DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02/06/26 has been entered.
Status of claims
Claims 11-25 and 27-31 are currently pending.
Response to Arguments
Applicant’s arguments, see pages 7-10 of Applicant’s Remarks, filed 12/23/25, with respect to the rejections of claims 11-12, 16, 18, 20-21, 25, 29, and 31 under 35 U.S.C. 103 as being unpatentable over Luckemeyer in view of Adahan and in further view of Burke, of claims 13-15 and 27-28 in further view of Robinson, of claims 17 and 30 in further view of Pratt, of claim 19 in further view of Couvillon, and of claims 22-24 in further view of Locke. Upon further search and consideration, new grounds of rejection have been made as indicated below.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 11-12, 16, 18, 20-21, 25, 29, and 31 rejected under 35 U.S.C. 103 as being unpatentable over Pratt et al. (WO 2016/065335 A1) in view of Adahan (US 2009/0157016 A1) and in further view of Burke et al. (US 2016/0303318 A1).
Regarding claim 11, Pratt discloses a system for providing negative-pressure and instillation to a tissue site (Fig. 1, feat. 100; ¶0034), the system comprising: a negative-pressure device comprising a negative-pressure source (104; ¶0043) and a controller electrically coupled to the negative-pressure source (¶0043), the controller configured to turn on the negative-pressure source during a negative pressure interval and turn off the negative pressure source during a venting interval (¶0043); and an instillation device (Fig. 1, feat. 116; ¶0035) comprising: a dosing valve (600; ¶0066-0082) having a dosing chamber (Figs. 9A-C, feat. 902; ¶0075-0082) including a dosing outlet configured to be fluidly coupled to a fluid port (608; ¶0082) and a dosing inlet (606; ¶0075) configured to be fluidly coupled to a source of instillation solution (Fig. 1, feat. 114; ¶0035), the dosing valve also having a working chamber (Figs. 9A-C, feat. 904; ¶0079-0082) including a biasing element operably engaged to the dosing chamber (704; ¶0067) and configured to be fluidly coupled to the negative-pressure source (Figs. 7A-B and 9A-C; ¶0079: Negative pressure is delivered to chamber 904 via outlet port 608, passage 722, and channel 723); a vent fluidly coupled to the negative-pressure source through the working chamber (719; ¶0070 and 0082).
Pratt discloses a hydrophobic filter (Figs. 7A-B, feat. 716) coupled to the vent (¶0070 and 0082) and therefore does not disclose a venting valve at the vent coupled to the negative-pressure source through the working chamber such that an application of negative pressure to the working chamber is configured to close the venting valve. Pratt is further silent with respect to a wireless transceiver configured to communicate with the controller, and at least one sensor coupled to the wireless transceiver to provide a signal indicative of an operating condition of the dosing valve, wherein the wireless transceiver is configured to communicate the at least one signal to the controller.
In an alternate embodiment, Pratt teaches a dosing valve (Figs. 2-5B, feat. 200; ¶0054) comprising a similar working chamber (Fig. 5A, feat. 504; ¶0062) in fluid communication with a negative-pressure source and which further comprises a vent (Figs. 3A-B, feat. 220) with a flow limiter (316) which may be a hydrophobic filter or an adjustable valve (¶0058). Pratt teaches that the flow limiter, which may either be a hydrophobic filter or a valve, coupled to the working chamber vent controls the rate of venting from the working chamber to the atmosphere, which determines the rate at which instillation fluid is delivered (¶0058, 0070, 0082). Pratt does not teach a flow limiter which is a negative pressure operated valve.
Adahan teaches a negative pressure wound therapy system (Fig. 2, feat. 110; ¶0152) comprising a pressure regulating vent valve (135; ¶0162) which is closed by the pressure differential applied by the vacuum pump (114) until the pressure differential exceeds a desired pressure differential (M; ¶0163-0167). Adahan teaches that such a venting valve advantageously allows for passive pressure regulation in the system (¶0041). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system disclosed by Pratt so that it comprises a venting valve at the vent coupled to the negative-pressure source through the working chamber such that an application of negative pressure to the working chamber is configured to close the venting valve in order to passively regulate the pressure differential across the vent as taught by Adahan and thereby passively control the rate at which instillation fluid is delivered as taught by Pratt.
Pratt in view of Adahan is silent with respect to the claimed wireless transceiver and sensor.
Burke teaches drug delivery pumps with flow measuring capabilities (Figs. 2-7, feat. 30; ¶0004 and 0023-0026). Burke teaches dosing pumps comprising a dosing chamber in which fluid is drawn into and expressed out of (Figs. 2A-2D, feat. 57; ¶0023 and 0027-0030), an inlet valve (26), an outlet valve (28), a working chamber (52; ¶0023), and a sealing diaphragm separating the dosing and working chambers (40; ¶0024). Therefore, the dosing pump of Burke corresponds to the dosing valve of Pratt which also comprises a dosing chamber and a working chamber separated by a seal. Burke teaches a variety of embodiments comprising different types of sensors for monitoring the operating of the pump (Figs. 3-7, feats. 301, 401, 501, 601, and 701; ¶0034, 0042, 0047, 0051, and 0055). In each of the embodiments, Burke teaches that the sensors are connected to an electronics module (Figs. 3-7, feat. 32; ¶0036) that, among other things, wirelessly transmits information from the sensors to an external programmer (Figs. 3-7, feat. 34; ¶0022 and 0038-0041). Additionally, the electronics module (32) wireless receives information from the external programmer (34; ¶0022 and 0040). Because the electronics module wirelessly transmits and receives information, it comprises a wireless transceiver. Burke teaches that a sensor for monitoring the operating condition of the pump in conjunction with a wireless transceiver allows for the operating condition of the pump to be monitored without the programmer or controller needing to be directly electrically coupled to the pump sensors (¶0003-0004). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system suggested by Pratt in view of Adahan so that the instillation device further comprises a wireless transceiver configured to communicate with the controller, and at least one sensor coupled to the wireless transceiver to provide at least one signal indicative of an operating condition of the dosing valve, wherein the wireless transceiver is configured to communicate the at least one signal to the controller so that the controller can monitor the operating condition of the dosing pump or valve without being directly connected to it as taught by Burke.
Regarding claim 12 Pratt in view of Adahan and in further view of Burke suggests the system of claim 11, and Pratt further discloses that the negative-pressure device (Fig. 1, feat. 104) is configured to be coupled to the instillation device (116; ¶0035).
Regarding claim 16, Pratt in view of Adahan and in further view of Burke suggests the system of claim 11. Burke further teaches an embodiment in which the sensor is a pressure sensor disposed in the working chamber that monitors the pressure changes in the working chamber (Fig. 6, feat. 601; ¶0051-0053). Therefore, Pratt in view of Adahan and in further view of Burke further suggests that the at least one sensor is disposed within the working chamber to provide a charging signal indicative of pressure changes within the working chamber, wherein the wireless transceiver is configured to communicate the charging signal to the controller.
Regarding claim 18, Pratt in view of Adahan and in further view of Burke suggests the system of claim 11. Burke further discloses an embodiment in which the sensor is a strain gauge disposed on the diaphragm, and is therefore adjacent to the dosing chamber (Fig. 3, feat. 301; ¶0034-0037). The strain gauge measures the deflection or position of the diaphragm, which is directly related to the rate that fluid is pumped, and is therefore indicative of dosing (¶0037). Therefore, Pratt in view of Adahan and in further view of Burke further suggests that the at least one sensor is disposed adjacent the dosing chamber to provide a fluid dosing signal indicative of a dosage of instillation solution provided by the dosing valve, wherein the wireless transceiver is configured to communicate the fluid dosing to the controller.
Regarding claim 20, Pratt in view of Adahan and in further view of Burke suggests the system of claim 11. Pratt further discloses that the dosing valve further comprises a diaphragm disposed therein to separate the dosing chamber from the working chamber (Figs. 7A-B, feat. 724; ¶0070-0073).
Regarding claim 21, Pratt in view of Adahan and in further view of Burke discloses the system of claim 20. Pratt further discloses that the biasing element is a spring biased against the diaphragm for motivating the diaphragm (Figs. 7A-B and 9A-C, feat. 704; ¶0067).
Regarding claim 25, Pratt discloses a method for managing fluid in a system for negative-pressure and instillation therapy (¶0012), the method comprising: fluidly coupling a therapy system (Fig. 1, feats. 100; ¶0034) to a dressing (102), the therapy system comprising: a negative-pressure device comprising a negative-pressure source (104; ¶0043) and a controller electrically coupled to the negative-pressure source (¶0043), the controller configured to turn on the negative-pressure source during a negative pressure interval and turn off the negative pressure source during a venting interval (¶0043); and an instillation device (Fig. 1, feat. 116; ¶0035) comprising: a dosing valve (600; ¶0066-0082) having a dosing chamber (Figs. 9A-C, feat. 902; ¶0075-0082) including a dosing outlet configured to be fluidly coupled to a fluid port (608) and a dosing inlet (606) configured to be fluidly coupled to a source of instillation solution (Fig. 1, feat. 114; ¶0035), the dosing valve also having a working chamber (Figs. 9A-C, feat. 904; ¶0079-0082) including a biasing element operably engaged to the dosing chamber (704; ¶0067) and configured to be fluidly coupled to the negative-pressure source (Figs. 7A-B and 9A-C; ¶0079: Negative pressure is delivered to chamber 904 via outlet port 608, passage 722, and channel 723); a vent fluidly coupled to the negative-pressure source through the working chamber (719; ¶0070 and 0082); applying the dressing to a tissue site (¶0035 and 0038); applying negative pressure to the tissue site for a first interval during which instillation solution is drawn into the dosing chamber from the instillation source (¶0079); venting negative pressure from the tissue site for a second interval during which instillation solution is delivered from the dosing chamber to the tissue site (¶0082).
Pratt discloses a hydrophobic filter (Figs. 7A-B, feat. 716) coupled to the vent (¶0070 and 0082) and therefore does not disclose a venting valve at the vent coupled to the negative-pressure source through the working chamber such that an application of negative pressure to the working chamber is configured to close the venting valve. Pratt does not disclose that the instillation device further comprises a wireless transceiver configured to communicate with the controller, and at least one sensor coupled to the wireless transceiver to provide at least one signal indicative of an operating condition of the dosing valve, wherein the wireless transceiver is configured to communicate the at least one signal to the controller or that the method comprises sensing at least one signal indicative of an operating condition of the dosing valve and communicating the at least one signal to the controller.
In an alternate embodiment, Pratt teaches a dosing valve (Figs. 2-5B, feat. 200; ¶0054) comprising a similar working chamber (Fig. 5A, feat. 504; ¶0062) in fluid communication with a negative-pressure source and which further comprises a vent (Figs. 3A-B, feat. 220) with a flow limiter (316) which may be a hydrophobic filter or an adjustable valve (¶0058). Pratt teaches that the flow limiter, which may either be a hydrophobic filter or a valve, coupled to the working chamber vent controls the rate of venting from the working chamber to the atmosphere, which determines the rate at which instillation fluid is delivered (¶0058, 0070, 0082). Pratt does not teach a flow limiter which is a negative pressure operated valve.
Adahan teaches a negative pressure wound therapy system (Fig. 2, feat. 110; ¶0152) comprising a pressure regulating vent valve (135; ¶0162) which is closed by the pressure differential applied by the vacuum pump (114) until the pressure differential exceeds a desired pressure differential (M; ¶0163-0167). Adahan teaches that such a venting valve advantageously allows for passive pressure regulation in the system (¶0041). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system used in the method disclosed by Pratt to include a venting valve at the vent coupled to the negative-pressure source through the working chamber such that an application of negative pressure to the working chamber is configured to close the venting valve in order to passively regulate the pressure differential across the vent as taught by Adahan and thereby passively control the rate at which instillation fluid is delivered as taught by Pratt.
Pratt in view of Adahan is silent with respect to the claimed wireless transceiver and sensor.
Burke teaches drug delivery pumps with flow measuring capabilities (Figs. 2-7, feat. 30; ¶0004 and 0023-0026). Burke teaches dosing pumps comprising a dosing chamber in which fluid is drawn into and expressed out of (Figs. 2A-2D, feat. 57; ¶0023 and 0027-0030), an inlet valve (26), an outlet valve (28), a working chamber (52; ¶0023), and a sealing diaphragm separating the dosing and working chambers (40; ¶0024). Therefore, the dosing pump of Burke corresponds to the dosing valve of Pratt which also comprises a dosing chamber and a working chamber separated by a seal. Burke teaches a variety of embodiments comprising different types of sensors for monitoring the operating of the pump (Figs. 3-7, feats. 301, 401, 501, 601, and 701; ¶0034, 0042, 0047, 0051, and 0055). In each of the embodiments, Burke teaches that the sensors are connected to an electronics module (Figs. 3-7, feat. 32; ¶0036) that, among other things, wirelessly transmits information from the sensors to an external programmer (Figs. 3-7, feat. 34; ¶0022 and 0038-0041). Additionally, the electronics module (32) wireless receives information from the external programmer (34; ¶0022 and 0040). Because the electronics module wirelessly transmits and receives information, it comprises a wireless transceiver. Burke teaches that a sensor for monitoring the operating condition of the pump in conjunction with a wireless transceiver allows for the operating condition of the pump to be monitored without the programmer or controller needing to be directly electrically coupled to the pump sensors (¶0003-0004). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system and method disclosed by Pratt in view of Adahan so that the instillation device further comprises a wireless transceiver configured to communicate with the controller, and at least one sensor coupled to the wireless transceiver to provide at least one signal indicative of an operating condition of the dosing valve, wherein the wireless transceiver is configured to communicate the at least one signal to the controller and so that the method includes sensing at least one signal indicative of an operating condition of the dosing valve and communicating the at least one signal to the controller so that the controller can monitor the operating condition of the dosing pump or valve without being directly connected to it as taught by Burke.
Regarding claim 29, Pratt in view of Adahan and in further view of Burke suggests the method of claim 25. Burke further teaches an embodiment in which the sensor is a pressure sensor disposed in the working chamber that monitors the pressure changes in the working chamber (Fig. 6, feat. 601; ¶0051-0053). Therefore, Pratt in view of Adahan and in further view of Burke further suggests that the at least one sensor is disposed within the working chamber, the method further comprising providing a charging signal indicative of the pressure changes within the working chamber, and communicating the charging signal to the controller with the wireless transceiver.
Regarding claim 31, Pratt in view of Adahan and in further view of Burke suggests the method of claim 25. Burke further discloses an embodiment in which the sensor is a strain gauge disposed on the diaphragm, and is therefore adjacent to the dosing chamber (Fig. 3, feat. 301; ¶0034-0037). The strain gauge measures the deflection or position of the diaphragm, which is directly related to the rate that fluid is pumped, and is therefore indicative of dosing (¶0037). Therefore, Pratt in view of Adahan and in further view of Burke further suggests that the at least one sensor is disposed adjacent the dosing chamber, the method further comprising providing a fluid dosing signal indicative of the dosage of instillation solution provided by the dosing valve, and communicating the fluid dosing signal to the controller with the wireless transceiver.
Claims 13-15 and 27-28 are rejected under 35 U.S.C. 103 as being unpatentable over Pratt in view of Adahan, in further view of Burke, and in further view of Robinson et a. (US 2016/0015873 A1).
Regarding claim 13, Pratt in view of Adahan and in further view of Burke suggests the system of claim 11, but does not disclose a canister configured to be coupled to the instillation device and fluidly coupled through the instillation device between the negative-pressure source and the fluid port for collecting fluids.
Robinson teaches a system for providing negative pressure and instillation to a tissue site (Fig. 1, feat. 100; ¶0018) comprising an instillation device (Figs. 1-4, feat. 112), a negative pressure source (104), and a canister coupled between them such that is fluidly coupled through the instillation device (Fig. 5; ¶0018-0019 and 0089). Robinson teaches that such a canister allows for exudate management (¶0036). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system suggested by Pratt in view of Adahan and in further view of Burke so that it further comprises a canister configured to be coupled to the instillation device and fluidly coupled through the instillation device between the negative-pressure source and the fluid port for collecting fluids in order to manage exudate as taught by Robinson.
Regarding claim 14, Pratt in view of Adahan, in further view of Burke, and in further view of Robinson suggests the system of claim 13. Robinson further teaches that the negative-pressure device is configured to be coupled interchangeably to the instillation device and the canister (Fig. 5; ¶0089). Therefore, Pratt in view of Adahan, in further view of Burke, and in further view of Robinson further suggests that the negative-pressure device is configured to be coupled interchangeably to the instillation device and the canister.
Regarding claim 15, Pratt in view of Adahan, in further view of Burke, and in further view of Robinson suggests the system of claim 13. Robinson further teaches that the instillation device (Fig. 5, feat. 112) is configured to be coupled between the negative-pressure device (104) and the canister (113), wherein the negative-pressure device is fluidly coupled through the instillation device to the canister (Fig. 2; ¶0076: cartridge 112 comprises therapy conduit 142 which fluidly couples to the therapy port 162 of the negative pressure source at one end and the canister at the other end. ¶0077: pump 146 generates negative pressure in the canister 113 that is communicated to the dressing 102 via therapy conduit 142). Therefore, Pratt in view of Adahan, in further view of Burke, and in further view of Robinson further suggests that the instillation device is configured to be coupled between the negative-pressure device and the canister, wherein the negative-pressure device is fluidly coupled through the instillation device to the canister.
Regarding claim 27, Pratt in view of Adahan and in further view of Burke suggests the method of claim 25, but does not disclose coupling a canister for collecting fluids to the instillation device and fluidly coupling the canister through the instillation device between the negative-pressure source and the fluid port.
As discussed above, Robinson teaches a system for providing negative pressure and instillation to a tissue site (Fig. 1, feat. 100; ¶0018) comprising an instillation device (Figs. 1-4, feat. 112), a negative pressure source (104), and a canister coupled between them such that is fluidly coupled through the instillation device (Fig. 5; ¶0018-0019 and 0089). Robinson teaches that such a canister allows for exudate management (¶0036). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method suggested by Pratt in view of Adahan and in further view of Burke so that it includes coupling a canister for collecting fluids to the instillation device and fluidly coupling the canister through the instillation device between the negative-pressure source and the fluid port in order to manage exudate as taught by Robinson.
Regarding claim 28, Pratt in view of Adahan, in further view of Burke, and in further view of Robinson suggests the method of claim 27. Robinson further teaches that the instillation device (Fig. 5, feat. 112) may be coupled between the negative-pressure source (104) and the canister (113) such that the negative-pressure source is fluidly coupled to the instillation device through the canister (¶0018-0019 and 0089). Therefore, Pratt in view of Adahan, in further view of Burke, and in further view of Robinson further suggests that the method further comprises coupling the instillation device between the negative-pressure device and the canister, and fluidly coupling the negative-pressure device through the instillation device to the canister.
Claims 17 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Pratt (hereinafter referred to as Pratt 2016) in view of Adahan, in further view of Burke, and in further view of Pratt et al. (US 2015/0165182 A1) (hereinafter referred to as Pratt 2015).
Regarding claim 17, Pratt 2016 in view of Adahan and in further view of Burke suggests the system of claim 11, but does not disclose that the at least one sensor is disposed between the source of instillation solution and the dosing input of the dosing chamber to provide a fluid supply signal indicative of the amount of instillation solution within the source of instillation solution, wherein the wireless transceiver is configured to communicate the fluid supply signal to the controller.
Pratt 2015 teaches a negative pressure wound therapy and instillation system (Figs. 1 and 4, feat. 100; ¶0028 and 0057) comprising a fluid source (118) with a reservoir (210; ¶0063) in fluid communication with a check valve (208), in further fluid communication with a flow meter (209; ¶0064), and in further fluid communication with an instillation pump (212; ¶0068). The flow meter (209) monitors the fluid flow rate downstream to the pump (212) in order to calculate the total volume of fluid delivered downstream (¶0064) and the pump is configured to pre-charge a dosage volume of fluid for delivery to the tissue site (¶0068). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system suggested by Pratt 2016 in view of Adahan and in further view of Burke so that the at least one sensor is disposed between the source of instillation solution and a dosing input of the dosing chamber to provide a fluid supply signal indicative of an amount of instillation solution within the source of instillation solution, wherein the wireless transceiver is configured to communicate the fluid supply signal to the controller in order to monitor the volume of delivered fluid as taught by Pratt 2015.
Regarding claim 30, Pratt 2016 in view of Adahan and in further view of Burke suggests the method of claim 25, but does not disclose that the at least one sensor is disposed between the source of instillation solution and the dosing input of the dosing chamber, the method further comprising providing a fluid supply signal indicative of the amount of instillation solution within the source of instillation solution, and communicating the fluid supply signal to the controller with the wireless transceiver.
As discussed above, Pratt 2015 teaches a negative pressure wound therapy and instillation system (Figs. 1 and 4, feat. 100; ¶0028 and 0057) comprising a fluid source (118) with a reservoir (210; ¶0063) in fluid communication with a check valve (208), in further fluid communication with a flow meter (209; ¶0064), and in further fluid communication with an instillation pump (212; ¶0068). The flow meter (209) monitors the fluid flow rate downstream to the pump (212) in order to calculate the total volume of fluid delivered downstream (¶0064) and the pump is configured to pre-charge a dosage volume of fluid for delivery to the tissue site (¶0068). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method suggested by Pratt 2016 in view of Adahan and in further view of Burke so that the at least one sensor is disposed between the source of instillation solution and the dosing input of the dosing chamber, the method further comprising providing a fluid supply signal indicative of the amount of instillation solution within the source of instillation solution, and communicating the fluid supply signal to the controller with the wireless transceiver in order to monitor the volume of delivered fluid as taught by Pratt 2015.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Pratt 2016 in view of Adahan, in further view of Burke, and in further view of Couvillon et al. (US 2004/0068224 A1).
Regarding claim 19, Pratt 2016 in view of Adahan and in further view of Burke suggests the system of claim 18, but does not disclose that the sensor is an electroactive polymer (EAP) sensor. As discussed above, Burke teaches a sensor for detecting the change in position or deflection of the diaphragm adjacent to the dosing chamber, such as a strain gauge located on the surface of the diaphragm (Fig. 3, feat. 301; ¶0033-0034). Burke teaches that suitable strain gauges include bonded foil strain gauges and piezoresistor strain gauges, among others (¶0035). Therefore, the system of Pratt 2016 in view of Adahan and in further view of Burke is a system which differs from the claimed system by the substitution of the claimed EAP sensor disposed adjacent the dosing chamber to provide a fluid dosing signal, for a prior art sensor which is not an EAP sensor.
Couvillon teaches drug delivery pumps with EAP actuators for controlling the volume of a medication reservoir for medication delivery (¶0008). Couvillon teaches that EAP actuators have intrinsic position-dependent electrical properties that allows the volume of the reservoir, and therefore dosing information, to be inferred (¶0075, lines 1-3). Couvillon further teaches that additional strain gauge elements may be used to provide feedback concerning reservoir volume or pressure, and therefore dosing information (¶0075, lines 4-23; ¶0076). Couvillon teaches that strain gauges based on EAP are suitable alternatives to conventional strain gauges such as piezoresistive strain gauges and bonded metallic strain gauges (¶0075, lines 4-23). Therefore, EAP sensors for providing dosing information were known in the prior art. One of ordinary skill in the art could have substituted the EAP strain gauge sensor of Couvillon for the conventional strain gauge sensor of Burke with the predictable result of providing a strain gauge that captures the dosing information, because Couvillon teaches that conventional strain gauges and EAP strain gauges are interchangeable. Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system suggested by Pratt 2016 in view of Adahan and in further view of Burke so that the sensor is an EAP sensor. Please see MPEP §2143(I)(B).
Claims 22-24 are rejected under 35 U.S.C. 103 as being unpatentable over Pratt 2016 in view of Adahan, in further view of Burke, and in further view of Locke et al. (US 2011/0190735 A1).
Regarding claim 22, Pratt 2016 in view of Adahan and in further view of Burke suggests the system of claim 20, but does not disclose that the biasing element is a linear actuator biased against the diaphragm for motivating the diaphragm.
Locke teaches a wound treatment system (Fig. 1, feat. 10; ¶0027) comprising an instillation system comprising a pump cassette with a diaphragm valve (Fig. 3, feat. 250; ¶0035). The diaphragm (Fig. 3, feat. 270; ¶0035) is moved by a linear actuator (Figs. 3-6, feat. 304; ¶0035-0037) which is controlled by a controller (¶0038). The linear actuator (Figs. 3-6, feat. 304; ¶0035-0037) is engaged to the diaphragm (270) on the opposite side of a dosing chamber (258) such that when the linear actuator moves the diaphragm to expand the dosing chamber (Fig. 3, direction 278; ¶0035), fluid is loaded into the dosing chamber, and when the linear actuator moves the diaphragm to compress the dosing chamber (Fig. 3, direction 274; ¶0035), fluid is dispensed from the dosing chamber. This is analogous to the spring biasing element of Pratt 2016, which is in a working chamber and engaged to a seal on the opposite side of the seal from a dosing chamber such that when negative pressure is applied to the working chamber, the diaphragm moves to expand the dosing chamber and load fluid into the dosing chamber, and when the negative pressure is stopped, the spring biasing element moves the diaphragm to compress the dosing chamber and dispense the fluid. Locke teaches that the parameters of the linear actuator can advantageously be adjusted by the controller in order to optimize the actuation of the diaphragm (¶0038). By modifying the system suggested by Pratt 2016 in view of Adahan and in further view of Burke so that the spring biasing member of Pratt 2016 is replaced by a linear actuator controlled by a controller as taught by Locke, the actuation of the diaphragm, and therefore pumping of the instillation fluid, could be optimized as taught by Locke. Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system suggested by Pratt 2016 in view of Adahan and in further view of Burke so that the biasing element is a linear actuator biased against the diaphragm for motivating the diaphragm so that the actuation of the diaphragm can be optimized as taught by Locke.
Regarding claim 23, Pratt 2016 in view of Adahan, in further view of Burke, and in further view of Locke suggests the system of claim 22. As discussed above, Burke teaches drug delivery diaphragm pumps with flow measuring capabilities (Figs. 2-7, feat. 30; ¶0004 and 0023-0026) comprising a sensor in conjunction with a wireless transceiver that advantageously allows a controller to monitor the operating condition of the pump without being directly connected to it. As discussed above, Locke teaches that a linear actuator may have its parameters adjusted by a controller in order to optimize the actuation of a diaphragm motivated by the linear actuator. Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system suggested by Pratt 2016 in view of Adahan, in further view of Burke, and in further view of Locke so that the linear actuator is coupled to the wireless transceiver and actuated by the controller so that the controller can monitor and control the biasing member without being directly connected to it as taught by Burke.
Regarding claim 24, Pratt 2016 in view of Adahan, in further view of Burke, and in further view of Locke suggests the system of claim 23. As discussed above, Burke teaches an embodiment in which the position of the diaphragm is monitored by a strain gauge disposed on the diaphragm (Burke: Fig. 3, feat. 301; ¶0034-0037). The strain gauge measures the deflection or position of the diaphragm, which is directly related to the rate that fluid is pumped, and is therefore indicative of dosing (Burke: ¶0037). Locke teaches that the position of the diaphragm is coupled to the movement of the linear actuator (Locke: ¶0035). Therefore, Pratt 2016 in view of Adahan, in further view of Burke, and in further view of Locke further suggests that the linear actuator comprises a feedback mechanism to provide a position signal indicative of a position of the diaphragm and a dosage of instillation solution selected to be provided by the dosing valve, and wherein the wireless transceiver is configured to communicate the position signal to the controller.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARJUNA P CHATRATHI whose telephone number is (571)272-8063. The examiner can normally be reached M-F 8:30-5:00.
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ARJUNA P CHATRATHI/Examiner, Art Unit 3781
/ANDREW J MENSH/Primary Examiner, Art Unit 3781