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 April 7th 2026 has been entered. Claims 1-2, 4, 7-9, 12, 15-24, 26-27, and 29-35 are pending in the application. Applicant’s amendments to the Drawings and Claims have overcome each and every objection and 112(b) rejection previously set forth in the Non-Final Office Action mailed November 12th 2025.
Claim Objections
Claims 29 and 31-32 are objected to because of the following informalities:
Regarding claim 29, “the therapeutic valve” should be corrected to “the therapeutic fluid”, as the word “valve” is being interpreted as a typographical error, and “the dosage” should be corrected to “the dose” for claim language consistency.
Regarding claim 31, “a target dose volume of the fluid is in the range of 1 nL to 3 mL” should be corrected to “the target volume of the dose of therapeutic fluid is in the range of 1 nL to 3 mL” for claim language consistency.
Regarding claim 32, “a plurality of target dose volumes” should be corrected to “a plurality of target volumes” and “the target dose volumes” should be corrected to “the target volumes” for claim language consistency. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 20 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 20, the newly amended limitation of “wherein the control circuit is configured… to receive the signal from the first dispense confirmation sensor to deliver a variable target dose volume of a therapeutic fluid with a resolution down to 10 nL or lower” is not supported by the original disclosure. The first dispense confirmation sensor (DCS) does not send a signal to the control circuit “to deliver a variable target dose volume of a therapeutic fluid”. The DCS “provides a delivery signal… when insulin is actually being delivered.” ([0078] of the specification). As supported in the originally filed disclosure, the DCS provides signal of a confirmation of the target dose volume being delivered or of a dispense error ([0072]-[0073] and [0077] of the specification) but the DCS does not provide signal to the control circuit to deliver the volume. In other words, the DCS does not direct the control circuit to initiate dose delivery.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-2, 4, 8, 12, 15-18, 20-24, 26-27, and 29-35 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ledden (WO 2019036564 A1), hereafter referred to as Ledden ‘564, with the disclosure of Ledden (US 20200368429 A1) being used for citations, and Evans (US 8187441 B2), which is incorporated in reference in its entirety.
Regarding claim 1, Ledden discloses a fluid delivery device (drug delivery device 100, [0024] & Fig. 1), comprising: a reciprocating pump positioned in a first flow path between a reservoir and an outlet (dual sided pump positioned in a flow path from reservoir A 102 to fluid identification sensor (FIS) 106 and out through a cannula, see [0022] and [0024] & Fig. 1), wherein the reciprocating pump comprises a first side and wherein the reciprocating pump is an electrochemical or electrochemiosmotic pump (Evans, as is incorporated – see [0009] of Ledden – in its entirety, discloses the use of an electrochemical/electrochemiosmotic dual sided-pump mechanism to push and pull fluid through inlet 124 into compartment 120 and out an outlet 126, which is being interpreted as a first side, see abstract, Col 13 lines 25-33 & Fig. 3, and Col 14 lines 64-67 to Col 15 lines 1-29 & Fig. 5 of Evans);
a dosing chamber adjacent to the first side of the reciprocating pump (the top half of the dual sided pump is being interpreted as the first side, which includes chamber 104, synonymous to compartment 120 of Evans, [0024] & Fig. 1 of Ledden and Fig. 5 of Evans);
a first active valve positioned in the first flow path between the reservoir and the dosing chamber (valve 103, [0024] and [0030] & Fig. 1), wherein the first active valve is configured to remain in an open position or a closed position when no power is applied to the first active valve (“To dispense drug A to the patient, valve 103 is opened and the dual-sided pump draws fluid from reservoir A 102 into chamber 104. Valve 103 is then closed, valve 105 is opened…”, [0024] & Fig. 1; since valve 103 is disclosed as being controlled to open and close, the default position of the valve will necessarily either be open or closed when no power is applied from control electronics 113);
a second active valve positioned between the dosing chamber and the outlet (valve 105, [0024] and [0030] & Fig. 1), wherein the second active valve is configured to remain in an open position or a closed position when no power is applied to the second active valve (“Valve 103 is then closed, valve 105 is opened…”, [0024] & Fig. 1; “After loading the drugs, the system will automatically prime itself 502. This step will alternatively cycle the valves 103, 105, 109, and 111 and draw solution from the reservoirs 102, 108 into the pump chambers 104, and 110 depicted in FIG. 1”, [0030]; since valve 105 is disclosed as being controlled to open and close, the default position of the valve will necessarily either be open or closed when no power is applied from control electronics 113);
a control circuit configured to independently control the reciprocating pump, the first active valve, and the second active valve to control flow from the reservoir to the outlet (control electronics 113 connected to valves 103 and 105 and the dual sided pump, see Fig. 1; control electronics 113 configured to open and close valves 103 and 105 and “permit dispense of the drugs to the patient”, [0024] and [0030] & Fig. 1 and 5; the control system cycling the valves to draw solution from the reservoir into the pump chamber 104 and out through the cannula to a patient, [0024]-[0025] and [0030]); wherein the device is configured to deliver a target dose with a variable volume of a therapeutic fluid and wherein the variable volume of the therapeutic fluid is delivered with a resolution down to 10 nL or lower (“The devices of the invention can be sized to produce a variety of flow rates. In different embodiments, the flow rate is between about 0.01 nL/min to about 10 nL/min, or between about 1 nL/min to about 10 µL/min, or between about 1 µL/min to about 1 mL/min. In an embodiment, only modest voltage/current conditions are required to produce flow.”, Col 3 lines 19-26 & Fig. 3B of Evans; the dual-sided pump can deliver fluid with a resolution down to 10 nL or lower).
Regarding claim 2, Ledden discloses all the limitations of claim 1. Ledden further discloses the fluid delivery device wherein the fluid delivery device is configured to deliver the target dose volume of the therapeutic fluid in the variable volume range of 1 µL to 3 mL (insulin, being the therapeutic fluid, is delivered at a volume of 20µL/min for 30 seconds, which results in 10 µL being delivered, which is in the range of 1 µL to 3 mL, [0026]-[0027] of Ledden; “The devices of the invention can be sized to produce a variety of flow rates. In different embodiments, the flow rate is between about… 1 nL/min to about 10 µL/min or between about 1 µL/min to about 1 mL/min.”, Col 3 lines 19-26 & Fig. 3B of Evans, which falls within the range of 1µL to 3 mL), ninety percent of the target dose volumes are delivered with an accuracy in an accuracy range of plus or minus ten percent (in the example disclosed by Evans, the result of pumping at 2.5 microliters/minute is shown in Fig. 3B, which shows the pump delivering about 2.5 microliters/minute with a plus/minus, or accuracy range, of at most 9 nL/min, or about 0.35% of about 2.5 µL/min, see Col 13 lines 41-51 & Fig. 3B of Evans; the dual-sided electrochemical pump of Evans is configured to deliver a dose of fluid with a variable volume range of 1 nL/min to about 10 µL/min or 1 µL/min to about 1 mL/min, both of which fall in the range of 1 µL to 3 mL, with an accuracy range of plus or minus 9 nL/min, which is 0.35% of the exemplary delivery rate, which falls in the accuracy range of plus or minus 10%).
Regarding claim 4, Ledden discloses all the limitations of claim 1. Ledden further discloses the fluid delivery device wherein the fluid delivery device is configured to deliver the target dose volume of the therapeutic fluid in the variable volume range of 1 nL to 1 µL (insulin, being the therapeutic fluid, is delivered at a volume of 20µL/min for 30 seconds, which results in 10 µL being delivered, which is in the range of 1 µL to 3 mL, [0026]-[0027] of Ledden; “The devices of the invention can be sized to produce a variety of flow rates. In different embodiments, the flow rate is between about… 1 nL/min to about 10 µL/min.”, Col 3 lines 19-26 & Fig. 3B of Evans, which falls within the range of 1 nL to 1 µL), wherein eighty percent of the target dose volumes are delivered with an accuracy range of plus or minus ten percent (in the example disclosed by Evans, the result of pumping at 2.5 microliters/minute is shown in Fig. 3B, which shows the pump delivering about 2.5 microliters/minute with a plus/minus, or accuracy range, of at most 9 nL/min, or about 0.35% of about 2.5 µL/min, see Col 13 lines 41-51 & Fig. 3B of Evans; the dual-sided electrochemical pump of Evans is configured to deliver a dose of fluid with a variable volume range of 1 nL/min to about 10 µL/min, which falls in the range of 1 nL to 1 µL, with an accuracy range of plus or minus 9 nL/min, which is 0.35% of the exemplary delivery rate or 0.9% of 1 µL/min, which falls in the accuracy range of plus or minus 10%).
Regarding claim 8, Ledden discloses all the limitations of claim 1. Ledden further discloses the fluid delivery device wherein operation remains reliable when operating against varying pressure (“…changes in the pressure and/or volume of electrolyte solution or ionic liquid associated with one compartment of the electrochemical cell can be used to induce movement of a solid body external to the electrochemical cell. In one embodiment, changes in pressure and volume in one compartment of the cell can be used to drive movement of a flexible diaphragm which forms part of the cell compartment wall.”, see Col 5 lines 52-60 of Evans & Fig. 5; pressure changes in compartments 120, 121, and 122 may occur while operation remain reliable, Col 14 line 59-Col 15 lines 29 of Evans).
Regarding claim 12, Ledden discloses all the limitations of claim 1. Ledden further discloses the fluid delivery device wherein the reciprocating pump is assembled uniaxially (the dual sided pump is seen moving along a single axis to draw and then dispense fluid from chamber 104, [0024]-[0025] & Fig. 1 and Fig. 5 of Evans).
Regarding claim 15, Ledden discloses all the limitations of claim 1. Ledden further discloses the fluid delivery device wherein the first flow path contains or is contained in a fluidic manifold (the flow path, path from reservoir A 102 to fluid identification sensor (FIS) 106 and out through a cannula, is contained in device 100, [0024] & Fig. 1; the space in which the flow path exists is being interpreted as a fluidic manifold).
Regarding claim 16, Ledden discloses all the limitations of claim 1. Ledden further discloses the fluid delivery device wherein the reciprocating pump further comprises a second side opposite to the first side, and a second dosing chamber adjacent to the second side of the reciprocating pump (the bottom half of dual sided pump is being interpreted as the second side, which includes chamber 110, synonymous to compartment 122 of Evans, [0025] & Fig. 1 of Ledden and Col 15 lines 5-44 & Fig. 5 of Evans).
Regarding claim 17, Ledden discloses all the limitations of claim 16. Ledden further discloses the fluid delivery device wherein the second dosing chamber is connected in a second flow path with a second reservoir and a third active valve, and a fourth active valve to deliver a complimentary therapeutic fluid to an outlet of the second flow path (chamber 110 is connected to a second flow path including reservoir B 108 and valves 109 and 111, [0025] & Fig. 1; chamber 110 and the second flow path configured to deliver drug B from reservoir B to a cannula at the outlet of the second flow path, [0025] & Fig. 1; the dual sided pump of Evans including the second side, compartment 122, including an inlet 128 and outlet 130, Col 15 lines 5-45 & Fig. 5 of Evans).
Regarding claim 18, Ledden discloses all the limitations of claim 17. Ledden further discloses the fluid delivery device where the first dosing chamber can dispense one or more doses of a first therapeutic fluid without the second dosing chamber dispensing any doses of a second therapeutic fluid (chambers 104 and 110 are configured to operate independently to dispense fluid from either reservoir A 102 or reservoir B 108, [0024]-[0025] & Fig. 1; additionally, in the example use case of device 100, insulin and glucagon are noted as drugs A and drugs B, which would not be dispensed together, as is apparent to one of ordinary skill in the art, see [0034]).
Regarding claim 20, Ledden discloses a fluid delivery device (drug delivery device 100, [0024] & Fig. 1), comprising: a reciprocating pump positioned in a flow path (dual sided pump positioned in a flow path from reservoir A 102 to fluid identification sensor (FIS) 106 and out through a cannula, see [0022] and [0024] & Fig. 1), wherein the reciprocating pump is an electrochemical pump or an electrochemiosmotic pump (Evans, as is incorporated – see [0009] of Ledden – in its entirety, discloses the use of an electrochemical/electrochemiosmotic dual sided-pump mechanism to push and pull fluid through inlet 124 into compartment 120 and out an outlet 126, see abstract, Col 13 lines 25-33 & Fig. 3, and Col 14 lines 64-67 to Col 15 lines 1-29 & Fig. 5);
a first active valve positioned in the flow path between a reservoir and the reciprocating pump (valve 103, [0024] and [0030] & Fig. 1), wherein the first active valve is configured to remain in an open position or a closed position when no power is applied to the first active valve (“To dispense drug A to the patient, valve 103 is opened and the dual-sided pump draws fluid from reservoir A 102 into chamber 104. Valve 103 is then closed, valve 105 is opened…”, [0024] & Fig. 1; since valve 103 is disclosed as being controlled to open and close, the default position of the valve will necessarily either be open or closed when no power is applied from control electronics 113);
a second active valve positioned between the reciprocating pump and an outlet of the flow path (valve 105, [0024] and [0030] & Fig. 1), wherein the second active valve is configured to remain in an open position or a closed position when no power is applied to the second active valve (“Valve 103 is then closed, valve 105 is opened…”, [0024] & Fig. 1; “After loading the drugs, the system will automatically prime itself 502. This step will alternatively cycle the valves 103, 105, 109, and 111 and draw solution from the reservoirs 102, 108 into the pump chambers 104, and 110 depicted in FIG. 1”, [0030]; since valve 105 is disclosed as being controlled to open and close, the default position of the valve will necessarily either be open or closed when no power is applied from control electronics 113);
a first dispense confirmation sensor in the flow path between the second active valve and the outlet of the flow path (FIS 106 between valve 105 and the cannula at the end of the flow path past FIS 106, [0024] & Fig. 1) configured to send a signal to a control circuit indicative of at least one of a dispense and a dispense error (FIS 106 configured to signal to control electronics 113 whether the fluid flowing through FIS 106 is the proper fluid or not, [0024] & Fig. 1 and 5; “If drug B had been inadvertently loaded into reservoir A 102, then upon passage through the FIS 106 a current characteristic of drug A would not be obtained and the control electronics 113 would then sound either an audible alarm or issue some other type of warning message and prevent the pump from dispensing an incorrect drug. Alternatively, if the correct characteristic current for drug A is obtained, the pump then is permitted to dispense the correct drug.”; if FIS 106 senses the correct fluid, it will be dispensed, this is being interpreted as the signal indicative of a dispense; if FIS 106 senses the incorrect fluid, it will not be dispensed, this is being interpreted as the signal indicative of a dispense error), wherein the dispense error may comprise a failure of the reciprocating pump (if FIS 106 indicates the drugs are misloaded, “control electronics 113 would… prevent the pump from dispensing an incorrect drug”, [0024]; “The user will be notified that the drugs were mis-loaded, and the user can dispose of the pod.” [0030]; the pump being prevented from dispensing and the pod having to be disposed of is being interpreted as failure of the reciprocating pump); and
wherein the control circuit is configured to independently control the reciprocating pump, the first active valve, and the second active valve to control flow from the reservoir to the outlet of the flow path and to receive the signal from the first dispense confirmation sensor to deliver a variable target dose volume of a therapeutic fluid with a resolution down to 10 nL or lower (control electronics 113 connected to valves 103 and 105, the dual sided pump, and FIS 106, see Fig. 1; control electronics 113 configured to open and close valves 103 and 105 and “permit dispense of the drugs to the patient”, [0024] and [0030] & Fig. 1 and 5; the control system cycling the valves to draw solution from the reservoir into the pump chamber 104 and out through the cannula to a patient, [0024]-[0025] and [0030]; FIS 106 configured to send signal to control electronics 113, [0024] & Fig. 1 and 5;
“The devices of the invention can be sized to produce a variety of flow rates. In different embodiments, the flow rate is between about 0.01 nL/min to about 10 nL/min, or between about 1 nL/min to about 10 µL/min, or between about 1 µL/min to about 1 mL/min. In an embodiment, only modest voltage/current conditions are required to produce flow.”, Col 3 lines 19-26 & Fig. 3B of Evans; the dual-sided pump, controlled by electronics 113, can deliver fluid with a resolution down to 10 nL or lower; “A simple algorithm to determine if the fluids are loaded correctly is shown in FIG. 6. After priming of the fluid into the sensors a potential can be applied and the characteristic current measured 601. The control electronics 113 compare 602 the measured characteristic current with values stored in memory 603. The pod will expect drug A to be loaded into reservoir A and if the measured currents match expected values 504 the pod can continue and proceed with infusion”, [0031]; the FIS 106 can communicate with electronics 113 to allow for infusion, see Fig. 6).
Regarding claim 21, Ledden discloses all the limitations of claim 20. Ledden further discloses the fluid delivery device wherein the first dispense confirmation sensor is configured to send either a confirmation or a dispense error message to the control circuit prior to a next dispense (“If drug B had been inadvertently loaded into reservoir A 102, then upon passage through the FIS 106 a current characteristic of drug A would not be obtained and the control electronics 113 would then sound either an audible alarm or issue some other type of warning message and prevent the pump from dispensing an incorrect drug”, [0024]; FIS 106 indicating to control electronics 113 that an incorrected drug has been loaded and preventing the pump from dispensing would inherently occur prior to a next dispense output; also see Fig. 2-4 for continuous monitoring from FIS 106, [0026]).
Regarding claim 22, Ledden discloses all the limitations of claim 20. Ledden further discloses the fluid delivery device wherein the control circuit is further configured to dispense a first therapeutic fluid according to a dosing algorithm (“After filling with drug, the pod will undergo a start-up sequence which will entail switching the valves and dispensing a few units of each drug to fill the tubing inside the delivery device as well as tubing to the patient.”, [0030] and [0034] & Fig. 5) and wherein the control circuit is further configured to receive the signal as a dispense signal from the first dispense confirmation sensor to inform the dosing algorithm (see Fig. 6; “A simple algorithm to determine if the fluids are loaded correctly is shown in FIG. 6. After priming of the fluid into the sensors a potential can be applied and the characteristic current measured 601. The control electronics 113 compare 602 the measured characteristic current with values stored in memory 603. The pod will expect drug A to be loaded into reservoir A and if the measured currents match expected values 504 the pod can continue and proceed with infusion”, [0031]).
Regarding claim 23, Ledden discloses all the limitations of claim 22. Ledden further discloses the fluid delivery device wherein the control circuit is further configured to receive the signal as a dispense error signal from the first dispense confirmation sensor to inform the dosing algorithm (“If the currents do not equal stored values the control electronics 113 will recognize and incorrect solution has been loaded 505 and issue an alarm. Infusion will be prevented in this case.”, [0031] & Fig. 5-6).
Regarding claim 24, Ledden discloses all the limitations of claim 20. Ledden further discloses the fluid delivery device wherein the control circuit is configured to take the signal from the first dispense confirmation sensor as input to algorithmically determine dispense or error conditions (“A simple algorithm to determine if the fluids are loaded correctly is shown in FIG. 6. After priming of the fluid into the sensors a potential can be applied and the characteristic current measured 601. The control electronics 113 compare 602 the measured characteristic current with values stored in memory 603. The pod will expect drug A to be loaded into reservoir A and if the measured currents match expected values 504 the pod can continue and proceed with infusion. If the currents do not equal stored values the control electronics 113 will recognize and incorrect solution has been loaded 505 and issue an alarm. Infusion will be prevented in this case.”, [0031] & Fig. 5-6; the signal from FIS 106 sent to electronics 113 is used as input in the algorithm of Fig. 6 to determine whether the fluid will be dispensed or not).
Regarding claim 26, Ledden discloses all the limitations of claim 20. Ledden further discloses the fluid delivery device wherein the control circuit compares an average current to a set threshold to confirm the dispense or the dispense error (“Other mechanisms to determine correct drug loading could be used. One method is to apply a predetermined excitation voltage and record characteristic currents during pumping and during rest. The currents are compared to stored values like those plotted in FIG. 2 and FIG. 3. This method allows confirmation at characteristic voltages for each solution”, see [0033]; the stored values, which are being interpreted as the set threshold to confirm dispense or error, are compared to the characteristic current value, which is obtained by finding a stable signal over the course of recording, see [0026] & Fig. 2-4; finding a stable signal is being interpreted as finding an average current over a period of time).
Regarding claim 27, Ledden discloses all the limitations of claim 20. Ledden further discloses the fluid delivery device further comprising a second dispense confirmation sensor to confirm delivery of a second therapeutic fluid (“…the pump pushes fluid through FIS 112 and out through the cannula. If the control electronics 113 sense an incorrect characteristic current from the fluid identification sensor 112 then an alarm is issued, preventing the pump from dispensing an incorrect drug (or allowing dispense if the correct drug is identified”, [0025] & Fig. 1; FIS 112 is being interpreted as the second dispense confirmation sensor, which is intended to function with reservoir B containing drug B).
Regarding claim 29, Ledden discloses a method of delivering a variable dosage of a therapeutic fluid to a patient (abstract and [0010]), comprising the steps of: positioning a reciprocating pump between a reservoir and an outlet to create a first flow path (dual sided pump positioned in a flow path from reservoir A 102 to fluid identification sensor (FIS) 106 and out through a cannula, see [0022] and [0024] & Fig. 1), wherein the reciprocating pump is an electrochemical or electrochemiosmotic pump (Evans, as is incorporated – see [0009] of Ledden – in its entirety, discloses the use of an electrochemical/electrochemiosmotic dual sided-pump mechanism to push and pull fluid through inlet 124 into compartment 120 and out an outlet 126, which is being interpreted as a first side, see abstract, Col 13 lines 25-33 & Fig. 3, and Col 14 lines 64-67 to Col 15 lines 1-29 & Fig. 5 of Evans);
positioning a first active valve between the reservoir and the reciprocating pump (valve 103 positioned between reservoir A 102 and the dual sided pump, [0024] and [0030] & Fig. 1), wherein the first active valve is configured to remain in an open position or a closed position when no power is applied to the first active valve (“To dispense drug A to the patient, valve 103 is opened and the dual-sided pump draws fluid from reservoir A 102 into chamber 104. Valve 103 is then closed, valve 105 is opened…”, [0024] & Fig. 1; since valve 103 is disclosed as being controlled to open and close, the default position of the valve will necessarily either be open or closed when no power is applied from control electronics 113);
positioning a second active valve between the reciprocating pump and the outlet (valve 105 positioned between the dual sided pump and the cannula, [0024] and [0030] & Fig. 1), wherein the second active valve is configured to remain in an open position or a closed position when no power is applied to the second active valve (“Valve 103 is then closed, valve 105 is opened…”, [0024] & Fig. 1; “After loading the drugs, the system will automatically prime itself 502. This step will alternatively cycle the valves 103, 105, 109, and 111 and draw solution from the reservoirs 102, 108 into the pump chambers 104, and 110 depicted in FIG. 1”, [0030]; since valve 105 is disclosed as being controlled to open and close, the default position of the valve will necessarily either be open or closed when no power is applied from control electronics 113);
opening the first active valve to allow the flow of a dose of therapeutic fluid between the reservoir and the pump; closing the first active valve; opening the second active valve to allow the dose of therapeutic fluid to flow from the outlet, wherein a target volume of the dose of the therapeutic fluid flowing from the outlet is delivered with a resolution down to 10 nL or lower; and closing the second active valve (“To dispense drug A to the patient, valve 103 is opened and the dual-sided pump draws fluid from reservoir A 102 into chamber 104. Valve 103 is then closed, valve 105 is opened, and the pump dispenses drug A through the fluid identification sensor (FIS) 106 and out through the cannula.”, [0024] & Fig. 1; valve 105 would inherently close after dispensing considering it is explicitly disclosed as being opened after valve 103 is closed; [0030] also discloses alternatively cycling the valves, including valve 105, which implies opening and closing functionality;
“The devices of the invention can be sized to produce a variety of flow rates. In different embodiments, the flow rate is between about 0.01 nL/min to about 10 nL/min, or between about 1 nL/min to about 10 µL/min, or between about 1 µL/min to about 1 mL/min. In an embodiment, only modest voltage/current conditions are required to produce flow.”, Col 3 lines 19-26 & Fig. 3B of Evans; the dual-sided pump can deliver fluid with a resolution down to 10 nL or lower); wherein the dosage of the therapeutic [[valve]] fluid is controlled by a control circuit in communication with the reciprocating pump (control electronics 113 connected to valves 103 and 105 and the dual sided pump, see Fig. 1; control electronics 113 configured to open and close valves 103 and 105 and “permit dispense of the drugs to the patient”, [0024] and [0030] & Fig. 1 and 5; the control system cycling the valves to draw solution from the reservoir into the pump chamber 104 and out through the cannula to a patient, which is being interpreted as controlling the dosage of delivered fluid, see [0024]-[0025] and [0030]; Evans also discloses wherein the dual-sided pump is operated with feedback control to control the fluid flow rate, see Col 13 lines 52-64 of Evans).
Regarding claim 30, Ledden discloses all the limitations of claim 29. Ledden further discloses the method wherein the opening and closing steps are repeated to deliver multiple doses of therapeutic fluid (“The user will begin by loading the drugs into Reservoir A 102 and Reservoir B 108 in the first step 501. After loading the drugs, the system will automatically prime itself 502. This step will alternatively cycle the valves 103, 105, 109, and 111 and draw solution from the reservoirs 102, 108 into the pump chambers 104, and 110 depicted in FIG. 1”, [0030] & Fig. 1; “The data shows the increased current measured when four pulses of flow at 20 μL/min were passed for approximately 30 seconds separated by 30 seconds without flow.”, [0026]; the cycling of the valves and the drawing of the solution from the reservoir, capable of occurring over at least four pulses, is being interpreted as delivering multiple doses of therapeutic fluid).
Regarding claim 31, Ledden discloses all the limitations of claim 29. Ledden further discloses the method wherein the target dose volume of the fluid is in the range of 1 nL to 3 mL (insulin, being the therapeutic fluid, is delivered at a volume of 20µL/min for 30 seconds, which results in 10 µL being delivered, which is in the range of 1 nL to 3 mL, [0026]-[0027] of Ledden; “The devices of the invention can be sized to produce a variety of flow rates. In different embodiments, the flow rate is between about… 1 nL/min to about 10 µL/min or between about 1 µL/min to about 1 mL/min.”, Col 3 lines 19-26 & Fig. 3B of Evans, which falls within the range of 1nL to 3 mL).
Regarding claim 32, Ledden discloses all the limitations of claim 31. Ledden further discloses the method wherein a plurality of target dose volumes are delivered (multiple doses can be delivered with the dual sided pump of Evans, see Col 13 lines 40-51 & Fig. 3B), and wherein eighty percent of the target dose volumes are delivered with an accuracy in an accuracy range of plus or minus ten percent (in the example disclosed by Evans, the result of pumping at 2.5 microliters/minute is shown in Fig. 3B, which shows the pump delivering about 2.5 microliters/minute with a plus/minus, or accuracy range, of at most 9 nL/min, or about 0.35% of about 2.5 µL/min, see Col 13 lines 41-51 & Fig. 3B of Evans; the dual-sided electrochemical pump of Evans is configured to deliver doses of fluid with an accuracy range of plus or minus 9 nL/min, which is 0.35% of the exemplary delivery rate, which falls in the accuracy range of plus or minus 10%).
Regarding claim 33, Ledden discloses all the limitations of claim 29. Ledden further discloses the method further comprising the step of creating a second independently controlled flow path on a second side of the reciprocating pump to allow for delivery of a second therapeutic fluid (the bottom half of dual sided pump is being interpreted as the second side, which includes chamber 110, synonymous to compartment 122 of Evans, see [0025] & Fig. 1 of Ledden and Col 15 lines 5-44 & Fig. 5 of Evans; chamber 110 is connected to a second flow path including reservoir B 108 and valves 109 and 111, [0025] & Fig. 1; chamber 110 and the second flow path configured to deliver drug B from reservoir B to a cannula at the outlet of the second flow path, [0025] & Fig. 1).
Regarding claim 34, Ledden discloses all the limitations of claim 29. Ledden further discloses the method further comprising the step of confirming a dispense or dispense error with a dispense confirmation sensor between the second active valve and the outlet (FIS 106 between valve 105 and the cannula at the end of the flow path past FIS 106, [0024] & Fig. 1; FIS 106 configured to signal to control electronics 113 whether the fluid flowing through FIS 106 is the proper fluid or not, [0024] & Fig. 1 and 5; “If drug B had been inadvertently loaded into reservoir A 102, then upon passage through the FIS 106 a current characteristic of drug A would not be obtained and the control electronics 113 would then sound either an audible alarm or issue some other type of warning message and prevent the pump from dispensing an incorrect drug. Alternatively, if the correct characteristic current for drug A is obtained, the pump then is permitted to dispense the correct drug.”; if FIS 106 senses the correct fluid, it will be dispensed, this is being interpreted as the signal indicative of a dispense; if FIS 106 senses the incorrect fluid, it will not be dispensed, this is being interpreted as the signal indicative of a dispense error).
Regarding claim 35, Ledden discloses all the limitations of claim 29. Ledden further discloses the method further comprising the step of relaying a confirmation of the dispense or the or dispense error to a control circuit to inform a user or a dosing algorithm (control electronics 113 connected FIS 106, see Fig. 1; FIS 106 configured to signal to control electronics 113, [0024] & Fig. 1 and 5; “A simple algorithm to determine if the fluids are loaded correctly is shown in FIG. 6. After priming of the fluid into the sensors a potential can be applied and the characteristic current measured 601. The control electronics 113 compare 602 the measured characteristic current with values stored in memory 603. The pod will expect drug A to be loaded into reservoir A and if the measured currents match expected values 504 the pod can continue and proceed with infusion. If the currents do not equal stored values the control electronics 113 will recognize and incorrect solution has been loaded 505 and issue an alarm. Infusion will be prevented in this case.”, [0031] & Fig. 5-6; the signal from FIS 106 sent to electronics 113 is used as input in the algorithm of Fig. 6 to determine whether the fluid will be dispensed or not and inform the user).
Claim Rejections - 35 USC § 103
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) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ledden (WO 2019036564 A1), hereafter referred to as Ledden ‘564, with the disclosure of Ledden (US 20200368429 A1) being used for citations, and Evans (US 8187441 B2), which is incorporated in reference in its entirety, as applied to claim 1 above, and further in view of Saaski (US 5585011 A).
Regarding claim 7, Ledden discloses all the limitations of claim 1. However, Ledden fails to explicitly disclose the fluid delivery device wherein the fluid delivery device is configured to deliver a dose in laminar flow conditions wherein the therapeutic fluid remains efficacious with respect to a therapeutic property of the therapeutic fluid between the reservoir and the outlet.
However, Saaski teaches a fluid delivery device wherein the fluid delivery device is configured to deliver a dose in laminar flow conditions wherein the therapeutic fluid remains efficacious with respect to a therapeutic property of the therapeutic fluid between the reservoir and the outlet (micromachined diaphragm fluid pump 130, including inlet valve 134 and outlet valve 137, configured to deliver fluid medication 12, Col 45 lines 54-60 and Col 48 lines 30-36 & Fig. 16-17; “pump 130 is very efficient when operated at comparatively low average flow rates, such as about 1.0 microliters/second... This is because at such low flow rates and operating pressures the flow of the medication 12 through the pump 130 tends to be laminar; meaning that less energy is lost due to friction, turbulence, and geometric shape changes of the medication 12.”, Col 53 lines 39-50).
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 Ledden with Saaski to include the fluid delivery device configured to deliver a dose in laminar flow conditions wherein the therapeutic fluid remains efficacious with respect to a therapeutic property of the therapeutic fluid between the reservoir and the outlet, since such a modification would decrease the energy lost due to friction, turbulence, and any potential geometric shape changes of the delivered medication (see Col 53 lines 45-50 of Saaski).
Claim(s) 9 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ledden (WO 2019036564 A1), hereafter referred to as Ledden ‘564, with the disclosure of Ledden (US 20200368429 A1) being used for citations, and Evans (US 8187441 B2), which is incorporated in reference in its entirety, as applied to claims 1 and 18 above, and further in view of Payne (US 20190290842 A1).
Regarding claim 9, Ledden discloses all the limitations of claim 1. However, Ledden fails to explicitly disclose the fluid delivery device wherein the first active valve and the second active valve are a set of dual latching microvalves.
However, Payne teaches a fluid delivery device (electrochemical pump, see abstract and [0025]-[0026] & Fig. 7-8) wherein the first active valve (inlet valve 410, Fig. 7-8) and the second active valve (outlet valve 404, Fig. 7-8) are a set of dual latching microvalves (“FIG. 8 shows an application of a two-sided ePump 825 used in combination with two dual-latching valves to generate near-continuous controlled dosing of a fluid, such as a drug, to a patient 821… Flow through each path is controlled by a dual latching valve. The upper dual latching valve has inlet valve arm 401 and outlet valve arm 404 which control flow through path 805-806-807.”, [0026]).
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 first active valve and the second active valve of Ledden with Payne to include the valves being a set of dual latching microvalves since such a modification would allow only the delivery of a metered dose of fluid to be delivered and prevent the possibility of an open channel running from reservoir to the patient (see [0026-[0027] of Payne).
Regarding claim 19, Ledden discloses all the limitations of claim 18. However, Ledden fails to explicitly disclose the fluid delivery device wherein the control circuit is configured to control bi-directional flow from the reciprocating pump.
However, Payne teaches a fluid delivery device (abstract) wherein the control circuit (circuit 103 used to control the valves and, inherently, used to control the electrochemical pump, [0017] and [0025]) is configured to control bi-directional flow from the reciprocating pump (see [0029] & Fig. 9; “The first action of ePump 825 draws a metered amount of fluid from reservoir A into chamber 806 where it is stored. Simultaneously, fluid is expelled from chamber 816 through the only open path: back into reservoir 902. In Step 2, the top dual-latching valve switches positions such that inlet valve 401 is closed and outlet valve 404 is open. This means that the second action of ePump 825 expels the fluid stored in reservoir 806 out through path 807 and into the patient 821. Repeating Steps 1 and 2 results in only fluid from reservoir 901 (drug A) being delivered to the patient, while the fluid from reservoir 902 (drug B) is cycled back and forth between reservoir 902 and chamber 816”).
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 control circuit of Ledden with Payne to include the control circuit being configured to control bi-directional flow from the reciprocating pump since such a modification would having a mixing or stirring effect on the contents of the reservoir and allow for each drug to be selectively pumped back into its originating reservoir or to the patient as needed (see [0029] of Payne).
Response to Arguments
Applicant’s arguments with respect to the claims 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.
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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/MARTIN A RADOMSKI/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783
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