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 .
Claims Status
Claims 1-20 are currently pending, claims 1, 12 and 15 are currently amended.
Response to Arguments
Applicant's arguments filed on 03/09/2026 have been fully considered but they are not persuasive.
Regarding claims 1 and 15, applicant argues that GOETZ is directed to remote management of therapy programming in which a remote networking device and monitors therapy-use patterns for purposes of therapy programming and device/feature usage and that its focus is on programming overflow rather than recharging efficiency metrics. Applicant further adds that nothing in GOETZ discloses or suggests a remote server that, upon receiving charging measurements during recharging, computes recharging-efficiency metrics, compares those metrics to server-resident thresholds or ranges, and issues patient/clinician alerts in response to a threshold miss.
The examiner respectfully disagrees and explains that GOETZ discloses a remote networking device (See Fig.1, Item#34) which acts as a server (See Par.50, discloses the remote networking device may be a server) which receives raw energy storage usage data and automatically analyzes the data and generates user actions to the IMD or to an external programming device to alert the clinician that an event took place and that an action is required (See Pars.30, 50, 69 and 90 and Figs.1 and 8, disclose power usage information that is shared with the IMD to the remote networking device include coupling efficiency [Par.69], the remote networking device receives the power usage data including coupling data and analyzes the data [interpreted to mean comparing the received coupling efficiency data with thresholds to determine if an action is required], the remote networking device then sends an action request “alert” to a clinician to retrain the patient based on the analysis, i.e. in case of a coupling efficiency lower than a threshold based on the analysis [Par.30]. The server performs the analysis and response process automatically [Par.50] and the analysis [comparison] is done at the server 34 and not at the IMD or the external programmer to preserver resources [Par.90]).
Applicant argues that Fig.8 of GOETZ that is relied on by the examiner discloses a clinician-facing usage timeline in a remote therapy-programming system where events such as a "recharge event window 107" are annotated alongside other patient/programmer interactions. The "alert 111" shown in this figure is likewise a visual annotation on that same historical display, used to draw a clinician's attention when reviewing the patient's therapy-usage history. Applicant further emphasizes that GOETZ discloses a system which looks back at past recharging events, evaluates them and marks an alert to the previous charging events if warranted to allow the clinician to understand what has previously transpired. Applicant further states that the next step is not system-triggered action but rather clinician intervention.
The examiner explains that the claim limitations do not require that the alert that is sent via the internet or the analysis to this fact are done in real time while the charging process is taking place. The claim limitations only require “…one or more measurements obtained from the IPG during the recharging, the data is sufficient to identify a charging session”. The examiner argues that power usage information including coupling efficiency between the IMD and an external charger is information that is sufficient to identify a charging session and that information is obtained from the IPG during recharging. The examiner further argues that as stated above, the server analyzes the power usage data and sends a requested action to the clinician “system-triggered action” to retrain the patient. This meets the limitations of claims 1 and 15 “send an alert via the internet to the patient and/or the clinician.”
Applicant further argues that GOETZ does not disclose a server that computes recharging-efficiency metrics, identifies charging sessions from uploaded IPG charging measurements, or compares those metrics to server-resident thresholds or acceptable ranges as the basis for an automated classification; instead, the disclosure ties the alert to clinician recognition and follow-up coaching on proper recharging technique, confirming a programming/oversight workflow rather than a cloud-analytics pipeline for charging behavior. Applicant further explains that the present application claims and describes a remote server that ingests charging data during recharging [emphasis added].
The examiner respectfully disagrees and explains that GOETZ discloses receiving raw usage data [interpreted to mean length of charge, amount of charge as shown in Fig.8], the server analyzes the data and makes a decision to send an alert to a clinician to take action or not based on the analysis and that the analysis is done at the server and not at the IMD (Pars.50 and 90. For example Fig.8 shows a charging period 107 where battery voltage rises a very small amount in a 5 hour charging period, the server analyzes and determines the charging efficiency and whether that is acceptable or not and based on that sends an action to the user). As explained above the claim limitations do not require that the remote server ingests charging data during recharging. Applicant is asked to make an amendment to clarify that limitation if this is their intention.
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) 1-2, 5-7, 9, 11-12, 15-16 and 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over GOETZ (US 2010/0222847 A1, hereinafter GOETZ).
Regarding claims 1, 11 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 an Par.50, disclose a remote networking device in the form of a server) configured to:
receive via an internet, data indicative of one or more measurements obtained from the IPG during recharging, the data including information sufficient to identify a charging session (See Fig.1, Item#32 and Par.44, disclose a network 32 which maybe an internet connection. Pars.7 and 36, disclose power usage data is sent from an IMD device 14 to an external device 26 and then through network 32 to server 34 or directly from IMD device 14 to server 34. Par.69 discloses that usage data that I shared from the IMD to the server include coupling efficiency data, the disclosure of Par.69 in addition to Fig.8 is interpreted by the examiner to be data that is obtained from the IPG during recharging. As shown in Fig.8, the usage data received by the server is sufficient for the server to identify and represent charging period 107 and 109),
identify, from the received data, one or more recharging efficiency metrics for the recharging (See Par.50, discloses the server 34 performs automatic analysis of the power usage data including coupling efficiency information received from the IMD [Par.69]. The coupling efficiency is interpreted as the recharging efficiency metric),
compare the one or more recharging efficiency metrics to one or more predetermined thresholds or ranges stored at the server (See Pars.50 and 90 disclose the server 34 performs automatic monitoring and transmission of instruction to the IMD based on the analysis. The analysis is interpreted to inherently include a comparison to an efficiency threshold in order to determine if an action is required by the clinician or not as outline in Par.30 [an alert to retrain]), and
responsive to determining that the thresholds or acceptable ranges are not met, send an alert via the internet to the patient and/or a clinician (See Par.30, discloses that remote server sends an instruction to retrain the patient due to reduced coupling).
GOETZ further discloses that the remote server “analyzes raw power usage information” and then send the instruction to the clinician, however GOETZ does not explicitly disclose the server computes, from the received data, one or more recharging efficiency metrics for the recharging.
However, the examiner explains that computing the coupling efficiency at the server instead of at the IMD would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for the benefit of preserving resources at the IMD for therapy delivery (See GOETZ, Par.90, discloses that analysis is done at the server and not at the IMD device. The examiner further explains that computing the coupling at the server is done by the IMD sending raw data comprising the length of the charging period and amount of increased charge[V2-V1]. This meets the limitation of claim 11. The idea outsourcing computation to a remote server instead of being done locally is well known is further evidenced by KOGUSI US 2024/0319286, Par.39, which discloses a server that receives battery data and determines the battery state of health).
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 as discussed above, 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 comparing or more recharging efficiency metrics to the one or more predetermined thresholds or acceptable ranges comprises identifying a charging session using the data. (See Pars.30, 85 and 90, discloses determining reduced charging efficiency by analyzing that coupling efficiency in charging area 11/7 is low. The examiner explains that a charging session is identified by analyzing that the batter voltage increases from one level to another as disclosed in Par.81).
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 the 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
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 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Drew Dunn can be reached at 571-272-2312. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AHMED H OMAR/Primary Examiner, Art Unit 2859
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