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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/12/2026 has been entered.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (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.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over Spohn et al. (US 20180240548 A1) in further view of Sehgal et al. (US 20140266713 A1).
Regarding claim 1, Spohn discloses a fluid injector system (monitoring system 10 comprising injector 100, Fig 8) configured for use in administering at least one fluid to a patient ([0049]), the fluid injector system comprising: at least one sensor (pressure sensor, [0065]: “pressure sensor can be used to calculate the unused viable life for replaceable components of the injector”) configured for detecting operation data (fluid pressure; [0065]) during administration of the at least one fluid (fluid; [0065]) using the fluid injector system (10) wherein the operation data (fluid pressure; [0065]) includes one or more operation parameters (pressure; [0025]) associated with one or more components of the fluid injector system ([0008];[0065]; disposable or replaceable components of the injector system); and a control device (controller 12, Fig 8) comprising at least one processor (processor 16, Fig 8) programmed or configured to: receive the operation data (fluid pressure; [0065]) from the at least one sensor (pressure sensor; [0065]) ([0013]); determine a component status (status of the disposable or replaceable components; [0020], [0048]) for the one or more components (disposable or replaceable components, [0048]) of the fluid injector system (10) by comparing the received operation data with stored operation data; ([0048]; [0074] the amount of stress is determined using the operation data and is compared to stored values to estimate the remaining life of the component) wherein the component status includes one or more predictions of an operation failure or a misuse of the one or more components of the fluid injector system ([0074]; [0075]); and perform at least one action ([0089]: automatically reduce programmed inputs to suitable levels to ensure that the injection is performed safely) based on the component status deviating from a predetermined threshold ([0065]: “The controller or user interface device can provide information, such as the measured pressure of the injection and information about the unused viable life of the injector component to the system operator”)([0089]; controller 12 can assess if a programmed injection input will need a replacement of disposable components based on the cumulative distress endured thus far and unused viable life of the components and indicate replacement if input will exceed stablished values (threshold)); [0066]), wherein the at least one action comprises recursively updating one or more algorithms used for operating the fluid injector system ([0089]: automatically reduce programmed inputs to suitable levels to ensure that the injection is performed safely; this action is performed every time injection programed inputs exceed the safety thresholds of cumulative distress).
Spohn is silent regarding wherein the operation failure of the one or more components of the fluid injector system includes at least one of the following: a failure of an electrical component, a failure of a software component, or a combination thereof.
Sehgal discloses a fluid injector system (100, Fig 1) comprising an operation failure wherein the operation failure ([0045]: “(…)when the measured parameter value 320 meets or exceeds the corresponding maintenance threshold value”) of the one or more components of the fluid injector system (100) includes at least one of the following: a failure of an electrical component (Fig 4; touchscreen), a failure of a software component (internal clock, Fig 4), or a combination thereof ([0045]; failure of an electrical component, which is automatically turned off).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Spohn to include similar alerts configurations based on measured parameters and thresholds as taught by Sehgal to notify the user when an electrical component or internal clock maintenance is needed based on measured parameter and corresponding threshold ([0045]).
Regarding claim 2, Spohn/Sehgal discloses the fluid injector system of claim 1. Spohn discloses wherein the at least one action includes a prompt (display device 30 shows a warning; [0089]; [0096]: “the feedback device 14 can display a warning or alert indicating which replaceable component is the weakest link and when it will need to be replaced.”) for a user to initiate at least one maintenance action (replacement before injection; [0089]) associated with the one or more components of the fluid injector system (disposable component in need of replacement; [0089]).
Regarding claim 3, Spohn/Sehgal discloses the fluid injector system of claim 2. Spohn discloses wherein the at least one maintenance action (replacement of disposable component; [0089]) includes at least one of the following: scheduling a service of the fluid injector system, operating the one or more components of the fluid injector system in a specific manner indicated by the component status, replacing at least one disposable component, replacing at least one administration line, or any combination thereof ([0089]).
Regarding claim 4, Spohn/Sehgal discloses the fluid injector system of claim 1. Spohn discloses wherein the at least one action includes at least one of: automatically scheduling at least one maintenance action in response to the component status deviating from the predetermined threshold; automatically stopping the operation of the fluid injector system in response to the component status deviating from the predetermined threshold; and repeating at least a portion of the operation of the fluid injector system during which the component status indicated the operation failure or misuse with the least one processor being further programmed or configured to store the operation data detected by the at least one sensor during the repetition of the at least a portion of the operation of the fluid injector system (Action includes at least: Stop 84, Fig 5, which causes automatic stopping of operation when reusable component reaches the end of its expected life (threshold is being interpreted as end of expected life); [0061]).
Regarding claim 5, Spohn/Sehgal discloses the fluid injector system of claim 1. Spohn discloses wherein the one or more operation parameters include a viable life rating ([0065]) associated with the one or more components of the fluid injector system (variable life associated with at least one disposable component; [0065]), and wherein at least one processor (processor of controller 12, Fig 8) is further programmed or configured to: determine the viable life rating based on at least one of the following: number of uses of at least one disposable component, a force measurement of one or more drive components of the fluid injector system during pressurized delivery of the at least one fluid from the at least one disposable component, or any combination thereof ([0078]; The algorithm of controller 12 can be a simple linear relationship based only on injection force and number of injection cycles).
Regarding claim 6, Spohn/Sehgal discloses the fluid injector system of claim 1. Spohn discloses wherein the operation failure or misuse of the one or more components of the fluid injector system, (MUDS; [0048]) further includes at least one of the following: failure of a mechanical component, receiving user input from a user that causes the fluid injector system to operate contrary to one or more predefined operation thresholds, or any combination thereof (Failure of a mechanical component as result of viable life reaching predetermined threshold which triggers alert for user to replace the component; [0048]).
Regarding claim 7, Spohn/Sehgal discloses the fluid injector system of claim 1. Spohn discloses wherein the at least one sensor is a temperature sensor, a vibration sensor, a humidity sensor, an acoustic sensor, an optical sensor, an ultrasonic sensor, a load/pressure sensor, a capacitive sensor, a sensor configured for detecting electromagnetic radiation, a user interface configured for accepting a user input, or any combination thereof (pressure sensor; [0065]).
Claim Rejections - 35 USC § 102
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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fern et al. (US20140265611A1).
Regarding claim 1, Fern discloses a fluid injector system (Fig. 2) configured for use in administering at least one fluid (fluid/medication containers 222, 224, Fig 2) to a patient ([0056], Fig 2), the fluid injector system comprising: at least one sensor (first sensor, [0023]) configured for detecting operation data (sensing at least one parameter; [0027]) during administration of the at least one fluid using the fluid injector system ([0056]), wherein the operation data includes one or more operation parameters associated with one or more components of the fluid injector system (claim 12; “at least one sensor for sensing at least one parameter of the at least one inductor”; [0027]); and a control device (control unit 140, Fig 1; [0028]) comprising at least one processor (processor of control unit 140, Fig 1) programmed or configured to: receive the operation data from the at least one sensor (the at least one sensor; claim 4; [0023]); determine a component status for the one or more components of the fluid injector system by comparing the received operation data with stored operation data ([0027]; [0029]; action is taken when limit is exceeded), wherein the component status includes one or more predictions of an operation failure ([0029]: “analyzing the at least one parameter and generating a predictive maintenance action”) or a misuse of the one or more components of the fluid injector system; and perform at least one action based on the component status deviating from a predetermined threshold ([0029]), wherein the at least one action comprises recursively updating one or more algorithms used for operating the fluid injector system ([0029: “monitoring the at least one parameter over a period of time to generate a trend, and controlling each medical device module based on the trend”), and wherein the operation failure of the one or more components of the fluid injector system includes at least one of the following: a failure of an electrical component, a failure of a software component, or a combination thereof ([0029]: failure of an electrical component; method reduces power to the component when the parameter measured by the sensor exceed limit and monitor over time to generate a trend, where the medical device is controlled based on the trend created).
Response to Arguments
Applicant’s arguments with respect to claims 1-7 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Rejection relies in an alternative interpretation of Spohn et al. (US 20180240548 A1). In efforts to advance prosecution, claim 1 is further rejected over Fern et al. (US20140265611A1).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GUILLERMO G PAZ ESTEVEZ whose telephone number is (703)756-5951. The examiner can normally be reached Monday- Friday 8:00-5:00.
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/GUILLERMO G PAZ ESTEVEZ/ Examiner, Art Unit 3783
/Lauren P Farrar/ Primary Examiner, Art Unit 3783
