DETAILED ACTION
This action is pursuant to the claims filed on February 23, 2026. Currently, claims 7-12 are pending with claims 7, 9 and 11 amended and claims 1-6 previously canceled. Below follows a complete non-final action on the merits of claims 7-12.
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
Receipt is acknowledged of a request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e) and a submission, filed on 02/23/2026.
Response to Amendment
Examiner acknowledges the amendments made to claims 7, 9 and 11 with claims 7-12 currently pending in prosecution. The amendment made to the independent claim 7 overcomes the prior outstanding 112(f) claim interpretation issue.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Examiner acknowledges applicants’ receipt for appropriate terminal disclaimer filed 04/22/2024.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 7-9 and 11,12 are rejected under 35 U.S.C. 103 as being unpatentable over Keidar (US PGUB: 2020/0069355) in view of Thompson et al (US PGPUB: 2015/0238248), further in view of Figley et al (US Patent No. 6,668,828), Weltmann et al (US PGPUB: 2019/0110933), and Jones et al (US Patent No.: 5,918,597).
Regarding independent claim 7, Keidar discloses a gas assisted electrosurgical generator (Figs. 1A, 9, see high voltage power supply) for applying treatment to target tissue (at least abstract; [0028]) comprising:
a housing (see body 121, [0029]) an electrical connector on said housing (see in which there is a central electrode 126 which extends outside the syringe housing body 121 through the plug 124 as to be in electrical communication with the exterior components, [0029], thereby functioning as an electrical connector)
a source of electrosurgical energy in said housing (112, where the power supply is sourced inside the body 121, [0029]), said source of electrical energy being connected to said electrical connector (see in which the electrode component 126 is attached to the power supply 112 via wires or cables, [0030]);
a gas control module in said housing, said gas control module (combination of 104 emitter device/114 gas source; [0031], found in the body 121, [0029]) having an inlet port connected to an inlet connector on said housing (opening through the top of the syringe 120, [0029], which is found in the body 121) and an outlet port connected to an outlet connector on said housing (discharge end 122 opening, [0029], found within the body 121), said inlet connector being configured to connect to a source of an inert gas (114; Fig. 1A) to control a flow of gas flowing through said gas control module (“A separate gas controller (not shown) may be provided to control the flow rate of the gas in the supply tube 118, or the gas controller may be integrated with the controller 108”, [0031]) from said inlet port (opening through the top of the syringe 120, [0029]) to said outlet port (discharge end 122 opening, [0029]);
a processor (108) in said housing (wherein the processor 108 is connected to the power supply 112 which is found within the body 121, and therefore the processor 108 is found within the body 121 as well, [0029]) configured to control said gas control module ([0031]) and said source of electrosurgical energy ([0030]) to apply energy from said source of electrosurgical energy to gas flowing from said gas control module (The controller 108 is coupled to the high voltage power supply 112 and regulates the discharge voltage and frequency that is applied to the central electrode 126 and the ring electrode 128 and therefore controls the intensity of a plasma jet 130 emitted by the nozzle 129, [0030]-[0031]);
an electronic storage medium connected to said processor ([0061]);
a database stored in said storage medium, said database comprising identifying information of each of a plurality of soft tissue sarcoma cell lines and optimum cold atmospheric plasma settings associated with each of said plurality of soft tissue sarcoma cell lines (Fig. 9; [0061]- [0064] discusses the storage of initial parameters, interpreted as a database, that includes optimum settings associated with certain cell lines and types);
connected to said processor, said graphical user interface configured to provide for a user input of a selected soft tissue sarcoma cell line (Fig. 9; [0061]-[0064]); and in response to the input of said selected soft tissue cell sarcoma cell line the processor automatically accesses the database in said storage medium and adopts cold atmospheric plasma settings associated with the entered soft tissue cell sarcoma cell line in said database (Fig. 9; [0061]-[0064] discusses the storage of initial parameters, interpreted as a database, that includes optimum settings associated with certain cell lines and types, see also specifically [0061] in which storage mediums such as the flash memory or CD-ROM devices which store the optimum settings are used in conjunction with the processor to execute the machine readable instructions)
an applicator (104) connected to said outlet connector and said electrical connector for applying cold atmospheric plasma to target tissue (Fig. 1A; [0028]);
While Keidar discloses an interface for a user to input initial parameters ([0062]), Keidar does not explicitly disclose the interface is a graphical user interface which also contains a display.
However, Thompson disclose a non-thermal plasma system (Fig. 1-2; [0031]) comprising a graphical user interface (244) containing multiple display screens (242, 244, 246) for entering surgical parameters (Fig. 2; [0081]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the interface of Keidar to incorporate the graphical user interface of Thompson. This configuration provides the benefit of variety of different control inputs for achieving the desired plasma output ([0081]).
Further regarding claim 7, Keidar does not explicitly disclose the gas control module as structurally claimed in claim 9 (outlined below). Note the below is both a rejection of claims 7 and 9.
Regarding dependent claim 9, in view of the combination of claim 7, Keidar does not explicitly disclose wherein said gas control module comprises: said inlet port; a first solenoid valve connected to said inlet port, said first solenoid valve being configured to turn a flow of gas into the gas control module on and off, a first pressure sensor configured to sense a first pressure of gas entering the gas control module through the first solenoid valve; a first pressure regulator configured to change said first pressure of gas entering said first pressure regulator to a second pressure; a first flow sensor configured to sense a flow rate of gas exiting said first pressure regulator; a first proportional valve having an inlet and an outlet, said first proportional valve being configured to adjust said outlet as a percentage of said inlet; a second flow sensor configured to sense a flow of gas exiting said first proportional valve; a second solenoid valve, said second solenoid valve being a 3-way valve; a vent connected to said second solenoid valve; a second pressure sensor for sensing a pressure of gas passing through said second solenoid valve; and a third solenoid valve, said third solenoid valve being configured to turn a flow of gas out of the gas control module on and off, and said exit port.
However, Figley (pertinent to the problem of gas control) discloses a gas control module (Fig. 1):
a first solenoid valve (24) connected to said inlet port (Fig. 1 displays 24 connected to the inlet port), said first solenoid valve being configured to turn a flow of gas into the gas control module on and off (Col. 13, Line 16-17), a first pressure sensor (30) configured to sense a first pressure of gas entering the gas control module through the first solenoid valve (Col. 13, Line 47-54);
a first pressure regulator (32) configured to change said first pressure of gas entering said first pressure regulator to a second pressure (Col. 13, Line 54-56);
a first proportional valve (33) having an inlet and an outlet, said first proportional valve being configured to adjust said outlet as a percentage of said inlet (Col. 14, Lines 3-4);
a second solenoid valve (41);
a vent (44; Col. 14, Lines 42-43) connected to said second solenoid valve (Fig. 1);
a second pressure sensor (37) for sensing a pressure of gas passing through said second solenoid valve (Col. 14, Lines 16-21); and
a third solenoid valve (51), said third solenoid valve being configured to turn a flow of gas out of the gas control module on and off (col. 14, Lines 50-55 where the flow of gas, i.e., on/off, is determined by whether the valve is opened/closed), and
an exit port (see exit port in Fig. 1).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the gas control module of Keidar to incorporate a gas control module that comprises: an inlet port; a first solenoid valve connected to said inlet port, said first solenoid valve being configured to turn a flow of gas into the gas control module on and off, a first pressure sensor configured to sense a first pressure of gas entering the gas control module through the first solenoid valve; a first pressure regulator configured to change said first pressure of gas entering said first pressure regulator to a second pressure; a first flow sensor configured to sense a flow rate of gas exiting said first pressure regulator; a first proportional valve having an inlet and an outlet, said first proportional valve being configured to adjust said outlet as a percentage of said inlet; a second flow sensor configured to sense a flow of gas exiting said first proportional valve; a second solenoid valve; a vent connected to said second solenoid valve; a second pressure sensor for sensing a pressure of gas passing through said second solenoid valve; and a third solenoid valve, said third solenoid valve being configured to turn a flow of gas out of the gas control module on and off, and an exit port of Figley. This configuration provides the benefit of a safer system as the system can detect when there is a leak (Col. 11, Lines 34-37).
Further, combination does not explicitly disclose the second solenoid valve is a 3-way valve.
However, Weltmann discloses a medical system (Fig. 6) comprising a gas control module (combination of 7/18/15/19/14) comprising a 3-way proportional valve (14; [0081]- [0082]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified Keidar to incorporate the 3-way proportional valve connected to the gas control module of Weltmann. This configuration provides the benefit of reducing the number of parts needed, thereby simplifying the device.
Further, the combination does not explicitly disclose a first flow sensor configured to sense a flow rate of gas exiting said first pressure regulator; a second flow sensor configured to sense a flow of gas exiting said first proportional valve.
However, Jones (pertinent to the problem of gas control) discloses a gas control module (Fig. 1) comprising a first flow sensor (44) and second flow sensor (96) configured to measure flow rate of gas in the system (Col. 5, Lines 39-41; Col. 7, Lines 26-29; note capable of measuring flow from first pressure regulator and first proportional valve. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified Konesky to incorporate a first flow sensor configured to sense a flow rate of gas exiting said first pressure regulator; a second flow sensor configured to sense a flow of gas exiting said first proportional valve of Jones. This configuration provides the benefit of continuous improved control during the delivery of gas (Col. 3, Lines 30-36).
Regarding dependent claim 8, in view of the combination of claim 7, Keidar does not explicitly disclose further comprising: 3-way proportional valve connected to the gas control module.
However, Weltmann discloses a medical system (Fig. 6) comprising a gas control module (combination of 7/18/15/19/14) comprising a 3-way proportional valve (14; [0081]- [0082]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified Keidar to incorporate the 3-way proportional valve connected to the gas control module of Weltmann. This configuration provides the benefit of reducing the number of parts needed, thereby simplifying the device.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Keidar (US PGUB: 2020/0069355) in view of Thompson et al (US PGPUB: 2015/0238248), further in view of Figley et al (US Patent No. 6,668,828), Weltmann et al (US PGPUB: 2019/0110933), and Jones et al (US Patent No.: 5,918,597) as applied to claims 7 and 9 above, further in view of Canady et al (US PGPUB: 2019/0231411) herein referred to as Canady R1.
Regarding claim 11, Keidar teaches a system (Figs. 1A, 9) for applying cold atmospheric plasma treatment to target tissue (at least abstract; [0028]) comprising: a first source of a first inert gas; a second source of a second inert gas ([0031], gas source 114 may include multiple gas sources for mixtures of different gases such as helium, argon, and nitrogen, as well as separate control measures for the different gas sources); a gas-assisted electrosurgical generator comprising: a housing (see body 121, [0029]); a first gas connector on said housing (114; Fig. 1A); a second gas connector on said housing (discharge end 122 opening, [0029]): an electrical connector on said housing (see in which there is a central electrode 126 which extends outside the syringe housing body 121 through the plug 124 as to be in electrical communication with the exterior components, [0029], thereby functioning as an electrical connector); a source of electrosurgical energy (112) in said housing, said source of energy being connected to said electric connector (see in which the electrode component 126 is attached to the power supply 112 via wires or cables, [0030]); a first gas control module in said housing having an inlet port (opening through the top of the syringe 120, [0029]) (combination of 104/114; [0031] “A separate gas controller (not shown) may be provided to control the flow rate of the gas in the supply tube 118, or the gas controller may be integrated with the controller 108”) connected to said first source of said first inert gas (114; Fig. 1A), said first gas control module having an outlet port connected to said first connector on said housing (discharge end 122 opening, [0029], found on the housing body 121) said first gas control module being configured to control a flow of said first gas through said gas control module ([0031] may control the flow rate of the gas); a second gas control module in said housing having an inlet port connected to a second source of a second inert gas different from said first inert gas, said second gas control module having an outlet port connected to said second connector on said house and said second gas control module being configured to control a flow of said second gas through said second gas control module ([0031], gas source 114 may include multiple gas sources for mixtures of different gases such as helium, argon, and nitrogen, and therefore in combination with the controller 108 has the capabilities to have a second gas control module); a processor configured to control said first and second gas control modules ([0031], The controller 108 or separate gas controller can also control gas composition in the example of multiple gas sources as well as the flow rate of the gasses in the composition)and said source of electrosurgical energy to apply energy from said source of electrosurgical energy to gas flowing from one of said first and second gas control module (The controller 108 is coupled to the high voltage power supply 112 and regulates the discharge voltage and frequency that is applied to the central electrode 126 and the ring electrode 128 and therefore controls the intensity of a plasma jet 130 emitted by the nozzle 129, [0030]-[0031]); an electronic storage medium connected to said processor ([0061]); a database stored in said storage medium, said database comprising identifying information of each of a plurality of soft tissue sarcoma cell lines and optimum cold atmospheric plasma settings associated with each of said plurality of soft tissue sarcoma cell lines (Fig. 9; [0061]-[0064] discusses the storage of initial parameters, interpreted as a database, that includes optimum settings associated with certain cell lines and types); a display; and a graphical user interface displayed on said display and connected to said processor, said graphical user interface configured to provide for a user input of a selected soft tissue sarcoma cell line and in response to the input of said selected soft tissue cell sarcoma cell line the processor automatically accesses the database in said storage medium and adopts cold atmospheric plasma settings associated with the entered soft tissue cell sarcoma cell line in said database (Fig. 9; [0061]-[0064] discusses the storage of initial parameters, interpreted as a database, that includes optimum settings associated with certain cell lines and types, see also specifically [0061] in which storage mediums such as the flash memory or CD-ROM devices which store the optimum settings are used in conjunction with the processor to execute the machine readable instructions); and an applicator (104) connected to said gas-assisted electrosurgical generator for applying cold atmospheric plasma to target tissue (Fig. 1A; [0028]).
Wherein, the gas control modules would be of the same structure and limitations of the inherit gas control modules described by the previous combination of Keidar, Figley, Weltmann, and Jones.
Wherein, the display and graphical user interface display would be of the same structure and limitations of the inherit graphical user interface display described by the previous combination of Keidar and Thompson (Fig. 1-2; [0031] comprising a graphical user interface (244) containing multiple display screens (242, 244, 246) for entering surgical parameters Fig. 2; [0081]).
The previous combination does not teach wherein the processor, storage medium and display around found in/on the housing of the device.
However, the analogous cold plasma treatment system taught by Canady R1 does disclose a housing 110 which contains a display 120 found on the housing, seen in fig 1A, as well as storage capabilities 211 and a control system 200 which are both found internal to the housing member 110, [0056].
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the system taught by the previous combination with that of the housing member which contains all of the components including processor, storage medium and display as taught by Canady R1 in order to create a compact system which is easy to control by the user, as disclosed by Canady R1, [0047].
Regarding claim 12, the combination teaches the system for applying cold atmospheric plasma treatment to target tissue (Keidar, at least abstract; [0028]) according to claim 11, wherein said first gas control module comprises: an inlet port; a first solenoid valve (Figley, 24) connected to said inlet port (Figley, Fig. 1 displays 24 connected to the inlet port), said first solenoid valve being configured to turn a flow of gas into the gas control module on and off (Figley, Col. 13, Line 16-17); a first pressure sensor (Figley, 30) configured to sense a first pressure of gas entering the gas control module through the first solenoid valve (Figley, Col. 13, Line 47-54); a first pressure regulator (Figley, 32) configured to change said first pressure of gas entering said first pressure regulator to a second pressure (Figley, Col. 13, Line 54-56); a first flow sensor configured to sense a flow rate of gas exiting said first pressure regulator (Jones, Col. 5 , Lines 39-41; Col. 7, Lines 26-29); a first proportional valve (Figley, 33) having an inlet and an outlet, said first proportional valve being configured to adjust said outlet as a percentage of said inlet (Figley, Col. 14, Lines 3-4); a second flow sensor configured to sense a flow of gas exiting said first proportional valve (Jones, Col. 5 , Lines 39-41; Col. 7, Lines 26-29); a second solenoid valve (Figley, 41), said second solenoid valve being a 3-way valve (Weltmann, 14; [0081]-[0082]); a vent connected to said second solenoid valve; a second pressure sensor (Figley, 37) for sensing a pressure of gas passing through said second solenoid valve (Figley, Col. 14, Lines 16-21); and a third solenoid valve, said third solenoid valve being configured to turn a flow of gas out of the gas control module on and off; and an exit port (Figley, col. 14, Lines 50-55 where the flow of gas, i.e. on/off, is determined by whether the valve is opened/closed).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Keidar (US PGUB: 2020/0069355) in view of Thompson et al (US PGPUB: 2015/0238248), further in view of Figley et al (US Patent No. 6,668,828), Weltmann et al (US PGPUB: 2019/0110933), and Jones et al (US Patent No.: 5,918,597) as applied to claims 7 and 9 above, further in view of Canady et al (US PGPUB: 2015/0342663) herein referred to as Canady R2.
Regarding dependent claim 10, in view of the combination of claim 7, Keidar further discloses wherein said a source of electrosurgical energy comprises: a high frequency power module for supplying high frequency electrical energy for various types of electrosurgical procedures ([0028], [0030]).
Konesky does not explicitly disclose a low frequency converter for converting electrical energy from said high frequency power module to low frequency energy.
However, Canady R2 discloses cold plasma system (Fig. 1; abstract) comprising low frequency converter (200) for converting electrical energy to low frequency energy ([0037]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified Konesky to incorporate the low frequency converter for converting electrical energy from said high frequency power module to low frequency energy of Canady R2. This configuration provides the benefit of reliably converting electrical energy, thereby increasing the efficiency of the device. Note Applicant admits such reference discloses the claimed low frequency converter in [0044] of the instant specification.
Response to Arguments
Applicant's arguments with respect to claim 7 filed 02/23/2026 have been fully considered but they are not persuasive.
Applicant’s arguments with respect to claim(s) 11 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.
In regards to the argument presented that the prior art of Keidar does not teach the amended limitation of containing an electrical connector attached to the housing member, has been considered but ultimately falls unpersuasive. After further consideration of the prior art of Keidar, as necessitated by the amended claim language, it has been found that Keidar does teach an electrical connector on said housing (see in which there is a central electrode 126 which extends outside the syringe housing body 121 through the plug 124 as to be in electrical communication with the exterior components, [0029], thereby functioning as an electrical connector) a source of electrosurgical energy in said housing (112, where the power supply is sourced inside the body 121, [0029]), said source of electrical energy being connected to said electrical connector (see in which the electrode component 126 is attached to the power supply 112 via wires or cables, [0030]). Therefore, as Keidar continues to disclose the amended claim language as analyzed under the broadest reasonable interpretation, the amended claim 7 remains rejected under the previous prior art of record rejection in view of Keidar set forth in the present office action.
Furthermore, in regards to argument that the amended claim language of claim 11, which adds the limitation that the processor, storage medium and display around found in/on the housing of the device is not taught by Keidar, this argument has been considered and found persuasive. Specifically, the examiner agrees that the prior art of Keidar alone does not appear to teach these components are found within the housing member. However, after further search and consideration, necessitated by the amended claim language, it has been found that the analogous cold plasma treatment system taught by Canady R1 does disclose a housing 110 which contains a display 120 found on the housing, seen in fig 1A, as well as storage capabilities 211 and a control system 200 which are both found internal to the housing member 110, [0056]. Therefore, as containing all these components within the same housing is obvious for one skilled in the art, the amended claim 11 remains rejected under the new prior art of record rejection of Keidar in view of Canady R1, set forth in the present office action
Applicant has not provided any additional arguments for any dependent claims and thus the rejections of those claims are tenable for at least the same reasons as outlined above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYLE M BROWN whose telephone number is (703)756-4534. The examiner can normally be reached 8:00-5:00pm EST, Mon-Fri, alternating Fridays off.
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/KYLE M. BROWN/Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
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