generator module 106.”).
Regarding Claim 7, the combination of Perryman, Khanaslee and Thelin renders obvious the entirety of Claim 1 as explained above.
Perryman additionally teaches:
wherein a charge balance circuit is further connected between the electrode interface and the digital to analog conversion current source circuit of the main control chip, which is capable of applying a reverse pulse to the electrode interface between adjacent electrical stimulation pulses, thereby achieving active charge balance. (Para. [0066], “The rectifier signal may also be fed to a charge balance component 246 that is configured to create one or more electrical pulses based such that the one or more electrical pulses result in a substantially zero net charge at the one or more electrodes (that is, the pulses are charge balanced). The charge-balanced pulses are passed through the current limiter 248 to the electrode interface 252, which applies the pulses to the electrodes 254 as appropriate.”).
Claims 2 and 8-14 are rejected under 35 U.S.C. 103 as being unpatentable over US 2014/0058480 A1 to Perryman et al. (“Perryman”) in view of Non-Patent Literature E. Khansalee et al., "High Frequency Rectifier for RF Energy Harvesting Systems," 2015 7th International Conference on Information Technology and Electrical Engineering (ICITEE), Chiang Mai, Thailand, 2015, pp. 304-308 (“Khansalee”) and Non-Patent Literature J. Thelin et al., "Implant Size and Fixation Mode Strongly Influence Tissue Reactions in the CNS;" PLoS ONE 6(1): e16267, January 2011 (“Thelin”) as applied to Claim 1 above, and further in view of US 20020077673 A1 to Penner et al. (“Penner”).
Regarding Claim 2, the combination of Perryman, Khansalee and Thelin renders obvious the entirety of Claim 1 as explained above.
The combination of Perryman, Khansalee and Thelin does not disclose:
wherein the main memory is a non- volatile memory
Penner describes “Systems And Methods For Communicating With Implantable Device” (Title). Penner is analogous art.
Penner teaches:
wherein the main memory is a non- volatile memory (Para. [0042], “The memory 424 may be a temporary buffer that holds data before transfer to another device, or non-volatile memory capable of storing the data substantially indefinitely, e.g., until extracted by the processor 418 or other electronic device.”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Perryman, Khansalee and Thelin with the teachings of Penner (i.e., to employ such non-volatile memory as taught by Penner as the memory of Perryman as modified by Khansalee and Thelin) in order to allow for permanent data storage (Penner at Para. [0042]).
Regarding Claim 8, the combination of Perryman, Khanaslee and Thelin renders obvious the entirety of Claim 1 as explained above.
Perryman additionally teaches:
and the control information further comprises a data read instruction, in response to the data read instruction the main control CPU is configured to send data stored in the operation data memory to the extracorporeal energy controller. (Para. [0062], “The controller 242 of the stimulator 114 may transmit informational signals, such as a telemetry signal, through the antenna 238 to communicate with the RF pulse generator module 106 during its receive cycle. For example, the telemetry signal from the stimulator 114 may be coupled to the modulated signal on the dipole antenna(s) 238, during the on and off state of the transistor circuit to enable or disable a waveform that produces the corresponding RF bursts necessary to transmit to the external (or remotely implanted) pulse generator module 106.”)
The combination of Perryman, Khanaslee and Thelin does not disclose:
further comprising an operation data memory which is electrically connected to the main control chip for storing various operation data generated during operation of the implantable neurostimulator,
Penner describes “Systems And Methods For Communicating With Implantable Device” (Title). Penner is analogous art.
Penner teaches:
further comprising an operation data memory which is electrically connected to the main control chip for storing various operation data generated during operation of the implantable neurostimulator, (Para. [0042], “In a preferred embodiment, the controller 414 also includes memory 424 coupled to the processor 418, e.g., for storing data provided to the controller 414, as explained further below.”);
The term “for storing various operation data generated during operation of the implantable neurostimulator” is being interpreted as an intended use of the claimed “operation data memory.”
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Perryman, Khanaslee and Thelin with the teachings of Penner (i.e., to additionally include such an “operation data memory” as taught by Penner) in order to store data for subsequent transfer (Penner at Para. [0042]).
Regarding Claim 9, the combination of Perryman, Khanaslee, Thelin and Penner renders obvious the entirety of Claim 8 as explained above.
Penner additionally teaches:
wherein the operation data memory is a non-volatile memory (Para. [0042], “The memory 424 may be a temporary buffer that holds data before transfer to another device, or non-volatile memory capable of storing the data substantially indefinitely, e.g., until extracted by the processor 418 or other electronic device.”).
Regarding Claim 10, the combination of Perryman, Khanaslee, Thelin and Penner renders obvious the entirety of Claim 8 as explained above.
Perryman additionally teaches:
further comprising a post measurement feedback circuit which is respectively connected to the electrode interface and the main control chip to measure real-time stimulation parameters on the stimulation electrode and transmit the real-time stimulation parameters to the main control chip, (Para. [0119], “…power and impedance sensing circuitry may be used to determine the power delivered to the tissue and the impedance of the tissue. For example, a sensing resistor 1518 may be placed in serial connection with the anodic branch 1514. Current sensing circuit 1519 senses the current across the resistor 1518 and voltage sensing circuit 1520 senses the voltage across the resistor. The measured current and voltage may correspond to the actual current and voltage applied by the electrodes to the tissue.”).
Penner additionally teaches:
and the main control chip is configured to store the real-time stimulation parameters into the operation data memory (Para. [0042], “In a preferred embodiment, the controller 414 also includes memory 424 coupled to the processor 418, e.g., for storing data provided to the controller 414, as explained further below.”).
Regarding Claim 11, the combination of Perryman, Khanaslee, Thelin and Penner renders obvious the entirety of Claim 10 as explained above.
Perryman additionally teaches:
wherein the main control chip is configured to compare the real-time stimulation parameters with the clinical stimulation parameters, and to correct the stimulation signals applied to each stimulation electrode based on the comparing result (Para. [0120], “As described below, the measured current and voltage may be provided as feedback information to RF pulse generator module 106. The power delivered to the tissue may be determined by integrating the product of the measured current and voltage over the duration of the waveform being delivered to electrodes 254.”).
Regarding Claim 12, the combination of Perryman, Khanaslee, Thelin and Penner renders obvious the entirety of Claim 10 as explained above.
Perryman additionally teaches:
further comprising a front measurement feedback circuit which is provided between the rectification energy storage circuit and the main control chip to measure amount of real-time electrical energy storage in the rectification energy storage circuit at any time, (Para. [0121], “The measurements from the current sensing circuitry 1519 and the voltage sensing circuitry 1520 may be routed to a voltage controlled oscillator (VCO) 1533 or equivalent circuitry capable of converting from an analog signal source to a carrier signal for modulation. VCO 1533 can generate a digital signal with a carrier frequency. The carrier frequency may vary based on analog measurements such as, for example, a voltage, a differential of a voltage and a power, etc. VCO 1533 may also use amplitude modulation or phase shift keying to modulate the feedback information at the carrier frequency.”).
Penner additionally teaches:
which is then transmitted to the main control chip and stored in the operation data memory by the main control chip (Para. [0042], “In a preferred embodiment, the controller 414 also includes memory 424 coupled to the processor 418, e.g., for storing data provided to the controller 414, as explained further below.”).
Regarding Claim 13, the combination of Perryman, Khanaslee, Thelin and Penner renders obvious the entirety of Claim 12 as explained above.
Perryman additionally teaches:
wherein the main control chip is configured to evaluate whether it is necessary to adjust the radio-frequency input electrical energy based on the amount of real-time electrical energy storage, when the amount of real-time electrical energy storage is lower than the set value, the main control chip is configured to send a power adjustment instruction to an antenna of the external energy controller through the stimulator antenna and its impedance matching circuit, thereby adjusting the transmission power of the extracorporeal energy controller (Para. [0121], “The VCO or the equivalent circuit may be generally referred to as an analog controlled carrier modulator. The modulator may transmit information encoding the sensed current or voltage back to RF pulse generator 106;” Para. [0122], “Antenna 1525 may transmit the modulated signal, for example, in the GHz frequency range, back to the RF pulse generator module 106. In some embodiments, antennas 1505 and 1525 may be the same physical antenna. In other embodiments, antennas 1505 and 1525 may be separate physical antennas. In the embodiments of separate antennas, antenna 1525 may operate at a resonance frequency that is higher than the resonance frequency of antenna 1505 to send stimulation feedback to RF pulse generator module 106. In some embodiments. antenna 1525 may also operate at the higher resonance frequency to receive data encoding the polarity assignment information from RF pulse generator module 106.”).
Regarding Claim 14, the combination of Perryman, Khanaslee, Thelin and Penner renders obvious the entirety of Claim 8 as explained above.
Perryman additionally teaches:
wherein the main control chip is configured to control the implantable neurostimulator (Para. [0082], “In some implementations, the amplitude and timing of stimulus and charge-balancing phases is controlled by the amplitude and timing of RF pulses from the RF pulse generator module 106…”);
and to periodically send various operation data stored in the operation data memory to the extracorporeal energy controller (Para. [0085], “The implanted stimulator 114 communicates with the pulse generator 106 by using antenna 238 to send a telemetry signal, as shown in block 308. The telemetry signal may contain information about parameters of the electrical pulses applied to the electrodes, such as the impedance of the electrodes, whether the safe current limit has been reached, or the amplitude of the current that is presented to the tissue from the electrodes.”).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over US 2014/0058480 A1 to Perryman et al. (“Perryman”) in view of Non-Patent Literature E. Khansalee et al., "High Frequency Rectifier for RF Energy Harvesting Systems," 2015 7th International Conference on Information Technology and Electrical Engineering (ICITEE), Chiang Mai, Thailand, 2015, pp. 304-308 (“Khansalee”) and Non-Patent Literature J. Thelin et al., "Implant Size and Fixation Mode Strongly Influence Tissue Reactions in the CNS;" PLoS ONE 6(1): e16267, January 2011 (“Thelin”) as applied to Claim 1 above, and further in view of US 2018/0236241 A1 to Harkema et al. (“Harkema”).
Regarding Claim 6, the combination of Perryman, Khanaslee and Thelin renders obvious the entirety of Claim 1 as explained above.
The combination of Perryman, Khanaslee and Thelin does not disclose:
wherein the parameters in the combination of clinical stimulation parameters further comprises a charge balance time, the length of which is sufficient to ensure full release of charges between adjacent electrical stimulation pulses, thereby achieving passive charge balance
Harkema describes “Methods for providing optimized neurostimulation” (Title). Harkema is analogous art.
Harkema teaches:
wherein the parameters in the combination of clinical stimulation parameters further comprises a charge balance time, (Para. [0043], “The third method for managing waveforms is a charge balance time optimization approach.”);
the length of which is sufficient to ensure full release of charges between adjacent electrical stimulation pulses, thereby achieving passive charge balance (Para. [0043], “In some cases it is possible to shorten pulses or parts of pulses to help eliminate overlap conditions between waveforms. In particular, the charge balance portion of the pulse (i.e., the recharge pulse and shorting period) may be reduced. For example, the recharge period could be reduced from (4) to (3) and the shorting period from (4) to (2) resulting in an approximate 33% reduction in duration for the active portion of the pulse. Brief periods of charge balance time optimization may be used to allow spacing between pulses from different waveforms and reduce the need to blank a pulse;” Para. [0056] refers to the above as “passive charge balance”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Perryman, Khanaslee and Thelin with the teachings of Harkema (i.e., to modify the device of Perryman, Khanaslee and Thelin such that it uses charge balance time as a parameter) in order to prevent pulses from overlapping, which is desirable because overlapping pulses can result in undesired stimuli (Harkema at Para. [0005]).
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/C.J.M./Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796