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 .
Drawings
Figure(s) 12-14C, 15A should be designated by a legend such as --Prior Art-- because only that which is old is illustrated, as seen in Figure(s) 1-3C and 4 in Zheng et al. (WO 2019156852 A2). See MPEP § 608.02(g). Corrected drawings in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. The replacement sheet(s) should be labeled “Replacement Sheet” in the page header (as per 37 CFR 1.84(c)) so as not to obstruct any portion of the drawing figures. If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claim(s) 1, 2, 4, 6, 7, 9, 10, 13, 14 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zheng et al. (WO2019156852A2) and further in view of Lee et al. (WO 2021183489 A1).
Regarding claim 1, Zheng disclosed a fluid delivery device (medication delivery device [0026]) comprising:
a pump (pump assembly 20 in Fig. 1) comprising a chamber of fluid (chamber 38 in Fig. 3A), and a drive mechanism (pump actuator 66 can be a pump driving mechanism [0051]) configured to control movement of a designated volume of fluid with respect to the chamber during a fluid movement operation (pumping mechanism configured to control aspiration of a volume of the fluid [0007]);
a processing device configured, during a fluid movement operation, to generate measured data comprising unloaded measured data obtained during a portion of the fluid movement operation wherein the pump does not move fluid, and loaded measured data obtained while the pump is moving fluid during the fluid movement operation, the measured data being indicative of fluid movement in the pump, and to normalize the loaded measured data to the unloaded measured data (a processing device configured to analyze pump measurements comprising the pump measurement for each of a plurality of the at least one of the aspirate stroke and the dispense stroke and determine when the pump measurements comprise a plurality of the pump measurement that satisfy a predetermined metric designated as an indication of occlusion [0007]), but failed to explicitly disclose the processing device being configured to normalize the loaded measured data to the unloaded measured data via dead band normalization performed by the processing device whereby dead band normalization is adjusting or normalizing measured data related to the fluid movement operation controlled by the drive mechanism in the fluid delivery device to data obtained during a dead portion of that fluid movement operation when the drive mechanism is not moving fluid.
However Lee teaches in Fig. 16 that the signal 154 may be analyzed by the controller 56 in the motor unit 120 to identify a dead band 202 where movement of the shaft 24 doesn't correspond to actual pumping of fluid indicated by lack of pressure and compliance band 204 where there is pumping a fluid but less than would be indicated by movement of the syringe shaft 24 which may be empirically measured [00137].
Therefore it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the fluid delivery device of Zheng to include the processing device configured to normalize the loaded measured data to the unloaded measured data via dead band normalization performed by the processing device whereby dead band normalization is adjusting or normalizing measured data related to the fluid movement operation controlled by the drive mechanism in the fluid delivery device to data obtained during a dead portion of that fluid movement operation when the drive mechanism is not moving fluid, as taught by Lee, since such a modification enables the device of Zheng to calculate and provide a more precise measurement of pumped volume [Lee, 00137].
Regarding claim 2, Zheng as modified by Lee disclosed all limitations of claim 1. Zheng further discloses wherein the processing device is further configured to analyze the normalized loaded measured data (processing device configured to analyze pump measurements [0007]) to determine if it satisfies a designated metric related to pressure in the infusion device that indicates occlusion (the pump measurements comprise a plurality of the pump measurement that satisfy a predetermined metric designated as an indication of occlusion [0007]).
Regarding claim 4, Zheng as modified by Lee disclosed all limitations of claim 1. Zheng further discloses wherein the fluid movement operation is an incremental operation among a plurality of fluid movement operations (the pump measurement for each of a plurality of the at least one of the aspirate stroke and the dispense stroke [0007]) to dispense fluid from the chamber (to control dispensing of a volume of fluid from the chamber [0007]) or aspirate fluid into the chamber (pumping mechanism configured to control aspiration of a volume of the fluid into the chamber [0007]).
Regarding claim 6, Zheng as modified by Lee disclosed all limitations of claim 1. Zheng further discloses wherein the fluid movement operation is chosen from an aspirate operation to draw fluid into the chamber (pump mechanism 64 used to aspirate a controlled volume of medication into a pump chamber 38 [0052]) and a dispense operation to expel fluid from the chamber (dispense a controlled volume of medication from the pump chamber [0052]).
Regarding claim 7, Zheng as modified by Lee disclosed all limitations of claim 1. Zheng further discloses wherein the measured data indicates a fluid characteristic chosen from fluid pressure and fluid flow rate (a pressure sensor in the infusion pump system and report occlusion when the pressure is above a certain threshold [0004]).
Regarding claim 9, Zheng as modified by Lee disclosed all limitations from claim 1. Zheng further disclosed wherein the pump is characterized by an interface (fluidics sub-system 54 [0051]) comprising at least one or more components in the drive mechanism (comprising the pump 64 and a pump actuator 66; pump actuator can be a DC motor and gearbox assembly or other pump driving mechanism [0051]) and the operation of which causes the portion of a fluid movement operation wherein the pump does not move fluid to occur (pump actuator can be a DC motor and gearbox assembly or other pump driving mechanism for controlling the plunger [0051]).
Regarding claim 10, Zheng as modified by Lee disclosed all limitations of claim 9. Zheng also discloses wherein the pump is a syringe-type pump (reciprocating plunger-type pump [0048]) having a barrel as the chamber (chamber 38 in Fig. 3A) and the interface comprises a plunger (pump plunger 32 in Fig. 3A), the drive mechanism being operable to selectively drive the plunger to dispense fluid from the barrel (as the piston 30 is rotated by the DC motor and gearbox assembly, the piston 30 translates through the sleeve 24, guided by travel of the pin 28 on the piston through a helical slot 26 in the sleeve 24. Once the piston 30 translates fully through the sleeve 24 and completes its aspiration stage or dispensing stage of fluid [0058]), and the processing device is configured to generate the unloaded measured data during a dispensing fluid movement operation by temporarily retracting the plunger in the barrel a nominal amount (processing device configured to analyze pump measurements comprising the pump measurement for each of a plurality of the at least one of the aspirate stroke and the dispense stroke [0007]).
Regarding claim 13, Zheng as modified by Lee disclosed all limitations of claim 9. Zheng further disclosed wherein the pump is a syringe-type pump (reciprocating plunger-type pump [0048]) having a barrel as the chamber (chamber 38 in Fig. 3A) and a plunger (pump plunger 32 in Fig. 3A), the interface comprises a pusher (piston 30 in Fig. 3A is interpreted as pusher) coupled to the drive mechanism, the drive mechanism being operable to selectively drive the pusher to abut the plunger to dispense fluid from the barrel (pump actuator 66 can be a DC motor and gearbox assembly or other pump driving mechanism for controlling the plunger [0051]), and the processing device is configured to generate the unloaded measured data during a dispensing fluid movement operation by temporarily retracting the pusher in the barrel (a pump measurement device configured to generate pump measurement related to at least one of each aspirate stroke performed by the pump; processing device configured to analyze pump measurements comprising the pump measurement for each of a plurality of the at least one of the aspirate stroke and the dispense stroke [0007]).
Regarding claim 14, Zheng as modified by Lee disclosed all limitations of claim 9. Zheng further disclosed wherein the pump is a rotational metering- type pump (a rotational metering-type pump [0048]) comprising an inlet port (inlet port 44 in Fig. 3A) and an outlet port (outlet port 46 in Fig. 3A) and wherein the drive mechanism is connected to a pump motor via a gearbox (pump actuator 66 can be a DC motor and gearbox assembly or other pump driving mechanism [0051]) and the chamber has at least one aperture (side hole in sleeve 24 is aligned with inlet 44 [0050]), the drive mechanism being operable to selectively drive a piston to dispense fluid from (piston or plunger is then re-inserted into the chamber to dispense or discharge a volume of the medication from the chamber [0048]) or aspirate fluid into the chamber (piston or plunger is retracted from a chamber to aspirate or draw medication into the chamber and allow the chamber to fill with a volume of medication [0048]) and to control cooperation of the at least one aperture with the inlet port during an aspirating fluid movement operation (from a reservoir or cartridge of medication into an inlet port [0048]) and with the outlet port during a dispensing fluid movement operation (dispense or discharge a volume of the medication from the chamber via an outlet port[0048]), the interface comprising a feature on the drive mechanism [pump actuator 66 [0051]) that is configured to cooperate with the gearbox to enable the drive mechanism to not move fluid with respect to the chamber during at least a portion of the aspirating fluid movement operation and the dispensing fluid movement operation (pump actuator can be a DC motor and gearbox assembly or other pump driving mechanism for controlling the plunger [0051]).
Regarding claim 15, Zheng as modified by Lee disclosed all limitations from claim 9. Zheng further disclosed wherein the pump is a rotational metering-type pump (rotational metering- type pump [0049]) and the interface comprises a pin (coupling pin 28 in Fig. 3A) on a piston (piston 30 in Fig. 3A) that is controllably inserted and retracted within a sleeve and a helical groove in the sleeve (coupling pin 28 connected to a piston 30 translates along the helical groove to guide the retraction and insertion of the piston 30 within the sleeve 24[0049]), the drive mechanism being operable to rotate the sleeve (DC motor and gearbox assembly to rotate a sleeve 24 in a pump manifold 22 [0049]) causing the controlling fluid volume in the chamber via a helical groove in the sleeve to guide the pin to translate along the helical groove to guide the retraction and insertion of the piston within the sleeve (coupling pin 28 connected to a piston 30 translates along the helical groove to guide the retraction and insertion of the piston 30 within the sleeve 24 [0049]) to control fluid volume of the chamber (volume of the chamber 38 therefore changes depending on the degree of retraction of the piston 30 [0049]), the pin and/or groove being configured to enable the piston to not move fluid with respect to the chamber during at least a portion of a fluid movement operation (interlock 42 prevents the sleeve 24 from rotating until the torque passes a predetermined threshold, as shown in Fig. 3A. This ensures that piston 30 fully rotates within the sleeve until the coupling pin reaches the end of the helical groove 26 [0050]).
Claim(s) 3, 5, 8, 11, 12 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zheng et al. (WO2019156852A2) and further in view of Lee et al. (WO 2021183489 A1) and Yodfat et al. (EP 2026862 B1, herein Yodfat)
Regarding claim 3, Zheng as modified by Lee disclosed all limitations of claim 1. However, Zheng failed to explicitly disclose wherein the processing device is further configured, during a subsequent fluid movement operation by the pump to
generate unloaded measured data during a portion of the subsequent fluid movement operation wherein the pump does not move fluid,
generate loaded measured data while the pump is moving fluid during the subsequent fluid movement operation, the measured data being indicative of fluid movement in the pump, and
normalize the loaded measured data to the unloaded measured data.
However Lee teaches the signal 154 may be analyzed by the controller 56 in the motor unit 120 to identify a dead band 202 where movement of the shaft 24 doesn't correspond to actual pumping of fluid indicated by lack of pressure and compliance band 204 where there is pumping a fluid but less than would be indicated by movement of the syringe shaft 24 which may be empirically measured [00137].
However, Yodfat teaches a processor may be configured to be coupled to the system 1100 and interpret such change of collection location as downstream occlusion, normal pulsating delivery of fluid through the tube 1110, leakage in the tube 1110, or any other condition occurring in the system 1100 that causes change of location [0038]. Interpreting such changes necessarily requires generating measured data representative of fluid movement and processing the data in a standardized or normalized manner to allow meaningful comparison between normal and abnormal operating conditions.
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the fluid delivery device of Zheng as modified by Lee to include processing device to monitor and interpret fluid movement conditions as taught by Lee and Yodfat. Incorporating such a known data-processing technique amounts to the use of a known technique to improve similar device in a predictable manner (see MPEP 2143.I.C)
Regarding claim 5, Zheng as modified by Lee disclosed all limitations of claim 1. However, Zheng as modified by Lee failed to explicitly disclose wherein the processing device is further configured to normalize the loaded measured data to the unloaded measured data for each fluid movement operation of the fluid delivery device, or least for a selected subset of fluid movement operations of the fluid delivery device.
However, Yodfat teaches a processor may be configured to be coupled to the system 1100 and interpret such change of collection location as downstream occlusion, normal pulsating delivery of fluid through the tube 1110, leakage in the tube 1110, or any other condition occurring in the system 1100 that causes change of location [0038]. Interpreting such changes necessarily requires processing data representative of fluid movement in a standardized or normalized manner to allow meaningful comparison between normal and abnormal operating conditions.
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the fluid delivery device of Zheng as modified by Lee with Yodfat to include processing device to monitor and interpret fluid movement conditions. Incorporating such a known data-processing technique amounts to the use of a known technique to improve similar device in a predictable manner (see MPEP 2143.I.C).
Regarding claim 8, Zheng as modified by Lee disclosed all limitations of claim 1. Zheng further disclosed wherein the pump is a syringe-type pump (reciprocating plunger-type pump [0048]) having a barrel as the chamber (chamber 38 in Fig. 3A) and a plunger (pump plunger 32 in Fig. 3A) and the drive mechanism is operable to selectively drive the plunger to dispense fluid from the barrel (as the piston 30 is rotated by the DC motor and gearbox assembly, the piston 30 translates through the sleeve 24, guided by travel of the pin 28 on the piston through a helical slot 26 in the sleeve 24. Once the piston 30 translates fully through the sleeve 24 and completes its aspiration stage or dispensing stage of fluid [0058]), but fails to explicitly disclose the processing device is configured to generate the unloaded measured data before the measured data indicates that fluid pressure or flow rate has begun to increase from driving the plunger by the drive mechanism during the fluid movement operation.
However, Yodfat teaches that the processor can be configured to interpret change of pressure in the fluid delivery tube 810 as either downstream occlusion, leakage in the tube, normal pulsating delivery of the fluid, or any other condition in the tube [0033]. Interpreting changes in pressure necessarily requires continuous monitoring and generation of measured data both before and during pressure changes in order to establish a baseline and detect deviations from normal operation.
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the fluid delivery device of Zheng modified by Lee to include processing device to monitor fluid pressure during operation of the plunger as taught by Yodfat. Applying a known pressure-monitoring and interpretation technique to a similar represents the use of a known technique to improve a similar device in a predictable manner (see MPEP 2143.I.C)
Regarding claim 11, Zheng as modified by Lee disclosed all limitations of claim 9. Zheng further disclosed wherein the pump is a syringe-type pump (reciprocating plunger-type pump [0048]) having a barrel as the chamber (chamber 38 in Fig. 3A) and the interface comprises a pusher (piston 30 in Fig. 3A is interpreted as a pusher) and a plunger (pump plunger 32 in Fig. 3A), the drive mechanism being operable to selectively drive the plunger via the pusher to dispense fluid from the barrel (as the piston 30 is rotated by the DC motor and gearbox assembly, the piston 30 translates through the sleeve 24, guided by travel of the pin 28 on the piston through a helical slot 26 in the sleeve 24. Once the piston 30 translates fully through the sleeve 24 and completes its aspiration stage or dispensing stage of fluid [0058]), however, fails to explicitly disclose the processing device is configured to generate the unloaded measured data prior to gathering of loaded measured data by incrementing through a known number of dispense cycles in which the pusher has not yet hit the plunger.
However, Yodfat teaches that the processor can be configured to interpret change of pressure in the fluid delivery tube 810 as either downstream occlusion, leakage in the tube, normal pulsating delivery of the fluid, or any other condition in the tube [0033]. Interpreting pressure changes necessarily requires generating pressure-related data corresponding to fluid delivery events over time, including data associated with repeated dispensing cycles.
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the fluid delivery device of Zheng as modified by Lee to include the processing device is configured to generate the unloaded measured data prior to gathering of loaded measured data by incrementing through a known number of dispense cycles in which the pusher has not yet hit the plunger as taught by Yodfat, because incorporating known data-processing functionality to generate data associated with fluid dispensing is a predictable use of a known technique (see MPEP 2143.I.C).
Regarding claim 12, Zheng as modified by Lee disclosed all limitations of claim. Zheng further disclosed wherein the pump is a syringe-type pump (reciprocating plunger-type pump [0048]) having a barrel as the chamber (chamber 38 in Fig. 3A) and the interface comprises a plunger (pump plunger 32 in Fig. 3A), the drive mechanism being operable to selectively drive the plunger to dispense fluid from the barrel (as the piston 30 is rotated by the DC motor and gearbox assembly, the piston 30 translates through the sleeve 24, guided by travel of the pin 28 on the piston through a helical slot 26 in the sleeve 24. Once the piston 30 translates fully through the sleeve 24 and completes its aspiration stage or dispensing stage of fluid [0058]), but fails to explicitly disclose the processing device is configured to generate the unloaded measured data during an aspirating fluid movement operation by manual or externally controlled filling of the barrel via an inlet port to the barrel, and to generate the loaded measured data during the aspirating fluid movement operation by controlling the pump to temporarily retract the plunger within the barrel.
However, Zheng teaches the microcontroller 58 can be provided with an integrated or separate memory device having computer software instructions to actuate, for example, rotation of the sleeve 24 in a selected direction, translational or axial movement of a piston 30 in the sleeve 24 for an aspirate or dispense stroke [0051]. Thus, Zheng teaches active control of plunger movement by a processing device.
Furthermore, Yodfat teaches a processor may be configured to be coupled to the system 1100 and interpret such change of collection location as downstream occlusion, normal pulsating delivery of fluid through the tube 1110, leakage in the tube 1110, or any other condition occurring in the system 1100 that causes change of location [0038]. Interpreting such changes necessarily requires processing data representative of fluid movement in a standardized or normalized manner to allow meaningful comparison between normal and abnormal operating conditions.
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention, to modify the fluid delivery device of Zheng as modified by Lee to incorporate the data generation and interpretation techniques of Yodfat using the microcontroller of Zheng to both control fluid delivery and generate data about fluid’s behavior. Combining known control capability with known data-processing functionality represents the use of prior art elements according to their established functions, yielding predictable results (see MPEP 2143.I.C)
Regarding claim 17, Zheng as modified by Lee disclosed all limitations of claim 1. Zheng further disclosed wherein the pump (reciprocating plunger-type pump [0048]) has a reservoir as the chamber (chamber 38 in Fig. 3A), a plunger (pump plunger 32 in Fig. 3A) and a drive mechanism operable to selectively drive the plunger to dispense fluid from the reservoir (as the piston 30 is rotated by the DC motor and gearbox assembly, the piston 30 translates through the sleeve 24, guided by travel of the pin 28 on the piston through a helical slot 26 in the sleeve 24. Once the piston 30 translates fully through the sleeve 24 and completes its aspiration stage or dispensing stage of fluid [0058]).
However Zheng failed to explicitly disclose and the processing device is configured with baseline data related to a designated waveform of the measured data during fluid movement operations, the waveform having a dead portion therein corresponding to when fluid pressure or rate from driving the plunger by the drive mechanism has not yet begun to increase, the processing device being configured to analyze the measured data using the baseline data to determine when to generate the unloaded measured data during a fluid dispense operation.
Zheng teaches that data, instructions, commands, information, signals, bits, symbols, and chips that may be referenced throughout the above description may be represented by voltages, currents, electromagnetic waves, magnetic fields or particles, optical fields or particles, or any combination thereof [0081], which would enable one of ordinary skill in the art to store or transmit fluid delivery data in a conventional manner.
Furthermore, Yodfat teaches a processor may be configured to be coupled to the system 1100 and interpret such change of collection location as downstream occlusion, normal pulsating delivery of fluid through the tube 1110, leakage in the tube 1110, or any other condition occurring in the system 1100 that causes change of location [0038]. Interpreting such changes necessarily requires processing data representative of fluid movement to distinguish normal operation from abnormal events and provide feedback about status of fluid delivery.
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 fluid delivery device of Zheng as modified by Lee to include the processing device is configured with baseline data related to a designated waveform of the measured data during fluid movement operations, the waveform having a dead portion therein corresponding to when fluid pressure or rate from driving the plunger by the drive mechanism has not yet begun to increase, the processing device being configured to analyze the measured data using the baseline data to determine when to generate the unloaded measured data during a fluid dispense operation as taught by Yodfat, because comparing current system operation to an expected reference is a routine and predictable technique for assessing fluid delivery performance (see MPEP 2143.I.C. )
Response to Amendment
Applicant has canceled claim 16 and therefore the Examiner accordingly withdraws the drawing objection set forth in the previous Non-Final Office Action regarding the missing features “cam” and “cam follower” in the Figures from claim 16. However, the Applicant failed to address the drawing objection regarding Figures 12-14C and 15A and therefore the drawing objection is maintained.
Applicant has amended claims 6, 9 and 15 which were previously objected to; Examiner accordingly withdraws the objections of claims 6, 9 and 15.
Applicant has amended claim 11 which was previously rejected under 35 U.S.C § 112(b) rejection; Examiner accordingly withdraws the 112(b) rejection of claim 11.
Response to Arguments
Applicant’s argument filed on 06/15/2026 have been fully considered but they are not found persuasive.
Applicant has argued in page 8 and 10 that Zheng either separately or in combination with Yodfat fail to disclose the limitation of amended claim 1 reciting “a processing device to normalize the loaded measured data to the unloaded measured data via dead band normalization performed by the processing device whereby dead band normalization is adjusting or normalizing measured data related to the fluid movement operation controlled by the drive mechanism in the fluid delivery device to data obtained during a dead portion of that fluid movement operation when the drive mechanism is not moving fluid”. However, the combination of Zheng with Lee reads on the limitations of amended claim 1 as per the 103 rejection of claim 1 as set forth above.
Applicant has argued in page 9 that Zheng teaches away from Yodfat since Zheng expressly seek to perform occlusion detection without adding infusion pump components to increase infusion pump complexity and Yodfat expressly teach using additional sensors such as optical sensors for occlusion detection. While one of the advantage of Zheng’s invention is to seek to reduce power consumption and cost of infusion pump as indicated in para [0005], Zheng’s device is fully capable of utilizing sensors as disclosed in para [0063] wherein pump 64 employs one or more optical sensors, and therefore is interpreted to be capable of utilizing the sensors of Yodfat.
Applicant further argued in page 10, paragraphs 1-3 that Yodfat is mischaracterized to teach “normal and abnormal conditions, where data related to fluid movement is used” and teaches away from dead band normalization as required by amended claim 1. However Zheng in combination with Lee reads on the “dead band normalization” limitation of amended claim 1, and Zheng in combination with Lee and Yodfat reads on dependent claims 3, 5, 8, 11, 12 and 17.
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).
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/M.F./Patent Examiner, Art Unit 3783
/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783