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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06/29/2026 has been entered.
Response to Amendment
This office action is in response to the communications filed on 06/29/2026, concerning Application No. 17/270,102. The amendments to the claims filed on 06/29/2026 are acknowledged. Presently, claims 1-11, 14-24, and 27 remain pending.
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 1-5, 7-8, 10-11, 14-18, 20-21, 23-24, and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Duchon et al. (US 2008/0183131 A1, of record, hereinafter Duchon) in view of Blomquist (US 2010/0262078 A1, of record, hereinafter Blomquist), further in view of Ciolkosz et al. (US 2017/0343446 A1, of record, hereinafter Ciolkosz), and even further in view of Burbank et al. (US 2015/0005699 A1, of record, hereinafter Burbank).
Regarding claims 1, 14, and 27, Duchon discloses a fluid injector system configured to perform an injection protocol in connection with a diagnostic imaging procedure (of claim 1), a computer program product for detecting multiple uses of an administration line using a fluid injector system configured to perform an injection protocol in connection with a diagnostic imaging procedure (of claim 14), and a method for detecting multiple uses of an administration line using a fluid injector system configured to perform an injection protocol in connection with a diagnostic imaging procedure (of claim 27) (see, e.g., Abstract, and Para. [0007], [0008], and [0013], and Disclosed Claims 40-41), the fluid injector system comprising:
a pressure of a priming fluid over a course of a priming operation, the priming operation performed on the exemplary administration line during which the priming fluid delivered into the exemplary administration line completely displaces an extant fluid from the exemplary administration line into a waste reservoir (waste bag 60) (see, e.g., Para. [0045], “the peristaltic pump 62 operates in a priming mode whereby it turns in a stutter fashion to send pressure pulses through the various lines. These pressure pulses act to dislodge air bubbles from the inner walls of the lines, thus obviating the need for the operator to tap on the lines during the priming procedure. To monitor for the presence of bubbles, a bubble detector 74 is placed in one or more locations and are electrically connected to the computer of the automatic injector. In priming mode, detection of bubbles is expected. However, when the injector is in injection mode, the receipt of a signal from the bubble detector(s) 74 will cause the injector to stop forward movement of the plunger of the syringe 36. The waste bag 60 eventually receives all of the priming fluid”; also see, e.g., Para. [0043-0047], [0064-0068], and [0071]);
a control device operatively associated with at least one drive component configured to pressurize and inject at least one fluid through a subject administration line into a patient (see, e.g., Disclosed Claim 41, “comprising a program segment, stored in a computer readable medium readable by said computer”, and Para. [0037], “To provide controlled saline pressure when the patient manifold 22 is aligned to deliver saline to the output line 26, the saline line 24 is fed through a pump, preferably a peristaltic pump 62, of the automatic injection device”, and Para. [0041], “The fluid network 20 is thus designed to be attached to an automatic injection device quickly and primed with little or no human interaction”, and Para. [0044], “The priming program segment 64 then aligns the patient manifold 22 for saline. After manifold position detector 72 verifies that the patient manifold 22 is aligned for saline, the peristaltic pump 62 is activated for a predetermined interval”), the control device including at least one processor programmed or configured to perform an operation (see, e.g., Disclosed Claim 41, “comprising a program segment, stored in a computer readable medium readable by said computer”) comprising:
actuating the at least one drive component to prime the subject administration line with the at least one fluid as the priming fluid (see, e.g., Para. [0044], “The priming program segment 64 then aligns the patient manifold 22 for saline. After manifold position detector 72 verifies that the patient manifold 22 is aligned for saline, the peristaltic pump 62 is activated for a predetermined interval. The interval is long enough, for a given pump speed, to fill the saline line 24, the patient manifold 22 and the output line 26 with saline”; also see, e.g., Para. [0043-0047]).
Duchon does not specifically disclose [1] a memory for storing therein a predetermined pressure profile, the predetermined pressure profile being representative of pressure expected to be generated within an exemplary administration line, wherein the priming operation is between a first check valve located in a proximal end of the exemplary administration line for precluding flow in a proximal direction and a second check valve located in a distal end of the exemplary administration line for precluding flow in the proximal direction, the first check valve and the second check valve being one-way check valves configured to be opened by an accumulation of fluid pressure of at least one fluid applied to the one-way check valves in the proximal direction exceeding a predetermined pressure threshold of the one-way check valves; [2] determining a distinct pressure profile indicative of a measurement of current pressure generated during the priming of the subject administration line with the at least one fluid over the course of the priming operation performed therewith; comparing the distinct pressure profile to the predetermined pressure profile; and determining, based on a result of the comparison, whether the subject administration line, prior to the priming thereof, contained therein at least one of a liquid as the extant fluid and a gas as the extant fluid; and [3] wherein the subject administration line, like the exemplary administration line, comprises the first check valve and the second check valve; and wherein, during the priming of the subject administration line, the operation further comprises identifying at least one of: a first pressure inflection point in the distinct pressure profile caused by the at least one fluid having passed through the first check valve in the subject administration line by exceeding the predetermined pressure threshold of the first check valve; a second pressure inflection point in the distinct pressure profile caused by the at least one fluid having passed through the second check valve in the subject administration line by exceeding the predetermined pressure threshold of the second check valve; and a steady state portion of the distinct pressure profile over which the pressure generated within the subject administration line remains substantially constant caused by the at least one fluid flowing through both the first check valve and the second check valve; whereupon the subject administration line at a distal end thereof is determined to have a fluid path set component connected thereto.
However, in the same field of endeavor of priming of medical tubing, Blomquist discloses a memory for storing therein a predetermined pressure profile, the predetermined pressure profile being representative of pressure expected to be generated within an exemplary administration line (see, e.g., Para. [0045], “the controller is configured to adjust thresholds including pressure thresholds, […] (stored for instance in the storage module 408, described below)”, and Para. [0047], “The comparison module 414 is configured to compare measured values (e.g., temperature, pressure, pressure rates of change and the like) with other values including, but not limited to stored threshold values”; also see, e.g., Para. [0045-0052] and [0148-0151]), wherein the operation is between a first check valve located in a proximal end of the exemplary administration line for precluding flow in a proximal direction, the first check valve being a one-way check valve (see, e.g., Para. [0096], “the infusion tube is automatically occluded until connected to the infusion site, for instance with at least one of a pierceable septum, valve and the like”, where it is disclosed that a valve is capable of occluding / obstructing the fluid flow of insulin within the infusion tube at the connection end to the infusion site (i.e., this disclosed valve that obstructs the flow in one direction at the distal end of the infusion tube is interpreted as being a non-return valve / one way valve / check valve); also see, e.g., Para. [0095-0098]);
determining a distinct pressure profile indicative of a measurement of current pressure generated during the priming of the subject administration line with the at least one fluid over the course of the priming operation performed therewith (see, e.g., Para. [0060], “the pressure within at least one of the infusion tube and the insulin cartridge is monitored”, and Para. [0076], “a first pressure generated by the movement of the pump mechanism is measured in at least one of the insulin cartridge and the infusion tube while the cartridge plunger is moved the predetermined distance”; also see, e.g., Para. [0076-0080] and [0107-0109]);
comparing the distinct pressure profile to the predetermined pressure profile (see, e.g., Para. [0047], “The comparison module 414 is configured to compare measured values (e.g., temperature, pressure, pressure rates of change and the like) with other values including, but not limited to stored threshold values”, and Para. [0078], “The controller 400 performs comparisons between a specified pressure rate of change and the measured pressure rate of change. Similarly to a single specified pressure modeled on a system without air present in either of the insulin cartridge and the infusion tube, the specified pressure rate of change will have a steep slope (because of the incompressibility of the insulin) relative to a pressure rate of change where air is present in the system”; also see, e.g., Para. [0077-0078] and [0151-0152]); and
determining, based on a result of the comparison, whether the subject administration line, prior to the priming thereof, contained therein at least one of a liquid as the extant fluid and a gas as the extant fluid (see, e.g., Para. [0078], “The controller 400 performs comparisons between a specified pressure rate of change and the measured pressure rate of change. Similarly to a single specified pressure modeled on a system without air present in either of the insulin cartridge and the infusion tube, the specified pressure rate of change will have a steep slope (because of the incompressibility of the insulin) relative to a pressure rate of change where air is present in the system”; also see, e.g., Para. [0077-0078] and [0151-0152]),
wherein the subject administration line, like the exemplary administration line, comprises the first check valve (see, e.g., Para. [0096], “the infusion tube is automatically occluded until connected to the infusion site, for instance with at least one of a pierceable septum, valve and the like”, where it is disclosed that a valve is capable of occluding / obstructing the fluid flow of insulin within the infusion tube at the connection end to the infusion site (i.e., this valve that obstructs the flow in one direction at the distal end of the infusion tube is interpreted as being a non-return valve / one way valve / check valve); also see, e.g., Para. [0095-0098]); and
wherein, during the priming of the subject administration line, the operation further comprises identifying at least one of: a first pressure inflection point in the distinct pressure profile caused by the at least one fluid having passed through the first check valve in the subject administration line; and a steady state portion of the distinct pressure profile over which the pressure generated within the subject administration line remains substantially constant caused by the at least one fluid flowing through the first check valve; whereupon the subject administration line at a distal end thereof is determined to have a fluid path set component connected thereto (see, e.g., Para. [0076], “a first pressure generated by the movement of the pump mechanism is measured in at least one of the insulin cartridge and the infusion tube while the cartridge plunger is moved the predetermined distance. In another example, the first pressure is measured in at least one of the insulin cartridge and the infusion tube when the pump mechanism is operated through range of motion. That is to say, pressure is measured and recorded in at least one of the insulin cartridge and the infusion tube throughout the movement of the pump mechanism thereby generating a series of pressure measurement data points”, and Para. [0077], “the method 900 includes determining that at least one of the insulin cartridge in the infusion tube set contains some amount of air if the pressure measurement is less than a specified pressure, such as a specified pressure stored in the memory module 408”, where monitoring the pressure within the infusion tube is disclosed, and where generating/identifying a series of pressure measurement data points based on the movement of the pump mechanism is disclosed (i.e., identifying pressure inflection points in the pressure profile caused by the fluid flow through an open valve within the infusion tube); also see, e.g., Para. [0045-0048], [0060-0063], [0076-0078], and [0092-0095]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the fluid injector system, the computer program product, and the method of Duchon by including [1] a memory for storing therein a predetermined pressure profile, the predetermined pressure profile being representative of pressure expected to be generated within an exemplary administration line, wherein the operation is between a first check valve located in a proximal end of the exemplary administration line for precluding flow in a proximal direction, the first check valve being a one-way check valve; [2] determining a distinct pressure profile indicative of a measurement of current pressure generated during the priming of the subject administration line with the at least one fluid over the course of the priming operation performed therewith; comparing the distinct pressure profile to the predetermined pressure profile; and determining, based on a result of the comparison, whether the subject administration line, prior to the priming thereof, contained therein at least one of a liquid as the extant fluid and a gas as the extant fluid; and [3] wherein the subject administration line, like the exemplary administration line, comprises the first check valve; and wherein, during the priming of the subject administration line, the operation further comprises identifying at least one of: a first pressure inflection point in the distinct pressure profile caused by the at least one fluid having passed through the first check valve in the subject administration line; and a steady state portion of the distinct pressure profile over which the pressure generated within the subject administration line remains substantially constant caused by the at least one fluid flowing through the first check valve; whereupon the subject administration line at a distal end thereof is determined to have a fluid path set component connected thereto, as disclosed by Blomquist. One of ordinary skill in the art would have been motivated to make this modification in order to enable alerting the operator about various errors in the system, as recognized by Blomquist (see, e.g., Para. [0047] and [0052]), by combining the fluid injector in connection with the diagnostic imaging procedure of Duchon with the tube air determination of Blomquist.
Duchon modified by Blomquist still does specifically not disclose [1] a second check valve located in a distal end of the exemplary administration line for precluding flow in the proximal direction, the second check valve being a one-way check valve configured to be opened by an accumulation of fluid pressure of at least one fluid applied to the one-way check valves in the proximal direction exceeding a predetermined pressure threshold of the one-way check valves; and [3] wherein the subject administration line, like the exemplary administration line, comprises the second check valve; and wherein, during the priming of the subject administration line, the operation further comprises identifying at least one of: a second pressure inflection point in the distinct pressure profile caused by the at least one fluid having passed through the second check valve in the subject administration line by exceeding the predetermined pressure threshold of the second check valve.
However, in the same field of endeavor of fluid movement systems, Ciolkosz discloses a second check valve located in a distal end of the exemplary administration line for precluding flow in the proximal direction, the second check valve being a one-way check valve, and wherein the subject administration line, like the exemplary administration line, comprises the second check valve (see, e.g., Para. [0050], “the at least one fluid connection means 40 is preferably a multiport valve having at least a first port and a second port. In the first position, fluid flows between the ports, and in the second position fluid does not flow between any of the ports. When the multiport valve has more than two ports, there may be more than one first position in that in a first first position fluid flows between ports A and B, while in a second first position fluid may flow between ports A and C (or C and D)”, where this disclosed valve that can obstruct the fluid “flow between any of the ports” is interpreted as being a non-return valve / one way valve / check valve; also see, e.g., Para. [0043] and [0067-0070]); and
wherein, during the priming of the subject administration line, the operation further comprises identifying at least one of: a second pressure inflection point in the distinct pressure profile caused by the at least one fluid having passed through the second check valve in the subject administration line (see, e.g., Para. [0058], “After washing with the first fluid, the control means 14 uses the first connection means 40″ to select the second wash syringe and sends a second pressure command signal to the second wash syringe until the measured pressure equals a predetermined second wash pressure. The control means 14 causes the second wash fluid to flow at the second wash pressure until a predetermined volume of second wash fluid has been provided”; also see, e.g., Para. [0055-0058] and [0070]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the fluid injector system, the computer program product, and the method of Duchon modified by Blomquist by further including [1] a second check valve located in a distal end of the exemplary administration line for precluding flow in the proximal direction, the second check valve being a one-way check valve; and [3] wherein the subject administration line, like the exemplary administration line, comprises the second check valve; and wherein, during the priming of the subject administration line, the operation further comprises identifying at least one of: a second pressure inflection point in the distinct pressure profile caused by the at least one fluid having passed through the second check valve in the subject administration line, as disclosed by Ciolkosz. One of ordinary skill in the art would have been motivated to make this modification in order to provide improved operation and maintenance of such systems utilizing pressure monitors having multiple fluid flow valves, as recognized by Ciolkosz (see, e.g., Para. [0003], [0043], and [0067-0070]).
Duchon modified by Blomquist and Ciolkosz still does specifically not disclose [1] the first check valve and the second check valve being one-way check valves configured to be opened by an accumulation of fluid pressure of at least one fluid applied to the one-way check valves in the proximal direction exceeding a predetermined pressure threshold of the one-way check valves; and [3] the operation further comprises identifying at least one of: a first pressure inflection point in the distinct pressure profile caused by the at least one fluid having passed through the first check valve in the subject administration line by exceeding the predetermined pressure threshold of the first check valve; or a second pressure inflection point in the distinct pressure profile caused by the at least one fluid having passed through the second check valve in the subject administration line by exceeding the predetermined pressure threshold of the second check valve.
However, in the same field of endeavor of medical fluid movement systems, Burbank discloses wherein the one-way check valves are configured to be opened by an accumulation of fluid pressure of at least one fluid applied to the one-way check valves in the proximal direction exceeding a predetermined pressure threshold of the one-way check valves, and wherein the operation further comprises identifying a pressure inflection point in the distinct pressure profile caused by the at least one fluid having passed through the check valve in the subject administration line by exceeding the predetermined pressure threshold of the check valve (see, e.g., Para. [0133], “FIG. 14 shows details of the process within S61 of FIG. 11. At S61B valve 923 is opened, 918 closed, and air pressure increased as registered by pressure sensor 919 until, at S61A, pressure reaches a predetermined pressure (e.g. 45 psi) then the air pump is turned off and the valve 923 closed. At S61D, pressure is monitored (and may be profiled to generate a decay curve) as indicated by pressure sensor 919 for an interval of time, for example 3 minutes S61C. If the pressure falls below a threshold (e.g. 40 psi) an alarm is output S61F and if not (S61C) the valves 918 and 923 are opened until at S61E the pressure at 919 is detected to be below a threshold, for example 10 mm Hg” (emphasis added), where Examiner notes that the recitation of “if not (S61C)…” means that the pressure falls above / is exceeding the threshold, and therefore, the valves are open at that point of the pressure exceeding the threshold).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the fluid injector system, the computer program product, and the method of Duchon modified by Blomquist and Ciolkosz by including [1] the first check valve and the second check valve being one-way check valves configured to be opened by an accumulation of fluid pressure of at least one fluid applied to the one-way check valves in the proximal direction exceeding a predetermined pressure threshold of the one-way check valves; and [3] wherein the operation further comprises identifying a pressure inflection point in the distinct pressure profile caused by the at least one fluid having passed through the check valve in the subject administration line by exceeding the predetermined pressure threshold of the check valve, as disclosed by Burbank. One of ordinary skill in the art would have been motivated to make this modification in order to desirably monitor the pressures, as recognized by Burbank (see, e.g., Para. [0133]).
Regarding claims 2 and 15, Duchon modified by Blomquist, Ciolkosz, and Burbank discloses the fluid injector system of claim 1 and the computer program product of claim 14, respectively. Duchon does not disclose wherein the exemplary administration line is one of: (i) an unused administration line and, as a result thereof, the extant fluid therein is the gas and the predetermined pressure profile thereby represents the pressure expected to be generated by the priming fluid during the priming of the unused administration line as the gas therein is completely displaced thereby over the course of the priming operation; and (ii) a previously used administration line and, as a result thereof, the extant fluid therein is at least partially a liquid and the predetermined pressure profile thereby represents the pressure expected to be generated by the priming fluid during the priming of the previously used administration line as the liquid therein is completely displaced thereby over the course of the priming operation.
However, in the same field of endeavor of priming of medical tubing, Blomquist discloses wherein the exemplary administration line is one of: (i) an unused administration line and, as a result thereof, the extant fluid therein is the gas and the predetermined pressure profile thereby represents the pressure expected to be generated by the priming fluid during the priming of the unused administration line as the gas therein is completely displaced thereby over the course of the priming operation; and (ii) a previously used administration line and, as a result thereof, the extant fluid therein is at least partially a liquid and the predetermined pressure profile thereby represents the pressure expected to be generated by the priming fluid during the priming of the previously used administration line as the liquid therein is completely displaced thereby over the course of the priming operation (see, e.g., Para. [0082], “the method 900 includes measuring the first pressure in the insulin cartridge with the insulin cartridge sealed relative to the infusion tube. The comparison between the pressure measurement and the specified pressure is performed to determine whether air is present in the insulin cartridge. If the insulin cartridge does not contain air based on the comparison, the insulin cartridge is unsealed allowing communication between the cartridge and the infusion tube. The infusion tube (primed with insulin) is then sealed, for instance at a distal end, and a second pressure measurement is taken and compared with the specified pressure. If the comparison shows the system of the insulin cartridge and the infusion tube contain air, then the previous assessment that air was not present in the insulin cartridge indicates that air is only present in the infusion tube”; also see, e.g., Para. [0082-0086], [0093], and [0106-0110]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the fluid injector system and the computer program product of Duchon modified by Blomquist, Ciolkosz, and Burbank by including wherein the exemplary administration line is one of: (i) an unused administration line and, as a result thereof, the extant fluid therein is the gas and the predetermined pressure profile thereby represents the pressure expected to be generated by the priming fluid during the priming of the unused administration line as the gas therein is completely displaced thereby over the course of the priming operation; and (ii) a previously used administration line and, as a result thereof, the extant fluid therein is at least partially a liquid and the predetermined pressure profile thereby represents the pressure expected to be generated by the priming fluid during the priming of the previously used administration line as the liquid therein is completely displaced thereby over the course of the priming operation, as disclosed by Blomquist. One of ordinary skill in the art would have been motivated to make this modification in order to enable alerting the operator about various errors in the system, as recognized by Blomquist (see, e.g., Para. [0047] and [0052]), by combining the fluid injector in connection with the diagnostic imaging procedure of Duchon with the tube air determination of Blomquist.
Regarding claims 3 and 16, Duchon modified by Blomquist, Ciolkosz, and Burbank discloses the fluid injector system of claim 2 and the computer program product of claim 15, respectively. Duchon does not disclose wherein the exemplary administration line is the unused administration line and upon the comparison resulting in a correlation within a specified tolerance between the distinct pressure profile and the predetermined pressure profile, the at least one processor is configured to determine that the subject administration line contained the gas as the extant fluid.
However, in the same field of endeavor of priming of medical tubing, Blomquist discloses wherein the exemplary administration line is the unused administration line and upon the comparison resulting in a correlation within a specified tolerance between the distinct pressure profile and the predetermined pressure profile, the at least one processor is configured to determine that the subject administration line contained the gas as the extant fluid (see, e.g., Para. [0077], “the method 900 includes determining that at least one of the insulin cartridge in the infusion tube set contains some amount of air if the pressure measurement is less than a specified pressure, such as a specified pressure stored in the memory module 408”; also see, e.g., Para. [0077-0078], [0082-0086], [0093], and [0151-0152]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the fluid injector system and the computer program product of Duchon modified by Blomquist, Ciolkosz, and Burbank by including wherein the exemplary administration line is the unused administration line and upon the comparison resulting in a correlation within a specified tolerance between the distinct pressure profile and the predetermined pressure profile, the at least one processor is configured to determine that the subject administration line contained the gas as the extant fluid, as disclosed by Blomquist. One of ordinary skill in the art would have been motivated to make this modification in order to enable alerting the operator about various errors in the system, as recognized by Blomquist (see, e.g., Para. [0047] and [0052]), by combining the fluid injector in connection with the diagnostic imaging procedure of Duchon with the tube air determination of Blomquist.
Regarding claims 4 and 17, Duchon modified by Blomquist, Ciolkosz, and Burbank discloses the fluid injector system of claim 3 and the computer program product of claim 16, respectively. Duchon does not disclose wherein the operation further comprises: upon the comparison resulting in the correlation within the specified tolerance between the distinct pressure profile and the predetermined pressure profile, generating an alert indicating that the subject administration line had not been used prior to being primed with the at least one fluid during the priming operation.
However, in the same field of endeavor of priming of medical tubing, Blomquist discloses wherein the operation further comprises: upon the comparison resulting in the correlation within the specified tolerance between the distinct pressure profile and the predetermined pressure profile, generating an alert indicating that the subject administration line had not been used prior to being primed with the at least one fluid during the priming operation (see, e.g., Para. [0052], “Optionally, if the air bubble is included within the desired insulin infusion an alert may be provided to the user through, for example, the display 102 (e.g., visual display, audible display, vibration, and the like). Once an alert is provided the user is notified of the presence of the air bubble and can monitor the location of the air bubble within the infusion tube as the air bubble moves to near the distal end of the infusion tube (e.g., near the infusion site 140 shown in FIG. 1B). In another example, the controller 404 including the air bubble module 413 monitors the location of the air bubble based on the insulin infusions preceding the air bubble in the infusion tube. An alert is provided when the monitored position of the air bubble is near the infusion site 140”; also see, e.g., Para. [0052], [0082], and [0158-0161]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the fluid injector system and the computer program product of Duchon modified by Blomquist, Ciolkosz, and Burbank by including wherein the operation further comprises: upon the comparison resulting in the correlation within the specified tolerance between the distinct pressure profile and the predetermined pressure profile, generating an alert indicating that the subject administration line had not been used prior to being primed with the at least one fluid during the priming operation, as disclosed by Blomquist. One of ordinary skill in the art would have been motivated to make this modification in order to enable alerting the operator about various errors in the system, as recognized by Blomquist (see, e.g., Para. [0047] and [0052]), by combining the fluid injector in connection with the diagnostic imaging procedure of Duchon with the tube air determination of Blomquist.
Regarding claims 5 and 18, Duchon modified by Blomquist, Ciolkosz, and Burbank discloses the fluid injection system of claim 3 and the computer program product of claim 16, respectively. Duchon does not disclose wherein the operation further comprises: upon the comparison resulting in the correlation within the specified tolerance between the distinct pressure profile and the predetermined pressure profile, permitting performance of the injection protocol.
However, in the same field of endeavor of priming of medical tubing, Blomquist discloses wherein the operation further comprises: upon the comparison resulting in the correlation within the specified tolerance between the distinct pressure profile and the predetermined pressure profile, permitting performance of the injection protocol (see, e.g., Para. [0087], “a change in pressure (e.g., between the first and second pressure measurements) where the plunger is maintained at a predetermined distance over the first time period indicates that there may be a leak within at least one of the insulin cartridge and the system of the insulin cartridge and the infusion tube where the infusion tube is in communication with the insulin cartridge. Optionally, the user is alerted and instructed to change out the infusion tube and attach the tube with the insulin cartridge and the method 1000 is repeated. If the first and second pressure measurements are consistent over the first time period the user has confidence that the leak was in the infusion tube and may proceed with normal use of the pump”; also see, e.g., Para. [0087], [0129], and [0160-0163]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the fluid injector system and the computer program product of Duchon modified by Blomquist, Ciolkosz, and Burbank by including wherein the operation further comprises: upon the comparison resulting in the correlation within the specified tolerance between the distinct pressure profile and the predetermined pressure profile, permitting performance of the injection protocol, as disclosed by Blomquist. One of ordinary skill in the art would have been motivated to make this modification in order to enable alerting the operator about various errors in the system, as recognized by Blomquist (see, e.g., Para. [0047] and [0052]), by combining the fluid injector in connection with the diagnostic imaging procedure of Duchon with the tube air determination of Blomquist.
Regarding claims 7 and 20, Duchon modified by Blomquist, Ciolkosz, and Burbank discloses the fluid injector system of claim 2 and the computer program product of claim 15, respectively. Duchon does not disclose wherein the exemplary administration line is the previously used administration line and upon the comparison resulting in a correlation within a specified tolerance between the distinct pressure profile and the predetermined pressure profile, the at least one processor is configured to determine that the subject administration line contained the liquid as the extant fluid.
However, in the same field of endeavor of priming of medical tubing, Blomquist discloses wherein upon the comparison resulting in a correlation within a specified tolerance between the distinct pressure profile and the predetermined pressure profile, the at least one processor is configured to determine that the subject administration line contained the liquid as the extant fluid (see, e.g., Para. [0047], “The comparison module 414 is configured to compare measured values (e.g., temperature, pressure, pressure rates of change and the like) with other values including, but not limited to stored threshold values, other measured values and the like. The alert module 416 is configured to provide alerts to the user regarding at least one of a location of an air bubble, the presence of air in the insulin cartridge or infusion tube, the presence of a leak, the presence of blockage in the infusion tube, the status of an insulin infusion and the like”, and Para. [0077], “the method 900 includes determining that at least one of the insulin cartridge in the infusion tube set contains some amount of air if the pressure measurement is less than a specified pressure, such as a specified pressure stored in the memory module 408”; also see, e.g., Para. [0047], [0077-0078], and [0151-0152]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the fluid injector system and the computer program product of Duchon modified by Blomquist, Ciolkosz, and Burbank by including wherein upon the comparison resulting in a correlation within a specified tolerance between the distinct pressure profile and the predetermined pressure profile, the at least one processor is configured to determine that the subject administration line contained the liquid as the extant fluid, as disclosed by Blomquist. One of ordinary skill in the art would have been motivated to make this modification in order to enable alerting the operator about various errors in the system, as recognized by Blomquist (see, e.g., Para. [0047] and [0052]), by combining the fluid injector in connection with the diagnostic imaging procedure of Duchon with the tube air determination of Blomquist.
Duchon modified by Blomquist, Ciolkosz, and Burbank still does not specifically disclose wherein the exemplary administration line is the previously used administration line. However, it would have been obvious to one of ordinary skill in the art to identify that the tube is a previously used tube upon the determining signs of use, such as the presence/determination of liquid and/or air in the tube, as taught by Blomquist.
Regarding claims 8 and 21, Duchon modified by Blomquist, Ciolkosz, and Burbank discloses the fluid injector system of claim 7 and the computer program product of claim 20, respectively. Duchon does not disclose wherein the operation further comprises: upon the comparison resulting in the correlation within the specified tolerance between the distinct pressure profile and the predetermined pressure profile, generating an alert indicating that the subject administration line had been used prior to being primed with the at least one fluid during the priming operation.
However, in the same field of endeavor of priming of medical tubing, Blomquist discloses wherein the operation further comprises: upon the comparison resulting in the correlation within the specified tolerance between the distinct pressure profile and the predetermined pressure profile, generating an alert indicating that the subject administration line had been used prior to being primed with the at least one fluid during the priming operation (see, e.g., Para. [0052], “Optionally, if the air bubble is included within the desired insulin infusion an alert may be provided to the user through, for example, the display 102 (e.g., visual display, audible display, vibration, and the like). Once an alert is provided the user is notified of the presence of the air bubble and can monitor the location of the air bubble within the infusion tube as the air bubble moves to near the distal end of the infusion tube (e.g., near the infusion site 140 shown in FIG. 1B). In another example, the controller 404 including the air bubble module 413 monitors the location of the air bubble based on the insulin infusions preceding the air bubble in the infusion tube. An alert is provided when the monitored position of the air bubble is near the infusion site 140”; also see, e.g., Para. [0052], [0082], and [0158-0161]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the fluid injector system and the computer program product of Duchon modified by Blomquist, Ciolkosz, and Burbank by including wherein the operation further comprises: upon the comparison resulting in the correlation within the specified tolerance between the distinct pressure profile and the predetermined pressure profile, generating an alert indicating that the subject administration line had been used prior to being primed with the at least one fluid during the priming operation, as disclosed by Blomquist. One of ordinary skill in the art would have been motivated to make this modification in order to enable alerting the operator about various errors in the system, as recognized by Blomquist (see, e.g., Para. [0047] and [0052]), by combining the fluid injector in connection with the diagnostic imaging procedure of Duchon with the tube air determination of Blomquist; and in order to improve the quality of the patient care by generating an alert to alert the operator of the detection of a previously used tube.
Regarding claims 10 and 23, Duchon modified by Blomquist, Ciolkosz, and Burbank discloses the fluid injector system of claim 1 and the computer program product of claim 14, respectively. Duchon further discloses wherein the at least one fluid used in the priming of the subject administration line comprises at least one of (i) a diluent (see, e.g., Para. [0036], “a fluid network 20 comprising a disposable patient manifold 22 connected to a saline line 24 and an output line 26. The saline line 24 has a first end 28 and a second end 30. The first end 26 is connected to a bag connector 32, useable to establish fluid communication between the line 24 and a saline bag 34”, and Para. [0037], “To provide controlled saline pressure when the patient manifold 22 is aligned to deliver saline to the output line 26, the saline line 24 is fed through a pump, preferably a peristaltic pump 62, of the automatic injection device”), (ii) a contrast medium and (iii) a mixture of the contrast medium and the diluent.
Regarding claims 11 and 24, Duchon modified by Blomquist, Ciolkosz, and Burbank discloses the fluid injector system of claim 1 and the computer program product of claim 14, respectively. Duchon further discloses wherein the determining the distinct pressure profile comprises measuring a motor current of the at least one drive component (see, e.g., Para. [0065], “pressure may be measured as a function of the load placed on the linear actuator module 174. For example, if a DC motor is used to drive the linear actuator of the module 174, a circuit may be incorporated into the electronics driving the motor that is constructed and arranged to measure motor torque as a function of current drawn”).
Claims 6, 9, 19, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Duchon (US 2008/0183131 A1) in view of Blomquist (US 2010/0262078 A1), Ciolkosz (US 2017/0343446 A1), and Burbank (US 2015/0005699 A1), as applied to claims 3, 7, 16, and 20 above, and further in view of Singh et al. (US Patent 4,793,413 A, of record, hereinafter Singh).
Regarding claims 6, 9, 19, and 22, Duchon modified by Blomquist, Ciolkosz, and Burbank discloses the fluid injector system of claims 3 and 7, and the computer program product of claims 16 and 20, respectively. Duchon modified by Blomquist, Ciolkosz, and Burbank does not specifically disclose wherein the comparison resulting in the correlation within the specified tolerance between the distinct pressure profile and the predetermined pressure profile comprises at least one of: normalizing the distinct pressure profile about a steady state value thereof, normalizing the predetermined pressure profile about a steady state value thereof, and determining that an area under a curve of the normalized distinct pressure profile correlates to an area under a curve of the predetermined pressure profile; and normalizing the distinct pressure profile about a steady state value thereof, normalizing the predetermined pressure profile about a steady state value thereof, and determining that each point along the distinct pressure profile correlates within a specified tolerance to corresponding points on the predetermined pressure profile.
As set forth above, Blomquist does disclose the comparison resulting in the correlation within the specified tolerance between the distinct pressure profile and the predetermined pressure profile (see, e.g., Para. [0047], “The comparison module 414 is configured to compare measured values (e.g., temperature, pressure, pressure rates of change and the like) with other values including, but not limited to stored threshold values”, and Para. [0076-0078]); and identifying, with the at least one processor, at least one pressure inflection point in the distinct pressure profile caused by the at least one fluid having passed through the first check valve in the subject administration line that correlates to at least one pressure inflection point corresponding thereto in the predetermined pressure profile caused by the priming fluid having passed through the first check valve in the exemplary administration line (see, e.g., Para. [0076] and [0077], where monitoring the pressure within the infusion tube is disclosed, and where generating/identifying a series of pressure measurement data points based on the movement of the pump mechanism is disclosed (i.e., identifying pressure inflection points in the pressure profile caused by the fluid flow through an open valve within the infusion tube); also see, e.g., Para. [0045-0048], [0060-0063], [0076-0078], and [0092-0095]).
However, in the same field of endeavor of analysis of fluid pressures, Singh discloses normalizing the distinct pressure profile about a steady state value thereof, normalizing the predetermined pressure profile about a steady state value thereof, and determining that each point along the distinct pressure profile correlates within a specified tolerance to corresponding points on the predetermined pressure profile (see, e.g., Abstract, “Fluid is injected into a wellbore at a first rate which is low enough to maintain formation pressure beneath formation parting pressure. Thereafter, the rate of fluid injection is increased to a second rate which is high enough to exceed formation parting pressure. The time and pressure data obtained during the first and second periods are normalized, plots thereof are superposed and the formation parting pressure is determined by noting the point at which the plots deviate from one another”, where two different pressure profiles are normalized and superimposed, and thereafter correlated such that each point of the two pressure profiles are correlated to one another in order to determine any deviation between points; also see, e.g., Col. 2, lines 28-41, and Col. 3, lines 9-19, and Col. 5, lines 30-44).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the fluid injector system and the computer program product of Duchon modified by Blomquist, Ciolkosz, and Burbank by including normalizing the distinct pressure profile about a steady state value thereof, normalizing the predetermined pressure profile about a steady state value thereof, and determining that each point along the distinct pressure profile correlates within a specified tolerance to corresponding points on the predetermined pressure profile, as disclosed by Singh. One of ordinary skill in the art would have been motivated to make this modification in order to desirably determine any deviation between points of pressure profiles/plots/data, as recognized by Singh (see, e.g., Abstract).
Response to Arguments
Applicant's arguments, see Remarks filed 06/29/2026, have been fully considered but they are not persuasive.
Regarding the rejections of the independent claims, Applicant argues that there is “no teaching of first and second one-way check valves configured to be opened by an accumulation of fluid pressure of at least one fluid applied to the one-way check valves in the proximal direction exceeding a predetermined pressure threshold of the one-way check valves”.
Examiner respectfully disagrees and emphasizes that the combination of Duchon modified by Blomquist, Ciolkosz, and Burbank does disclose each and every feature of the independent claims 1, 14, and 27. Specifically, Examiner emphasizes that Burbank discloses wherein the one-way check valves are configured to be opened by an accumulation of fluid pressure of at least one fluid applied to the one-way check valves in the proximal direction exceeding a predetermined pressure threshold of the one-way check valves, and wherein the operation further comprises identifying a pressure inflection point in the distinct pressure profile caused by the at least one fluid having passed through the check valve in the subject administration line by exceeding the predetermined pressure threshold of the check valve (see, e.g., Para. [0133], “FIG. 14 shows details of the process within S61 of FIG. 11. At S61B valve 923 is opened, 918 closed, and air pressure increased as registered by pressure sensor 919 until, at S61A, pressure reaches a predetermined pressure (e.g. 45 psi) then the air pump is turned off and the valve 923 closed. At S61D, pressure is monitored (and may be profiled to generate a decay curve) as indicated by pressure sensor 919 for an interval of time, for example 3 minutes S61C. If the pressure falls below a threshold (e.g. 40 psi) an alarm is output S61F and if not (S61C) the valves 918 and 923 are opened until at S61E the pressure at 919 is detected to be below a threshold, for example 10 mm Hg” (emphasis added), where Examiner notes that the recitation of “if not (S61C)…” means that the pressure falls above / is exceeding the threshold, and therefore, the valves are open at that point of the pressure exceeding the threshold).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAYLOR DEUTSCH whose telephone number is (571)272-0157. The examiner can normally be reached Monday-Friday 9am-5pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, PASCAL BUI-PHO can be reached at (571)272-2714. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/T.D./Examiner, Art Unit 3798
/PASCAL M BUI PHO/Supervisory Patent Examiner, Art Unit 3798
Prosecution Insights