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 June 03, 2026 has been entered. Claims 11-32 remain pending in the application. Claims 1-10 were previously cancelled. Applicant’s amendments to the claims have overcome the objections and rejections under 35 USC 112 previously set forth in the Non-Final Office Action mailed March 05, 2026, except for those repeated below.
Claim Objections
Claim 19 is objected to because there is a lack of antecedent basis for “the fluid line” in line 7 and “the pumping mechanism” in line 8. Appropriate correction is required.
Claim 27 is objected to because there is a typo regarding “a pressure limit” in line 8 as opposed to “a first pressure limit”. Appropriate correction is required.
Claim 29 objected to because there is a lack of antecedent basis for “the first limit” in line 5. Appropriate correction is required.
Claim 30 is objected to because there is a lack of antecedent basis for “the first delivery” as opposed to “the first fluid delivery” in line 2. Appropriate correction is required.
Claim 32 is objected to because there is a typo regarding “the infusion gradually…” in line 2 as opposed to “the infusion pump gradually…”. Appropriate correction is required.
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 11-15, 18-23, and 26-32 are rejected under 35 U.S.C. 103 as being unpatentable over Pope et al. (US 20050096593) in view of Butterfield (USPN 5827223).
Regarding claim 11, Pope discloses an infusion pump (syringe pump system 10) comprising:
a pressure sensor configured to sense pressure in a fluid line received by the infusion pump (“The force value may be detected by a force or pressure sensor in communication with the downstream infusion tube 22, for instance.” [0062]);
a pumping mechanism to move a fluid through the fluid line (“a motor internal to the housing 14 actuates a pusher, or plunger driver mechanism 17, to move the plunger 16.” [0026]);
a display (display 19);
a processor (processor 31); and
a non-transitory computer readable medium (memory 32; “memory 32 may represent the random access memory (RAM) devices comprising the main storage of the system 30, as well as any supplemental levels of memory, e.g., cache memory, non-volatile or backup memories (e.g., programmable or flash memories), read-only memories, etc” [0031]) comprising instructions executable by the processor (“The processor 31 may execute various computer software applications, components, programs, objects, modules, etc. (e.g., rapid detection program 42, cancellation program 43, steady state program 44, and bolus program 45, among others).” [0031], see also [0032]) to cause the infusion pump to:
receive a parameter for a first fluid delivery pursuant to a first fluid delivery mode (“steady state”; see flowchart 200; Figure 3) through the fluid line (“The system 10 initializes at block 202 of FIG. 3…The initialization of block 202 may include user specified infusion protocols, operating parameters and other data. For instance, the user may select one or more fluid flow rates or sequences may be selected based on a desired pattern of drug delivery that is appropriate to the protocol of the patient.” [0036-0037], see also [0038-0042]);
operate the pumping mechanism based on the parameter (“steady state”: “At the onset of an infusion process, an initial slope is generated that approaches or exceeds an occlusion slope. This elevated force level may be caused by the tubing 22 and other components of the system 10 reacting to a sudden influx, or ramping up, of pumped fluid. That is, some time is required by the system 10 in order to adjust and achieve a relaxed flow of fluid toward the patient 24. Given time, pressure/force within the system 10 eventually and relatively relaxes in the absence of an occlusion. That is, the force levels off to a more moderate slope. This period of leveling generally coincides with the system 10 achieving steady state.” [0059]);
receive a pressure measurement from the pressure sensor (“The system 10 at block 207 of FIG. 3 uses the force values obtained at blocks 204 and 206 to determine a relationship between them. For instance, the system 10 may determine a slope at block 207. More particularly, the difference between the obtained force values may be divided by the difference in the times that the respective force values were obtained.” [0043]; “while force transducers are discussed above in connection with several embodiments, pressure transducers may have equal or greater applicability in other others that are consistent with the principles of the present invention. For instance, a sensor comprising a pressure transducer may be used at the outlet of a syringe or in the tubing.” [0085]);
identify a first pressure limit associated with the first fluid delivery mode (“The occlusion slope specified at block 202 of FIG. 3 is retrieved at block 209 by the system 10.” [0048]; “Initialization may include recalling or defining an expected relationship. This expected relationship may include an occlusion slope. Such a slope may be predetermined using clinical data. For instance, force measurements may be taken under known laboratory conditions at the beginning and end of a window interval. These force measurements are divided by the window to determine the occlusion slope. Some such slopes may be stored in an associative relationship with one or more of the known conditions as applicable to a given pumping system scenario. For instance, a slope may be stored in associative relationship with a particular type or size of syringe, and/or a given infusion rate.” [0038]);
determine that the pressure measurement indicates an actual occlusion in the fluid line based at least in part on the first pressure limit (“At block 210 of FIG. 3, the retrieved occlusion slope is compared to the trial slope determined at block 207… Where the detected slope is greater than or equal to the occlusion slope, and the occlusion detection time has lapsed at block 212, the system 10 will generate an occlusion alarm at block 217.” [0048-0051]); and
display an indicator of the actual occlusion via the display (“Where the detected slope is greater than or equal to the occlusion slope, and the occlusion detection time has lapsed at block 212, the system 10 will generate an occlusion alarm at block 217. While a typical alarm may include an audible signal and/or a flashing display 19” [0051]).
Pope fails to explicitly disclose dynamically adapt the first pressure limit such that the pumping mechanism operates at an increased fluid pressure in the fluid line without causing a false indication of an occlusion in the fluid line.
Butterfield teaches an infusion pump (system 10) comprising a pressure sensor (pressure sensor 26); a pumping mechanism (pump 24); and instructions executable by a processor (microprocessor 30 and control electronics 38) to cause the infusion pump to operate the pumping mechanism (“A motor 36 and control electronics 38 are used to drive the peristaltic fingers 40 of the linear peristaltic pump 24.” [Col 4, lines 59-61]); receive a pressure measurement from the pressure sensor (“An analog-to-digital converter 28 is coupled to the pressure sensor 26 to provide a digital signal to a signal processor 30,” [Col 4, lines 49-50]); and dynamically adapt a pressure limit (“the cautionary threshold pressure line 80 is adaptable and may be adjusted during operation of the system to prevent unnecessary pump reversal confirmation tests or to enhance system sensitivity.” [Col 8, line 15-18], see also Figure 5) such that the pumping mechanism operates at an increased fluid pressure in the fluid line without causing a false indication of an occlusion in the fluid line (“Where a particular pressure difference and average pressure combination, such as the combination indicated by point 82, maps into the fourth or cautionary region 78 and a pump reversal confirmation test (described below) is initiated that determines no upstream occlusion exists, the cautionary pressure threshold line 80 can be adjusted (adapted) in the negative direction” [Col 8, line 64- Col 9, line 3]; “If the post-reversal pressure difference is less than the post-reversal pressure difference cutoff, no occlusion is deemed to exist and pump operation continues. The value of the cautionary threshold pressure may be adjusted downward, as discussed above with respect to FIG. 4A, to avoid further unnecessary pump reversal confirmation tests.” [Col 12, lines 59-65]); and determine that the pressure measurement indicates an actual occlusion in the fluid line based at least in part on the pressure limit (“Where a particular pressure difference and average pressure combination, such as the combination indicated by point 82, maps into the fourth or cautionary region 78 and a pump reversal confirmation test (described below) is initiated that determines no upstream occlusion exists, the cautionary pressure threshold line 80 can be adjusted (adapted) in the negative direction” [Col 11, lines 15-17]).
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 infusion pump of Pope to include dynamically adapting the first pressure limit such that the pumping mechanism operates at an increased fluid pressure in the fluid line without causing a false indication of an occlusion in the fluid line based on the teachings of Butterfield to decrease the chance of false occlusion alarms and avoid unnecessary stoppage of an infusion procedure (Butterfield [Col 3, lines 54-57] and [Col 12, lines 59-65]).
Regarding claim 12, modified Pope discloses the infusion pump of claim 11, wherein the instructions executable by the processor further cause the infusion pump to receive the first pressure limit (“The occlusion slope specified at block 202 of FIG. 3 is retrieved at block 209 by the system 10. Such an occlusion slope may comprise the expected relationship as discussed herein” [0048]).
Regarding claim 13, modified Pope discloses the infusion pump of claim 11, wherein the instructions executable by the processor further cause the infusion pump to: receive a request to change to a second fluid delivery pursuant to a second fluid delivery mode (“The user may initialize the system 10 at block 502 of FIG. 8…Initialization at block 502 may also include commencing infusion of medication. For example, a user may instruct the system 10 to pump fluid at a rate of 600 ml/hr for a given bolus injection.” [0075]); and identify a second pressure limit associated with the second fluid delivery mode (“Initialization processes may include setting a bolus occlusion limit.” [0075]) wherein the second pressure limit is different from the first pressure limit (Figure 3 having flowchart 200 describing the first fluid delivery mode and Figure 8 having flow chart 500 describing the second fluid delivery mode, wherein the first limit is an “occlusion slope” and the second limit is an “occlusion limit”).
Regarding claim 14, modified Pope discloses the infusion pump of claim 13, wherein the second fluid delivery corresponds to a same fluid as the first fluid delivery (Figure 1) and wherein the first fluid delivery mode corresponds to a continuous fluid delivery (“steady state”: “Given time, pressure/force within the system 10 eventually and relatively relaxes in the absence of an occlusion. That is, the force levels off to a more moderate slope. This period of leveling generally coincides with the system 10 achieving steady state.” [0059]) while the second fluid delivery mode corresponds to a bolus fluid delivery (“The flowchart 500 of FIG. 8 shows additional processes configured to detect an occlusion within an infusion system 10. The exemplary process steps are particularly suited for application within the context of a bolus injection” [0074]).
Regarding claim 15, modified Pope disclose the infusion pump of claim 13, wherein one of the first delivery mode or the second fluid delivery mode corresponds to a bolus fluid delivery (“The flowchart 500 of FIG. 8 shows additional processes configured to detect an occlusion within an infusion system 10. The exemplary process steps are particularly suited for application within the context of a bolus injection” [0074]).
Regarding claim 18, modified Pope discloses the infusion pump of claim 11, wherein the display is a touchscreen (“A typical display 19 may include operator interface input mechanisms, such as a keyboard, touch screen features, switches, a microphone, dials, and the like.” [0026]) and the parameter is received via the touchscreen (“The display 19 may include options for a user to enter input. Such input may include data pertaining to drug concentration, patient weight, as well as desired doses and dose rates…the processor 31 contained within the pump housing 14 may initiate the volume and fluid flow rates to be delivered to the patient.” [0029-0030]).
Regarding claim 19, Pope discloses a medical fluid delivery system (Figures 1-2) comprising:
a programming module (Figure 2; see described in at least [0030-0031]);
an infusion pump (syringe pump system 10); and
a non-transitory computer readable medium (memory 32; “memory 32 may represent the random access memory (RAM) devices comprising the main storage of the system 30, as well as any supplemental levels of memory, e.g., cache memory, non-volatile or backup memories (e.g., programmable or flash memories), read-only memories, etc. In addition, memory 32 may be considered to include memory storage physically located elsewhere in the system 30, e.g., any cache memory in a processor 31, as well as any storage capacity used as a virtual memory, e.g., as stored within mass storage or on a computer coupled to the system 30 via a network 38.” [0031]) comprising instructions executable by the processor (“The processor 31 may execute various computer software applications, components, programs, objects, modules, etc. (e.g., rapid detection program 42, cancellation program 43, steady state program 44, and bolus program 45, among others).” [0031], see also [0032]) to cause a remote device separate from and in communication with the infusion pump (“The digital communication port 20 provides a mechanism for external control, where desired. For instance, the pump housing 14 may be continuously cabled to a separate remote personal computing device. One skilled in the art will appreciate that wireless communications may be alternatively used. In any case, this personal computing device can then run a particular program tailored to provide the desired pattern of drug delivery appropriate to the specific circumstance.” [0029]; for example: “The initialization step of block 202 may include or be preceded by connecting a personal computer to the communications port 20 of the housing 14. Thus, the system 10 may include external processing devices configured to connect to the port 20” [0036]) to:
receive a parameter for a first fluid delivery pursuant to a first fluid delivery mode (“steady state”; see flowchart 200; Figure 3) through the fluid line (“The system 10 initializes at block 202 of FIG. 3…The initialization of block 202 may include user specified infusion protocols, operating parameters and other data. For instance, the user may select one or more fluid flow rates or sequences may be selected based on a desired pattern of drug delivery that is appropriate to the protocol of the patient.” [0036-0037], see also [0038-0042]);
operate the pumping mechanism based on the parameter (“steady state”: “At the onset of an infusion process, an initial slope is generated that approaches or exceeds an occlusion slope. This elevated force level may be caused by the tubing 22 and other components of the system 10 reacting to a sudden influx, or ramping up, of pumped fluid. That is, some time is required by the system 10 in order to adjust and achieve a relaxed flow of fluid toward the patient 24. Given time, pressure/force within the system 10 eventually and relatively relaxes in the absence of an occlusion. That is, the force levels off to a more moderate slope. This period of leveling generally coincides with the system 10 achieving steady state.” [0059]);
receive a pressure measurement from a pressure sensor (“The system 10 at block 207 of FIG. 3 uses the force values obtained at blocks 204 and 206 to determine a relationship between them. For instance, the system 10 may determine a slope at block 207. More particularly, the difference between the obtained force values may be divided by the difference in the times that the respective force values were obtained.” [0043]; “while force transducers are discussed above in connection with several embodiments, pressure transducers may have equal or greater applicability in other others that are consistent with the principles of the present invention. For instance, a sensor comprising a pressure transducer may be used at the outlet of a syringe or in the tubing.” [0085]);
identify a first pressure limit associated with the first fluid delivery mode (“The occlusion slope specified at block 202 of FIG. 3 is retrieved at block 209 by the system 10.” [0048]; “Initialization may include recalling or defining an expected relationship. This expected relationship may include an occlusion slope. Such a slope may be predetermined using clinical data. For instance, force measurements may be taken under known laboratory conditions at the beginning and end of a window interval. These force measurements are divided by the window to determine the occlusion slope. Some such slopes may be stored in an associative relationship with one or more of the known conditions as applicable to a given pumping system scenario. For instance, a slope may be stored in associative relationship with a particular type or size of syringe, and/or a given infusion rate.” [0038]);
determine that the pressure measurement indicates an actual occlusion in the fluid line based at least in part on the first pressure limit (“At block 210 of FIG. 3, the retrieved occlusion slope is compared to the trial slope determined at block 207… Where the detected slope is greater than or equal to the occlusion slope, and the occlusion detection time has lapsed at block 212, the system 10 will generate an occlusion alarm at block 217.” [0048-0051]); and
display an indicator of the occlusion via a display (“Where the detected slope is greater than or equal to the occlusion slope, and the occlusion detection time has lapsed at block 212, the system 10 will generate an occlusion alarm at block 217. While a typical alarm may include an audible signal and/or a flashing display 19” [0051]).
Pope fails to explicitly disclose dynamically adapt the first pressure limit such that the pumping mechanism operates at an increased fluid pressure in the fluid line without causing a false indication of an occlusion in the fluid line.
Butterfield teaches a medical fluid delivery system (system 10) comprising an infusion pump (pump 24) and instructions executable by a processor (microprocessor 30 and control electronics 38) to operate a pumping mechanism (“A motor 36 and control electronics 38 are used to drive the peristaltic fingers 40 of the linear peristaltic pump 24.” [Col 4, lines 59-61]); receive a pressure measurement from a pressure sensor (“An analog-to-digital converter 28 is coupled to the pressure sensor 26 to provide a digital signal to a signal processor 30,” [Col 4, lines 49-50]); and dynamically adapt a pressure limit (“the cautionary threshold pressure line 80 is adaptable and may be adjusted during operation of the system to prevent unnecessary pump reversal confirmation tests or to enhance system sensitivity.” [Col 8, line 15-18]; see also Figure 5) such that the pumping mechanism operates at an increased fluid pressure in the fluid line without causing a false indication of an occlusion in the fluid line (“Where a particular pressure difference and average pressure combination, such as the combination indicated by point 82, maps into the fourth or cautionary region 78 and a pump reversal confirmation test (described below) is initiated that determines no upstream occlusion exists, the cautionary pressure threshold line 80 can be adjusted (adapted) in the negative direction” [Col 8, line 64- Col 9, line 3]; “If the post-reversal pressure difference is less than the post-reversal pressure difference cutoff, no occlusion is deemed to exist and pump operation continues. The value of the cautionary threshold pressure may be adjusted downward, as discussed above with respect to FIG. 4A, to avoid further unnecessary pump reversal confirmation tests.” [Col 12, lines 59-65]); and determine that the pressure measurement indicates an actual occlusion in the fluid line based at least in part on the pressure limit (“Where a particular pressure difference and average pressure combination, such as the combination indicated by point 82, maps into the fourth or cautionary region 78 and a pump reversal confirmation test (described below) is initiated that determines no upstream occlusion exists, the cautionary pressure threshold line 80 can be adjusted (adapted) in the negative direction” [Col 11, lines 15-17]).
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 medical fluid delivery system of Pope to include dynamically adapting the first pressure limit such that the pumping mechanism operates at an increased fluid pressure in the fluid line without causing a false indication of an occlusion in the fluid line based on the teachings of Butterfield to decrease the chance of false occlusion alarms and avoid unnecessary stoppage of an infusion procedure (Butterfield [Col 3, lines 54-57] and [Col 12, lines 59-65]).
Regarding claim 20, modified Pope discloses the medical fluid delivery system of claim 19, wherein the instructions executable by the processor further cause the infusion pump to receive the first pressure limit (“The occlusion slope specified at block 202 of FIG. 3 is retrieved at block 209 by the system 10. Such an occlusion slope may comprise the expected relationship as discussed herein” [0048]).
Regarding claim 21, modified Pope discloses the medical fluid delivery system of claim 19, wherein the instructions executable by the processor further cause the infusion pump to: receive a request to change to a second fluid delivery pursuant to a second fluid delivery mode (“The user may initialize the system 10 at block 502 of FIG. 8…Initialization at block 502 may also include commencing infusion of medication. For example, a user may instruct the system 10 to pump fluid at a rate of 600 ml/hr for a given bolus injection.” [0075]); and identify a second pressure limit associated with the second fluid delivery mode (“Initialization processes may include setting a bolus occlusion limit.” [0075]) wherein the second pressure limit is different from the first pressure limit (Figure 3 having flowchart 200 describing the first fluid delivery mode and Figure 8 having flow chart 500 describing the second fluid delivery mode, wherein the first limit is an “occlusion slope” and the second limit is an “occlusion limit”).
Regarding claim 22, modified Pope discloses the medical fluid delivery system of claim 21, wherein the second fluid delivery corresponds to a same fluid as the first fluid delivery (Figure 1) and wherein the first fluid delivery mode corresponds to a continuous fluid delivery (“steady state”: “Given time, pressure/force within the system 10 eventually and relatively relaxes in the absence of an occlusion. That is, the force levels off to a more moderate slope. This period of leveling generally coincides with the system 10 achieving steady state.” [0059]) while the second fluid delivery mode corresponds to a bolus fluid delivery (“The flowchart 500 of FIG. 8 shows additional processes configured to detect an occlusion within an infusion system 10. The exemplary process steps are particularly suited for application within the context of a bolus injection” [0074]).
Regarding claim 23, modified Pope disclose the medical fluid delivery system of claim 21, wherein one of the first delivery mode or the second fluid delivery mode corresponds to a bolus fluid delivery (“The flowchart 500 of FIG. 8 shows additional processes configured to detect an occlusion within an infusion system 10. The exemplary process steps are particularly suited for application within the context of a bolus injection” [0074]).
Regarding claim 26, modified Pope discloses the medical fluid delivery system of claim 19, wherein the display is a touchscreen (“A typical display 19 may include operator interface input mechanisms, such as a keyboard, touch screen features, switches, a microphone, dials, and the like.” [0026]) and the parameter is received via the touchscreen (“The display 19 may include options for a user to enter input. Such input may include data pertaining to drug concentration, patient weight, as well as desired doses and dose rates…the processor 31 contained within the pump housing 14 may initiate the volume and fluid flow rates to be delivered to the patient.” [0029-0030]).
Regarding claim 27, Pope discloses a method of dynamically adapting a medical infusion system (Figures 2 and 8), comprising
receiving a parameter for a first fluid delivery pursuant to a first fluid delivery mode (“steady state”; see flowchart 200; Figure 3) through a fluid line (“The system 10 initializes at block 202 of FIG. 3…The initialization of block 202 may include user specified infusion protocols, operating parameters and other data. For instance, the user may select one or more fluid flow rates or sequences may be selected based on a desired pattern of drug delivery that is appropriate to the protocol of the patient.” [0036-0037], see also [0038-0042]) coupled to a pumping mechanism (“a motor internal to the housing 14 actuates a pusher, or plunger driver mechanism 17, to move the plunger 16.” [0026]) of an infusion pump (syringe pump system 10);
operating the pumping mechanism based on the parameter (“steady state”: “At the onset of an infusion process, an initial slope is generated that approaches or exceeds an occlusion slope. This elevated force level may be caused by the tubing 22 and other components of the system 10 reacting to a sudden influx, or ramping up, of pumped fluid. That is, some time is required by the system 10 in order to adjust and achieve a relaxed flow of fluid toward the patient 24. Given time, pressure/force within the system 10 eventually and relatively relaxes in the absence of an occlusion. That is, the force levels off to a more moderate slope. This period of leveling generally coincides with the system 10 achieving steady state.” [0059]);
receiving a pressure measurement from a pressure sensor (“The system 10 at block 207 of FIG. 3 uses the force values obtained at blocks 204 and 206 to determine a relationship between them. For instance, the system 10 may determine a slope at block 207. More particularly, the difference between the obtained force values may be divided by the difference in the times that the respective force values were obtained.” [0043]; “while force transducers are discussed above in connection with several embodiments, pressure transducers may have equal or greater applicability in other others that are consistent with the principles of the present invention. For instance, a sensor comprising a pressure transducer may be used at the outlet of a syringe or in the tubing.” [0085]; “The force value may be detected by a force or pressure sensor in communication with the downstream infusion tube 22, for instance.” [0062]);
identifying a pressure limit associated with the first fluid delivery mode (“The occlusion slope specified at block 202 of FIG. 3 is retrieved at block 209 by the system 10.” [0048]; “Initialization may include recalling or defining an expected relationship. This expected relationship may include an occlusion slope. Such a slope may be predetermined using clinical data. For instance, force measurements may be taken under known laboratory conditions at the beginning and end of a window interval. These force measurements are divided by the window to determine the occlusion slope. Some such slopes may be stored in an associative relationship with one or more of the known conditions as applicable to a given pumping system scenario. For instance, a slope may be stored in associative relationship with a particular type or size of syringe, and/or a given infusion rate.” [0038]);
determining that the pressure measurement indicates an actual occlusion in the fluid line based at least in part on the first pressure limit (“At block 210 of FIG. 3, the retrieved occlusion slope is compared to the trial slope determined at block 207… Where the detected slope is greater than or equal to the occlusion slope, and the occlusion detection time has lapsed at block 212, the system 10 will generate an occlusion alarm at block 217.” [0048-0051]); and
displaying an indicator of the occlusion via a display (display 19) coupled to the infusion pump (“Where the detected slope is greater than or equal to the occlusion slope, and the occlusion detection time has lapsed at block 212, the system 10 will generate an occlusion alarm at block 217. While a typical alarm may include an audible signal and/or a flashing display 19” [0051]).
Pope fails to explicitly disclose dynamically adapting the first pressure limit such that the pumping mechanism operates at an increased fluid pressure in the fluid line without causing a false indication of an occlusion in the fluid line.
Butterfield teaches a method of dynamically adapting a medical fluid delivery system (system 10), comprising operating a pumping mechanism (“A motor 36 and control electronics 38 are used to drive the peristaltic fingers 40 of the linear peristaltic pump 24.” [Col 4, lines 59-61]); receiving a pressure measurement from a pressure sensor (“An analog-to-digital converter 28 is coupled to the pressure sensor 26 to provide a digital signal to a signal processor 30,” [Col 4, lines 49-50]); dynamically adapting a pressure limit (“the cautionary threshold pressure line 80 is adaptable and may be adjusted during operation of the system to prevent unnecessary pump reversal confirmation tests or to enhance system sensitivity.” [Col 8, line 15-18]; see also Figure 5) such that the pumping mechanism operates at an increased fluid pressure in the fluid line without causing a false indication of an occlusion in the fluid line (“Where a particular pressure difference and average pressure combination, such as the combination indicated by point 82, maps into the fourth or cautionary region 78 and a pump reversal confirmation test (described below) is initiated that determines no upstream occlusion exists, the cautionary pressure threshold line 80 can be adjusted (adapted) in the negative direction” [Col 8, line 64- Col 9, line 3]; “If the post-reversal pressure difference is less than the post-reversal pressure difference cutoff, no occlusion is deemed to exist and pump operation continues. The value of the cautionary threshold pressure may be adjusted downward, as discussed above with respect to FIG. 4A, to avoid further unnecessary pump reversal confirmation tests.” [Col 12, lines 59-65]); and determining that the pressure measurement indicates an actual occlusion in the fluid line based at least in part on the pressure limit (“Where a particular pressure difference and average pressure combination, such as the combination indicated by point 82, maps into the fourth or cautionary region 78 and a pump reversal confirmation test (described below) is initiated that determines no upstream occlusion exists, the cautionary pressure threshold line 80 can be adjusted (adapted) in the negative direction” [Col 11, lines 15-17]).
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 method of Pope to include dynamically adapting the first pressure limit such that the pumping mechanism operates at an increased fluid pressure in the fluid line without causing a false indication of an occlusion in the fluid line based on the teachings of Butterfield to decrease the chance of false occlusion alarms and avoid unnecessary stoppage of an infusion procedure (Butterfield [Col 3, lines 54-57] and [Col 12, lines 59-65]).
Regarding claim 28, modified Pope discloses the method of claim 27, wherein the infusion pump receives the first pressure limit (“The occlusion slope specified at block 202 of FIG. 3 is retrieved at block 209 by the system 10. Such an occlusion slope may comprise the expected relationship as discussed herein” [0048]).
Regarding claim 29, modified Pope discloses the method of claim 27, further comprising receiving a request to change to a second fluid delivery pursuant to a second fluid delivery mode (“The user may initialize the system 10 at block 502 of FIG. 8…Initialization at block 502 may also include commencing infusion of medication. For example, a user may instruct the system 10 to pump fluid at a rate of 600 ml/hr for a given bolus injection.” [0075]); and identifying a second limit associated with the second fluid delivery mode (“Initialization processes may include setting a bolus occlusion limit.” [0075]) wherein the second limit is different from the first limit (Figure 3 having flowchart 200 describing the first fluid delivery mode and Figure 8 having flow chart 500 describing the second fluid delivery mode, wherein the first limit is an “occlusion slope” and the second limit is an “occlusion limit”).
Regarding claim 30, modified Pope discloses the method of claim 29, wherein the second fluid delivery corresponds to a same fluid as the first delivery (Figure 1) and wherein the first fluid delivery mode corresponds to a continuous fluid delivery (“steady state”: “Given time, pressure/force within the system 10 eventually and relatively relaxes in the absence of an occlusion. That is, the force levels off to a more moderate slope. This period of leveling generally coincides with the system 10 achieving steady state.” [0059]) while the second fluid delivery mode corresponds to a bolus fluid delivery (“The flowchart 500 of FIG. 8 shows additional processes configured to detect an occlusion within an infusion system 10. The exemplary process steps are particularly suited for application within the context of a bolus injection” [0074]).
Regarding claims 31-32, modified Pope discloses the infusion pump of claim 13.
Modified Pope fails to explicitly disclose the infusion pump dynamically adapts by increasing the first pressure limit, as required by claim 31; and wherein the infusion gradually lowers the first pressure limit, as required by claim 32.
Butterfield teaches an infusion pump (system 10) comprising instructions executable by a processor (microprocessor 30 and control electronics 38) to cause the infusion pump to operate a pumping mechanism (“A motor 36 and control electronics 38 are used to drive the peristaltic fingers 40 of the linear peristaltic pump 24.” [Col 4, lines 59-61]); receive a pressure measurement from a pressure sensor (“An analog-to-digital converter 28 is coupled to the pressure sensor 26 to provide a digital signal to a signal processor 30,” [Col 4, lines 49-50]); and dynamically adapt a pressure limit (“the cautionary threshold pressure line 80 is adaptable and may be adjusted during operation of the system to prevent unnecessary pump reversal confirmation tests or to enhance system sensitivity.” [Col 8, line 15-18]), wherein the infusion pump dynamically adapts by increasing the first pressure limit (“Where a particular pressure difference and average pressure combination, such as the combination indicated by point 82, maps into the fourth or cautionary region 78 and a pump reversal confirmation test (described below) is initiated that determines no upstream occlusion exists, the cautionary pressure threshold line 80 can be adjusted (adapted) in the negative direction” [Col 8, lines 64], wherein negatively adjusting the cautionary pressure threshold line corresponds to an increased pressure limit); and wherein the infusion gradually lowers the first pressure limit (“The cautionary threshold pressure line 80 can also be positively adjusted to enlarge the cautionary region 78 and hence enhance the sensitivity of the system. Such an adjustment may be made when, as an example, the cautionary threshold pressure line 80a has previously been negatively adjusted to accommodate previous pressure difference/average pressure combinations, but recent pressure difference/average pressure combinations are mapping well beyond the negatively adjusted cautionary threshold line 80a and the previous unadjusted line 80…The positive adjustment, in one embodiment, is in an amount equal to one half of the difference between the negatively adjusted cautionary threshold line 80a and the recent pressure difference/average pressure combination 84.” [Col 9, line 21-42], wherein positively adjusting the cautionary pressure threshold line corresponds to a decreased pressure limit, see also Figure 5).
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 infusion pump of Pope to include the infusion pump dynamically adapts by increasing the first pressure limit and wherein the infusion gradually lowers the first pressure limit based on the teachings of Butterfield to decrease the chance of false occlusion alarms and avoid unnecessary stoppage of an infusion procedure (Butterfield [Col 3, line 54-57], [Col 12, line 59-65]) in a manner that also allow for increasing the sensitivity of an occlusion detection system if multiple pressure readings indicate potential occlusions (Butterfield [Col 9, lines 21-46]).
Claims 16 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Pope et al. (US 20050096593) in view of Butterfield (USPN 5827223)as applied in claims 13 and 21 above, and in further view of Lee et al. (US 20060030836).
Regarding claim 16, modified Pope discloses the infusion pump of claim 13, wherein the instructions executable by the processor further cause the infusion pump to operate the second fluid delivery mode within the first fluid delivery mode (“The system 10 may verify that it is operating in bolus delivery mode at block 510. This step at block 510 allows the bolus infusion processes to work within the context of normal, non-bolus infusions.” [0079]).
Modified Pope fails to explicitly wherein the instructions executable by the processor further cause the infusion pump to gradually revert from the second fluid delivery mode back to the first fluid delivery mode over time.
Lee teaches an infusion pump (infusion apparatus 2) comprising a non-transitory computer readable medium comprising instruction (“a data storage unit for storing medicinal substance infusion algorithms according to a continuous infusion mode, a patient controlled analgesia (PCA) mode…and a control unit for receiving a signal according to the input of each button of the button unit to perform an algorithm according to the corresponding mode previously stored in the data storage unit” [0021]) executable by a processor (“a microprocessor” [0086]) to cause the infusion pump to gradually revert from a second fluid delivery mode (“a patient controlled analgesia (PCA) mode for further infusing another prescribed amount of medicinal substance in addition to the prescribed amount of the medicinal substance in the continuous infusion mode;” [0023]) back to a first fluid delivery (“a continuous infusion mode for continuously infusing a prescribed amount of medicinal substance from the time when infusion of the medicinal substance is initiated to the time when infusion of the medicinal substance is completed;” [0023]) mode over time (Figure 11b, showing the infusion pump reverting to the continuous flow/first mode after a bolus dose/second mode; see described in [0106] and [0132]).
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 executable by the processor of the infusion pump of Pope to include cause the infusion pump to gradually revert from the second fluid delivery mode back to the first fluid delivery mode over time based on the teachings of Lee to ensure that the minimum necessary dose of medicine is delivered while also allowing the patient some control over the infusion in order to take their pain into consideration (Lee [0008], [0106]).
Regarding claim 24, modified Pope discloses the medical fluid delivery system of claim 21, wherein the instructions executable by the processor further cause the infusion pump to operate the second fluid delivery mode within the first fluid delivery mode (“The system 10 may verify that it is operating in bolus delivery mode at block 510. This step at block 510 allows the bolus infusion processes to work within the context of normal, non-bolus infusions.” [0079]).
Modified Pope fails to explicitly wherein the instructions executable by the processor further cause the infusion pump to gradually revert from the second fluid delivery mode back to the first fluid delivery mode over time.
Lee teaches an infusion pump (infusion apparatus 2) comprising a non-transitory computer readable medium comprising instruction (“a data storage unit for storing medicinal substance infusion algorithms according to a continuous infusion mode, a patient controlled analgesia (PCA) mode…and a control unit for receiving a signal according to the input of each button of the button unit to perform an algorithm according to the corresponding mode previously stored in the data storage unit” [0021]) executable by a processor (“a microprocessor” [0086]) to cause the infusion pump to gradually revert from a second fluid delivery mode (“a patient controlled analgesia (PCA) mode for further infusing another prescribed amount of medicinal substance in addition to the prescribed amount of the medicinal substance in the continuous infusion mode;” [0023]) back to a first fluid delivery (“a continuous infusion mode for continuously infusing a prescribed amount of medicinal substance from the time when infusion of the medicinal substance is initiated to the time when infusion of the medicinal substance is completed;” [0023]) mode over time (Figure 11b, showing the infusion pump reverting to the continuous flow/first mode after a bolus dose/second mode; see described in [0106] and [0132]).
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 executable by the processor of the medical fluid delivery system of Pope to include cause the infusion pump to gradually revert from the second fluid delivery mode back to the first fluid delivery mode over time based on the teachings of Lee to ensure that the minimum necessary dose of medicine is delivered while also allowing the patient some control over the infusion in order to take their pain into consideration (Lee [0008], [0106]).
Claims 17 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Pope et al. (US 20050096593) in view of Butterfield (USPN 5827223)as applied in claims 11 and 19 above, and in further view of Butterfield et al. (US 20120053533), hereinafter Butterfield 2012.
Regarding claim 17, modified Pope discloses the infusion pump of claim 11, wherein the disclosed instructions executable by the processor are applicable to peristaltic pumps (“while this specification focused generally on a syringe pump, one skilled in the art will recognize that the underlying principles of the present invention apply equally to other medical pumping systems, to include cassette based and peristaltic pumps” [0085]).
Modified Pope fails to explicitly discloses the display is located on a door of the infusion pump.
Butterfield 2012 discloses an infusion pump (infusion pump 22) comprising: a pumping mechanism (pumping mechanism 70) and a display (display 55) located on a door (door 53) of the infusion pump (“A display 55, such as an LED display, is located in plain view on the doo” [0032]).
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 infusion pump of Pope to include the display is located on a door of the infusion pump based on the teachings of Butterfield 2012 to adapt the infusion pump for peristaltic infusion and allow the user to access the internal pumping mechanism and load the fluid line into the pump (Butterfield [0032, 0036]).
Regarding claim 25, modified Pope discloses the medical fluid delivery system of claim 19, wherein the disclosed instructions executable by the processor are applicable to peristaltic pumps (“while this specification focused generally on a syringe pump, one skilled in the art will recognize that the underlying principles of the present invention apply equally to other medical pumping systems, to include cassette based and peristaltic pumps” [0085]).
Modified Pope fails to explicitly discloses the display is located on a door of the infusion pump.
Butterfield 2012 discloses an infusion pump (infusion pump 22) comprising: a pumping mechanism (pumping mechanism 70) and a display (display 55) located on a door (door 53) of the infusion pump (“A display 55, such as an LED display, is located in plain view on the doo” [0032]).
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 infusion pump of Pope to include the display is located on a door of the infusion pump based on the teachings of Butterfield 2012 to adapt the infusion pump for peristaltic infusion and allow the user to access the internal pumping mechanism and load the fluid line into the pump (Butterfield [0032, 0036]).
Response to Arguments
Applicant’s arguments with respect to claims 11-32 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/LEAH J SWANSON/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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