DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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, and 9-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Abal et al. (US 2023/0067655) in view of Evans et al. (US 2008/0033360).
Regarding claims 1 and 11, Abal et al. (henceforth Abal) discloses a system for monitoring fluid delivery to a patient (Figure 1B; ¶ [0074]; see also ¶ [0071] which discloses monitoring fluid line issues due to misloading the pump device), the system comprising: at least one processing device; and at least one computer readable data storage device storing software instructions that, when executed by the at least one processing device (see ¶¶ [0047], [0075], and [0079] which discloses the use of computer readable data storage via a number of means such as an computer or mobile phone as well as the processing unit or CPU; it is noted that the processor claim is being interpreted as explicitly required and is therefore the processor programming is analogous to the method of claim 11 since the steps need to be explicitly taught rather than functionally capable), cause the at least one processing device to: analyze video data captured by one or more cameras to confirm whether a condition triggering the alarm exists (e.g., ¶¶ [0080]-[0084] discloses using a camera to check portions of the pump assembly to determine if an error exists in the system and generating a message with instructions on how to correct the error); and send an alert to a communications device associated with a caregiver when the condition that triggers the alarm is confirmed to exist based on the video data (see Abal ¶ [0084] wherein the camera and machine learning algorithm determine whether or not the pump is working as intended or if an error exists; if an error exists a user is notified via a message or alert). Abal fails to explicitly disclose that the initialization of the alert generation analysis is performed after the system receives an alert that a component is not functioning as intended.
Evans et al. (henceforth Evans) teaches an interface for a medical infusion pump which comprises means for tracking various features of a medical infusion pump and generating alerts when components are not functioning as desired (see e.g., ¶ [0152] which discloses alerts being a flag in the software which is not output to the patient, audible or visual alarms, indicators, or the like; see also ¶ [0154] which discloses that the alarm is based on a malfunction of the pump which is operating outside the intended range).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the system of Abal to check for system alerts as taught by Evans and to utilize the video-based monitoring and analysis system to verify whether or not those alerts are valid. Since Abal teaches video monitoring and adjustment of an infusion system in real-time, it would be obvious to incorporate the ability to monitor system alerts which are video verifiable (e.g., IV drop size or rate, plunger movement, or air occlusions in the fluid lines) into the system. In this manner, the video verification software can double check system alerts (such as the flag alert of Evans which tells the system to double check the issue before issuing a user alert) to determine if the alert is valid before recommending or taking action to deal with the alert. Abal clearly discloses the use of the video analysis system to check for visible faults during an infusion procedure and this would allow the system to check for various issues related to infusion or operation as taught by Evans via the generation of an internal system alert before using system resources to verify whether or not the device is working as intended.
Regarding claims 2 and 12, Abal/Evans further teach causing the processing device to suppress the alarm on the pump when the condition that triggers the alarm is not confirmed to exist based on the video data (as above, Abal, as modified by Evans, would be programmed to receive software flags for potential issues from the algorithm of Evans. These flags would then trigger the analysis of the target component during video or image processing as taught by Abal. In the cited combination, since the potential error is only a software flag, the alarm would not be generated or would be suppressed since the device is detected as working properly; this step is analogous to the general state of alarm systems wherein if there is no problem, there is no alert generated; in this state, the method of claim 12 is anticipated since the condition is determined to not exist and therefor the output alarm is never triggered and the user alert is therefore suppressed).
Regarding claim 9, Abal further discloses the processing device as applying frequency filtering to identify one or more components connected to the system (¶ [0080] discloses that the camera is designed to detect wavelengths of light which occupy different portions of the electromagnetic spectrum including visible light, infrared, and ultraviolet; this anticipates the frequency filtering as the camera is designed to detect all of these distinct frequency ranges).
Regarding claim 10, Abal further discloses the processor using machine learning to identify the infusion pump and one or more components connected to the infusion pump in the video data (see ¶ [0026] which discloses the use of a machine learning algorithm to detect pump issues via image analysis).
Claim(s) 3, 4, and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Abal et al. (US 2023/0067655) in view of Evans et al. (US 2008/0033360), and further in view of Lin et al. (US 10,456,084).
Regarding claims 3 and 13, Abal/Evans disclose the claimed invention substantially as set forth above for claim 1, but do not explicitly disclose movement of the camera assembly.
Lin et al. (henceforth Lin) teaches a camera (31) device for monitoring a medical are (Figure 1) which is designed to zoom or be remotely turned during use to monitor an IV bag (Col. 3, lines 48-52; the movement of the camera of Lin is applied as the movement control step of the method of claim 13).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the system of Abal/Evans to utilize a camera system that allows for remote control of movement and zoom functions so as to allow for the system to use the camera to check various components of the infusion system during a procedure as taught by Lin. This also allows a caregiver to control the status of a patient and the medical device while the procedure is performed.
Regarding claim 4, Abal/Evans fail to explicitly teach the use of multiple cameras (Abal locates the camera on the pump housing to view the pump loading). However, Lin teaches the use of an externally mounted camera (31) for observing the patient and infusion system (IV bag) during a procedure (Col. 3, lines 44-47 disclose the external camera for monitoring the liquid level in the IV bag). Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to utilize multiple cameras in the system of Abal/Evans depending on what parameters the user wishes to track during a procedure (e.g., the attached camera of Abal for verifying pump set attachment to housing as well as the external camera of Evans for monitoring other infusion system parameters such as the liquid level in the IV bag). Abal/Evans teach the use of cameras to check pump status as well as other alerts and so it would be obvious to place cameras to monitor the flow line and pump housing as taught by Abal/Evans, and Lin. It is further noted that the location of the cameras is not required by the system claims and it would be obvious to place the cameras in any location (including on a patient) one wished to monitor for the reasons set forth above.
Claim(s) 5-8 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Abal et al. (US 2023/0067655) in view of Evans et al. (US 2008/0033360), and further in view of Naik et al. (US 2009/0037217).
Regarding claims 5, 7, 8, and 14, Abal/Evans teach the claimed invention substantially as set forth above for claim 1, but fail to explicitly disclose the use of a coating, dye, or luminescent material.
Naik et al. (henceforth Naik) teaches (¶ [0054]) the use, in a medical infusion system, of a drug identification label (as per claim 8; see ¶ [0055] for identification information of the label) which comprises a fluorescent component for verification purposes (the fluorescence of the label via dye or ink may be considered an impregnated dye as per claim 7; see also ¶ [0061] which discloses that all ID means are covered by a coating; this applies to the method of claim 14 since the luminescent coating is identified by the camera system to verify the label).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the system of Abal/Evans to comprise a fluorescent label on any component or medication attached to the system to provide a means of optically verifying the component or drug is proper before or during a procedure as taught by Naik (e.g., label identification means). In this manner, the system can determine whether or not the correct medicament has been placed in the system for an infusion procedure based upon the machine readable fluorescent label taught by Naik.
Regarding claim 6, Naik further teaches that the component comprises a fluorescent dye coating (the fluorescent label is considered to meet this limitation as the dye can be considered a coating applied to the label to allow it to fluoresce when illuminated.
Claim(s) 15-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Abal et al. (US 2023/0067655) in view of Pham et al. (US 2020/0330681).
Regarding claim 15, Abal discloses a system for monitoring fluid delivery to a patient (Figure 1B; ¶ [0074]; see also ¶ [0071] which discloses monitoring fluid line issues due to misloading the pump device), comprising: at least one processing device; and at least one computer readable data storage device storing software instructions (see ¶¶ [0047], [0075], and [0079] which discloses the use of computer readable data storage via a number of means such as an computer or mobile phone as well as the processing unit or CPU) that, when executed by the at least one processing device, cause the at least one processing device to: capture video data of one or more components connected to the infusion pump (pump set or IV line; ¶¶ [0082]-[0084] and [0101] which discloses the determination of other non-conformities in the pump system including contaminants or air in the line via improper priming), and issue an alert when a difference between the observed and accepted status is outside of a predetermined range (see ¶ [0084] which discloses triggering an alarm if the observed pump loading is determined by image analysis to be incorrect). Abal fails to explicitly disclose the use of the system to monitor flow rate using fiducial markings on a container and issuing an alert if the determined flow rate does not match a predetermined range.
Pham et al. (henceforth Pham) teaches (Figures 2-3) a flow indicator means for an infusion pump system which utilizes a container (body of 120), onto which is provided a fiducial marking (128) which is monitored for a change to determine the flow rate of the system (see ¶¶ [0034]-[0038] which disclose that the marking 128 changes size and shape as the body of the container is deformed during an infusion; it discloses that the rate of change of the shape on the body is used to determine the flow rate or possible errors).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the system of Abal to incorporate the fluid flow rate visual feature of Pham so as to allow the system to track the infusion flow rate of a medicament during a procedure and to issue an alert if the flow rate is not determined to match a pre-determined flow rate. Abal teaches the use of machine learning to visually capture elements of the system, compare them to expected ranges, and issue an alert if there is a mis-match in the observed versus accepted values. In this manner, it would be obvious to add the use of a visual flow rate inspection system, such as that of Pham, to the overall system of Abal to utilize the camera-based verification process to also ensure that the fluid flow rate is within a defined range so as to prevent possible over-infusion or to prevent damage to the system or patient via a low infusion or occlusion issue in the pump system.
Regarding claim 16, Pham further teaches that the flow rates can be calculated via rates of change of the fiducial markings (e.g., ¶ [0036] discloses that the indicator 128 changes in size and shape as the infusion progresses; see also ¶ [0037] wherein the indicator aids in determining flow rates based upon the perception of the change in size of the marking).
Regarding claim 17, Pham further teaches wherein the marking or pattern (e.g., “+”) includes a pattern that deforms as the one or more containers empty of the fluids (¶ [0036] the plus sign pattern changes size and shape as the infusion progresses).
Regarding claim 18, Pham further teaches wherein the fiducial markings include a first color that transitions into a second color as the one or more containers empty of the fluids (see ¶ [0039] wherein the use of a color change is disclosed as an alternative visual indicator to the use of a pattern such as the plus sign of Figure 2; it also teaches the use of first and second colors and/or patterns as the indicator).
Regarding claim 19, Abal further discloses wherein the alert is generated on the infusion pump (see Figure 1B, alarm 164 is on the infusion pump housing; ¶ [0084] triggers the alarm via message and instructions).
Regarding claim 20, Abal further discloses wherein the alert is sent over a network to a communications device associated with a caregiver (see ¶ [0075] and Figure 1A, the system is connected at network 140 which is also connected to client device 130; also a wired or wireless network is contemplated; as per ¶ [0084], the alarm is sent through a progressive care unit which is connected to the network and is embodied as workstations, smart phones, tablets, or the like which would be used by a caregiver as per¶ [0075]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUSTIN L ZAMORY whose telephone number is (571)270-1238. The examiner can normally be reached M-F 8:30am-4:30pm ET.
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/JUSTIN L ZAMORY/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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