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 February 9th 2026 has been entered. Claims 1-6, 8-11, and 13-15 are pending in the application. Applicant’s amendments to the Claims have overcome the 112(a) and 112(b) previously set forth in the Non-Final Office Action mailed October 7th 2025.
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 1-2, 6-10, and 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Shimizu (US 20150238689 A1) in view of Yagi (US 20180001022 A1).
Regarding claim 1, Shimizu discloses an infusion pump (infusion pump 1, [0032] & Fig. 3), comprising: a pumping mechanism (liquid delivering drive unit 60, [0066] & Fig. 3) configured to deliver medicament through an infusion set to a patient (infusion tube 200 and drive unit 60 configured to deliver liquid to the inside of a patient, [0032], [0068] & Fig. 2 and 3); a downstream pressure sensor (downstream occlusion sensor (DOS) 53, [0045] & Fig. 3) arranged between the pumping mechanism and an outlet of downstream tubing connected to the infusion set (DOS sensor 53 arranged between drive unit 60 and the outlet of downstream side 200B of infusion tube 200 which terminates with catheter 172, [0033], [0054] & Fig. 2 and 3), the outlet configured to be coupleable to the patient (catheter 172, which is being interpreted as the outlet, configured to indwell inside a vein of a patient, [0032] & Fig. 2);
an upstream pressure sensor (upstream occlusion sensor (UOS) 52, [0045] & Fig. 3) arranged between the pumping mechanism and a source of the medicament connected to the infusion set (UOS sensor 52 arranged between drive unit 60 and drug bad 170, [0032] & Fig. 2 and 3); and a control unit coupled to the pumping mechanism, the downstream pressure sensor and the upstream pressure sensor (infusion pump 1, containing the DOS 53, the UOS 52, and the drive unit 60, having a control unit 100, [0059] & Fig. 4; the control unit configured to control the entire operation), the control unit configured to: operate the pumping mechanism in a first direction to deliver medicament through the infusion set to the patient (via control unit 100 issuing commands to a motor driver which operates the drive motor 61, which is an element of drive unit 60; this rotates the fingers 63 of the cam structure 62 in the forward rotation direction, clock wise, which subsequently press on the infusion tube 200 thereby delivering drug, [0090] & Fig. 2, 3, and 6);
stop the pumping mechanism operating in the first direction in response to an indication from the downstream pressure sensor of a downstream pressure exceeding a first predetermined occlusion pressure limit (via control unit 100 stopping the forward rotation of the drive motor 61 if a downstream occlusion signal S3, which is being interpreted as the indication from the downstream pressure sensor, is sent from the DOS 53, [0092] & Fig. 3 and 4; the downstream occlusion signal S3 is sent when an occlusion state (which occurs when a predetermined internal pressure threshold is exceeded, [0063]) is detected in the downstream side of infusion tub 200, this is being interpreted as the first predetermined occlusion pressure limit, [0057] and [0063]; the occlusion state also being disclosed as a state determined by a threshold being reached);
operate the pumping mechanism in a second direction while monitoring upstream pressure using the upstream pressure sensor, the second direction being opposite the first direction (after the drive motor 61 is stopped, the control unit 100 causes reverse rotation, counter clock wise rotation, [0084], [0092] & Fig. 3 and 8; via “The upstream occlusion sensor 52 is a sensor which detects whether or not the inside of the infusion tube 200 is occluded on the upstream side 200A of the infusion tube 200 depending on whether or not degree of swelling (diameter expansion) of an outer diameter of the infusion tube 200 reaches a threshold value by detecting and outputting the swelling thereof,” [0057] & Fig. 3; the upstream pressure sensing would continue normal operation during reverse rotation); stop the pumping mechanism operating in the second direction in response to an indication from the downstream pressure sensor that the downstream pressure has returned to a safe level below the first predetermined occlusion pressure limit, (stopping the reverse rotation is determined by a set of conditions, one of which includes “An output by the Hall element drops to the extent of 80% with respect to a value corresponding to an occlusion state,” (hereafter referred to as Condition 1 which is being interpreted as the claimed safe level) [0093], [0094] & Fig. 3 and 8; the value corresponding to an occlusion state is being interpreted as the downstream pressure of the infusion tube 200, the limit being a set pressure which is predetermined, [0057] and [0062]).
However, Shimizu does not explicitly disclose the control unit configured to automatically restart of operation of the pumping mechanism in the first direction in response to an indication from the downstream pressure sensor that the downstream pressure has returned to the safe level.
However, Yagi teaches an infusion pump comprising a control unit configured to automatically restart operation of the pumping mechanism in the first direction in response to an indication from the downstream pressure sensor that the downstream pressure has returned to the safe level (infusion state detection system 10 comprising delivery pump 20, comprising control unit 54, which comprises determination unit 58, [0032] and [0048]; control unit 54 and determination unit 58 configured to restart delivery of a medicinal solution, after having stopped delivery due to a pressure increase in the infusion line, once the pressure has returned to a safe level, [0042] and [0067]-[0068] & Fig. 7; in S12, control unit 54 stops liquid delivery once a pressure threshold is reached, step S11, [0076]-[0077]; then, without alarm output (S16 or S20), the liquid delivery may be restarted at S18 when control unit 54 decides that no extravasation phenomenon has occurred, which is being interpreted as the system returning to a safe level, [0081] and see [0004]).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the infusion pump of Shimizu with Yagi to include the control unit configured to automatically restart operation of the pumping mechanism in the first direction in response to an indication from the downstream pressure sensor that the downstream pressure has returned to the safe level since such a modification would allow for continued device use after the mitigation of an event resulting in an undesired pressure change and would “avoid prolongation of the liquid delivery stop state” ([0068] of Yagi). The modification provides predictable results pertaining to infusion pump automation.
Additionally, in Shimizu, it would follow that treatment would be restarted after mitigation of the occlusion. The reverse rotation of the drive motor stops once the occlusion state is resolved and there would be a limited number of options for the next step, either the user initiates continued delivery via the control or the forward rotation restarts; paragraph [0004] of Shimizu mentions the reverse rotation as “mitigation treatment of the occlusion” which implies a removal/resolution of the occlusion which would allow for continued normal operation of the infusion pump.
Regarding claim 2, Shimizu discloses all the limitations of claim 1, Shimizu further discloses the infusion pump wherein the control unit further includes memory containing the first predetermined occlusion pressure limit (via the infusion pump 1 having a memory 101 capable of containing the required threshold values needed for sensor use, [0059] & Fig. 4).
Regarding claim 6, Shimizu, as modified by Yagi, discloses all the limitations of claim 1. Shimizu further discloses the infusion pump wherein the control system is further configured to provide an alarm signal in response to an indication from the downstream pressure sensor of the downstream pressure exceeding the first predetermined occlusion pressure limit (the control unit can display a notification or can issue an alarm through a sound using buzzer 132 when the drive unit is in a reverse rotation which is caused by the DOS 53 sending signal S3 to control unit 100 when an occlusion state is reached, [0057], [0119] & Fig. 4).
Regarding claim 8, Shimizu discloses a method of operating an infusion pump to prevent post-occlusion bolus (abstract), the infusion pump (infusion pump 1, [0032] & Fig. 3) including a pumping mechanism (liquid delivering drive unit 60, [0066] & Fig. 3), a downstream pressure sensor (downstream occlusion sensor (DOS) 53, [0045] & Fig. 3) and an upstream pressure sensor (upstream occlusion sensor (UOS) 52, [0045] & Fig. 3), the method being performed by the infusion pump and comprising: operating the pumping mechanism in a first direction to deliver medicament to a patient (via control unit 100 issuing commands to a motor driver which operates the drive motor 61, which is an element of drive unit 60; this rotates the fingers 63 of the cam structure 62 in the forward rotation direction, clock wise, which subsequently press on the infusion tube 200 thereby delivering drug, [0090] & Fig. 2, 3, and 6); monitoring downstream pressure with the downstream pressure sensor (via “The downstream occlusion sensor 53 is a sensor which detects whether or not the inside of the infusion tube 200 is occluded on the downstream side 200B of the infusion tube 200 depending on whether or not degree of swelling (diameter expansion) of the outer diameter of the infusion tube 200 reaches the threshold value (whether or not the infusion tube 200 is in an occlusion state) by detecting and outputting the swelling thereof,” [0057] & Fig. 3);
stopping the pumping mechanism operating in the first direction in response to an indication from the downstream pressure sensor of a downstream pressure exceeding a first predetermined occlusion pressure limit (via control unit 100 stopping the forward rotation of the drive motor 61 if a downstream occlusion signal S3, which is being interpreted as the indication from the downstream pressure sensor, is sent from the DOS 53, [0092] & Fig. 3 and 4; the downstream occlusion signal S3 is sent when an occlusion state (which occurs when a predetermined internal pressure threshold is exceeded, [0063]) is detected in the downstream side of infusion tub 200, this is being interpreted as the first predetermined limit, [0057] and [0063]);
operating the pumping mechanism in a second direction to reduce possibility of inadvertent delivery of a bolus to the patient, the second direction being opposite the first direction (via after the drive motor 61 is stopped, the control unit 100 causes reverse rotation, counter clock wise rotation, [0084], [0092] & Fig. 3 and 8; “it is possible to perform controlling for processing mitigation treatment of an occlusion pressure by causing the rotor to reversely rotate until a prejudged condition is fulfilled” [0009]) while monitoring upstream pressure with the upstream pressure sensor (via “The upstream occlusion sensor 52 is a sensor which detects whether or not the inside of the infusion tube 200 is occluded on the upstream side 200A of the infusion tube 200 depending on whether or not degree of swelling (diameter expansion) of an outer diameter of the infusion tube 200 reaches a threshold value by detecting and outputting the swelling thereof,” [0057] & Fig. 3; the upstream pressure sensing would continue normal operation during reverse rotation); comparing the downstream pressure with the downstream pressure sensor to a predetermined safe level below the predetermined occlusion pressure limit (the DOS 53 used to determine whether or not the following condition is met which stops the reverse rotation: An output by the Hall element drops to the extent of 80% with respect to a value corresponding to an occlusion state, [0093], [0094] & Fig. 3; the condition is being interpreted as the safe level), and comparing the upstream pressure with the upstream pressure sensor to a second predetermined limit (via sensors 52 and 53 both configured to detect whether or not the inside of the infusion tube 200 reaches a threshold value which can be interpreted as the first and/or second predetermined limit of the upstream and downstream pressures respectively, [0057]);
stopping the pumping mechanism in the second direction in response to an indication from the downstream pressure sensor that the downstream pressure has returned to the predetermined safe level (via stopping the reverse rotation is determined by a set of conditions, one of which includes “An output by the Hall element drops to the extent of 80% with respect to a value corresponding to an occlusion state,” (which is being interpreted as the claimed safe level and hereafter referred to as “Condition 1”) [0093], [0094] & Fig. 3 and 8; the value corresponding to an occlusion state is being interpreted as the downstream pressure of the infusion tube 200, the limit being a set pressure inside of pump 1 which is predetermined, [0057] and [0062]); and
wherein the second predetermined limit corresponds to a safe pressure limit of tubing of the infusion set (the threshold value corresponding to excess swelling of an outer diameter of infusion tube 200 on an upstream side 200A is being interpreted as the second predetermined limit, see [0057] & Fig. 3; this reading is also being interpreted as corresponding to a safe pressure limit of tubing 200).
However, Shimizu does not explicitly disclose a method of operating an infusion pump comprising automatically restarting operation of the pumping mechanism in the first direction in response to an indication from the downstream pressure sensor that the downstream pressure has returned to the predetermined safe level and the infusion pump wherein the first predetermined occlusion pressure limit is less than the second predetermined limit.
However, Yagi teaches a method ([0027]-[0029] & Fig. 7) of operating an infusion pump comprising automatically restarting operation of the pumping mechanism in the first direction in response to an indication from the downstream pressure sensor that the downstream pressure has returned to the predetermined safe level (infusion state detection system 10 comprising delivery pump 20, comprising control unit 54, which comprises determination unit 58, [0032] and [0048]; control unit 54 and determination unit 58 configured to restart delivery of a medicinal solution, after having stopped delivery due to a pressure increase in the infusion line, once the pressure has returned to a safe level, [0042] and [0067]-[0068] & Fig. 7; in S12, control unit 54 stops liquid delivery once a pressure threshold is reached, step S11, [0076]-[0077]; then, without alarm output (S16 or S20), the liquid delivery may be restarted at S18 when control unit 54 decides that no extravasation phenomenon has occurred, which is being interpreted as the system returning to a safe level, [0081] and see [0004]).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the method of operating an infusion pump of Shimizu with Yagi to include automatically restarting operation of the pumping mechanism in the first direction in response to an indication from the downstream pressure sensor that the downstream pressure has returned to the predetermined safe level since such a modification would allow for continued device use after the mitigation of an event resulting in an undesired pressure change and would “avoid prolongation of the liquid delivery stop state” ([0068] of Yagi). The modification provides predictable results pertaining to infusion pump automation.
Additionally, in Shimizu, it would follow that treatment would be restarted after mitigation of the occlusion. The reverse rotation of the drive motor stops once the occlusion state is resolved and there would be a limited number of options for the next step, either the user initiates continued delivery via the control or the forward rotation restarts; paragraph [0004] of Shimizu mentions the reverse rotation as “mitigation treatment of the occlusion” which implies a removal/resolution of the occlusion which would allow for continued normal operation of the infusion pump.
Further, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the method of Shimizu to have the first predetermined limit less than the second predetermined limit since it has been held that “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Shimizu places no criticality on the threshold values or occlusion state threshold. The infusion pump of Shimizu would be able to operate under the conditions of the claimed relationship between the first and second predetermined limits. The DOS 53 and the UOS 52 are operable to detect and prevent occlusions; the threshold value can be any value associated with a reading from the sensor that could indicate an occlusion event. Further, applicant places no criticality on the range relationship, indicating simply that the first predetermined limit is less than the second predetermined limit.
Regarding claim 9, Shimizu, as modified by Yagi, discloses all the limitations of claim 8. Shimizu further discloses the method further comprising providing an alarm signal in response to an indication from the downstream pressure sensor of the downstream pressure exceeding the first predetermined occlusion pressure limit (via the control unit can display a notification or can issue an alarm through a sound using buzzer 132 when the drive unit is in a reverse rotation which is caused by the DOS 53 sending signal S3 to control unit 100 when an occlusion state is reached, [0057], [0119] & Fig. 4).
Regarding claim 10, Shimizu, as modified by Yagi, discloses all the limitations of claim 8. Shimizu further discloses the method wherein comparing downstream pressure with the downstream pressure sensor to a predetermined safe level further comprises comparing downstream pressure with the downstream pressure sensor to the predetermined safe level including an offset factor (via Condition 1, which is being interpreted as the safe level, includes an output by the Hall element which has dropped to the extent of 80% with respect to a value corresponding to an occlusion state; the 20% not factored into the output is being interpreted as the offset factor, [0094]).
Regarding claim 13, Shimizu discloses an infusion pump (infusion pump 1, [0032] & Fig. 3) including a pumping mechanism (liquid delivering drive unit 60, [0066] & Fig. 3), a downstream pressure sensor (downstream occlusion sensor (DOS) 53, [0045] & Fig. 3) and an upstream pressure sensor (upstream occlusion sensor (UOS) 52, [0045] & Fig. 3), the infusion pump configured to: operate the pumping mechanism in a first direction to deliver medicament through an infusion set to a patient (via control unit 100 issuing commands to a motor driver which operates the drive motor 61, which is an element of drive unit 60; this rotates the fingers 63 of the cam structure 62 in the forward rotation direction, clock wise, which subsequently press on the infusion tube 200 thereby delivering drug, [0090] & Fig. 2, 3, and 6);
stop the pumping mechanism operating in the first direction in response to an indication from the downstream pressure sensor of a downstream pressure exceeding a first predetermined occlusion pressure limit (via control unit 100 stopping the forward rotation of the drive motor 61 if a downstream occlusion signal S3, which is being interpreted as the indication from the downstream pressure sensor, is sent from the DOS 53, [0092] & Fig. 3 and 4; the downstream occlusion signal S3 is sent when an occlusion state (which occurs when a predetermined internal pressure threshold is exceeded, [0063]) is detected in the downstream side of infusion tub 200, this is being interpreted as the first predetermined limit, [0057] and [0063]); operate the pumping mechanism in a second direction to reduce possibility of inadvertent delivery of a bolus to the patient while monitoring upstream pressure using the upstream pressure sensor, the second direction being opposite the first direction (via after the drive motor 61 is stopped, the control unit 100 causes reverse rotation, counter clock wise rotation, [0084], [0092] & Fig. 3 and 8; “it is possible to perform controlling for processing mitigation treatment of an occlusion pressure by causing the rotor to reversely rotate until a prejudged condition is fulfilled” [0009]; “The upstream occlusion sensor 52 is a sensor which detects whether or not the inside of the infusion tube 200 is occluded on the upstream side 200A of the infusion tube 200 depending on whether or not degree of swelling (diameter expansion) of an outer diameter of the infusion tube 200 reaches a threshold value by detecting and outputting the swelling thereof,” [0057] & Fig. 3; the upstream pressure sensing would continue normal operation during reverse rotation);
compare downstream pressure with the downstream pressure sensor to a predetermined safe level below the first predetermined occlusion pressure limit (the DOS 53 used to determine whether or not the following condition is met which stops the reverse rotation: An output by the Hall element drops to the extent of 80% with respect to a value corresponding to an occlusion state, [0093], [0094] & Fig. 3; the condition is being interpreted as the safe level), and
compare upstream pressure with the upstream pressure sensor to a second predetermined limit (via sensors 52 and 53 both configured to detect whether or not the inside of the infusion tube 200 reaches a threshold value which can be interpreted as the first and/or second predetermined limit of the upstream and downstream pressures respectively, [0057]); stop the pumping mechanism operating in the second direction in response to an indication from the downstream pressure sensor that the downstream pressure has returned to the predetermined safe level (via stopping the reverse rotation is determined by a set of conditions, one of which includes “An output by the Hall element drops to the extent of 80% with respect to a value corresponding to an occlusion state,” (which is being interpreted as the claimed safe level and hereafter referred to as “Condition 1”) [0093], [0094] & Fig. 3 and 8; the value corresponding to an occlusion state is being interpreted as the downstream pressure of the infusion tube 200, the limit being a set pressure inside of pump 1 which is predetermined, [0057] and [0062]); and wherein the second predetermined limit corresponds to a safe pressure limit of tubing of the infusion set (the threshold value corresponding to excess swelling of an outer diameter of infusion tube 200 on an upstream side 200A is being interpreted as the second predetermined limit, see [0057] & Fig. 3; this reading is also being interpreted as corresponding to a safe pressure limit of tubing 200).
However, Shimizu does not explicitly disclose the infusion pump configured to automatically restart operation of the pumping mechanism in the first direction in response to an indication from the downstream pressure sensor that the downstream pressure has returned to the predetermined safe level and the infusion pump wherein the first predetermined occlusion pressure limit is less than the second predetermined limit.
However, Yagi teaches an infusion pump configured to automatically restart operation of the pumping mechanism in the first direction in response to an indication from the downstream pressure sensor that the downstream pressure has returned to the safe level (infusion state detection system 10 comprising delivery pump 20, comprising control unit 54, which comprises determination unit 58, [0032] and [0048]; control unit 54 and determination unit 58 configured to restart delivery of a medicinal solution, after having stopped delivery due to a pressure increase in the infusion line, once the pressure has returned to a safe level, [0042] and [0067]-[0068] & Fig. 7; in S12, control unit 54 stops liquid delivery once a pressure threshold is reached, step S11, [0076]-[0077]; then, without alarm output (S16 or S20), the liquid delivery may be restarted at S18 when control unit 54 decides that no extravasation phenomenon has occurred, which is being interpreted as the system returning to a safe level, [0081] and see [0004]).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the infusion pump of Shimizu with Yagi to include the infusion pump configured to automatically restart operation of the pumping mechanism in the first direction in response to an indication from the downstream pressure sensor that the downstream pressure has returned to the safe level since such a modification would allow for continued device use after the mitigation of an event resulting in an undesired pressure change and would “avoid prolongation of the liquid delivery stop state” ([0068] of Yagi). The modification provides predictable results pertaining to infusion pump automation.
Additionally, in Shimizu, it would follow that treatment would be restarted after mitigation of the occlusion. The reverse rotation of the drive motor stops once the occlusion state is resolved and there would be a limited number of options for the next step, either the user initiates continued delivery via the control or the forward rotation restarts; paragraph [0004] of Shimizu mentions the reverse rotation as “mitigation treatment of the occlusion” which implies a removal/resolution of the occlusion which would allow for continued normal operation of the infusion pump.
Further, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Shimizu to have the first predetermined limit less than the second predetermined limit since it has been held that “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Shimizu places no criticality on the threshold values or occlusion state threshold. The infusion pump of Shimizu would be able to operate under the conditions of the claimed relationship between the first and second predetermined limits. The DOS 53 and the UOS 52 are operable to detect and prevent occlusions; the threshold value can be any value associated with a reading from the sensor that could indicate an occlusion event. Further, applicant places no criticality on the range relationship, indicating simply that the first predetermined limit is less than the second predetermined limit.
Regarding claim 14, Shimizu, as modified by Yagi, discloses all the limitations of claim 13. Shimizu further discloses the infusion pump wherein the safe level includes an offset factor (via Condition 1, which is being interpreted as the safe level, includes an output by the Hall element which has dropped to the extent of 80% with respect to a value corresponding to an occlusion state; the 20% not factored into the output is being interpreted as the offset factor, [0094]).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Shimizu (US 20150238689 A1), as modified by Yagi (US 20180001022 A1), and in further view of Hall (US 20060189926 A1).
Regarding claim 3, Shimizu, as modified by Yagi, discloses all the limitations of claim 1. Shimizu and Yagi both fail to explicitly disclose the infusion pump wherein the upstream pressure sensor is arranged between the pumping mechanism and a check valve arranged on upstream tubing connected to the infusion set.
However, Hall teaches an infusion pump (abstract) wherein the upstream pressure sensor is arranged between the pumping mechanism and a check valve arranged on upstream tubing connected to the infusion set (connector 120 may include a valve, the connector 120 arranged on tube 13 which is connected to the system 100 and upstream of system 100; a pressure sensor may be included in system 100 which may be upstream of pump 203, [0100], [0121] & Fig. 1).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the device of Shimizu, as modified by Yagi, with Hall to include the check valve since such a modification would provide structure to aid in fluid flow control. The modification provides predictable results pertaining to controlled fluid flow ([0121 of Hall).
Claims 4-5, 11, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Shimizu (US 20150238689 A1), as modified by Yagi (US 20180001022 A1), and in further view of Mhatre (US 20080294094 A1).
Regarding claim 4, Shimizu, as modified by Yagi, discloses all the limitations of claim 1. However, Shimizu and Yagi both fail to explicitly disclose the infusion pump wherein the safe level is based on an average calculated from data received from the downstream pressure sensor.
However, Mhatre teaches the infusion pump wherein the safe level is based on an average calculated from data received from the downstream pressure sensor (to determine if there is an occlusion, an algorithm averages data values from a sensor and compares the average value to an initial value, [0159]). Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the infusion pump of Shimizu, as modified by Yagi, with Mhatre to include the infusion pump wherein the safe level is based on an average calculated from data received from a sensor since such a modification would provide a baseline value for the safe level that could help reduce false alarms and error, [0159]. The modification provides predicable results pertaining to reduced device error while in use ([0159] pf Mhatre).
Regarding claim 5, Shimizu, as modified by Yagi and Mhatre, discloses all the limitations of claim 4. Shimizu further discloses the infusion pump wherein the safe level includes an offset factor (via Condition 1, which is being interpreted as the safe level, includes an output by the Hall element which has dropped to the extent of 80% with respect to a value corresponding to an occlusion state; the 20% not factored into the output is being interpreted as the offset factor, [0094]).
Regarding claim 11, Shimizu, as modified by Yagi, discloses all the limitations of claim 8. Shimizu and Yagi both fail to explicitly disclose the method wherein the safe level is based on an average calculated from data received from the downstream pressure sensor during operation of the infusion pump.
However, Mhatre the method wherein the safe level is based on an average calculated from data received from the downstream pressure sensor during operation of the infusion pump (to determine if there is an occlusion, an algorithm averages data values from a sensor over a number of pump drive cycles and compares the average value to an initial value, [0159]). Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the infusion pump of Shimizu, as modified by Yagi, with Mhatre to include the method wherein the safe level is based on an average calculated from data received from the downstream pressure sensor during operation of the infusion pump since such a modification would provide a baseline value for the safe level that could help reduce false alarms and error, [0159]. The modification provides predicable results pertaining to reduced device error while in use ([0159] of Mhatre).
Regarding claim 15, Shimizu, as modified by Yagi, discloses all the limitations of claim 14. Shimizu and Yagi both fail to explicitly disclose the infusion pump wherein the safe level is based on an average calculated from data received from the downstream pressure sensor during operation of the infusion pump.
However, Mhatre the infusion pump wherein the safe level is based on an average calculated from data received from the downstream pressure sensor during operation of the infusion pump (to determine if there is an occlusion, an algorithm averages data values from a sensor over a number of pump drive cycles and compares the average value to an initial value, [0159]). Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the infusion pump of Shimizu, as modified by Yagi, with Mhatre to include the method wherein the safe level is based on an average calculated from data received from the downstream pressure sensor during operation of the infusion pump since such a modification would provide a baseline value for the safe level that could help reduce false alarms and error, [0159]. The modification provides predicable results pertaining to reduced device error while in use ([0159] of Mhatre).
Response to Arguments
Applicant's arguments filed February 9th 2026 have been fully considered but they are not persuasive.
In response to Applicant’s arguments that the references fail to teach operating the pumping mechanism in the second direction while monitoring upstream pressure using the upstream pressure sensor, the Examiner finds that a scenario as taught by Shimizu exists in which the upstream pressure sensor 52 indicates an occlusion and initiates the reverse rotation of the drive unit 60. In this scenario, as presented in the Office Action mailed October 7th 2025, Condition 1 being met by the UOS 52 would stop the reverse rotation (see [0058] and [0063]). The Examiner notes that Shimizu explicitly discloses that the UOS 52 and the DOS 53 are configured to operate the same way (see [0057] of Shimizu). One of ordinary skill in the art would be able to select a suitable second predetermined limit to allow for proper device operation.
Further, there is no indication in Shimizu that the upstream pressure sensor would stop functioning while the pump operates in the reverse direction in response to the downstream pressure sensor indicating an occlusion. The UOS 52 would continue monitoring pressure.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARTIN ADAM RADOMSKI whose telephone number is (571)272-2703. The examiner can normally be reached Monday-Friday: 7:30-4:30 CT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARTIN A RADOMSKI/ Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783
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