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).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-20 are rejected on the ground of non-statutory double patenting over claims 1-20 of U.S. Patent No. 12136478 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 1-4, 6-8, 10, 12, 13, 15-17, 19 and 20 are rejected on the ground of non-statutory double patenting as being unpatentable over claim 1-20 of U.S. Patent No. 12136478 (hereinafter referred to as Bazargan)
Regarding claim 1, Bazargan discloses a method for automatically configuring a medical device with user-specific configuration data, the method comprising: determining, by a first medical device, that the first medical device is being removed from service on a patient based at least in part on detecting removal of a portion of the first medical device from contact with or being coupled to the patient (Claim 1)
A method for automatically configuring a medical device with user-specific configuration data, the method comprising: determining, by a first medical device, that the first medical device is being removed from service on a patient based at least in part on detecting removal of a portion of the first medical device from contact with or being coupled to the patient, wherein the first medical device was previously placed into service on the patient to provide therapy to the patient in accordance with user-specific configuration data stored on the first medical device, and wherein the first medical device is to be replaced with a second medical device that is a replacement medical device for the first medical device responsive to the determination that the first medical device is being removed from service on the patient; and causing, by the first medical device in response to determining that the first medical device is being removed from service on the patient, configuration of the second medical device to provide therapy to the patient in accordance with the user-specific configuration data, wherein causing configuration of the second medical device comprises communicating the user-specific configuration data toward the second medical device.[Cl-1]
Bazargan then teaches in response to determining that the first medical device is being removed from service on the patient, communicating user-specific configuration data used by the first medical device to a second medical device, wherein the second medical device is a replacement medical device for the first medical device.
A method for automatically configuring a medical device with user-specific configuration data, the method comprising: determining, by a first medical device, that the first medical device is being removed from service on a patient based at least in part on detecting removal of a portion of the first medical device from contact with or being coupled to the patient, wherein the first medical device was previously placed into service on the patient to provide therapy to the patient in accordance with user-specific configuration data stored on the first medical device, and wherein the first medical device is to be replaced with a second medical device that is a replacement medical device for the first medical device responsive to the determination that the first medical device is being removed from service on the patient; and causing, by the first medical device in response to determining that the first medical device is being removed from service on the patient, configuration of the second medical device to provide therapy to the patient in accordance with the user-specific configuration data, wherein causing configuration of the second medical device comprises communicating the user-specific configuration data toward the second medical device.[Cl-1]
Here we see Bazargan teaching in response to determining that the first medical device is being removed from service on the patient, configuration of the second medical device to provide therapy to the patient in accordance with the user-specific configuration data, wherein causing configuration of the second medical device comprises communicating the user-specific configuration data toward the second medical device. Though the removal is in the midst of therapeutic medical practices, the protocol of removal and transition disclosed as the pending applicant and therefore obvious to one of ordinary skill in the art that in the act of providing medical therapy Bazargan’s teaching disclose the applicant’s disclosure in its entirety.
Regarding claim 2, Bazargan teaches prior to communicating the user-specific configuration data toward the second medical device, establishing a communication link through which the first medical device communicates the user-specific configuration (Claim 2)
The method of claim 1, further comprising: prior to communicating the user-specific configuration data toward the second medical device, establishing a communication link through which the first medical device communicates the user-specific configuration data.[Cl-2]
Regarding claim 3, Bazargan teaches the user-specific configuration data comprises at least one of a group including information indicative of insulin-on-board, a safe basal rate, one or more insulin delivery rate limits, one or more glucose sensor calibration factors, an insulin sensitivity factor, and a history of insulin delivery.(Claim 3)
The method of claim 1, wherein the user-specific configuration data comprises at least one of: information indicative of insulin-on-board, a safe basal rate, one or more insulin delivery rate limits, one or more glucose sensor calibration factors, an insulin sensitivity factor, or a history of insulin delivery.[Cl-3]
Regarding claim 4, Bazargan teaches communicating the user-specific configuration data to the second medical device comprises communicating the user-specific configuration data to an intermediate device.(Claim 10)
The method of claim 1, wherein communicating the user-specific configuration data toward the second medical device comprises communicating the user-specific configuration data to an intermediate device.[Cl-10]
Regarding claim 6, Bazargan teaches detecting the removal of the portion of the first medical device from contact with or being coupled to the patient comprises determining removal of a cannula associated with the first medical device(Claim 5)
The method of claim 1, wherein determining that the first medical device is being removed from service comprises determining removal of a cannula associated with the first medical device.[Cl-5]
Regarding claim 7, Bazargan teaches detecting the removal of the portion of the first medical device from contact with or being coupled to the patient comprises determining that a glucose sensor is no longer in contact with interstitial fluid.(Claim 8)
The method of claim 1, wherein determining that the first medical device is being removed from service comprises determining that a glucose sensor is no longer in contact with interstitial fluid.[Cl-8]
Regarding claim 8, Bazargan teaches communicating the user-specific configuration data occurs without user input. (Claim 1)
A method for automatically configuring a medical device with user-specific configuration data, the method comprising: determining, by a first medical device, that the first medical device is being removed from service on a patient based at least in part on detecting removal of a portion of the first medical device from contact with or being coupled to the patient, wherein the first medical device was previously placed into service on the patient to provide therapy to the patient in accordance with user-specific configuration data stored on the first medical device, and wherein the first medical device is to be replaced with a second medical device that is a replacement medical device for the first medical device responsive to the determination that the first medical device is being removed from service on the patient; and causing, by the first medical device in response to determining that the first medical device is being removed from service on the patient, configuration of the second medical device to provide therapy to the patient in accordance with the user-specific configuration data, wherein causing configuration of the second medical device comprises communicating the user-specific configuration data toward the second medical device.[Cl-1]
By disclosing the method being automatically configured for the medical devices, then it would be obvious to one of ordinary skill in the art communicating the user-specific configuration data occurs without user input
Regarding claim 10, Bazargan on the other hand teaches a system for automatically configuring a medical device with user-specific configuration data, the system comprising: one or more processors; and one or more processor-readable storage media storing instructions which, when executed by the one or more processors, cause performance of: determining, by a first medical device, that the first medical device is being removed from service on a patient based at least in part on detecting removal of a portion of the first medical device from contact with or being coupled to the patient (Claim 11)
A system for automatically configuring a medical device with user-specific configuration data, the system comprising: one or more processors; and one or more processor-readable storage media storing instructions which, when executed by the one or more processors, cause performance of: determining that a first medical device is being removed from service on a patient based at least in part on detecting removal of a portion of the first medical device from contact with or being coupled to the patient, wherein the first medical device was previously placed into service on the patient to provide therapy to the patient in accordance with user-specific configuration data stored on the first medical device, and wherein the first medical device is to be replaced with a second medical device that is a replacement medical device for the first medical device responsive to the determination that the first medical device is being removed from service on the patient; and in response to determining that the first medical device is being removed from service on the patient, causing configuration of the second medical device to provide therapy to the patient in accordance with the user-specific configuration data, wherein causing configuration of the second medical device comprises communicating the user-specific configuration data toward the second medical device.[Cl-11]
Bazargan then teaches in response to determining that the first medical device is being removed from service on the patient, communicating user-specific configuration data used by the first medical device to a second medical device, wherein the second medical device is a replacement medical device for the first medical device.(Claim 11)
A system for automatically configuring a medical device with user-specific configuration data, the system comprising: one or more processors; and one or more processor-readable storage media storing instructions which, when executed by the one or more processors, cause performance of: determining that a first medical device is being removed from service on a patient based at least in part on detecting removal of a portion of the first medical device from contact with or being coupled to the patient, wherein the first medical device was previously placed into service on the patient to provide therapy to the patient in accordance with user-specific configuration data stored on the first medical device, and wherein the first medical device is to be replaced with a second medical device that is a replacement medical device for the first medical device responsive to the determination that the first medical device is being removed from service on the patient; and in response to determining that the first medical device is being removed from service on the patient, causing configuration of the second medical device to provide therapy to the patient in accordance with the user-specific configuration data, wherein causing configuration of the second medical device comprises communicating the user-specific configuration data toward the second medical device.[Cl-11]
Here we see Bazargan teaching in response to determining that the first medical device is being removed from service on the patient, configuration of the second medical device to provide therapy to the patient in accordance with the user-specific configuration data, wherein causing configuration of the second medical device comprises communicating the user-specific configuration data toward the second medical device. Though the removal is in the midst of therapeutic medical practices, the protocol of removal and transition disclosed as the pending applicant and therefore obvious to one of ordinary skill in the art that in the act of providing medical therapy Bazargan’s teaching disclose the applicant’s disclosure in its entirety.
Regarding claim 12, Bazargan teaches the user-specific configuration data comprises at least one of a group including information indicative of insulin-on-board, a safe basal rate, one or more insulin delivery rate limits, one or more glucose sensor calibration factors, an insulin sensitivity factor, and a history of insulin delivery (Claim 12)
The system of claim 11, wherein the user-specific configuration data comprises at least one of: information indicative of insulin-on-board, a safe basal rate, one or more insulin delivery rate limits, one or more glucose sensor calibration factors, an insulin sensitivity factor, or a history of insulin delivery.[Cl-12]
Regarding claim 13, Bazargan teaches communicating the user-specific configuration data to the second medical device comprises communicating the user-specific configuration data to an intermediate device.(Claim 13)
The system of claim 11, wherein the first medical device comprises a first portion and a second portion, and wherein determining that the first medical device is being removed from service comprises determining that the first portion is separated from the second portion.[Cl-13]
Regarding claim 15, Bazargan teaches detecting the removal of the portion of the first medical device from contact with or being coupled to the patient comprises determining removal of a cannula associated with the first medical device.(Claim 14)
The system of claim 11, wherein determining that the first medical device is being removed from service comprises determining removal of a cannula associated with the first medical device.[Cl-14]
Regarding claim 16, Bazargan teaches detecting the removal of the portion of the first medical device from contact with or being coupled to the patient comprises determining that a glucose sensor is no longer in contact with interstitial fluid.(Claim 17)
The system of claim 11, wherein determining that the first medical device is being removed from service comprises determining that a glucose sensor is no longer in contact with interstitial fluid.[Cl-17]
Regarding claim 17, Bazargan teaches communicating the user-specific configuration data occurs without user input. (Claim 11)
A system for automatically configuring a medical device with user-specific configuration data, the system comprising: one or more processors; and one or more processor-readable storage media storing instructions which, when executed by the one or more processors, cause performance of: determining that a first medical device is being removed from service on a patient based at least in part on detecting removal of a portion of the first medical device from contact with or being coupled to the patient, wherein the first medical device was previously placed into service on the patient to provide therapy to the patient in accordance with user-specific configuration data stored on the first medical device, and wherein the first medical device is to be replaced with a second medical device that is a replacement medical device for the first medical device responsive to the determination that the first medical device is being removed from service on the patient; and in response to determining that the first medical device is being removed from service on the patient, causing configuration of the second medical device to provide therapy to the patient in accordance with the user-specific configuration data, wherein causing configuration of the second medical device comprises communicating the user-specific configuration data toward the second medical device.[Cl-11]
By disclosing the method being automatically configured for the medical devices, then it would be obvious to one of ordinary skill in the art communicating the user-specific configuration data occurs without user input
Regarding claim 19, Bazargan teaches a method for automatically configuring a medical device with user-specific configuration data, the method comprising: detecting removal of a portion of a first medical device from contact with or being coupled to a patient based on signals from one or more sensors associated with a first medical device; determining, by the first medical device, that the first medical device is being removed from service based at least in part on the detection(Claim 1)
A method for automatically configuring a medical device with user-specific configuration data, the method comprising: determining, by a first medical device, that the first medical device is being removed from service on a patient based at least in part on detecting removal of a portion of the first medical device from contact with or being coupled to the patient, wherein the first medical device was previously placed into service on the patient to provide therapy to the patient in accordance with user-specific configuration data stored on the first medical device, and wherein the first medical device is to be replaced with a second medical device that is a replacement medical device for the first medical device responsive to the determination that the first medical device is being removed from service on the patient; and causing, by the first medical device in response to determining that the first medical device is being removed from service on the patient, configuration of the second medical device to provide therapy to the patient in accordance with the user-specific configuration data, wherein causing configuration of the second medical device comprises communicating the user-specific configuration data toward the second medical device.[Cl-1]
Bazargan then teaches in response to determining that the first medical device is being removed from service on the patient, communicating user-specific configuration data used by the first medical device to a second medical device, wherein the second medical device is a replacement medical device for the first medical device(Claim 1)
A method for automatically configuring a medical device with user-specific configuration data, the method comprising: determining, by a first medical device, that the first medical device is being removed from service on a patient based at least in part on detecting removal of a portion of the first medical device from contact with or being coupled to the patient, wherein the first medical device was previously placed into service on the patient to provide therapy to the patient in accordance with user-specific configuration data stored on the first medical device, and wherein the first medical device is to be replaced with a second medical device that is a replacement medical device for the first medical device responsive to the determination that the first medical device is being removed from service on the patient; and causing, by the first medical device in response to determining that the first medical device is being removed from service on the patient, configuration of the second medical device to provide therapy to the patient in accordance with the user-specific configuration data, wherein causing configuration of the second medical device comprises communicating the user-specific configuration data toward the second medical device.[Cl-1]
Regarding claim 20, Bazargan teaches the user-specific configuration data comprises at least one of a group including information indicative of insulin-on-board, a safe basal rate, one or more insulin delivery rate limits, one or more glucose sensor calibration factors, an insulin sensitivity factor, and a history of insulin delivery.(Claim 3)
The method of claim 1, wherein the user-specific configuration data comprises at least one of: information indicative of insulin-on-board, a safe basal rate, one or more insulin delivery rate limits, one or more glucose sensor calibration factors, an insulin sensitivity factor, or a history of insulin delivery.[Cl-3]
Claims 5 and 14 are rejected on the ground of non-statutory double patenting as being unpatentable over claim 1, 11 of U.S. Patent No. 12136478 (hereinafter referred to as Bazargan) in view of Remde (US 20110218495 A1)
Regarding claim 5, Bazargan fails to explicitly teach the intermediate device comprises a charger device.
Remde on the other hand teaches the intermediate device comprises a charger device (Paragraph 35, Remde)
In one exemplary embodiment, the status may further comprise the status of a battery 80 of the insulin pump 1. Such an embodiment may be utilized, for example, when the battery 80 is integral with the pump 1 and cannot be replaced. While the battery 80 capacity of these types of devices may include a safety factor to ensure that the battery 80 is not exhausted prior to the reservoir being empty, this situation may nonetheless occur if the battery is, due to improper assembly, partly discharged during assembly of the infusion pump, or due to a defective of the battery 80 itself, or the like. Therefore, the battery voltage may be monitored by a voltage monitoring unit in an analogue way to the filling volume of the insulin reservoir. Additionally or alternatively to the voltage, the energy effectively taken from the batter may be monitored by a gauging unit known in the art.[P-35]
Here we see Remde teaches a voltage monitoring unit that supplies charge as an intermediate device. Therefore, it would have been obvious to one of ordinary skill in the art to combine Remde’s teaching with Bazargan’s teaching in order to enable a more effective method to monitor and further supply/charge the medical device(s).
Regarding claim 14, Bazargan fails to explicitly teach the intermediate device comprises a charger device.
Remde on the other hand teaches the intermediate device comprises a charger device (Paragraph 35, Remde)
In one exemplary embodiment, the status may further comprise the status of a battery 80 of the insulin pump 1. Such an embodiment may be utilized, for example, when the battery 80 is integral with the pump 1 and cannot be replaced. While the battery 80 capacity of these types of devices may include a safety factor to ensure that the battery 80 is not exhausted prior to the reservoir being empty, this situation may nonetheless occur if the battery is, due to improper assembly, partly discharged during assembly of the infusion pump, or due to a defective of the battery 80 itself, or the like. Therefore, the battery voltage may be monitored by a voltage monitoring unit in an analogue way to the filling volume of the insulin reservoir. Additionally or alternatively to the voltage, the energy effectively taken from the batter may be monitored by a gauging unit known in the art.[P-35]
Here we see Remde teaches a voltage monitoring unit that supplies charge as an intermediate device. Therefore, it would have been obvious to one of ordinary skill in the art to combine Remde’s teaching with Bazargan’s teaching in order to enable a more effective method to monitor and further supply/charge the medical device(s).
Claims 9 and 18 are rejected on the ground of non-statutory double patenting as being unpatentable over claim 1, 11 of U.S. Patent No. 12136478 (hereinafter referred to as Bazargan) in view of McCullough et al. (US 20200353169 A1)
Regarding claim 9, Bazargan fails to teach detecting the removal of the portion of the first medical device from contact with or being coupled to the patient comprises processing data from at least one of a force sensor or a light sensor.
McCullough on the other hand teaches detecting the removal of the portion of the first medical device from contact with or being coupled to the patient comprises processing data from at least one of a force sensor or a light sensor (Paragraph 160)
A variety of sensors may be used to determine the operational state of application to patient. For example, back EMF through a coil from moving magnet on needle shield may indicate that the device has been applied to the patient. Alternatively, displacement of component or assembly (such as the needle shield) because of application of the drug delivery device to the patient may open or close a switch/circuit to signal this operational state. Along similar lines, the movement of components or assemblies may be detected using an optical sensor, with the light beam between a transmitter and receiver being broken by a change in the position of components, such as the needle shield or the reservoir (e.g., syringe or cartridge), upon application of the drug delivery device to the patient. As a further alternative, a capacitive or resistive sensor may be used, as may a pressure sensor. In fact, information regarding cannula (or needle) insertion may be determined by measuring the resistance through the needle and/or skin relative to external contact. Changes in temperature at the end of the drug delivery device intended to abut the patient's skin may also be used to determine the operational state of application to the patient.[P-160]
Here we see optical/light sensors used to determine movement of the medical device with respect to the patient especially in relation to needle relative to skin/contact. Thereby it is obvious to one of ordinary skill in the art to combine McCullough’s teaching with Bazargan’s teaching in order to be more effectively enable the detection of the removal of a medical device accordingly.
Regarding claim 18, Bazargan fails to teach detecting the removal of the portion of the first medical device from contact with or being coupled to the patient comprises processing data from at least one of a force sensor or a light sensor.
McCullough on the other hand teaches detecting the removal of the portion of the first medical device from contact with or being coupled to the patient comprises processing data from at least one of a force sensor or a light sensor (Paragraph 160)
A variety of sensors may be used to determine the operational state of application to patient. For example, back EMF through a coil from moving magnet on needle shield may indicate that the device has been applied to the patient. Alternatively, displacement of component or assembly (such as the needle shield) because of application of the drug delivery device to the patient may open or close a switch/circuit to signal this operational state. Along similar lines, the movement of components or assemblies may be detected using an optical sensor, with the light beam between a transmitter and receiver being broken by a change in the position of components, such as the needle shield or the reservoir (e.g., syringe or cartridge), upon application of the drug delivery device to the patient. As a further alternative, a capacitive or resistive sensor may be used, as may a pressure sensor. In fact, information regarding cannula (or needle) insertion may be determined by measuring the resistance through the needle and/or skin relative to external contact. Changes in temperature at the end of the drug delivery device intended to abut the patient's skin may also be used to determine the operational state of application to the patient.[P-160]
Here we see optical/light sensors used to determine movement of the medical device with respect to the patient especially in relation to needle relative to skin/contact. Thereby it is obvious to one of ordinary skill in the art to combine McCullough’s teaching with Bazargan’s teaching in order to be more effectively enable the detection of the removal of a medical device accordingly.
Claims 11 are rejected on the ground of non-statutory double patenting as being unpatentable over claim 11 of U.S. Patent No. 12136478 (hereinafter referred to as Bazargan) in view of Durrant et al. (CN 107615396 B)
Regarding claim 11, Bazargan fails to teach the instructions further cause performance of: prior to communicating the user-specific configuration data toward the second medical device, establishing a communication link through which the first medical device communicates the user-specific configuration.
Durrant on the other hand teaches the instructions further cause performance of: prior to communicating the user-specific configuration data toward the second medical device, establishing a communication link through which the first medical device communicates the user-specific configuration(Page 2, content of the invention; Page 4, Paragraph 3; Page 14, Paragraph 6, Durant)
A system for clinical data transfer (handovers) in a medical event according to an embodiment of the present disclosure comprises a server device communicatively coupled to the network, the server device comprises a memory and a processor communicatively coupled to the memory, the memory comprises instructions, the instructions when executed by the processor cause the processor to start at least one component, the at least one component comprising: a communication component, configured to facilitate communication with the first medical device and the second medical device during the medical event, receiving a first clinical information from the first medical device, and the following one or more of the or (a) displaying at least some of the first clinical information on the second medical device, (b) displaying on the second medical device from at least some of the first clinical information, (c) modifying the operation of the second medical device based on the first clinical information, and (d) storing the first clinical information in a remote database of the second medical device or and a graphical user interface (GUI) configured to facilitate interaction between a user and the communication component.[Pg 2, contents of invention]
The embodiment of the present disclosure for delivering clinical data (e.g., in a medical event) system comprises a first medical device, configured to monitor patient portion of the medical event during monitoring and storing the first clinical information a second medical device, the second medical device is configured to monitor the patient in the second portion of the medical event and storing the second patient information a control module configured to receive an indication of the same patient using the first medical device and the second medical device during the medical event, and based on the indication, establishing access of the second medical device to the first clinical information to allow the second medical device to perform one of or following in the medical event period: (a) displaying at least some of the first clinical information on the second medical device, (b) displaying at least some of the information from the first clinical information on the second medical device, (c) modifying the operation of the second medical device based on the first clinical information, and (d) storing the first clinical information in a remote database of the second medical device or [Pg 4, P-3]
FIG. 3 depicts an illustrative operating environment 300 according to an embodiment of the present invention. The illustrative operation environment 300 includes a management server 302, which is configured to communicate with the medical device 304 via a network 306. Any number of additional medical devices 308 may also be configured to communicate with the management server 302. The communication between the management server 302 and the medical device 304 and/or the medical device 304 may be uni-directional or bidirectionally. According to the embodiment, the user can use the user device 310 to communicate with the management server 302. The management server 302 may be (or to), for example, the management server 108 shown in FIG. 1; The medical device 304 and/or the medical device 308 may be (or to) medical devices 102, 104 and/or 106 as shown in FIG. 1; The network 306 may be (or to) or one of the networks 110, 112 and 114 shown in FIG. 1; and the user device 310 may be (or to) the user device 118 and/or 120 shown in FIG. 1.[Pg 14, P-6]
Thereby it is obvious to one of ordinary skill in the art to combine Durrant’s teaching with Bazargan’s teaching in order to enable a secure communication between the medical devices to enable the transitional replacement.
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(s) 1, 2, 4, 5, 8, 10, 11, 13, 14, 17, 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Durrant et al. (CN 107615396 B) in view of Remde (US 20110218495 A1).
In regards to claim 1, Durrant teaches a method for automatically configuring a medical device with user-specific configuration data(Abstract; Page 2, contents of invention; Claim 1)
The invention relates to a system for transmitting clinical data during medical event, method and device. Certain embodiments of the present disclosure include a first medical device and a second medical device, the first medical device is configured to monitor and patient clinical information during the first portion of the medical event. the second medical device can display at least some of the clinical information, modifying the operation or the second medical device to store the clinical information[Abstract]
A system for clinical data transfer (handovers) in a medical event according to an embodiment of the present disclosure comprises a server device communicatively coupled to the network, the server device comprises a memory and a processor communicatively coupled to the memory, the memory comprises instructions, the instructions when executed by the processor cause the processor to start at least one component, the at least one component comprising: a communication component, configured to facilitate communication with the first medical device and the second medical device during the medical event, receiving a first clinical information from the first medical device, and the following one or more of the or (a) displaying at least some of the first clinical information on the second medical device, (b) displaying on the second medical device from at least some of the first clinical information, (c) modifying the operation of the second medical device based on the first clinical information, and (d) storing the first clinical information in a remote database of the second medical device or and a graphical user interface (GUI) configured to facilitate interaction between a user and the communication component.[Pg 2, contents of invention]
Durrant teaches communicating user-specific configuration data used by the first medical device to a second medical device, wherein the second medical device is a replacement medical device for the first medical device (Page 23, Paragraph 6-Page 24, Paragraph 1)
Any medical device 602/604 may be used during the first portion of the emergency medical event. In some cases, the second part of the emergency medical event occurs after the first part of the emergency medical event. For example, the first part of the emergency medical event can be characterized as, wherein the first responder (such as having an emergency response condition with little or no training of the person) help patient In other instances, the first portion of the emergency medical event may be characterized as the trained medical device personnel in response to emergency medical event. any one of medical device 602 and medical device 604 can be used for emergency medical event of the second part. The second portion of the emergency medical event may be characterized as, for example, the EMT participates in the emergency medical event after the first responder, and the or of the hospital takes part in the case of emergency medical events after the EMT and/or the first responder. [Pg 23, P-6]
In a potential emergency medical event, (first) medical device 602 is configured to monitor and patient the first clinical information in its memory 610 (and such memory can be on the device 602, on the networking device or both, and/or across the device 602 or device 602 of a plurality of devices distributed). (Second) the medical device 604 is configured to monitor and patient the second patient information in its memory 610 (and such a memory may be on the device 602), on the networking device or both, and/or across the device 602 or device 602 of a plurality of devices distributed). (first) medical device 602 and (second) medical device 604 provides control module 616, or (first) medical device 602 and (second) medical device 604 provides control module 616, or optionally, The cloud-based network 606 provides a control module 616 as or cloud-based network 606-provides control module 616. (second) medical device 604 provides control module 616 is configured to receive the same emergency medical event during the same patient (first) medical device 602 and (second) medical device 604). The indication is discussed in more detail with reference to FIG. 7. Based on the indication, the (second) medical device 604 establishes access to the first clinical information stored on the (first) medical device 602. As a result of this access, (second) the medical device 604 is allowed to display at least some of the first clinical information on the display 612 of the emergency medical event. In addition, (second) medical device 604 may also be based on the first clinical information (second) medical device 604 operation. In addition, (second) medical device 604 may also store the first clinical information in (second) medical device 604 memory 610. (second) medical device 604 may also be based on cloud-based network 606 the first clinical information is transmitted to the remote database.[Pg 24, P-1]
Durrant fails to teach determining, by a first medical device, that the first medical device is being removed from service on a patient based at least in part on detecting removal of a portion of the first medical device from contact with or being coupled to the patient.
Remde on the other hand teaches determining, by a first medical device, that the first medical device is being removed from service on a patient based at least in part on detecting removal of a portion of the first medical device from contact with or being coupled to the patient (Paragraphs 8, 9, 28, 33, 65, 66)
In another embodiment, a method for replacing a first insulin pump by a second insulin pump, includes operating the first insulin pump according to an infusion program stored in a memory of the first insulin pump, and controlling the first insulin pump to autonomously perform the steps of activating a search for the presence of the second insulin pump, and, upon detection of the presence of the second insulin pump, and transmitting, via communication interfaces of the first insulin pump and the second insulin pump, the infusion program from the first insulin pump to the second insulin pump.[P-8]
In yet another embodiment An insulin pump includes a communication interface for data exchange with a replacement pump, a memory which can be configured to store an infusion program, and a control unit which is configured to control operation of the insulin pump. The control unit can be configured to autonomously perform the steps of monitoring, during operation of the infusion pump according to the infusion program, a status of the insulin pump, activating a search for the presence of the replacement pump when a predetermined status is assumed by the insulin pump, and transmitting, upon detecting the presence of the replacement pump, via the communication interface, the infusion program stored in the memory to the replacement pump.[P-9]
In yet another embodiment, the insulin pump 1 may generally comprise a communication interface for data exchange with a replacement pump, a memory which is configured to store an infusion program, and a control unit which is configured to control operation of the insulin pump 1. The control unit of the insulin pump 1 may be configured to autonomously perform the steps of activating a search for the presence of the replacement pump, and transmitting, upon detecting the presence of the replacement pump, via the communication interface the infusion program stored in the memory to the replacement pump.[P-28]
In one embodiment, the insulin pump 1 may comprise an insulin pump 1 of an insulin infusion system and may be used in an insulin pump replacement method as will become appreciated herein. Therefore, the disclosed embodiments of the insulin pump 1 and its operation also define corresponding embodiments of the insulin pumps 1 in an insulin infusion system and of the method for replacing a first insulin pump 1 by a second insulin pump 1. For example, the insulin pump 1 may be configured to perform the steps of searching for the presence of a source pump, and, when the presence of a source pump is detected, performing the steps of receiving, via the communication interface, an infusion program from the source pump, and storing the infusion program in the memory. An insulin pump of this type of embodiment may be capable of alternatively serving as both the first insulin pump 1 or the second insulin pump 1 in an insulin infusion system and a replacement method as described herein.[P-29]
Furthermore, in one particular embodiment, searching for a replacement pump 1 may only occur if a predetermined status is assumed. Such an embodiment may limit energy consumption as well as avoid handling errors since it prevents an unintended program transfer. The status of the insulin pump 1 may also be checked in a test mode which is periodically activated by a timer of the control unit 40. Alternatively or additionally, the search for a replacement pump 1 may be activated by an interrupt signal which is generated when the predetermined status is assumed. In such an embodiment, a dedicated test mode may not be required.[P-33]
As soon as an infrared signal of a replacement pump is detected during the search mode 203, the insulin pump 1 may test whether the infrared signal has a known and valid code. If no code is recognized, the insulin pump 1 may change back to the interface deactivation mode 204. However, if the code of the infrared signal is recognized by the insulin pump 1, the control unit 40 may change to the connection mode 205. An acknowledgement signal may be sent to the replacement pump via the infrared interface 50, and the radiofrequency interface 60 may then switched on. A connection to the replacement pump detected by the infrared interface 50 may then be set up via the radiofrequency interface 60. Among other things, the data transfer rates may be established on the basis of the signal quality.[P-65]
In the subsequent transmit mode 206, the infusion program stored in the memory 42 of the insulin pump 1 may be transferred to the replacement pump via the radiofrequency interface 60. After the data transfer has taken place, the insulin pump 1 may change to the switch-off mode 207 in which operation of the insulin pump 1 is terminated. In the switch-off mode 207, a standby time, for example of 2 minutes, may be allowed to elapse. The control unit 40 may then deactivate the delivery device 20 and thus stop the delivery of insulin 32. Thereafter, the control unit 40 may optionally cause the inserter 10 to retract the cannula 11. The control unit 40 may then emit an acoustic signal via the sound generator 71 to indicate termination of the operation and switch off all the other components of the insulin pump 1. The insulin pump 1 can then be removed by the patient from his or her body and, for example, replaced by the replacement pump.[P-66]
Here, Remde teaches the detection of the transfer/removal of a pump, using predetermined status such as a transitional process of the initial insulin pump, or low battery, thereby initiating the search for its replacement pump.
Furthermore, when combined with Durrant’s teaching of communicating user-specific configuration data used by the first medical device to a second medical device, it would be obvious to one of ordinary skill in the art to enable the user specific data upon detection to be transmitted upon initiation of the replacement medical device for a first medical device(in response to removal).
It would have been obvious to one of ordinary skill in the art during the effective filing date of the invention to combine Remde’s teaching with Durrant’s teaching in order to avoid interruption or miscommunication of multiple medical devices during a period of a medical event
In regards to claim 2, Durrant modified teaches comprising prior to communicating the user-specific configuration data toward the second medical device, establishing a communication link through which the first medical device communicates the user-specific configuration (Page 2, content of the invention; Page 4, Paragraph 3; Page 14, Paragraph 6, Durrant)
A system for clinical data transfer (handovers) in a medical event according to an embodiment of the present disclosure comprises a server device communicatively coupled to the network, the server device comprises a memory and a processor communicatively coupled to the memory, the memory comprises instructions, the instructions when executed by the processor cause the processor to start at least one component, the at least one component comprising: a communication component, configured to facilitate communication with the first medical device and the second medical device during the medical event, receiving a first clinical information from the first medical device, and the following one or more of the or (a) displaying at least some of the first clinical information on the second medical device, (b) displaying on the second medical device from at least some of the first clinical information, (c) modifying the operation of the second medical device based on the first clinical information, and (d) storing the first clinical information in a remote database of the second medical device or and a graphical user interface (GUI) configured to facilitate interaction between a user and the communication component.[Pg 2, contents of invention]
The embodiment of the present disclosure for delivering clinical data (e.g., in a medical event) system comprises a first medical device, configured to monitor patient portion of the medical event during monitoring and storing the first clinical information a second medical device, the second medical device is configured to monitor the patient in the second portion of the medical event and storing the second patient information a control module configured to receive an indication of the same patient using the first medical device and the second medical device during the medical event, and based on the indication, establishing access of the second medical device to the first clinical information to allow the second medical device to perform one of or following in the medical event period: (a) displaying at least some of the first clinical information on the second medical device, (b) displaying at least some of the information from the first clinical information on the second medical device, (c) modifying the operation of the second medical device based on the first clinical information, and (d) storing the first clinical information in a remote database of the second medical device or [Pg 4, P-3]
FIG. 3 depicts an illustrative operating environment 300 according to an embodiment of the present invention. The illustrative operation environment 300 includes a management server 302, which is configured to communicate with the medical device 304 via a network 306. Any number of additional medical devices 308 may also be configured to communicate with the management server 302. The communication between the management server 302 and the medical device 304 and/or the medical device 304 may be uni-directional or bidirectionally. According to the embodiment, the user can use the user device 310 to communicate with the management server 302. The management server 302 may be (or to), for example, the management server 108 shown in FIG. 1; The medical device 304 and/or the medical device 308 may be (or to) medical devices 102, 104 and/or 106 as shown in FIG. 1; The network 306 may be (or to) or one of the networks 110, 112 and 114 shown in FIG. 1; and the user device 310 may be (or to) the user device 118 and/or 120 shown in FIG. 1.[Pg 14, P-6]
In regards to claim 4, Durrant modified teaches communicating the user-specific configuration data to the second medical device comprises communicating the user-specific configuration data to an intermediate device (Page 24, Paragraph 1, Durrant)
In a potential emergency medical event, (first) medical device 602 is configured to monitor and patient the first clinical information in its memory 610 (and such memory can be on the device 602, on the networking device or both, and/or across the device 602 or device 602 of a plurality of devices distributed). (Second) the medical device 604 is configured to monitor and patient the second patient information in its memory 610 (and such a memory may be on the device 602), on the networking device or both, and/or across the device 602 or device 602 of a plurality of devices distributed). (first) medical device 602 and (second) medical device 604 provides control module 616, or (first) medical device 602 and (second) medical device 604 provides control module 616, or optionally, The cloud-based network 606 provides a control module 616 as or cloud-based network 606-provides control module 616. (second) medical device 604 provides control module 616 is configured to receive the same emergency medical event during the same patient (first) medical device 602 and (second) medical device 604). The indication is discussed in more detail with reference to FIG. 7. Based on the indication, the (second) medical device 604 establishes access to the first clinical information stored on the (first) medical device 602. As a result of this access, (second) the medical device 604 is allowed to display at least some of the first clinical information on the display 612 of the emergency medical event. In addition, (second) medical device 604 may also be based on the first clinical information (second) medical device 604 operation. In addition, (second) medical device 604 may also store the first clinical information in (second) medical device 604 memory 610. (second) medical device 604 may also be based on cloud-based network 606 the first clinical information is transmitted to the remote database.[Pg 24, P-1]
In regards to claim 5, Durrant modified via Remde teaches the intermediate device comprises a charger device (Paragraph 35, Remde)
In one exemplary embodiment, the status may further comprise the status of a battery 80 of the insulin pump 1. Such an embodiment may be utilized, for example, when the battery 80 is integral with the pump 1 and cannot be replaced. While the battery 80 capacity of these types of devices may include a safety factor to ensure that the battery 80 is not exhausted prior to the reservoir being empty, this situation may nonetheless occur if the battery is, due to improper assembly, partly discharged during assembly of the infusion pump, or due to a defective of the battery 80 itself, or the like. Therefore, the battery voltage may be monitored by a voltage monitoring unit in an analogue way to the filling volume of the insulin reservoir. Additionally or alternatively to the voltage, the energy effectively taken from the batter may be monitored by a gauging unit known in the art.[P-35]
In regards to claim 8, Durrant modified via Remde teaches communicating the user-specific configuration data occurs without user input (Paragraph 9, Remde).
In yet another embodiment An insulin pump includes a communication interface for data exchange with a replacement pump, a memory which can be configured to store an infusion program, and a control unit which is configured to control operation of the insulin pump. The control unit can be configured to autonomously perform the steps of monitoring, during operation of the infusion pump according to the infusion program, a status of the insulin pump, activating a search for the presence of the replacement pump when a predetermined status is assumed by the insulin pump, and transmitting, upon detecting the presence of the replacement pump, via the communication interface, the infusion program stored in the memory to the replacement pump.[P-9]
Here Remde discloses autonomously configuring the replacement steps, including obviously, communicating the user-specific configuration data occurs without user input
In regards to claim 10, Durrant teaches a system for automatically configuring a medical device with user-specific configuration data(Abstract; Page 2, contents of invention; Claim 1)
The invention relates to a system for transmitting clinical data during medical event, method and device. Certain embodiments of the present disclosure include a first medical device and a second medical device, the first medical device is configured to monitor and patient clinical information during the first portion of the medical event. the second medical device can display at least some of the clinical information, modifying the operation or the second medical device to store the clinical information[Abstract]
A system for clinical data transfer (handovers) in a medical event according to an embodiment of the present disclosure comprises a server device communicatively coupled to the network, the server device comprises a memory and a processor communicatively coupled to the memory, the memory comprises instructions, the instructions when executed by the processor cause the processor to start at least one component, the at least one component comprising: a communication component, configured to facilitate communication with the first medical device and the second medical device during the medical event, receiving a first clinical information from the first medical device, and the following one or more of the or (a) displaying at least some of the first clinical information on the second medical device, (b) displaying on the second medical device from at least some of the first clinical information, (c) modifying the operation of the second medical device based on the first clinical information, and (d) storing the first clinical information in a remote database of the second medical device or and a graphical user interface (GUI) configured to facilitate interaction between a user and the communication component.[Pg 2, contents of invention]
the system comprising: one or more processors; and one or more processor-readable storage media storing instructions which, when executed by the one or more processors, cause performance of: determining, by a first medical device, that the first medical device is being removed from service on a patient based at least in part on detecting removal of a portion of the first medical device from contact with or being coupled to the patient; and in response to determining that the first medical device is being removed from service on the patient, communicating user-specific configuration data used by the first medical device to a second medical device, wherein the second medical device is a replacement medical device for the first medical device.
Durrant teaches communicating user-specific configuration data used by the first medical device to a second medical device, wherein the second medical device is a replacement medical device for the first medical device (Page 23, Paragraph 6-Page 24, Paragraph 1)
Any medical device 602/604 may be used during the first portion of the emergency medical event. In some cases, the second part of the emergency medical event occurs after the first part of the emergency medical event. For example, the first part of the emergency medical event can be characterized as, wherein the first responder (such as having an emergency response condition with little or no training of the person) help patient In other instances, the first portion of the emergency medical event may be characterized as the trained medical device personnel in response to emergency medical event. any one of medical device 602 and medical device 604 can be used for emergency medical event of the second part. The second portion of the emergency medical event may be characterized as, for example, the EMT participates in the emergency medical event after the first responder, and the or of the hospital takes part in the case of emergency medical events after the EMT and/or the first responder. [Pg 23, P-6]
In a potential emergency medical event, (first) medical device 602 is configured to monitor and patient the first clinical information in its memory 610 (and such memory can be on the device 602, on the networking device or both, and/or across the device 602 or device 602 of a plurality of devices distributed). (Second) the medical device 604 is configured to monitor and patient the second patient information in its memory 610 (and such a memory may be on the device 602), on the networking device or both, and/or across the device 602 or device 602 of a plurality of devices distributed). (first) medical device 602 and (second) medical device 604 provides control module 616, or (first) medical device 602 and (second) medical device 604 provides control module 616, or optionally, The cloud-based network 606 provides a control module 616 as or cloud-based network 606-provides control module 616. (second) medical device 604 provides control module 616 is configured to receive the same emergency medical event during the same patient (first) medical device 602 and (second) medical device 604). The indication is discussed in more detail with reference to FIG. 7. Based on the indication, the (second) medical device 604 establishes access to the first clinical information stored on the (first) medical device 602. As a result of this access, (second) the medical device 604 is allowed to display at least some of the first clinical information on the display 612 of the emergency medical event. In addition, (second) medical device 604 may also be based on the first clinical information (second) medical device 604 operation. In addition, (second) medical device 604 may also store the first clinical information in (second) medical device 604 memory 610. (second) medical device 604 may also be based on cloud-based network 606 the first clinical information is transmitted to the remote database.[Pg 24, P-1]
Durrant fails to teach one or more processors; and one or more processor-readable storage media storing instructions which, when executed by the one or more processors, cause performance of: determining, by a first medical device, that the first medical device is being removed from service on a patient based at least in part on detecting removal of a portion of the first medical device from contact with or being coupled to the patient.
Remde on the other hand teaches one or more processors; and one or more processor-readable storage media storing instructions which, when executed by the one or more processors, cause performance of: determining, by a first medical device, that the first medical device is being removed from service on a patient based at least in part on detecting removal of a portion of the first medical device from contact with or being coupled to the patient. (Paragraphs 8, 9, 28, 33, 65, 66)
In another embodiment, a method for replacing a first insulin pump by a second insulin pump, includes operating the first insulin pump according to an infusion program stored in a memory of the first insulin pump, and controlling the first insulin pump to autonomously perform the steps of activating a search for the presence of the second insulin pump, and, upon detection of the presence of the second insulin pump, and transmitting, via communication interfaces of the first insulin pump and the second insulin pump, the infusion program from the first insulin pump to the second insulin pump.[P-8]
In yet another embodiment An insulin pump includes a communication interface for data exchange with a replacement pump, a memory which can be configured to store an infusion program, and a control unit which is configured to control operation of the insulin pump. The control unit can be configured to autonomously perform the steps of monitoring, during operation of the infusion pump according to the infusion program, a status of the insulin pump, activating a search for the presence of the replacement pump when a predetermined status is assumed by the insulin pump, and transmitting, upon detecting the presence of the replacement pump, via the communication interface, the infusion program stored in the memory to the replacement pump.[P-9]
In yet another embodiment, the insulin pump 1 may generally comprise a communication interface for data exchange with a replacement pump, a memory which is configured to store an infusion program, and a control unit which is configured to control operation of the insulin pump 1. The control unit of the insulin pump 1 may be configured to autonomously perform the steps of activating a search for the presence of the replacement pump, and transmitting, upon detecting the presence of the replacement pump, via the communication interface the infusion program stored in the memory to the replacement pump.[P-28]
In one embodiment, the insulin pump 1 may comprise an insulin pump 1 of an insulin infusion system and may be used in an insulin pump replacement method as will become appreciated herein. Therefore, the disclosed embodiments of the insulin pump 1 and its operation also define corresponding embodiments of the insulin pumps 1 in an insulin infusion system and of the method for replacing a first insulin pump 1 by a second insulin pump 1. For example, the insulin pump 1 may be configured to perform the steps of searching for the presence of a source pump, and, when the presence of a source pump is detected, performing the steps of receiving, via the communication interface, an infusion program from the source pump, and storing the infusion program in the memory. An insulin pump of this type of embodiment may be capable of alternatively serving as both the first insulin pump 1 or the second insulin pump 1 in an insulin infusion system and a replacement method as described herein.[P-29]
Furthermore, in one particular embodiment, searching for a replacement pump 1 may only occur if a predetermined status is assumed. Such an embodiment may limit energy consumption as well as avoid handling errors since it prevents an unintended program transfer. The status of the insulin pump 1 may also be checked in a test mode which is periodically activated by a timer of the control unit 40. Alternatively or additionally, the search for a replacement pump 1 may be activated by an interrupt signal which is generated when the predetermined status is assumed. In such an embodiment, a dedicated test mode may not be required.[P-33]
As soon as an infrared signal of a replacement pump is detected during the search mode 203, the insulin pump 1 may test whether the infrared signal has a known and valid code. If no code is recognized, the insulin pump 1 may change back to the interface deactivation mode 204. However, if the code of the infrared signal is recognized by the insulin pump 1, the control unit 40 may change to the connection mode 205. An acknowledgement signal may be sent to the replacement pump via the infrared interface 50, and the radiofrequency interface 60 may then switched on. A connection to the replacement pump detected by the infrared interface 50 may then be set up via the radiofrequency interface 60. Among other things, the data transfer rates may be established on the basis of the signal quality.[P-65]
In the subsequent transmit mode 206, the infusion program stored in the memory 42 of the insulin pump 1 may be transferred to the replacement pump via the radiofrequency interface 60. After the data transfer has taken place, the insulin pump 1 may change to the switch-off mode 207 in which operation of the insulin pump 1 is terminated. In the switch-off mode 207, a standby time, for example of 2 minutes, may be allowed to elapse. The control unit 40 may then deactivate the delivery device 20 and thus stop the delivery of insulin 32. Thereafter, the control unit 40 may optionally cause the inserter 10 to retract the cannula 11. The control unit 40 may then emit an acoustic signal via the sound generator 71 to indicate termination of the operation and switch off all the other components of the insulin pump 1. The insulin pump 1 can then be removed by the patient from his or her body and, for example, replaced by the replacement pump.[P-66]
Here, Remde teaches the detection of the transfer/removal of a pump, using predetermined status such as a transitional process of the initial insulin pump, or low battery, thereby initiating the search for its replacement pump.
Furthermore, when combined with Durrant’s teaching of communicating user-specific configuration data used by the first medical device to a second medical device, it would be obvious to one of ordinary skill in the art to enable the user specific data upon detection to be transmitted upon initiation of the replacement medical device for a first medical device(in response to removal).
It would have been obvious to one of ordinary skill in the art during the effective filing date of the invention to combine Remde’s teaching with Durrant’s teaching in order to avoid interruption or miscommunication of multiple medical devices during a period of a medical event
In regards to claim 11, Durrant modified teaches causing performance of: prior to communicating the user-specific configuration data toward the second medical device, establishing a communication link through which the first medical device communicates the user-specific configuration (Page 2, content of the invention; Page 4, Paragraph 3; Page 14, Paragraph 6, Durant)
A system for clinical data transfer (handovers) in a medical event according to an embodiment of the present disclosure comprises a server device communicatively coupled to the network, the server device comprises a memory and a processor communicatively coupled to the memory, the memory comprises instructions, the instructions when executed by the processor cause the processor to start at least one component, the at least one component comprising: a communication component, configured to facilitate communication with the first medical device and the second medical device during the medical event, receiving a first clinical information from the first medical device, and the following one or more of the or (a) displaying at least some of the first clinical information on the second medical device, (b) displaying on the second medical device from at least some of the first clinical information, (c) modifying the operation of the second medical device based on the first clinical information, and (d) storing the first clinical information in a remote database of the second medical device or and a graphical user interface (GUI) configured to facilitate interaction between a user and the communication component.[Pg 2, contents of invention]
The embodiment of the present disclosure for delivering clinical data (e.g., in a medical event) system comprises a first medical device, configured to monitor patient portion of the medical event during monitoring and storing the first clinical information a second medical device, the second medical device is configured to monitor the patient in the second portion of the medical event and storing the second patient information a control module configured to receive an indication of the same patient using the first medical device and the second medical device during the medical event, and based on the indication, establishing access of the second medical device to the first clinical information to allow the second medical device to perform one of or following in the medical event period: (a) displaying at least some of the first clinical information on the second medical device, (b) displaying at least some of the information from the first clinical information on the second medical device, (c) modifying the operation of the second medical device based on the first clinical information, and (d) storing the first clinical information in a remote database of the second medical device or [Pg 4, P-3]
FIG. 3 depicts an illustrative operating environment 300 according to an embodiment of the present invention. The illustrative operation environment 300 includes a management server 302, which is configured to communicate with the medical device 304 via a network 306. Any number of additional medical devices 308 may also be configured to communicate with the management server 302. The communication between the management server 302 and the medical device 304 and/or the medical device 304 may be uni-directional or bidirectionally. According to the embodiment, the user can use the user device 310 to communicate with the management server 302. The management server 302 may be (or to), for example, the management server 108 shown in FIG. 1; The medical device 304 and/or the medical device 308 may be (or to) medical devices 102, 104 and/or 106 as shown in FIG. 1; The network 306 may be (or to) or one of the networks 110, 112 and 114 shown in FIG. 1; and the user device 310 may be (or to) the user device 118 and/or 120 shown in FIG. 1.[Pg 14, P-6]
In regards to claim 13, Durrant modified teaches communicating the user-specific configuration data to the second medical device comprises communicating the user-specific configuration data to an intermediate device (Page 24, Paragraph 1, Durrant)
In a potential emergency medical event, (first) medical device 602 is configured to monitor and patient the first clinical information in its memory 610 (and such memory can be on the device 602, on the networking device or both, and/or across the device 602 or device 602 of a plurality of devices distributed). (Second) the medical device 604 is configured to monitor and patient the second patient information in its memory 610 (and such a memory may be on the device 602), on the networking device or both, and/or across the device 602 or device 602 of a plurality of devices distributed). (first) medical device 602 and (second) medical device 604 provides control module 616, or (first) medical device 602 and (second) medical device 604 provides control module 616, or optionally, The cloud-based network 606 provides a control module 616 as or cloud-based network 606-provides control module 616. (second) medical device 604 provides control module 616 is configured to receive the same emergency medical event during the same patient (first) medical device 602 and (second) medical device 604). The indication is discussed in more detail with reference to FIG. 7. Based on the indication, the (second) medical device 604 establishes access to the first clinical information stored on the (first) medical device 602. As a result of this access, (second) the medical device 604 is allowed to display at least some of the first clinical information on the display 612 of the emergency medical event. In addition, (second) medical device 604 may also be based on the first clinical information (second) medical device 604 operation. In addition, (second) medical device 604 may also store the first clinical information in (second) medical device 604 memory 610. (second) medical device 604 may also be based on cloud-based network 606 the first clinical information is transmitted to the remote database.[Pg 24, P-1]
In regards to claim 14, Durrant modified via Remde teaches the intermediate device comprises a charger device (Paragraph 35, Remde)
In one exemplary embodiment, the status may further comprise the status of a battery 80 of the insulin pump 1. Such an embodiment may be utilized, for example, when the battery 80 is integral with the pump 1 and cannot be replaced. While the battery 80 capacity of these types of devices may include a safety factor to ensure that the battery 80 is not exhausted prior to the reservoir being empty, this situation may nonetheless occur if the battery is, due to improper assembly, partly discharged during assembly of the infusion pump, or due to a defective of the battery 80 itself, or the like. Therefore, the battery voltage may be monitored by a voltage monitoring unit in an analogue way to the filling volume of the insulin reservoir. Additionally or alternatively to the voltage, the energy effectively taken from the batter may be monitored by a gauging unit known in the art.[P-35]
In regards to claim 17, Durrant modified via Remde teaches communicating the user-specific configuration data occurs without user input (Paragraph 9, Remde).
In yet another embodiment An insulin pump includes a communication interface for data exchange with a replacement pump, a memory which can be configured to store an infusion program, and a control unit which is configured to control operation of the insulin pump. The control unit can be configured to autonomously perform the steps of monitoring, during operation of the infusion pump according to the infusion program, a status of the insulin pump, activating a search for the presence of the replacement pump when a predetermined status is assumed by the insulin pump, and transmitting, upon detecting the presence of the replacement pump, via the communication interface, the infusion program stored in the memory to the replacement pump.[P-9]
Here Remde discloses autonomously configuring the replacement steps, including obviously, communicating the user-specific configuration data occurs without user input
In regards to claim 19, Durrant teaches a method for automatically configuring a medical device with user-specific configuration data(Abstract; Page 2, contents of invention; Claim 1)
The invention relates to a system for transmitting clinical data during medical event, method and device. Certain embodiments of the present disclosure include a first medical device and a second medical device, the first medical device is configured to monitor and patient clinical information during the first portion of the medical event. the second medical device can display at least some of the clinical information, modifying the operation or the second medical device to store the clinical information[Abstract]
A system for clinical data transfer (handovers) in a medical event according to an embodiment of the present disclosure comprises a server device communicatively coupled to the network, the server device comprises a memory and a processor communicatively coupled to the memory, the memory comprises instructions, the instructions when executed by the processor cause the processor to start at least one component, the at least one component comprising: a communication component, configured to facilitate communication with the first medical device and the second medical device during the medical event, receiving a first clinical information from the first medical device, and the following one or more of the or (a) displaying at least some of the first clinical information on the second medical device, (b) displaying on the second medical device from at least some of the first clinical information, (c) modifying the operation of the second medical device based on the first clinical information, and (d) storing the first clinical information in a remote database of the second medical device or and a graphical user interface (GUI) configured to facilitate interaction between a user and the communication component.[Pg 2, contents of invention]
Durrant teaches communicating user-specific configuration data used by the first medical device to a second medical device, wherein the second medical device is a replacement medical device for the first medical device (Page 23, Paragraph 6-Page 24, Paragraph 1)
Any medical device 602/604 may be used during the first portion of the emergency medical event. In some cases, the second part of the emergency medical event occurs after the first part of the emergency medical event. For example, the first part of the emergency medical event can be characterized as, wherein the first responder (such as having an emergency response condition with little or no training of the person) help patient In other instances, the first portion of the emergency medical event may be characterized as the trained medical device personnel in response to emergency medical event. any one of medical device 602 and medical device 604 can be used for emergency medical event of the second part. The second portion of the emergency medical event may be characterized as, for example, the EMT participates in the emergency medical event after the first responder, and the or of the hospital takes part in the case of emergency medical events after the EMT and/or the first responder. [Pg 23, P-6]
In a potential emergency medical event, (first) medical device 602 is configured to monitor and patient the first clinical information in its memory 610 (and such memory can be on the device 602, on the networking device or both, and/or across the device 602 or device 602 of a plurality of devices distributed). (Second) the medical device 604 is configured to monitor and patient the second patient information in its memory 610 (and such a memory may be on the device 602), on the networking device or both, and/or across the device 602 or device 602 of a plurality of devices distributed). (first) medical device 602 and (second) medical device 604 provides control module 616, or (first) medical device 602 and (second) medical device 604 provides control module 616, or optionally, The cloud-based network 606 provides a control module 616 as or cloud-based network 606-provides control module 616. (second) medical device 604 provides control module 616 is configured to receive the same emergency medical event during the same patient (first) medical device 602 and (second) medical device 604). The indication is discussed in more detail with reference to FIG. 7. Based on the indication, the (second) medical device 604 establishes access to the first clinical information stored on the (first) medical device 602. As a result of this access, (second) the medical device 604 is allowed to display at least some of the first clinical information on the display 612 of the emergency medical event. In addition, (second) medical device 604 may also be based on the first clinical information (second) medical device 604 operation. In addition, (second) medical device 604 may also store the first clinical information in (second) medical device 604 memory 610. (second) medical device 604 may also be based on cloud-based network 606 the first clinical information is transmitted to the remote database.[Pg 24, P-1]
Durrant fails to teach determining, by a first medical device, that the first medical device is being removed from service on a patient based at least in part on detecting removal of a portion of the first medical device from contact with or being coupled to the patient.
Remde on the other hand teaches determining, by a first medical device, that the first medical device is being removed from service on a patient based at least in part on detecting removal of a portion of the first medical device from contact with or being coupled to the patient (Paragraphs 8, 9, 28, 33, 65, 66)
In another embodiment, a method for replacing a first insulin pump by a second insulin pump, includes operating the first insulin pump according to an infusion program stored in a memory of the first insulin pump, and controlling the first insulin pump to autonomously perform the steps of activating a search for the presence of the second insulin pump, and, upon detection of the presence of the second insulin pump, and transmitting, via communication interfaces of the first insulin pump and the second insulin pump, the infusion program from the first insulin pump to the second insulin pump.[P-8]
In yet another embodiment An insulin pump includes a communication interface for data exchange with a replacement pump, a memory which can be configured to store an infusion program, and a control unit which is configured to control operation of the insulin pump. The control unit can be configured to autonomously perform the steps of monitoring, during operation of the infusion pump according to the infusion program, a status of the insulin pump, activating a search for the presence of the replacement pump when a predetermined status is assumed by the insulin pump, and transmitting, upon detecting the presence of the replacement pump, via the communication interface, the infusion program stored in the memory to the replacement pump.[P-9]
In yet another embodiment, the insulin pump 1 may generally comprise a communication interface for data exchange with a replacement pump, a memory which is configured to store an infusion program, and a control unit which is configured to control operation of the insulin pump 1. The control unit of the insulin pump 1 may be configured to autonomously perform the steps of activating a search for the presence of the replacement pump, and transmitting, upon detecting the presence of the replacement pump, via the communication interface the infusion program stored in the memory to the replacement pump.[P-28]
In one embodiment, the insulin pump 1 may comprise an insulin pump 1 of an insulin infusion system and may be used in an insulin pump replacement method as will become appreciated herein. Therefore, the disclosed embodiments of the insulin pump 1 and its operation also define corresponding embodiments of the insulin pumps 1 in an insulin infusion system and of the method for replacing a first insulin pump 1 by a second insulin pump 1. For example, the insulin pump 1 may be configured to perform the steps of searching for the presence of a source pump, and, when the presence of a source pump is detected, performing the steps of receiving, via the communication interface, an infusion program from the source pump, and storing the infusion program in the memory. An insulin pump of this type of embodiment may be capable of alternatively serving as both the first insulin pump 1 or the second insulin pump 1 in an insulin infusion system and a replacement method as described herein.[P-29]
Furthermore, in one particular embodiment, searching for a replacement pump 1 may only occur if a predetermined status is assumed. Such an embodiment may limit energy consumption as well as avoid handling errors since it prevents an unintended program transfer. The status of the insulin pump 1 may also be checked in a test mode which is periodically activated by a timer of the control unit 40. Alternatively or additionally, the search for a replacement pump 1 may be activated by an interrupt signal which is generated when the predetermined status is assumed. In such an embodiment, a dedicated test mode may not be required.[P-33]
As soon as an infrared signal of a replacement pump is detected during the search mode 203, the insulin pump 1 may test whether the infrared signal has a known and valid code. If no code is recognized, the insulin pump 1 may change back to the interface deactivation mode 204. However, if the code of the infrared signal is recognized by the insulin pump 1, the control unit 40 may change to the connection mode 205. An acknowledgement signal may be sent to the replacement pump via the infrared interface 50, and the radiofrequency interface 60 may then switched on. A connection to the replacement pump detected by the infrared interface 50 may then be set up via the radiofrequency interface 60. Among other things, the data transfer rates may be established on the basis of the signal quality.[P-65]
In the subsequent transmit mode 206, the infusion program stored in the memory 42 of the insulin pump 1 may be transferred to the replacement pump via the radiofrequency interface 60. After the data transfer has taken place, the insulin pump 1 may change to the switch-off mode 207 in which operation of the insulin pump 1 is terminated. In the switch-off mode 207, a standby time, for example of 2 minutes, may be allowed to elapse. The control unit 40 may then deactivate the delivery device 20 and thus stop the delivery of insulin 32. Thereafter, the control unit 40 may optionally cause the inserter 10 to retract the cannula 11. The control unit 40 may then emit an acoustic signal via the sound generator 71 to indicate termination of the operation and switch off all the other components of the insulin pump 1. The insulin pump 1 can then be removed by the patient from his or her body and, for example, replaced by the replacement pump.[P-66]
Here, Remde teaches the detection of the transfer/removal of a pump, using predetermined status such as a transitional process of the initial insulin pump, or low battery, thereby initiating the search for its replacement pump.
Furthermore, when combined with Durrant’s teaching of communicating user-specific configuration data used by the first medical device to a second medical device, it would be obvious to one of ordinary skill in the art to enable the user specific data upon detection to be transmitted upon initiation of the replacement medical device for a first medical device(in response to removal).
It would have been obvious to one of ordinary skill in the art during the effective filing date of the invention to combine Remde’s teaching with Durrant’s teaching in order to avoid interruption or miscommunication of multiple medical devices during a period of a medical event
Claim(s) 3, 6, 12, 15, 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Durrant et al. (CN 107615396 B) in view of Remde (US 20110218495 A1) as applied to claim 1, 10, 19 above, and further in view of Smith (US 10159786 B2)
In regards to claim 3, Durrant modified fails to teach the user-specific configuration data comprises at least one of a group including information indicative of insulin-on-board, a safe basal rate, one or more insulin delivery rate limits, one or more glucose sensor calibration factors, an insulin sensitivity factor, and a history of insulin delivery.
Smith on the other hand teaches the user-specific configuration data comprises at least one of a group including information indicative of insulin-on-board, a safe basal rate, one or more insulin delivery rate limits, one or more glucose sensor calibration factors, an insulin sensitivity factor, and a history of insulin delivery(Column 5, lines 20-30)
For instance, 20-30 μl may be required to fill the entire infusion set tube and, accordingly, the priming procedure may involve the rapid delivery of 10-15 IUs of U-500 insulin to the tube. The present inventors have determined that it would be advantageous to prevent users from initiating a priming procedure when the system is in the “patch pump” configuration, with a cannula positioned to deliver medicament essentially directly from the medicament reservoir to the patient, because rapidly delivering 10-15 IUs of insulin to the patient could adversely affect patient health.[Col 5, ln 20-30]
It would have been obvious to a person of ordinary skill in the art before the effective filing of the invention to combine Smith's teaching with Durrant modified's teaching in order to accurately monitor specific parameters of a medical event.
In regards to claim 6, Durrant modified fails to teach detecting the removal of the portion of the first medical device from contact with or being coupled to the patient comprises determining removal of a cannula associated with the first medical device.
Smith on the other hand teaches detecting the removal of the portion of the first medical device from contact with or being coupled to the patient comprises determining removal of a cannula associated with the first medical device.(Column 10, lines 3-5)
Use of an exemplary system 100 will now be described. At the most basic level, a patient's use of the exemplary infusion pump systems (e.g., system 100 in FIGS. 1A-2B) involves obtaining a new disposable assembly 300, connecting the disposable assembly to the durable assembly 200, peeling the liner from the baseplate adhesive layer, gaining subcutaneous access, and initiating a medicament delivery operation. In some instances, use may involve additional steps such as attaching a cannula to connector 501 of the disposable assembly and removing a cannula cap, if necessary. Various aspects of the basic operation of the present systems are described below. Operation of a system does not necessarily require all of the steps each time the system is deployed, and the order of some of the steps may be changed. Operation is also discussed below, in the exemplary context of the above-described durable assembly 200 and disposable assembly 300 used as a patch pump, through the use of a flow chart (FIG. 8). The discussion is, however, equally applicable to other patch pump implementations, as well as to pocket pump implementations with minor variations. Also, unless otherwise indicated, the actions and determinations performed by the durable assembly 200 are controlled by the durable assembly microprocessor and further references to the controller are limited in the interest of brevity.[Col 10, ln 3-5]
It would have been obvious to a person of ordinary skill in the art before the effective filing of the invention to combine Smith's teaching with Durrant modified's teaching in order to enable the detection of key medical components related to medical devices during a medical event.
In regards to claim 12, Durrant modified fails to teach the user-specific configuration data comprises at least one of a group including information indicative of insulin-on-board, a safe basal rate, one or more insulin delivery rate limits, one or more glucose sensor calibration factors, an insulin sensitivity factor, and a history of insulin delivery.
Smith on the other hand teaches the user-specific configuration data comprises at least one of a group including information indicative of insulin-on-board, a safe basal rate, one or more insulin delivery rate limits, one or more glucose sensor calibration factors, an insulin sensitivity factor, and a history of insulin delivery(Column 5, lines 20-30)
For instance, 20-30 μl may be required to fill the entire infusion set tube and, accordingly, the priming procedure may involve the rapid delivery of 10-15 IUs of U-500 insulin to the tube. The present inventors have determined that it would be advantageous to prevent users from initiating a priming procedure when the system is in the “patch pump” configuration, with a cannula positioned to deliver medicament essentially directly from the medicament reservoir to the patient, because rapidly delivering 10-15 IUs of insulin to the patient could adversely affect patient health.[Col 5, ln 20-30]
It would have been obvious to a person of ordinary skill in the art before the effective filing of the invention to combine Smith's teaching with Durrant modified's teaching in order to accurately monitor specific parameters of a medical event.
In regards to claim 15, Durrant modified fails to teach detecting the removal of the portion of the first medical device from contact with or being coupled to the patient comprises determining removal of a cannula associated with the first medical device.
Smith on the other hand teaches detecting the removal of the portion of the first medical device from contact with or being coupled to the patient comprises determining removal of a cannula associated with the first medical device.(Column 10, lines 3-5)
Use of an exemplary system 100 will now be described. At the most basic level, a patient's use of the exemplary infusion pump systems (e.g., system 100 in FIGS. 1A-2B) involves obtaining a new disposable assembly 300, connecting the disposable assembly to the durable assembly 200, peeling the liner from the baseplate adhesive layer, gaining subcutaneous access, and initiating a medicament delivery operation. In some instances, use may involve additional steps such as attaching a cannula to connector 501 of the disposable assembly and removing a cannula cap, if necessary. Various aspects of the basic operation of the present systems are described below. Operation of a system does not necessarily require all of the steps each time the system is deployed, and the order of some of the steps may be changed. Operation is also discussed below, in the exemplary context of the above-described durable assembly 200 and disposable assembly 300 used as a patch pump, through the use of a flow chart (FIG. 8). The discussion is, however, equally applicable to other patch pump implementations, as well as to pocket pump implementations with minor variations. Also, unless otherwise indicated, the actions and determinations performed by the durable assembly 200 are controlled by the durable assembly microprocessor and further references to the controller are limited in the interest of brevity.[Col 10, ln 3-5]
It would have been obvious to a person of ordinary skill in the art before the effective filing of the invention to combine Smith's teaching with Durrant modified's teaching in order to enable the detection of key medical components related to medical devices during a medical event.
In regards to claim 20, Durrant modified fails to teach detecting the removal of the portion of the first medical device from contact with or being coupled to the patient comprises determining removal of a cannula associated with the first medical device.
Smith on the other hand teaches detecting the removal of the portion of the first medical device from contact with or being coupled to the patient comprises determining removal of a cannula associated with the first medical device.(Column 10, lines 3-5)
Use of an exemplary system 100 will now be described. At the most basic level, a patient's use of the exemplary infusion pump systems (e.g., system 100 in FIGS. 1A-2B) involves obtaining a new disposable assembly 300, connecting the disposable assembly to the durable assembly 200, peeling the liner from the baseplate adhesive layer, gaining subcutaneous access, and initiating a medicament delivery operation. In some instances, use may involve additional steps such as attaching a cannula to connector 501 of the disposable assembly and removing a cannula cap, if necessary. Various aspects of the basic operation of the present systems are described below. Operation of a system does not necessarily require all of the steps each time the system is deployed, and the order of some of the steps may be changed. Operation is also discussed below, in the exemplary context of the above-described durable assembly 200 and disposable assembly 300 used as a patch pump, through the use of a flow chart (FIG. 8). The discussion is, however, equally applicable to other patch pump implementations, as well as to pocket pump implementations with minor variations. Also, unless otherwise indicated, the actions and determinations performed by the durable assembly 200 are controlled by the durable assembly microprocessor and further references to the controller are limited in the interest of brevity.[Col 10, ln 3-5]
It would have been obvious to a person of ordinary skill in the art before the effective filing of the invention to combine Smith's teaching with Durrant modified's teaching in order to enable the detection of key medical components related to medical devices during a medical event.
Claim(s) 7, 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Durrant et al. (CN 107615396 B) in view of Remde (US 20110218495 A1) as applied to claim 1, 10 above, and further in view of Feldman et al (CA 2933166 C)
In regards to claim 7, Durrant modified fails to teach detecting the removal of the portion of the first medical device from contact with or being coupled to the patient comprises determining that a glucose sensor is no longer in contact with interstitial fluid.
Feldman on the other hand teaches detecting the removal of the portion of the first medical device from contact with or being coupled to the patient comprises determining that a glucose sensor is no longer in contact with interstitial fluid (Paragraphs 62, 73).
In certain embodiments, on body electronics 110 and data processing module 160 may be positioned on the skin surface of the user within a predetermined distance of each other (for example, about 1-12 inches, or about1-10 inches, or about 1-7 inches, or about 1-5 inches) such that periodic communication between on body electronics 110 and data processing module 160 is maintained. Alternatively, data processing module 160 may be worn on a belt or clothing item of the user, such that the desired distance for communication between the on body electronics 110 and data processing module 160 for data communication is maintained. In a further aspect, the housing of data processing module 160 may be configured to couple to or engage with on body electronics 110 such that the two devices are combined or integrated as a single assembly and positioned on the skin surface. In further embodiments, data processing module 160 is detachably engaged or connected to on body electronics 110 providing additional modularity such that data processing module 160 may be optionally removed or reattached as desired.[P-62]
FIG. 2 is a block diagram of an analyte monitoring system including a self-powered analyte sensor and RFID data communication module in accordance with one embodiment of the present disclosure. As shown in FIG. 2, in certain embodiments, the analyte monitoring system 200 includes self-powered sensor 210 operatively coupled to buffering circuit 220 that is further provided in signal communication with RFID circuit 230. The self-powered sensor 210, the buffering circuit 220 and the RFID circuit 230 in certain embodiments may be provided in a single on body sensor electronics housing, with a portion of the self-powered sensor 210 positioned under the skin surface of a user and in fluid contact with interstitial fluid. The single on body sensor electronics housing in certain embodiments is a waterproof housing. Referring back to FIG. 2, also shown is an external power source and Reader device ("reader") 240 which in certain embodiments, includes an RFID reader that is capable of radiating an RF field, and when in proximity to an RFID device, receives data communication back from the RFID device using the RF field.[P-73]
It would have been obvious to a person of ordinary skill in the art before the effective filing of the invention to combine Feldman's teaching with Durrant modified's teaching in order to effectively add or remove medical devises related to skin contact evaluating protocols.
In regards to claim 16, Durrant modified fails to teach detecting the removal of the portion of the first medical device from contact with or being coupled to the patient comprises determining that a glucose sensor is no longer in contact with interstitial fluid.
Feldman on the other hand teaches detecting the removal of the portion of the first medical device from contact with or being coupled to the patient comprises determining that a glucose sensor is no longer in contact with interstitial fluid (Paragraphs 62, 73).
In certain embodiments, on body electronics 110 and data processing module 160 may be positioned on the skin surface of the user within a predetermined distance of each other (for example, about 1-12 inches, or about1-10 inches, or about 1-7 inches, or about 1-5 inches) such that periodic communication between on body electronics 110 and data processing module 160 is maintained. Alternatively, data processing module 160 may be worn on a belt or clothing item of the user, such that the desired distance for communication between the on body electronics 110 and data processing module 160 for data communication is maintained. In a further aspect, the housing of data processing module 160 may be configured to couple to or engage with on body electronics 110 such that the two devices are combined or integrated as a single assembly and positioned on the skin surface. In further embodiments, data processing module 160 is detachably engaged or connected to on body electronics 110 providing additional modularity such that data processing module 160 may be optionally removed or reattached as desired.[P-62]
FIG. 2 is a block diagram of an analyte monitoring system including a self-powered analyte sensor and RFID data communication module in accordance with one embodiment of the present disclosure. As shown in FIG. 2, in certain embodiments, the analyte monitoring system 200 includes self-powered sensor 210 operatively coupled to buffering circuit 220 that is further provided in signal communication with RFID circuit 230. The self-powered sensor 210, the buffering circuit 220 and the RFID circuit 230 in certain embodiments may be provided in a single on body sensor electronics housing, with a portion of the self-powered sensor 210 positioned under the skin surface of a user and in fluid contact with interstitial fluid. The single on body sensor electronics housing in certain embodiments is a waterproof housing. Referring back to FIG. 2, also shown is an external power source and Reader device ("reader") 240 which in certain embodiments, includes an RFID reader that is capable of radiating an RF field, and when in proximity to an RFID device, receives data communication back from the RFID device using the RF field.[P-73]
It would have been obvious to a person of ordinary skill in the art before the effective filing of the invention to combine Feldman's teaching with Durrant modified's teaching in order to effectively add or remove medical devises related to skin contact evaluating protocols.
Claim(s) 9, 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Durrant et al. (CN 107615396 B) in view of Remde (US 20110218495 A1) as applied to claim 1,10 above, and further in view of McCullough et al. (US 20200353169 A1)
Regarding claim 9, Durrant modified fails to teach detecting the removal of the portion of the first medical device from contact with or being coupled to the patient comprises processing data from at least one of a force sensor or a light sensor.
McCullough on the other hand teaches detecting the removal of the portion of the first medical device from contact with or being coupled to the patient comprises processing data from at least one of a force sensor or a light sensor (Paragraph 160)
A variety of sensors may be used to determine the operational state of application to patient. For example, back EMF through a coil from moving magnet on needle shield may indicate that the device has been applied to the patient. Alternatively, displacement of component or assembly (such as the needle shield) because of application of the drug delivery device to the patient may open or close a switch/circuit to signal this operational state. Along similar lines, the movement of components or assemblies may be detected using an optical sensor, with the light beam between a transmitter and receiver being broken by a change in the position of components, such as the needle shield or the reservoir (e.g., syringe or cartridge), upon application of the drug delivery device to the patient. As a further alternative, a capacitive or resistive sensor may be used, as may a pressure sensor. In fact, information regarding cannula (or needle) insertion may be determined by measuring the resistance through the needle and/or skin relative to external contact. Changes in temperature at the end of the drug delivery device intended to abut the patient's skin may also be used to determine the operational state of application to the patient.[P-160]
Here we see optical/light sensors used to determine movement of the medical device with respect to the patient especially in relation to needle relative to skin/contact. Thereby it is obvious to one of ordinary skill in the art to combine McCullough’s teaching with Durrant modified’s teaching in order to be more effectively enable the detection of the removal of a medical device accordingly.
Regarding claim 18, Durrant modified fails to teach detecting the removal of the portion of the first medical device from contact with or being coupled to the patient comprises processing data from at least one of a force sensor or a light sensor.
McCullough on the other hand teaches detecting the removal of the portion of the first medical device from contact with or being coupled to the patient comprises processing data from at least one of a force sensor or a light sensor (Paragraph 160)
A variety of sensors may be used to determine the operational state of application to patient. For example, back EMF through a coil from moving magnet on needle shield may indicate that the device has been applied to the patient. Alternatively, displacement of component or assembly (such as the needle shield) because of application of the drug delivery device to the patient may open or close a switch/circuit to signal this operational state. Along similar lines, the movement of components or assemblies may be detected using an optical sensor, with the light beam between a transmitter and receiver being broken by a change in the position of components, such as the needle shield or the reservoir (e.g., syringe or cartridge), upon application of the drug delivery device to the patient. As a further alternative, a capacitive or resistive sensor may be used, as may a pressure sensor. In fact, information regarding cannula (or needle) insertion may be determined by measuring the resistance through the needle and/or skin relative to external contact. Changes in temperature at the end of the drug delivery device intended to abut the patient's skin may also be used to determine the operational state of application to the patient.[P-160]
Here we see optical/light sensors used to determine movement of the medical device with respect to the patient especially in relation to needle relative to skin/contact. Thereby it is obvious to one of ordinary skill in the art to combine McCullough’s teaching with Durrant modified’s teaching in order to be more effectively enable the detection of the removal of a medical device accordingly.
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