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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 2/26/2026 has been entered.
Response to Amendment
The amendment filed on 2/26/2026 has been entered. Claims 1-14 are pending in the application.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-5 and 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Truckai et al. (US 2020/0146703 A1) in view of Woods (US 4,657,160 A) and further in view of Lark et al. (US 2020/0384189 A1).
Regarding claim 1, Truckai discloses a fluid management system (fluid management system 105, see Figs. 1A-B and 10), comprising:
a control unit (base unit 118) carrying a first peristaltic pump (inflow peristaltic pump 140A) and a second peristaltic pump (outflow peristaltic pump 140B) (see Figs. 1A and 10, par. [0045]-[0046]);
a cassette (cassette 440) carrying a first tubing loop (first tubing loop 442a) and a second tubing loop (second tubing loop 442b), each adapted for coupling to the first peristaltic pump (inflow peristaltic pump 140A) and the second peristaltic pump (outflow peristaltic pump 140B), respectively (see Figs. 1A-B and 10, par. [0071]-[0073]);
a saline bag (fluid source/saline bag 145) (see Figs. 1A and 10, par. [0046] and [0070]);
wherein the second peristaltic pump (outflow peristaltic pump 140B) and the second tubing loop (second tubing loop 442b) are adapted to pump air into a flow regulator (see par. [0069], controller components) coupled to outflow tubing (outflow tubing 190B) that is configured to carry fluid outflows from the working space (see Figs. 1A-B and 10, par. [0069], [0073], and [0080]).
However, Truckai fails to state a pressure cuff; the saline bag carried within the pressure cuff; wherein the first peristaltic pump and the first tubing loop are adapted to pump air into the pressure cuff to apply pressure to an exterior of the saline bag to cause fluid flows from the saline bag into a working space; and wherein the flow regulator comprises a valve and an inflatable element configured to apply pressure to a sliding pinch element upon inflation of the inflatable element, wherein the valve closes around the outflow tubing to clamp the outflow tubing, wherein the sliding pinch element moves into the outflow tubing upon applying pressure from the inflatable element directly to the sliding pinch element via an actuator in the valve, wherein pressure applied by the sliding pinch element to the outflow tubing controls a fluid outflow rate.
Woods teaches a fluid management system (see Fig. 1) comprising a pressure cuff (pressure means 15) (see Fig. 1, col. 2 lines 15-48); and a saline bag (flexible bag 13) carried within the pressure cuff (pressure means 15) (see Fig. 1, col. 2 lines 15-48); wherein the first pump (control means 41) and the first tubing loop (tubing within control means 41, see Fig. 5) are adapted to pump air into the pressure cuff (pressure means 15) to apply pressure to an exterior of the saline bag (flexible bag 13) to cause fluid flows from the saline bag (flexible bag 13) into a working space (see Fig. 1, col. 2 line 15 - col. 3 line 27).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the fluid management system of Truckai to include a pressure cuff, the saline bag carried within the pressure cuff, wherein the first peristaltic pump and the first tubing loop are adapted to pump air into the pressure cuff to apply pressure to an exterior of the saline bag to cause fluid flows from the saline bag into a working space, as taught by Woods, in order to pressurize the saline bag to allow for quicker changes to the fluid pressure and quicker replacement of the saline bag during the procedure (see Woods col. 1 lines 26-33, col. 1 lines 46-55, and col. 5 lines 38-43).
However, modified Truckai still fails to state wherein the flow regulator comprises a valve and an inflatable element configured to apply pressure to a sliding pinch element upon inflation of the inflatable element, wherein the valve closes around the outflow tubing to clamp the outflow tubing, wherein the sliding pinch element moves into the outflow tubing upon applying pressure from the inflatable element directly to the sliding pinch element via an actuator in the valve, wherein pressure applied by the sliding pinch element to the outflow tubing controls a fluid outflow rate.
Lark teaches a fluid management system (see Fig. 5) wherein the flow regulator comprises a valve (valve 28) and an inflatable element (membrane 15 and cavity between membrane 15 and control pressure inlet tube 4) configured to apply pressure to a sliding pinch element (pincher 19) upon inflation of the inflatable element (membrane 15 and cavity between membrane 15 and control pressure inlet tube 4), wherein the valve (valve 28) closes around the outflow tubing (tube 11) to clamp the outflow tubing (tube 11) (see Fig. 5), wherein the sliding pinch element (pincher 19) moves into the outflow tubing (tube 11) upon applying pressure from the inflatable element (membrane 15 and cavity between membrane 15 and control pressure inlet tube 4) directly to the sliding pinch element (pincher 19) via an actuator (control pressure inlet tube 4) in the valve (valve 28), wherein pressure applied by the sliding pinch element (pincher 19) to the outflow tubing (tube 11) controls a fluid outflow rate (see Fig. 5, par. [0160]-[0165], [0010], [0106]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the fluid management system of modified Truckai to include wherein the flow regulator comprises a valve and an inflatable element configured to apply pressure to a sliding pinch element upon inflation of the inflatable element, wherein the valve closes around the outflow tubing to clamp the outflow tubing, wherein the sliding pinch element moves into the outflow tubing upon applying pressure from the inflatable element directly to the sliding pinch element via an actuator in the valve, wherein pressure applied by the sliding pinch element to the outflow tubing controls a fluid outflow rate, as taught by Lark, in order to provide the structure of the flow regulator of modified Truckai which can be pump-actuated to selectively open and close the valve and thus selectively open and close the outflow tubing to provide a precisely controlled flow rate through the outflow tubing (see Lark par. [0160]-[0165], [0010], [0106]).
Regarding claim 2, modified Truckai teaches the fluid management system of claim 1 substantially as claimed. Truckai further teaches a controller (system controller 115) for controlling operation of the first peristaltic pump (inflow peristaltic pump 140A) and the second peristaltic pump (outflow peristaltic pump 140B) (see Figs. 1A-B and 10, par. [0045], [0069], and [0078]).
Regarding claim 3, modified Truckai teaches the fluid management system of claim 2 substantially as claimed. Modified Truckai further teaches wherein the first peristaltic pump (Truckai, inflow peristaltic pump 140A) responsive to the controller (Truckai, system controller 115) is adapted to increase or decrease pressure in the pressure cuff (Woods, pressure means 15) (see Truckai Figs. 1A-B and 10, Truckai par. [0045], [0069], and [0078], Woods col. 3 lines 16-27, see previous modifications in view of Woods in rejection of claim 1 above).
Regarding claim 4, modified Truckai teaches the fluid management system of claim 2 substantially as claimed. Modified Truckai further teaches wherein the second peristaltic pump (Truckai, outflow peristaltic pump 140B) responsive to the controller (Truckai, system controller 115) is adapted to increase or decrease pressure in the flow regulator (Lark; valve 28, membrane 15, cavity of valve 28, and control pressure inlet tube 4 form the flow regulator) (see Truckai Figs. 1A-B and 10, Truckai par. [0045], [0069], and [0078], Lark par. [0160]-[0165], see previous modifications in view of Lark in rejection of claim 1 above).
Regarding claim 5, modified Truckai teaches the fluid management system of claim 2 substantially as claimed. Truckai further teaches a sensor mechanism (see par. [0074]) coupled to the controller (system controller 115) for sensing a volume of fluid in the saline bag (fluid source/saline bag 145), wherein the sensor mechanism comprises at least one of a weight sensor, or an electrical sensor (see Fig. 10, par. [0074], note: only one of "a weight sensor", "an ultrasound sensor", "an optical sensor", or "an electrical sensor" is required by the claim since this limitation is written in the alternative).
Regarding claim 7, modified Truckai teaches the fluid management system of claim 5 substantially as claimed. Truckai further teaches wherein the control unit (base unit 118) carries a pressure sensor (pressure sensor 270) for sensing pressure in the first tubing loop (first tubing loop 442a) of the cassette (cassette 440), and the pressure sensor (pressure sensor 270) sends pressure signals to the controller (system controller 115) (see par. [0058]).
Regarding claim 8, modified Truckai teaches the fluid management system of claim 7 substantially as claimed. Truckai further teaches wherein the controller (system controller 115) is adapted to maintain a set pressure in the working space in response to the pressure signals (see par. [0003] and [0088]).
Claims 6 and 9-13 are rejected under 35 U.S.C. 103 as being unpatentable over Truckai et al. (US 2020/0146703 A1) in view of Woods (US 4,657,160 A), further in view of Lark et al. (US 2020/0384189 A1), as applied to claim 5 above, and further in view of Clare (US 6,396,583 B1).
Regarding claim 6, modified Truckai teaches the fluid management system of claim 5 substantially as claimed. However, modified Truckai fails to state wherein the controller is responsive to signals from the sensor mechanism and is adapted to adjust the operation of the first peristaltic pump to provide a selected rate of fluid flow from the saline bag when the volume of fluid in the saline bag is at any volume level.
Clare teaches a fluid management system (see Fig. 2) comprising wherein the controller (controller 40) is responsive to signals from the sensor mechanism (sensors 36/38) and is adapted to adjust the operation of the first peristaltic pump (pump 32) to provide a selected rate of fluid flow from the saline bag (reservoir 16) when the volume of fluid in the saline bag (reservoir 16) is at any volume level (see Fig. 2, col. 3 lines 21- 48).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the fluid management system of modified Truckai to include wherein the controller is responsive to signals from the sensor mechanism and is adapted to adjust the operation of the first peristaltic pump to provide a selected rate of fluid flow from the saline bag when the volume of fluid in the saline bag is at any volume level, as taught by Clare, in order for the fluid management system to function via a feedback control loop which allows sensed conditions of the system to determine the proper settings for the first peristaltic pump (see Clare col. 3 lines 21-48).
Regarding claim 9, modified Truckai teaches the fluid management system of claim 6 substantially as claimed. Truckai further teaches a collection reservoir (collection reservoir 148) adapted to collect fluid after being circulated through the working space (see Figs. 1A-B and 10, par. [0046], [0070], and [0073]).
Regarding claim 10, modified Truckai teaches the fluid management system of claim 9 substantially as claimed. However, modified Truckai fails to state a surgical drape adapted to collect a volume of the fluid lost from the working space.
Clare teaches a fluid management system (see Fig. 2) comprising a surgical drape (drape system 28) adapted to collect a volume of the fluid lost from the working space (see Fig. 2, col. 3 lines 6-21 and col. 3 lines 49-54).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the fluid management system of modified Truckai to comprise a surgical drape adapted to collect a volume of the fluid lost from the working space, as taught by Clare, in order to aid in maintaining an acceptable equilibrium fluid volume and pressure in the working space (see Clare col. 3 lines 6-21 and col. 3 lines 49-54).
Regarding claim 11, modified Truckai teaches the fluid management system of claim 10 substantially as claimed. However, modified Truckai fails to state a drape pump adapted to pump the fluid from the surgical drape to the collection reservoir.
Clare teaches a fluid management system (see Fig. 2) comprising a drape pump (vacuum controller 46) adapted to pump the fluid from the surgical drape (drape system 28) to the collection reservoir (reservoir of drape system 28, see Fig. 2) (see Fig. 2, col. 3 line 6 - col. 4 line 2).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the fluid management system of modified Truckai to comprise drape pump adapted to pump the fluid from the surgical drape to the collection reservoir, as taught by Clare, in order to aid in maintaining an acceptable equilibrium fluid volume and pressure in the working space (see Clare col. 3 line 6 - col. 4 line 2).
Regarding claim 12, modified Truckai teaches the fluid management system of claim 11 substantially as claimed. Truckai further teaches a weight sensor (see par. [0074]) adapted to sense a weight of the fluid in the collection reservoir (collection reservoir 148) (see Fig. 10, par. [0074]).
Regarding claim 13, modified Truckai teaches the fluid management system of claim 12 substantially as claimed. Truckai further teaches wherein the controller (system controller 115) is adapted to calculate a fluid deficit (see Fig. 10, par. [0075]).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Truckai et al. (US 2020/0146703 A1) in view of Woods (US 4,657,160 A), further in view of Lark et al. (US 2020/0384189 A1), as applied to claim 2 above, and further in view of Blomquist (US 5,338,157 A).
Regarding claim 14, modified Truckai teaches the fluid management system of claim 2 substantially as claimed. However, modified Truckai fails to state wherein the controller is adapted to lock and unlock the cassette from the first peristaltic pump and the second peristaltic pump.
Blomquist teaches a fluid management system (see Fig. 1A) wherein the controller (controller of pump 40) is adapted to lock and unlock the cassette (fluid reservoir 47, see col. 6 lines 15-26) from the pump (pump 40) (see Fig. 1A, col. 6 lines 15-26 and col. 14 lines 31-45).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the fluid management system of modified Truckai to include wherein the controller is adapted to lock and unlock the cassette from the first peristaltic pump and the second peristaltic pump, as suggested by Blomquist, in order to prevent the patient from being able to alter the pump operations (see Blomquist col. 14 lines 31-45).
Response to Arguments
Applicant’s arguments with respect to claim 1 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
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AVERY SMALE whose telephone number is (571)270-7172. The examiner can normally be reached Mon.-Fri. 8-4 ET.
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/AVERY SMALE/Examiner, Art Unit 3783
/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
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