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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 December 22, 2025 has been entered.
Claims 1-11, 14, 16-18, and 20-24 remain pending in the application. Claims 12-13, 15, and 19 have been cancelled. Applicant’s amendments to the claims have overcome the objections previously set forth in the Final Office Action mailed October 07, 2025.
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 1-4, 6-7, 9, 14, 16-18, 22, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Hiraga et al. (WO 2017057030, citations in reference to provided English Translation) in view of Silver (US 20190365417), and further in view of Radl et al. (US 20200268989).
Regarding claim 1, Hiraga discloses a gas recirculation system (Figures 1 and 2) for use in managing a flow of gas an endoscopic surgical procedure, the system comprising:
a first tube (suction tube 8) in fluid communication with a gas input connection, wherein the first tube is configured to be connectable to surgical equipment (trocar 12b) that is insertable into a peritoneal cavity (Figure 1; “The circulation device 2 is connected to one end of a suction tube 8. The other end of the suction tube 8 is connected to the trocar 12b.” [Page 3, 8th paragraph]); and
a second tube (air support tube 9) in fluid communication with a gas output connection, wherein the second tube is configured to be connectable to surgical equipment (trocar 12c) that is insertable into a peritoneal cavity (Figure 1; “The circulation device 2 is connected to one end of an air supply tube 9 as an air supply line capable of supplying a predetermined gas in the vicinity of the distal end of the endoscope. The other end of the air supply tube 9 is connected to the trocar 12c.” [Page 3, 8th paragraph]);
a pump (pump 20) having a motor (motor 22), wherein the pump is configured to draw gas into the gas input connection from a peritoneal cavity through the first tube and to discharge gas out of the gas output connection and into a peritoneal cavity through the second tube (“the circulation device 2 sucks carbon dioxide gas including smoke generated by using the electric knife 11 through the suction tube 8 and the trocar 12b. After the smoke and mist are removed from the carbon dioxide gas in the circulation device 2, the carbon dioxide gas is returned to the body cavity of the patient 14 via the air supply tube 9 and the trocar 12c.” [Page 4, 3rd paragraph]);
a smoke detection sensor (filter 211 and filter color detection unit 25) positioned at a location along a gas flow path defined by the first tube, the pump and the second tube (“The sucked carbon dioxide gas passes through the filter 211 to remove smoke and mist.” [Page 4, 2nd paragraph]; Figure 2) and configured to measure an amount of smoke present in the gas (“The filter color detection unit 25 as a clogging state monitoring unit includes a commonly used color sensor or the like, and detects the color of the filter 211…The color information of the filter 211 detected by the filter color detection unit 25 is input to the pump control unit 24. The pump control unit 24 controls the rotation speed of the motor 22 based on the color information of the filter 211 input from the filter color detection unit 25. The filter 211 is white in a fresh state before use, but changes from yellow to brown to black as the fine particles such as smoke are adsorbed and captured. That is, the color of the filter 211 changes according to the degree of filter clogging.” [Page 4, 5th-6th paragraphs], wherein the color of the filter 211 is a measure of the amount of smoke present in the gas over time); and
a controller (pump control unit 24) configured to:
receive an output signal from the smoke detection sensor representative of an amount of smoke detected (“The color information of the filter 211 detected by the filter color detection unit 25 is input to the pump control unit 24…The filter 211 is white in a fresh state before use, but changes from yellow to brown to black as the fine particles such as smoke are adsorbed and captured. That is, the color of the filter 211 changes according to the degree of filter clogging.” [Page 4, 5th-6th paragraphs], wherein the color of the filter 211 is representative of the amount of smoke present in the gas over time);
and adjust a speed of the motor of the pump in response to the amount of smoke detected (“The pump control unit 24 controls the rotation speed of the motor 22 based on the color information of the filter 211 input from the filter color detection unit 25.” [Page 4, 6th paragraph]; wherein the color of the filter 211 is representative of the amount of smoke detected in the gas over time).
Hiraga fails to explicitly disclose a filter positioned along the second tube, the filter configured to remove smoke from the flow of gas through the second tube; a valve positioned along the first tube between the smoke detection sensor and the pump, the valve adjustable via a controller to bypass the pump and direct the flow of gas from the first tube to a suction exhaust tube; and wherein the controller is configured to adjust the valve to direct the flow of gas to the suction exhaust tube in response to the output signal indicating an amount of smoke above an evacuation threshold.
Silver teaches a gas recirculation system (gas evacuation system 300) comprising a first tube (flow path 340) and a second tube (inlet flow path 310), a pump (pump 360), a smoke detection sensor (sensor 34; “Sensor 34 is operatively connected to the processor 370 for control of gas composition in the surgical cavity 16.” [0055]) positioned along a gas flow path defined by the first tube, the pump and the second tube (Figure 3) and configured to measure an amount of unwanted contaminants present in the gas (“The sensor 34 is configured for monitoring a plurality of gas species in the gas flow from a surgical cavity 16 of a patient” [0034]); a filter (filter 390; “filters 390 similar to those described above with reference to FIG. 1.” [0051]) positioned along the second tube (“A filter 32 is operatively associated with at least one of the inlet flow path 22 and the outlet flow path 24” [0042]; Figure 1 and 3), the filter configured to remove smoke from the flow of gas through the second tube (“A filter 32…for cleaning or otherwise conditioning the gas passing therethrough.” [0042]); and a valve (valve 392) positioned along the first tube between the smoke detection sensor (sensor 34) and the pump (pump 360; Figure 3), the valve adjustable via a controller (processor 370) to bypass the pump and direct the flow of gas from the first tube to a location outside of the gas flow path (“the processor can open valve 392 in order to bleed the methane out of the surgical cavity” [0055]; Figure 3); and wherein the controller is configured to adjust the valve to direct the flow of gas out of the gas flow path in response to an output signal from the smoke detection sensor indicating an amount of contaminants in the gas above an evacuation threshold (“System 300 can use the valves 392, 394 to bleed off unwanted gas species if the sensor 34 reads presence and/or concentration of a potentially harmful gas. For example, the gas sensor 34 reads 10% methane, the processor can open valve 392 in order to bleed the methane out of the surgical cavity...the smoke evacuator shown in FIG. 3 detects the methane, opens valve 392 to bleed the methane off, which creates an under pressure that the insufflator will sense and flow in carbon dioxide to compensate.” [0055]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the gas recirculation system of Hiraga to further include a filter positioned along the second tube, the filter configured to remove smoke from the flow of gas through the second tube based on the teachings of Silver to clean the gas passing through the second tube (Silver [0042]) and to modify the gas recirculation system having a smoke detection sensor that produces an output signal representative of an amount of smoke present in the gas disclosed by Hiraga to further include a valve positioned along the first tube between the smoke detection sensor and the pump, the valve adjustable via the controller to bypass the pump and direct the flow of gas from the first tube to a suction exhaust tube in response to the output signal indicating an amount of smoke above an evacuation threshold based on the teachings of Silver to remove harmful gas from the gas flow path (Silver [0055]).
Modified Hiraga in view of Silver fails to explicitly teach the valve directs the flow of gas from the first tube to a suction exhaust tube.
Radl teaches a gas circulation system (system 20), the system comprising a first tube (flexible tube 18A), and a valve (regulator device 22) adjustable to direct the flow of gas from the first tube to a suction exhaust tube (flexible tube 22D; “The third device port 22C is coupled to the vacuum source, e.g., the hospital's suction line, via a flexible tube 22D.” [0086]; “The dial 30 of the regulator device will be rotated to a desired position to establish a set point pressure at which the valve will open…Thus, when the monitored pressure exceeds the set point…the valve 46A will automatically open to bring the passageway 32F and its associated port 22B into fluid communication with the passageway 32G and its associated port 22C. Accordingly, the suction applied at port 22C will draw smoke 4 from within the laparoscopic field through the trocar 18, the associated flexible tube 18A, and the port 22B to the vacuum source, thereby clearing the laparoscopic field of smoke.” [0097]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the valve of the gas recirculation system of Hiraga in view of Silver to direct the flow of gas from the first tube to a suction exhaust tube based on the teachings of Radl to clear the laparoscopic field and operating room of smoke (Radl [0097]).
Regarding claim 2, modified Hiraga discloses the gas recirculation system of claim 1, wherein the smoke detection sensor (filter 211 and filter color detection unit 25) is positioned along the first tube (suction tube 8; Figure 2 wherein at least filter 211 is located at the end/along tube 8).
Regarding claim 3, modified Hiraga discloses the gas recirculation system of claim 1, wherein the smoke detection sensor (filter 211 and filter color detection unit 25) is positioned along the second tube (air supply tube 9; Figure 2 wherein at least filter 211 is located at the end/along tube 9).
Regarding claim 4, modified Hiraga discloses the gas recirculation system of claim 1, wherein the smoke detection sensor (filter 211 and filter color detection unit 25) is positioned in the pump (pump 20; Figure 2, wherein at least filter 211 is in the pump 20).
Regarding claim 6, modified Hiraga discloses the gas recirculation system of claim 1, wherein the smoke detection sensor (filter 211 and filter color detection unit 25) comprises an optical sensor (“The filter color detection unit 25 as a clogging state monitoring unit includes a commonly used color sensor or the like, and detects the color of the filter 211. For example, the filter color detection unit 25 irradiates the filter 211 with white light from a light source such as an incandescent lamp, receives reflected light, decomposes it into R, G, and B, and determines the color based on the ratio. The color information of the filter 211 detected by the filter color detection unit 25 is input to the pump control unit 24.” [Page 4, 4th paragraph]).
Regarding claim 7, modified Hiraga discloses the gas recirculation system of claim 6, wherein the optical sensor comprises a light source and a photoreceptor positioned to receive light emitted from the light source (“The filter color detection unit 25 as a clogging state monitoring unit includes a commonly used color sensor or the like, and detects the color of the filter 211. For example, the filter color detection unit 25 irradiates the filter 211 with white light from a light source such as an incandescent lamp, receives reflected light, decomposes it into R, G, and B, and determines the color based on the ratio. The color information of the filter 211 detected by the filter color detection unit 25 is input to the pump control unit 24.” [Page 4, 4th paragraph]).
Regarding claim 9, modified Hiraga discloses the gas recirculation system of claim 1, wherein the controller (pump control unit 24) is configured to increase the speed of the motor of the pump in response to an increase in the amount of smoke detected (“the circulating smoke exhaust device of the present embodiment controls the rotation speed of the motor 22 according to the degree of clogging of the filter 211, and by increasing the rotation speed of the motor 22 as the clogging degree increases” [Page 5, 2nd paragraph]; “when the color of the filter 211 is brown or a color darker than brown, it is determined that the degree of filter clogging is “medium” or more (step S64, YES), and the rotation speed of the motor 22 is increased to high speed. Set (step S65).” [Page 6, 4th paragraph], for example).
Regarding claim 14, Hiraga discloses a gas recirculation system (Figures 1 and 2) for use in managing a flow of gas an endoscopic surgical procedure, the system comprising:
a first tube (suction tube 8) in fluid communication with a gas input connection (), wherein the first tube is configured to be connectable to surgical equipment (trocar 12b) that is insertable into a peritoneal cavity (Figure 1; “The circulation device 2 is connected to one end of a suction tube 8. The other end of the suction tube 8 is connected to the trocar 12b.” [Page 3, 8th paragraph]); and
a second tube (air support tube 9) in fluid communication with a gas output connection, wherein the second tube is configured to be connectable to surgical equipment (trocar 12c) that is insertable into a peritoneal cavity (Figure 1; “The circulation device 2 is connected to one end of an air supply tube 9 as an air supply line capable of supplying a predetermined gas in the vicinity of the distal end of the endoscope. The other end of the air supply tube 9 is connected to the trocar 12c.” [Page 3, 8th paragraph]);
a pump (pump 20) having a motor (motor 22), wherein the pump is configured to draw gas into the gas input connection from a peritoneal cavity through the first tube and to discharge gas out of the gas output connection and into a peritoneal cavity through the second tube (“the circulation device 2 sucks carbon dioxide gas including smoke generated by using the electric knife 11 through the suction tube 8 and the trocar 12b. After the smoke and mist are removed from the carbon dioxide gas in the circulation device 2, the carbon dioxide gas is returned to the body cavity of the patient 14 via the air supply tube 9 and the trocar 12c.” [Page 4, 3rd paragraph]);
a smoke detection sensor (filter 211 and filter color detection unit 25) positioned at a location along a gas flow path defined by the first tube, the pump and the second tube (“The sucked carbon dioxide gas passes through the filter 211 to remove smoke and mist.” [Page 4, 2nd paragraph]; Figure 2) and configured to measure an amount of smoke present in the gas (“The filter color detection unit 25 as a clogging state monitoring unit includes a commonly used color sensor or the like, and detects the color of the filter 211…The color information of the filter 211 detected by the filter color detection unit 25 is input to the pump control unit 24. The pump control unit 24 controls the rotation speed of the motor 22 based on the color information of the filter 211 input from the filter color detection unit 25. The filter 211 is white in a fresh state before use, but changes from yellow to brown to black as the fine particles such as smoke are adsorbed and captured. That is, the color of the filter 211 changes according to the degree of filter clogging.” [Page 4, 5th-6th paragraphs], wherein the color of the filter 211 is a measure of the amount of smoke present in the gas over time); and
a controller (pump control unit 24) configured to:
receive an output signal from the smoke detection sensor representative of an amount of smoke detected (“The color information of the filter 211 detected by the filter color detection unit 25 is input to the pump control unit 24…The filter 211 is white in a fresh state before use, but changes from yellow to brown to black as the fine particles such as smoke are adsorbed and captured. That is, the color of the filter 211 changes according to the degree of filter clogging.” [Page 4, 5th-6th paragraphs], wherein the color of the filter 211 is representative of the amount of smoke present in the gas over time);
and in response to determining that an amount of smoke detected exceeds an evacuation threshold, direct gas from the first tube to a suction source (“diaphragm 212 that performs suction and delivery operations of the gas to the pumping member 21” [Page 5, 2nd paragraph]; “the circulating smoke exhaust device of the present embodiment controls the rotation speed of the motor 22 according to the degree of clogging of the filter 211, and by increasing the rotation speed of the motor 22 as the clogging degree increases” [Page 5, 2nd paragraph]; “when the color of the filter 211 is brown or a color darker than brown, it is determined that the degree of filter clogging is “medium” or more (step S64, YES), and the rotation speed of the motor 22 is increased to high speed. Set (step S65).” [Page 6, 4th paragraph], for example; “As the rotational speed of the motor 22 increases, the stroke of the diaphragm 212 increases, so that the flow rate of carbon dioxide gas supplied from the circulation device 2 increases.” [Page 4, 4th paragraph]; wherein as the filter color exceeds each threshold, the controller increases the motor speed and therefore the stroke of the diaphragm, increasing the suction).
Hiraga fails to explicitly disclose a filter positioned along the second tube, the filter configured to remove smoke from the flow of gas through the second tube; a valve positioned along the first tube between the smoke detection sensor and the pump, the valve adjustable via the controller to bypass the pump and direct the flow of gas from the first tube to a suction exhaust tube; and wherein the controller is configured to adjust the valve to direct the flow of gas to the suction exhaust tube in response to the output signal indicating an amount of smoke above an evacuation threshold.
Silver teaches a gas recirculation system (gas evacuation system 300) comprising a first tube (flow path 340) and a second tube (inlet flow path 310), a pump (pump 360), a smoke detection sensor (sensor 34; “Sensor 34 is operatively connected to the processor 370 for control of gas composition in the surgical cavity 16.” [0055]) positioned at a location along a gas flow path defined by the first tube, the pump and the second tube (Figure 3) and configured to measure an amount of unwanted contaminants present in the gas (“The sensor 34 is configured for monitoring a plurality of gas species in the gas flow from a surgical cavity 16 of a patient” [0034]); a filter (filter 390; “filters 390 similar to those described above with reference to FIG. 1.” [0051]) positioned along the second tube (“A filter 32 is operatively associated with at least one of the inlet flow path 22 and the outlet flow path 24” [0042]; Figure 1 and 3), the filter configured to remove smoke from the flow of gas through the second tube (“A filter 32…for cleaning or otherwise conditioning the gas passing therethrough.” [0042]); and a valve (valve 392) positioned along the first tube between the smoke detection sensor (sensor 34) and the pump (pump 360; Figure 3), the valve adjustable via a controller (processor 370) to bypass the pump and direct the flow of gas from the first tube to a location outside of the gas flow path (“the processor can open valve 392 in order to bleed the methane out of the surgical cavity” [0055]; Figure 3); and wherein the controller is configured to adjust the valve to direct the flow of gas out of the gas flow path in response to an output signal from the smoke detection sensor indicating an amount of contaminants in the gas above an evacuation threshold (“System 300 can use the valves 392, 394 to bleed off unwanted gas species if the sensor 34 reads presence and/or concentration of a potentially harmful gas. For example, the gas sensor 34 reads 10% methane, the processor can open valve 392 in order to bleed the methane out of the surgical cavity...the smoke evacuator shown in FIG. 3 detects the methane, opens valve 392 to bleed the methane off, which creates an under pressure that the insufflator will sense and flow in carbon dioxide to compensate.” [0055]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the gas recirculation system of Hiraga to further include a filter positioned along the second tube, the filter configured to remove smoke from the flow of gas through the second tube based on the teachings of Silver to clean the gas passing through the second tube (Silver [0042]) and to modify the gas recirculation system having a smoke detection sensor that produces an output signal representative of an amount of smoke present in the gas disclosed by Hiraga to further include a valve positioned along the first tube between the smoke detection sensor and the pump, the valve adjustable via the controller to bypass the pump and direct the flow of gas from the first tube to a suction exhaust tube in response to the output signal indicating an amount of smoke above an evacuation threshold based on the teachings of Silver to remove harmful gas from the gas flow path (Silver [0055]).
Modified Hiraga in view of Silver fails to explicitly teach the valve directs the flow of gas from the first tube to a suction exhaust tube.
Radl teaches a gas circulation system (system 20), the system comprising a first tube (flexible tube 18A), and a valve (regulator device 22) adjustable to direct the flow of gas from the first tube to a suction exhaust tube (flexible tube 22D; “The third device port 22C is coupled to the vacuum source, e.g., the hospital's suction line, via a flexible tube 22D.” [0086]; “The dial 30 of the regulator device will be rotated to a desired position to establish a set point pressure at which the valve will open…Thus, when the monitored pressure exceeds the set point…the valve 46A will automatically open to bring the passageway 32F and its associated port 22B into fluid communication with the passageway 32G and its associated port 22C. Accordingly, the suction applied at port 22C will draw smoke 4 from within the laparoscopic field through the trocar 18, the associated flexible tube 18A, and the port 22B to the vacuum source, thereby clearing the laparoscopic field of smoke.” [0097]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the valve of the gas recirculation system of Hiraga in view of Silver to direct the flow of gas from the first tube to a suction exhaust tube based on the teachings of Radl to clear the laparoscopic field and operating room of smoke (Radl [0097]).
Regarding claim 16, modified Hiraga discloses the gas recirculation system of claim 14, wherein the smoke detection sensor (filter 211 and filter color detection unit 25) is positioned in the pump (pump 20; Figure 2, wherein at least filter 211 is in the pump 20).
Regarding claim 17, modified Hiraga discloses the gas recirculation system of claim 14, wherein the smoke detection sensor comprises a photoelectric sensor (“The filter color detection unit 25 as a clogging state monitoring unit includes a commonly used color sensor or the like, and detects the color of the filter 211. For example, the filter color detection unit 25 irradiates the filter 211 with white light from a light source such as an incandescent lamp, receives reflected light, decomposes it into R, G, and B, and determines the color based on the ratio. The color information of the filter 211 detected by the filter color detection unit 25 is input to the pump control unit 24.” [Page 4, 4th paragraph]).
Regarding claim 18, modified Hiraga discloses the gas recirculation system of claim 14, wherein the controller (pump control unit 24) is configured to increase the speed of the motor of the pump in response to an increase in the amount of smoke detected (“the circulating smoke exhaust device of the present embodiment controls the rotation speed of the motor 22 according to the degree of clogging of the filter 211, and by increasing the rotation speed of the motor 22 as the clogging degree increases” [Page 5, 2nd paragraph]; “when the color of the filter 211 is brown or a color darker than brown, it is determined that the degree of filter clogging is “medium” or more (step S64, YES), and the rotation speed of the motor 22 is increased to high speed. Set (step S65).” [Page 6, 4th paragraph], for example).
Regarding claim 22, modified Hiraga discloses the gas recirculation system of claim 1, wherein the first tube (suction tube 8) has a first end (at trocar 12b) and a second end (at circulation device 2) and wherein the second end is configured to be connectable to surgical equipment (Figures 1 and 2); and wherein the smoke detection sensor (filter 211 and filter color detection unit 25) is positioned along the first tube at the second end (Figure 2 wherein at least filter 211 is located at the end/along tube 8).
Regarding claim 24, modified Hiraga discloses the gas recirculation system of claim 14, wherein the first tube (suction tube 8) has a first end (at trocar 12b) and a second end (at circulation device 2) and wherein the second end is configured to be connectable to surgical equipment (Figures 1 and 2); and wherein the smoke detection sensor (filter 211 and filter color detection unit 25) is positioned along the first tube at the second end (Figure 2 wherein at least filter 211 is located at the end/along tube 8).
Claims 5, 8, and 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Hiraga et al. (WO 2017057030) in view of Silver (US 20190365417), and further in view of Radl et al. (US 20200268989) as applied in claims 1 and 7 above, and further in view of Shelton et al. (US 20190201594).
Regarding claim 5, modified Hiraga discloses the gas recirculation system of claim 1.
Modified Hiraga fails to explicitly disclose the smoke detection sensor comprises an ionizing smoke detector circuit.
Shelton teaches a gas recirculation system for use in managing a flow of gas (surgical evacuation system 50000; “the airflow path can contain a recirculation channel or secondary fluid channel back to the primary reservoir from downstream of the exhaust port of the main fluid management chamber.” [0285]), the system comprising a smoke detection sensor comprising an ionizing smoke detector circuit (ionization sensor 51200; “an ionization sensor can be used to detect particles in smoke. An ionization sensor includes two electrodes and radioactive material, which converts air molecules into positive and negative ions. The positive ions move toward the negative electrode, and the negative ions move toward the positive electrode. If smoke passes between the electrodes, the smoke bonds with the ions, which breaks the circuit. Drops in the current through the circuit can be converted into an electrical signal (current) that corresponds to the volume of smoke passing between the electrodes.” [0346]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the smoke detection sensor of Hiraga to further comprise an ionizing smoke detector circuit based on the teachings of Shelton to allow the smoke detection circuit to directly and accurately measure the volume of smoke passing through the gas flow path at a given time (Shelton [0346-0348]).
Regarding claim 8, modified Hiraga discloses the gas recirculation system of claim 7.
Modified Hiraga fails to explicitly disclose the photoreceptor is positioned at an angle with respect to the light source such that the photoreceptor can only receive light from the light source that has been reflected from smoke in the gas.
Shelton teaches a gas recirculation system for use in managing a flow of gas (surgical evacuation system 50000; “the airflow path can contain a recirculation channel or secondary fluid channel back to the primary reservoir from downstream of the exhaust port of the main fluid management chamber.” [0285]), the system comprising a smoke detection sensor (reflective photoelectric sensor 51000; “A photoelectric sensor for detecting particles in the smoke can be a pass-through beam sensor, reflective sensor, or a diffuse sensor.” [0343]) comprising a light source (light source 51006) and a photoreceptor (photo detector 51004), wherein the photoreceptor is positioned at an angle with respect to the light source (Figure 20; “the photo detector 51004 in FIG. 20 is 90-degrees offset from the light source 51006.” [0343]) such that the photoreceptor can only receive light from the light source that has been reflected from smoke in the gas (“When smoke S obscures the light beam 51002 intermediate the light source 51006 and a light catcher 51008, the light is reflected and the reflected light 51010 is scattered toward a lens 51014 and onto the photo detector 51004.” [0343]; Figure 20).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the smoke detection sensor of Hiraga to further include the photoreceptor positioned at an angle with respect to the light source and photoreceptor, wherein the light source such that the photoreceptor can only receive light from the light source that has been reflected from smoke in the gas based on the teachings of Shelton to allow the smoke detection circuit to directly and accurately measure the particulate concentration of smoke passing through the gas flow path at a given time (Shelton [0342-0343]).
Regarding claim 10, modified Hiraga discloses the gas recirculation system of claim 1, wherein the smoke detection sensor is configured to transmit the output signal to the controller (“The color information of the filter 211 detected by the filter color detection unit 25 is input to the pump control unit 24.” [Page 4, 5th paragraph]).
Modified Hiraga fails to explicitly disclose the smoke detection sensor is configured to wirelessly transmit the output signal to the controller.
Shelton teaches a gas recirculation system for use in managing a flow of gas (surgical evacuation system 50000; “the airflow path can contain a recirculation channel or secondary fluid channel back to the primary reservoir from downstream of the exhaust port of the main fluid management chamber.” [0285]), the system comprising a sensor (external sensor 50432) configured to wirelessly transmit the output signal to a controller (processor 50408; “The communication device 50418 can allow the processor 50408 in the surgical evacuation system 50400 to communicate with other devices within a surgical system. For example, the communication device 50418 can allow wired and/or wireless communication to one or more external sensors 50432” [0274].
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the smoke detection sensor of Hiraga to wirelessly transmit the output signal to the controller based on the teachings of Shelton to allow the controller to communicate with both the sensor and other features of the gas recirculation system in a simple manner (Shelton [0274]).
Regarding claim 11, modified Hiraga discloses the gas recirculation system of claim 7.
Modified Hiraga fails to explicitly teach the light source is an infrared light source.
Shelton teaches a gas recirculation system for use in managing a flow of gas (surgical evacuation system 50000), the system comprising a smoke detection sensor (reflective photoelectric sensor 51000) comprising an optical sensor (reflective photoelectric sensor 51000) comprising an infrared light source (“In a photoelectric sensor for a surgical evacuation system, such as the sensor 51000 in FIG. 20 and/or the sensor 51100 in FIG. 21, the wavelength of the light can be selected to tune the sensor 51000 for specific types of smoke while ignoring other types of smoke. In certain instances, multiple sensors and/or multiple wavelengths can be used to dial the sensor 51000 into the right combination(s). Water vapor, even thick water vapor, absorbs light of a certain wavelength. For example, water vapor absorbs infrared light instead of reflecting it. Due to these absorption properties of water vapor, infrared light can be useful in the presence of water vapor to accurately count particles in the fluid in a surgical evacuation system.” [0345]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the smoke detection sensor of Hiraga to further include an infrared light source based on the teachings of Shelton to allow the smoke detection circuit to directly and accurately measure the particulate concentration of smoke passing through the gas flow path at a given time even in the presence of water vapor (Shelton [0345]).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Hiraga et al. (WO 2017057030) in view of Mantell et al. (US 20170000959), in further view of Silver (US 20190365417), and further in view of Radl et al. (US 20200268989).
Regarding claim 20, Hiraga discloses a gas recirculation system (Figures 1 and 2) for use in managing a flow of gas an endoscopic surgical procedure, the system comprising:
a first tube (suction tube 8) in fluid communication with a gas input connection (), wherein the first tube is configured to be connectable to surgical equipment (trocar 12b) that is insertable into a peritoneal cavity (Figure 1; “The circulation device 2 is connected to one end of a suction tube 8. The other end of the suction tube 8 is connected to the trocar 12b.” [Page 3, 8th paragraph]); and
a second tube (air support tube 9) in fluid communication with a gas output connection, wherein the second tube is configured to be connectable to surgical equipment (trocar 12c) that is insertable into a peritoneal cavity (Figure 1; “The circulation device 2 is connected to one end of an air supply tube 9 as an air supply line capable of supplying a predetermined gas in the vicinity of the distal end of the endoscope. The other end of the air supply tube 9 is connected to the trocar 12c.” [Page 3, 8th paragraph]);
a pump (pump 20) comprising: a motor (motor 22); and a pump cartridge (pumping member 21) coupled to the motor (Figure 2), wherein: the pump cartridge connects with the first tube (suction tube 8) at the gas input connection, and with the second tube (air supply tube 9) at the gas output connection (“The One end of the suction tube 8 and one end of the air supply tube 9 are connected to the pumping member 21.” [Page 4, 2nd paragraph]; Figure 2);
wherein the pump is configured to draw gas into the gas input connection from a peritoneal cavity through the first tube and to discharge gas out of the gas output connection and into a peritoneal cavity through the second tube (“the circulation device 2 sucks carbon dioxide gas including smoke generated by using the electric knife 11 through the suction tube 8 and the trocar 12b. After the smoke and mist are removed from the carbon dioxide gas in the circulation device 2, the carbon dioxide gas is returned to the body cavity of the patient 14 via the air supply tube 9 and the trocar 12c.” [Page 4, 3rd paragraph]);
a smoke detection sensor (filter 211 and filter color detection unit 25) positioned at the pump cartridge (“The pumping member 21 that performs suction and delivery of gas mainly includes a filter 211” [Page 4, 2nd paragraph]; Figure 2) and configured to measure an amount of smoke present in the gas (“The filter color detection unit 25 as a clogging state monitoring unit includes a commonly used color sensor or the like, and detects the color of the filter 211…The color information of the filter 211 detected by the filter color detection unit 25 is input to the pump control unit 24. The pump control unit 24 controls the rotation speed of the motor 22 based on the color information of the filter 211 input from the filter color detection unit 25. The filter 211 is white in a fresh state before use, but changes from yellow to brown to black as the fine particles such as smoke are adsorbed and captured. That is, the color of the filter 211 changes according to the degree of filter clogging.” [Page 4, 5th-6th paragraphs], wherein the color of the filter 211 is a measure of the amount of smoke present in the gas over time); and
a controller (pump control unit 24) configured to:
receive an output signal from the smoke detection sensor representative of an amount of smoke detected (“The color information of the filter 211 detected by the filter color detection unit 25 is input to the pump control unit 24…The filter 211 is white in a fresh state before use, but changes from yellow to brown to black as the fine particles such as smoke are adsorbed and captured. That is, the color of the filter 211 changes according to the degree of filter clogging.” [Page 4, 5th-6th paragraphs], wherein the color of the filter 211 is representative of the amount of smoke present in the gas over time);
and adjust a speed of the motor of the pump in response to the amount of smoke detected (“The pump control unit 24 controls the rotation speed of the motor 22 based on the color information of the filter 211 input from the filter color detection unit 25.” [Page 4, 6th paragraph] wherein the color of the filter 211 is representative of the amount of smoke detected in the gas over time).
Hiraga fails to explicitly disclose the pump cartridge is detachable from the motor and is sealed such that a gas within the pump cartridge cannot contact the motor, the system comprising a filter positioned along the second tube, the filter configured to remove smoke from the flow of gas through the second tube; a valve positioned along the first tube between the smoke detection sensor and the pump, the valve adjustable via the controller to bypass the pump and direct the flow of gas from the first tube to a suction exhaust tube; and wherein the controller is configured to adjust the valve to direct the flow of gas to the suction exhaust tube in response to the output signal indicating an amount of smoke above an evacuation threshold.
Mantell teaches a gas recirculation system (gas recirculation system 100) comprising a first tube (output tubing 225), a second tube (input tubing 220), a pump (recirculating pump 205) comprising a motor (motor 207) and a pump cartridge (cartridge 206) detachable from the motor (“Cartridge 206 may be disconnectable from motor 207” [0043]) and sealed such that a gas within the pump cartridge cannot contact the motor (“Cartridge 206 may be sealed so that it is only in fluid communication with the opening to inlet tubing 220 and outlet tubing 225. Accordingly, gas within cartridge 206 may not come in contact with motor 207 or other parts of recirculation pump 205.” [0043]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the pump and pump cartridge of Hiraga such that the pump cartridge is detachable from the motor and is sealed such that a gas within the pump cartridge cannot contact the motor based on the teachings of Mantell to prevent contamination of the motor and allow the motor to be reused without requiring sterilization (Mantell [0043]).
Modified Hiraga fails to explicitly disclose a filter positioned along the second tube, the filter configured to remove smoke from the flow of gas through the second tube; a valve positioned along the first tube between the smoke detection sensor and the pump, the valve adjustable via the controller to bypass the pump and direct the flow of gas from the first tube to a suction exhaust tube; and wherein the controller is configured to adjust the valve to direct the flow of gas to the suction exhaust tube in response to the output signal indicating an amount of smoke above an evacuation threshold.
Silver teaches a gas recirculation system (gas evacuation system 300) comprising a first tube (flow path 340) and a second tube (inlet flow path 310), a pump (pump 360), a smoke detection sensor (sensor 34; “Sensor 34 is operatively connected to the processor 370 for control of gas composition in the surgical cavity 16.” [0055]) configured to measure an amount of unwanted contaminants present in the gas (“The sensor 34 is configured for monitoring a plurality of gas species in the gas flow from a surgical cavity 16 of a patient” [0034]); a filter (filter 390; “filters 390 similar to those described above with reference to FIG. 1.” [0051]) positioned along the second tube (“A filter 32 is operatively associated with at least one of the inlet flow path 22 and the outlet flow path 24” [0042]; Figure 1 and 3), the filter configured to remove smoke from the flow of gas through the second tube (“A filter 32…for cleaning or otherwise conditioning the gas passing therethrough.” [0042]); and a valve (valve 392) positioned along the first tube between the smoke detection sensor (sensor 34) and the pump (pump 360; Figure 3), the valve adjustable via a controller (processor 370) to bypass the pump and direct the flow of gas from the first tube to a location outside of the gas flow path (“the processor can open valve 392 in order to bleed the methane out of the surgical cavity” [0055]; Figure 3); and wherein the controller is configured to adjust the valve to direct the flow of gas out of the gas flow path in response to an output signal from the smoke detection sensor indicating an amount of contaminants in the gas above an evacuation threshold (“System 300 can use the valves 392, 394 to bleed off unwanted gas species if the sensor 34 reads presence and/or concentration of a potentially harmful gas. For example, the gas sensor 34 reads 10% methane, the processor can open valve 392 in order to bleed the methane out of the surgical cavity...the smoke evacuator shown in FIG. 3 detects the methane, opens valve 392 to bleed the methane off, which creates an under pressure that the insufflator will sense and flow in carbon dioxide to compensate.” [0055]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the gas recirculation system of Hiraga to further include a filter positioned along the second tube, the filter configured to remove smoke from the flow of gas through the second tube based on the teachings of Silver to clean the gas passing through the second tube (Silver [0042]) and to modify the gas recirculation system having a smoke detection sensor that produces an output signal representative of an amount of smoke present in the gas as disclosed by Hiraga to further include a valve positioned along the first tube between the smoke detection sensor and the pump, the valve adjustable via the controller to bypass the pump and direct the flow of gas from the first tube to a suction exhaust tube in response to the output signal indicating an amount of smoke above an evacuation threshold based on the teachings of Silver to remove harmful gas from the gas flow path (Silver [0055]).
Modified Hiraga fails to explicitly teach the valve directs the flow of gas from the first tube to a suction exhaust tube.
Radl teaches a gas circulation system (system 20), the system comprising a first tube (flexible tube 18A), and a valve (regulator device 22) adjustable to direct the flow of gas from the first tube to a suction exhaust tube (flexible tube 22D; “The third device port 22C is coupled to the vacuum source, e.g., the hospital's suction line, via a flexible tube 22D.” [0086]; “The dial 30 of the regulator device will be rotated to a desired position to establish a set point pressure at which the valve will open…Thus, when the monitored pressure exceeds the set point…the valve 46A will automatically open to bring the passageway 32F and its associated port 22B into fluid communication with the passageway 32G and its associated port 22C. Accordingly, the suction applied at port 22C will draw smoke 4 from within the laparoscopic field through the trocar 18, the associated flexible tube 18A, and the port 22B to the vacuum source, thereby clearing the laparoscopic field of smoke.” [0097]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the valve of the gas recirculation system of Hiraga in view of Silver to direct the flow of gas from the first tube to a suction exhaust tube based on the teachings of Radl to clear the laparoscopic field and operating room of smoke (Radl [0097]).
Claims 21 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Hiraga et al. (WO 2017057030) in view of Silver (US 20190365417), and further in view of Radl et al. (US 20200268989) as applied in claims 1 and 14 above, and further in view of Marman et al. (USPN 5945924).
Regarding claim 21, modified Hiraga in view of Silver and Radl teaches the gas recirculation system of claim 1.
Modified Hiraga fails to explicitly disclose the output signal includes a percentage of light attenuation sensed; and wherein the threshold includes a percentage of light attenuation and a duration of the percentage of light attenuation.
Marman teaches a smoke detection sensor (smoke detector 300 of fire detector 100) configured to measure an amount of smoke present and to output an output signal (output 310) including a percentage of light attenuation sensed (“an output 310 of a smoke detector 300 exceeds a threshold level A.sub.1 of 3% light obscuration per 0.3048 meter (1 foot) for greater than a first preselected time A.sub.2 of two minutes. Smoke concentration is typically measured in units of "percent light obscuration per 0.3048 meter (1 foot)." This terminology is derived from the use of projected beam or extinguishment photoelectric smoke detectors in which a beam of light is projected through air and the attenuation of the light beam by particles is measured.” [Col 5, lines 54-64], see also [Col 6, lines 35-47]); and initiate an alarm in response to the output signal indicating an amount of smoke above an evacuation threshold that includes a percentage of light attenuation and a duration of the percentage of light attenuation (“First, an alarm signal 51 will be generated if an output 310 of a smoke detector 300 exceeds a threshold level A.sub.1 of 3% light obscuration per 0.3048 meter (1 foot) for greater than a first preselected time A.sub.2 of two minutes” [Col 5, lines 54-58]; “Second, an alarm signal 51 will be generated if output 310 from smoke detector 300 exceeds a reduced threshold level B.sub.1 of 1% light obscuration per 0.3048 meter (1 foot) for greater than a second preselected time B.sub.2 of 5 to 15 minutes.” [Col 6, lines 3-6]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the output signal of the smoke detection sensor of Hiraga to include a percentage of light attenuation and to modify the evacuation threshold of Hiraga in view of Silver to include a percentage of light attenuation and a duration of the percentage of light attenuation based on the teachings of Marman to allow for the quick detection of excess smoke while minimizing false alarms (Marman [Col 4, lines 20-30]) which could lead to prematurely redirected the flow of gas and disruption of the gas recirculation system.
Regarding claim 23, modified Hiraga in view of Silver and Radl teaches the gas recirculation system of claim 14.
Modified Hiraga fails to explicitly disclose the output signal includes a percentage of light attenuation sensed; and wherein the threshold includes a percentage of light attenuation and a duration of the percentage of light attenuation.
Marman teaches a smoke detection sensor (smoke detector 300 of fire detector 100) configured to measure an amount of smoke present and to output an output signal (output 310) including a percentage of light attenuation sensed (“an output 310 of a smoke detector 300 exceeds a threshold level A.sub.1 of 3% light obscuration per 0.3048 meter (1 foot) for greater than a first preselected time A.sub.2 of two minutes. Smoke concentration is typically measured in units of "percent light obscuration per 0.3048 meter (1 foot)." This terminology is derived from the use of projected beam or extinguishment photoelectric smoke detectors in which a beam of light is projected through air and the attenuation of the light beam by particles is measured.” [Col 5, lines 54-64], see also [Col 6, lines 35-47]); and initiate an alarm in response to the output signal indicating an amount of smoke above an evacuation threshold that includes a percentage of light attenuation and a duration of the percentage of light attenuation (“First, an alarm signal 51 will be generated if an output 310 of a smoke detector 300 exceeds a threshold level A.sub.1 of 3% light obscuration per 0.3048 meter (1 foot) for greater than a first preselected time A.sub.2 of two minutes” [Col 5, lines 54-58]; “Second, an alarm signal 51 will be generated if output 310 from smoke detector 300 exceeds a reduced threshold level B.sub.1 of 1% light obscuration per 0.3048 meter (1 foot) for greater than a second preselected time B.sub.2 of 5 to 15 minutes.” [Col 6, lines 3-6]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the output signal of the smoke detection sensor of Hiraga to include a percentage of light attenuation and to modify the evacuation threshold of Hiraga in view of Silver to include a percentage of light attenuation and a duration of the percentage of light attenuation based on the teachings of Marman to allow for the quick detection of excess smoke while minimizing false alarms (Marman [Col 4, lines 20-30]) which could lead to prematurely redirected the flow of gas and disruption of the gas recirculation system.
Response to Arguments
Applicant's arguments filed December 22, 2025 have been fully considered but they are not persuasive.
Regarding the argument that the prior art of record, specifically Hiraga et al. (WO 2017057030) in view of Silver (US 20190365417), fails to explicitly teach or suggest “the controller configured to:…adjust the valve to direct the flow of gas to the suction exhaust tube in response to the output signal indicating an amount of smoke above an evacuation threshold” as required by independent claims 1, 14, and 20 (Remarks Pages 9-10), the examiner respectfully disagrees. As detailed above, Silver discloses a gas recirculation system (300) comprising a smoke detection sensor (34) configured to measure an amount of unwanted contaminants present in the gas (“The sensor 34 is configured for monitoring a plurality of gas species in the gas flow from a surgical cavity 16 of a patient” [0034]); and a valve (392) adjustable via a controller to bypass the pump and direct the flow of gas from the first tube to a location outside of the gas flow path ([0055]); and the controller is configured to adjust the valve to direct the flow of gas out of the gas flow path in response to an output signal from the smoke detection sensor indicating an amount of contaminants in the gas above an evacuation threshold (“System 300 can use the valves 392, 394 to bleed off unwanted gas species if the sensor 34 reads presence and/or concentration of a potentially harmful gas. For example, the gas sensor 34 reads 10% methane, the processor can open valve 392 in order to bleed the methane out of the surgical cavity...the smoke evacuator shown in FIG. 3 detects the methane, opens valve 392 to bleed the methane off, which creates an under pressure that the insufflator will sense and flow in carbon dioxide to compensate.” [0055]). Though Silver does not explicitly disclose that the smoke detection sensor is configured to measure an amount of smoke present in the gas, Hiraga, rather than Silver, was relied upon for this limitation. Hiraga discloses a smoke detection sensor (211 and 25) configured to measure an amount of smoke present in the gas ([Page 4, 5th-6th paragraphs]). Therefore, it is maintained that one having ordinary skill in the art would have found it obvious to modify the gas recirculation system having a smoke detection sensor that produces and output signal representative of an amount of smoke present in the gas disclosed by Hiraga to further include a valve positioned along the first tube between the smoke detection sensor and the pump, the valve adjustable via the controller to bypass the pump and direct the flow of gas from the first tube to a suction exhaust tube in response to the output signal indicating an amount of smoke above an evacuation threshold based on the teachings of Silver to remove harmful gas from the gas flow path (Silver [0055]).
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “senses a density…of smoke within the surgical cavity and remove smoke from the surgical cavity to increase visibility within the cavity”, see Remarks Page 10) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicant’s arguments with respect to new claims 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.
Conclusion
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/LEAH J SWANSON/Examiner, Art Unit 3783 /KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783