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 .
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 11/29/2023 has/have been acknowledged and is/are being considered by the Examiner.
Drawings
The Applicant is reminded to carefully review the drawing figures and the accompanying specification to ensure that all reference numerals present in the drawing figures are defined within the specification.
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 1-14 and 20 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.
Claim 1 recites the limitation "the telemetry circuitry" in line 10. There is insufficient antecedent basis for this limitation in the claim.
Claim 20 recites the limitation "the telemetry circuitry" in line 13. There is insufficient antecedent basis for this limitation in the claim.
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.
Claims 1-6, 9-11, and 14-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wang et al. (U.S. 2020/0261733), herein Wang. Regarding claim 1, Wang 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 pulse generator of a cardiac pacemaker that is implanted in the patient's body.”, paragraph [0038]), 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 [0042]), 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 [0021], where BLE is known to operate in the 2.4 GHz ISM frequency band); output a set of pulses based on the first set of data (“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 [0043] 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 [0045]); detect a data pattern using the set of pulses (“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 [0046]); 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 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. In response to the logical wakeup 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 [0048]); 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 [0040] and “The Bluetooth communications transceiver circuitry 15 of the implantable pulse director IPG is then turned on and starts advertising by transmitting advertising messages. Such an advertising message may be received by the patient remote PR, which is in scan mode.”, paragraph [0065], 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 [0048]).
Regarding claim 2, Wang 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 [0046]).
Regarding claim 3, Wang 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 [0046]); 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 [0046]); 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 [0048]).
Regarding claim 4, Wang 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 [0011]), 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 [0038]).
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 Wang 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, Wang 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 [0042]).
Regarding claim 9, Wang 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 [0019]).
Regarding claim 10, Wang 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 wakeup protocol may be compatible with an established communication standard, such as the Bluetooth protocol.”, paragraph [0021] 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 [0010]).
Regarding claim 11, Wang 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 [0021]).
Regarding claim 14, Wang 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 [0041]), 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 [0060]), and wherein each advertisement of the first set of advertisements and the second set of advertisements comprises information for connecting devices.
Regarding claim 15, Wang discloses a method comprising: receiving, by wake circuitry of a medical device configured to provide a therapy to a patient, a first set of data from a device associated with the medical device (“The modulated wakeup signal W1 is received by an antenna 12 of the implantable medical device 1.”, paragraph [0042]), 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 [0021], where BLE is known to operate in the 2.4 GHz ISM frequency band); outputting, by the wake circuitry, a set of pulses based on the first set of data (“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 [0043] 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 [0045]); detecting, by the wake circuitry, a data pattern using the set of pulses (“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 [0046]); 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 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. In response to the logical wakeup 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 [0048]); 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 [0040] and “The Bluetooth communications transceiver circuitry 15 of the implantable pulse director IPG is then turned on and starts advertising by transmitting advertising messages. Such an advertising message may be received by the patient remote PR, which is in scan mode.”, paragraph [0065], 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 [0048]).
Regarding claim 16, Wang 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 wakeup signal W2 may be recognized according to its amplitude and frequency, for example”, paragraph [0046]).
Regarding claim 17, Wang 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 [0046]); receiving, by a second input of the comparator, 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 [0046]); 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 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 [0048]).
Regarding claim 18, Wang 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 wakeup protocol may be compatible with an established communication standard, such as the Bluetooth protocol.”, paragraph [0021] 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 [0010]).
Regarding claim 19, Wang 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 [0041]), 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 [0060]), and wherein each advertisement of the first set of advertisements and the second set of advertisements comprises information for connecting devices.
Regarding claim 20, Wang discloses a system comprising: a device 2 associated with a medical device 1 configured to provide a therapy to a patient, 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 [0019]); 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 [0042]), 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 [0021], where BLE is known to operate in the 2.4 GHz ISM frequency band); output a set of pulses based on the first set of data (“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 [0043] 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 [0045]); detect a data pattern using the set of pulses (“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 [0046]); 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 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. In response to the logical wakeup 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 [0048]); 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 [0040] and “The Bluetooth communications transceiver circuitry 15 of the implantable pulse director IPG is then turned on and starts advertising by transmitting advertising messages. Such an advertising message may be received by the patient remote PR, which is in scan mode.”, paragraph [0065], 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 [0048]).
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, 8, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Wang (U.S. 2020/0261733) in view of Wu et al. (U.S. 2022/0022745). Regarding claim 7, Wang 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 Wang to include switch circuitry, as taught by Wu, in order to switch between the low power state and the fully awake state of Wang, 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 Wang); 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 Wang), as it has been held that applying a known technique (switching) to a known device ready for improvement (the device of Wang) 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 8, Wang discloses that to determine whether the data pattern satisfies the data pattern requirement, the wake circuitry is configured to: determine one or more advertising intervals using the set of pulses, wherein the data pattern comprises the one or more advertising intervals; responsive to the data pattern matching a predetermined advertising 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 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. In response to the logical wakeup 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 [0048]); and responsive to the data pattern not matching the predetermined advertising interval sequence, 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 [0066]).
Regarding claim 13, Wang 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 Wang 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 Wang (U.S. 2020/0261733) 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, Wang 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 Wang 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See attached PTO-892.
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/TAMMIE K MARLEN/Primary Examiner, Art Unit 3796