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 Preliminary Amendment
The amendment filed 06/21/23 has been entered. Claims 1, 5-10, 12-14, 18, 22-27, and 29-31 have been amended. Claims 2-4, 11, 15-17, 19-21, 28, and 32-34 are cancelled. Thus, claims 1, 5-10, 12-14, 18, 22-27, and 29-31 remain pending in the application.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/25/23 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 22, 23, and 25 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 claim 22, in view of Applicant disclosure, it is unclear to the examiner how in lines 1-3 “the first wireless transceiver is inactive while the device is in the first state, and wherein the first wireless transceiver is active while the device is in the second state.” According to claim 18 from which claim 22 depends, the “second” transceiver is the higher powered transceiver that would only be operational in the second state (see Applicant disclosure FIG. 9 and [0161]).
Therefore, for purposes of examination and to align with Applicant disclosure, the examiner interprets each recitation of the “first” wireless transceiver in claim 22 to be the “second” wireless transceiver. Applicant could adopt this interpretation to overcome this 112b rejection.
Regarding claim 23, similar to that in claim 22, the second transceiver, according to claim 18, is the higher powered transceiver only on in the second state. Therefore, for purposes of examination and to align with Applicant disclosure, the examiner interprets each recitation of the “first” wireless transceiver in claim 23 to be the “second” wireless transceiver. Applicant could adopt this interpretation to overcome this 112b rejection.
Regarding claim 25, similar to that in claim 22, the second transceiver, according to claim 18, is the higher powered transceiver only on in the second state. Therefore, for purposes of examination and to align with Applicant disclosure, the examiner interprets each recitation of the “first” wireless transceiver in claim 25 to be the “second” wireless transceiver. Applicant could adopt this interpretation to overcome this 112b rejection.
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 18 and 22-27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by von Arx et al. (U.S. PGPUB No. 2021/0106833), hereinafter Arx.
Regarding claim 18, Arx discloses a method comprising:
receiving, at a first wireless transceiver (111, see FIG. 1B and [0074]: NIR) of an implantable monitor (11, see [0070]: implanted device can be a shallow subcutaneous implant or other implantable devices, see [0042]), a first signal over a first communication link (see [0074]);
after receiving the first signal, transitioning the implantable monitor from a low-power first state to a higher-power second state (see [0078]: NIR transmitter of external device sends wake up signal to NIR transceiver 111 switch implantable device from low power mode to high power mode, such as for using far-field RF, see [0009]);
sensing, at one or more sensors of the implantable monitor, at least one physiological parameter while implanted within the patient (see [0005]); and
while in the second state (see [0009] and [0078]: when device is awakened), transmitting data associated with the at least one physiological parameter to one or more external devices over a second communication link via a second wireless transceiver different from the first (see [0070] & [0085]: device may also have RF telemetry to communicate with remote monitoring infrastructure. RF telemetry inherently requires a transceiver).
Regarding claim 22, Arx discloses the method of claim 18, and Arx further discloses wherein the [[first]] second wireless transceiver (RF transceiver as in [0070] & [0085]) is inactive while the device is in the first state (see [0009]: RF turned off >98% of time), and wherein the [[first]] second wireless transceiver is active while the device is in the second state (see [0078]: NIR transmitter of external device sends wake up signal to switch implantable device from low power mode to high power mode, such as for using far-field RF, see [0009]).
Regarding claim 23, Arx discloses the method of claim 18, and Arx further discloses wherein the [[first]] second wireless transceiver (RF transceiver as in [0070] & [0085]) transmits data only while the device is in the second state (see [0009]: RF off unless woken up such as described in [0042] & [0078]).
Regarding claim 24, Arx discloses the method of claim 18, and Arx further discloses wherein the first state is a lower-power standby state, and wherein the second state is a higher- power operational state (see [0078]: wake up signal moves to high power mode for, see [0009]: using RF).
Regarding claim 25, Arx discloses the method of claim 24, and Arx further discloses wherein, in the standby state, the device does not transmit data via the [[first]] second wireless transceiver (see [0009]: RF off until awakened), and wherein in the operational state, the device transmits data via the [[first]] second wireless transceiver (see [0009], [0070], [0078], and [0085]).
Regarding claim 26, Arx discloses the method of claim 18, and Arx further discloses wherein the device transitions between the first state and the second state after a trigger event (see [0078]: trigger event/ wakeup notification received at receiver 113 from an external device).
Regarding claim 27, Arx discloses the method of claim 26, and Arx further discloses wherein the trigger event (see [0078]: trigger event/ wakeup notification received at receiver 113 from an external device) comprises at least one of a measurement of a physiological parameter that falls above or below a predetermined threshold, a measurement of a physiological parameter that indicates a rate of change that is above or below a predetermined threshold, a measurement of a physiological parameter that falls outside of a predetermined range, elapsing of a predetermined time, or receiving a modulation signal from an external device (see [0078]: signal sent via NIR from external device comprises a modulation signal).
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.
Claims 1 and 5-10 are rejected under 35 U.S.C. 103 as being unpatentable over Adams et al. (U.S. PGPUB No. 2004/0054352), hereinafter Adams, in view of Arx (U.S. PGPUB No. 2021/0106833).
Regarding claim 1, Adams discloses an implantable vascular access device (see FIG. 4) comprising:
a fluid reservoir (110, see [0032]);
a cover (106) disposed over (see FIG. 4 and [0032]) the reservoir (110);
an outlet port (108) configured to mate with (see [0032]) a catheter (104), the outlet port (108) fluidically coupled (by way of catheter 104) to the fluid reservoir (110);
one or more sensors configured to capture physiological data while the device is implanted within a patient (see [0033-0034]: several examples of sensors for different kinds of desired data gathering);
a first wireless transceiver (electronics unit 760 includes a transmitter 774 and receiver 776, thus forming a transceiver, see FIG. 8 and [0071]) configured to transmit the physiological data to one or more external devices (see [0067] & [0074-0075]: external device) via a first communication link (see [0067]: 760 sends physiological parameters to external transceiver 770); and
wherein the device is configured to transition between a low-power first state and a higher-power second state (see [0043]: device turns on and thus is “configured to transition” from low-power/ off to high power/ on).
Adams is silent to “a second wireless transceiver configured to communicate with one or more external devices via a second communication link. ”
However, Arx teaches an implantable vascular access device (11, see FIG. 1B and see [0070]: implanted device can be a shallow subcutaneous implant or other implantable devices, see [0042]) comprising: one or more sensors configured to capture physiological data while the device is implanted within a patient (see [0005]); a first wireless transceiver (see [0070] & [0085]: device may also have RF telemetry to communicate with remote monitoring infrastructure) configured to transmit the physiological data to one or more external devices (136) via a first communication link (see [0009]); and a second wireless transceiver (111, see [0074]) configured to communicate with one or more external devices (136) via a second communication link (see NIR in FIG. 1B and described in [0074]); wherein the device is configured to transition between a low-power first state and a higher-power second state (see [0078]: NIR transmitter of external device sends wake up signal to switch implantable device from low power mode to high power mode, such as for using far-field RF, see [0009]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the electronics unit comprising the first transceiver disclosed in Adams to include a second transceiver for communicating via a second communications link such that the first transceiver is only utilized in the high power state as taught by Arx for the purpose of improving the power efficiency of the device (see [0009-0010] & [0042]), thus achieving “a second wireless transceiver configured to communicate with one or more external devices via a second communication link. ”
Regarding claim 5, the modified system of Adams teaches the device of claim 1, but Adams is silent to “wherein the first wireless transceiver is inactive while the device is in the first state, and wherein the first wireless transceiver is active while the device is in the second state.”
However, Arx teaches an implantable vascular access device (11, see FIG. 1B and see [0070]: implanted device can be a shallow subcutaneous implant or other implantable devices, see [0042]) comprising a first wireless transceiver (RF transceiver as in [0070] & [0085]) and second wireless transceiver (111, see [0074]), wherein the device is configured to transition between a low-power first state and a higher-power second state (see [0078]: NIR transmitter of external device sends wake up signal to switch implantable device from low power mode to high power mode, such as for using far-field RF, see [0009]). Arx further teaches wherein the first wireless transceiver is inactive while the device is in the first state (see [0009]: RF turned off >98% of time), and wherein the first wireless transceiver is active while the device is in the second state (see [0078]: NIR transmitter of external device sends wake up signal to switch implantable device from low power mode to high power mode, such as for using far-field RF, see [0009]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the electronics unit comprising the first transceiver disclosed in Adams to include a second transceiver for communicating via a second communications link such that the first transceiver is inactive in the first state and active in the second state as taught by Arx for the purpose of forming a coordinated wake-up system for the RF transceiver such that the device’s power efficiency is increased (see [0009-0010] and [0042]), thus achieving “wherein the first wireless transceiver is inactive while the device is in the first state, and wherein the first wireless transceiver is active while the device is in the second state.”
Regarding claim 6, the modified system of Adams teaches the device of claim 1, but Adams is silent to “wherein the first wireless transceiver transmits data only while the device is in the second state.”
However, Arx teaches an implantable vascular access device (11, see FIG. 1B and see [0070]: implanted device can be a shallow subcutaneous implant or other implantable devices, see [0042]) comprising a first wireless transceiver (RF transceiver as in [0070] & [0085]) and second wireless transceiver (111, see [0074]), wherein the device is configured to transition between a low-power first state and a higher-power second state (see [0078]: NIR transmitter of external device sends wake up signal to switch implantable device from low power mode to high power mode, such as for using far-field RF, see [0009]). Arx further teaches wherein the first wireless transceiver (RF transceiver as in [0070] & [0085]) transmits data only while the device is in the second state (see [0009]: RF off unless woken up such as described in [0042]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the electronics unit comprising the first transceiver disclosed in Adams to include a second transceiver for communicating via a second communications link such that the first transceiver only transmits in the in the second state as taught by Arx for the purpose of forming a coordinated wake-up system for the RF transceiver such that the device’s power efficiency is increased (see [0009-0010] and [0042]), thus achieving “wherein the first wireless transceiver transmits data only while the device is in the second state.”
Regarding claim 7, the modified system of Adams teaches the device of claim 1, but Adams is silent to “wherein the first state is a lower-power standby state, and wherein the second state is a higher- power operational state.”
However, Arx teaches an implantable vascular access device (11, see FIG. 1B and see [0070]: implanted device can be a shallow subcutaneous implant or other implantable devices, see [0042]) comprising a first wireless transceiver (RF transceiver as in [0070] & [0085]) and second wireless transceiver (111, see [0074]), wherein the device is configured to transition between a low-power first state and a higher-power second state (see [0078]: NIR transmitter of external device sends wake up signal to switch implantable device from low power mode to high power mode, such as for using far-field RF, see [0009]), wherein the first state is a lower-power standby state, and wherein the second state is a higher- power operational state (see [0078]: wake up signal moves to high power mode for, see [0009]: using RF).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the electronics unit comprising the first transceiver disclosed in Adams to include a second transceiver for communicating via a second communications link for waking the device between a lower-power standby state and a higher- power operational state as taught by Arx for the purpose of forming a coordinated wake-up system for the RF transceiver such that the device’s power efficiency is increased (see [0009-0010] and [0042]), thus achieving “wherein the first state is a lower-power standby state, and wherein the second state is a higher- power operational state.”
Regarding claim 8, the modified system of Adams teaches the device of claim 7, but Adams is silent to “wherein, in the standby state, the device does not transmit data via the first wireless transceiver, and wherein in the operational state, the device transmits data via the first wireless transceiver.”
However, Arx teaches an implantable vascular access device (11, see FIG. 1B and see [0070]: implanted device can be a shallow subcutaneous implant or other implantable devices, see [0042]) comprising a first wireless transceiver (RF transceiver as in [0070] & [0085]) and second wireless transceiver (111, see [0074]), wherein the device is configured to transition between a low-power first state and a higher-power second state (see [0078]: NIR transmitter of external device sends wake up signal to switch implantable device from low power mode to high power mode, such as for using far-field RF, see [0009]), wherein the first state is a lower-power standby state, and wherein the second state is a higher- power operational state (see [0078]: wake up signal moves to high power mode for, see [0009]: using RF). Arx further teaches wherein, in the standby state, the device does not transmit data via the first wireless transceiver (see [0009]: RF off until awakened), and wherein in the operational state, the device transmits data via the first wireless transceiver (see [0009], [0070], [0078], and [0085]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the electronics unit comprising the first transceiver and second transceiver for waking the device between a lower-power standby state and a higher- power operational state taught by Adams in view of Arx to only transmit data from the first transceiver in the second higher power state as taught by Arx for the purpose of forming a coordinated wake-up system for the RF transceiver such that the device’s power efficiency is increased (see [0009-0010] and [0042]), thus achieving “wherein, in the standby state, the device does not transmit data via the first wireless transceiver, and wherein in the operational state, the device transmits data via the first wireless transceiver.”
Regarding claim 9, the modified system of Adams teaches the device of claim 1, but Adams is silent to “wherein the device is configured to transition between the first state and the second state after a trigger event.”
However, Arx teaches an implantable vascular access device (11, see FIG. 1B and see [0070]: implanted device can be a shallow subcutaneous implant or other implantable devices, see [0042]) comprising a first wireless transceiver (RF transceiver as in [0070] & [0085]) and second wireless transceiver (111, see [0074]), wherein the device is configured to transition between a low-power first state and a higher-power second state (see [0078]: NIR transmitter of external device sends wake up signal to switch implantable device from low power mode to high power mode, such as for using far-field RF, see [0009]), wherein the device is configured to transition between the first state and the second state after a trigger event (see [0078]: trigger event/ wakeup notification received at receiver 113 from an external device).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the electronics unit comprising the first transceiver disclosed in Adams to include a second transceiver for communicating via a second communications link for waking the device between a lower-power standby state and a higher- power operational state, the waking being in response to a trigger event as taught by Arx for the purpose of forming a coordinated wake-up system for the RF transceiver such that the device’s power efficiency is increased (see [0009-0010] and [0042]), thus achieving “wherein the device is configured to transition between the first state and the second state after a trigger event.”
Regarding claim 10, the modified system of Adams teaches the device of claim 9, but Adams is silent to “wherein the trigger event comprises at least one of a measurement of a physiological parameter that falls above or below a predetermined threshold, a measurement of a physiological parameter that falls outside of a predetermined range, elapsing of a predetermined time, or receiving a modulation signal from an external device.”
However, Arx teaches an implantable vascular access device (11, see FIG. 1B and see [0070]: implanted device can be a shallow subcutaneous implant or other implantable devices, see [0042]) comprising a first wireless transceiver (RF transceiver as in [0070] & [0085]) and second wireless transceiver (111, see [0074]), wherein the device is configured to transition between a low-power first state and a higher-power second state (see [0078]: NIR transmitter of external device sends wake up signal to switch implantable device from low power mode to high power mode, such as for using far-field RF, see [0009]), wherein the device is configured to transition between the first state and the second state after a trigger event (see [0078]: trigger event/ wakeup notification received at receiver 113 from an external device), wherein the trigger event (see [0078]) comprises at least one of a measurement of a physiological parameter that falls above or below a predetermined threshold, a measurement of a physiological parameter that falls outside of a predetermined range, elapsing of a predetermined time, or receiving a modulation signal from an external device (see [0078]: signal sent via NIR from external device comprises a modulation signal).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the electronics unit comprising the first transceiver disclosed in Adams to include a second transceiver for communicating via a second communications link for waking the device between a lower-power standby state and a higher- power operational state, the waking being in response to a modulation signal from an external device as taught by Arx for the purpose of forming a coordinated wake-up system for the RF transceiver such that the device’s power efficiency is increased (see [0009-0010] and [0042]), thus achieving “wherein the trigger event comprises at least one of a measurement of a physiological parameter that falls above or below a predetermined threshold, a measurement of a physiological parameter that falls outside of a predetermined range, elapsing of a predetermined time, or receiving a modulation signal from an external device.”
Claims 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Adams in view of Arx as applied to claim 9 above, and further in view of Wang et al. (U.S. PGPUB No. 2020/0261733), hereinafter Wang.
Regarding claim 12, the modified system of Adams teaches the device of claim 9, but Modified Adams is silent to “wherein the device is configured to transition from the second state back to the first state after a second trigger event.”
However, Wang teaches an implantable vascular access device (see FIG. 1 and [0038]: an implantable medical device) comprising a first wireless transceiver (15, see [0039]: transceiver circuitry 15 such as Bluetooth chip) and second wireless receiver (12, see [0042]), wherein the device is configured to transition between a low-power first state and a higher-power second state (see [0040-0048]), wherein the device is configured to transition between the first state and the second state after a trigger event (see [0040-0043]: trigger event is wakeup signal received by antenna 12 from external device 2), wherein the device is configured to transition from the second state back to the first state after a second trigger event (see [0065-0066]: high powered Bluetooth communications—via transceiver 15-- turned off after predetermined programmable delay to wait for next wake up signal).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the electronics device comprising the low and high power states via the first and second transceivers taught by Modified Adams to transition back to the low powered state as taught by Wang for the purpose of allowing the dormant and wake-up states to be selectively assumed (see [0024] and [0065-0066]), which ensure further increase in power efficiency by turning off the high powered transceiver once it is no longer needed, thus achieving “wherein the device is configured to transition from the second state back to the first state after a second trigger event.”
Regarding claim 13, the modified system of Adams teaches the device of claim 12, but Modified Adams is silent to “wherein the second trigger event comprises at least one of a measurement of a physiological parameter that falls within a predetermined range, a measurement of a physiological parameter that falls above or below a predetermined threshold, elapsing of a predetermined time, or completion of data transmission to an external device.”
However, Wang teaches an implantable vascular access device (see FIG. 1 and [0038]: an implantable medical device) comprising a first wireless transceiver (15, see [0039]: transceiver circuitry 15 such as Bluetooth chip) and second wireless receiver (12, see [0042]), wherein the device is configured to transition between a low-power first state and a higher-power second state (see [0040-0048]), wherein the device is configured to transition between the first state and the second state after a trigger event (see [0040-0043]: trigger event is wakeup signal received by antenna 12 from external device 2), wherein the device is configured to transition from the second state back to the first state after a second trigger event (see [0065-0066]: high powered Bluetooth communications—via transceiver 15-- turned off after predetermined programmable delay to wait for next wake up signal), wherein the second trigger event comprises at least one of a measurement of a physiological parameter that falls within a predetermined range, a measurement of a physiological parameter that falls above or below a predetermined threshold, elapsing of a predetermined time, or completion of data transmission to an external device (see [0065-0066]: predetermined time).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the electronics device comprising the low and high power states via the first and second transceivers taught by Modified Adams to transition back to the low powered state after a predetermined time as taught by Wang for the purpose of allowing the dormant and wake-up states to be selectively assumed (see [0024] and [0065-0066]), which ensure further increase in power efficiency by turning off the high powered transceiver once it is no longer needed, thus achieving “wherein the second trigger event comprises at least one of a measurement of a physiological parameter that falls within a predetermined range, a measurement of a physiological parameter that falls above or below a predetermined threshold, elapsing of a predetermined time, or completion of data transmission to an external device.”
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Adams in view of Arx as applied to claim 1 above, and further in view of Soykan et al. (U.S. PGPUB No. 2020/0352441), hereinafter Soykan.
Regarding claim 14, the modified system of Adams teaches the device of claim 1, and Adams discloses sensors of the device (see [0033-0034]), but Modified Adams is silent to “wherein, in the first state, at least one sensor has a first sampling frequency and, in the second state, the at least one sensor has a second sampling frequency greater than the first.”
However, Soykan teaches an implantable vascular access device (40, see and FIG. 5), comprising a first wireless transceiver (55, see [0056]: RF long range telemetry module) and second wireless receiver (53, see [0056]: galvanic communications module), wherein the device is configured to transition between a low-power first state and a higher-power second state (see [0082-0083]: low power galvanic vs high power RF), wherein, in the first state, at least one sensor has a first sampling frequency and, in the second state, the at least one sensor has a second sampling frequency greater than the first (see [0072-0073]: real time of high power second state vs daily/weekly/monthly sampling via galvanic/ low power first state and [0082]: lower power state of galvanic. See also [0116]: data sampling correlated to storage capacity).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sensors in the first and second states taught by Modified Adams to have a lower sampling frequency (periodic instead of real time) in the first state as taught by Soykan for the purpose of acquiring data in the low power mode to further enhance the power efficiency to extend device longevity (see [0029], [0034-0036], [0073], and [0082]), thus achieving “wherein, in the first state, at least one sensor has a first sampling frequency and, in the second state, the at least one sensor has a second sampling frequency greater than the first.”
Claims 29-30 are rejected under 35 U.S.C. 103 as being unpatentable over Arx as applied to claim 26 above, and further in view of Wang (U.S. PGPUB No. 2020/0261733).
Regarding claim 29, Arx discloses the method of claim 26, but Arx is silent to “further comprising transitioning from the second state back to the first state after a second trigger event.”
However, Wang teaches a method comprising receiving at a first wireless receiver (12, see [0042]) of an implantable monitor (see FIG. 1 and [0038]: an implantable medical device) a first signal (see [0042]); after receiving the first signal, transitioning the implantable monitor from a low-power first state to a higher-power second state (see [0040-0048]); and transmitting data over a second communication link via a second wireless transceiver (15, see [0039]: transceiver circuitry 15 such as Bluetooth chip) different from the first (15 separate from 12, see FIG. 1), wherein the device transitions between the first state and the second state after a trigger event (see [0040-0043]: trigger event is wakeup signal received by antenna 12 from external device 2), and further comprising transitioning from the second state back to the first state after a second trigger event (see [0065-0066]: high powered Bluetooth communications—via transceiver 15-- turned off after predetermined programmable delay to wait for next wake up signal).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method comprising transitioning from a first low power state to a second higher power state by a trigger event disclosed by Arx to include the step of transitioning back to the low powered state by a second trigger event as taught by Wang for the purpose of allowing the dormant and wake-up states to be selectively assumed (see [0024] and [0065-0066]), which ensure further increase in power efficiency by turning off the high powered transceiver once it is no longer needed, thus achieving “further comprising transitioning from the second state back to the first state after a second trigger event.”
Regarding claim 30, the modified system of Arx teaches the method of claim 29, but Arx is silent to “wherein the second trigger event comprises at least one of a measurement of a physiological parameter that falls within a predetermined range, a measurement of a physiological parameter that falls above or below a predetermined threshold, elapsing of a predetermined time, or completion of data transmission to an external device.”
However, Wang teaches a method comprising receiving at a first wireless receiver (12, see [0042]) of an implantable monitor (see FIG. 1 and [0038]: an implantable medical device) a first signal (see [0042]); after receiving the first signal, transitioning the implantable monitor from a low-power first state to a higher-power second state (see [0040-0048]); and transmitting data over a second communication link via a second wireless transceiver (15, see [0039]: transceiver circuitry 15 such as Bluetooth chip) different from the first (15 separate from 12, see FIG. 1), wherein the device transitions between the first state and the second state after a trigger event (see [0040-0043]: trigger event is wakeup signal received by antenna 12 from external device 2), and further comprising transitioning from the second state back to the first state after a second trigger event (see [0065-0066]: high powered Bluetooth communications—via transceiver 15-- turned off after predetermined programmable delay to wait for next wake up signal), wherein the second trigger event comprises at least one of a measurement of a physiological parameter that falls within a predetermined range, a measurement of a physiological parameter that falls above or below a predetermined threshold, elapsing of a predetermined time, or completion of data transmission to an external device (see [0065-0066]: predetermined time).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method comprising transitioning from a first low power state to a second higher power state by a trigger event disclosed by Arx to include the step of transitioning back to the low powered state by a second trigger event of an elapsing of a predetermined time as taught by Wang for the purpose of allowing the dormant and wake-up states to be selectively assumed (see [0024] and [0065-0066]), which ensure further increase in power efficiency by turning off the high powered transceiver once it is no longer needed, thus achieving “wherein the second trigger event comprises at least one of a measurement of a physiological parameter that falls within a predetermined range, a measurement of a physiological parameter that falls above or below a predetermined threshold, elapsing of a predetermined time, or completion of data transmission to an external device.”
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Arx as applied to claim 18 above, and further in view of Soykan (U.S. PGPUB No. 2020/0352441).
Regarding claim 31, Arx discloses the method of claim 18, but Arx is silent to “wherein, in the first state, at least one sensor has a first sampling frequency and, in the second state, the at least one sensor has a second sampling frequency greater than the first”.
However, Soykan teaches an implantable vascular access device (40, see and FIG. 5), comprising a first wireless transceiver (55, see [0056]: RF long range telemetry module) and second wireless receiver (53, see [0056]: galvanic communications module), wherein the device is configured to transition between a low-power first state and a higher-power second state (see [0082-0083]: low power galvanic vs high power RF), wherein, in the first state, at least one sensor has a first sampling frequency and, in the second state, the at least one sensor has a second sampling frequency greater than the first (see [0072-0073]: real time of high power second state vs daily/weekly/monthly sampling via galvanic/ low power first state and [0082]: lower power state of galvanic. See also [0116]: data sampling correlated to storage capacity).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to provide the sensors for sensing the different parameters as disclosed in Arx to have a lower sampling frequency (periodic instead of real time) in the first state as taught by Soykan for the purpose of acquiring data in the low power mode to further enhance the power efficiency to extend device longevity (see [0029], [0034-0036], [0073], and [0082]), thus achieving “wherein, in the first state, at least one sensor has a first sampling frequency and, in the second state, the at least one sensor has a second sampling frequency greater than the first”.
Conclusion
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/KATHLEEN PAIGE FARRELL/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783