DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim 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 10 and 11 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.
Claims 10 and 11 recites the limitations "first predetermined threshold value" and “second predetermined threshold value” in the first and second lines of both claims. Additionally, claim 11 recites the limitations of “first predetermined temporal span” and “second predetermined temporal span” in the second line of the claim. There is insufficient antecedent basis for this limitation in the independent claim 7 which both claims depend on.
Examiner believes claims should depend from claim 9, which does introduce a “first predetermined threshold value" and a “second predetermined threshold value”. Should this dependence be erroneously written in the claims as presented, appropriate correction is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-8 and 12-23 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C 102(a)(2) as being anticipated by Howard (U.S. PGPub No. 2018/0333587).
In regards to claim 1, Howard discloses an apparatus comprising: at least one housing configured to be implanted within a recipient's body ([0121]: "In embodiments, a large number of electrically active brain-probing sites may be provided, along with long-term use. In embodiments, an implantable neural connecting probing system may be enabled by compliant, biocompatible, carbon nanotube (CNT) electrical wires."), communication circuitry within the at least one housing, the communication circuitry configured to wirelessly communicate, via a transcutaneous wireless communication link, with a device external to the recipient's body ([0125]: "The implant device may include a communication module to transmit data to a Gateway device such as cell phone or other nearby computer which can in turn analyze data, give input to the implant device, and/or send the data to the Cloud for deep analysis."), control circuitry within the at least one housing, the control circuitry configured to generate control signals in response to power and/or data signals received via the transcutaneous wireless communication link, stimulation circuitry within the at least one housing, the stimulation circuitry configured to respond to the control signals by providing stimulation and/or at least one medicament to the recipient's body ([0259]: "Neuro stimulation signals 3208 may then be transmitted to zone selection/controller circuitry 3206, which may route each neuro stimulation signal 3208 to an appropriate electrical stimulation electrode or optical stimulation optrode."), and reset circuitry within the at least one housing, the reset circuitry configured to respond to reset signals received via the transcutaneous wireless communication link by resetting the control circuitry and/or the stimulation circuitry to a default operational state ([0332]: " In embodiments, the Provisioning Phase may provide the default parameters for all the initial configurations of the target implant device.", [0333]: "In embodiments, after the provisioning phase is finished, the implant device may execute a reset command.").
In regards to claim 2, Howard discloses at least one power source within the at least one housing, the at least one power source comprising at least one power storage device configured to store power received by the communication circuitry and to provide at least some of the power at least to the control circuitry and/or the stimulation circuitry ([0130]: "An inductive powering system 114, also shown in FIG. 5, may be used recharge the implant device 102 implant (see FIG. 1). Various wearable and/or kinetic inductive power technologies may be utilized during the design phase, including a retainer/mouthguard, a head-mounted cap to be worn at night, or an under the pillow charging mat.").
In regards to claim 3, Howard discloses that the at least one power source is responsive to the reset signals by disengaging the at least one power storage device from the control circuitry and/or the stimulation circuitry ([0334]: "In embodiments, the Gateway may have the rights to modify configuration parameters such as power system configuration parameters, wireless charging parameters, recording parameters, activated recording blocks, activated recording channels per block, etc. ").
In regards to claim 4, Howard discloses that the control circuitry is responsive to the reset signals by disengaging the at least one power storage device from the control circuitry and/or the stimulation circuitry ([0334]: "In embodiments, the Gateway may have the rights to modify configuration parameters such as power system configuration parameters, wireless charging parameters, recording parameters, activated recording blocks, activated recording channels per block, etc. ").
In regards to claim 5, Howard discloses that the power storage device comprises at least one battery ([0175]: "In embodiments, the power budget of the implant device may be in the range of about 100 W to 1 mW. Embodiments of battery options, assuming an implant device autonomy of 72 hours may include...").
In regards to claim 6, Howard discloses that the reset circuitry is configured to perform said resetting the control circuitry and/or thestimulation circuitry to the default operational state regardless of a current operational state of the control circuitry and/or the stimulation circuitry ([0334]: "In embodiments, the Gateway may have the rights to modify configuration parameters such as power system configuration parameters, wireless charging parameters, recording parameters, activated recording blocks, activated recording channels per block, etc. ").
In regards to claim 7, Howard discloses that the control circuitry and/or the stimulation circuitry are configured to enter the default operational state upon being reset by the reset circuitry regardless of a current operational state of the control circuitry and/or the stimulation circuitry ([0334]: "In embodiments, the Gateway may have the rights to modify configuration parameters such as power system configuration parameters, wireless charging parameters, recording parameters, activated recording blocks, activated recording channels per block, etc. ").
In regards to claim 8, Howard discloses that the control circuitry comprises a first portion of an application-specific integrated circuit (ASIC) microcontroller and the reset circuitry comprises a second portion of the ASIC microcontroller, the second portion dedicated to responding to the reset signals by resetting the control circuitry and/or the stimulation circuitry to a default operational state ([0217]: "Processing circuitry 1910 may include digital processing circuitry, such as one or more microprocessors, microcontrollers, digital signal processors (DSPs), custom or semi-custom circuitry, such as application specific integrated circuits (ASICs), field programmable circuitry, such as field programmable gate arrays (FPGAs), etc., or any other digital processing circuitry.").
In regards to claim 12, Howard discloses that the communication circuitry comprises at least one internal radio-frequency (RF) antenna in operative communication with at least one external RF antenna of the device to form the transcutaneous wireless communication link ([0171]: "RF communication between the implant device and BCCS may carried out either by making use of the processor's Bluetooth capability or by implementing an independent RF transceiver in each of the two devices.", [0327]: "Embodiments may use wireless communications such as Wireless Data Communication Type—802.11ac, Wireless Frequency—5 GHz, and Radio Channel Size—80 MHz.").
In regards to claim 13, Howard discloses that the communication circuitry comprises at least one internal magnetic induction (MI) antenna in operative communication with at least one external MI antenna of the device to form the transcutaneous wireless communication link ([0150]: "The BCCS may include multisensory wireless inductive earbuds and behavioral sensors and provide wireless communication with implant device, inductively recharge implant device, provide Bluetooth communication with a secure app on smartphones, tablets, etc...").
In regards to claim 14, Howard discloses that the control circuitry is configured to be unable to render the reset circuitry inoperable ([0332]: "In embodiments, the Provisioning Phase may provide the default parameters for all the initial configurations of the target implant device. In embodiments, the initial configuration may include parameters such as predetermined MAC addresses of the accepted Gateways, power system configuration parameters, local WAN credentials, recording parameters, wireless charging parameters, configured blocks for reading, etc.").
In regards to claim 15, Howard discloses that the apparatus comprises an acoustic prosthesis ([0162]: "Recent demonstrations of direct, real-time interfaces between living brain tissue and artificial devices, such as with computer cursors, robots and mechanical prostheses, have opened new avenues for experimental and clinical investigation of Brain Machine Interfaces (BMIs).").
In regards to claim 16, Howard discloses a method comprising: wirelessly receiving, using an implant within a recipient's body, signals transmitted through tissue from a device external to a recipient's body, the implant comprising control circuitry and an internal power source ([0125]: "The implant device may include a communication module to transmit data to a Gateway device such as cell phone or other nearby computer which can in turn analyze data, give input to the implant device, and/or send the data to the Cloud for deep analysis."), in response to the signals, controlling the implant while the implant is in at least one functional state in which the internal power source is operationally engaged with the control circuitry ([0259]: "Neuro stimulation signals 3208 may then be transmitted to zone selection/controller circuitry 3206, which may route each neuro stimulation signal 3208 to an appropriate electrical stimulation electrode or optical stimulation optrode."), detecting, using the implant, a predetermined modulation of the signals while the implant is in a malfunctioning state ([0128]: "Returning to FIG. 1, the BCCS earbud 106, also shown in FIG. 3, wirelessly communicates with the implant device 102. The earbud contains a signal amplifier and a relay for modulation schemes, algorithms and instructions to and from the implant.", [0257]: "Processing circuitry 3102 may encode stimulation commands for the output signal. For example, such commands may be 5 bits, for up to 32 different modulation commands."), and responding to the detected predetermined modulation of the signals by transitioning the implant from the malfunctioning state to a reset state in which the internal power source is operationally disengaged from the control circuitry ([0332]: "In embodiments, the Provisioning Phase may provide the default parameters for all the initial configurations of the target implant device.", [0333]: "In embodiments, after the provisioning phase is finished, the implant device may execute a reset command.").
In regards to claim 17, Howard discloses that the implant in the at least one functional state operates normally and the implant in the malfunctioning state operates abnormally ([0348]: "If the temperature increases by, for example, about 1° C., the implant device may stop all recording and stimulation activities and all processing until the temperature is back to normal.").
In regards to claim 18, Howard discloses subsequently operationally re-engaging the internal power source with the control circuitry in response to the signals ([0332]: "In embodiments, the Provisioning Phase may provide the default parameters for all the initial configurations of the target implant device.", [0333]: "In embodiments, after the provisioning phase is finished, the implant device may execute a reset command.").
In regards to claim 19, Howard discloses that detecting comprises decoding, using firmware of the implant, modulations of the signals, the firmware dedicated to said decoding ([0401]: "In embodiments, the data coming from the implant device may be encoded/compressed. Accordingly, when it arrives on the Cloud, the data may be reconstructed by applying a decoding/decompressing process.").
In regards to claim 20, Howard discloses A system comprising: a first portion configured to be worn externally on a recipient's body, the device configured to generate electromagnetic carrier waves with time-varying modulations ([0121]: "In embodiments, a large number of electrically active brain-probing sites may be provided, along with long-term use. In embodiments, an implantable neural connecting probing system may be enabled by compliant, biocompatible, carbon nanotube (CNT) electrical wires.", [0125]: "The implant device may include a communication module to transmit data to a Gateway device such as cell phone or other nearby computer which can in turn analyze data, give input to the implant device, and/or send the data to the Cloud for deep analysis.", [0157]: "Using unary controls in combinations and in rapid closed loop controls within the implant device will enable neural synapse firings with highly precise timing, intensity, and frequency modulation. Optical neuromodulation has many benefits over traditional electrode-based neurostimulation. This strategy will allow precision stimulation in near real time."), and a second portion configured to be implanted within the recipient's body, the second portion configured to transcutaneously receive at least a portion of the electromagnetic carrier waves from the first portion, the second portion comprising:at least one microprocessor configured to execute firmware configured to control operation of the second portion in response to the electromagnetic carrier waves received from the first portion ([0259]: "Neuro stimulation signals 3208 may then be transmitted to zone selection/controller circuitry 3206, which may route each neuro stimulation signal 3208 to an appropriate electrical stimulation electrode or optical stimulation optrode."), and reset circuitry configured to operate independently from operation of the firmware, the reset circuitry further configured to monitor the time-varying modulations for a pattern indicative of a reset signal from the first portion and to respond to detection of the pattern on the electromagnetic carrier waves by resetting the at least one microprocessor ([0332]: " In embodiments, the Provisioning Phase may provide the default parameters for all the initial configurations of the target implant device.", [0333]: "In embodiments, after the provisioning phase is finished, the implant device may execute a reset command.").
In regards to claim 21, Howard discloses that the firmware is unable to prevent and/or interfere with the resetting of the at least one microprocessor ([0332]: "In embodiments, the initial configuration may include parameters such as predetermined MAC addresses of the accepted Gateways, power system configuration parameters, local WAN credentials, recording parameters, wireless charging parameters, configured blocks for reading, etc.", [0333]: "In embodiments, after the provisioning phase is finished, the implant device may execute a reset command. After the implant device has restarted, it may connect to the local WAN, being ready to receive new commands from the Gateway.").
In regards to claim 22, Howard discloses that the pattern comprises an on/off keying pattern ([0285]: "In embodiments, different types of control techniques may be used for closed loop control. For example, such techniques may include simple on/off control, Proportional Integral Derivative (PID) control, Model Predictive Control (MPC), robust control, adaptive control, and optimal control.").
In regards to claim 23, Howard discloses that the first portion comprises an external component of an auditory prosthesis system and the second portion comprises an implanted component of the auditory prosthesis system ([0162]: "Recent demonstrations of direct, real-time interfaces between living brain tissue and artificial devices, such as with computer cursors, robots and mechanical prostheses, have opened new avenues for experimental and clinical investigation of Brain Machine Interfaces (BMIs).").
Allowable Subject Matter
Claims 9-11 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRYAN M LEE whose telephone number is (703)756-1789. The examiner can normally be reached 9:00 am - 6:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Carl Layno can be reached at (571) 272-4949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/B.M.L./Examiner, Art Unit 3796
/MICHAEL J LAU/Examiner, Art Unit 3796
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