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 .
Response to Amendment
The amendment filed December 10, 2025 has been entered. Claims 18 and 20-26 remain pending in the application. Claims 1-17 and 19 were previously cancelled.
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 18, 20 and 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Kalafut et al. (USPN 7925330) in view of Capone et al. (WO 2013/043868) in further view of Harman et al. (US 20140350863).
Regarding claim 18, Kalafut discloses a fluid injection apparatus (dual syringe injection system 100), comprising:
at least one pressurizing system (drive member 110A, 110B);
at least a first fluid path (Figure 27) operably connectible to the at least one pressurizing system to transport a contrast fluid pressurized by the pressurizing system (“The controller 200 is operable to control the operation of drive members 110A and 110B to control injection of fluid A (for example, contrast medium) from source A and injection of fluid B (for example, saline) from source B, respectively.” [Col 9, lines 59-63]), the at least a first fluid path comprising a first tubing set (“low pressure connector (LPCT) tubing” [Col 20, line 49]; Figure 27) and a first catheter (“catheter inserted into the patient for intravascular access” [Col 10, line 15]; Figure 27);
a control system (controller 200) operably associated with the at least one pressurizing system (Figure 1), a processor system (processor 220), and an input system (display 210; “Controller 200 can, for example, include a user interface comprising a display 210.” [Col 9, line 63-64]) for receiving an injection protocol (“The controller includes a programming system to allow programming of an injection protocol” [Col 4, line 48-50]) specifying a first flow rate according to which the contrast fluid is intended to be injected into a patient (“the term "protocol" refers to a group of parameters such as flow rate, volume injected, duration etc. that define the amount of fluid(s) to be delivered to a patient during an injection procedure.” [Col 4, lines 55-59]; “The clinical operator can, for example, control the injection system by either entering volumes and flow rates manually into the fields provided on the User Interface (see FIG. 1)” [Col 10, lines 59-61]); and
a predictive model (Figure 26) stored in a memory system (memory 230) and executable by the processor system (“the programming system of the fluid injection apparatus includes a computer, and the parameter generator includes software stored in a computer memory (and executable by a computer).” [Col 6, line 44]) to determine whether a pressure threshold value would be reached in the at least a first fluid flow path were the injection protocol initiated using the first flow rate (“The pressure modeling system can further include a mechanism adapted to determine if the predicted pressure exceeds a pressure threshold” [Col 7, line 30]; Figure 26), the predictive model is determined experimentally based on data associated with a plurality of contrast fluids and a plurality of flow paths, the at least a first flow path different from the plurality of flow paths (“the flow rate predicted for a phase (or time instance of an injection) can be used as an input to a system or model adapted or operable to predict the amount of pressure generated in the syringe or other container as a result of the volumetric flow rate, the fluid path characteristics (for example, the inner diameter of the catheter (gauge)), and the viscosity of the contrast agent…The pressure resulting from a set of values of these variables may be…determined from prior experimental data” [Col 18, line 5]; “it is possible to further optimize this coefficient with respect to experimental data sets. K.sub.contraction--loss attributable to the pressure generated when the fluid is forced from the larger diameter LPCT into the smaller diameter catheter. The value of this coefficient may again be found in fluid textbooks. The actual value of the constant is dependent on the ratio of the LPCT's area to the catheter's area.” [Col 20, line 58]; “The experimental data are taken from a study testing the pressure performance of MR disposable components (0.075'' ID LLPCT, 20-24 ga Angiocath catheters) with various MR contrast agents (Gadovist, Magnevist, and Saline were tested).” [Col 23, lines 2-6]; Figures 28-30 wherein the first flow path is different from at least some of the plurality of flow paths, such as having a different gauge);
wherein the processor system, in response to the predictive model determining that the pressure threshold value would be reached in the at least a first fluid flow path were the injection protocol initiated using the first flow rate (Figure 26, center of flow chart: “Does the computed Pressure exceed the Pressure Limit?”), is configured to update the injection protocol to create an updated injection protocol so that an expected pressure level is determined via the predictive model to be less than or equal to the pressure threshold value thereby enabling the updated injection protocol to be carried out (“If the predicted pressure exceeds a pressure limit or threshold…the operator can be warned of a possible over -pressure indication by, for example, a color coding of the flow rate entry field” [Col 18, line 21]; “The pressure modeling system of the present invention addresses this problem by alerting the operator before the injection commences that the choice of injection parameters will result in an over-pressure situation. The operator can thus alter the injection parameters to avoid the over-pressure situation and the associated variation from the programmed volumetric flow rate” [Col 18, line 49]).
Kalafut fails to explicitly teach a fluid heating system configured to determine a temperature of the contrast fluid; the control system operably associated with the fluid heating system; the predictive model executable by the processor to determine whether a pressure threshold value would be reached using the contrast fluid at the temperature determined by the fluid heating system, the predictive model trained on experimental data; wherein the processor system, in response to the predictive model determining that the pressure threshold value would be reached in the at least a first fluid flow path were the injection protocol initiated using the first flow rate, is configured to automatically change the temperature to a changed temperature determined by the fluid heating system to update the injection protocol to create an updated injection protocol so that an expected pressure level is determined via the predictive model to be less than or equal to the pressure threshold value thereby enabling the updated injection protocol to be carried out with the fluid heating system heating the contrast fluid to the changed temperature.
Capone teaches a fluid injection apparatus (fluid delivery system 2) comprising: at least one pressurizing system (pump metering and pressurizing section 22); at least a first fluid path (pump outlet section 24) operably connectible to the at least one pressurizing system to transport a contrast fluid pressurized by the pressurizing system (see Figure 1 and [00121]), the at least a first fluid path comprising a first tubing set and a first catheter (“The pump outlet section 24 includes a disposable single-use or single -patient supply set 40…comprising medical tubing having opposed free ends each having a fluid connector 42 used to make a fluid connection, such as to a catheter inserted into a patient to convey a desired fluid or mixture of fluids to a desired location within a patient's body.” [00120]); a fluid heating system (heating system 734) configured to determine temperature of the contrast fluid (“the control system 800 may engage the heating system 734 to heat any installed fluid source containers 30.” [00262]); a control system (control system 800) operably associated with the at least one pressurizing system, the fluid heating system, a processor system (“the control system 800 comprises a system controller or computer 822 with appropriate software for controlling operation of the fluid delivery system 2” [0240]; Figure 46A); and an input system for receiving an injection protocol specifying a first flow rate according to which the contrast fluid is intended to be injected into a patient (“the user will specify a patient protocol that is used to perform a fluid injection…The local user interface display 806 is desirably available for installation of the pump 10 and the foregoing fluid priming processes. There may be several different options available for patient protocol entry including, but not limited to: (1) manually programming the patient protocol, specifying the relevant parameters for each phase (fluid type, flow rate, volume, etc.);” [00263]); the processor system configured to automatically change the temperature determined by the fluid heating system to update the injection protocol to have a lower pressure level thereby enabling the updated injection protocol to be carried out with the fluid heating system heading the contrast fluid to the changed temperature (“in the case of contrast media used in radiographic imaging procedures, increasing the temperature of the contrast media also has the desirable effect of reducing the viscosity of the contrast media for easier injection into the patient, among other advantages. Accordingly, each fluid handling compartment 712 is warmed by a convective heating system 734.” [00237], wherein increasing the temperature of the fluid lowers the viscosity and therefore also lowers the expected pressure level; see [00262] for automatic control of the fluid heating system: “Once both compartment doors 714 are closed to enclose the fluid handling compartments 712 within the support housing 702 and the convective heating system 734 is enabled, the control system 800 may engage the heating system 734 to heat any installed fluid source containers 30. Typically, the heating system 734 heats the air inside of the fluid handling compartment 712 to 40° C and the air inside of the fluid handling compartment 712 is circulated continuously around all of the installed or stored fluid source containers 30 to warm the fluids.” [00262]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the fluid injection apparatus of Kalafut to include a fluid heating system configured to determine a temperature of the contrast fluid, the model using the contrast fluid at the temperature determined by the fluid heating system; and the processor system being configured to automatically change the temperature to a changed temperature determined by the fluid heating system to update the injection protocol to create an updated injection protocol thereby enabling the updated injection protocol to be carried out with the fluid heating system heating the contrast fluid to the changed temperature based on the teachings of Capone to adjust the viscosity of the contrast fluid and therefore adjust the pressure in order to increase patient comfort and allow for easier injection of the contrast fluid into the patient (Capone [00237]).
Modified Kalafut fails to explicitly teach the predictive model trained on experimental data.
Hartman discloses a fluid delivery apparatus (Figures 1-4) comprising: a predictive model (“FIG. 1 depicts a flowchart of a process 100 for configuring a dose prediction model.” [0025]) stored in a memory system (RAM 402/ROM403) and executable by a processor system (processor 401), wherein the predictive model is trained on experimental data (“The system analyzes the patient anatomy (including, in some instances, anatomical information for each organ-at-risk (OAR)) and DVH values selected from this training set of plans (step 103), and trains a mathematical DVH estimation model (step 105) based on the patient anatomy and dose volume histogram values. Once trained, the prediction model may be used to predict (step 109) the dose parameters for the treatment plan of the radiation therapy patient.” [0027]; “Once the set of training data is selected, a prediction model may be trained (i.e., refined) to generate more precise dose estimations for the radiation therapy treatment being planned.” [0028]; “an implementation of a DVH estimation begins by analyzing the training set of data (selected at step 101) and parsing the data to collect structure sets (containing spatial information of various organs and the target), previously optimized treatment plans, and corresponding 3D dose distributions from multiple patients from the training set of data (step 201).” [0029]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the predictive model of the fluid injection apparatus of Kalafut to be trained on experimental data based on the teachings of Hartman to allow for automatic optimization and updating of the predictive model for the individual patient based on existing data of previous uses of similar fluid injection apparatuses (Hartman [0006-0012]).
Regarding claim 20, modified Kalafut teaches the fluid injection apparatus of claim 18, wherein the predictive model incorporates at least one of a catheter characteristic, a contrast fluid viscosity, and an effect of temperature on contrast fluid viscosity (“the flow rate predicted for a phase (or time instance of an injection) can be used as an input to a system or model adapted or operable to predict the amount of pressure generated in the syringe or other container as a result of the volumetric flow rate, the fluid path characteristics (for example, the inner diameter of the catheter (gauge)), and the viscosity of the contrast agent” [Col 18, line 5]).
Regarding claim 22, Kalafut discloses a non-transitory computer readable storage medium (memory 230 as part of controller 200) for executing an injection protocol (“the programming system of the fluid injection apparatus includes a computer, and the parameter generator includes software stored in a computer memory (and executable by a computer).” [Col 6, line 44]), the non-transitory computer readable storage medium having instructions stored thereon that, when executed by a processor (processor 220), causes the processor to:
receive an injection protocol (“The controller includes a programming system to allow programming of an injection protocol” [Col 4, line 48-50]) from an input system (display 210; “Controller 200 can, for example, include a user interface comprising a display 210.” [Col 9, line 63-64]), the injection protocol specifying a first flow rate (“the term "protocol" refers to a group of parameters such as flow rate, volume injected, duration etc. that define the amount of fluid(s) to be delivered to a patient during an injection procedure.” [Col 4, lines 55-59]; “The clinical operator can, for example, control the injection system by either entering volumes and flow rates manually into the fields provided on the User Interface (see FIG. 1)” [Col 10, lines 59-61]) according to which a contrast fluid (“The controller 200 is operable to control the operation of drive members 110A and 110B to control injection of fluid A (for example, contrast medium) from source A and injection of fluid B (for example, saline) from source B, respectively.” [Col 9, lines 59-63]) is intended to be injected into a patient via at least a first fluid path (Figure 27) comprising a first tubing set (“low pressure connector (LPCT) tubing” [Col 20, line 49]; Figure 27) and a first catheter (“catheter inserted into the patient for intravascular access” [Col 10, line 15]; Figure 27);
determine, based on a predictive model (Figure 26) stored in a memory system (“the programming system of the fluid injection apparatus includes a computer, and the parameter generator includes software stored in a computer memory (and executable by a computer).” [Col 6, lines 44-47]), whether a pressure threshold value would be reached in the at least a first fluid flow path were the injection protocol initiated using the first flow rate (“The pressure modeling system can further include a mechanism adapted to determine if the predicted pressure exceeds a pressure threshold” [Col 7, line 30]; Figure 26), the predictive model is determined experimentally based on data associated with a plurality of contrast fluids and a plurality of flow paths, the at least a first flow path different from the plurality of flow paths (“the flow rate predicted for a phase (or time instance of an injection) can be used as an input to a system or model adapted or operable to predict the amount of pressure generated in the syringe or other container as a result of the volumetric flow rate, the fluid path characteristics (for example, the inner diameter of the catheter (gauge)), and the viscosity of the contrast agent…The pressure resulting from a set of values of these variables may be…determined from prior experimental data” [Col 18, line 5]; “it is possible to further optimize this coefficient with respect to experimental data sets. K.sub.contraction--loss attributable to the pressure generated when the fluid is forced from the larger diameter LPCT into the smaller diameter catheter. The value of this coefficient may again be found in fluid textbooks. The actual value of the constant is dependent on the ratio of the LPCT's area to the catheter's area.” [Col 20, line 58]; “The experimental data are taken from a study testing the pressure performance of MR disposable components (0.075'' ID LLPCT, 20-24 ga Angiocath catheters) with various MR contrast agents (Gadovist, Magnevist, and Saline were tested).” [Col 23, lines 2-6]; Figures 28-30 wherein the first flow path is different from at least some of the plurality of flow paths, such as having a different gauge); and
in response to the predictive model determining that the pressure threshold value would be reached in the at least a first fluid flow path were the injection protocol initiated using the first flow rate (Figure 26, center of flow chart: “Does the computed Pressure exceed the Pressure Limit?”), update the injection protocol to create an updated injection protocol so that an expected pressure level is determined via the predictive model to be less than or equal to the pressure threshold value thereby enabling the updated injection protocol to be carried out (“If the predicted pressure exceeds a pressure limit or threshold…the operator can be warned of a possible over -pressure indication by, for example, a color coding of the flow rate entry field” [Col 18, line 21]; “The pressure modeling system of the present invention addresses this problem by alerting the operator before the injection commences that the choice of injection parameters will result in an over-pressure situation. The operator can thus alter the injection parameters to avoid the over-pressure situation and the associated variation from the programmed volumetric flow rate” [Col 18, line 49]).
Kalafut fails to explicitly teach determine, based on the predictive model, whether a pressure threshold value would be reached using the contrast fluid at a temperature determined by a fluid heating system, the predictive model trained on experimental data; and in response to the predictive model determining that the pressure threshold value would be reached in the at least a first fluid flow path were the injection protocol initiated using the first flow rate, automatically change the temperature to a changed temperature determined by the fluid heating system to update the injection protocol to create an updated injection protocol so that an expected pressure level is determined via the predictive model to be less than or equal to the pressure threshold value thereby enabling the updated injection protocol to be carried out with the fluid heating system heating the contrast fluid to the changed temperature.
Capone teaches a non-transitory computer readable storage medium for executing an injection protocol (“the programmed patient protocol.” [00268] in control system 800) including instructions that when executed by a processor (“the control system 800 comprises a system controller or computer 822 with appropriate software for controlling operation of the fluid delivery system 2” [0240]; Figure 46A) cause the processor to: receive an injection protocol form an input system, the injection protocol specifying a first flow rate (“the user will specify a patient protocol that is used to perform a fluid injection…The local user interface display 806 is desirably available for installation of the pump 10 and the foregoing fluid priming processes. There may be several different options available for patient protocol entry including, but not limited to: (1) manually programming the patient protocol, specifying the relevant parameters for each phase (fluid type, flow rate, volume, etc.);” [00263]) according to which a contrast fluid is intended to be injected into a patient via at least a first fluid path comprising a first tubing set and a first catheter (“The pump outlet section 24 includes a disposable single-use or single -patient supply set 40…comprising medical tubing having opposed free ends each having a fluid connector 42 used to make a fluid connection, such as to a catheter inserted into a patient to convey a desired fluid or mixture of fluids to a desired location within a patient's body.” [00120]); automatically change a temperature determined by a fluid heating system (heating system 734; (“the control system 800 may engage the heating system 734 to heat any installed fluid source containers 30.” [00262]) to update the injection protocol to have a lower pressure level thereby enabling the updated injection protocol to be carried out with the fluid heating system heading the contrast fluid to the changed temperature (“in the case of contrast media used in radiographic imaging procedures, increasing the temperature of the contrast media also has the desirable effect of reducing the viscosity of the contrast media for easier injection into the patient, among other advantages. Accordingly, each fluid handling compartment 712 is warmed by a convective heating system 734.” [00237], wherein increasing the temperature of the fluid lowers the viscosity and therefore also lowers the expected pressure level; see [00262] for automatic control of the fluid heating system: “Once both compartment doors 714 are closed to enclose the fluid handling compartments 712 within the support housing 702 and the convective heating system 734 is enabled, the control system 800 may engage the heating system 734 to heat any installed fluid source containers 30. Typically, the heating system 734 heats the air inside of the fluid handling compartment 712 to 40° C and the air inside of the fluid handling compartment 712 is circulated continuously around all of the installed or stored fluid source containers 30 to warm the fluids.” [00262]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the instructions of Kalafut to include determining, based on the model, whether a pressure threshold value would be reached using the contrast fluid at a temperature determined by a fluid heating system and automatically changing the temperature determined by the fluid heating system to update the injection protocol to create an updated injection protocol so that the expected pressure level is determined via the model to be less than or equal to the pressure threshold value thereby enabling the updated injection protocol to be carried out with the fluid heating system heating the contrast fluid to the changed temperature based on the teachings of Capone to adjust the viscosity of the contrast fluid and therefore adjust the pressure in order to increase patient comfort and allow for easier injection of the contrast fluid into the patient (Capone [00237]).
Modified Kalafut fails to explicitly teach the predictive model trained on experimental data.
Hartman discloses a fluid delivery apparatus (Figures 1-4) comprising: a predictive model (“FIG. 1 depicts a flowchart of a process 100 for configuring a dose prediction model.” [0025]) stored in a memory system (RAM 402/ROM403) and executable by a processor system (processor 401), wherein the predictive model is trained on experimental data (“The system analyzes the patient anatomy (including, in some instances, anatomical information for each organ-at-risk (OAR)) and DVH values selected from this training set of plans (step 103), and trains a mathematical DVH estimation model (step 105) based on the patient anatomy and dose volume histogram values. Once trained, the prediction model may be used to predict (step 109) the dose parameters for the treatment plan of the radiation therapy patient.” [0027]; “Once the set of training data is selected, a prediction model may be trained (i.e., refined) to generate more precise dose estimations for the radiation therapy treatment being planned.” [0028]; “an implementation of a DVH estimation begins by analyzing the training set of data (selected at step 101) and parsing the data to collect structure sets (containing spatial information of various organs and the target), previously optimized treatment plans, and corresponding 3D dose distributions from multiple patients from the training set of data (step 201).” [0029]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the predictive model Kalafut to be trained on experimental data based on the teachings of Hartman to allow for automatic optimization and updating of the predictive model for the individual patient based on existing data of previous uses of similar fluid injection apparatuses (Hartman [0006-0012])
Regarding claim 23, modified Kalafut teaches the non-transitory computer readable storage medium of claim 22, wherein the predictive model incorporates at least one of a catheter characteristic, a contrast fluid viscosity, and an effect of temperature on contrast fluid viscosity (“the flow rate predicted for a phase (or time instance of an injection) can be used as an input to a system or model adapted or operable to predict the amount of pressure generated in the syringe or other container as a result of the volumetric flow rate, the fluid path characteristics (for example, the inner diameter of the catheter (gauge)), and the viscosity of the contrast agent” [Col 18, line 5]).
Claims 21 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Kalafut et al. (USPN 7925330) in view of Capone et al. (WO 2013/043868) in further view of Harman et al. (US 20140350863) as applied in claims 18 and 22 above, and further in view of Barron et al. (US 2013/0053692).
Regarding claim 21, modified Kalafut teaches the fluid injection apparatus of claim 18.
Modified Kalafut fails to explicitly teach wherein the fluid heating system is configured to determine the temperature of the contrast fluid by sensing the temperature via a sensor in the fluid heating system.
Barron teaches a fluid injection apparatus (injection system 10) comprising a fluid heating system (heater drive 150 and heater 152) configured to determine the temperature of the contrast fluid by sensing the temperature via a sensor (temperature sensor 140) in the fluid heating system (“Computer 100 monitors temperature of the contrast material based upon a Temp Monitor signal from temperature sensor 140. Temperature sensor 140 is preferably positioned near syringe body 18. If the temperature being sensed by temperature sensor 140 is too high, computer 100 will disable operation motor 104 to discontinue patient injection. If the temperature is too low, computer 100 provides a/Temp Enable drive signal to heater drive 150, which energizes heater 152.” [0095]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the fluid injection apparatus of Kalafut to include fluid heating system is configured to determine the temperature of the contrast fluid by sensing the temperature via a sensor in the fluid heating system based on the teachings of Barron to monitor and maintain the temperature of the contrast fluid throughout use of the fluid injection apparatus (Barron [0095]).
Regarding claim 24, modified Kalafut teaches the non-transitory computer readable storage medium of claim 22.
Modified Kalafut fails to explicitly teach the temperature of the contrast fluid is determined by the fluid heating system via a sensor in the fluid heating system.
Barron teaches a fluid injection apparatus (injection system 10) for executing an injection protocol, wherein the temperature of the contrast fluid is determined by a fluid heating system (heater drive 150 and heater 152) via a sensor (temperature sensor 140) in the fluid heating system (“Computer 100 monitors temperature of the contrast material based upon a Temp Monitor signal from temperature sensor 140. Temperature sensor 140 is preferably positioned near syringe body 18. If the temperature being sensed by temperature sensor 140 is too high, computer 100 will disable operation motor 104 to discontinue patient injection. If the temperature is too low, computer 100 provides a/Temp Enable drive signal to heater drive 150, which energizes heater 152.” [0095]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the non-transitory computer readable storage medium of Kalafut to include the temperature of the contrast fluid is determined by the fluid heating system via a sensor in the fluid heating system based on the teachings of Barron to monitor and maintain the temperature of the contrast fluid throughout use of the fluid injection apparatus (Barron [0095]).
Claims 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Kalafut et al. (USPN 7925330) in view of Capone et al. (WO 2013/043868) in further view of Harman et al. (US 20140350863) as applied in claims 18 and 22 above, and further in view of Kalafut et al. (USPN 8295914), hereinafter Kalafut ‘914.
Regarding claim 25, modified Kalafut discloses the fluid injection apparatus of claim 18.
Modified Kalafut fails to explicitly disclose wherein after the predictive model is trained, the fluid injection apparatus is configured to collect data from at least one subsequent injection procedure, wherein the predictive model is updated based on the data from the at least one subsequent injection procedure.
Kalafut ‘914 teaches a fluid injection apparatus (“an injector system for the delivery of a fluid to a patient including: an injector and a controller” [Col 7, line 6]) comprising an predictive model determined based on experimentally data (“method of modeling propagation of a pharmaceutical fluid in a patient, including: collecting data corresponding to a time response curve resulting from injection of the fluid; and determining at least one mathematical model describing the data.” [Col 7, line 51-54]), wherein after the predictive model is determined, the fluid injection apparatus is configured to collect data from at least one subsequent injection procedure, wherein the predictive model is updated based on the data from the at least one subsequent injection procedure (“The model can also be determined and/or updated with data collected during the imaging (or other procedural) injection.” [Col 8, lines 7-11]; “In addition, the general or multi-patient model can be adjusted, modified, or updated based upon results of one or more patients for use with other patients.” [Col 26, line 58]; Figures 19A-19B).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the fluid injection apparatus of Kalafut to include wherein after the predictive model is trained, the fluid injection apparatus is configured to collect data from at least one subsequent injection procedure, wherein the predictive model is updated based on the data from the at least one subsequent injection procedure based on the teachings of Kalafut ‘914 to optimize delivery of the fluid in order to delivery only the minimum necessary amount of contrast agent (Kalafut ‘914 [Col 5, line 19], [Col 6, lines 34-38]) and to ensure that the predictive model is able to utilized for multiple patients without necessitating a test injection (Kalafut ‘914 [Col 26, line 60]).
Regarding claim 26, modified Kalafut discloses the non-transitory computer readable storage medium of claim 22.
Modified Kalafut fails to explicitly disclose wherein after the predictive model is trained, the instructions cause the processor to collect data from at least one subsequent injection procedure, wherein the predictive model is updated based on the data from the at least one subsequent injection procedure.
Kalafut ‘914 teaches a fluid injection apparatus (“an injector system for the delivery of a fluid to a patient including: an injector and a controller” [Col 7, line 6]) comprising an predictive model determined based on experimentally data (“method of modeling propagation of a pharmaceutical fluid in a patient, including: collecting data corresponding to a time response curve resulting from injection of the fluid; and determining at least one mathematical model describing the data.” [Col 7, line 51-54]), wherein after the predictive model is determined, the instructions cause the processor to collect data from at least one subsequent injection procedure, wherein the predictive model is updated based on the data from the at least one subsequent injection procedure (“The model can also be determined and/or updated with data collected during the imaging (or other procedural) injection.” [Col 8, lines 7-11]; “In addition, the general or multi-patient model can be adjusted, modified, or updated based upon results of one or more patients for use with other patients.” [Col 26, line 58]; Figures 19A-19B).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the non-transitory computer readable storage medium of Kalafut to include wherein after the predictive model is trained, the instructions cause the processor to collect data from at least one subsequent injection procedure, wherein the predictive model is updated based on the data from the at least one subsequent injection procedure based on the teachings of Kalafut ‘914 to optimize delivery of the fluid in order to delivery only the minimum necessary amount of contrast agent (Kalafut ‘914 [Col 5, line 19], [Col 6, lines 34-38]) and to ensure that the predictive model is able to utilized for multiple patients without necessitating a test injection (Kalafut ‘914 [Col 26, line 60]).
Response to Arguments
Applicant's arguments filed December 10, 2025 have been fully considered but they are not persuasive.
Regarding the argument that the prior art of record, specifically Kalafut (USPN 7925330) and Harman (US 20140350863), does not render obvious the limitation “the predictive model trained on experimental data associated with a plurality of contrast fluids and a plurality of flow paths, the at least a first flow path different from the plurality of flow paths” as required by the independent claims, the examiner respectfully disagrees. As detailed above with respect to the rejections of claims 18 and 22, Kalafut discloses a predictive model (Figure 26) that is determined experimentally based on data associated with a plurality of contrast fluids and a plurality of flow paths, the at least a first flow path different from the plurality of flow paths ([Col 18, line 5-18]; [Col 20, line 58-65]; [Col 23, lines 2-6]; Figures 28-30). Kalafut discloses that the predictive model is determined based on experimental data, but does not explicitly disclose that this predictive model is trained on the experimental data as claimed. However, Hartman discloses a fluid delivery system comprising a predictive model ([0025]) trained on experimental data ([0027]; [0028]; [0029]). One having ordinary skill in the art would recognize that it would have been obvious to modify the predictive model Kalafut to be trained on the experimental data, rather than just determined on the experimental data, based on the teachings of Hartman to allow for automatic optimization and updating of the predictive model for the individual patient based on existing data of previous uses of similar fluid injection apparatuses (Hartman [0006-0012])
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “the predictive model is enabled to determine whether a pressure threshold value would be reached…for flow paths on which the predictive model was not specifically trained” (Remarks page 6)) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). The claim language as currently presented requires “the at least a first flow path different from the plurality flow paths”, which is a broader limitation than “the predictive model not specifically trained for the first flow path”, for example. Kalafut discloses that its predictive model is determined based at least on a plurality of flow paths (“the flow rate predicted for a phase…can be used as an input to a system or model adapted or operable to predict the amount of pressure generated in the syringe or other container as a result of the volumetric flow rate, the fluid path characteristics (for example, the inner diameter of the catheter (gauge)), and the viscosity of the contrast agent…The pressure resulting from a set of values of these variables may be…determined from prior experimental data” [Col 18, line 5-18], emphasis added). Kalafut additionally discloses that the model was determined experimentally for flow paths having various gauges, including 20G, 22G, and 24G, as shown in Figures 28-30. The “first fluid path” is different from at least some of the plurality of flow paths, such as having only one of the determine gauges.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LEAH J SWANSON whose telephone number is (571)270-0394. The examiner can normally be reached M-F 9 AM- 5 PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LEAH J SWANSON/ Examiner, Art Unit 3783
/KEVIN C SIRMONS/ Supervisory Patent Examiner, Art Unit 3783