DETAILED ACTION
Notice to Applicant
This communication is in response to the Request for Continued Examination (RCE) submitted September 12, 2025. Claims 10 – 11, 22, and 25 are amended. Claims 1 – 9 were previously cancelled. Claims 10 – 25 are pending.
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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 September 12, 2025 has been entered.
Claim Objections
Claim 25 is objected to because of the following informalities: Spelling error – the word “amended” is misspelled in the claim. Appropriate correction is required.
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 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.
Claim(s) 10 - 11 and 13 – 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harr et al., herein after Harr (U.S. Publication Number 2015/0305073 A1) in view of Wiesner et al., herein after Wiesner (U.S. Publication Number 2015/0070187 A1).
Claim 10 (Currently Amended). Harr teaches a method for communicating information between a plurality of medical pump devices and at least one communication device (figures 4 and 5 discloses medical device data and a communication device), the method comprising:
communicating between a server and at least one communication device (paragraph 59 discloses an inbound web server that incorporates or has access to a transceiver for communication with the relay modules over the WWAN, the medical device data received by the inbound web server over the WWAN is forwarded to a secure data storage server),
communicating between at least one medical pump device and at least one gateway connected to the server via a network connection (Figure 1; paragraph 59 discloses an inbound web server that incorporates or otherwise has access to a transceiver for communication with the relay modules over the WWAN, an outbound web server is configured to receive and qualify data retrieval requests submitted by one or more remote monitoring devices over a broad-band network (e.g. the internet) to request associated medical device data to be retrieved from the secure data storage server), and
communicating between the at least one medical pump device and the at least one communication device, the at least one medical pump device communicating directly with the at least one gateway via a low power wide area network connection (paragraph 22 discloses providing a direct physical linkage or docking of the pump with the wireless module charging base, and the charging base can have the alternate ability to receive power for wireless communication via the direct link to the pump in an ambulatory situation, indicating a pump in direct communication with the network; paragraph 57 discloses that associated with each medical device (e.g. medical pump device) is an interface circuit that includes a transceiver for transmitting and receiving signals in a facility oriented wireless network such as a Low-Rate Wireless Personal Area Networks or “LR-WPAN”, ZIGBEE network, or other low-power personal area networks such as the low power Bluetooth networks) by at least one communication module disposed internal to the at least one medical pump device (paragraph 57 discloses that the interface circuit may be contained within or disposed external to the medical device).
Harr fails to explicitly teach the following limitations met by Wiesner as cited:
the communicating between the at least one communication device and the server being independent of a low power wide area network connection (Figure 1c illustrates a medical device in direct contact with the patient device; paragraph 75 discloses one or more wireless patient devices in communication with one or more relay modules and/or medical device, indicating direct communication between the patient device and the medical device, as shown in figure 1c), and
the communicating between the at least one medical pump device and the at least one communication device being independent of a low power wide area network connection (paragraph 75 discloses one or more wireless patient devices in communication with one or more relay modules and/or medical device, indicating direct communication between the patient device and the medical device, as shown in figure 1c, which indicates communication independent of the LoRaWan, as the patient device (reference character 17) is in direct communication with the medical device (reference character 10)).
It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to expand the method of Harr to further include systems and methods for communicating between a series of medical devices and remote monitoring devices utilizing a wireless relay module for receiving communications from and transmitting communication to, a medical device as disclosed by Wiesner.
One of ordinary skill, before the effective filing date of the claimed invention, would have been motivated to expand the method of Harr in this way to provide a network architecture for centralized monitoring of medical devices using relay networks and/or internet accessible wireless communications networks having emergency call functionality to provide a secondary level of protection, and enables the approximate location of the monitored medical devices (Wiesner: paragraph 57).
Claim 11 (Currently Amended). Harr teaches a system for communicating information between a plurality of medical pump devices and at least one communication device, the system comprising:
a server to which at least one communication device is connectable (Figure 1; paragraph 59 discloses an inbound web server that incorporates or otherwise has access to a transceiver for communication with the relay modules over the WWAN, an outbound web server is configured to receive and qualify data retrieval requests submitted by one or more remote monitoring devices over a broad-band network (e.g. the internet) to request associated medical device data to be retrieved from the secure data storage server),
a low power wide area network comprising at least one gateway connected to the server via a network connection (Figure 1; paragraph 59 discloses an inbound web server that incorporates or otherwise has access to a transceiver for communication with the relay modules over the WWAN, an outbound web server is configured to receive and qualify data retrieval requests submitted by one or more remote monitoring devices over a broad-band network (e.g. the internet) to request associated medical device data to be retrieved from the secure data storage server), and
at least one medical pump device, the at least one medical pump device having at least one communication module disposed internal to the at least one medical pump device by which the at least one medical pump is connected directly to the at least one gateway via a low power wide area network connection (paragraph 22 discloses providing a direct physical linkage or docking of the pump with the wireless module charging base, and the charging base can have the alternate ability to receive power for wireless communication via the direct link to the pump in an ambulatory situation, indicating a pump in direct communication with the network; paragraph 57 discloses that associated with each medical device (e.g. medical pump device) is an interface circuit that includes a transceiver for transmitting and receiving signals in a facility oriented wireless network such as a Low-Rate Wireless Personal Area Networks or “LR-WPAN”, ZIGBEE network, or other low-power personal area networks such as the low power Bluetooth networks, and that the interface circuit may be contained within or disposed external to the medical device).
Harr fails to explicitly teach the following limitations met by Wiesner as cited:
the at least one communication device being connectable to the server independent of the low power wide area network and being connectable to the at least one medical pump device independent of a low power wide area network paragraph 75 discloses one or more wireless patient devices in communication with one or more relay modules and/or medical device, indicating direct communication between the patient device and the medical device, as shown in figure 1c, which indicates communication independent of the LoRaWan, as the patient device (reference character 17) is in direct communication with the medical device (reference character 10)).
The motivation to combine the teachings of Harr and Wiesner is discussed in the rejection of claim 10, and incorporated herein.
Claim 13 (previously presented). Harr and Wiesner teach the system according to claim 11. Harr teaches a system wherein the at least one medical pump device comprises a first communication module for establishing the low power wide area network connection to the at least one gateway (Figure 1; paragraph 59 discloses an inbound web server that incorporates or otherwise has access to a transceiver for communication with the relay modules over the WWAN, an outbound web server is configured to receive and qualify data retrieval requests submitted by one or more remote monitoring devices over a broad-band network (e.g. the internet) to request associated medical device data to be retrieved from the secure data storage server).
Claim 14 (previously presented). Harr and Wiesner teach the system according to claim 13. Harr teaches a system wherein the at least one medical pump device comprises a second communication module for establishing a communication connection to the at least one communication device (Figure 4 discloses transmitting medical device data to a second relay module; paragraph 69 discloses the processor determines whether a second relay module is accessible via the WLAN or WPAN, if the WWAN is not accessible by the transceiver of the first relay module).
Claim 15 (previously presented). Harr and Wiesner teach the system according to claim 14. Harr discloses wherein the communication connection is a Bluetooth Low Energy connection (paragraph 57 discloses Bluetooth networks).
Claim 16 (previously presented). Harr and Wiesner teach the system according to claim 14. Harr teaches a system wherein the at least one medical pump device comprises a third communication module for generating localization information (paragraph 74 discloses if the second relay module is inaccessible, the process may be repeated to search for a third relay module).
Claim 17 (previously presented). Harr and Wiesner teach the system according to claim 11. Harr discloses a system wherein the at least one medical pump device is located at a remote location from the at least one communication device (paragraph 15 discloses the wireless communication module of the docking station enables wireless communication with one or all of: a local hospital network, an intranet, an internet, and/or a remote device; paragraph 26 discloses the feeding pump may contain a wireless transmitter for communicating data, such as operating parameters and/or status, to a remote monitor over a wireless communication link, preferably utilizing cellular telephony technology to permit remote monitoring of certain pump diagnostics).
Claim 18 (previously presented). Harr and Wiesner teach the system according to claim 11. Harr teaches a system wherein the server is accessible via a web application using a communication device comprising a computer device or a mobile communication device (paragraph 59 discloses an inbound web server that incorporates or otherwise has access to a transceiver for communicating with the relay modules over the WWAN).
Claim(s) 12 and 20 – 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harr et al., herein after Harr (U.S. Publication Number 2015/0305073 A1) in view of Wiesner et al., herein after Wiesner (U.S. Publication Number 2015/0070187 A1) further in view of Augustin et al., herein after Augustin (Augustin, A., Yi, J., & Townsley, W. M. (2016). A Study of LoRa: Long Range & Low Power Networks for the Internet of Things. Sensors, 16(1466), pp 1-18)).
Claim 12 (previously presented). Harr and Wiesner teach the system according to claim 11.
Harr and Wiesner fail to explicitly teach the following limitations met by Augustin as cited:
wherein the low power wide area network connection is a LoRaWAN connection (page 4, section 2.2. discloses the basic architecture of a LoRaWAN network includes end-devices using LoRa with LoRaWAN).
It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to expand the method of Harr and Wiesner to further include independently provide a quantification and evaluation of the performance of LoRA and LoRaWAN, and based on the analysis and performance evaluation, propose possible solutions for performance enhancement as disclosed by Augustin.
One of ordinary skill, before the effective filing date of the claimed invention, would have been motivated to expand the method of Harr and Wiesner in this way as LoRaWAN provides a medium access control mechanism, enabling many end-devices to communicate with a gateway using the LoRa modulation; the LoRa modulation is proprietary, whereas the LoRaWAN is an open standard being developed by the LoRa Alliance (Augustin: page 4).
Claim 20 (Previously Presented). Harr and Wiesner teach the system according to claim 11.
Harr and Wiesner fail to explicitly teach the following limitations met by Augustin as cited:
wherein the low power wide area network connection is a long-range wide area network (LoRaWAN) (page 4, section 2.2. discloses the basic architecture of a LoRaWAN network includes end-devices using LoRa with LoRaWAN).
The motivation to combine the teachings of Harr, Wiesner, and Augustin is discussed in the rejection of claim 12, and incorporated herein.
Claim 21 (Previously Presented). Harr and Wiesner teach the system according to claim 20.
Harr and Wiesner fail to explicitly teach the following limitations met by Augustin as cited:
wherein the low power wide area network has a range of up to 40 km (page 3, paragraph 1 discloses Sigfox (a LPWAN (Low Power Wide Area Network) has a coverage area of 30 – 50 km in rural areas, thus encompassing the 40 km claimed).
The motivation to combine the teachings of Harr, Wiesner, and Augustin is discussed in the rejection of claim 12, and incorporated herein.
Claim 22 (Currently Amended). Harr and Wiesner teach the system according to claim 20.
Harr and Wiesner fail to explicitly teach the following limitations met by Augustin as cited:
wherein the low power wide area network operates around 868 MHz or around 915 MHz (page 4, paragraph 2 discloses the LoRa physical layer allows for long-range, low power and low throughput communications, and operates on the 433-, 868-, or 915 MHz bands, depending on the region in which it is deployed).
The motivation to combine the teachings of Harr, Wiesner, and Augustin is discussed in the rejection of claim 12, and incorporated herein.
Claim 23 (Previously Presented). Harr and Wiesner teach the method according to claim 10.
Harr and Wiesner fail to explicitly teach the following limitations met by Augustin as cited:
wherein the low power wide area network connection is via a long-range wide area network (LoRaWAN) (page 4, section 2.2. discloses the basic architecture of a LoRaWAN network includes end-devices using LoRa with LoRaWAN).
The motivation to combine the teachings of Harr, Wiesner, and Augustin is discussed in the rejection of claim 12, and incorporated herein.
Claim 24 (Previously Presented). Harr, Wiesner, and Augustin teach the method according to claim 23.
Harr and Wiesner fail to explicitly teach the following limitations met by Augustin as cited:
wherein the long-range wide area network has a range of up to 40 km (page 16, Conclusion discloses LoRa can offer satisfactory network coverage up to 3 km in a suburban area with dense residential dwellings, where the 3 km is included in the range claimed).
The motivation to combine the teachings of Harr, Wiesner, and Augustin is discussed in the rejection of claim 12, and incorporated herein.
Claim 25 (Currently Amended). Harr, Wiesner, and Augustin teach the method according to claim 23.
Harr and Wiesner fail to explicitly teach the following limitations met by Augustin as cited:
wherein the long-range wide area network operates around 868 MHz or around 915 MHz (page 4, paragraph 2 discloses the LoRa physical layer allows for long-range, low power and low throughput communications, and operates on the 433-, 868-, or 915 MHz bands, depending on the region in which it is deployed).
The motivation to combine the teachings of Harr, Wiesner, and Augustin is discussed in the rejection of claim 12, and incorporated herein.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harr et al., herein after Harr (U.S. Publication Number 2015/0305073 A1) in view of Wiesner et al., herein after Wiesner (U.S. Publication Number 2015/0070187 A1) further in view of Blomquist (U.S. Publication Number 2005/0246416 A1) and Kamen et al., herein after Kamen (U.S. Publication Number 2013/0191513 A1).
Claim 19 (previously presented). Harr and Wiesner teach the system according to claim 18. Harr teaches a system wherein the web application (paragraph 59 discloses an inbound web server that incorporates or otherwise has access to a transceiver for communicating with the relay modules over the WWAN) is configured to provide information relating to:
alarm conditions of the at least one medical pump device (Figures 4 and 5 disclose issuing an alarm notification by the First Relay Module).
delivery operations carried out by the at least one medical pump device (paragraph 11 discloses a centralized medical information monitoring system capable of configuring medical devices according to associations with patients and individual sites; paragraph 12 discloses the pump may contain a receiver for receiving data such as operating parameter instructions, general operating conditions, and/or commands).
Harr fails to explicitly teach the following limitations met by Wiesner as cited:
patient information (paragraph 83 discloses patient identification data from a patient in proximity to the device the uniquely identifies the patient using one of a variety of commercially available sensors).
It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to expand the method of Harr to further include systems and methods for communicating between a series of medical devices and remote monitoring devices utilizing a wireless relay module for receiving communications from and transmitting communication to, a medical device as disclosed by Wiesner.
One of ordinary skill, before the effective filing date of the claimed invention, would have been motivated to expand the method of Harr in this way to provide a network architecture for centralized monitoring of medical devices using relay networks and/or internet accessible wireless communications networks having emergency call functionality to provide a secondary level of protection, and enables the approximate location of the monitored medical devices (Wiesner: paragraph 57).
Harr and Wiesner fail to explicitly teach the following limitations met by Blomquist as cited:
maintenance information of the at least one medical pump device, pump settings and/or localization information of the at least one medical pump device (paragraph 26 discloses the pump server stores a variety of data including scheduled maintenance).
It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to expand the method of Harr and Wiesner to further include a server for medical devices, including a web browser process for communicating with a remote device and a pump interface process for communicating with a medical device as disclosed by Blomquist.
One of ordinary skill, before the effective filing date of the claimed invention, would have been motivated to expand the method of Harr and Wiesner in this to enable the programmable devices to remotely interface with the medical pumps and other medical devices (Blomquist: paragraph 35).
Harr, Wiesner, and Blomquist fail to explicitly teach the following limitations met by Kamen as cited:
treatment compliance information of delivery operations carried out by the at least one medical pump device (paragraph 530 discloses caregiver authorization can be used to ensure a particular treatment is being given to the correct patient and/or to provide compliance with given regulations).
It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to expand the method of Harr, Wiesner, and Blomquist to further include an electronic patient care system in which a module may provide an infusion pump with patient treatment parameters, such as infusion settings including an infusion rate or infusion pressure, and receive from it various operating parameters as disclosed by Kamen.
One of ordinary skill, before the effective filing date of the claimed invention, would have been motivated to expand the method of Harr, Wiesner, and Blomquist in this to improve the process of providing comprehensive care to patients including ordering and delivering medical treatments (Kamen: paragraph 26).
Response to Arguments
Applicant's arguments filed September 12, 2025 have been fully considered but they are not persuasive. The Applicant’s arguments have been addressed in the order in which they were presented.
The Applicant argues Harr fails to disclose at least one module disposed internal to the at least one medical pump device. The Examiner respectfully disagrees. The Examiner submits Harr discloses one or more medical devices are provided at a patient facility for monitoring the medical condition and/or administering medical treatment to one or more patients. Associated with each medical device is an interface circuit interface circuit that includes a transceiver for transmitting and receiving signals in a facility oriented wireless network such as, for example, a Low-Rate Wireless Personal Area Networks or "LR-WPAN," ZIGBEE network or other low-power personal area networks such as the low power Bluetooth networks, e.g., Bluetooth 2.0, existing or presently under development or consideration. In addition, the interface circuit may be contained within or disposed external to the medical device (paragraph 57). Harr further discloses relay modules as depicted in Figure 3 which further include a second transceiver for wirelessly transmitting signals to and receiving signals from an access point via a wide-area network or WWAN (wireless wide area network) (paragraph 58). Harr also discloses the relay module (Figure 3) includes a first transceiver for wirelessly communicating with interface circuits and other relay modules 30, 30a in the WLAN or WPAN network via an antenna. The relay module also includes a second transceiver for wirelessly communicating with the access point over the WWAN via an antenna (paragraph 63). The processor of the one relay module determines whether the WWAN is accessible by that relay module (paragraph 66). A status module indicates if the WWAN is accessible by the transceiver to forward the medical device data over the WWAN (paragraph 68). The wireless wide-area network (WWAN) indicates the wireless network covers large areas. Thus, Applicant’s argument is not persuasive and the rejection is maintained.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISTINE K RAPILLO whose telephone number is (571)270-3325. The examiner can normally be reached Monday - Friday 7:30 - 4 pm.
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KRISTINE K. RAPILLO
Examiner
Art Unit 3626
/KRISTINE K RAPILLO/Examiner, Art Unit 3682