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 .
The amendment filed on June 8, 2026 has been received and considered. By this amendment, claims 1, 8, 15, and 20 are amended and claims 1-20 are now pending in the application.
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 1-6, 8-11, and 14-20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by von Arx (U.S. 2024/0236854, previously cited). Regarding claim 1, von Arx discloses a medical device 1 configured to provide a therapy to a patient (“The implantable medical device 1 may be or may comprise, for example, a recording device such as a loop recorder or a pulse generator of a cardiac pacemaker that is implanted in the patient's body.”, paragraph [0067]), the medical device comprising: wake circuitry configured to: receive a first set of data from a device 2 associated with the medical device (“The modulated wakeup signal W1 is received by an antenna 12 of the implantable medical device 1.”, paragraph [0072]), wherein the first set of data is received at a frequency band (“a BLE5.0 extended advertising sequence is used as a wakeup signal sequence”, paragraph [0050], where BLE is known to operate in the 2.4 GHz ISM frequency band); output, based on the first set of data, a set of pulses comprising a first pulse and a second pulse (“The frontend matching circuitry 13 is configured to receive and filter the modulated wakeup signal W1 before transmitting it to the demodulator circuitry 11.”, paragraph [0073] and “The always-on ASK demodulator circuitry 11 is configured to demodulate the modulated wakeup signal W1 so as to generate a demodulated wakeup signal W2 (e.g., a baseband signal).“, paragraph [0075]); detect a data pattern based on an interval between the first pulse and the second pulse, a first voltage of at the first pulse, and a second voltage at the second pulse (“The demodulated wakeup signal W2 is subsequently transmitted to a match detector circuitry 14 that is configured to validate the demodulated wakeup signal W2. This is to say that the match detector circuitry 14 verifies the demodulated wakeup signal W2”, paragraph [0076] and “Such wake-up sequences may be generated by the external device 2 by means of appropriate software. For example, the wake-up sequences may be generated in the form of customized (vendor-specific) Bluetooth advertising sequences. While the BLE signal itself encodes data with GFSK modulation, the envelope of packets and time between packets makes an ASK signal. As illustrated, such signal sequences are characterized essentially by a sequence of pulse groups having a period/interval T1 and using pulses (also denoted as PDUs, for Packet Date Units) having pulse durations t0, t1, t2, t3. These parameters T1, t0, t1, t2, t3 may be controlled at least to a certain degree by means of software, which may be provided by the external device 2 vendor (assuming the external device 2 is an ‘off the shelf’ device). It should be noted that the exemplary wake-up sequences shown in FIG. 4 yet have to be ASK modulated to form the modulated wake-up signal W1. In other words, the illustrated signal sequences may correspond to envelopes of the modulated wake-up signal W1, which may be reconstructed at the receiving end by means of the demodulator circuitry 11 of the implantable medical device 1.”, paragraph [0083]); and responsive to a determination that the data pattern satisfies a data pattern requirement, output an activation signal (“The control circuitry 16 activates the awake state in response to the detection of a valid wake-up signal W2 by means of the match detector circuitry 14. For example, to this end, the control circuitry 16 may transmit a logical wake-up signal W3 to the communications transceiver circuitry 15. In response to the logical wake-up signal W3, the communications transceiver circuitry 15 may be powered up so as to be able to support the wireless user communication with the external device 2. ”, paragraph [0078]); and telemetry circuitry configured to: responsive to receiving the activation signal, output a second set of data, wherein the second set of data is transmitted at the frequency band (“In the awake state, the communications transceiver circuitry 15 is active so as to support the wireless communication with the external device 2.”, paragraph [0070] and “After the activation of the awake mode, an advertising mode of the communications transceiver circuitry 15 of the implantable medical device 1 is activated (see reference “Ad” in the upper panel of FIG. 5). The external device 2 scans for an advertising package from the implantable medical device 1.”, paragraph [0090], where BLE is known to operate in the 2.4 GHz ISM frequency band); and establish a communication session with the device using the second set of data (“For example, after activating the awake state, a wireless communication session, such as a telemetry session, between the implantable medical device 1 and the external device 2 may be established.”, paragraph [0078]).
Regarding claim 2, von Arx discloses that the wake circuitry is further configured to: compare a voltage of each pulse of the set of pulses to a voltage threshold; and detect the data pattern based on the comparison of the voltage of each pulse of the set of pulses to the voltage threshold (“a valid wakeup signal W2 may be recognized according to its amplitude and frequency, for example”, paragraph [0076]).
Regarding claim 3, von Arx discloses that the wake circuitry comprises a comparator 14 comprising: a first input configured to receive the set of pulses (“The demodulated wakeup signal W2 is subsequently transmitted to a match detector circuitry 14”, paragraph [0076]); a second input configured to receive a voltage threshold (“the match detector circuitry 14 verifies the demodulated wakeup signal W2, wherein a valid wakeup signal W2 may be recognized according to its amplitude and frequency”, paragraph [0076]); and an output configured to output the data pattern (“The control circuitry 16 activates the awake state in response to the detection of a valid wakeup signal W2 by means of the match detector circuitry 14. For example, to this end, the control circuitry 16 may transmit a logical wakeup signal W3 to the communications transceiver circuitry 15”, paragraph [0078]).
Regarding claim 4, von Arx discloses that the wake circuitry is configured to receive, by the telemetry circuitry and using the communication session, electrical stimulation information from the device associated with the medical device (“Upon activating the awake state (and thereby exiting the dormant state), the implantable medical device may power up the communications transceiver for enabling a user communication, e.g., a telemetry session.”, paragraph [0040]), and wherein the medical device is configured to provide the therapy based on the electrical stimulation information (“a pulse generator of a cardiac pacemaker that is implanted in the patient's body”, paragraph [0067]).
Regarding claim 5, a “hop set of frequencies” is generally understood to be a set of frequencies available for use by a wireless network. It is respectfully submitted that the broadest reasonable interpretation for a “hop set of frequencies” is a set, which may include only one, of frequencies. As such, it is submitted that the frequencies disclosed by von Arx are considered to satisfy the limitation “the second set of data comprises a hop set of frequencies, and wherein the telemetry circuitry is configured to establish the communication session according to the hop set of frequencies”.
Regarding claim 6, von Arx discloses an antenna 12 configured to operate at the frequency band (“The modulated wakeup signal W1 is received by an antenna 12 of the implantable medical device 1.”, paragraph [0072]).
Regarding claim 8, Von Arx discloses that to detect the data pattern, the wake circuitry is configured to determine one or more intervals using the set of pulses, the one or more intervals comprising the interval between the first pulse and the second pulse (“The demodulated wakeup signal W2 is subsequently transmitted to a match detector circuitry 14 that is configured to validate the demodulated wakeup signal W2. This is to say that the match detector circuitry 14 verifies the demodulated wakeup signal W2”, paragraph [0076] and “Such wake-up sequences may be generated by the external device 2 by means of appropriate software. For example, the wake-up sequences may be generated in the form of customized (vendor-specific) Bluetooth advertising sequences. While the BLE signal itself encodes data with GFSK modulation, the envelope of packets and time between packets makes an ASK signal. As illustrated, such signal sequences are characterized essentially by a sequence of pulse groups having a period/interval T1 and using pulses (also denoted as PDUs, for Packet Date Units) having pulse durations t0, t1, t2, t3. These parameters T1, t0, t1, t2, t3 may be controlled at least to a certain degree by means of software, which may be provided by the external device 2 vendor (assuming the external device 2 is an ‘off the shelf’ device). It should be noted that the exemplary wake-up sequences shown in FIG. 4 yet have to be ASK modulated to form the modulated wake-up signal W1. In other words, the illustrated signal sequences may correspond to envelopes of the modulated wake-up signal W1, which may be reconstructed at the receiving end by means of the demodulator circuitry 11 of the implantable medical device 1.”, paragraph [0083]), and wherein, the wake circuitry is configured to: responsive to the data pattern matching a predetermined pattern, determine that the data pattern satisfies the data pattern requirement (“The control circuitry 16 activates the awake state in response to the detection of a valid wake-up signal W2 by means of the match detector circuitry 14. For example, to this end, the control circuitry 16 may transmit a logical wake-up signal W3 to the communications transceiver circuitry 15. In response to the logical wake-up signal W3, the communications transceiver circuitry 15 may be powered up so as to be able to support the wireless user communication with the external device 2.”, paragraph [0078]); and responsive to the data pattern not matching the predetermined pattern, determine that the data pattern does not satisfy the data pattern requirement (“In the alternative, if the implantable pulse director IPG determines that no connection has been established within the programmable delay period, the Bluetooth communications transceiver circuitry 15 is turned off again until the ASK demodulator circuitry 11 receives the next valid modulated wakeup signal W1.”, paragraph [0099]).
Regarding claim 9, von Arx discloses that the device associated with the medical device comprises one or more of an additional medical device, clinician programmer, a patient programmer, a recharger device, or a mobile device (“the external device is a mobile device, such as a smartphone.”, paragraph [0048]).
Regarding claim 10, von Arx discloses that the first set of data is compliant with a communication protocol, wherein the second set of data is compliant with the communication protocol, and wherein the first set of data and the second set of data are transmitted on a set of frequency channels assigned for data transmissions by the communication protocol (“the wake-up protocol may be compatible with an established communication standard, such as the Bluetooth protocol”, paragraph [0050] and “If, for example, an advertising sequence according to Bluetooth, in particular Bluetooth Low Energy, is used as the wake-up signal, the wake-up signal may be constructed of a number of transmission pulses (so-called PDUs), which, for example, may be sent on a single or on multiple Bluetooth channels.”, paragraph [0028]).
Regarding claim 11, von Arx discloses that the communication protocol is Bluetooth® low energy (BLE) (“In an exemplary embodiment, a BLE5.0 extended advertising sequence is used as a wakeup signal sequence.”, paragraph [0050]).
Regarding claim 14, Von Arx discloses that the first set of data comprises a first set of advertisements (“the modulated wakeup signal W1 may take the form of a customized advertising sequence compatible with BLE5.0”, paragraph [0071]), wherein the second set of data comprises a second set of advertisements (“After the activation of the awake mode, an advertising mode of the communications transceiver circuitry 15 of the implantable medical device 1 is activated”, paragraph [0090]), and wherein each advertisement of the first set of advertisements and the second set of advertisements comprises information for connecting devices.
Regarding claim 15, Von Arx discloses a method comprising: receiving, by wake circuitry of a medical device 1 configured to provide a therapy to a patient (“The implantable medical device 1 may be or may comprise, for example, a recording device such as a loop recorder or a pulse generator of a cardiac pacemaker that is implanted in the patient's body.”, paragraph [0067]), a first set of data from a device 2 associated with the medical device (“The modulated wakeup signal W1 is received by an antenna 12 of the implantable medical device 1.”, paragraph [0072], wherein the first set of data is received at a frequency band (“a BLE5.0 extended advertising sequence is used as a wakeup signal sequence”, paragraph [0050], where BLE is known to operate in the 2.4 GHz ISM frequency band); outputting, based on the first set of data and by the wake circuitry, a set of pulses comprising a first pulse and a second pulse (“The frontend matching circuitry 13 is configured to receive and filter the modulated wakeup signal W1 before transmitting it to the demodulator circuitry 11.”, paragraph [0073] and “The always-on ASK demodulator circuitry 11 is configured to demodulate the modulated wakeup signal W1 so as to generate a demodulated wakeup signal W2 (e.g., a baseband signal).“, paragraph [0075]); detecting, by the wake circuitry, a data pattern based on an interval between the first pulse and the second pulse, a first voltage of at the first pulse, and a second voltage at the second pulse (“The demodulated wakeup signal W2 is subsequently transmitted to a match detector circuitry 14 that is configured to validate the demodulated wakeup signal W2. This is to say that the match detector circuitry 14 verifies the demodulated wakeup signal W2”, paragraph [0076] and “Such wake-up sequences may be generated by the external device 2 by means of appropriate software. For example, the wake-up sequences may be generated in the form of customized (vendor-specific) Bluetooth advertising sequences. While the BLE signal itself encodes data with GFSK modulation, the envelope of packets and time between packets makes an ASK signal. As illustrated, such signal sequences are characterized essentially by a sequence of pulse groups having a period/interval T1 and using pulses (also denoted as PDUs, for Packet Date Units) having pulse durations t0, t1, t2, t3. These parameters T1, t0, t1, t2, t3 may be controlled at least to a certain degree by means of software, which may be provided by the external device 2 vendor (assuming the external device 2 is an ‘off the shelf’ device). It should be noted that the exemplary wake-up sequences shown in FIG. 4 yet have to be ASK modulated to form the modulated wake-up signal W1. In other words, the illustrated signal sequences may correspond to envelopes of the modulated wake-up signal W1, which may be reconstructed at the receiving end by means of the demodulator circuitry 11 of the implantable medical device 1.”, paragraph [0083]); responsive to a determination that the data pattern satisfies a data pattern requirement, outputting, by the wake circuitry, an activation signal (“The control circuitry 16 activates the awake state in response to the detection of a valid wake-up signal W2 by means of the match detector circuitry 14. For example, to this end, the control circuitry 16 may transmit a logical wake-up signal W3 to the communications transceiver circuitry 15. In response to the logical wake-up signal W3, the communications transceiver circuitry 15 may be powered up so as to be able to support the wireless user communication with the external device 2. ”, paragraph [0078]); responsive to receiving, by telemetry circuitry of the medical device, the activation signal, outputting, by the telemetry circuitry, a second set of data, wherein the second set of data is transmitted at the frequency band (“In the awake state, the communications transceiver circuitry 15 is active so as to support the wireless communication with the external device 2.”, paragraph [0070] and “After the activation of the awake mode, an advertising mode of the communications transceiver circuitry 15 of the implantable medical device 1 is activated (see reference “Ad” in the upper panel of FIG. 5). The external device 2 scans for an advertising package from the implantable medical device 1.”, paragraph [0090], where BLE is known to operate in the 2.4 GHz ISM frequency band); and establishing, by the telemetry circuitry, a communication session with the device using the second set of data (“For example, after activating the awake state, a wireless communication session, such as a telemetry session, between the implantable medical device 1 and the external device 2 may be established.”, paragraph [0078]).
Regarding claim 16, Von Arx discloses comparing, by the wake circuitry, a voltage of each pulse of the set of pulses to a voltage threshold; and detecting, by the wake circuitry, the data pattern based on the comparison of the voltage of each pulse of the set of pulses to the voltage threshold (“a valid wake-up signal W2 may be recognized according to its amplitude and frequency, for example”, paragraph [0076]).
Regarding claim 17, Von Arx discloses receiving, by a first input of a comparator, the set of pulses (“The demodulated wakeup signal W2 is subsequently transmitted to a match detector circuitry 14”, paragraph [0076]); receiving, by a second input of the comparator, a voltage threshold (“the match detector circuitry 14 verifies the demodulated wake-up signal W2, wherein a valid wake-up signal W2 may be recognized according to its amplitude and frequency”, paragraph [0076]); and outputting, by an output of the comparator, the data pattern (“The control circuitry 16 activates the awake state in response to the detection of a valid wake-up signal W2 by means of the match detector circuitry 14. For example, to this end, the control circuitry 16 may transmit a logical wake-up signal W3 to the communications transceiver circuitry 15.”, paragraph [0078]).
Regarding claim 18, Von Arx discloses that the first set of data is compliant with a communication protocol, wherein the second set of data is compliant with the communication protocol, and wherein the first set of data and the second set of data are transmitted on a set of frequency channels assigned for data transmissions by the communication protocol (“the wake-up protocol may be compatible with an established communication standard, such as the Bluetooth protocol.”, paragraph [0050] and “the implantable medical device comprises a communications transceiver circuitry being configured to support a wireless communication with the external device in the awake state. For example, the wireless communication may use an RF link. The wireless communication may be carried out according to an established communication standard, such as, e.g., Bluetooth.”, paragraph [0039]).
Regarding claim 19, Von Arx discloses that the first set of data comprises a first set of advertisements (“the modulated wake-up signal W1 may take the form of a customized advertising sequence compatible with BLE 5.0”, paragraph [0071]), wherein the second set of data comprises a second set of advertisements (“After the activation of the awake mode, an advertising mode of the communications transceiver circuitry 15 of the implantable medical device 1 is activated”, paragraph [0090]), and wherein each advertisement of the first set of advertisements and the second set of advertisements comprises information for connecting devices.
Regarding claim 20, Von Arx discloses a system comprising: a device 2 associated with a medical device 1 configured to provide a therapy to a patient (“The implantable medical device 1 may be or may comprise, for example, a recording device such as a loop recorder or a pulse generator of a cardiac pacemaker that is implanted in the patient's body.”, paragraph [0067]), wherein the device comprises one or more of an additional medical device, a clinician programmer, a patient programmer, a recharger device, or a mobile device (“the external device is a mobile device, such as a smartphone.”, paragraph [0048]); and the medical device 1 comprising: wake circuitry configured to: receive a first set of data from the device 2 (“The modulated wakeup signal W1 is received by an antenna 12 of the implantable medical device 1.”, paragraph [0072]), wherein the first set of data is received at a frequency band (“a BLE5.0 extended advertising sequence is used as a wakeup signal sequence”, paragraph [0050], where BLE is known to operate in the 2.4 GHz ISM frequency band); output, based on the first set of data, a set of pulses comprising a first pulse and a second pulse (“The frontend matching circuitry 13 is configured to receive and filter the modulated wakeup signal W1 before transmitting it to the demodulator circuitry 11.”, paragraph [0073] and “The always-on ASK demodulator circuitry 11 is configured to demodulate the modulated wakeup signal W1 so as to generate a demodulated wakeup signal W2 (e.g., a baseband signal).“, paragraph [0075]); detect a data pattern based on an interval between the first pulse and the second pulse, a first voltage of at the first pulse, and a second voltage at the second pulse (“The demodulated wakeup signal W2 is subsequently transmitted to a match detector circuitry 14 that is configured to validate the demodulated wakeup signal W2. This is to say that the match detector circuitry 14 verifies the demodulated wakeup signal W2”, paragraph [0076] and “Such wake-up sequences may be generated by the external device 2 by means of appropriate software. For example, the wake-up sequences may be generated in the form of customized (vendor-specific) Bluetooth advertising sequences. While the BLE signal itself encodes data with GFSK modulation, the envelope of packets and time between packets makes an ASK signal. As illustrated, such signal sequences are characterized essentially by a sequence of pulse groups having a period/interval T1 and using pulses (also denoted as PDUs, for Packet Date Units) having pulse durations t0, t1, t2, t3. These parameters T1, t0, t1, t2, t3 may be controlled at least to a certain degree by means of software, which may be provided by the external device 2 vendor (assuming the external device 2 is an ‘off the shelf’ device). It should be noted that the exemplary wake-up sequences shown in FIG. 4 yet have to be ASK modulated to form the modulated wake-up signal W1. In other words, the illustrated signal sequences may correspond to envelopes of the modulated wake-up signal W1, which may be reconstructed at the receiving end by means of the demodulator circuitry 11 of the implantable medical device 1.”, paragraph [0083]); and responsive to a determination that the data pattern satisfies a data pattern requirement, output an activation signal (“The control circuitry 16 activates the awake state in response to the detection of a valid wake-up signal W2 by means of the match detector circuitry 14. For example, to this end, the control circuitry 16 may transmit a logical wake-up signal W3 to the communications transceiver circuitry 15. In response to the logical wake-up signal W3, the communications transceiver circuitry 15 may be powered up so as to be able to support the wireless user communication with the external device 2. ”, paragraph [0078]); and telemetry circuitry configured to: responsive to receiving the activation signal, output a second set of data, wherein the second set of data is transmitted at the frequency band (“In the awake state, the communications transceiver circuitry 15 is active so as to support the wireless communication with the external device 2.”, paragraph [0070] and “After the activation of the awake mode, an advertising mode of the communications transceiver circuitry 15 of the implantable medical device 1 is activated (see reference “Ad” in the upper panel of FIG. 5). The external device 2 scans for an advertising package from the implantable medical device 1.”, paragraph [0090], where BLE is known to operate in the 2.4 GHz ISM frequency band); and establish a communication session with the device using the second set of data (“For example, after activating the awake state, a wireless communication session, such as a telemetry session, between the implantable medical device 1 and the external device 2 may be established.”, paragraph [0078]).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 7 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over von Arx (U.S. 2024/0236854) in view of Wu et al. (U.S. 2022/0022745). Regarding claim 7, Von Arx discloses the invention substantially as claimed, but fails to disclose switch circuitry configured to: responsive to a determination that the data pattern satisfies the data pattern requirement, connect the telemetry circuitry and the antenna and disconnect the wake circuitry and the antenna; and responsive to a termination of the communication session, connect the wake circuitry and the antenna disconnect the telemetry circuitry and the antenna. Wu teaches a system and method for managing Bluetooth low energy advertising that includes switch circuitry configured to switch between a low power (partially wake) state and a fully awake state (see paragraph [0066]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Von Arx to include switch circuitry, as taught by Wu, in order to switch between the low power state and the fully awake state of Von Arx, wherein responsive to a determination that the data pattern satisfies the data pattern requirement, connect the telemetry circuitry and the antenna and disconnect the wake circuitry and the antenna (fully awake state of Von Arx); and responsive to a termination of the communication session, connect the wake circuitry and the antenna disconnect the telemetry circuitry and the antenna (low power state of Von Arx), as it has been held that applying a known technique (switching) to a known device ready for improvement (the device of Von Arx) to yield predictable results requires only routine skill in the art. KSR Int'l Co. v. Teleflex Inc., 127 S.Ct. 1727, 1742, 82 USPQ2d 1385, 1396 (2007).
Regarding claim 13, Von Arx discloses the invention substantially as claimed, but fails to disclose that the therapy comprises one or more of deep brain stimulation (DBS), spinal cord stimulation (SCS), sacral neuromodulation (SNS), targeted drug delivery (TDD), pelvic stimulation, gastric stimulation, peripheral nerve field stimulation (PNFS), or tibial nerve stimulation (TNS). Wu teaches an IMD 101 that is “capable of treating the appropriate heart chamber(s) with cardioversion, defibrillation and/or pacing stimulation” and “may be used to generate neurostimulation for application to a desired area of a body, such as spinal cord stimulation, the brain and the like” (see paragraph [0031]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Von Arx to substitute the cardiac stimulation therapy with neurostimulation for application to a spinal cord or brain, as taught by Wu, as it has been held that simple substitution of one known element for another to yield predictable results requires only routine skill in the art. KSR Int'l Co. v. Teleflex Inc., 127 S.Ct. 1727, 1742, 82 USPQ2d 1385, 1396 (2007).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Von Arx (U.S. 2024/0236854) in view of Siddiqi et al. (“Towards Realistic Battery-DoS Protection of Implantable Medical Devices”, CF’19:Proceedings of the 16th ACM International Conference on Computing Frontiers, cited by Applicant). Regarding claim 12, Von Arx discloses the invention substantially as claimed, but fails to disclose that the wake circuitry is configured to harvest energy from a signal received by the wake circuitry, and wherein the wake circuitry is powered, at least in part, by the harvested energy. Siddiqi teaches that implantable medical devices are vulnerable to security attacks based on their wireless connectivity, one of which being a battery Denial-of-Service attach whereby attackers aim to fully deplete the battery by occupying the IMD with continuous authentication requests (see Abstract). Siddiqi teaches that a zero-power defense based on energy harvesting is known to be an excellent protection against these attacks (see Abstract), whereby the circuitry of the IMD is configured to harvest energy from an authentication signal and the circuitry is powered by the harvested energy (see section 3 ENERGY HARVESTING FOR IMD SECURITY). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Von Arx to include that the wake circuitry is configured to harvest energy from a signal received by the wake circuitry, and wherein the wake circuitry is powered, at least in part, by the harvested energy, as taught by Siddiqi, in order to ensure that the battery of the IMD is not depleted by authentication requests and, thereby ensuring the security of the IMD.
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAMMIE K MARLEN whose telephone number is (571)272-1986. The examiner can normally be reached Monday through Friday from 8 am until 4 pm.
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/TAMMIE K MARLEN/Primary Examiner, Art Unit 3796
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