DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 09/30/2025 has been entered.
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 .
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.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-5 and 12-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brodbeck et al., (US 20180353233; hereinafter Brodbeck) in view of Hancock et al., (US 20190083159; hereinafter Hancock) and Trivedi, (US 20170340376).
Regarding claim 1, Brodbeck (Figures 1-2b) discloses an electrosurgical system (10), comprising: a gas control unit (18), ([0073]); a surgical instrument (13) having an elongated shaft (12), the elongated shaft having a nozzle (17) disposed at a distal end portion thereof, the nozzle (17) defining a central longitudinal axis and at least one port (45a-b); an outflow conduit (22) having a proximal end portion coupled to the gas control unit (18) and a distal end portion coupled to the elongated shaft (12) and in fluid communication with the at least one port (45a-b), wherein the gas control unit (18) is configured to discharge a gas into the outflow conduit (22), ([0051]-[0058]).
Brodbeck fails to disclose wherein the at least one port has a distal opening in an outer surface of the nozzle and defines a longitudinal axis that extends radially outward in a distal direction relative to the central longitudinal axis such that the gas exits the nozzle at the at least one port in a radially outward direction of flow relative to the central longitudinal axis. However, Hancock (Figure 2) teaches an electrosurgical system (1) comprising a nozzle (4) with at least one port (26) having a distal opening (26b) in an outer surface of the nozzle (4) and defining a longitudinal axis that extends radially outward in a distal direction relative to the central longitudinal axis of the nozzle (4) such that gas exits the nozzle (4) at the at least one port (26) in a radially outward direction of flow relative to the central longitudinal axis of the nozzle (4), ([0106]-[0107]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the at least one parallel extending port disclosed by Brodbeck with the at least one port taught by Hancock, having a distal opening in an outer surface of the nozzle and defining a longitudinal axis that extends radially outward in a distal direction relative to the central longitudinal axis such that the gas exits the nozzle at the at least one port in a radially outward direction of flow relative to the central longitudinal axis, since both elements perform the same function of delivering a fluid to the distal end of the device, and it has been held that substituting parts of an invention which perform the same function involves only routine skill in the art. MPEP 2144.06 (II)(B).
Brodbeck/Hancock fails to teach an inflow conduit having a proximal end portion coupled to the gas control unit and a distal end portion configured for receipt in an incision, wherein the gas control unit is configured to induce suction in the inflow conduit in addition to discharge a gas into the outflow conduit. However, Trivedi (Figure 3) teaches an electrosurgical system comprising an inflow conduit (330) having a proximal end portion coupled to a gas control unit (332) and a distal end portion configured for receipt in an incision (as shown in Figure 3), wherein the gas control unit (332) is configured to induce suction in the inflow conduit (330), ([0030]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Brodbeck/Hancock to include an inflow conduit having a proximal end portion coupled to the gas control unit and a distal end portion configured for receipt in an incision, wherein the gas control unit is configured to induce suction in the inflow conduit, as taught by Trivedi, because the modification would provide and maintain pressure equilibration in the target area (Trivedi; [0030]). Furthermore, since the gas control of the modified system would be capable of both suction and discharge, the gas control unit would be configured to induce suction in the inflow conduit in addition to discharge a gas into the outflow conduit.
Regarding claim 2, Brodbeck/Hancock/Trivedi further teaches wherein the gas control unit is configured to adjust a suction pressure in the inflow conduit in proportion to a rate of flow of the gas to the outflow conduit. Specifically, the gas control unit of the modified system would be configured to maintain pressure equilibrium in the target area, as explained in the rejection of claim 1. Accordingly, the gas control unit would be configured to adjust a suction pressure in the inflow conduit in proportion to a rate of flow of the gas to the outflow conduit in order to maintain pressure equilibrium in the target area.
Regarding claim 3, Brodbeck/Hancock/Trivedi teaches the electrosurgical system according to claim 2, but fails to teach wherein the rate of flow of the gas is from about 2 liters per minute to about 7 liters per minute. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Brodbeck/Trivedi to include the rate of flow of the gas from about 2 liters per minute to about 7 liters per minute since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. MPEP 2144.05(I).
Regarding claim 4, Brodbeck (Figures 1-2b) further discloses wherein the surgical instrument (13) includes an electrode (61) coupled to the elongated shaft ([0051]-[0058], [0063]).
Regarding claim 5, Brodbeck (Figures 1-2b) further discloses wherein the nozzle (17) defines a central lumen (33) having the electrode (61) passing therethrough ([0051]-[0058], [0063]).
Regarding claim 12, Brodbeck (Figures 1-2b) further discloses wherein the at least one port (45a-b) is a plurality of ports disposed circumferentially about a central longitudinal axis defined by the nozzle (17), ([0051]-[0058], [0063]).
Regarding claim 13, Brodbeck (Figures 1-2b) further discloses wherein the nozzle (17) defines a central passageway (33), the plurality of ports (45a-b) disposed about the central passageway ([0051]-[0058], [0063]).
Regarding claim 14, Brodbeck (Figures 1-2b) further discloses wherein the nozzle (17) tapers in a distal direction ([0051]-[0058], [0063]).
Regarding claim 15, Brodbeck (Figures 1-2b) further discloses wherein the nozzle (17) has an elliptical cone shape or a parabolic cone shape ([0051]-[0058], [0063]).
Claim(s) 8-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brodbeck/Hancock/Trivedi, as applied to claim 1 above.
Regarding claim 8, Brodbeck/Hancock/Trivedi teaches the electrosurgical system according to claim 1, but fails to teach wherein the longitudinal axis of the at least one port is disposed at an angle of about 3 degree to about 7 degrees relative to the central longitudinal axis. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Brodbeck/Hancock/Trivedi such that the longitudinal axis of the at least one port is disposed at an angle of about 3 degree to about 7 degrees relative to the central longitudinal axis since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. MPEP 2144.05(I).
Regarding claim 9, Brodbeck/Hancock/Trivedi teaches the electrosurgical system according to claim 8, but fails to teach wherein the longitudinal axis of the at least one port is disposed at approximately a 5 degree angle relative to the central longitudinal axis. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Brodbeck/Hancock/Trivedi such that the longitudinal axis of the at least one port is disposed at approximately a 5 degree angle relative to the central longitudinal axis since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. MPEP 2144.05(I).
Regarding claim 10, Brodbeck/Hancock/Trivedi teaches the electrosurgical system according to claim 9, wherein the at least one port is about 0.5 mm in diameter. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Brodbeck/Hancock/Trivedi to include the at least one port about 0.5 mm in diameter since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. MPEP 2144.05(I).
Claim(s) 16, 23, and 25-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brodbeck in view of Hancock.
Regarding claim 16, Brodbeck (Figures 1-2b) discloses an electrosurgical instrument (10), comprising: a handle (not shown in the figures, but there is a handle portion that is held by the user in order to operate the instrument); an elongated shaft (12) extending distally from the handle; a nozzle (17) coupled to a distal end portion of the elongated shaft (12) and defining a plurality of discharge ports (45a-b) disposed circumferentially about a central longitudinal axis defined by the nozzle (17), ([0051]-[0058], [0063]).
Brodbeck fails to disclose wherein the at least one discharge port of the plurality of discharge has a distal opening in an outer surface of the nozzle and defines a longitudinal axis that extends radially outward in a distal direction relative to the central longitudinal axis such that gas exits the nozzle at the at least one port in a radially outward direction of flow relative to the central longitudinal axis. However, Hancock (Figure 2) teaches an electrosurgical system (1) comprising a nozzle (4) with at least one discharge port (26) having a distal opening (26b) in an outer surface of the nozzle (4) and defining a longitudinal axis that extends radially outward in a distal direction relative to the central longitudinal axis of the nozzle (4) such that gas exits the nozzle (4) at the at least one port (26) in a radially outward direction of flow relative to the central longitudinal axis of the nozzle (4), ([0106]-[0107]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the at least one parallel extending discharge port disclosed by Brodbeck with the at least one discharge port taught by Hancock, having a distal opening in an outer surface of the nozzle and defining a longitudinal axis that extends radially outward in a distal direction relative to the central longitudinal axis such that the gas exits the nozzle at the at least one port in a radially outward direction of flow relative to the central longitudinal axis, since both elements perform the same function of delivering a fluid to the distal end of the device, and it has been held that substituting parts of an invention which perform the same function involves only routine skill in the art. MPEP 2144.06 (II)(B).
Regarding claim 23, Brodbeck (Figures 1-2b) further discloses wherein the nozzle (17) defines a central passageway (33), the plurality of discharge ports (45a, b) being disposed about the central passageway (33), ([0051]-[0058], [0063]).
Regarding claim 25, Brodbeck (Figures 1-2b) further discloses wherein the nozzle (17) tapers in a distal direction ([0051]-[0058], [0063]).
Regarding claim 26, Brodbeck (Figures 1-2b) further discloses wherein the nozzle (17) has an elliptical cone shape or a parabolic cone shape ([0051]-[0058], [0063]).
Regarding claim 27, Brodbeck (Figures 1-2b) further discloses an outflow conduit (22) extending proximally from the elongated handle and connecting to gas control unit (18) and in fluid communication with the plurality of ports (45a-b), ([0051]-[0058], [0063]).
Claim(s) 19-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brodbeck/Hancock, as applied to claim 16 above.
Regarding claim 19, Brodbeck/Hancock teaches the electrosurgical instrument according to claim 16, but fails to teach wherein the longitudinal axis of each of the plurality of discharge ports is disposed at an angle of about 3 degree to about 7 degrees relative to the central longitudinal axis. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Brodbeck/Hancock such that the longitudinal axis of each of the plurality of discharge ports is disposed at an angle of about 3 degree to about 7 degrees relative to the central longitudinal axis since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. MPEP 2144.05(I).
Regarding claim 20, Brodbeck/Hancock teaches the electrosurgical instrument according to claim 19, but fails to teach wherein the longitudinal axis of each of the plurality of discharge ports is disposed at about a 5 degree angle relative to the central longitudinal axis. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Brodbeck/Hancock such that the longitudinal axis of each of the plurality of discharge ports is disposed at approximately a 5 degree angle relative to the central longitudinal axis since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. MPEP 2144.05(I).
Regarding claim 21, Brodbeck/Hancock teaches the electrosurgical instrument according to claim 20, wherein each of the plurality of discharge ports is from about 0.3 mm to about 0.7 mm in diameter. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Brodbeck/Hancock to include each of the plurality of discharge ports from about 0.3 mm to about 0.7 mm in diameter since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. MPEP 2144.05(I).
Claim(s) 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over the Brodbeck/Hancock as applied to claim 23 above, and further in view of Canady et al., (US 20160051313; hereinafter Canady).
Regarding claim 24, Brodbeck (Figures 1-2b) further discloses a monopolar electrode (61), ([0032], [0051]-[0058], [0063]), but Brodbeck/Hancock fails to teach that the electrode is movably received in the central passageway and configured to extend distally from the nozzle. However, Canady (Figures 3A-3D) teaches an electrosurgical system in which an electrode (330, 334) is movably received in a central passageway and configured to extend distally from a nozzle (320), ([0037]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Brodbeck/Hancock to include the electrode movably received in the central passageway and configured to extend distally from the nozzle, as taught by Canady, because the modification would enable extension and retraction of the electrode as desired (Canady; [0037]) to provide controlled treatment.
Response to Arguments
Applicant’s arguments 09/30/2025, with regard to the newly amended limitations of claims 1 and 16, have been fully considered and are persuasive. Therefore, the rejection(s) has/have been withdrawn. However, upon further consideration, a new ground(s) of rejection is/are made in view of newly found prior art reference Hancock, which teaches an electrosurgical instrument comprising at least one port having a distal opening in an outer surface of the nozzle and defining a longitudinal axis that extends radially outward in a distal direction relative to the central longitudinal axis such that the gas exits the nozzle at the at least one port in a radially outward direction of flow relative to the central longitudinal axis. In combination with Brodbeck/Trivedi, the modified device teaches the invention as recited at least in amended claim 1 and in combination with Brodbeck, the modified device teaches the invention as recited at least in amended claim 16.
Conclusion
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/C.C.P./Examiner, Art Unit 3794
/EUN HWA KIM/Primary Examiner, Art Unit 3794