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 .
Priority: The current application has the effective filing date of 06/04/2021 according to the priority chain on the record.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/24/2026 has been entered.
Claims 1, 3-12 and 14-17 are pending; claims 2 and 13 have been cancelled, and claims 1, 7, 11-12 and 16 have been amended.
Response to Amendment
The double patenting rejection has been overcome by the Terminal Disclaimer received on 04/28/2026.
The 35 USC 112(f) is maintained.
As for the 35 USC 103 rejections, new grounds of rejections are made below in view of the newly added claim features.
Claim Rejections - 35 USC § 103
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.
Claims 1, 3-10, 12 and 14-17 are rejected under 35 U.S.C. 103 as being unpatentable over Haller et al. US 7,149,773 B2 (hereinafter “Haller”, previously cited) and in view of Drew US 2013/0283030 A1 (hereinafter “Drew”, previously cited), and further in view of Mass et al. US 2009/0062887 A1 (hereinafter “Mass”).
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Regarding claim 1, Haller teaches system (Figs. 6B-6C) comprising at least one medical device (7) (IMD 10), a remote monitoring server (RMS, 1) (remote computer system 120) and at least one patient remote device (PR, 5) (communication module 100/mobile telephone or PDA 110), wherein the PR is configured to establish a first bidirectional communication connection (12, 14) of the PR and the RMS (see Fig. 6C; and col.7, ll.21-col.8, ll.45 two way communication between 100/110 and 120) and a second bidirectional communication connection (13, 14) of the PR and medical device (see Fig. 6C, and col.7, ll.21-col.8, ll.45 two way communication between 100/110 and 10), wherein the PR is further configured to manage remote processes associated with the medical device comprising remote interrogation of the medical device and remote programming of the medical device using the second bidirectional communication connection (col.8, ll.6-25 see (j)-(l), 100/110 is capable of relaying real-time programming/feedback information from the server 120 to the IMD 10, and capable of receiving physiological data and device interrogation/performance data to then relay back to the server 120) as well as data exchange with the RMS (130) concerning one or both of:
interrogation data (col.19, ll.65, col.20, ll.1 “IMD 10 may be interrogated directly by patient 5, or may be interrogated remotely by remote system 130 via communication module 100 and mobile telephone 110.”), or
program data with regard to the chosen medical device using the first bidirectional communication connection. (col.38, ll.21-28 “IMD 10 and/or communication module 100/mobile telephone or PDA 110, contact a physician or specialist indicated in a database of remote system 130 as being patient 5's emergency contact to request that the physician or specialist review data or reports provided by the system of the present invention and subsequently adjust the operating parameters of IMD 10. Or IMD 10 may be re-programmed with new software or algorithms in response to review and analysis of information obtained remotely from IMD 10.”);
wherein the system further comprises at least one health care professional (HCP) remote device (CP, 3) (Fig. 6B: remote computer system 131 and/or 131'), wherein the at least one CP is configured to establish a third bidirectional communication connection (11, 14) (Fig. 6B: 137’ and 137’’) of the at least one CP (131, 131’) and the RMS (1) (130) in order to provide one or both of:
(i) additional real-time remote programming (col.19, ll.35-53 physicians 135/136 utilizes the CP, i.e. 131’/131’’ for real-time remote communication with patient’s device 110 or IMD 10; also see col.36, ll.1-7 “emote system 130 or remote health care provider 136 initiates communication for patient monitoring, clinical study monitoring, therapeutic, clinical outcome study or other purposes to thereby minimize unnecessary patient-physician or patient-hospital interaction.”), or
(ii) interrogation of the medical device using the at least one CP via the RMS and one PR (5) corresponding to the medical device. (col.19, ll.35-53, and col.36, ll.61-col.37, ll.6 physician can be 131’/131’’ to interrogate the patient’s device 100 or IMD 10 for sensor data).
Haller further discloses wherein the RMS is configured to perform a validity check on program data received to determine if the program data complies with a predefined structural format before transmitting the program data to the medical device. (See Figs. 12B and 12C and col.43, ll.44- col.44, ll.46; the server 130, at least, checking whether software/firmware application (to be transmitted/uploaded to the IMD 10) complies with regulatory requirements associated with the IMD. Haller’s approval with respect to government and regulatory requirements as discussed here is taken to encompass “predefined structural format” in the claim). The approved software/firmware programs are then transmitted form the RMS, to the PR, and finally installed at the implantable medical device. Although Haller does not teach wherein the validity check is performed at the PR, it would have been an obvious design choice for a person to do so at the time of invention, because it is common practice to distribute processing functionalities amongst various computing components within a telemetry system, and Haller has certainly demonstrated that the PR has communications properties and computing capabilities to performed the discussed validity checks prior to updating the programming in the IMD, see Haller col.28, ll,.47-55 and col.38, ll.46-col.38, ll.11. Alternatively, Drew, a prior art reference in the analogous art of reprogramming an implantable medical device by an external programmer (see Abstract). Drew, Figs. 3-4 illustrates a communication process between an IMD and external programmer (interpreted as “PR” in this claim), wherein the external programmer has processing feature of creating restoration points, validating and/or invalidating therapy configurations that are compatible with the IMD, see [0073, 0075, 0077, 0094-0100]. It would have been obvious to modify Haller in view of Drew, such that the validity checks taught in Haller’s RMS is performed in the PR, because Drew has shown that that an external programmer can be configured to have the communication and processing capability to carry application validity checks.
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Haller teaches continuous and real-time data communications between a remote expert data center, remote computer, and/or remote health care provider or health care provider and the communication module via a mobile telephone (col.8, ll.21-27); but Haller does not teach wherein the medical device, the PR, the RMS and the CP are configured to autonomously maintain a continuous connection to its respective neighbor of a bidirectional communication connection. Mass, another prior art reference in the analogous art of in the analogous field of telemetric medical monitoring. Mass teaches a communications system (Figs.1A-1B, [0053-0054]) comprising implantable sensors (Fig.1: 13, 17A, 17B), patient communicator (Fig.1:19), server (200), and physician’s device (21, 23, 25, 27). Mass teaches bidirectional communications link between the various devices as shown in Fig. 1A and also in Fig. 3. Mass further discloses autonomous pairing between the server, patient and physicians’ devices as shown in Figs. 4C and 4D, see [0232-0233]. It would have been obvious to a person of ordinary skill in the art at the time of invention to modify Haller to include autonomously maintain a continuous connection in view of Mass, the motivation for doing so is because autonomous pairing is useful in a plurality of ways including: directly shipping a medical device to a patient, allow re-pairing between the medical device and patient remote device without patient interferences, and also to avoid losing information by reinstating communication between devices (Mass [0232]).
Regarding claim 3, Haller further teaches the system of claim 1, wherein the system is configured to maintain one or more of: (i) the first communication connection, (ii) the second communication connection, or (iii) the third communication connection as a continuous communicationsee Figs. 6B and 6C; and col.8, ll.21-27 “…(m) use of a highly flexible and adaptable communications scheme to promote continuous and preferably real-time data communications between a remote expert data center, remote computer, and/or remote health care provider or health care provider and the communication module via a mobile telephone…”)
Regarding claim 4, Haller modified teaches the system of claim 3, Haller and Drew do not explicitly teach wherein the system is configured such that the continuous communication connections are maintained until a close signal is sent from one or both of: (i) the one CP (3) to the chosen medical device via the RMS (1) and the corresponding PR (5), or (ii) one PR to the connected medical device and the RMS. However, Haller teaches the communications network utilizes telephone/internet communications network (col.18, ll.46-58, col.19, ll16-21), and that the server 130 can transmit remedial action to control/change the operations of the patient’s device 100 and IMD 10 (col.33, ll.16-25, col.40, ll.2-5). Further, it is common knowledge that a PDA or cellphone 100/100, and a computer server 130 can disconnect from a known telephone/internet communications network. As such, it would have been obvious to a person of ordinary skill in the art at the time of invention to modify Haller such that the RMS (server 130) can transmit a close signal to the PR (patient device 100/110), the motivation for doing so is such that a server would be able to disconnect from the patient devices in case of data corruption, and/or to end patient care.
Regarding claim 5, Haller further teaches the system of claim 1, wherein the at least one PR (5) is a smartphone. (100/110 is a PDA or mobile phone, this is sufficient to encompass “smartphone” recited in this claim based on the functionality of 100/110 discussed in col.30, ll. 7-col.31, ll.43, including communication, visual and audio input/output, processing and interactive capabilities)
Regarding claim 6, Haller further teaches the system of claim 1, wherein the at least one PR (5) (PDA 100/110) is configured to monitor and control incoming and outgoing communication data with regard to the second bidirectional communication connection. (As shown in Fig.6C, PDA 100/110 controls the uplink, i.e. “relay or store and relay”, and downlink, i.e. “reception of action & advice”; also see col.25, ll.34-40)
Regarding claim 7, Haller teaches the system of claim 1, wherein the at least one PR (5) (100/110) provides a user interface platform (col.22, ll.1-22, col.31, ll.4-17 PDA 100/110 has a under interface 108, this is taken to encompass “user interface platform”) configured to one or more of:
i) intervene in the management of remote processes in the at least one PR by the patient,
(ii) intervene in management of remote processes in the at least one PR by the HCP,
(iii) control the management of remote processes in the at least one PR by the patient, or
(iv) control the management of remote processes in the at least one PR by the HCP. (col.35, ll.,41-col.36, ll.15, col.39, ll.51-84, col.41, ll.43-47 PDA 100/110 has a display and keyboard that allows a user to receive and input information, including health monitoring, e.g. receive alerts, and for communicating with physician/call ambulance etc.; these are taken to encompass limitations (i) to (iv) as recited in this claim. Alternatively, see Figs. 9A-9C, patient device 100/110 initiates communication with either server 130, or HCP 131’)
Regarding claim 8, Haller further teaches the system of claim 1, wherein the management of remote processes in the at least one PR (5) (100/110) comprises a validity check on a program for remote programming of the medical device (7) (10). (col.8, ll.35-44 data integrity checks; col.8, ll.56-59 debugging data, as shown in Fig. 12B-12C)
Regarding claim 9, Haller further teaches the system of claim 1, wherein the at least one PR (5) (100/110) is configured to support one or both of video call functionality or audio call functionality simultaneously with displaying interrogation data of the medical device (7). (see col.43, ll.7-21 voice and video communications, and col.38, ll.19-38 interrogating data)
Regarding claim 10, Haller further teaches the system of claim 1, wherein, prior to or during establishing the second communication connection between the RMS (1) (130) and the corresponding PR (5) (100/110), the RMS is configured to send a push notification to the corresponding PR thereby triggering this PR to poll the RMS at a faster rate. (col.7, ll.36-40, col.22, ll.23-39 handshake protocol, and setting communication frequency as continuous, relative continuous or intermittent; see col.30, ll.49-54)
Regarding claim 12, these claims are rejected by Haller in view of Drew and Mass under the same rationale as discussed to claim 1 above.
Regarding claim 14, Haller teaches a computer program product comprising instructions which, when executed by at least one processing unit of the PR, cause the at least one processing unit to perform the steps of the method according to claim 12. (See col.9, ll.8-24 software for maintaining the communication module is remotely maintained. Alternatively, as shown in Figs. 6B-6C, the communication’s method is carried out by computer-based devices which individually include a processing unit; as such it is sufficient to encompass “computer program product” recited in this claim)
Regarding claim 15, Haller further teaches computer readable data carrier storing a computer program product according to claim 14. (See rejection to claim 14 above.)
Regarding claim 16, Haller further teaches the system of claim 1, wherein the at least one PR (5) (100/110) is configured to provide one or more of: (i) patient surveys (col.35, ll.42-53 displaying messages and question to a patient), (ii) patient information push to the HCP (Figs. 9A-9C, col.38, ll.63-67, col.39, ll.19-28, patient information push to the provider based on schedule or detected event), or (iii) patient appointment requests. (col.6, ll.48-51, col.21, ll.58, col.40, ll. 11-21 patient using PDA 100 to contact health care provider/physician)
Regarding claim 17, Haller further teaches the system of claim 1, wherein the at least one PR (5) (100/110) is configured to one or both of: (i) restrict pre-defined built-in functionality of the at least one PR, or (ii) prohibit pre-defined built-in functionality of the at least one PR. (col.37, ll.51-53 “…IMD functionalities or features can be enabled or disabled in IMD 10.”; col.44, ll.29-34 disable or defer updates or changes to operation)
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Haller, Drew and Mass as applied to claim 1 above, and further in view of Kumar US 2017/0120062 A1.
Regarding claim 11, Haller modified teaches the system of claim 1, wherein for remote programming of the chosen medical device the CP (3) (131’/131’’) is configured to produce a single program (this is interpreted as treatment regimen/program) containing the one or both of updates or changes of the medical device's parameters and to transmit the single program to the medical device via the RMS (1) (130) and the corresponding PR, wherein the RMS is configured to encrypt the single program received from the CP (131’/131’’) (col.34, ll.34-51, col.38, ll.16-35, col.45, ll.49-60, col.46, ll.51-col.47, ll.5, a physician can send entire prescribed treatment protocol or updates/changes to previously prescribed treatment protocol via the server 130 to the patient’s device 100/110 and IMD 10; these are taken to encompass both “updates or changes” as recited in this claim). Haller does not disclose wherein the corresponding PR (5) (100/110) is configured to transmit the encrypted single program to the chosen medical device (10).
Kumar, another prior art reference in the analogous art of remote programming and monitoring of an implantable device over a communications network (see Figs.1-2), discloses a system comprising a PR (204), RMS (210), medical device (150) and CP (208), and wherein the communication of data between these various components are encrypted so as to comply with data security requirements ([0051-0052]). It would have been obvious to a person of ordinary skill in the art at the time of invention to modify Haller so as to encrypt all data transmission between devices in view of Kumar, this is necessary in order to comply with medical data security requirements, i.e. HIPAA.
Conclusion
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/SHIRLEY X JIAN/ Primary Examiner, Art Unit 3792
June 10, 2026
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