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 .
Status of Claims
Claims 9-14, 16-17, and 21-26 are pending, claims 1-8, 15, and 18-20 have been cancelled, claims 25-26 have been added, and claims 9-14, 16-17, and 21-26 are currently under consideration for patentability under 37 CFR 1.104.
Response to Arguments
Applicant’s arguments with respect to claim(s) 9-17 and 21-24 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.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 9, 13, 21, and 24-26 are rejected under 35 U.S.C. 103 as being unpatentable over Banik (US 2006/0047184), in view of Cionni (US 2004/0077993).
Regarding claim 9, Banik discloses a surgical fluid management system (10, figure 2), comprising: an inflow pump (145, figure 2); a fluid source line (see conduit from 150 to 145, figure 2) for fluidly connecting the inflow pump to a fluid source (150, figure 2); a fluid inflow line extending downstream from the inflow pump (pump…flexible tube [0023]), the fluid inflow line configured to be fluidly connected to an inflow port of an endoscope (flexible tube that extends into the proximal connector 130…irrigate patient [0023]; figure 2); a controller configured to control the inflow pump (108, figure 2 | system control software application…input from sensors…operate the endoscope system [0024]); an electronically adjustable orifice (valves 140, figure 2 | valves that control the delivery of water…[0016]) located along the fluid inflow line (interpreted the valve to have an electronically adjustable orifice or opening to control the delivery of gas); and control circuitry (control cabinet 14…electronic and electromechanical apparatus…valves…[0016]); wherein the controller is in electronic communication with the inflow pump and the electronically adjustable orifice (see arrow and connector to 14 and 108, figure 2 | software application…input from sensors…operate the endoscope system [0024]); wherein the inflow pump is configured to pump fluid from the fluid source to the inflow port of the endoscope (pump…flexible tube…irrigate patient [0023]). Banik is silent regarding the electronically adjustable orifice adjustable to three or more different sizes; and the control circuitry for receiving a signal of a current size of the electronically adjustable orifice.
Cionni teaches an instrument (12, figure 1) with a surge-flow regulator (36, figure 1 | 300, figures 11) in communication with an aspiration line (24, figure 1). A flow limiting device (304, figure 11) is in the form of an iris member (306, figure 11) having a variable inner diameter, and is placed in fluid communication with the aspiration line ([0046]). The inner diameter of the iris member (306, figure 11) may be manually or automatically controlled ([0046]).
It would have been obvious to one of ordinary skill in the art to modify the system of Banik, specifically the electronically adjustable orifice, with the flow limiting device (304, figure 11) as taught by Cionni. Doing so would provide an automatically controlled flow limiting device with a variable inner diameter ([0046]). The modified system would have the electronically adjustable orifice adjustable to three or more different sizes (iris member 306, figures 11-12 of Cionni | variable inner diameter [0046]); and the control circuitry (control cabinet 14…electronic and electromechanical apparatus…valves…[0016]; Banik) for receiving a signal of a current size of the electronically adjustable orifice (valves that control the delivery of gas/water…[0016]; Banik | inner diameter…automatically controlled [0046]; Cionni).
Regarding claim 13, Cionni further teaches the electronically adjustable orifice includes an adjustable iris (variable inner diameter…[0046]; Cionni) having a plurality of movable leaves arranged around a central opening (see 306, figure 11), the plurality of movable leaves is configured to move to adjust a size of the central opening (inner diameter…automatically controlled [0046]).
Regarding claim 21, Banik discloses a surgical fluid management system (10, figure 2), comprising: a peristaltic pump (145, figure 2 | peristaltic pump [0023]); a fluid source line (see conduit from 150 to 145, figure 2) for fluidly connecting the peristaltic pump to a fluid source (150, figure 2); a fluid inflow line extending downstream from the peristaltic pump (pump…flexible tube [0023]), the fluid inflow line configured to be fluidly connected to an inflow port of an endoscope (flexible tube that extends into the proximal connector 130...irrigate patient [0023]); a controller configured to control the peristaltic pump (108, figure 2 | system control software application…input from sensors…operate the endoscope system [0024]); an electronically adjustable orifice (valves 140, figure 2 | valves that control the delivery of water…[0016]) located along the fluid inflow line (interpreted the valve to have an electronically adjustable orifice or opening to control the delivery of gas); and control circuitry (control cabinet 14…electronic and electromechanical apparatus…valves…[0016]); wherein the controller is in electronic communication with the peristaltic pump and the electronically adjustable orifice (see arrow and connector to 14 and 108, figure 2 | software application…input from sensors…operate the endoscope system [0024]). Banik is silent regarding an electronically variably adjustable orifice; and the control circuitry for receiving a signal of a current size of the electronically variably adjustable orifice; wherein the controller is in electronic communication with the peristaltic pump and the electronically variably adjustable orifice.
Cionni teaches an instrument (12, figure 1) with a surge-flow regulator (36, figure 1 | 300, figures 11) in communication with an aspiration line (24, figure 1). A flow limiting device (304, figure 11) is in the form of an iris member (306, figure 11) having a variable inner diameter, and is placed in fluid communication with the aspiration line ([0046]). The inner diameter of the iris member (306, figure 11) may be manually or automatically controlled ([0046]).
It would have been obvious to one of ordinary skill in the art to modify the system of Banik, specifically the electronically adjustable orifice, with the flow limiting device (304, figure 11) as taught by Cionni. Doing so would provide an automatically controlled flow limiting device with a variable inner diameter ([0046]). The modified system would have an electronically variably adjustable orifice (variable inner diameter…[0046]; Cionni); and the control circuitry for receiving a signal of a current size of the electronically variably adjustable orifice (valves that control the delivery of gas/water…[0016]; Banik | automatically controlled [0046]; Cionni); wherein the controller is in electronic communication with the peristaltic pump and the electronically variably adjustable orifice (see arrow and connector to 14 and 108, figure 2 | software application…input from sensors…operate the endoscope system [0024]; Banik | automatically controlled [0046]; Cionni).
Regarding claim 24, Cionni further teaches the electronically variably adjustable orifice includes an adjustable iris (variable inner diameter…[0046]; Cionni) having a plurality of movable leaves arranged around a central opening (see 306, figure 11), the plurality of movable leaves is configured to move to adjust a size of the central opening (inner diameter…automatically controlled [0046]).
Regarding claim 25, Banik and Cionni further disclose the control circuitry is configured to send a signal to change the size of the electronically adjustable orifice (valves that control the delivery of gas/water…[0016]; software application…input from sensors…operate the endoscope system [0024]; Banik | automatically controlled [0046]; Cionni).
Regarding claim 26, Banik and Cionni further disclose the control circuitry is configured to send a signal to change the size of the electronically variably adjustable orifice (valves that control the delivery of gas/water…[0016]; software application…input from sensors…operate the endoscope system [0024]; Banik | automatically controlled [0046]; Cionni).
Claim(s) 10-12 and 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Banik (US 2006/0047184) and Cionni (US 2004/0077993) as applied to claims 9 and 21 above, and further in view of Lemaire (US 5,586,973).
Regarding claim 10, Banik and Cionni disclose all of the features in the current invention as shown above in claim 9. They are silent regarding a first pressure sensor disposed upstream of the electronically adjustable orifice and a second pressure sensor disposed downstream of the electronically adjustable orifice.
Lemaire teaches an irrigation circuit for endoscopic surgery (abstract and title) with a peristaltic irrigation pump (PPIR, figure 1) and two coupled pressure sensors (CP1 and CP2, figure 1) with a Venturi conduit (CAB, figure 1) in between the pressure sensors. These elements constitute a block for measuring pressure difference (BCDP, figure 1). The pump and pressure sensors are connected to the central processor and control unit (UCCG, figure 1). Using the data from the weighing device (DISPE1, figure 1) of the reservoir (RESE, figure 1) and the pressure differential between sensors (CP1 and CP2, figure 1), the UCCG can calculate the weight, the volume and the pressure of the irrigation fluid, as well as the flow rate of the irrigation pump (Col. 7, line 62- Col. 8, line 3). Specifically, the UCCG can determine the irrigation flow rate from the difference between the pair of irrigation pressure values (claim 1).
It would have been obvious to one of ordinary skill in the art before the time of filing to modify the system to have pressure sensors (see CP1 and CP2, figure 1) disposed upstream and downstream of the electronically adjustable orifice as taught by Lemaire. Doing so would measure the pressure differential across the electronically adjustable orifice (BCDP, figure 1; Lemaire). The modified system would have a first pressure sensor (CP1, figure 1; Lemaire) disposed upstream of the electronically adjustable orifice (valves 140, figure 2; Banik | the modified system would have the valve of Banik instead of the Venturi conduit or CAB, figure 1 of Lemaire, both changes a pressure differential) and a second pressure sensor (CP2, figure 1; Lemaire) disposed downstream of the electronically adjustable orifice.
Regarding claim 11, Lemaire further teaches the control circuity is configured to calculate an approximate current flow rate of the fluid passing through the electronically adjustable orifice based on the current size of the electronically adjustable orifice, a first fluid pressure measured by the first pressure sensor, and a second fluid pressure measured by the second pressure sensor (valves 140, figure 2; Banik | pressure differential from CP1 and CP2, figure 1; Col. 7, line 62- Col. 8, line 3 and “determining an irrigation flow rate…from the different between the pair of irrigation pressure values” in claim 1 of Lemaire).
Regarding claim 12, Banik and Cionni disclose all of the features in the current invention as shown above in claim 9. They are silent regarding the control circuitry is configured to calculate an approximate current flow rate of the fluid passing through the electronically adjustable orifice based on the current size of the electronically adjustable orifice and a system pressure of the fluid measured between the inflow pump and the electronically adjustable orifice.
Lemaire teaches an irrigation circuit for endoscopic surgery (abstract and title) with a peristaltic irrigation pump (PPIR, figure 1) and two coupled pressure sensors (CP1 and CP2, figure 1) with a Venturi conduit (CAB, figure 1) in between the pressure sensors. These elements constitute a block for measuring pressure difference (BCDP, figure 1). The pump and pressure sensors are connected to the central processor and control unit (UCCG, figure 1). Using the data from the weighing device (DISPE1, figure 1) of the reservoir (RESE, figure 1) and the pressure differential between sensors (CP1 and CP2, figure 1), the UCCG can calculate the weight, the volume and the pressure of the irrigation fluid, as well as the flow rate of the irrigation pump (Col. 7, line 62- Col. 8, line 3). Specifically, the UCCG can determine the irrigation flow rate from the difference between the pair of irrigation pressure values (claim 1).
It would have been obvious to one of ordinary skill in the art before the time of filing to modify the system to have pressure sensors (see CP1 and CP2, figure 1) disposed upstream and downstream of the electronically adjustable orifice as taught by Lemaire. Doing so would measure the pressure differential across the electronically adjustable orifice (BCDP, figure 1; Lemaire). The modified system would have the control circuitry is configured to calculate an approximate current flow rate of the fluid passing through the electronically adjustable orifice based on the current size of the electronically adjustable orifice (valves 140, figure 2; Banik | valves that control the delivery of gas/water…[0016]) and a system pressure of the fluid measured between the inflow pump and the electronically adjustable orifice (CP1 and/or CP2, figure 1; Col. 7, line 62- Col. 8, line 3 and “determining an irrigation flow rate…from the different between the pair of irrigation pressure values” in claim 1 of Lemaire).
Regarding claim 22, Banik and Cionni disclose all of the features in the current invention as shown above in claim 21. They are silent regarding a first pressure sensor disposed upstream of the electronically adjustable orifice and a second pressure sensor disposed downstream of the electronically adjustable orifice.
Lemaire teaches an irrigation circuit for endoscopic surgery (abstract and title) with a peristaltic irrigation pump (PPIR, figure 1) and two coupled pressure sensors (CP1 and CP2, figure 1) with a Venturi conduit (CAB, figure 1) in between the pressure sensors. These elements constitute a block for measuring pressure difference (BCDP, figure 1). The pump and pressure sensors are connected to the central processor and control unit (UCCG, figure 1). Using the data from the weighing device (DISPE1, figure 1) of the reservoir (RESE, figure 1) and the pressure differential between sensors (CP1 and CP2, figure 1), the UCCG can calculate the weight, the volume and the pressure of the irrigation fluid, as well as the flow rate of the irrigation pump (Col. 7, line 62- Col. 8, line 3). Specifically, the UCCG can determine the irrigation flow rate from the difference between the pair of irrigation pressure values (claim 1).
It would have been obvious to one of ordinary skill in the art before the time of filing to modify the system to have pressure sensors (see CP1 and CP2, figure 1) disposed upstream and downstream of the electronically adjustable orifice as taught by Lemaire. Doing so would measure the pressure differential across the electronically adjustable orifice (BCDP, figure 1; Lemaire). The modified system would have a first pressure sensor (CP1, figure 1; Lemaire) disposed upstream of the electronically adjustable orifice (valves 140, figure 2; Banik | the modified system would have the valve of Banik instead of the Venturi conduit or CAB, figure 1 of Lemaire, both changes a pressure differential) and a second pressure sensor (CP2, figure 1; Lemaire) disposed downstream of the electronically adjustable orifice.
Regarding claim 23, Banik and Lemaire further disclose the control circuity is configured to calculate an approximate current flow rate of the fluid passing through the electronically variably adjustable orifice based on the current size of the electronically adjustable orifice, a first fluid pressure measured by the first pressure sensor, and a second fluid pressure measured by the second pressure sensor (valves 140, figure 2; Banik | pressure differential from CP1 and CP2, figure 1; Col. 7, line 62- Col. 8, line 3 and 3 and “determining an irrigation flow rate…from the different between the pair of irrigation pressure values” in claim 1 of Lemaire).
Claim(s) 14 and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Banik (US 2006/0047184), in view of Cionni (US 2004/0077993) and Lemaire (US 5,586,973).
Regarding claim 14, Banik discloses an endoscopic system (see figure 2), comprising: a fluid management system (10, figure 2) including a fluid source (150, figure 2), an inflow pump (145, figure 2), a fluid source line (see conduit from 150 to 145, figure 2) fluidly connecting the fluid source to the inflow pump, a fluid inflow line (pump…flexible tube [0023]) extending downstream from the inflow pump, and a controller (108, figure 2 | system control software application…input from sensors…operate the endoscope system [0024]) for controlling the inflow pump; an endoscope (18, figure 2) including a handle (122, figure 2) and an elongate shaft (120, figure 2) extending distally from the handle; wherein the handle includes an inflow port in fluid communication with the elongate shaft (flexible tube that extends into the proximal connector 130…irrigate patient [0023]; figure 2), the inflow port being fluidly connectable to the fluid inflow line (flexible tube…irrigate patient [0023]); an electronically adjustable orifice (valves 140, figure 2 | valves that control the delivery of water…[0016]) associated with the fluid inflow line (interpreted the valve to have an electronically adjustable orifice or opening to control the delivery of gas) and positioned between the inflow pump and the inflow port; and control circuitry (control cabinet 14…electronic and electromechanical apparatus…valves…[0016]); wherein the controller is in electronic communication with the inflow pump and the electronically adjustable orifice (see arrow and connector to 14 and 108, figure 2 | software application…input from sensors…operate the endoscope system [0024]); wherein the inflow pump is configured to pump fluid from the fluid source to the inflow port (pump…flexible tube…irrigate patient [0023]). Banik is silent regarding an electronically variably adjustable orifice; a first pressure sensor disposed upstream of the electronically variably adjustable orifice; a second pressure sensor disposed downstream of the electronically variably adjustable orifice and upstream of the elongate shaft; and the control circuitry for receiving a signal of a current size of the electronically variably adjustable orifice and for changing a size of the electronically variably adjustable orifice; wherein the controller is in electronic communication with the inflow pump and the electronically variably adjustable orifice.
Cionni teaches an instrument (12, figure 1) with a surge-flow regulator (36, figure 1 | 300, figures 11) in communication with an aspiration line (24, figure 1). A flow limiting device (304, figure 11) is in the form of an iris member (306, figure 11) having a variable inner diameter, and is placed in fluid communication with the aspiration line ([0046]). The inner diameter of the iris member (306, figure 11) may be manually or automatically controlled ([0046]).
Lemaire teaches an irrigation circuit for endoscopic surgery (abstract and title) with a peristaltic irrigation pump (PPIR, figure 1) and two coupled pressure sensors (CP1 and CP2, figure 1) with a Venturi conduit (CAB, figure 1) in between the pressure sensors. These elements constitute a block for measuring pressure difference (BCDP, figure 1). The pump and pressure sensors are connected to the central processor and control unit (UCCG, figure 1). Using the data from the weighing device (DISPE1, figure 1) of the reservoir (RESE, figure 1) and the pressure differential between sensors (CP1 and CP2, figure 1), the UCCG can calculate the weight, the volume and the pressure of the irrigation fluid, as well as the flow rate of the irrigation pump (Col. 7, line 62- Col. 8, line 3). Specifically, the UCCG can determine the irrigation flow rate from the difference between the pair of irrigation pressure values (claim 1).
It would have been obvious to one of ordinary skill in the art to modify the system of Banik, specifically the electronically adjustable orifice, with the flow limiting device (304, figure 11) as taught by Cionni. Doing so would provide an automatically controlled flow limiting device with a variable inner diameter ([0046]). Further, it would have been obvious to modify the system to have pressure sensors (see CP1 and CP2, figure 1) disposed upstream and downstream of the electronically variably adjustable orifice as taught by Lemaire. Doing so would measure the pressure differential across the electronically adjustable orifice (BCDP, figure 1; Lemaire). The modified system would have an electronically variably adjustable orifice (iris member 306, figures 11-12 of Cionni | variable inner diameter [0046]); a first pressure sensor (CP1, figure 1; Lemaire) disposed upstream of the electronically variably adjustable orifice (304, figure 11; Cionni | the modified system would have the flow limiting device 304 of Cionni instead of the Venturi conduit or CAB, figure 1 of Lemaire; both the flow limiting device and Venturi conduit/CAB changes a pressure differential); a second pressure sensor (CP2, figure 1; Lemaire) disposed downstream of the electronically variably adjustable orifice and upstream of the elongate shaft; and the control circuitry for receiving a signal of a current size of the electronically variably adjustable orifice and for changing a size of the electronically variably adjustable orifice (valves that control the delivery of gas/water…[0016]; Banik | automatically controlled [0046]; Cionni); wherein the controller is in electronic communication with the inflow pump and the electronically variably adjustable orifice (see arrow and connector to 14 and 108, figure 2 | software application…input from sensors…operate the endoscope system [0024]; Banik | automatically controlled [0046]; Cionni).
Regarding claim 16, Banik and Cionni further disclose the control circuity is configured to calculate an approximate current flow rate of the fluid passing through the electronically variably adjustable orifice based on the current size of the electronically variably adjustable orifice, a first fluid pressure measured by the first pressure sensor, and a second fluid pressure measured by the second pressure sensor (304, figure 11; Cionni | control cabinet 14…control the delivery of water…[0016]; Banik | pressure differential from CP1 and CP2, figure 1; Col. 7, line 62-Col. 8, line 3 and “determining an irrigation flow rate…from the different between the pair of irrigation pressure values” in claim 1 of Lemaire).
Regarding claim 17, Banik and Cionni further disclose the electronically variably adjustable orifice includes an adjustable iris (variable inner diameter…[0046]; Cionni) having a plurality of movable leaves arranged around a central opening (see 306, figure 11), the plurality of movable leaves is configured to move to adjust a size of the central opening (inner diameter…automatically controlled [0046]).
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 PAMELA F WU whose telephone number is (571)272-9851. The examiner can normally be reached M-F: 8-4 PM.
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PAMELA F. WU
Examiner
Art Unit 3795
May 15, 2026
/RYAN N HENDERSON/Primary Examiner, Art Unit 3795
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