DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 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.
Claim(s) 1-2, 5-7, 9, 12, 15-16 and 18-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by GOETZ (US 2010/0222847 A1, hereinafter GOETZ).
Regarding claims 1 and 15 (claim 1 is considered representative for limitation matching purposes), GOETZ discloses a cloud-based system for monitoring recharging of a rechargeable battery of an implantable pulse generator (IPG), wherein the IPG is configured to be implanted in a patient, the system comprising:
a remote server (See Fig.1, Item#34 and Par.50, disclose a remote networking device in the form of a server) configured to:
receive via internet, data indicative of one or more measurements obtained from the IPG during the recharging (See Fig.1, discloses network 32, Par.44, discloses network 32 maybe internet connection. Pars.7 and 36, disclose power usage information is sent from the IMD device 14 to the external device 26 and through network 32 to server 34. Par.50 discloses the server automatically performs analysis of the received data),
use the data to determine if one or more recharging efficiency metrics is outside of a predetermined range (See Fig.8 and Par.85, disclose determining if the coupling efficiency during a recharging window is low -i.e. charging efficiency metric is lower than a threshold- and indicate it as low coupling efficiency as in 11-7 charging window of Figure 8), and
if one or more recharging efficiency metrics is outside of the predetermined range, send an alert via internet to the patient and/or a clinician (See Par.85, discloses providing an alert to the clinician that a low coupling efficiency).
Regarding claims 2 and 16 (claim 2 is considered representative for limitation matching purposes), GOETZ discloses the system of claim 1 as discussed above, wherein receiving data indicative of one or more measurements obtained from the IPG during the recharging, comprises receiving the data from a patient’s remote controller (RC) associated with the IPG (See Fig.1, Item#26 and Par.28, discloses external device 26 transmit information to the server 34. Par.34 discloses external device 26 acts as an access point between the IMD 14 and the server 34).
Regarding claims 5 and 18 (Claim 5 is considered representative for limitation matching purposes), GOETZ discloses the system of claim 1, wherein the data indicative of one or more measurements obtained from the IPG during the recharging comprises one or more of: time stamps, IPG battery voltage measurements (See Par.30, discloses an over discharged power source i.e. low voltage measurement), IPG temperatures, and IPG battery charge currents.
Regarding claims 6 and 19 (Claim 6 is considered representative for limitation matching purposes), GOETZ discloses the system of claim 1 a discussed above, wherein the one or more recharging efficiency metrics comprises a duration of charging (See Par.69, discloses the information sent to the server comprising length of charging).
Regarding claim 7, GOETZ discloses the system of claim 1 as discussed above, wherein the one or more recharging efficiency metrics comprises a frequency of charging (See Par.36, discloses the data provided comprising frequency of charging events).
Regarding claim 9, GOETZ discloses the system of claim 1 as discussed above, wherein the one or more recharging efficiency metrics comprises alignment of an external charging coil with a charging coil configured within the IPG (See Fig.8 and Par.85, disclose determining if the coupling efficiency during a recharging window is low).
Regarding claim 12, GOETZ discloses the system of claim 1 as discussed above, wherein determining if one or more recharging efficiency metrics is outside of a predetermined range comprises identifying a charging session using the data (See Par.85, discloses a reduced charging efficiency by identifying that coupling efficiency in charging area 11/7 is low. Par.69 also discloses identifying the frequency of charging events this implicitly indicates that the charging events are detected in order to determine how frequent they are repeated).
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.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over GOETZ.
Regarding claim 11, GOETZ discloses the system of claim 1 as discussed above, GOETZ further discloses transmitting usage information such as charging duration (See Par.69, discloses the information sent to the server comprising length of charging). However, GOETZ does not disclose wherein the one or more recharging efficiency metrics comprises an initial battery voltage value when charging is initiated.
The examiner explains that even though initial battery voltage is not explicitly disclosed, the rate of change of voltage over time (how much charge was received over a specified period of time. Rate of charge of voltage is calculated as Voltage after a period of time V2 minus an initial voltage V1 divided over the time period (V2-V1)/T) is a well-known indicator of the charging efficiency, and it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the invention disclosed by GOETZ by detecting the charging efficiency based on initial voltage instead of based on coupling efficiency for the benefit of simplifying the charging efficiency detection process.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over GOETZ in view of CHUNG et al. (US 2016/0064991 A1, hereinafter CHUNG).
Regarding claim 13, GOETZ discloses the system of claim 12 as discussed above, However, GOETZ does not explicitly disclose wherein identifying a charging session is based on one or more of identifying a change in battery voltage as a function of time, identifying a charging current, and identifying the presence of an external magnetic field.
CHUNG discloses a wireless power receiving device identifying a charging session based on the presence of a magnetic field (See Fig.2, stepS200 and Par.55).
GOETZ and CHUNG are analogous art since they both deal with wireless charging.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the invention disclosed by GOETZ with the teachings of CHUNG by detecting the presence of a magnetic field to mark the starting of the beginning of a charging session for he benefit of accurately detecting the charging efficiency.
Claim(s) 3-4 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over GOETZ in view of BEVAN et al. (US 2010/0125174 A1, hereinafter BEVAN).
Regarding claim 3, GOETZ discloses the system of claim 2 as discussed above, However, GOETZ does not disclose wherein the RC comprises a smartphone.
BEVAN discloses a remote support system for an implantable medical device, the support system comprising an external device comprising a smartphone for receiving measurement data from the implantable medical device (See Fig.6, Item#606 and Pars.29 and 34, disclose a cellphone for processing and displaying IMD data, cellphone communicates with a server 610 to provide the data to it).
GOETZ and BEVAN are analogous art since they both deal with remote monitoring for implantable medical devices.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the invention disclosed by GOETZ with the teachings of BEVAN by using a smartphone for transmitting data to the server for further analysis for the benefit of providing an external device which can perform several function instead of a dedicated external device(A smartphone is able to provide a plurality of functions using multiple applications instead of a dedicated medical external device).
Regarding claims 4 and 17 (claim 4 is considered representative for limitation matching purposes), GOETZ and BEVAN disclose the system of claim 3 as discussed above, wherein the smartphone comprises a medical device application (MDA) configured to periodically send the data to the remote server (See BEVAN, Fig.6, Item#606 and Pars.29 and 34, disclose a cellphone for processing and displaying IMD data, cellphone communicates with a server 610 to provide the data to it. Pars.30-31, The smartphone disclosed by BEVAN implicitly uses a software/application to receive the data to process it as display it on the GUI 620. GOETZ further discloses the data is periodically sent [Par.28, The power source usage information may be transmitted upon a scheduled time]).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over GOETZ in view of ANNECCHINO et al. (US 2023/0148877 A1, hereinafter ANNECCHINO).
Regarding claim 8, GOETZ discloses the system of claim 1 as discussed above, However, GOETZ does not disclose wherein the one or more recharging efficiency metrics comprises battery health.
ANNECCHINO discloses an implantable medical device therapy optimization wherein the battery of the implantable medical device provides information comprising battery health (See 82).
GOETZ and ANNECCHINO are analogous art since they both deal with remote monitoring for implantable medical devices.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the invention disclosed by GOETZ with the teachings of ANNECCHINO by transferring battery health information for the benefit of further estimating the length of time the battery of the implantable medical device remains operational before it needs to be replaced.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over GOETZ in view of OZAKI (US 2018/0136048 A1, hereinafter OZAKI).
Regarding claim 10, GOETZ discloses the system of claim 9 as discussed above, However, GOETZ does not disclose wherein determining alignment of the external charging coil with the charging coil comprises using temperature data from the IPG.
OZAKI discloses a wireless charging system wherein determining alignment of the external charging coil with the charging coil comprises using temperature data (See Abstract discloses that when misalignment between the transmitting coil and the receiving coil increases, the temperature increases).
GOETZ and OZAKI are analogous art since they both deal with wireless charging.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the invention disclosed by GOETZ with the teachings of OZAKI by using temperature detecting to determine alignment for the benefit of providing an alignment detection system which also protects against damage caused by overheating.
14. Claim(s) 14 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over GOETZ in view of SULLIVAN et al. (US 2016/0135706 A1, hereinafter SULLIVAN).
Regarding claims 14 and 20 (claim 14 is considered representative for limitation matching purposes), GOETZ discloses the system of claim 1 as discussed above, However, GOETZ does not disclose wherein sending an alert via internet to the patient and/or a clinician comprises sending an alert to the patient’s RC.
SULLIVAN discloses an implanted medical device comprising an external device which communicates with the implantable medical device, the external device is further used to display alerts to the patient (See Pars.500 and 514).
GOETZ and SULLIVAN are analogous art since they both deal with wireless charging.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the invention disclosed by GOETZ with the teachings of SULLIVAN by sending an alert via internet to the patient by sending an alert to the patient’s RC for the benefit of providing a warning system to the user that charging efficiency is less than optimal such that the user takes remedial action.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AHMED H OMAR whose telephone number is (571)270-7165. The examiner can normally be reached 10:00 am -7:00 PM EST.
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/AHMED H OMAR/Examiner, Art Unit 2859
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