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 .
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.
Double Patenting
The non-statutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A non-statutory double patenting rejection is appropriate where the claims at issue are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a non-statutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
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Claims 1-20 are rejected on the ground of non-statutory double patenting over claims 1-18 of U.S. Patent No. 12233240 since the claims, if allowed, would improperly extend the “right to exclude” already granted in the patent.
The subject matter claimed in the instant application is fully disclosed in the patent and is covered by the patent since the patent and the application are claiming common subject matter, as follows:
Claims 1-3, 6-20 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 12233240 (hereinafter referred to as Michaud)
Regarding claim 1, Michaud teaches a method of coordinating wireless communications in an infusion pump system including an infusion pump, a remote control device for remotely controlling the infusion pump, and a continuous glucose monitoring (CGM) system (Claim 1)
A method of coordinating wireless communications in an infusion pump system including an infusion pump, a remote control device for remotely controlling the infusion pump, and a continuous glucose monitoring system, comprising: establishing communications between the infusion pump and the continuous glucose monitoring system to enable the continuous glucose monitoring system to transmit CGM data to the infusion pump; determining therapy parameters with the infusion pump utilizing the CGM data; determining, by the remote control device, that the infusion pump is no longer receiving the CGM data communicated by the continuous glucose monitoring system; receiving the CGM data from the continuous glucose monitoring system at the remote control device only when it has been determined by the remote control device that that the infusion pump is no longer receiving the CGM data; and relaying the CGM data received from the continuous glucose monitoring system from the remote control device to the infusion pump to enable the infusion pump to continue to determine therapy parameters utilizing the CGM data while the infusion pump is no longer receiving the CGM data from the continuous glucose monitoring system; wherein determining that the infusion pump is no longer receiving the CGM data includes the remote control device communicating with the infusion pump at regular intervals to determine if the infusion pump is receiving the CGM data.[Cl-1]
Michaud also teaches enabling the CGM system to transmit CGM data to the infusion pump via a wireless communication; determining that the infusion pump is no longer receiving the CGM data communicated by the CGM system, based at least in part by the remote control device communicating with the infusion pump at regular intervals to determine if the infusion pump is receiving the CGM data (Claim 1)
A method of coordinating wireless communications in an infusion pump system including an infusion pump, a remote control device for remotely controlling the infusion pump, and a continuous glucose monitoring system, comprising: establishing communications between the infusion pump and the continuous glucose monitoring system to enable the continuous glucose monitoring system to transmit CGM data to the infusion pump; determining therapy parameters with the infusion pump utilizing the CGM data; determining, by the remote control device, that the infusion pump is no longer receiving the CGM data communicated by the continuous glucose monitoring system; receiving the CGM data from the continuous glucose monitoring system at the remote control device only when it has been determined by the remote control device that that the infusion pump is no longer receiving the CGM data; and relaying the CGM data received from the continuous glucose monitoring system from the remote control device to the infusion pump to enable the infusion pump to continue to determine therapy parameters utilizing the CGM data while the infusion pump is no longer receiving the CGM data from the continuous glucose monitoring system; wherein determining that the infusion pump is no longer receiving the CGM data includes the remote control device communicating with the infusion pump at regular intervals to determine if the infusion pump is receiving the CGM data.[Cl-1]
Furthermore, Michaud teaches receiving the CGM data from the CGM system at the remote control device; and relaying the CGM data received from the CGM system by the remote control device to the infusion pump to enable the infusion pump to continue to determine therapy parameters utilizing the CGM data while the infusion pump is no longer receiving the CGM data from the CGM system (Claim 1)
A method of coordinating wireless communications in an infusion pump system including an infusion pump, a remote control device for remotely controlling the infusion pump, and a continuous glucose monitoring system, comprising: establishing communications between the infusion pump and the continuous glucose monitoring system to enable the continuous glucose monitoring system to transmit CGM data to the infusion pump; determining therapy parameters with the infusion pump utilizing the CGM data; determining, by the remote control device, that the infusion pump is no longer receiving the CGM data communicated by the continuous glucose monitoring system; receiving the CGM data from the continuous glucose monitoring system at the remote control device only when it has been determined by the remote control device that that the infusion pump is no longer receiving the CGM data; and relaying the CGM data received from the continuous glucose monitoring system from the remote control device to the infusion pump to enable the infusion pump to continue to determine therapy parameters utilizing the CGM data while the infusion pump is no longer receiving the CGM data from the continuous glucose monitoring system; wherein determining that the infusion pump is no longer receiving the CGM data includes the remote control device
communicating with the infusion pump at regular intervals to determine if the infusion pump is receiving the CGM data.[Cl-1]
Here, we see Michaud teaching the limitations of the applicants invention, however Michaud’s teaching includes limitations such as determining that the infusion pump is no longer receiving the CGM data includes the remote control device communicating with the infusion pump at regular intervals to determine if the infusion pump is receiving the CGM data.
Despite the added limitations of Michaud’s teaching, the broader scope of the pending application is still taught in Michaud’s inventive entity, thereby it is obvious to one of ordinary skill in the art the pending application infringes of Michaud’s existing pattern.
Regarding claim 2, Michaud teaches determining that the infusion pump is no longer receiving the CGM data includes the infusion pump communicating to the remote control device that the infusion pump is no longer receiving the CGM data (Claim 2)
The method of claim 1, wherein determining that the infusion pump is no longer receiving the CGM data includes the infusion pump communicating to the remote control device that the infusion pump is no longer receiving the CGM data.[Cl-2]
Regarding claim 3, Michaud teaches determining that the infusion pump is no longer receiving the CGM data includes the CGM system communicating to the remote control device that the infusion pump is no longer receiving the CGM data.
The method of claim 1, wherein determining that the infusion pump is no longer receiving the CGM data includes the continuous glucose monitoring system communicating to the remote control device that the infusion pump is no longer receiving the CGM data.[Cl-3]
Regarding claim 6, Michaud teaches determining that the infusion pump has resumed receiving the CGM data from the CGM system; and ceasing relaying the CGM data from the CGM system by the remote control device to the infusion pump(Claim 5)
The method of claim 1, further comprising determining that the infusion pump has resumed receiving the CGM data from the continuous glucose monitoring system and ceasing relaying the CGM data from the continuous glucose monitoring system from the remote control device to the infusion pump.[Cl-5]
Regarding claim 7, Michaud teaches the remote control device is at least one of: a dedicated remote control designed for use with the infusion pump; a multi-purpose consumer electronic device; or a smartphone. (Claims 6-8)
The method of claim 1, wherein the remote control device is a dedicated remote control designed for use with the infusion pump.[Cl-6]
The method of claim 1, wherein the remote control device is a multi-purpose consumer electronic device.[C7]
The method of claim 1, wherein the remote control device is a smartphone.[Cl-8]
Regarding claim 8, Michaud teaches a method of coordinating wireless communications in an infusion pump system including an infusion pump, a remote control device for remotely controlling the infusion pump, and a continuous glucose monitoring (CGM) system (Claim 9)
A method of coordinating wireless communications in an infusion pump system including an infusion pump, a remote control device for remotely controlling the infusion pump, and a continuous glucose monitoring system, comprising: monitoring, by the remote control device, a connection between the infusion pump and the continuous glucose monitoring system to determine whether the infusion pump is receiving CGM data from the continuous glucose monitoring system; determining, by the remote control device, that the infusion pump is not receiving the CGM data from the continuous glucose monitoring system; receiving the CGM data from the continuous glucose monitoring system only when it has been determined the remote control device that the infusion pump is no longer receiving the CGM data; and relaying the CGM data received from the continuous glucose monitoring system to the infusion pump; wherein determining that the infusion pump is no longer receiving the CGM data includes the remote control device communicating with the infusion pump at regular intervals to determine if the infusion pump is receiving the CGM data [Cl-9]
Michaud then teaches monitoring, by the remote control device, a connection between the infusion pump and the CGM system to determine whether the infusion pump is receiving CGM data from the CGM system, based at least in part by the remote control device communicating with the infusion pump at regular intervals to determine if the infusion pump is receiving the CGM data (Claim 9)
A method of coordinating wireless communications in an infusion pump system including an infusion pump, a remote control device for remotely controlling the infusion pump, and a continuous glucose monitoring system, comprising: monitoring, by the remote control device, a connection between the infusion pump and the continuous glucose monitoring system to determine whether the infusion pump is receiving CGM data from the continuous glucose monitoring system; determining, by the remote control device, that the infusion pump is not receiving the CGM data from the continuous glucose monitoring system; receiving the CGM data from the continuous glucose monitoring system only when it has been determined the remote control device that the infusion pump is no longer receiving the CGM data; and relaying the CGM data received from the continuous glucose monitoring system to the infusion pump; wherein determining that the infusion pump is no longer receiving the CGM data includes the remote control device communicating with the infusion pump at regular intervals to determine if the infusion pump is receiving the CGM data [Cl-9]
Michaud then teaches determining, by the remote control device, that the infusion pump is not receiving the CGM data from the CGM system; receiving the CGM data from the CGM system at the remote control device; and relaying the CGM data received from the CGM system by the remote control device to the infusion pump (Claim 9)
A method of coordinating wireless communications in an infusion pump system including an infusion pump, a remote control device for remotely controlling the infusion pump, and a continuous glucose monitoring system, comprising: monitoring, by the remote control device, a connection between the infusion pump and the continuous glucose monitoring system to determine whether the infusion pump is receiving CGM data from the continuous glucose monitoring system; determining, by the remote control device, that the infusion pump is not receiving the CGM data from the continuous glucose monitoring system; receiving the CGM data from the continuous glucose monitoring system only when it has been determined the remote control device that the infusion pump is no longer receiving the CGM data; and relaying the CGM data received from the continuous glucose monitoring system to the infusion pump; wherein determining that the infusion pump is no longer receiving the CGM data includes the remote control device communicating with the infusion pump at regular intervals to determine if the infusion pump is receiving the CGM data [Cl-9]
Here, we see Michaud teaching the limitations of the applicants invention, however Michaud’s teaching includes more specific limitations such as receiving the CGM data from the continuous glucose monitoring system only when it has been determined the remote control device that the infusion pump is no longer receiving the CGM data; and relaying the CGM data received from the continuous glucose monitoring system to the infusion pump.
Despite the added limitations of Michaud’s teaching, the broader scope of the pending application is still taught in Michaud’s inventive entity, thereby it is obvious to one of ordinary skill in the art the pending application infringes of Michaud’s existing pattern
Regarding claim 9, Michaud teaches monitoring the connection between the infusion pump and the CGM system includes receiving a communication from the infusion pump indicating that the infusion pump is no longer receiving the CGM data. (Claim 10)
The method of claim 9, wherein monitoring a connection between the infusion pump and the continuous glucose monitoring system includes receiving a communication from the infusion pump indicating that the infusion pump is no longer receiving the CGM data.[Cl-10]
Regarding claim 10, Michaud teaches monitoring the connection between the infusion pump and the CGM system includes receiving a communication from the CGM system indicating that the infusion pump is no longer receiving the CGM data.(Claim 11)
The method of claim 9, wherein monitoring a connection between the infusion pump and the continuous glucose monitoring system includes receiving a communication from the continuous glucose monitoring system indicating that that the infusion pump is no longer receiving the CGM data.[Cl-11]
Regarding claim 11, Michaud teaches receiving the CGM data from the CGM system includes only receiving the CGM data when it has been determined that the infusion pump is not receiving the CGM data. (Claim 1)
A method of coordinating wireless communications in an infusion pump system including an infusion pump, a remote control device for remotely controlling the infusion pump, and a continuous glucose monitoring system, comprising: establishing communications between the infusion pump and the continuous glucose monitoring system to enable the continuous glucose monitoring system to transmit CGM data to the infusion pump; determining therapy parameters with the infusion pump utilizing the CGM data; determining, by the remote control device, that the infusion pump is no longer receiving the CGM data communicated by the continuous glucose monitoring system; receiving the CGM data from the continuous glucose monitoring system at the remote control device only when it has been determined by the remote control device that that the infusion pump is no longer receiving the CGM data; and relaying the CGM data received from the continuous glucose monitoring system from the remote control device to the infusion pump to enable the infusion pump to continue to determine therapy parameters utilizing the CGM data while the infusion pump is no longer receiving the CGM data from the continuous glucose monitoring system; wherein determining that the infusion pump is no longer receiving the CGM data includes the remote control device communicating with the infusion pump at regular intervals to determine if the infusion pump is receiving the CGM data.[Cl-1]
Regarding claim 12, Michaud teaches relaying communications from the infusion pump to the CGM system via the remote control device.(Claim 1)
A method of coordinating wireless communications in an infusion pump system including an infusion pump, a remote control device for remotely controlling the infusion pump, and a continuous glucose monitoring system, comprising: establishing communications between the infusion pump and the continuous glucose monitoring system to enable the continuous glucose monitoring system to transmit CGM data to the infusion pump; determining therapy parameters with the infusion pump utilizing the CGM data; determining, by the remote control device, that the infusion pump is no longer receiving the CGM data communicated by the continuous glucose monitoring system; receiving the CGM data from the continuous glucose monitoring system at the remote control device only when it has been determined by the remote control device that that the infusion pump is no longer receiving the CGM data; and relaying the CGM data received from the continuous glucose monitoring system from the remote control device to the infusion pump to enable the infusion pump to continue to determine therapy parameters utilizing the CGM data while the infusion pump is no longer receiving the CGM data from the continuous glucose monitoring system; wherein determining that the infusion pump is no longer receiving the CGM data includes the remote control device communicating with the infusion pump at regular intervals to determine if the infusion pump is receiving the CGM data.[Cl-1]
Regarding claim 13, Michaud teaches determining that the infusion pump has resumed receiving the CGM data from the CGM system; and ceasing relaying the CGM data received from the CGM system to the infusion pump.(Claim 5)
The method of claim 1, further comprising determining that the infusion pump has resumed receiving the CGM data from the continuous glucose monitoring system and ceasing relaying the CGM data from the continuous glucose monitoring system from the remote control device to the infusion pump.[Cl-5]
Regarding claim 14, Michaud teaches the remote control device is at least one of: a dedicated remote control designed for use with the infusion pump; a multi-purpose consumer electronic device; or a smartphone (Claims 6-8)
The method of claim 1, wherein the remote control device is a dedicated remote control designed for use with the infusion pump.[Cl-6]
The method of claim 1, wherein the remote control device is a multi-purpose consumer electronic device.[Cl-7]
The method of claim 1, wherein the remote control device is a smartphone.[Cl-8]
Regarding claim 15, Michaud teaches a control device configured to control an infusion pump, the control device comprising: a processor in a wireless communication with the infusion pump and a continuous glucose monitoring (CGM) system (Claim 1, 17)
A method of coordinating wireless communications in an infusion pump system including an infusion pump, a remote control device for remotely controlling the infusion pump, and a continuous glucose monitoring system, comprising: establishing communications between the infusion pump and the continuous glucose monitoring system to enable the continuous glucose monitoring system to transmit CGM data to the infusion pump; determining therapy parameters with the infusion pump utilizing the CGM data; determining, by the remote control device, that the infusion pump is no longer receiving the CGM data communicated by the continuous glucose monitoring system; receiving the CGM data from the continuous glucose monitoring system at the remote control device only when it has been determined by the remote control device that that the infusion pump is no longer receiving the CGM data; and relaying the CGM data received from the continuous glucose monitoring system from the remote control device to the infusion pump to enable the infusion pump to continue to determine therapy parameters utilizing the CGM data while the infusion pump is no longer receiving the CGM data from the continuous glucose monitoring system; wherein determining that the infusion pump is no longer receiving the CGM data includes the remote control device communicating with the infusion pump at regular intervals to determine if the infusion pump is receiving the CGM data.[Cl-1]
A control device configured to control an infusion pump system including an infusion pump, the control device comprising: a processor configured to wireless communicate with the infusion pump system and a continuous glucose monitoring system, and execute a plurality of operations associated with controlling the infusion pump such that the processor is configured to: monitor a connection between the infusion pump and the continuous glucose monitoring system to determine whether the infusion pump is receiving CGM data from the continuous glucose monitoring system; determine that the infusion pump is not receiving the CGM data from the continuous glucose monitoring system; receive the CGM data from the continuous glucose monitoring system only when it has been determined that the infusion pump is no longer receiving the CGM data; and relay the CGM data received from the continuous glucose monitoring system to the infusion pump; wherein determining that the infusion pump is no longer receiving the CGM data includes the remote control device communicating with the infusion pump at regular intervals to determine if the infusion pump is receiving the CGM data.[Cl-17]
Michaud teaches the processor is configured to monitor a connection between the infusion pump and the CGM system to determine whether the infusion pump is receiving CGM data from the CGM system, based at least in part by communicating with the infusion pump at regular intervals to determine if the infusion pump is receiving the CGM data (Claims 1, 17)
A method of coordinating wireless communications in an infusion pump system including an infusion pump, a remote control device for remotely controlling the infusion pump, and a continuous glucose monitoring system, comprising: establishing communications between the infusion pump and the continuous glucose monitoring system to enable the continuous glucose monitoring system to transmit CGM data to the infusion pump; determining therapy parameters with the infusion pump utilizing the CGM data; determining, by the remote control device, that the infusion pump is no longer receiving the CGM data communicated by the continuous glucose monitoring system; receiving the CGM data from the continuous glucose monitoring system at the remote control device only when it has been determined by the remote control device that that the infusion pump is no longer receiving the CGM data; and relaying the CGM data received from the continuous glucose monitoring system from the remote control device to the infusion pump to enable the infusion pump to continue to determine therapy parameters utilizing the CGM data while the infusion pump is no longer receiving the CGM data from the continuous glucose monitoring system; wherein determining that the infusion pump is no longer receiving the CGM data includes the remote control device communicating with the infusion pump at regular intervals to determine if the infusion pump is receiving the CGM data.[Cl-1]
A control device configured to control an infusion pump system including an infusion pump, the control device comprising: a processor configured to wireless communicate with the infusion pump system and a continuous glucose monitoring system, and execute a plurality of operations associated with controlling the infusion pump such that the processor is configured to: monitor a connection between the infusion pump and the continuous glucose monitoring system to determine whether the infusion pump is receiving CGM data from the continuous glucose monitoring system; determine that the infusion pump is not receiving the CGM data from the continuous glucose monitoring system; receive the CGM data from the continuous glucose monitoring system only when it has been determined that the infusion pump is no longer receiving the CGM data; and relay the CGM data received from the continuous glucose monitoring system to the infusion pump; wherein determining that the infusion pump is no longer receiving the CGM data includes the remote control device communicating with the infusion pump at regular intervals to determine if the infusion pump is receiving the CGM data.[Cl-17]
Furthermore, Michaud teaches determine that the infusion pump is not receiving the CGM data from the CGM system; receive the CGM data from the CGM system; and relay the CGM data received from the CGM system to the infusion pump (Claim 1, 17)
A method of coordinating wireless communications in an infusion pump system including an infusion pump, a remote control device for remotely controlling the infusion pump, and a continuous glucose monitoring system, comprising: establishing communications between the infusion pump and the continuous glucose monitoring system to enable the continuous glucose monitoring system to transmit CGM data to the infusion pump; determining therapy parameters with the infusion pump utilizing the CGM data; determining, by the remote control device, that the infusion pump is no longer receiving the CGM data communicated by the continuous glucose monitoring system; receiving the CGM data from the continuous glucose monitoring system at the remote control device only when it has been determined by the remote control device that that the infusion pump is no longer receiving the CGM data; and relaying the CGM data received from the continuous glucose monitoring system from the remote control device to the infusion pump to enable the infusion pump to continue to determine therapy parameters utilizing the CGM data while the infusion pump is no longer receiving the CGM data from the continuous glucose monitoring system; wherein determining that the infusion pump is no longer receiving the CGM data includes the remote control device communicating with the infusion pump at regular intervals to determine if the infusion pump is receiving the CGM data.[Cl-1]
A control device configured to control an infusion pump system including an infusion pump, the control device comprising: a processor configured to wireless communicate with the infusion pump system and a continuous glucose monitoring system, and execute a plurality of operations associated with controlling the infusion pump such that the processor is configured to: monitor a connection between the infusion pump and the continuous glucose monitoring system to determine whether the infusion pump is receiving CGM data
from the continuous glucose monitoring system; determine that the infusion pump is not receiving the CGM data from the continuous glucose monitoring system; receive the CGM data from the continuous glucose monitoring system only when it has been determined that the infusion pump is no longer receiving the CGM
data; and relay the CGM data received from the continuous glucose monitoring system to the infusion pump; wherein determining that the infusion pump is no longer receiving the CGM data includes the remote control
device communicating with the infusion pump at regular intervals to determine if the infusion pump is receiving the CGM data[Cl-17]
Here, we see Michaud teaching the limitations of the applicants invention, however Michaud’s teaching includes more specific limitations such as determining therapy parameters with the infusion pump utilizing the CGM data as well as execute a plurality of operations associated with controlling the infusion pump
such that the processor is configured to: monitor a connection between the infusion pump and the continuous glucose monitoring system
Despite the added limitations of Michaud’s teaching, the broader scope of the pending application is still taught in Michaud’s inventive entity, thereby it is obvious to one of ordinary skill in the art the pending application infringes of Michaud’s existing pattern.
Regarding claim 16, Michaud teaches the connection between the infusion pump and the CGM system is monitored based at least in part by receiving a communication from the infusion pump indicating that the infusion pump is no longer receiving the CGM data (Claim 2)
The method of claim 1, wherein determining that the infusion pump is no longer receiving the CGM data includes the infusion pump communicating to the remote control device that the infusion pump is no longer receiving the CGM data.[Cl-2]
Regarding claim 17, Michaud teaches the connection between the infusion pump and the CGM system is monitored based at least in part by receiving a communication from the CGM system indicating that the infusion pump is no longer receiving the CGM data (Claim 3)
The method of claim 1, wherein determining that the infusion pump is no longer receiving the CGM data includes the continuous glucose monitoring system communicating to the remote control device that the infusion pump is no longer receiving the CGM data.[Cl-3]
Regarding claim 18, Michaud teaches the CGM data is received from the CGM system only when it has been determined that the infusion pump is not receiving the CGM data (Claim 17)
A control device configured to control an infusion pump system including an infusion pump, the control device comprising: a processor configured to wireless communicate with the infusion pump system and a continuous glucose monitoring system, and execute a plurality of operations associated with controlling the
infusion pump such that the processor is configured to: monitor a connection between the infusion pump and the continuous glucose monitoring system to determine whether the infusion pump is receiving CGM data from the continuous glucose monitoring system; determine that the infusion pump is not receiving the CGM
data from the continuous glucose monitoring system; receive the CGM data from the continuous glucose monitoring system only when it has been determined that the infusion pump is no longer receiving the CGM
data; and relay the CGM data received from the continuous glucose monitoring system to the infusion pump; wherein determining that the infusion pump is no longer receiving the CGM data includes the remote control
device communicating with the infusion pump at regular intervals to determine if the infusion pump is receiving the CGM data[Cl-17]
Regarding claim 19, Michaud teaches the processor is further configured to relay communications from the infusion pump to the CGM system (Claim 4)
The method of claim 1, further comprising relaying with the remote control device communications from the infusion pump to the continuous glucose monitoring system while the infusion pump is no longer receiving the CGM data from the continuous glucose monitoring system. [Cl-4]
Regarding claim 20, Michaud teaches the processor is further configured to determine that the infusion pump has resumed receiving the CGM data from the CGM system; and cease relaying the CGM data received from the CGM system to the infusion pump (Claim 5)
The method of claim 1, further comprising determining that the infusion pump has resumed receiving the CGM data from the continuous glucose monitoring system and ceasing relaying the CGM data from the continuous glucose monitoring system from the remote control device to the infusion pump.[Cl-5]
Claim 4, 5 is rejected on the ground of non-statutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12233240 (hereinafter referred to as Michaud) in view of Jollota (US 20110149759 A1).
Regarding claim 4, Michaud fails to teach specifically receiving the CGM data from the CGM system at the remote control device includes the remote control device only receiving the CGM data when it has been determined that the infusion pump is no longer receiving the CGM data.
Jollota on the other hand teaches receiving the CGM data from the CGM system at the remote control device includes the remote control device only receiving the CGM data when it has been determined that the infusion pump is no longer receiving the CGM data.
Jollota teaches the rerouting or the relay of communication data between medical devices, such that if data communication between two medical devices is lost, the communication maybe reroute through other node medical devices to the desired device destination (Paragraphs 37, 39, 40 76, 77, Jollota)
A plurality of wireless devices in the local infusion system 102 can be arranged and configured to operate in any suitable network topology. For example, the wireless devices may be arranged in a star network topology, a mesh network configuration, a tree network topology, an ad-hoc network topology, or the like. In this regard, FIG. 2 is a diagram that depicts four wireless devices arranged in a star network configuration 200 having a beacon-transmitting wireless device 202 and three listening wireless devices 204, 206, 208. This exemplary star network configuration 200 is shown here for ease of description, and is not intended to limit or otherwise restrict the scope of the disclosed subject matter.[P-39]
In the star network configuration 200, the designated beacon-transmitting wireless device 202 may be referred to as the "hub" or "coordinator" device, where the beacon-transmitting wireless device 202 generates and transmits wireless beacons 210, which can be received by the designated listening wireless devices 204, 206, 208. For this implementation, listening wireless devices 204, 206, 208 do not generate or transmit wireless beacons. Moreover, the beacon-transmitting wireless device 202 can directly communicate with any of the listening wireless devices 204, 206, 208 (as represented by the solid arrows 212 in FIG. 2). When functioning as the hub or coordinator device, the beacon-transmitting wireless device 202 facilitates communication between the listening wireless devices 204, 206, 208 by acting as a wireless repeater, router, or redirector with or without modifications to facilitate such communication. For example, the solid arrow 214 in FIG. 2 schematically illustrates the manner in which the beacon-transmitting wireless device 202 can wirelessly route data between the listening wireless device 204 and the listening wireless device 206. Notably, for this implementation the listening wireless devices 204, 206, 208 are unable to directly communicate with each other in the star network configuration 200. Rather, the beacon-transmitting wireless device 202 must be utilized as the wireless router between the listening wireless devices 204, 206, 208.[P-40]
Although not required of all embodiments, this example assumes that the coordinator device keeps track of missed pings (that are normally expected from the end node device), which could be an indication of poor wireless channel quality. In this regard, the coordinator device could detect loss of wireless synchronization with the end node device, based upon missed pings. For example, if the coordinator device detects that it has missed at least a threshold number of expected pings (as indicated by the ping schedule), then it might conclude that it has lost wireless synchronization with the end node device. Accordingly, the coordinator device may utilize or maintain a counter (such as the counter/timer 316 depicted in FIG. 3) for missed pings, and process 400 may initialize a missed ping count (task 412) for the initial wireless channel. Although not required, this description assumes that the missed ping count is initialized to a count of zero.[P-76]
If the coordinator device fails to receive an expected ping (query task 414), then process 400 increments the missed ping count (task 416) by some amount. For this simple example, task 416 increments the missed ping count by one. If the currently held missed ping count exceeds a threshold count value (query task 418), then the coordinator device will cease the sending of wireless beacons on the initial wireless channel (task 420) and enter a diagnostic or test mode (task 422). The threshold count value used during query task 418 is chosen such that it accurately reflects conditions that can be attributed to loss of wireless synchronization. If the threshold count value has not been exceeded, then process 400 may return to query task 414 to monitor for more missed pings. This example relates to an implementation where the coordinator device considers consecutive or sequential missed pings (although an embodiment could alternatively monitor for missed pings that occur during a specified time period, whether or not they are consecutive). Therefore, if process 400 subsequently determines that an expected ping has not been missed (the "no" branch of query task 414), then the missed ping count is initialized again.[P-77]
Thereby in conjunction with Michaud’s teaching of a remote control device of a main control unit capable of detecting the disconnection of wireless communication between a the infusion pump and CGM system medical device and another device [Cl-1], then it is obvious to one of ordinary skill in the art to configure receiving the CGM data from the CGM system at the remote control device, when it has been determined that the infusion pump is no longer receiving the CGM data.
It is therefore obvious to one of ordinary skill in the art during the time of the filing date of the said invention, to combine Jollota’s teaching with Michaud’s teaching in order to enable the continuous communication of medical devise int the event of disrupted connection.
Regarding claim 5, Michaud fails to explicitly teach relaying communications from the infusion pump to the CGM system via the remote control device while the infusion pump is no longer receiving the CGM data from the CGM system.
Jollota teaches relaying communications from the infusion pump to the CGM system via the remote control device while the infusion pump is no longer receiving the CGM data from the CGM system.
Jollota teaches the rerouting or the relay of communication data between medical devices, such that if data communication between two medical devices is lost, the communication maybe reroute through other node medical devices to the desired device destination (Paragraphs 37, 39, 40 76, 77, Jollota)
As shown in FIG. 1, the local infusion system 102 is capable of establishing many potential communication paths between the local devices. In certain embodiments, a controller device (e.g., the remote control device 134, the command display controller 138, or the monitor 140) may serve as a translator between the infusion pump 128 and the other components of the local infusion system 102, such as the BG meter 136. For example, the controller device may have the ability to determine how best to translate data received from the infusion pump 128 for compatibility with the display requirements of a destination device within the local infusion system 102. As depicted in FIG. 1, the infusion pump 128 may communicate directly with the BG meter 136. In some embodiments, the local infusion system 102 may include multiple controllers that can communicate with the infusion pump 128. In other embodiments, only one controller device can communicate with the infusion pump 128 at any given moment. The controller device functionality may also be integrated into the infusion pump 128 in some embodiments. In yet another embodiment, the BG meter 136 may be integrated into the controller device such that both features share a single device housing.[P-37]
A plurality of wireless devices in the local infusion system 102 can be arranged and configured to operate in any suitable network topology. For example, the wireless devices may be arranged in a star network topology, a mesh network configuration, a tree network topology, an ad-hoc network topology, or the like. In this regard, FIG. 2 is a diagram that depicts four wireless devices arranged in a star network configuration 200 having a beacon-transmitting wireless device 202 and three listening wireless devices 204, 206, 208. This exemplary star network configuration 200 is shown here for ease of description, and is not intended to limit or otherwise restrict the scope of the disclosed subject matter.[P-39]
In the star network configuration 200, the designated beacon-transmitting wireless device 202 may be referred to as the "hub" or "coordinator" device, where the beacon-transmitting wireless device 202 generates and transmits wireless beacons 210, which can be received by the designated listening wireless devices 204, 206, 208. For this implementation, listening wireless devices 204, 206, 208 do not generate or transmit wireless beacons. Moreover, the beacon-transmitting wireless device 202 can directly communicate with any of the listening wireless devices 204, 206, 208 (as represented by the solid arrows 212 in FIG. 2). When functioning as the hub or coordinator device, the beacon-transmitting wireless device 202 facilitates communication between the listening wireless devices 204, 206, 208 by acting as a wireless repeater, router, or redirector with or without modifications to facilitate such communication. For example, the solid arrow 214 in FIG. 2 schematically illustrates the manner in which the beacon-transmitting wireless device 202 can wirelessly route data between the listening wireless device 204 and the listening wireless device 206. Notably, for this implementation the listening wireless devices 204, 206, 208 are unable to directly communicate with each other in the star network configuration 200. Rather, the beacon-transmitting wireless device 202 must be utilized as the wireless router between the listening wireless devices 204, 206, 208.[P-40]
Although not required of all embodiments, this example assumes that the coordinator device keeps track of missed pings (that are normally expected from the end node device), which could be an indication of poor wireless channel quality. In this regard, the coordinator device could detect loss of wireless synchronization with the end node device, based upon missed pings. For example, if the coordinator device detects that it has missed at least a threshold number of expected pings (as indicated by the ping schedule), then it might conclude that it has lost wireless synchronization with the end node device. Accordingly, the coordinator device may utilize or maintain a counter (such as the counter/timer 316 depicted in FIG. 3) for missed pings, and process 400 may initialize a missed ping count (task 412) for the initial wireless channel. Although not required, this description assumes that the missed ping count is initialized to a count of zero.[P-76]
If the coordinator device fails to receive an expected ping (query task 414), then process 400 increments the missed ping count (task 416) by some amount. For this simple example, task 416 increments the missed ping count by one. If the currently held missed ping count exceeds a threshold count value (query task 418), then the coordinator device will cease the sending of wireless beacons on the initial wireless channel (task 420) and enter a diagnostic or test mode (task 422). The threshold count value used during query task 418 is chosen such that it accurately reflects conditions that can be attributed to loss of wireless synchronization. If the threshold count value has not been exceeded, then process 400 may return to query task 414 to monitor for more missed pings. This example relates to an implementation where the coordinator device considers consecutive or sequential missed pings (although an embodiment could alternatively monitor for missed pings that occur during a specified time period, whether or not they are consecutive). Therefore, if process 400 subsequently determines that an expected ping has not been missed (the "no" branch of query task 414), then the missed ping count is initialized again.[P-77]
Thereby one of ordinary skill in the art may obviously configure the relay capability of the medical device mesh network to configure receiving the CGM data from the CGM system at the remote control device, when it has been determined that the infusion pump is no longer receiving the CGM data.
It is therefore obvious to one of ordinary skill in the art during the time of the filing date of the said invention, to combine Jollota’s teaching with Michaud’s teaching in order to enable the continuous communication of medical devise int the event of disrupted connection.
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.
Claim 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kamen et al. (US 20150011970 A1) in view of Yagyu et al. (JP 2013081128 A), Zhang et al. (CN 204951875 U), and Jollota (US 20110149759 A1).
In regards to claim 1, Kamen teaches a method of coordinating wireless communications in an infusion pump system including an infusion pump, a remote control device for remotely controlling the infusion pump and a continuous glucose monitoring system (Paragraph 10).
Some embodiments of this aspect of the invention may include one or more of the following. Wherein the first medical device is an infusion pump. Wherein the first remote interface is a medical device data system. Wherein the second remote interface is not a medical device data system. Wherein the system further comprising a blood glucose meter in communication with the second remote interface. Wherein the system further comprising a continuous glucose monitor transmitter in communication with the second remote interface. Wherein the first remote interface receives a command related to the communication of safety critical information to the first medical device, displays a message that the communication of the safety critical information to the first medical device requires confirmation using the second remote interface, sends the communication to the second remote interface, and once confirmation received by the second remote interface, the second remote interface communicates the command to the first medical device. Wherein the first remote interface receives an input of information related to the delivery by the infusion pump of a bolus volume of infusible fluid, displays a message that the delivery of the bolus volume requires confirmation using the second remote interface, and once confirmation received by the second remote interface, the second remote interface communicates the information required for the delivery of the bolus volume of infusible fluid to the infusion pump.[P-10]
Furthermore, Kamen teaches enabling the CGM system to transmit CGM data to the infusion pump via a wireless communication (Paragraph 18).
Some embodiments of this aspect of the invention may include one or more of the following. Where the first medical device is an infusion pump; wherein the first medical device further includes at least one disposable portion and at least two reusable portions, each of the two reusable portions configured to connect to the at least one disposable portion; wherein the charging device configured to receive at least one of the at least two reusable portions of the first medical device; wherein the second medical device including a continuous glucose monitor system including at least one transmitter wherein the at least one transmitter in wireless communication with the first medical device; wherein the second medical device including a blood glucose meter in wireless communication with the first medical device; wherein the first medical device and the remote interface are paired using near field communication; wherein the first medical device and the second medical device are paired using near field communication.[P-18]
Kamen fails to teach determining that the infusion pump is no longer receiving the CGM data communicated by the CGM system, based at least in part by the remote control device communicating with the infusion pump at regular intervals to determine if the infusion pump is receiving the CGM data
Yagyu on the other hand teaches determining that the pump is no longer receiving CGM data communicated by the continuous glucose monitoring system, receiving the CGM data from the continuous glucose monitoring system(Page 2, Paragraph 3; Page 8, Paragraphs 4-5),
FIG. 1 is a diagram illustrating a configuration example of a wireless communication system according to the present embodiment and an outline of an operation in the wireless communication method according to the present embodiment. As an example, the wireless communication system shown in FIG. 1 is an information collecting device that collects information obtained from the hub 1 that is an information aggregating device and sensors (such as a heart rate monitor and a blood glucose meter) attached to itself. , 4. Hub 1 collects information collected by Nodes 2, 3, and 4 by establishing individual connections with Nodes 2, 3, and 4 and individually communicating with them. Nodes 2 and 3 operate as an information collection device (Node) that notifies Hub 1 of information collected by itself, and can also operate as a relay Node having a function as a relay device. Note that Node 4 operates as an information collection device (Node) that notifies Hub 1 of information collected by itself, and does not have a function as a relay device. [Pg 2, P-3]
As described above, in the present embodiment, when communication between Hub 1 and Node 4 is interrupted, Node 2 and Node 3 that can operate as relay Nodes search for Node 4 where communication is disconnected. Thereafter, the specific Node that has discovered Node 4 notifies Hub 1 to that effect and transmits broadcast information to Node 4 by unicast. And Node4 which received alerting | reporting information requests | requires the start of relay communication to Hub1 via the said specific Node, Hub1 allocates the communication band between an own apparatus-specific Node, and between specific Node-Node4, and relay communication of Instructed to start. Thereafter, relay communication is performed between Hub 1 and Node 4 via the specific node. Thus, in this embodiment, only the relay node that has discovered Node 4 that has lost communication with Hub 1 transmits broadcast information, and the relay Node that has not found Node 4 does not transmit broadcast information. . Thereby, the relay Node of a present Example can reduce the power consumption concerning transmission of alerting | reporting information conventionally. [Pg 8, P-4]
In addition, conventionally, all relay nodes periodically transmit broadcast information, and when transmitting broadcast information, the broadcast information is transmitted and waiting for reception of a relay start request after the broadcast information is transmitted. Occupied the bandwidth. On the other hand, in the present embodiment, only the relay node that has discovered Node 4 that has lost communication with Hub 1 transmits broadcast information, so that it occupies in order to transmit broadcast information compared to the conventional case. It is possible to greatly reduce the bandwidth to be used. [Pg 8, P-5]
It would therefore be obvious to a person of ordinary skill in the art before the effective filing of the invention to combine Yagyu’s teaching with Kamen’s teaching in order to continuously maintain the communication with the glucose monitoring device despite the loss of communication with one transitional medical device accordingly.
Kamen modified fails to teach the determined lost data connection being based at least in part by the remote control device communicating with the infusion pump at regular intervals to determine if the infusion pump is receiving the CGM data
Zhang on the other hand teaches a remote control device of a main control unit capable of detecting the disconnection of wireless communication between a ventilator device and the main control unit (Page 2, Last Paragraph; Page 4, Paragraph 3).
The utility model claims respirator provides a remote alarm device, remote alarming device by short-distance wireless communication module communication with the respirator, thereby adjusting and controlling ventilator. and without requiring the patient or walking near the ventilator operating respirator; on the other hand, when the machine has fault, the wireless communication channel of the respirator is disconnected from remote alarm device, alarm module of the remote alarm device to the main control module detects that the short-range wireless communication channel is disconnected, starting alarm. so as to wake the patient, prevent patient does not obtain the air continuously and resentment[Pg 2, Last Pgph]
remote control warning device 100 having an alarm function, the alarm module 8 may include an audio module and/or a vibration module, the alarm module 8 may be any one of the following or the combination: a speaker, buzzer, vibrating motor matched with the audio alarm module, remote control warning device side of the shell 100 is provided with a sound hole 102, when the host 200 fails to stop operation, wireless communication channel can be disconnected, remote control warning device 100 of the main control module 5 detects that the wireless communication channel is disconnected. control alarm module 8 starts the alarm to send out warning sound prompt or vibration indication. The utility model has the remote control function and alarming module are combined together so that the user of the remote terminal can find alarm prompt.[Pg 4, P-3]
Thereby it is obvious to one of ordinary skill to use Zhang’s disconnection detection means with Kamen modified’s teaching via Yagyu of a relay communication is performed between Hub 1 and Node 4 via the specific node, only when the relay/specific node that has discovered Node 4 that has lost communication with Hub 1 transmits broadcast information, (page 8, Paragraphs 4-5). Zhang’s teaching being the detection means to initiate the relay communication mode to avoid operation disruption due to loss of communication.
Since the claim language lacks the clarification as to how the remote control device is specific to the infusion pump and the CGM system, then one can reasonably interpret the system to merely be a communication network that is monitored by a remote control device.
It would therefore be obvious to a person of ordinary skill in the art before the effective filing of the invention to combine Zhang’s teaching with Kamen modified’s in order to securely ensure continuous communication is maintained between medical devices in order to enable the appropriate operation of the medical devices.
Though Kamen modified via Yagyu teaches the relay of communication data between medical devices , the combination is not specific to relaying the CGM data received from the CGM system by the remote control device to the infusion pump to enable the infusion pump to continue to determine therapy parameters utilizing the CGM data while the infusion pump is no longer receiving the CGM data from the CGM system.
Jollota on the other hand teaches the relay of communication data between medical devices , the combination is not specific to relaying the CGM data received from the CGM system by the remote control device to the infusion pump to enable the infusion pump to continue to determine therapy parameters utilizing the CGM data while the infusion pump is no longer receiving the CGM data from the CGM system. (Paragraphs 37, 39, 40 76, 77)
A plurality of wireless devices in the local infusion system 102 can be arranged and configured to operate in any suitable network topology. For example, the wireless devices may be arranged in a star network topology, a mesh network configuration, a tree network topology, an ad-hoc network topology, or the like. In this regard, FIG. 2 is a diagram that depicts four wireless devices arranged in a star network configuration 200 having a beacon-transmitting wireless device 202 and three listening wireless devices 204, 206, 208. This exemplary star network configuration 200 is shown here for ease of description, and is not intended to limit or otherwise restrict the scope of the disclosed subject matter.[P-39]
In the star network configuration 200, the designated beacon-transmitting wireless device 202 may be referred to as the "hub" or "coordinator" device, where the beacon-transmitting wireless device 202 generates and transmits wireless beacons 210, which can be received by the designated listening wireless devices 204, 206, 208. For this implementation, listening wireless devices 204, 206, 208 do not generate or transmit wireless beacons. Moreover, the beacon-transmitting wireless device 202 can directly communicate with any of the listening wireless devices 204, 206, 208 (as represented by the solid arrows 212 in FIG. 2). When functioning as the hub or coordinator device, the beacon-transmitting wireless device 202 facilitates communication between the listening wireless devices 204, 206, 208 by acting as a wireless repeater, router, or redirector with or without modifications to facilitate such communication. For example, the solid arrow 214 in FIG. 2 schematically illustrates the manner in which the beacon-transmitting wireless device 202 can wirelessly route data between the listening wireless device 204 and the listening wireless device 206. Notably, for this implementation the listening wireless devices 204, 206, 208 are unable to directly communicate with each other in the star network configuration 200. Rather, the beacon-transmitting wireless device 202 must be utilized as the wireless router between the listening wireless devices 204, 206, 208.[P-40]
Although not required of all embodiments, this example assumes that the coordinator device keeps track of missed pings (that are normally expected from the end node device), which could be an indication of poor wireless channel quality. In this regard, the coordinator device could detect loss of wireless synchronization with the end node device, based upon missed pings. For example, if the coordinator device detects that it has missed at least a threshold number of expected pings (as indicated by the ping schedule), then it might conclude that it has lost wireless synchronization with the end node device. Accordingly, the coordinator device may utilize or maintain a counter (such as the counter/timer 316 depicted in FIG. 3) for missed pings, and process 400 may initialize a missed ping count (task 412) for the initial wireless channel. Although not required, this description assumes that the missed ping count is initialized to a count of zero.[P-76]
If the coordinator device fails to receive an expected ping (query task 414), then process 400 increments the missed ping count (task 416) by some amount. For this simple example, task 416 increments the missed ping count by one. If the currently held missed ping count exceeds a threshold count value (query task 418), then the coordinator device will cease the sending of wireless beacons on the initial wireless channel (task 420) and enter a diagnostic or test mode (task 422). The threshold count value used during query task 418 is chosen such that it accurately reflects conditions that can be attributed to loss of wireless synchronization. If the threshold count value has not been exceeded, then process 400 may return to query task 414 to monitor for more missed pings. This example relates to an implementation where the coordinator device considers consecutive or sequential missed pings (although an embodiment could alternatively monitor for missed pings that occur during a specified time period, whether or not they are consecutive). Therefore, if process 400 subsequently determines that an expected ping has not been missed (the "no" branch of query task 414), then the missed ping count is initialized again.[P-77]
Here, Jollota elaborates on a mesh network of medical devices such that a reconfigurable hierarchy of communication channels of a coordinator facilitating communication protocol between devices including acting as a relay/repeater device between two other medical devices, one being the end node (Remote control device (134), BG Meter (136), Infusion Pump (128)) [P-39,40]. Furthermore, Jollota teaches the hierarchy of communication can be reconfigurable as far as which device is the coordinator (conducting direct communication with one device or a relay repeater from a second device to an end node), the second device and end node[P-41, 56]. Jollota then teaches ping calls between device channels to establish communication between the said medical devices. When a threshold number of pings expires such that communication is lost between any two devices, a different channel of communication is established via another device[P-75, 81, 88].
It would therefore be obvious to a person of ordinary skill in the art before the effective filing of the invention to combine Jollota’s teaching with Kamen’s in order to continuously monitor glucose whilst using an infusion pump.
In regards to claim 2, Kamen modified teaches determining that the infusion pump is no longer receiving the CGM data includes the infusion pump communicating to the remote control device that the infusion pump is no longer receiving the CGM data. (Paragraph 436, Kamen).
Referring now also to FIG. 35E, in some embodiments, the mini-remote interface 3500 and a remote interface 3512 may each be used to control an infusion pump 3502 and/or one or more additional device/medical devices 3504, 3506. In some embodiments of this embodiment of the system, the mini-remote interface 3500 may "trump" and therefore, if the remote interface 3512 and the mini-remote interface 3500 were simultaneously both within communication distance with the infusion pump 3502 and/or the one or more devices/medical devices 3504, 3506, then the mini-remote interface 3500 would be the device that may communicate with the infusion pump 3502 and/or the one or more devices/medical devices 3504, 3506. In some embodiments, the mini-remote interface 3500 and the remote interface 3512 may communicate and synchronize information at pre-programmed intervals and/or when within a pre-programmed communication distance, for example, when the mini-remote interface 3500 and the remote interface 3512 recognize that they are within communication distance and/or an interval of time has passed since the last synchronization, the mini-remote interface 3500 and the remote interface 3512 may synchronize using a synchronization protocol which may be any synchronization protocol. The mini-remote interface 3500 and the remote interface 3512 may also pair using the various protocols described and discussed herein.[P-436]
Here we see Kamen describe the communication of the remote control interface with the infusion pump as well as other medical devices during intervals.
When considered with Zhang’s teaching of a remote control device of a main control unit capable of detecting the disconnection of wireless communication between a ventilator device and the main control unit [P-2, Last Pgrph; Pg-4, P-3], then it is obvious to one of ordinary skill in the art to be able to detect the disconnection of the communication of CGM data at the infusion pump, based on the intervals of communication with the infusion pump
In regards to claim 3, Kamen modified teaches determining that the infusion pump is no longer receiving the CGM data includes the CGM system communicating to the remote control device that the infusion pump is no longer receiving the CGM data. (Paragraph 436, Kamen)
Referring now also to FIG. 35E, in some embodiments, the mini-remote interface 3500 and a remote interface 3512 may each be used to control an infusion pump 3502 and/or one or more additional device/medical devices 3504, 3506. In some embodiments of this embodiment of the system, the mini-remote interface 3500 may "trump" and therefore, if the remote interface 3512 and the mini-remote interface 3500 were simultaneously both within communication distance with the infusion pump 3502 and/or the one or more devices/medical devices 3504, 3506, then the mini-remote interface 3500 would be the device that may communicate with the infusion pump 3502 and/or the one or more devices/medical devices 3504, 3506. In some embodiments, the mini-remote interface 3500 and the remote interface 3512 may communicate and synchronize information at pre-programmed intervals and/or when within a pre-programmed communication distance, for example, when the mini-remote interface 3500 and the remote interface 3512 recognize that they are within communication distance and/or an interval of time has passed since the last synchronization, the mini-remote interface 3500 and the remote interface 3512 may synchronize using a synchronization protocol which may be any synchronization protocol. The mini-remote interface 3500 and the remote interface 3512 may also pair using the various protocols described and discussed herein.[P-436]
Here we see Kamen describe the communication of the remote control interface with one or more medical devices during intervals.
When considered with Zhang’s teaching of a remote control device of a main control unit capable of detecting the disconnection of wireless communication between a ventilator device and the main control unit [P-2, Last Pgrph; Pg-4, P-3], then it is obvious to one of ordinary skill in the art to be able to detect the disconnection of the communication of CGM data at the infusion pump, based on the intervals of communication with the CGM system.
In regards to claim 4, Kamen modified via Jollota teaches receiving the CGM data from the CGM system at the remote control device includes the remote control device only receiving the CGM data when it has been determined that the infusion pump is no longer receiving the CGM data.
Jollota teaches the rerouting or the relay of communication data between medical devices, such that if data communication between two medical devices is lost, the communication maybe reroute through other node medical devices to the desired device destination (Paragraphs 37, 39, 40 76, 77, Jollota)
A plurality of wireless devices in the local infusion system 102 can be arranged and configured to operate in any suitable network topology. For example, the wireless devices may be arranged in a star network topology, a mesh network configuration, a tree network topology, an ad-hoc network topology, or the like. In this regard, FIG. 2 is a diagram that depicts four wireless devices arranged in a star network configuration 200 having a beacon-transmitting wireless device 202 and three listening wireless devices 204, 206, 208. This exemplary star network configuration 200 is shown here for ease of description, and is not intended to limit or otherwise restrict the scope of the disclosed subject matter.[P-39]
In the star network configuration 200, the designated beacon-transmitting wireless device 202 may be referred to as the "hub" or "coordinator" device, where the beacon-transmitting wireless device 202 generates and transmits wireless beacons 210, which can be received by the designated listening wireless devices 204, 206, 208. For this implementation, listening wireless devices 204, 206, 208 do not generate or transmit wireless beacons. Moreover, the beacon-transmitting wireless device 202 can directly communicate with any of the listening wireless devices 204, 206, 208 (as represented by the solid arrows 212 in FIG. 2). When functioning as the hub or coordinator device, the beacon-transmitting wireless device 202 facilitates communication between the listening wireless devices 204, 206, 208 by acting as a wireless repeater, router, or redirector with or without modifications to facilitate such communication. For example, the solid arrow 214 in FIG. 2 schematically illustrates the manner in which the beacon-transmitting wireless device 202 can wirelessly route data between the listening wireless device 204 and the listening wireless device 206. Notably, for this implementation the listening wireless devices 204, 206, 208 are unable to directly communicate with each other in the star network configuration 200. Rather, the beacon-transmitting wireless device 202 must be utilized as the wireless router between the listening wireless devices 204, 206, 208.[P-40]
Although not required of all embodiments, this example assumes that the coordinator device keeps track of missed pings (that are normally expected from the end node device), which could be an indication of poor wireless channel quality. In this regard, the coordinator device could detect loss of wireless synchronization with the end node device, based upon missed pings. For example, if the coordinator device detects that it has missed at least a threshold number of expected pings (as indicated by the ping schedule), then it might conclude that it has lost wireless synchronization with the end node device. Accordingly, the coordinator device may utilize or maintain a counter (such as the counter/timer 316 depicted in FIG. 3) for missed pings, and process 400 may initialize a missed ping count (task 412) for the initial wireless channel. Although not required, this description assumes that the missed ping count is initialized to a count of zero.[P-76]
If the coordinator device fails to receive an expected ping (query task 414), then process 400 increments the missed ping count (task 416) by some amount. For this simple example, task 416 increments the missed ping count by one. If the currently held missed ping count exceeds a threshold count value (query task 418), then the coordinator device will cease the sending of wireless beacons on the initial wireless channel (task 420) and enter a diagnostic or test mode (task 422). The threshold count value used during query task 418 is chosen such that it accurately reflects conditions that can be attributed to loss of wireless synchronization. If the threshold count value has not been exceeded, then process 400 may return to query task 414 to monitor for more missed pings. This example relates to an implementation where the coordinator device considers consecutive or sequential missed pings (although an embodiment could alternatively monitor for missed pings that occur during a specified time period, whether or not they are consecutive). Therefore, if process 400 subsequently determines that an expected ping has not been missed (the "no" branch of query task 414), then the missed ping count is initialized again.[P-77]
Thereby in conjunction with Zhang’s teaching of a remote control device of a main control unit capable of detecting the disconnection of wireless communication between a medical device and another device[P-2, Last Pgrph; Pg-4, P-3], then it is obvious to one of ordinary skill in the art to configure receiving the CGM data from the CGM system at the remote control device, when it has been determined that the infusion pump is no longer receiving the CGM data.
In regards to claim 5, Kamen modified via Jollota teaches relaying communications from the infusion pump to the CGM system via the remote control device while the infusion pump is no longer receiving the CGM data from the CGM system.
Jollota teaches the rerouting or the relay of communication data between medical devices, such that if data communication between two medical devices is lost, the communication maybe reroute through other node medical devices to the desired device destination (Paragraphs 37, 39, 40 76, 77, Jollota)
As shown in FIG. 1, the local infusion system 102 is capable of establishing many potential communication paths between the local devices. In certain embodiments, a controller device (e.g., the remote control device 134, the command display controller 138, or the monitor 140) may serve as a translator between the infusion pump 128 and the other components of the local infusion system 102, such as the BG meter 136. For example, the controller device may have the ability to determine how best to translate data received from the infusion pump 128 for compatibility with the display requirements of a destination device within the local infusion system 102. As depicted in FIG. 1, the infusion pump 128 may communicate directly with the BG meter 136. In some embodiments, the local infusion system 102 may include multiple controllers that can communicate with the infusion pump 128. In other embodiments, only one controller device can communicate with the infusion pump 128 at any given moment. The controller device functionality may also be integrated into the infusion pump 128 in some embodiments. In yet another embodiment, the BG meter 136 may be integrated into the controller device such that both features share a single device housing.[P-37]
A plurality of wireless devices in the local infusion system 102 can be arranged and configured to operate in any suitable network topology. For example, the wireless devices may be arranged in a star network topology, a mesh network configuration, a tree network topology, an ad-hoc network topology, or the like. In this regard, FIG. 2 is a diagram that depicts four wireless devices arranged in a star network configuration 200 having a beacon-transmitting wireless device 202 and three listening wireless devices 204, 206, 208. This exemplary star network configuration 200 is shown here for ease of description, and is not intended to limit or otherwise restrict the scope of the disclosed subject matter.[P-39]
In the star network configuration 200, the designated beacon-transmitting wireless device 202 may be referred to as the "hub" or "coordinator" device, where the beacon-transmitting wireless device 202 generates and transmits wireless beacons 210, which can be received by the designated listening wireless devices 204, 206, 208. For this implementation, listening wireless devices 204, 206, 208 do not generate or transmit wireless beacons. Moreover, the beacon-transmitting wireless device 202 can directly communicate with any of the listening wireless devices 204, 206, 208 (as represented by the solid arrows 212 in FIG. 2). When functioning as the hub or coordinator device, the beacon-transmitting wireless device 202 facilitates communication between the listening wireless devices 204, 206, 208 by acting as a wireless repeater, router, or redirector with or without modifications to facilitate such communication. For example, the solid arrow 214 in FIG. 2 schematically illustrates the manner in which the beacon-transmitting wireless device 202 can wirelessly route data between the listening wireless device 204 and the listening wireless device 206. Notably, for this implementation the listening wireless devices 204, 206, 208 are unable to directly communicate with each other in the star network configuration 200. Rather, the beacon-transmitting wireless device 202 must be utilized as the wireless router between the listening wireless devices 204, 206, 208.[P-40]
Although not required of all embodiments, this example assumes that the coordinator device keeps track of missed pings (that are normally expected from the end node device), which could be an indication of poor wireless channel quality. In this regard, the coordinator device could detect loss of wireless synchronization with the end node device, based upon missed pings. For example, if the coordinator device detects that it has missed at least a threshold number of expected pings (as indicated by the ping schedule), then it might conclude that it has lost wireless synchronization with the end node device. Accordingly, the coordinator device may utilize or maintain a counter (such as the counter/timer 316 depicted in FIG. 3) for missed pings, and process 400 may initialize a missed ping count (task 412) for the initial wireless channel. Although not required, this description assumes that the missed ping count is initialized to a count of zero.[P-76]
If the coordinator device fails to receive an expected ping (query task 414), then process 400 increments the missed ping count (task 416) by some amount. For this simple example, task 416 increments the missed ping count by one. If the currently held missed ping count exceeds a threshold count value (query task 418), then the coordinator device will cease the sending of wireless beacons on the initial wireless channel (task 420) and enter a diagnostic or test mode (task 422). The threshold count value used during query task 418 is chosen such that it accurately reflects conditions that can be attributed to loss of wireless synchronization. If the threshold count value has not been exceeded, then process 400 may return to query task 414 to monitor for more missed pings. This example relates to an implementation where the coordinator device considers consecutive or sequential missed pings (although an embodiment could alternatively monitor for missed pings that occur during a specified time period, whether or not they are consecutive). Therefore, if process 400 subsequently determines that an expected ping has not been missed (the "no" branch of query task 414), then the missed ping count is initialized again.[P-77]
Thereby one of ordinary skill in the art may obviously configure the relay capability of the medical device mesh network to configure receiving the CGM data from the CGM system at the remote control device, when it has been determined that the infusion pump is no longer receiving the CGM data.
In regards to claim 6, Kamen modified via Jollota teaches determining that the infusion pump has resumed receiving the CGM data from the CGM system; and ceasing relaying the CGM data from the CGM system by the remote control device to the infusion pump.
Jollota teaches the rerouting or the relay of communication data between medical devices, such that if data communication between two medical devices is lost, the communication maybe reroute through other node medical devices to the desired device destination (Paragraphs 37, 39, 40 76, 77, Jollota)
A plurality of wireless devices in the local infusion system 102 can be arranged and configured to operate in any suitable network topology. For example, the wireless devices may be arranged in a star network topology, a mesh network configuration, a tree network topology, an ad-hoc network topology, or the like. In this regard, FIG. 2 is a diagram that depicts four wireless devices arranged in a star network configuration 200 having a beacon-transmitting wireless device 202 and three listening wireless devices 204, 206, 208. This exemplary star network configuration 200 is shown here for ease of description, and is not intended to limit or otherwise restrict the scope of the disclosed subject matter.[P-39]
In the star network configuration 200, the designated beacon-transmitting wireless device 202 may be referred to as the "hub" or "coordinator" device, where the beacon-transmitting wireless device 202 generates and transmits wireless beacons 210, which can be received by the designated listening wireless devices 204, 206, 208. For this implementation, listening wireless devices 204, 206, 208 do not generate or transmit wireless beacons. Moreover, the beacon-transmitting wireless device 202 can directly communicate with any of the listening wireless devices 204, 206, 208 (as represented by the solid arrows 212 in FIG. 2). When functioning as the hub or coordinator device, the beacon-transmitting wireless device 202 facilitates communication between the listening wireless devices 204, 206, 208 by acting as a wireless repeater, router, or redirector with or without modifications to facilitate such communication. For example, the solid arrow 214 in FIG. 2 schematically illustrates the manner in which the beacon-transmitting wireless device 202 can wirelessly route data between the listening wireless device 204 and the listening wireless device 206. Notably, for this implementation the listening wireless devices 204, 206, 208 are unable to directly communicate with each other in the star network configuration 200. Rather, the beacon-transmitting wireless device 202 must be utilized as the wireless router between the listening wireless devices 204, 206, 208.[P-40]
Although not required of all embodiments, this example assumes that the coordinator device keeps track of missed pings (that are normally expected from the end node device), which could be an indication of poor wireless channel quality. In this regard, the coordinator device could detect loss of wireless synchronization with the end node device, based upon missed pings. For example, if the coordinator device detects that it has missed at least a threshold number of expected pings (as indicated by the ping schedule), then it might conclude that it has lost wireless synchronization with the end node device. Accordingly, the coordinator device may utilize or maintain a counter (such as the counter/timer 316 depicted in FIG. 3) for missed pings, and process 400 may initialize a missed ping count (task 412) for the initial wireless channel. Although not required, this description assumes that the missed ping count is initialized to a count of zero.[P-76]
If the coordinator device fails to receive an expected ping (query task 414), then process 400 increments the missed ping count (task 416) by some amount. For this simple example, task 416 increments the missed ping count by one. If the currently held missed ping count exceeds a threshold count value (query task 418), then the coordinator device will cease the sending of wireless beacons on the initial wireless channel (task 420) and enter a diagnostic or test mode (task 422). The threshold count value used during query task 418 is chosen such that it accurately reflects conditions that can be attributed to loss of wireless synchronization. If the threshold count value has not been exceeded, then process 400 may return to query task 414 to monitor for more missed pings. This example relates to an implementation where the coordinator device considers consecutive or sequential missed pings (although an embodiment could alternatively monitor for missed pings that occur during a specified time period, whether or not they are consecutive). Therefore, if process 400 subsequently determines that an expected ping has not been missed (the "no" branch of query task 414), then the missed ping count is initialized again.[P-77]
Thereby in conjunction with Zhang’s teaching of a remote control device of a main control unit capable of detecting the disconnection of wireless communication between a medical device and another device[P-2, Last Pgrph; Pg-4, P-3], then in the same respect, it is obvious to one of ordinary skill in the art to detect when communication between a medical device and another device has resumed, so as to configure ceasing relaying the CGM data from the CGM system by the remote control device to the infusion pump (via Jollota’s mesh network).
In regards to claim 7, Kamen modified teaches the remote control device is at least one of: a dedicated remote control designed for use with the infusion pump ;a multi-purpose consumer electronic device; or a smartphone (Paragraph 432, Kamen)
Referring now also to FIG. 35C, in some embodiments, the mini-remote interface 3500 is in communication with an infusion pump 3502, and in some embodiments, may also be in communication with additional devices, including but not limited to, medical devices, which, in some embodiments, may include one or more devices, which, in some embodiments, may include at least one blood glucose meter 3506 and/or at least one continuous glucose monitor sensor/transmitter 3504. In some embodiments, the mini-remote interface 3500 may also be in communication with a remote interface 3512, which may be any remote interface, including, but not limited to, a Smartphone, for example, an ADROID.RTM. Smartphone. In some embodiments of this embodiment, the remote interface 3512 may include one-way communication between the mini-remote interface 3500 and the remote interface 3512. Thus, in these embodiments, the remote interface 3512 may receive and display information related to the one or more devices/medical devices 3502, 3504, 3506 in which are in communication with the mini-remote interface 3500, however, the remote interface 3512 may not control the one more devices 3502, 3504, 3506, nor control the mini-remote interface 3500, nor send information to the mini-remote interface 3500. In some embodiments, therefore, the remote interface 3512 may be used as an adjunct user interface, including the ability to display information, for example, graphs and logbook information, in a larger format for easier viewing by the user. In some embodiments, the remote interface 3512 may be a Smartphone that may be used as a phone, however, may also include an application that allows for the mini-remote interface 3500 to send information to the remote interface 3512 to present the information to the user in a graphic rich format. Thus, in this embodiment, the mini-remote interface 3500 controls the infusion pump 3502, and also receives information from the other devices 3504, 3506, and is the only device in the system that may send commands and/or control the infusion pump 3502, wherein said control includes, but is not limited to, one or more of the following: programming/commanding the delivery of a bolus and/or programming and delivering basal and/or programming/commanding any therapy related command, including, but not limited to, changing therapy or commanding the delivery of therapy. In some embodiments of this embodiment of the system, the mini-remote interface 3500 may also communicate with and send information to a personal computer 3508 and/or the internet. In some embodiments of this embodiment of the system, the remote interface 3512 may also display alarms, alerts, etc., and show the status of the infusion pump 3502 and/or other devices 3504, 3506. In some embodiments, the mini-remote interface 3500 may send data to the remote interface 3512 at regular/programmable intervals, for example, every 2 minutes, however, the intervals may be any interval desired. In some embodiments, the mini-remote interface 3500 may send data to the remote interface 3512 when commanded by the user. In some embodiments, information that is programmed by the user/caregiver into the mini-remote interface 3500 may be shared by the mini-remote interface 3500 to other devices 3512, 3504, 3506 in the system. This information may include, but is not limited to, a blood glucose reading, e.g., a reading from the blood glucose meter that is not otherwise in wireless communication with the mini-remote interface 3500.[P-432]
In regards to claim 8, Kamen teaches a method of coordinating wireless communications in an infusion pump system including an infusion pump, a remote control device for remotely controlling the infusion pump, and a continuous glucose monitoring (CGM) system (Paragraph 10).
Some embodiments of this aspect of the invention may include one or more of the following. Wherein the first medical device is an infusion pump. Wherein the first remote interface is a medical device data system. Wherein the second remote interface is not a medical device data system. Wherein the system further comprising a blood glucose meter in communication with the second remote interface. Wherein the system further comprising a continuous glucose monitor transmitter in communication with the second remote interface. Wherein the first remote interface receives a command related to the communication of safety critical information to the first medical device, displays a message that the communication of the safety critical information to the first medical device requires confirmation using the second remote interface, sends the communication to the second remote interface, and once confirmation received by the second remote interface, the second remote interface communicates the command to the first medical device. Wherein the first remote interface receives an input of information related to the delivery by the infusion pump of a bolus volume of infusible fluid, displays a message that the delivery of the bolus volume requires confirmation using the second remote interface, and once confirmation received by the second remote interface, the second remote interface communicates the information required for the delivery of the bolus volume of infusible fluid to the infusion pump.[P-10]
Furthermore, Kamen teaches enabling the CGM system to transmit CGM data to the infusion pump via a wireless communication (Paragraph 18).
Some embodiments of this aspect of the invention may include one or more of the following. Where the first medical device is an infusion pump; wherein the first medical device further includes at least one disposable portion and at least two reusable portions, each of the two reusable portions configured to connect to the at least one disposable portion; wherein the charging device configured to receive at least one of the at least two reusable portions of the first medical device; wherein the second medical device including a continuous glucose monitor system including at least one transmitter wherein the at least one transmitter in wireless communication with the first medical device; wherein the second medical device including a blood glucose meter in wireless communication with the first medical device; wherein the first medical device and the remote interface are paired using near field communication; wherein the first medical device and the second medical device are paired using near field communication.[P-18]
Kamen fails to teach determining that the infusion pump is no longer receiving the CGM data communicated by the CGM system, based at least in part by the remote control device communicating with the infusion pump at regular intervals to determine if the infusion pump is receiving the CGM data
Yagyu on the other hand teaches determining that the pump is no longer receiving CGM data communicated by the continuous glucose monitoring system, receiving the CGM data from the continuous glucose monitoring system(Page 2, Paragraph 3; Page 8, Paragraphs 4-5),
FIG. 1 is a diagram illustrating a configuration example of a wireless communication system according to the present embodiment and an outline of an operation in the wireless communication method according to the present embodiment. As an example, the wireless communication system shown in FIG. 1 is an information collecting device that collects information obtained from the hub 1 that is an information aggregating device and sensors (such as a heart rate monitor and a blood glucose meter) attached to itself. , 4. Hub 1 collects information collected by Nodes 2, 3, and 4 by establishing individual connections with Nodes 2, 3, and 4 and individually communicating with them. Nodes 2 and 3 operate as an information collection device (Node) that notifies Hub 1 of information collected by itself, and can also operate as a relay Node having a function as a relay device. Note that Node 4 operates as an information collection device (Node) that notifies Hub 1 of information collected by itself, and does not have a function as a relay device. [Pg 2, P-3]
As described above, in the present embodiment, when communication between Hub 1 and Node 4 is interrupted, Node 2 and Node 3 that can operate as relay Nodes search for Node 4 where communication is disconnected. Thereafter, the specific Node that has discovered Node 4 notifies Hub 1 to that effect and transmits broadcast information to Node 4 by unicast. And Node4 which received alerting | reporting information requests | requires the start of relay communication to Hub1 via the said specific Node, Hub1 allocates the communication band between an own apparatus-specific Node, and between specific Node-Node4, and relay communication of Instructed to start. Thereafter, relay communication is performed between Hub 1 and Node 4 via the specific node. Thus, in this embodiment, only the relay node that has discovered Node 4 that has lost communication with Hub 1 transmits broadcast information, and the relay Node that has not found Node 4 does not transmit broadcast information. . Thereby, the relay Node of a present Example can reduce the power consumption concerning transmission of alerting | reporting information conventionally. [Pg 8, P-4]
In addition, conventionally, all relay nodes periodically transmit broadcast information, and when transmitting broadcast information, the broadcast information is transmitted and waiting for reception of a relay start request after the broadcast information is transmitted. Occupied the bandwidth. On the other hand, in the present embodiment, only the relay node that has discovered Node 4 that has lost communication with Hub 1 transmits broadcast information, so that it occupies in order to transmit broadcast information compared to the conventional case. It is possible to greatly reduce the bandwidth to be used. [Pg 8, P-5]
It would therefore be obvious to a person of ordinary skill in the art before the effective filing of the invention to combine Yagyu’s teaching with Kamen’s teaching in order to continuously maintain the communication with the glucose monitoring device despite the loss of communication with one transitional medical device accordingly.
Kamen modified fails to teach the determined lost data connection being based at least in part by the remote control device communicating with the infusion pump at regular intervals to determine if the infusion pump is receiving the CGM data
Zhang on the other hand teaches a remote control device of a main control unit capable of detecting the disconnection of wireless communication between a ventilator device and the main control unit (Page 2, Last Paragraph; Page 4, Paragraph 3).
The utility model claims respirator provides a remote alarm device, remote alarming device by short-distance wireless communication module communication with the respirator, thereby adjusting and controlling ventilator. and without requiring the patient or walking near the ventilator operating respirator; on the other hand, when the machine has fault, the wireless communication channel of the respirator is disconnected from remote alarm device, alarm module of the remote alarm device to the main control module detects that the short-range wireless communication channel is disconnected, starting alarm. so as to wake the patient, prevent patient does not obtain the air continuously and resentment[Pg 2, Last Pgph]
remote control warning device 100 having an alarm function, the alarm module 8 may include an audio module and/or a vibration module, the alarm module 8 may be any one of the following or the combination: a speaker, buzzer, vibrating motor matched with the audio alarm module, remote control warning device side of the shell 100 is provided with a sound hole 102, when the host 200 fails to stop operation, wireless communication channel can be disconnected, remote control warning device 100 of the main control module 5 detects that the wireless communication channel is disconnected. control alarm module 8 starts the alarm to send out warning sound prompt or vibration indication. The utility model has the remote control function and alarming module are combined together so that the user of the remote terminal can find alarm prompt.[Pg 4, P-3]
Thereby it is obvious to one of ordinary skill to use Zhang’s disconnection detection means with Kamen modified’s teaching via Yagyu of a relay communication is performed between Hub 1 and Node 4 via the specific node, only when the relay/specific node that has discovered Node 4 that has lost communication with Hub 1 transmits broadcast information, (page 8, Paragraphs 4-5). Zhang’s teaching being the detection means to initiate the relay communication mode to avoid operation disruption due to loss of communication.
Since the claim language lacks the clarification as to how the remote control device is specific to the infusion pump and the CGM system, then one can reasonably interpret the system to merely be a communication network that is monitored by a remote control device.
It would therefore be obvious to a person of ordinary skill in the art before the effective filing of the invention to combine Zhang’s teaching with Kamen modified’s in order to securely ensure continuous communication is maintained between medical devices in order to enable the appropriate operation of the medical devices.
Though Kamen modified via Yagyu teaches the relay of communication data between medical devices , the combination is not specific to relaying the CGM data received from the CGM system by the remote control device to the infusion pump to enable the infusion pump to continue to determine therapy parameters utilizing the CGM data while the infusion pump is no longer receiving the CGM data from the CGM system.
Jollota on the other hand teaches the relay of communication data between medical devices , the combination is not specific to relaying the CGM data received from the CGM system by the remote control device to the infusion pump to enable the infusion pump to continue to determine therapy parameters utilizing the CGM data while the infusion pump is no longer receiving the CGM data from the CGM system. (Paragraphs 37, 39, 40 76, 77)
A plurality of wireless devices in the local infusion system 102 can be arranged and configured to operate in any suitable network topology. For example, the wireless devices may be arranged in a star network topology, a mesh network configuration, a tree network topology, an ad-hoc network topology, or the like. In this regard, FIG. 2 is a diagram that depicts four wireless devices arranged in a star network configuration 200 having a beacon-transmitting wireless device 202 and three listening wireless devices 204, 206, 208. This exemplary star network configuration 200 is shown here for ease of description, and is not intended to limit or otherwise restrict the scope of the disclosed subject matter.[P-39]
In the star network configuration 200, the designated beacon-transmitting wireless device 202 may be referred to as the "hub" or "coordinator" device, where the beacon-transmitting wireless device 202 generates and transmits wireless beacons 210, which can be received by the designated listening wireless devices 204, 206, 208. For this implementation, listening wireless devices 204, 206, 208 do not generate or transmit wireless beacons. Moreover, the beacon-transmitting wireless device 202 can directly communicate with any of the listening wireless devices 204, 206, 208 (as represented by the solid arrows 212 in FIG. 2). When functioning as the hub or coordinator device, the beacon-transmitting wireless device 202 facilitates communication between the listening wireless devices 204, 206, 208 by acting as a wireless repeater, router, or redirector with or without modifications to facilitate such communication. For example, the solid arrow 214 in FIG. 2 schematically illustrates the manner in which the beacon-transmitting wireless device 202 can wirelessly route data between the listening wireless device 204 and the listening wireless device 206. Notably, for this implementation the listening wireless devices 204, 206, 208 are unable to directly communicate with each other in the star network configuration 200. Rather, the beacon-transmitting wireless device 202 must be utilized as the wireless router between the listening wireless devices 204, 206, 208.[P-40]
Although not required of all embodiments, this example assumes that the coordinator device keeps track of missed pings (that are normally expected from the end node device), which could be an indication of poor wireless channel quality. In this regard, the coordinator device could detect loss of wireless synchronization with the end node device, based upon missed pings. For example, if the coordinator device detects that it has missed at least a threshold number of expected pings (as indicated by the ping schedule), then it might conclude that it has lost wireless synchronization with the end node device. Accordingly, the coordinator device may utilize or maintain a counter (such as the counter/timer 316 depicted in FIG. 3) for missed pings, and process 400 may initialize a missed ping count (task 412) for the initial wireless channel. Although not required, this description assumes that the missed ping count is initialized to a count of zero.[P-76]
If the coordinator device fails to receive an expected ping (query task 414), then process 400 increments the missed ping count (task 416) by some amount. For this simple example, task 416 increments the missed ping count by one. If the currently held missed ping count exceeds a threshold count value (query task 418), then the coordinator device will cease the sending of wireless beacons on the initial wireless channel (task 420) and enter a diagnostic or test mode (task 422). The threshold count value used during query task 418 is chosen such that it accurately reflects conditions that can be attributed to loss of wireless synchronization. If the threshold count value has not been exceeded, then process 400 may return to query task 414 to monitor for more missed pings. This example relates to an implementation where the coordinator device considers consecutive or sequential missed pings (although an embodiment could alternatively monitor for missed pings that occur during a specified time period, whether or not they are consecutive). Therefore, if process 400 subsequently determines that an expected ping has not been missed (the "no" branch of query task 414), then the missed ping count is initialized again.[P-77]
Here, Jollota elaborates on a mesh network of medical devices such that a reconfigurable hierarchy of communication channels of a coordinator facilitating communication protocol between devices including acting as a relay/repeater device between two other medical devices, one being the end node (Remote control device (134), BG Meter (136), Infusion Pump (128)) [P-39,40]. Furthermore, Jollota teaches the hierarchy of communication can be reconfigurable as far as which device is the coordinator (conducting direct communication with one device or a relay repeater from a second device to an end node), the second device and end node[P-41, 56]. Jollota then teaches ping calls between device channels to establish communication between the said medical devices. When a threshold number of pings expires such that communication is lost between any two devices, a different channel of communication is established via another device[P-75, 81, 88].
It would therefore be obvious to a person of ordinary skill in the art before the effective filing of the invention to combine Jollota’s teaching with Kamen’s in order to continuously monitor glucose whilst using an infusion pump.
In regards to claim 9, Kamen modified monitoring the connection between the infusion pump and the CGM system includes receiving a communication from the infusion pump indicating that the infusion pump is no longer receiving the CGM data. (Paragraph 436, Kamen ).
Referring now also to FIG. 35E, in some embodiments, the mini-remote interface 3500 and a remote interface 3512 may each be used to control an infusion pump 3502 and/or one or more additional device/medical devices 3504, 3506. In some embodiments of this embodiment of the system, the mini-remote interface 3500 may "trump" and therefore, if the remote interface 3512 and the mini-remote interface 3500 were simultaneously both within communication distance with the infusion pump 3502 and/or the one or more devices/medical devices 3504, 3506, then the mini-remote interface 3500 would be the device that may communicate with the infusion pump 3502 and/or the one or more devices/medical devices 3504, 3506. In some embodiments, the mini-remote interface 3500 and the remote interface 3512 may communicate and synchronize information at pre-programmed intervals and/or when within a pre-programmed communication distance, for example, when the mini-remote interface 3500 and the remote interface 3512 recognize that they are within communication distance and/or an interval of time has passed since the last synchronization, the mini-remote interface 3500 and the remote interface 3512 may synchronize using a synchronization protocol which may be any synchronization protocol. The mini-remote interface 3500 and the remote interface 3512 may also pair using the various protocols described and discussed herein.[P-436]
Here we see Kamen describe the communication of the remote control interface with the infusion pump as well as other medical devices during intervals.
When considered with Zhang’s teaching of a remote control device of a main control unit capable of detecting the disconnection of wireless communication between a ventilator device and the main control unit [P-2, Last Pgrph; Pg-4, P-3], then it is obvious to one of ordinary skill in the art to be able to detect the disconnection of the communication of CGM data at the infusion pump, based on the intervals of communication with the infusion pump
In regards to claim 10, Kamen modified teaches monitoring the connection between the infusion pump and the CGM system includes receiving a communication from the CGM system indicating that the infusion pump is no longer receiving the CGM data (Paragraph 436, Kamen)
Referring now also to FIG. 35E, in some embodiments, the mini-remote interface 3500 and a remote interface 3512 may each be used to control an infusion pump 3502 and/or one or more additional device/medical devices 3504, 3506. In some embodiments of this embodiment of the system, the mini-remote interface 3500 may "trump" and therefore, if the remote interface 3512 and the mini-remote interface 3500 were simultaneously both within communication distance with the infusion pump 3502 and/or the one or more devices/medical devices 3504, 3506, then the mini-remote interface 3500 would be the device that may communicate with the infusion pump 3502 and/or the one or more devices/medical devices 3504, 3506. In some embodiments, the mini-remote interface 3500 and the remote interface 3512 may communicate and synchronize information at pre-programmed intervals and/or when within a pre-programmed communication distance, for example, when the mini-remote interface 3500 and the remote interface 3512 recognize that they are within communication distance and/or an interval of time has passed since the last synchronization, the mini-remote interface 3500 and the remote interface 3512 may synchronize using a synchronization protocol which may be any synchronization protocol. The mini-remote interface 3500 and the remote interface 3512 may also pair using the various protocols described and discussed herein.[P-436]
Here we see Kamen describe the communication of the remote control interface with one or more medical devices during intervals.
When considered with Zhang’s teaching of a remote control device of a main control unit capable of detecting the disconnection of wireless communication between a ventilator device and the main control unit [P-2, Last Pgrph; Pg-4, P-3], then it is obvious to one of ordinary skill in the art to be able to detect the disconnection of the communication of CGM data at the infusion pump, based on the intervals of communication with the CGM system.
In regards to claim 11, Kamen modified receiving the CGM data from the CGM system includes only receiving the CGM data when it has been determined that the infusion pump is not receiving the CGM data (Paragraph 436)
Referring now also to FIG. 35E, in some embodiments, the mini-remote interface 3500 and a remote interface 3512 may each be used to control an infusion pump 3502 and/or one or more additional device/medical devices 3504, 3506. In some embodiments of this embodiment of the system, the mini-remote interface 3500 may "trump" and therefore, if the remote interface 3512 and the mini-remote interface 3500 were simultaneously both within communication distance with the infusion pump 3502 and/or the one or more devices/medical devices 3504, 3506, then the mini-remote interface 3500 would be the device that may communicate with the infusion pump 3502 and/or the one or more devices/medical devices 3504, 3506. In some embodiments, the mini-remote interface 3500 and the remote interface 3512 may communicate and synchronize information at pre-programmed intervals and/or when within a pre-programmed communication distance, for example, when the mini-remote interface 3500 and the remote interface 3512 recognize that they are within communication distance and/or an interval of time has passed since the last synchronization, the mini-remote interface 3500 and the remote interface 3512 may synchronize using a synchronization protocol which may be any synchronization protocol. The mini-remote interface 3500 and the remote interface 3512 may also pair using the various protocols described and discussed herein.[P-436]
Here we see Kamen describe the communication of the remote control interface with one or more medical devices during intervals.
When considered with Zhang’s teaching of a remote control device of a main control unit capable of detecting the disconnection of wireless communication between a ventilator device and the main control unit [P-2, Last Pgrph; Pg-4, P-3], then it is obvious to one of ordinary skill in the art to be able to detect the disconnection of the communication of CGM data at the infusion pump, based on the intervals of communication with the CGM system.
In regards to claim 12, Kamen modified via Jollota teaches relaying communications from the infusion pump to the CGM system via the remote control device.
Jollota teaches the rerouting or the relay of communication data between medical devices, such that if data communication between two medical devices is lost, the communication maybe reroute through other node medical devices to the desired device destination (Paragraphs 37, 39, 40 76, 77, Jollota)
A plurality of wireless devices in the local infusion system 102 can be arranged and configured to operate in any suitable network topology. For example, the wireless devices may be arranged in a star network topology, a mesh network configuration, a tree network topology, an ad-hoc network topology, or the like. In this regard, FIG. 2 is a diagram that depicts four wireless devices arranged in a star network configuration 200 having a beacon-transmitting wireless device 202 and three listening wireless devices 204, 206, 208. This exemplary star network configuration 200 is shown here for ease of description, and is not intended to limit or otherwise restrict the scope of the disclosed subject matter.[P-39]
In the star network configuration 200, the designated beacon-transmitting wireless device 202 may be referred to as the "hub" or "coordinator" device, where the beacon-transmitting wireless device 202 generates and transmits wireless beacons 210, which can be received by the designated listening wireless devices 204, 206, 208. For this implementation, listening wireless devices 204, 206, 208 do not generate or transmit wireless beacons. Moreover, the beacon-transmitting wireless device 202 can directly communicate with any of the listening wireless devices 204, 206, 208 (as represented by the solid arrows 212 in FIG. 2). When functioning as the hub or coordinator device, the beacon-transmitting wireless device 202 facilitates communication between the listening wireless devices 204, 206, 208 by acting as a wireless repeater, router, or redirector with or without modifications to facilitate such communication. For example, the solid arrow 214 in FIG. 2 schematically illustrates the manner in which the beacon-transmitting wireless device 202 can wirelessly route data between the listening wireless device 204 and the listening wireless device 206. Notably, for this implementation the listening wireless devices 204, 206, 208 are unable to directly communicate with each other in the star network configuration 200. Rather, the beacon-transmitting wireless device 202 must be utilized as the wireless router between the listening wireless devices 204, 206, 208.[P-40]
Although not required of all embodiments, this example assumes that the coordinator device keeps track of missed pings (that are normally expected from the end node device), which could be an indication of poor wireless channel quality. In this regard, the coordinator device could detect loss of wireless synchronization with the end node device, based upon missed pings. For example, if the coordinator device detects that it has missed at least a threshold number of expected pings (as indicated by the ping schedule), then it might conclude that it has lost wireless synchronization with the end node device. Accordingly, the coordinator device may utilize or maintain a counter (such as the counter/timer 316 depicted in FIG. 3) for missed pings, and process 400 may initialize a missed ping count (task 412) for the initial wireless channel. Although not required, this description assumes that the missed ping count is initialized to a count of zero.[P-76]
If the coordinator device fails to receive an expected ping (query task 414), then process 400 increments the missed ping count (task 416) by some amount. For this simple example, task 416 increments the missed ping count by one. If the currently held missed ping count exceeds a threshold count value (query task 418), then the coordinator device will cease the sending of wireless beacons on the initial wireless channel (task 420) and enter a diagnostic or test mode (task 422). The threshold count value used during query task 418 is chosen such that it accurately reflects conditions that can be attributed to loss of wireless synchronization. If the threshold count value has not been exceeded, then process 400 may return to query task 414 to monitor for more missed pings. This example relates to an implementation where the coordinator device considers consecutive or sequential missed pings (although an embodiment could alternatively monitor for missed pings that occur during a specified time period, whether or not they are consecutive). Therefore, if process 400 subsequently determines that an expected ping has not been missed (the "no" branch of query task 414), then the missed ping count is initialized again.[P-77]
Thereby in conjunction with Zhang’s teaching of a remote control device of a main control unit capable of detecting the disconnection of wireless communication between a medical device and another device[P-2, Last Pgrph; Pg-4, P-3], it is obvious to one of ordinary skill in the art to configure relaying communications from the infusion pump to the CGM system via the remote control device. (via Jollota’s mesh network).
In regards to claim 13, Kamen modified via Jollota teaches determining that the infusion pump has resumed receiving the CGM data from the CGM system; and ceasing relaying the CGM data received from the CGM system to the infusion pump.
Jollota teaches the rerouting or the relay of communication data between medical devices, such that if data communication between two medical devices is lost, the communication maybe reroute through other node medical devices to the desired device destination (Paragraphs 37, 39, 40 76, 77, Jollota)
A plurality of wireless devices in the local infusion system 102 can be arranged and configured to operate in any suitable network topology. For example, the wireless devices may be arranged in a star network topology, a mesh network configuration, a tree network topology, an ad-hoc network topology, or the like. In this regard, FIG. 2 is a diagram that depicts four wireless devices arranged in a star network configuration 200 having a beacon-transmitting wireless device 202 and three listening wireless devices 204, 206, 208. This exemplary star network configuration 200 is shown here for ease of description, and is not intended to limit or otherwise restrict the scope of the disclosed subject matter.[P-39]
In the star network configuration 200, the designated beacon-transmitting wireless device 202 may be referred to as the "hub" or "coordinator" device, where the beacon-transmitting wireless device 202 generates and transmits wireless beacons 210, which can be received by the designated listening wireless devices 204, 206, 208. For this implementation, listening wireless devices 204, 206, 208 do not generate or transmit wireless beacons. Moreover, the beacon-transmitting wireless device 202 can directly communicate with any of the listening wireless devices 204, 206, 208 (as represented by the solid arrows 212 in FIG. 2). When functioning as the hub or coordinator device, the beacon-transmitting wireless device 202 facilitates communication between the listening wireless devices 204, 206, 208 by acting as a wireless repeater, router, or redirector with or without modifications to facilitate such communication. For example, the solid arrow 214 in FIG. 2 schematically illustrates the manner in which the beacon-transmitting wireless device 202 can wirelessly route data between the listening wireless device 204 and the listening wireless device 206. Notably, for this implementation the listening wireless devices 204, 206, 208 are unable to directly communicate with each other in the star network configuration 200. Rather, the beacon-transmitting wireless device 202 must be utilized as the wireless router between the listening wireless devices 204, 206, 208.[P-40]
Although not required of all embodiments, this example assumes that the coordinator device keeps track of missed pings (that are normally expected from the end node device), which could be an indication of poor wireless channel quality. In this regard, the coordinator device could detect loss of wireless synchronization with the end node device, based upon missed pings. For example, if the coordinator device detects that it has missed at least a threshold number of expected pings (as indicated by the ping schedule), then it might conclude that it has lost wireless synchronization with the end node device. Accordingly, the coordinator device may utilize or maintain a counter (such as the counter/timer 316 depicted in FIG. 3) for missed pings, and process 400 may initialize a missed ping count (task 412) for the initial wireless channel. Although not required, this description assumes that the missed ping count is initialized to a count of zero.[P-76]
If the coordinator device fails to receive an expected ping (query task 414), then process 400 increments the missed ping count (task 416) by some amount. For this simple example, task 416 increments the missed ping count by one. If the currently held missed ping count exceeds a threshold count value (query task 418), then the coordinator device will cease the sending of wireless beacons on the initial wireless channel (task 420) and enter a diagnostic or test mode (task 422). The threshold count value used during query task 418 is chosen such that it accurately reflects conditions that can be attributed to loss of wireless synchronization. If the threshold count value has not been exceeded, then process 400 may return to query task 414 to monitor for more missed pings. This example relates to an implementation where the coordinator device considers consecutive or sequential missed pings (although an embodiment could alternatively monitor for missed pings that occur during a specified time period, whether or not they are consecutive). Therefore, if process 400 subsequently determines that an expected ping has not been missed (the "no" branch of query task 414), then the missed ping count is initialized again.[P-77]
Thereby in conjunction with Zhang’s teaching of a remote control device of a main control unit capable of detecting the disconnection of wireless communication between a medical device and another device[P-2, Last Pgrph; Pg-4, P-3], then in the same respect, it is obvious to one of ordinary skill in the art to detect when communication between a medical device and another device has resumed, so as to configure ceasing relaying the CGM data from the CGM system by the remote control device to the infusion pump (via Jollota’s mesh network).
In regards to claim 14, Kamen modified teaches the remote control device is at least one of: a dedicated remote control designed for use with the infusion pump; a multi-purpose consumer electronic device; or a smartphone(Paragraph 432, Kamen)
Referring now also to FIG. 35C, in some embodiments, the mini-remote interface 3500 is in communication with an infusion pump 3502, and in some embodiments, may also be in communication with additional devices, including but not limited to, medical devices, which, in some embodiments, may include one or more devices, which, in some embodiments, may include at least one blood glucose meter 3506 and/or at least one continuous glucose monitor sensor/transmitter 3504. In some embodiments, the mini-remote interface 3500 may also be in communication with a remote interface 3512, which may be any remote interface, including, but not limited to, a Smartphone, for example, an ADROID.RTM. Smartphone. In some embodiments of this embodiment, the remote interface 3512 may include one-way communication between the mini-remote interface 3500 and the remote interface 3512. Thus, in these embodiments, the remote interface 3512 may receive and display information related to the one or more devices/medical devices 3502, 3504, 3506 in which are in communication with the mini-remote interface 3500, however, the remote interface 3512 may not control the one more devices 3502, 3504, 3506, nor control the mini-remote interface 3500, nor send information to the mini-remote interface 3500. In some embodiments, therefore, the remote interface 3512 may be used as an adjunct user interface, including the ability to display information, for example, graphs and logbook information, in a larger format for easier viewing by the user. In some embodiments, the remote interface 3512 may be a Smartphone that may be used as a phone, however, may also include an application that allows for the mini-remote interface 3500 to send information to the remote interface 3512 to present the information to the user in a graphic rich format. Thus, in this embodiment, the mini-remote interface 3500 controls the infusion pump 3502, and also receives information from the other devices 3504, 3506, and is the only device in the system that may send commands and/or control the infusion pump 3502, wherein said control includes, but is not limited to, one or more of the following: programming/commanding the delivery of a bolus and/or programming and delivering basal and/or programming/commanding any therapy related command, including, but not limited to, changing therapy or commanding the delivery of therapy. In some embodiments of this embodiment of the system, the mini-remote interface 3500 may also communicate with and send information to a personal computer 3508 and/or the internet. In some embodiments of this embodiment of the system, the remote interface 3512 may also display alarms, alerts, etc., and show the status of the infusion pump 3502 and/or other devices 3504, 3506. In some embodiments, the mini-remote interface 3500 may send data to the remote interface 3512 at regular/programmable intervals, for example, every 2 minutes, however, the intervals may be any interval desired. In some embodiments, the mini-remote interface 3500 may send data to the remote interface 3512 when commanded by the user. In some embodiments, information that is programmed by the user/caregiver into the mini-remote interface 3500 may be shared by the mini-remote interface 3500 to other devices 3512, 3504, 3506 in the system. This information may include, but is not limited to, a blood glucose reading, e.g., a reading from the blood glucose meter that is not otherwise in wireless communication with the mini-remote interface 3500.[P-432]
In regards to claim 15, Kamen teaches a control device configured to control an infusion pump, the control device comprising, a processor in a wireless communication with the infusion pump and a continuous glucose monitoring (CGM) system(Paragraph 10).
Some embodiments of this aspect of the invention may include one or more of the following. Wherein the first medical device is an infusion pump. Wherein the first remote interface is a medical device data system. Wherein the second remote interface is not a medical device data system. Wherein the system further comprising a blood glucose meter in communication with the second remote interface. Wherein the system further comprising a continuous glucose monitor transmitter in communication with the second remote interface. Wherein the first remote interface receives a command related to the communication of safety critical information to the first medical device, displays a message that the communication of the safety critical information to the first medical device requires confirmation using the second remote interface, sends the communication to the second remote interface, and once confirmation received by the second remote interface, the second remote interface communicates the command to the first medical device. Wherein the first remote interface receives an input of information related to the delivery by the infusion pump of a bolus volume of infusible fluid, displays a message that the delivery of the bolus volume requires confirmation using the second remote interface, and once confirmation received by the second remote interface, the second remote interface communicates the information required for the delivery of the bolus volume of infusible fluid to the infusion pump.[P-10]
Kamen then teaches the processor is configured to monitor a connection between the infusion pump and the CGM system to determine whether the infusion pump is receiving CGM data from the CGM system, based at least in part by communicating with the infusion pump at regular intervals to determine if the infusion pump is receiving the CGM data (Paragraphs 268, 432)
Referring also to FIG. 11, there is shown another illustrative example of the interaction amongst processors 900, 902, this time during the scheduling of a dose of infusible fluid. The command processor 902 may monitor 1100, 1102 for the receipt of a basal scheduling message or a bolus request message (respectively). Upon receipt 1100, 1102 of either of these messages, the command processor 902 may set 1104 the desired delivery volume and may provide 1106 a "delivery request" message to the supervisor processor 900. Upon receiving 1108 the "delivery request" message, supervisor processor 900 may verify 1110 the volume defined 1104 by command processor 902. Once verified 1110, the supervisor processor 900 may provide 1112 a "delivery accepted" message to the command processor 902. Upon receipt 1114 of the "delivery accepted" message, the command processor 902 may update 1116 the remote interface (e.g., the remote interface discussed above and illustrated in FIGS. 6-8) and execute 1118 delivery of the basal/bolus dose of infusible fluid. The command processor 902 may monitor and update 1122 the total quantity of infusible fluid delivered to the user (as discussed above and illustrated in FIGS. 10A-10B). Once the appropriate quantity of infusible fluid is delivered to the user, the command processor 902 may provide 1124 a "delivery done" message to the supervisor processor 900. Upon receipt 1126 of the "delivery done" message, the supervisor processor 900 may update 1128 the total quantity of infusible fluid delivered to the user. In the event that the total quantity of infusible fluid delivered 1118 to the user is less than the quantity defined above (in step 1104), the infusion process discussed above may be repeated (by way of loop 1130).[P-268]
Referring now also to FIG. 35C, in some embodiments, the mini-remote interface 3500 is in communication with an infusion pump 3502, and in some embodiments, may also be in communication with additional devices, including but not limited to, medical devices, which, in some embodiments, may include one or more devices, which, in some embodiments, may include at least one blood glucose meter 3506 and/or at least one continuous glucose monitor sensor/transmitter 3504. In some embodiments, the mini-remote interface 3500 may also be in communication with a remote interface 3512, which may be any remote interface, including, but not limited to, a Smartphone, for example, an ADROID.RTM. Smartphone. In some embodiments of this embodiment, the remote interface 3512 may include one-way communication between the mini-remote interface 3500 and the remote interface 3512. Thus, in these embodiments, the remote interface 3512 may receive and display information related to the one or more devices/medical devices 3502, 3504, 3506 in which are in communication with the mini-remote interface 3500, however, the remote interface 3512 may not control the one more devices 3502, 3504, 3506, nor control the mini-remote interface 3500, nor send information to the mini-remote interface 3500. In some embodiments, therefore, the remote interface 3512 may be used as an adjunct user interface, including the ability to display information, for example, graphs and logbook information, in a larger format for easier viewing by the user. In some embodiments, the remote interface 3512 may be a Smartphone that may be used as a phone, however, may also include an application that allows for the mini-remote interface 3500 to send information to the remote interface 3512 to present the information to the user in a graphic rich format. Thus, in this embodiment, the mini-remote interface 3500 controls the infusion pump 3502, and also receives information from the other devices 3504, 3506, and is the only device in the system that may send commands and/or control the infusion pump 3502, wherein said control includes, but is not limited to, one or more of the following: programming/commanding the delivery of a bolus and/or programming and delivering basal and/or programming/commanding any therapy related command, including, but not limited to, changing therapy or commanding the delivery of therapy. In some embodiments of this embodiment of the system, the mini-remote interface 3500 may also communicate with and send information to a personal computer 3508 and/or the internet. In some embodiments of this embodiment of the system, the remote interface 3512 may also display alarms, alerts, etc., and show the status of the infusion pump 3502 and/or other devices 3504, 3506. In some embodiments, the mini-remote interface 3500 may send data to the remote interface 3512 at regular/programmable intervals, for example, every 2 minutes, however, the intervals may be any interval desired. In some embodiments, the mini-remote interface 3500 may send data to the remote interface 3512 when commanded by the user. In some embodiments, information that is programmed by the user/caregiver into the mini-remote interface 3500 may be shared by the mini-remote interface 3500 to other devices 3512, 3504, 3506 in the system. This information may include, but is not limited to, a blood glucose reading, e.g., a reading from the blood glucose meter that is not otherwise in wireless communication with the mini-remote interface 3500.[P-432]
\Kamen fails to teach determining that the infusion pump is not receiving the CGM data from the CGM system; receive the CGM data from the CGM system; and relay the CGM data received from the CGM system to the infusion pump.
Yagyu on the other hand teaches determining that the pump is no longer receiving CGM data communicated by the continuous glucose monitoring system, receiving the CGM data from the continuous glucose monitoring system(Page 2, Paragraph 3; Page 8, Paragraphs 4-5),
FIG. 1 is a diagram illustrating a configuration example of a wireless communication system according to the present embodiment and an outline of an operation in the wireless communication method according to the present embodiment. As an example, the wireless communication system shown in FIG. 1 is an information collecting device that collects information obtained from the hub 1 that is an information aggregating device and sensors (such as a heart rate monitor and a blood glucose meter) attached to itself. , 4. Hub 1 collects information collected by Nodes 2, 3, and 4 by establishing individual connections with Nodes 2, 3, and 4 and individually communicating with them. Nodes 2 and 3 operate as an information collection device (Node) that notifies Hub 1 of information collected by itself, and can also operate as a relay Node having a function as a relay device. Note that Node 4 operates as an information collection device (Node) that notifies Hub 1 of information collected by itself, and does not have a function as a relay device. [Pg 2, P-3]
As described above, in the present embodiment, when communication between Hub 1 and Node 4 is interrupted, Node 2 and Node 3 that can operate as relay Nodes search for Node 4 where communication is disconnected. Thereafter, the specific Node that has discovered Node 4 notifies Hub 1 to that effect and transmits broadcast information to Node 4 by unicast. And Node4 which received alerting | reporting information requests | requires the start of relay communication to Hub1 via the said specific Node, Hub1 allocates the communication band between an own apparatus-specific Node, and between specific Node-Node4, and relay communication of Instructed to start. Thereafter, relay communication is performed between Hub 1 and Node 4 via the specific node. Thus, in this embodiment, only the relay node that has discovered Node 4 that has lost communication with Hub 1 transmits broadcast information, and the relay Node that has not found Node 4 does not transmit broadcast information. . Thereby, the relay Node of a present Example can reduce the power consumption concerning transmission of alerting | reporting information conventionally. [Pg 8, P-4]
In addition, conventionally, all relay nodes periodically transmit broadcast information, and when transmitting broadcast information, the broadcast information is transmitted and waiting for reception of a relay start request after the broadcast information is transmitted. Occupied the bandwidth. On the other hand, in the present embodiment, only the relay node that has discovered Node 4 that has lost communication with Hub 1 transmits broadcast information, so that it occupies in order to transmit broadcast information compared to the conventional case. It is possible to greatly reduce the bandwidth to be used. [Pg 8, P-5]
It would therefore be obvious to a person of ordinary skill in the art before the effective filing of the invention to combine Yagyu’s teaching with Kamen’s teaching in order to continuously maintain the communication with the glucose monitoring device despite the loss of communication with one transitional medical device accordingly.
Kamen modified fails to teach the determined lost data connection being based at least in part by the remote control device communicating with the infusion pump at regular intervals to determine if the infusion pump is receiving the CGM data
Zhang on the other hand teaches a remote control device of a main control unit capable of detecting the disconnection of wireless communication between a ventilator device and the main control unit (Page 2, Last Paragraph; Page 4, Paragraph 3).
The utility model claims respirator provides a remote alarm device, remote alarming device by short-distance wireless communication module communication with the respirator, thereby adjusting and controlling ventilator. and without requiring the patient or walking near the ventilator operating respirator; on the other hand, when the machine has fault, the wireless communication channel of the respirator is disconnected from remote alarm device, alarm module of the remote alarm device to the main control module detects that the short-range wireless communication channel is disconnected, starting alarm. so as to wake the patient, prevent patient does not obtain the air continuously and resentment[Pg 2, Last Pgph]
remote control warning device 100 having an alarm function, the alarm module 8 may include an audio module and/or a vibration module, the alarm module 8 may be any one of the following or the combination: a speaker, buzzer, vibrating motor matched with the audio alarm module, remote control warning device side of the shell 100 is provided with a sound hole 102, when the host 200 fails to stop operation, wireless communication channel can be disconnected, remote control warning device 100 of the main control module 5 detects that the wireless communication channel is disconnected. control alarm module 8 starts the alarm to send out warning sound prompt or vibration indication. The utility model has the remote control function and alarming module are combined together so that the user of the remote terminal can find alarm prompt.[Pg 4, P-3]
Thereby it is obvious to one of ordinary skill to use Zhang’s disconnection detection means with Kamen modified’s teaching via Yagyu of a relay communication is performed between Hub 1 and Node 4 via the specific node, only when the relay/specific node that has discovered Node 4 that has lost communication with Hub 1 transmits broadcast information, (page 8, Paragraphs 4-5). Zhang’s teaching being the detection means to initiate the relay communication mode to avoid operation disruption due to loss of communication.
Since the claim language lacks the clarification as to how the remote control device is specific to the infusion pump and the CGM system, then one can reasonably interpret the system to merely be a communication network that is monitored by a remote control device.
It would therefore be obvious to a person of ordinary skill in the art before the effective filing of the invention to combine Zhang’s teaching with Kamen modified’s in order to securely ensure continuous communication is maintained between medical devices in order to enable the appropriate operation of the medical devices.
Though Kamen modified via Yagyu teaches the relay of communication data between medical devices , the combination is not specific to relaying the CGM data received from the CGM system by the remote control device to the infusion pump to enable the infusion pump to continue to determine therapy parameters utilizing the CGM data while the infusion pump is no longer receiving the CGM data from the CGM system.
Jollota on the other hand teaches the relay of communication data between medical devices , the combination is not specific to relaying the CGM data received from the CGM system by the remote control device to the infusion pump to enable the infusion pump to continue to determine therapy parameters utilizing the CGM data while the infusion pump is no longer receiving the CGM data from the CGM system. (Paragraphs 37, 39, 40 76, 77)
A plurality of wireless devices in the local infusion system 102 can be arranged and configured to operate in any suitable network topology. For example, the wireless devices may be arranged in a star network topology, a mesh network configuration, a tree network topology, an ad-hoc network topology, or the like. In this regard, FIG. 2 is a diagram that depicts four wireless devices arranged in a star network configuration 200 having a beacon-transmitting wireless device 202 and three listening wireless devices 204, 206, 208. This exemplary star network configuration 200 is shown here for ease of description, and is not intended to limit or otherwise restrict the scope of the disclosed subject matter.[P-39]
In the star network configuration 200, the designated beacon-transmitting wireless device 202 may be referred to as the "hub" or "coordinator" device, where the beacon-transmitting wireless device 202 generates and transmits wireless beacons 210, which can be received by the designated listening wireless devices 204, 206, 208. For this implementation, listening wireless devices 204, 206, 208 do not generate or transmit wireless beacons. Moreover, the beacon-transmitting wireless device 202 can directly communicate with any of the listening wireless devices 204, 206, 208 (as represented by the solid arrows 212 in FIG. 2). When functioning as the hub or coordinator device, the beacon-transmitting wireless device 202 facilitates communication between the listening wireless devices 204, 206, 208 by acting as a wireless repeater, router, or redirector with or without modifications to facilitate such communication. For example, the solid arrow 214 in FIG. 2 schematically illustrates the manner in which the beacon-transmitting wireless device 202 can wirelessly route data between the listening wireless device 204 and the listening wireless device 206. Notably, for this implementation the listening wireless devices 204, 206, 208 are unable to directly communicate with each other in the star network configuration 200. Rather, the beacon-transmitting wireless device 202 must be utilized as the wireless router between the listening wireless devices 204, 206, 208.[P-40]
Although not required of all embodiments, this example assumes that the coordinator device keeps track of missed pings (that are normally expected from the end node device), which could be an indication of poor wireless channel quality. In this regard, the coordinator device could detect loss of wireless synchronization with the end node device, based upon missed pings. For example, if the coordinator device detects that it has missed at least a threshold number of expected pings (as indicated by the ping schedule), then it might conclude that it has lost wireless synchronization with the end node device. Accordingly, the coordinator device may utilize or maintain a counter (such as the counter/timer 316 depicted in FIG. 3) for missed pings, and process 400 may initialize a missed ping count (task 412) for the initial wireless channel. Although not required, this description assumes that the missed ping count is initialized to a count of zero.[P-76]
If the coordinator device fails to receive an expected ping (query task 414), then process 400 increments the missed ping count (task 416) by some amount. For this simple example, task 416 increments the missed ping count by one. If the currently held missed ping count exceeds a threshold count value (query task 418), then the coordinator device will cease the sending of wireless beacons on the initial wireless channel (task 420) and enter a diagnostic or test mode (task 422). The threshold count value used during query task 418 is chosen such that it accurately reflects conditions that can be attributed to loss of wireless synchronization. If the threshold count value has not been exceeded, then process 400 may return to query task 414 to monitor for more missed pings. This example relates to an implementation where the coordinator device considers consecutive or sequential missed pings (although an embodiment could alternatively monitor for missed pings that occur during a specified time period, whether or not they are consecutive). Therefore, if process 400 subsequently determines that an expected ping has not been missed (the "no" branch of query task 414), then the missed ping count is initialized again.[P-77]
Here, Jollota elaborates on a mesh network of medical devices such that a reconfigurable hierarchy of communication channels of a coordinator facilitating communication protocol between devices including acting as a relay/repeater device between two other medical devices, one being the end node (Remote control device (134), BG Meter (136), Infusion Pump (128)) [P-39,40]. Furthermore, Jollota teaches the hierarchy of communication can be reconfigurable as far as which device is the coordinator (conducting direct communication with one device or a relay repeater from a second device to an end node), the second device and end node[P-41, 56]. Jollota then teaches ping calls between device channels to establish communication between the said medical devices. When a threshold number of pings expires such that communication is lost between any two devices, a different channel of communication is established via another device[P-75, 81, 88].
It would therefore be obvious to a person of ordinary skill in the art before the effective filing of the invention to combine Jollota’s teaching with Kamen’s in order to continuously monitor glucose whilst using an infusion pump.
In regards to claim 16, Kamen modified teaches monitoring the connection between the infusion pump and the CGM system is monitored based at least in part by receiving a communication from the infusion pump indicating that the infusion pump is no longer receiving the CGM data. (Paragraph 436).
Referring now also to FIG. 35E, in some embodiments, the mini-remote interface 3500 and a remote interface 3512 may each be used to control an infusion pump 3502 and/or one or more additional device/medical devices 3504, 3506. In some embodiments of this embodiment of the system, the mini-remote interface 3500 may "trump" and therefore, if the remote interface 3512 and the mini-remote interface 3500 were simultaneously both within communication distance with the infusion pump 3502 and/or the one or more devices/medical devices 3504, 3506, then the mini-remote interface 3500 would be the device that may communicate with the infusion pump 3502 and/or the one or more devices/medical devices 3504, 3506. In some embodiments, the mini-remote interface 3500 and the remote interface 3512 may communicate and synchronize information at pre-programmed intervals and/or when within a pre-programmed communication distance, for example, when the mini-remote interface 3500 and the remote interface 3512 recognize that they are within communication distance and/or an interval of time has passed since the last synchronization, the mini-remote interface 3500 and the remote interface 3512 may synchronize using a synchronization protocol which may be any synchronization protocol. The mini-remote interface 3500 and the remote interface 3512 may also pair using the various protocols described and discussed herein.[P-436]
Here we see Kamen describe the communication of the remote control interface with the infusion pump as well as other medical devices during intervals.
When considered with Zhang’s teaching of a remote control device of a main control unit capable of detecting the disconnection of wireless communication between a ventilator device and the main control unit [P-2, Last Pgrph; Pg-4, P-3], then it is obvious to one of ordinary skill in the art to be able to monitor the connection between the infusion pump and the CGM system is monitored based at least in part by receiving a communication from the infusion pump indicating that the infusion pump is no longer receiving the CGM data
In regards to claim 17, Kamen modified teaches the connection between the infusion pump and the CGM system is monitored based at least in part by receiving a communication from the CGM system indicating that the infusion pump is no longer receiving the CGM data. (Paragraph 436, Kamen)
Referring now also to FIG. 35E, in some embodiments, the mini-remote interface 3500 and a remote interface 3512 may each be used to control an infusion pump 3502 and/or one or more additional device/medical devices 3504, 3506. In some embodiments of this embodiment of the system, the mini-remote interface 3500 may "trump" and therefore, if the remote interface 3512 and the mini-remote interface 3500 were simultaneously both within communication distance with the infusion pump 3502 and/or the one or more devices/medical devices 3504, 3506, then the mini-remote interface 3500 would be the device that may communicate with the infusion pump 3502 and/or the one or more devices/medical devices 3504, 3506. In some embodiments, the mini-remote interface 3500 and the remote interface 3512 may communicate and synchronize information at pre-programmed intervals and/or when within a pre-programmed communication distance, for example, when the mini-remote interface 3500 and the remote interface 3512 recognize that they are within communication distance and/or an interval of time has passed since the last synchronization, the mini-remote interface 3500 and the remote interface 3512 may synchronize using a synchronization protocol which may be any synchronization protocol. The mini-remote interface 3500 and the remote interface 3512 may also pair using the various protocols described and discussed herein.[P-436]
Here we see Kamen describe the communication of the remote control interface with one or more medical devices during intervals.
When considered with Zhang’s teaching of a remote control device of a main control unit capable of detecting the disconnection of wireless communication between a ventilator device and the main control unit [P-2, Last Pgrph; Pg-4, P-3], then it is obvious to one of ordinary skill in the art to enable the connection between the infusion pump and the CGM system to be monitored based at least in part by receiving a communication from the CGM system indicating that the infusion pump is no longer receiving the CGM data
In regards to claim 18, Kamen modified via Jollota teaches the CGM data is received from the CGM system only when it has been determined that the infusion pump is not receiving the CGM data.
Jollota teaches the rerouting or the relay of communication data between medical devices, such that if data communication between two medical devices is lost, the communication maybe reroute through other node medical devices to the desired device destination (Paragraphs 37, 39, 40 76, 77, Jollota)
A plurality of wireless devices in the local infusion system 102 can be arranged and configured to operate in any suitable network topology. For example, the wireless devices may be arranged in a star network topology, a mesh network configuration, a tree network topology, an ad-hoc network topology, or the like. In this regard, FIG. 2 is a diagram that depicts four wireless devices arranged in a star network configuration 200 having a beacon-transmitting wireless device 202 and three listening wireless devices 204, 206, 208. This exemplary star network configuration 200 is shown here for ease of description, and is not intended to limit or otherwise restrict the scope of the disclosed subject matter.[P-39]
In the star network configuration 200, the designated beacon-transmitting wireless device 202 may be referred to as the "hub" or "coordinator" device, where the beacon-transmitting wireless device 202 generates and transmits wireless beacons 210, which can be received by the designated listening wireless devices 204, 206, 208. For this implementation, listening wireless devices 204, 206, 208 do not generate or transmit wireless beacons. Moreover, the beacon-transmitting wireless device 202 can directly communicate with any of the listening wireless devices 204, 206, 208 (as represented by the solid arrows 212 in FIG. 2). When functioning as the hub or coordinator device, the beacon-transmitting wireless device 202 facilitates communication between the listening wireless devices 204, 206, 208 by acting as a wireless repeater, router, or redirector with or without modifications to facilitate such communication. For example, the solid arrow 214 in FIG. 2 schematically illustrates the manner in which the beacon-transmitting wireless device 202 can wirelessly route data between the listening wireless device 204 and the listening wireless device 206. Notably, for this implementation the listening wireless devices 204, 206, 208 are unable to directly communicate with each other in the star network configuration 200. Rather, the beacon-transmitting wireless device 202 must be utilized as the wireless router between the listening wireless devices 204, 206, 208.[P-40]
Although not required of all embodiments, this example assumes that the coordinator device keeps track of missed pings (that are normally expected from the end node device), which could be an indication of poor wireless channel quality. In this regard, the coordinator device could detect loss of wireless synchronization with the end node device, based upon missed pings. For example, if the coordinator device detects that it has missed at least a threshold number of expected pings (as indicated by the ping schedule), then it might conclude that it has lost wireless synchronization with the end node device. Accordingly, the coordinator device may utilize or maintain a counter (such as the counter/timer 316 depicted in FIG. 3) for missed pings, and process 400 may initialize a missed ping count (task 412) for the initial wireless channel. Although not required, this description assumes that the missed ping count is initialized to a count of zero.[P-76]
If the coordinator device fails to receive an expected ping (query task 414), then process 400 increments the missed ping count (task 416) by some amount. For this simple example, task 416 increments the missed ping count by one. If the currently held missed ping count exceeds a threshold count value (query task 418), then the coordinator device will cease the sending of wireless beacons on the initial wireless channel (task 420) and enter a diagnostic or test mode (task 422). The threshold count value used during query task 418 is chosen such that it accurately reflects conditions that can be attributed to loss of wireless synchronization. If the threshold count value has not been exceeded, then process 400 may return to query task 414 to monitor for more missed pings. This example relates to an implementation where the coordinator device considers consecutive or sequential missed pings (although an embodiment could alternatively monitor for missed pings that occur during a specified time period, whether or not they are consecutive). Therefore, if process 400 subsequently determines that an expected ping has not been missed (the "no" branch of query task 414), then the missed ping count is initialized again.[P-77]
Thereby in conjunction with Zhang’s teaching of a remote control device of a main control unit capable of detecting the disconnection of wireless communication between a medical device and another device[P-2, Last Pgrph; Pg-4, P-3], then it is obvious to one of ordinary skill in the art to configure the CGM data being received from the CGM system only when it has been determined that the infusion pump is not receiving the CGM data.
In regards to claim 19, Kamen modified via Jollota teaches the processor is further configured to relay communications from the infusion pump to the CGM system.
Jollota teaches the rerouting or the relay of communication data between medical devices, such that if data communication between two medical devices is lost, the communication maybe reroute through other node medical devices to the desired device destination (Paragraphs 37, 39, 40 76, 77, Jollota)
A plurality of wireless devices in the local infusion system 102 can be arranged and configured to operate in any suitable network topology. For example, the wireless devices may be arranged in a star network topology, a mesh network configuration, a tree network topology, an ad-hoc network topology, or the like. In this regard, FIG. 2 is a diagram that depicts four wireless devices arranged in a star network configuration 200 having a beacon-transmitting wireless device 202 and three listening wireless devices 204, 206, 208. This exemplary star network configuration 200 is shown here for ease of description, and is not intended to limit or otherwise restrict the scope of the disclosed subject matter.[P-39]
In the star network configuration 200, the designated beacon-transmitting wireless device 202 may be referred to as the "hub" or "coordinator" device, where the beacon-transmitting wireless device 202 generates and transmits wireless beacons 210, which can be received by the designated listening wireless devices 204, 206, 208. For this implementation, listening wireless devices 204, 206, 208 do not generate or transmit wireless beacons. Moreover, the beacon-transmitting wireless device 202 can directly communicate with any of the listening wireless devices 204, 206, 208 (as represented by the solid arrows 212 in FIG. 2). When functioning as the hub or coordinator device, the beacon-transmitting wireless device 202 facilitates communication between the listening wireless devices 204, 206, 208 by acting as a wireless repeater, router, or redirector with or without modifications to facilitate such communication. For example, the solid arrow 214 in FIG. 2 schematically illustrates the manner in which the beacon-transmitting wireless device 202 can wirelessly route data between the listening wireless device 204 and the listening wireless device 206. Notably, for this implementation the listening wireless devices 204, 206, 208 are unable to directly communicate with each other in the star network configuration 200. Rather, the beacon-transmitting wireless device 202 must be utilized as the wireless router between the listening wireless devices 204, 206, 208.[P-40]
Although not required of all embodiments, this example assumes that the coordinator device keeps track of missed pings (that are normally expected from the end node device), which could be an indication of poor wireless channel quality. In this regard, the coordinator device could detect loss of wireless synchronization with the end node device, based upon missed pings. For example, if the coordinator device detects that it has missed at least a threshold number of expected pings (as indicated by the ping schedule), then it might conclude that it has lost wireless synchronization with the end node device. Accordingly, the coordinator device may utilize or maintain a counter (such as the counter/timer 316 depicted in FIG. 3) for missed pings, and process 400 may initialize a missed ping count (task 412) for the initial wireless channel. Although not required, this description assumes that the missed ping count is initialized to a count of zero.[P-76]
If the coordinator device fails to receive an expected ping (query task 414), then process 400 increments the missed ping count (task 416) by some amount. For this simple example, task 416 increments the missed ping count by one. If the currently held missed ping count exceeds a threshold count value (query task 418), then the coordinator device will cease the sending of wireless beacons on the initial wireless channel (task 420) and enter a diagnostic or test mode (task 422). The threshold count value used during query task 418 is chosen such that it accurately reflects conditions that can be attributed to loss of wireless synchronization. If the threshold count value has not been exceeded, then process 400 may return to query task 414 to monitor for more missed pings. This example relates to an implementation where the coordinator device considers consecutive or sequential missed pings (although an embodiment could alternatively monitor for missed pings that occur during a specified time period, whether or not they are consecutive). Therefore, if process 400 subsequently determines that an expected ping has not been missed (the "no" branch of query task 414), then the missed ping count is initialized again.[P-77]
Thereby it is obvious to one of ordinary skill in the art to enable the processor to be configured to relay communications from the infusion pump to the CGM system.
(via Jollota’s mesh network).
In regards to claim 20, Kamen modified via Jollota teaches the processor is further configured to determine that the infusion pump has resumed receiving the CGM data from the CGM system; and cease relaying the CGM data received from the CGM system to the infusion pump.
Jollota teaches the rerouting or the relay of communication data between medical devices, such that if data communication between two medical devices is lost, the communication maybe reroute through other node medical devices to the desired device destination (Paragraphs 37, 39, 40 76, 77, Jollota)
A plurality of wireless devices in the local infusion system 102 can be arranged and configured to operate in any suitable network topology. For example, the wireless devices may be arranged in a star network topology, a mesh network configuration, a tree network topology, an ad-hoc network topology, or the like. In this regard, FIG. 2 is a diagram that depicts four wireless devices arranged in a star network configuration 200 having a beacon-transmitting wireless device 202 and three listening wireless devices 204, 206, 208. This exemplary star network configuration 200 is shown here for ease of description, and is not intended to limit or otherwise restrict the scope of the disclosed subject matter.[P-39]
In the star network configuration 200, the designated beacon-transmitting wireless device 202 may be referred to as the "hub" or "coordinator" device, where the beacon-transmitting wireless device 202 generates and transmits wireless beacons 210, which can be received by the designated listening wireless devices 204, 206, 208. For this implementation, listening wireless devices 204, 206, 208 do not generate or transmit wireless beacons. Moreover, the beacon-transmitting wireless device 202 can directly communicate with any of the listening wireless devices 204, 206, 208 (as represented by the solid arrows 212 in FIG. 2). When functioning as the hub or coordinator device, the beacon-transmitting wireless device 202 facilitates communication between the listening wireless devices 204, 206, 208 by acting as a wireless repeater, router, or redirector with or without modifications to facilitate such communication. For example, the solid arrow 214 in FIG. 2 schematically illustrates the manner in which the beacon-transmitting wireless device 202 can wirelessly route data between the listening wireless device 204 and the listening wireless device 206. Notably, for this implementation the listening wireless devices 204, 206, 208 are unable to directly communicate with each other in the star network configuration 200. Rather, the beacon-transmitting wireless device 202 must be utilized as the wireless router between the listening wireless devices 204, 206, 208.[P-40]
Although not required of all embodiments, this example assumes that the coordinator device keeps track of missed pings (that are normally expected from the end node device), which could be an indication of poor wireless channel quality. In this regard, the coordinator device could detect loss of wireless synchronization with the end node device, based upon missed pings. For example, if the coordinator device detects that it has missed at least a threshold number of expected pings (as indicated by the ping schedule), then it might conclude that it has lost wireless synchronization with the end node device. Accordingly, the coordinator device may utilize or maintain a counter (such as the counter/timer 316 depicted in FIG. 3) for missed pings, and process 400 may initialize a missed ping count (task 412) for the initial wireless channel. Although not required, this description assumes that the missed ping count is initialized to a count of zero.[P-76]
If the coordinator device fails to receive an expected ping (query task 414), then process 400 increments the missed ping count (task 416) by some amount. For this simple example, task 416 increments the missed ping count by one. If the currently held missed ping count exceeds a threshold count value (query task 418), then the coordinator device will cease the sending of wireless beacons on the initial wireless channel (task 420) and enter a diagnostic or test mode (task 422). The threshold count value used during query task 418 is chosen such that it accurately reflects conditions that can be attributed to loss of wireless synchronization. If the threshold count value has not been exceeded, then process 400 may return to query task 414 to monitor for more missed pings. This example relates to an implementation where the coordinator device considers consecutive or sequential missed pings (although an embodiment could alternatively monitor for missed pings that occur during a specified time period, whether or not they are consecutive). Therefore, if process 400 subsequently determines that an expected ping has not been missed (the "no" branch of query task 414), then the missed ping count is initialized again.[P-77]
Thereby in conjunction with Zhang’s teaching of a remote control device of a main control unit capable of detecting the disconnection of wireless communication between a medical device and another device[P-2, Last Pgrph; Pg-4, P-3], then in the same respect, it is obvious to one of ordinary skill in the art to detect when communication between a medical device and another device has resumed, so as to configure ceasing relaying the CGM data from the CGM system to the infusion pump (via Jollota’s mesh network).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANTHONY D AFRIFA-KYEI whose telephone number is (571)270-7826. The examiner can normally be reached Monday-Friday 10am-7pm.
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/ANTHONY D AFRIFA-KYEI/Examiner, Art Unit 2686
/BRIAN A ZIMMERMAN/Supervisory Patent Examiner, Art Unit 2686
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