DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendment filed on 2/2/2026 has been entered. Claims 1-20 are pending in the application. Claims 11 and 20 remain withdrawn.
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, 10, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Brown et al. (US 5,417,703 A) in view of Desai (US 5,395,312 A).
Regarding claim 1, Brown discloses a control apparatus (pumps 54 and 48, pump regulators, and cutter actuating device 23, see col. 4 line 56-col. 5 line 8) for an elongated tubular medical device (thrombectomy device 10) configured to be inserted into a living body (see Figs. 1-6, col. 3 lines 23-35), the elongated tubular medical device (thrombectomy device 10) having a distal portion in which a treatment unit (cutting elements 28 and 34) configured to cut an object forming a stenosis or an occlusion in a biological lumen is disposed (see Fig. 4, col. 5 lines 18-36, col. 5 lines 56-61), the control apparatus (pumps 54 and 48, pump regulators, and cutter actuating device 23, see col. 4 line 56-col. 5 line 8) comprising:
an aspiration source (vacuum pump 54) or a liquid delivering source (fluid supply means 48) connected to the elongated tubular medical device (thrombectomy device 10) (see Fig. 1, col. 4 line 56-col. 5 line 4);
a control unit (pump regulators, see col. 4 line 56-col. 5 line 4) configured to control a flow rate of a fluid flowing inside the elongated tubular medical device (thrombectomy device 10) (see Fig. 1, col. 4 line 56-col. 5 line 4, fluid flow to/from pumps 54 and 48 is adjustable/regulatable); and
a) wherein in a case where the aspiration source (vacuum pump 54) is connected to the elongated tubular medical device (thrombectomy device 10), the control unit (pump regulators, see col. 4 line 56-col. 5 line 4) is configured to control the aspiration source (vacuum pump 54) to aspirate the fluid inside the elongated tubular medical device (thrombectomy device 10) via an aspiration lumen (lumen 30, see col. 4 lines 56-64, col. 5 lines 56-61) at a first flow rate during a treatment period of the treatment unit (cutting elements 28 and 34) (see col. 5 lines 56-61, suction is applied to lumen 30 at a rate while the cutting elements 28 and 34 are rotating), the aspiration lumen (lumen 30) surrounding an outer surface of an inner sheath (inner shaft 26) of the elongated tubular medical device (thrombectomy device 10) and within an outer sheath (inner tube 32) of the elongated tubular medical device (thrombectomy device 10) (see Figs. 5-6, col. 5 lines 24-31, col. 5 lines 37-61), the inner sheath (inner shaft 26) including a liquid delivering lumen (lumen 24, see col. 5 lines 37-61) in communication with the liquid delivering source (fluid supply means 48) (see Figs. 1 and 5-6, col. 4 line 65-col. 5 line 4, col. 5 lines 37-61), the treatment period including rotating the treatment unit (cutting elements 28 and 34) to cut the object forming the stenosis or the occlusion in the biological lumen (see Fig. 4, col. 3 lines 23-35, col. 5 lines 18-36, col. 5 lines 56-61), or
b) wherein in a case where the liquid delivering source (fluid supply means 48) is connected to the elongated tubular medical device (thrombectomy device 10), the control unit (pump regulators, see col. 4 line 56-col. 5 line 4) is configured to control the liquid delivering source (fluid supply means 48) to deliver the fluid into the elongated tubular medical device (thrombectomy device 10) at a third flow rate during the treatment period of the treatment unit (cutting elements 28 and 34) (see col. 5 lines 56-61, fluid is supplied to lumen 24 at a rate while the cutting elements 28 and 34 are rotating).
However, Brown fails to expressly state wherein the fluid inside the elongated tubular medical device is aspirated at a second constant flow rate lower than the first flow rate during a period other than the treatment period, while the elongated tubular medical device is inserted into the living body, or wherein the fluid is delivered into the elongated tubular medical device at a fourth constant flow rate lower than the third flow rate during the period other than the treatment period, while the elongated tubular medical device is inserted into the living body.
Brown teaches a control apparatus for an elongated tubular medical device (see Fig. 10, col. 9 lines 8-38, col. 9 lines 56-65) wherein the fluid inside the elongated tubular medical device (see Fig. 10) is aspirated at a second constant flow rate lower than the first flow rate during a period other than the treatment period (see col. 9 lines 8-38, col. 9 lines 56-65, aspiration rates are regulated by button 294 and trigger 218 and cutting rates are also regulated by trigger 218 such that a particular aspiration rate occurs at a particular trigger pressure/cutting rate and another aspiration rate occurs at another trigger pressure/cutting rate), while the elongated tubular medical device is inserted into the living body (see Fig. 10, col. 2 lines 33-37), or wherein the fluid is delivered into the elongated tubular medical device (see Fig. 10) at a fourth constant flow rate lower than the third flow rate during the period other than the treatment period (see col. 9 lines 8-38, col. 9 lines 56-65, irrigation rates are regulated by button 294 and trigger 218 and cutting rates are also regulated by trigger 218 such that a particular irrigation rate occurs at a particular trigger pressure/cutting rate and another irrigation rate occurs at another trigger pressure/cutting rate), while the elongated tubular medical device is inserted into the living body (see Fig. 10, col. 2 lines 33-37).
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 control apparatus of Brown to include wherein the fluid inside the elongated tubular medical device is aspirated at a second constant flow rate lower than the first flow rate during a period other than the treatment period, while the elongated tubular medical device is inserted into the living body, or wherein the fluid is delivered into the elongated tubular medical device at a fourth constant flow rate lower than the third flow rate during the period other than the treatment period, while the elongated tubular medical device is inserted into the living body, in order to allow the surgeon to easily and directly control the rates of cutting, irrigation, and aspiration during the surgical procedure (see Desai col. 2 lines 33-49, col. 9 lines 33-38, col. 9 lines 56-65).
Regarding claim 4, modified Brown teaches the control apparatus according to claim 1 substantially as claimed. Modified Brown further teaches wherein during the period other than the treatment period, while the elongated tubular medical device (Brown, thrombectomy device 10) is inserted into the living body, the control unit (Brown, pump regulators, see col. 4 line 56-col. 5 line 4) is configured to rotate the elongated tubular medical device (Brown, thrombectomy device 10) at a lower speed than during the treatment period (see previous modifications in rejection of claim 1 above, see Desai col. 9 lines 8-38, col. 9 lines 56-65, cutting rates are regulated by trigger 218 such that a particular cutting rate occurs at a particular trigger pressure and another cutting rate occurs at another trigger pressure, by which one cutting rate would necessarily be lower than the other cutting rate).
Regarding claim 10, Brown discloses a control apparatus (pumps 54 and 48, pump regulators, and cutter actuating device 23, see col. 4 line 56-col. 5 line 8) for an elongated tubular medical device (thrombectomy device 10) configured to be inserted into a living body (see Figs. 1-6, col. 3 lines 23-35), the elongated tubular medical device (thrombectomy device 10) having a distal portion in which a treatment unit (cutting elements 28 and 34) configured to cut an object forming a stenosis or an occlusion in a biological lumen is disposed (see Fig. 4, col. 5 lines 18-36, col. 5 lines 56-61), the control apparatus (pumps 54 and 48, pump regulators, and cutter actuating device 23, see col. 4 line 56-col. 5 line 8) comprising:
an aspiration source (vacuum pump 54) connected to the elongated tubular medical device (thrombectomy device 10) (see Fig. 1, col. 4 line 56-col. 5 line 4);
a liquid delivering source (fluid supply means 48) connected to the elongated tubular medical device (thrombectomy device 10) (see Fig. 1, col. 4 line 56-col. 5 line 4);
a control unit (pump regulators, see col. 4 line 56-col. 5 line 4) configured to control a flow rate of a fluid flowing inside the elongated tubular medical device (thrombectomy device 10) (see Fig. 1, col. 4 line 56-col. 5 line 4, fluid flow to/from pumps 54 and 48 is adjustable/regulatable); and
wherein the control unit (pump regulators, see col. 4 line 56-col. 5 line 4) is configured to control the aspiration source (vacuum pump 54) to aspirate the fluid inside the elongated tubular medical device (thrombectomy device 10) via an aspiration lumen (lumen 30, see col. 4 lines 56-64, col. 5 lines 56-61) at a first flow rate during a treatment period of the treatment unit (cutting elements 28 and 34) (see col. 5 lines 56-61, suction is applied to lumen 30 at a rate while the cutting elements 28 and 34 are rotating), the aspiration lumen (lumen 30) surrounding an outer surface of an inner sheath (inner shaft 26) of the elongated tubular medical device (thrombectomy device 10) and within an outer sheath (inner tube 32) of the elongated tubular medical device (thrombectomy device 10) (see Figs. 5-6, col. 5 lines 24-31, col. 5 lines 37-61), the inner sheath (inner shaft 26) including a liquid delivering lumen (lumen 24, see col. 5 lines 37-61) in communication with the liquid delivering source (fluid supply means 48) (see Figs. 1 and 5-6, col. 4 line 65-col. 5 line 4, col. 5 lines 37-61), the treatment period including rotating the treatment unit (cutting elements 28 and 34) to cut the object forming the stenosis or the occlusion in the biological lumen (see Fig. 4, col. 3 lines 23-35, col. 5 lines 18-36, col. 5 lines 56-61), and
wherein the control unit (pump regulators, see col. 4 line 56-col. 5 line 4) is configured to control the liquid delivering source (fluid supply means 48) to deliver the fluid into the elongated tubular medical device (thrombectomy device 10) at a third flow rate during the treatment period of the treatment unit (cutting elements 28 and 34) (see col. 5 lines 56-61, fluid is supplied to lumen 24 at a rate while the cutting elements 28 and 34 are rotating).
However, Brown fails to expressly state wherein the fluid inside the elongated tubular medical device is aspirated at a second constant flow rate lower than the first flow rate during a period other than the treatment period, while the elongated tubular medical device is inserted into the living body, and wherein the fluid is delivered into the elongated tubular medical device at a fourth constant flow rate lower than the third flow rate during the period other than the treatment period, while the elongated tubular medical device is inserted into the living body.
Brown teaches a control apparatus for an elongated tubular medical device (see Fig. 10, col. 9 lines 8-38, col. 9 lines 56-65) wherein the fluid inside the elongated tubular medical device (see Fig. 10) is aspirated at a second constant flow rate lower than the first flow rate during a period other than the treatment period (see col. 9 lines 8-38, col. 9 lines 56-65, aspiration rates are regulated by button 294 and trigger 218 and cutting rates are also regulated by trigger 218 such that a particular aspiration rate occurs at a particular trigger pressure/cutting rate and another aspiration rate occurs at another trigger pressure/cutting rate), while the elongated tubular medical device is inserted into the living body (see Fig. 10, col. 2 lines 33-37), and wherein the fluid is delivered into the elongated tubular medical device (see Fig. 10) at a fourth constant flow rate lower than the third flow rate during the period other than the treatment period (see col. 9 lines 8-38, col. 9 lines 56-65, irrigation rates are regulated by button 294 and trigger 218 and cutting rates are also regulated by trigger 218 such that a particular irrigation rate occurs at a particular trigger pressure/cutting rate and another irrigation rate occurs at another trigger pressure/cutting rate), while the elongated tubular medical device is inserted into the living body (see Fig. 10, col. 2 lines 33-37).
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 control apparatus of Brown to include wherein the fluid inside the elongated tubular medical device is aspirated at a second constant flow rate lower than the first flow rate during a period other than the treatment period, while the elongated tubular medical device is inserted into the living body, and wherein the fluid is delivered into the elongated tubular medical device at a fourth constant flow rate lower than the third flow rate during the period other than the treatment period, while the elongated tubular medical device is inserted into the living body, in order to allow the surgeon to easily and directly control the rates of cutting, irrigation, and aspiration during the surgical procedure (see Desai col. 2 lines 33-49, col. 9 lines 33-38, col. 9 lines 56-65).
Regarding claim 15, modified Brown teaches the control apparatus according to claim 10 substantially as claimed. Modified Brown further teaches wherein during the period other than the treatment period, while the elongated tubular medical device (Brown, thrombectomy device 10) is inserted into the living body, the control unit (Brown, pump regulators, see col. 4 line 56-col. 5 line 4) is configured to rotate the elongated tubular medical device (Brown, thrombectomy device 10) at a lower speed than during the treatment period (see previous modifications in rejection of claim 10 above, see Desai col. 9 lines 8-38, col. 9 lines 56-65, cutting rates are regulated by trigger 218 such that a particular cutting rate occurs at a particular trigger pressure and another cutting rate occurs at another trigger pressure, by which one cutting rate would necessarily be lower than the other cutting rate).
Claims 2-3 and 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Brown et al. (US 5,417,703 A) in view of Desai (US 5,395,312 A), as applied to claims 1 and 10 above, further in view of Higgins et al. (US 2015/0201956 A1).
Regarding claim 2, modified Brown teaches the control apparatus according to claim 1 substantially as claimed. However, modified Brown fails to explicitly state wherein in the case where the aspiration source is connected to the elongated tubular medical device, when priming is performed on the elongated tubular medical device, the control unit is configured to cause the aspiration source to aspirate the fluid at a flow rate higher than the second constant flow rate.
Higgins teaches a control apparatus (see Figs. 1-4) wherein in the case where the aspiration source is connected to the elongated tubular medical device (see par. [0006]-[0007]), when priming is performed on the elongated tubular medical device (see par. [0068]), the control unit is configured to cause the aspiration source to aspirate the fluid at a flow rate higher than the second constant flow rate (see par. [0006]-[0007] and [0068], priming the pump causes the flow rate to be higher than the flow rate for regular operation).
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 control apparatus of modified Brown to include wherein in the case where the aspiration source is connected to the elongated tubular medical device, when priming is performed on the elongated tubular medical device, the control unit is configured to cause the aspiration source to aspirate the fluid at a flow rate higher than the second constant flow rate, as taught by Higgins, in order to flush the elongated tubular medical device and get any initial air out of it (see Higgins par. [0068]).
Regarding claim 3, modified Brown teaches the control apparatus according to claim 1 substantially as claimed. However, modified Brown fails to explicitly state wherein in the case where the liquid delivering source is connected to the elongated tubular medical device, when priming is performed on the elongated tubular medical device, the control unit is configured to cause the liquid delivering source to deliver the fluid at a flow rate higher than the fourth constant flow rate.
Higgins teaches a control apparatus (see Figs. 1-4) wherein in the case where the liquid delivering source is connected to the elongated tubular medical device (see par. [0065]), when priming is performed on the elongated tubular medical device (see par. [0068]), the control unit is configured to cause the liquid delivering source to deliver the fluid at a flow rate higher than the fourth constant flow rate (see par. [0065] and [0068], priming the pump causes the flow rate to be higher than the flow rate for regular operation).
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 control apparatus of modified Brown to include wherein in the case where the liquid delivering source is connected to the elongated tubular medical device, when priming is performed on the elongated tubular medical device, the control unit is configured to cause the liquid delivering source to deliver the fluid at a flow rate higher than the fourth constant flow rate, as taught by Higgins, in order to flush the elongated tubular medical device and get any initial air out of it (see Higgins par. [0068]).
Regarding claim 13, modified Brown teaches the control apparatus according to claim 10 substantially as claimed. However, modified Brown fails to explicitly state wherein when priming is performed on the elongated tubular medical device, the control unit is configured to cause the aspiration source to aspirate the fluid at a flow rate higher than the second constant flow rate.
Higgins teaches a control apparatus (see Figs. 1-4) wherein when priming is performed on the elongated tubular medical device (see par. [0068]), the control unit is configured to cause the aspiration source to aspirate the fluid at a flow rate higher than the second constant flow rate (see par. [0006]-[0007] and [0068], priming the pump causes the flow rate to be higher than the flow rate for regular operation).
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 control apparatus of modified Brown to include wherein when priming is performed on the elongated tubular medical device, the control unit is configured to cause the aspiration source to aspirate the fluid at a flow rate higher than the second constant flow rate, as taught by Higgins, in order to flush the elongated tubular medical device and get any initial air out of it (see Higgins par. [0068]).
Regarding claim 14, modified Brown teaches the control apparatus according to claim 10 substantially as claimed. However, modified Brown fails to explicitly state wherein when priming is performed on the elongated tubular medical device, the control unit is configured to cause the liquid delivering source to deliver the fluid at a flow rate higher than the fourth constant flow rate.
Higgins teaches a control apparatus (see Figs. 1-4) wherein when priming is performed on the elongated tubular medical device (see par. [0068]), the control unit is configured to cause the liquid delivering source to deliver the fluid at a flow rate higher than the fourth constant flow rate (see par. [0065] and [0068], priming the pump causes the flow rate to be higher than the flow rate for regular operation).
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 control apparatus of modified Brown to include wherein when priming is performed on the elongated tubular medical device, the control unit is configured to cause the liquid delivering source to deliver the fluid at a flow rate higher than the fourth constant flow rate, as taught by Higgins, in order to flush the elongated tubular medical device and get any initial air out of it (see Higgins par. [0068]).
Claims 5-8 and 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Brown et al. (US 5,417,703 A) in view of Desai (US 5,395,312 A), as applied to claims 1 and 10 above, further in view of Shelton, IV et al. (US 2019/0059980 A1, hereinafter referred to as "Shelton").
Regarding claim 5, modified Brown teaches the control apparatus according to claim 1 substantially as claimed. However, modified Brown fails to state a sensor unit configured to detect a state where the elongated tubular medical device is inserted into the living body; and wherein in the case where the aspiration source is connected to the elongated tubular medical device, the control unit is configured to cause the fluid inside the elongated tubular medical device to flow at the second constant flow rate during the period other than the treatment period, while the sensor unit detects the state where the elongated tubular medical device is inserted into the living body.
Shelton teaches a control apparatus (see Figs. 2-3 and 22) comprising: a sensor unit (see par. [0171]) configured to detect a state where the elongated tubular medical device (surgical tool 300) is inserted into the living body (see par. [0112]-[0113], [0157], and [0171]); and wherein in the case where the aspiration source (vacuum source 334) is connected to the elongated tubular medical device (surgical tool 300), the control unit (control system 342) is configured to cause the fluid inside the elongated tubular medical device (surgical tool 300) to flow at the constant second flow rate during the period other than the treatment period, while the sensor unit (see par. [0171]) detects the state where the elongated tubular medical device (surgical tool 300) is inserted into the living body (see par. [0112]-[0113], [0157], and [0171], a sensor determines the degree to which the surgical tool 300 is contacting tissue (i.e. inserted into the living body) and the flow rate is reduced as the surgical tool 300 is lifted from the tissue).
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 control apparatus of modified Brown to include a sensor unit configured to detect a state where the elongated tubular medical device is inserted into the living body; and wherein in the case where the aspiration source is connected to the elongated tubular medical device, the control unit is configured to cause the fluid inside the elongated tubular medical device to flow at the second constant flow rate during the period other than the treatment period, while the sensor unit detects the state where the elongated tubular medical device is inserted into the living body, as taught by Shelton, in order to ensure that the cutting treatment, fluid delivery, and aspiration are occurring when the elongated tubular medical device is actually in contact with the treatment site and that they are only occurring within desirable thresholds (see Shelton par. [0112]-[0113], [0157]-[0158]).
Regarding claim 6, modified Brown teaches the control apparatus according to claim 1 substantially as claimed. However, modified Brown fails to state a sensor unit configured to detect a state where the elongated tubular medical device is inserted into the living body; and wherein in the case where the liquid delivering source is connected to the elongated tubular medical device, the control unit is configured to cause the fluid inside the elongated tubular medical device to flow at the fourth constant flow rate during the period other than the treatment period, while the sensor unit detects the state where the elongated tubular medical device is inserted into the living body.
Shelton teaches a control apparatus (see Figs. 2-3 and 22) comprising: a sensor unit (see par. [0171]) configured to detect a state where the elongated tubular medical device (surgical tool 300) is inserted into the living body (see par. [0112]-[0113], [0157], and [0171]); and wherein in the case where the liquid delivering source (fluid source 324) is connected to the elongated tubular medical device (surgical tool 300), the control unit (control system 342) is configured to cause the fluid inside the elongated tubular medical device (surgical tool 300) to flow at the fourth constant flow rate during the period other than the treatment period, while the sensor unit (see par. [0171]) detects the state where the elongated tubular medical device (surgical tool 300) is inserted into the living body (see par. [0112]-[0113], [0157], and [0171], a sensor determines the degree to which the surgical tool 300 is contacting tissue (i.e. inserted into the living body) and the flow rate is reduced as the surgical tool 300 is lifted from the tissue).
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 control apparatus of modified Brown to include a sensor unit configured to detect a state where the elongated tubular medical device is inserted into the living body; and wherein in the case where the liquid delivering source is connected to the elongated tubular medical device, the control unit is configured to cause the fluid inside the elongated tubular medical device to flow at the fourth constant flow rate during the period other than the treatment period, while the sensor unit detects the state where the elongated tubular medical device is inserted into the living body, as taught by Shelton, in order to ensure that the cutting treatment, fluid delivery, and aspiration are occurring when the elongated tubular medical device is actually in contact with the treatment site and that they are only occurring within desirable thresholds (see Shelton par. [0112]-[0113], [0157]-[0158]).
Regarding claim 7, modified Brown teaches the control apparatus according to claim 1 substantially as claimed. However, modified Brown fails to state a temporary stop operation unit configured to temporarily stop aspiration, in the case where the aspiration source is connected to the elongated tubular medical device, when the control unit causes the aspiration source to aspirate the fluid inside the elongated tubular medical device at the second constant flow rate.
Shelton teaches a control apparatus (see Figs. 2-3 and 22) comprising: a temporary stop operation unit (see par. [0112]-[0113]) configured to temporarily stop aspiration, in the case where the aspiration source (vacuum source 334) is connected to the elongated tubular medical device (surgical tool 300), when the control unit (control system 342) causes the aspiration source (vacuum source 334) to aspirate the fluid inside the elongated tubular medical device (surgical tool 300) at the second constant flow rate (see par. [0112]-[0113] and [0190]; control system 342 can reduce the speed of or stop the motor/pump and the aspiration flow rate is determined by the speed of the motor/pump).
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 control apparatus of modified Brown to include a temporary stop operation unit configured to temporarily stop aspiration, in the case where the aspiration source is connected to the elongated tubular medical device, when the control unit causes the aspiration source to aspirate the fluid inside the elongated tubular medical device at the second constant flow rate, as taught by Shelton, in order to function as a closed feedback loop which ensures that the cutting treatment, fluid delivery, and aspiration are occurring only within desirable thresholds (see Shelton par. [0112]-[0113]).
Regarding claim 8, modified Brown teaches the control apparatus according to claim 1 substantially as claimed. However, modified Brown fails to state a temporary stop operation unit configured to temporarily stop liquid delivering, in the case where the liquid delivering source is connected to the elongated tubular medical device, when the control unit causes the liquid delivering source to deliver the fluid into the elongated tubular medical device at the fourth constant flow rate.
Shelton teaches a control apparatus (see Figs. 2-3 and 22) comprising: a temporary stop operation unit (see par. [0113]) configured to temporarily stop liquid delivering, in the case where the liquid delivering source (fluid source 324) is connected to the elongated tubular medical device (surgical tool 300), when the control unit (control system 342) causes the liquid delivering source (fluid source 324) to deliver the fluid into the elongated tubular medical device (surgical tool 300) at the fourth constant flow rate (see par. [0113] and [0190]; control system 342 can reduce the speed of or stop the motor/pump and the liquid delivering flow rate is determined by the speed of the motor/pump).
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 control apparatus of modified Brown to include a temporary stop operation unit configured to temporarily stop liquid delivering, in the case where the liquid delivering source is connected to the elongated tubular medical device, when the control unit causes the liquid delivering source to deliver the fluid into the elongated tubular medical device at the fourth constant flow rate, as taught by Shelton, in order to function as a closed feedback loop which ensures that the cutting treatment, fluid delivery, and aspiration are occurring only within desirable thresholds (see Shelton par. [0112]-[0113]).
Regarding claim 16, modified Brown teaches the control apparatus according to claim 10 substantially as claimed. However, modified Brown fails to state a sensor unit that detects a state where the elongated tubular medical device is inserted into the living body; and wherein the control unit is configured to cause the fluid inside the elongated tubular medical device to flow at the second constant flow rate during the period other than the treatment period, while the sensor unit detects the state where the elongated tubular medical device is inserted into the living body.
Shelton teaches a control apparatus (see Figs. 2-3 and 22) comprising: a sensor unit (see par. [0171]) that detects a state where the elongated tubular medical device (surgical tool 300) is inserted into the living body (see par. [0112]-[0113], [0157], and [0171]); and wherein the control unit (control system 342) is configured to cause the fluid inside the elongated tubular medical device (surgical tool 300) to flow at the constant second flow rate during the period other than the treatment period, while the sensor unit (see par. [0171]) detects the state where the elongated tubular medical device (surgical tool 300) is inserted into the living body (see par. [0112]-[0113], [0157], and [0171], a sensor determines the degree to which the surgical tool 300 is contacting tissue (i.e. inserted into the living body) and the flow rate is reduced as the surgical tool 300 is lifted from the tissue).
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 control apparatus of modified Brown to include a sensor unit that detects a state where the elongated tubular medical device is inserted into the living body; and wherein the control unit is configured to cause the fluid inside the elongated tubular medical device to flow at the second constant flow rate during the period other than the treatment period, while the sensor unit detects the state where the elongated tubular medical device is inserted into the living body, as taught by Shelton, in order to ensure that the cutting treatment, fluid delivery, and aspiration are occurring when the elongated tubular medical device is actually in contact with the treatment site and that they are only occurring within desirable thresholds (see Shelton par. [0112]-[0113], [0157]-[0158]).
Regarding claim 17, modified Brown teaches the control apparatus according to claim 10 substantially as claimed. However, modified Brown fails to state a sensor unit that detects a state where the elongated tubular medical device is inserted into the living body; and wherein the control unit is configured to cause the fluid inside the elongated tubular medical device to flow at the fourth constant flow rate during the period other than the treatment period, while the sensor unit detects the state where the elongated tubular medical device is inserted into the living body.
Shelton teaches a control apparatus (see Figs. 2-3 and 22) comprising: a sensor unit (see par. [0171]) that detects a state where the elongated tubular medical device (surgical tool 300) is inserted into the living body (see par. [0112]-[0113], [0157], and [0171]); and wherein the control unit (control system 342) is configured to cause the fluid inside the elongated tubular medical device (surgical tool 300) to flow at the fourth constant flow rate during the period other than the treatment period, while the sensor unit (see par. [0171]) detects the state where the elongated tubular medical device (surgical tool 300) is inserted into the living body (see par. [0112]-[0113], [0157], and [0171], a sensor determines the degree to which the surgical tool 300 is contacting tissue (i.e. inserted into the living body) and the flow rate is reduced as the surgical tool 300 is lifted from the tissue).
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 control apparatus of modified Brown to include a sensor unit that detects a state where the elongated tubular medical device is inserted into the living body; and wherein the control unit is configured to cause the fluid inside the elongated tubular medical device to flow at the fourth constant flow rate during the period other than the treatment period, while the sensor unit detects the state where the elongated tubular medical device is inserted into the living body, as taught by Shelton, in order to ensure that the cutting treatment, fluid delivery, and aspiration are occurring when the elongated tubular medical device is actually in contact with the treatment site and that they are only occurring within desirable thresholds (see Shelton par. [0112]-[0113], [0157]-[0158]).
Regarding claim 18, modified Brown teaches the control apparatus according to claim 10 substantially as claimed. However, modified Brown fails to state a temporary stop operation unit configured to temporarily stop aspiration, and wherein the control unit is configured to cause the aspiration source to aspirate the fluid inside the elongated tubular medical device at the second constant flow rate, or a temporary stop operation unit configured to temporarily stop liquid delivering, and wherein the control unit is configured to cause the liquid delivering source to deliver the fluid into the elongated tubular medical device at the fourth constant flow rate.
Shelton teaches a control apparatus (see Figs. 2-3 and 22) comprising: a temporary stop operation unit (see par. [0112]-[0113]) configured to temporarily stop aspiration, and wherein the control unit (control system 342) is configured to cause the aspiration source (vacuum source 334) to aspirate the fluid inside the elongated tubular medical device (surgical tool 300) at the second constant flow rate (see par. [0112]-[0113] and [0190]; control system 342 can reduce the speed of or stop the motor/pump and the aspiration flow rate is determined by the speed of the motor/pump), or a temporary stop operation unit (see par. [0113]) configured to temporarily stop liquid delivering, and wherein the control unit (control system 342) is configured to cause the liquid delivering source (fluid source 324) to deliver the fluid into the elongated tubular medical device (surgical tool 300) at the fourth constant flow rate (see par. [0113] and [0190]; control system 342 can reduce the speed of or stop the motor/pump and the liquid delivering flow rate is determined by the speed of the motor/pump).
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 control apparatus of modified Brown to include a temporary stop operation unit configured to temporarily stop aspiration, and wherein the control unit is configured to cause the aspiration source to aspirate the fluid inside the elongated tubular medical device at the second constant flow rate, or a temporary stop operation unit configured to temporarily stop liquid delivering, and wherein the control unit is configured to cause the liquid delivering source to deliver the fluid into the elongated tubular medical device at the fourth constant flow rate, as taught by Shelton, in order to function as a closed feedback loop which ensures that the cutting treatment, fluid delivery, and aspiration are occurring only within desirable thresholds (see Shelton par. [0112]-[0113]).
Claims 9 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Brown et al. (US 5,417,703 A) in view of Desai (US 5,395,312 A), as applied to claims 1 and 10 above, further in view of Williams et al. (US 2013/0197471 A1).
Regarding claim 9, modified Brown teaches the control apparatus according to claim 1 substantially as claimed. However, modified Brown fails to state a notification unit configured to issue a notification by sound or light that the control unit is causing the aspiration source to aspirate the fluid inside the elongated tubular medical device at the second constant flow rate in the case where the aspiration source is connected to the elongated tubular medical device, or to issue a notification that the control unit is causing the liquid delivering source to deliver the fluid into the elongated tubular medical device at the fourth constant flow rate in the case where the liquid delivering source is connected to the elongated tubular medical device.
Williams teaches a control apparatus (see Fig. 1) comprising a notification unit (display 106) configured to issue a notification by sound or light (see par. [0155], [0157], [0266]) that the control unit is causing the aspiration source (see par. [0160]) to aspirate the fluid inside the elongated tubular medical device (see par. [0242]) at the second constant flow rate in the case where the aspiration source (see par. [0160]) is connected to the elongated tubular medical device (see par. [0242]) (see par. [0155] and [0157], flow rates are displayed on display 106 and alarm the user at configurable parameters), or to issue a notification that the control unit is causing the liquid delivering source (see par. [0162]) to deliver the fluid into the elongated tubular medical device (see par. [(0242]) at the fourth constant flow rate in the case where the liquid delivering source (see par. [0162]) is connected to the elongated tubular medical device (see par. [0242]) (see par. [0155] and [0157], flow rates are displayed on display 106 and alarm the user at configurable parameters).
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 control apparatus of modified Brown to include a notification unit configured to issue a notification by sound or light that the control unit is causing the aspiration source to aspirate the fluid inside the elongated tubular medical device at the second constant flow rate in the case where the aspiration source is connected to the elongated tubular medical device, or to issue a notification that the control unit is causing the liquid delivering source to deliver the fluid into the elongated tubular medical device at the fourth constant flow rate in the case where the liquid delivering source is connected to the elongated tubular medical device, as taught by Williams, in order to display actual operating parameters to the user and alert the user when selectable parameters are met (see Williams par. [0155] and [0157]).
Regarding claim 19, modified Brown teaches the control apparatus according to claim 10 substantially as claimed. However, modified Brown fails to state a notification unit configured to issue a notification by sound or light that the control unit is causing one or more of the aspiration source to aspirate the fluid inside the elongated tubular medical device at the second constant flow rate, and that the control unit is causing the liquid delivering source to deliver the fluid into the elongated tubular medical device at the fourth constant flow rate.
Williams teaches a control apparatus (see Fig. 1) comprising a notification unit (display 106) configured to issue a notification by sound or light (see par. [0155], [0157], [0266]) that the control unit is causing one or more of the aspiration source (see par. [0160]) to aspirate the fluid inside the elongated tubular medical device (see par. [0242]) at the second constant flow rate (see par. [0155] and [0157], flow rates are displayed on display 106 and alarm the user at configurable parameters), and that the control unit is causing the liquid delivering source (see par. [0162]) to deliver the fluid into the elongated tubular medical device (see par. [0242]) at the fourth constant flow rate (see par. [0155] and [0157], flow rates are displayed on display 106 and alarm the user at configurable parameters).
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 control apparatus of modified Brown to include a notification unit configured to issue a notification by sound or light that the control unit is causing one or more of the aspiration source to aspirate the fluid inside the elongated tubular medical device at the second constant flow rate, and that the control unit is causing the liquid delivering source to deliver the fluid into the elongated tubular medical device at the fourth constant flow rate, as taught by Williams, in order to display actual operating parameters to the user and alert the user when selectable parameters are met (see Williams par. [0155] and [0157]).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Brown et al. (US 5,417,703 A) in view of Desai (US 5,395,312 A), as applied to claim 10 above, further in view of Fujio et al. (US 5,213,571 A).
Regarding claim 12, modified Brown teaches the control apparatus according to claim 10 substantially as claimed. However, modified Brown fails to expressly state wherein the control unit is configured to control the aspiration source and the liquid delivering source so that the fourth constant flow rate is higher than the second constant flow rate.
Fujio teaches a control apparatus (see Fig. 34) wherein the control unit is configured to control the aspiration source (suction pump 323) and the liquid delivering source (irrigation pump 322) so that the fourth constant flow rate (irrigation flow rate) is higher than the second constant flow rate (suction flow rate) (see col. 30 lines 1-62).
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 control apparatus of modified Brown to include wherein the control unit is configured to control the aspiration source and the liquid delivering source so that the fourth constant flow rate is higher than the second constant flow rate, as taught by Fujio, in order to safely allow treatment at the surgical site while the pressure at the surgical site is not too high (see Fujio col. 30 lines 1-62).
Response to Arguments
Applicant’s arguments with respect to claims 1 and 10 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/AVERY SMALE/Examiner, Art Unit 3783
/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
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