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 .
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 2, 4, 7, 10, 11, 16-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zaidi (US 20150366042 A1).
Regarding claim 1, Zaidi teaches a plasma delivery tip of a medical-grade cold plasma generating device for the delivery of cold plasma to a target surface external to the plasma delivery tip (Fig 1; exit port 20) and internal to a body lumen (Fig 1; exit port 20), the plasma delivery tip comprising: a gas delivery lumen having a proximal-to-distal axis (Fig 1; gas supply tube 30), sized to insert within an endoscope working channel (Fig 1; elongate housing 18), and along which a flow of ionization gas flows to a plurality of distal apertures of the gas delivery lumen, each distal aperture being defined by a separate tubular ring (Fig 10; [0088] elongate housing 257 having a central axis and opposed end walls 257a, 257b, each of which includes an exit port 259, 260 through which the plasma plume 8 is expelled); and a plurality of discharge electrodes (Fig 1; inner electrode 36 and outer electrode 42) ([0085] The inner electrode 236 has an elongate base 238 extending generally parallel to the central axis of the ionization conduit 232 and a plurality of electrically-conductive bristles 240 fixed to and extending radially from the electrode base 238) ([0091] FIG. 10, the inner electrodes 236, 254 and outer electrodes 242, 265, 266 are connected in series to the same power source 16) ([0090] A pair of outer electrodes 265, 266 are slideably arranged on the outer surface of the ionization conduit 253), each electrically isolated from the flow of ionization gas by a dielectric barrier (Fig 1; [0044] An elongate, dielectric ionization conduit 32 is arranged in a generally coaxial relationship with the housing 18. The conduit 32 has a port 34 at a distal discharge end 32b, which tapers in the form of a concentrating nozzle. The port 34 in the conduit aligns with the exit port 20 in the distal end of the housing 18. The proximal end 32a of the conduit is connected in sealed fluid communication with the gas supply tube 30), and positioned within the flow of ionization gas to generate a corresponding respective cold plasma plume at a respective plasma generating site through which the flow of ionization gas passes (Fig 10; plume 8) (Fig 10; outer electrodes 265, 266) ([0091] FIG. 10, the inner electrodes 236, 254 and outer electrodes 242, 265, 266 are connected in series to the same power source 16); wherein each cold plasma plume exits the tip through a respective one of the plurality of distal apertures (Fig 10; plume 8) ([0059] Plasma production within the ionization conduit 32 occurs in the region of overlap (axial alignment) between the inner 36 and outer 42 electrodes).
Regarding claim 2, Zaidi teaches the plasma delivery tip of claim 1, wherein flow of the ionization gas through the one or more distal apertures directs the plasma plumes to different respective regions of the target surface ([0087] FIG. 10, the deflector nozzle 251 is attached to the distal end of the housing 218. The nozzle 251 acts as an extension of the ionization conduit 232 and changes the direction of the plasma plume 8 compared to the embodiments disclosed above. In this embodiment, the nozzle re-directs the plasma plume approximately 90 degrees relative to the longitudinal axis of the primary ionization conduit 232. In this embodiment, the nozzle 251 also bifurcates the plasma plume 8; however, in other embodiments the nozzle 251 re-directs the plume 8 without bifurcating or otherwise dividing the plume 8).
Regarding claim 4, Zaidi teaches the plasma delivery tip of any one of claim 1, wherein the one or more distal apertures comprise a plurality of separate apertures from which respective separate plasma plumes are emitted after generation of plasma by respective different discharge electrodes (Fig 10; [0088] The nozzle 251 includes an elongate housing 257 having a central axis and opposed end walls 257a, 257b, each of which includes an exit port 259, 260 through which the plasma plume 8 is expelled).
Regarding claim 7, Zaidi teaches the plasma delivery tip of claim 1, wherein the electrodes positioned within the flow of ionization gas are circumferentially surrounded by the flow of ionization gas ([0085] The inner electrode 236 has an elongate base 238 extending generally parallel to the central axis of the ionization conduit 232 and a plurality of electrically-conductive bristles 240 fixed to and extending radially from the electrode base 238. In the embodiment shown in FIG. 10, the bristles 240 are equally spaced both axially and radially on the electrode base 238 and along the entire length of the base 238 located within the ionization conduit 232).
Regarding claim 10, Zaidi teaches the plasma delivery tip of any one of claim 1, wherein the discharge electrodes are arranged along the proximal-to-distal axis of the gas delivery lumen, and the corresponding respective plasma plumes are directed laterally away from the axis ([0087] FIG. 10, the deflector nozzle 251 is attached to the distal end of the housing 218. The nozzle 251 acts as an extension of the ionization conduit 232 and changes the direction of the plasma plume 8 compared to the embodiments disclosed above. In this embodiment, the nozzle re-directs the plasma plume approximately 90 degrees relative to the longitudinal axis of the primary ionization conduit 232).
Regarding claim 11, Zaidi teaches the plasma delivery tip of claim 1, wherein the distal apertures are oriented to direct the cold plasma plumes emitted from the plasma delivery tip away from the proximal-to-distal axis (Fig 10; [0089] An inner electrode 254 extends within the nozzle ionization conduit 253. The electrode 254 has a “T” shape with a trunk end 254a, which is connected to the distal end of the primary inner electrode 236, and two branch ends 254b, 254c which are located proximate the exit ports 259, 260 in the nozzle 251. The inner electrode 254 has an elongate base 267 extending generally parallel to the central axis of the ionization conduit 253, and a plurality of electrically-conductive bristles 269 fixed to and extending radially from the electrode base 267).
Regarding claim 16, Zaidi teaches the plasma delivery tip of claim 11, wherein the distal apertures direct the plasma plumes in radially opposite directions ([0087] FIG. 10, the deflector nozzle 251 is attached to the distal end of the housing 218. The nozzle 251 acts as an extension of the ionization conduit 232 and changes the direction of the plasma plume 8 compared to the embodiments disclosed above. In this embodiment, the nozzle re-directs the plasma plume approximately 90 degrees relative to the longitudinal axis of the primary ionization conduit 232).
Regarding claim 17, Zaidi teaches the plasma delivery tip of claim 11, wherein the distal apertures direct the plasma plumes to at least two different angles away from the proximal-to-distal axis ([0087] FIG. 10, the deflector nozzle 251 is attached to the distal end of the housing 218. The nozzle 251 acts as an extension of the ionization conduit 232 and changes the direction of the plasma plume 8 compared to the embodiments disclosed above. In this embodiment, the nozzle re-directs the plasma plume approximately 90 degrees relative to the longitudinal axis of the primary ionization conduit 232) ([0092] In this preferred embodiment, the nozzle 251 can be rotated about the central axis of the primary housing 218 so that the plume 8 exits at any desired angle).
Regarding claim 18, Zaidi teaches plasma delivery tip of claim 11, also including a distal aperture that directs a plasma plume along the proximal-to-distal axis (Fig 1).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zaidi (US 20150366042 A1) in view of Konesky (US 20140316403 A1).
Regarding claim 3, Zaidi teaches plasma delivery tip of claim 1, but fails to teach wherein the plasma plumes partially overlap on the way to the target surface.
However, Konesky teaches wherein the plasma plumes partially overlap on the way to the target surface ([0039] FIG. 4, the gas conduits 110-1 and 110-2 are adjustable relative to each other and can be set at a predetermined angle a. What defines the predetermined angle a depends on the geometry and the length of the two plasma jets. Plasma jets that are widely spaced must be pointed at a wide angle for them to cross, while jets that are close to each other only need a shallow angle before they meet). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the invention of Zaidi to include wherein the plasma plumes partially overlap on the way to the target surface. Doing so allows for total coverage of the target spot.
Claim(s) 14 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zaidi (US 20150366042 A1) in view of Kim (WO 0079843 A1).
Regarding claim 14, Zaidi teaches the plasma delivery tip of claim 12, but fails to teach wherein the at least one discharge electrode comprises a separate respective discharge electrode positioned to generate plasma at each of the plurality of distal apertures.
However, Kim teaches wherein the at least one discharge electrode comprises a separate respective discharge electrode positioned to generate plasma at each of the plurality of distal apertures ([Pg 5, Para 6] A metal tube 37 has a plurality of holes on its entire surfaces except for portions for receiving gas and for being connected to the power source. The holes on the metal tube 37 match capillaries in a capillary dielectric electrode 35. Thus, the metal tube 37 acts as a metal electrode. The capillary dielectric electrode 35 surrounds and is connected to the metal tube 37 as shown in FIG. 3C). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the invention of Zaidi to include wherein the at least one discharge electrode comprises a separate respective discharge electrode positioned to generate plasma at each of the plurality of distal apertures. Doing so allows for each of the distal apertures to generate plasma for full generation coverage of the plasma device.
Regarding claim 19, Zaidi teaches the plasma delivery tip of claim 11, sized to be delivered along a working channel of an endoscopic device, and rotatable around the proximal-to-distal axis to distribute plasma from the plasma plumes circumferentially ([0087] FIG. 10, the deflector nozzle 251 is attached to the distal end of the housing 218. The nozzle 251 acts as an extension of the ionization conduit 232 and changes the direction of the plasma plume 8 compared to the embodiments disclosed above. In this embodiment, the nozzle re-directs the plasma plume approximately 90 degrees relative to the longitudinal axis of the primary ionization conduit 232). Zaidi fails to fully teach sized to be delivered along a working channel of an endoscopic device.
However, Kim teaches sized to be delivered along a working channel of an endoscopic device ([Pg 5, Para 6] A metal tube 37 has a plurality of holes on its entire surfaces except for portions for receiving gas and for being connected to the power source. The holes on the metal tube 37 match capillaries in a capillary dielectric electrode 35. Thus, the metal tube 37 acts as a metal electrode. The capillary dielectric electrode 35 surrounds and is connected to the metal tube 37 as shown in FIG. 3C). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the invention of Zaidi to include the tip to be sized to be delivered along a working channel of an endoscopic device. Doing so allows for the tip to reside within an outer endoscope for extension and protection.
Claim(s) 12 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zaidi (US 20150366042 A1) in view of Fornsel (US 6262386 B1).
Regarding claim 12, Zaidi teaches the plasma delivery tip of claim 11, wherein a distal portion of the gas delivery lumen is rotatingly coupled to the plasma delivery tip ([0092] In this preferred embodiment, the nozzle 251 can be rotated about the central axis of the primary housing 218 so that the plume 8 exits at any desired angle), but fails to teach and the distal apertures are oriented to direct the flow of the ionization gas out of them in a direction generating thrust that rotates the distal portion of the gas lumen and spins the plasma plumes.
However, Fornsel teaches the distal apertures are oriented to direct the flow of the ionization gas out of them in a direction generating thrust that rotates the distal portion of the gas lumen and spins the plasma plumes ([2] The plasma nozzle shown in FIG. 1 has a tubular casing 10 which has an increased diameter in the upper part, as seen in the drawing, and this upper part is rotatably supported on a stationary supporting tube 14 by means of a bearing 12) ([6] the casing 10 driven by the motor is caused to rotate with a high speed of revolution around the axis A, so that the plasma jet 28 describes the generatrix of a cone which sweeps over the surface of a workpiece to be treated (not shown)) ([8] the rotary movement of the mouth piece 30 can be created by a slightly tilted arrangement of the mouth 18 in circumferential direction, so that the mouth piece is rotated by the reaction forces of the air that is being jetted out). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the invention of Zaidi to include the distal apertures are oriented to direct the flow of the ionization gas out of them in a direction generating thrust that rotates the distal portion of the gas lumen and spins the plasma plumes. Doing so allows for the angels of the plasma to be adjusted for a specific outcome and direction.
Regarding claim 13, Zaidi teaches the plasma delivery tip of claim 12, but fails to teach comprising a discharge electrode positioned proximal to the rotating distal portion of the gas delivery lumen.
However, Fornsel teaches comprising a discharge electrode positioned proximal to the rotating distal portion of the gas delivery lumen (Fig 1; electrode 24 spaced proximal to the distal rotating portion 30). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the invention of Zaidi to include comprising a discharge electrode positioned proximal to the rotating distal portion of the gas delivery lumen. Doing so allows for plasma to be generated near the rotating end for a specified plasma discharge location.
Claim(s) 15, 24, and 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zaidi (US 20150366042 A1) in view of Hancock (US 20180318459 A1).
Regarding claim 15, Zaidi teaches the plasma delivery tip of claim 14, but fails to teach comprising a sliding electrical coupling through which electrical power is conducted to the distal portion of the plasma delivery tip.
However, Hancock teaches comprising a sliding electrical coupling through which electrical power is conducted to the distal portion of the plasma delivery tip ([0040] A dielectric cylinder may be placed over the inner conductor, and the inner conductor which passes through the dielectric cylinder may be considered the first electrode of the probe tip. The second electrode may preferably be a metal cylinder, e.g. a thin wall metal tube, preferably copper, which is electrically connected to the outer conductor of the layer-structured coaxial cable, for example by sliding over the dielectric cylinder and a portion of the outer conductor). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the invention of Zaidi to include comprising a sliding electrical coupling through which electrical power is conducted to the distal portion of the plasma delivery tip. Doing so allows the option for selectively applying the electrode for plasma generation.
Regarding claim 24, Zaidi teaches the plasma delivery tip of claim 1, but fails to teach wherein the gas delivery lumen has a lumenal diameter of at least 0.4 mm.
However, Hancock teaches wherein the gas delivery lumen has a lumenal diameter of at least 0.4 mm ([0009] The instrument channel may have a diameter suitable for receiving invasive surgical tools. The diameter of the instrument channel may be 5 mm or less) ([0030] he diameter of the channel formed in the innermost insulating layer is preferably 3 mm or less, e.g. 2.8 mm. The channel may form the gas conduit for conveying gas to the probe tip). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the invention of Zaidi to include wherein the gas delivery lumen has a lumenal diameter of at least 0.4 mm. Doing so allows to modify the plasma generating parameters to control the gas delivery. Further, it would have been obvious to one having ordinary skill in the art at the time the invention was made to include wherein the gas delivery lumen has a lumenal diameter of at least 0.4 mm, 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. In re Aller, 105 USPQ 233.
Regarding claim 25, Zaidi teaches the plasma delivery tip of claim 1, but fails to teach wherein the dielectric barrier is at least 0.07 mm in thickness.
However, Hancock teaches wherein the dielectric barrier is at least 0.07 mm in thickness ([0042] The probe tip may have an outer diameter of 2.5 mm, a channel diameter of 0.8 mm and a dielectric wall thickness of 0.65 mm). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the invention of Zaidi to include wherein the dielectric barrier is at least 0.07 mm in thickness. Doing so allows to modify the plasma generating parameters to prevent voltage breakdown. Further, it would have been obvious to one having ordinary skill in the art at the time the invention was made to include wherein the dielectric barrier is at least 0.07 mm in thickness, 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. In re Aller, 105 USPQ 233.
Claim(s) 8, 9, and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zaidi (US 20150366042 A1) in view of Kalghatgi (US 20160121134 A1).
Regarding claim 8, Zaidi teaches plasma delivery tip of any one of claim 1, but fails to fully teach wherein the electrodes positioned within the flow of ionization gas are also positioned at least partially distal to the distal aperture out of which the ionization gas used to generate the corresponding respective plasma plume flows.
However, Kalghatgi teaches wherein the electrodes positioned within the flow of ionization gas are also positioned at least partially distal to the distal aperture out of which the ionization gas used to generate the corresponding respective plasma plume flows ([0030] In some embodiments the internal tube 232 may be separately extendable out from the distal end of the larger tube 226, thus allowing the tube 232 to extend into the area surrounded by the enclosure 202 and closer to the area where plasma is to be applied) ([0034] In some embodiments the enclosure 202 includes a spring mechanism that pushes the enclosure open when it is extended out from the distal end 204 of the medical device 200 and allows compression of the enclosure 202 when it is retracted into the channel 206 of the medical device 200). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the invention of Zaidi to include wherein the electrodes positioned within the flow of ionization gas are also positioned at least partially distal to the distal aperture out of which the ionization gas used to generate the corresponding respective plasma plume flows. Doing so allows the electrodes to be extended for a larger area of treatment.
Regarding claim 9, Zaidi teaches the plasma delivery tip of any one of claim 1, but fails to fully teach wherein the electrodes positioned within the flow of ionization gas are also positioned external to the distal aperture out of which the ionization gas used to generate the corresponding respective plasma plume flows.
However, Kalghatgi teaches wherein the electrodes positioned within the flow of ionization gas are also positioned external to the distal aperture out of which the ionization gas used to generate the corresponding respective plasma plume flows ([0030] In some embodiments the internal tube 232 may be separately extendable out from the distal end of the larger tube 226, thus allowing the tube 232 to extend into the area surrounded by the enclosure 202 and closer to the area where plasma is to be applied) ([0034] In some embodiments the enclosure 202 includes a spring mechanism that pushes the enclosure open when it is extended out from the distal end 204 of the medical device 200 and allows compression of the enclosure 202 when it is retracted into the channel 206 of the medical device 200). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the invention of Zaidi to include wherein the electrodes positioned within the flow of ionization gas are also positioned external to the distal aperture out of which the ionization gas used to generate the corresponding respective plasma plume flows. Doing so allows the electrodes to be extended for a larger area of treatment.
Regarding claim 23, Zaidi teaches the plasma delivery tip of claim 1, but fails to teach including a sleeve, wherein the plasma delivery tip is sized and shaped to be advanced through the sleeve to a location at which plasma will be delivered beyond a distal end of the sleeve.
However, Kalghatgi teaches plasma delivery tip of claim 1, including a sleeve ([0034] In some embodiments the enclosure 202 includes a spring mechanism that pushes the enclosure open when it is extended out from the distal end 204 of the medical device 200 and allows compression of the enclosure 202 when it is retracted into the channel 206 of the medical device 200), wherein the plasma delivery tip is sized and shaped to be advanced through the sleeve to a location at which plasma will be delivered beyond a distal end of the sleeve ([0034] In some embodiments the enclosure 202 includes a spring mechanism that pushes the enclosure open when it is extended out from the distal end 204 of the medical device 200 and allows compression of the enclosure 202 when it is retracted into the channel 206 of the medical device 200) ([0030] In some embodiments the internal tube 232 may be separately extendable out from the distal end of the larger tube 226, thus allowing the tube 232 to extend into the area surrounded by the enclosure 202 and closer to the area where plasma is to be applied). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the invention of Zaidi to include a sleeve, wherein the plasma delivery tip is sized and shaped to be advanced through the sleeve to a location at which plasma will be delivered beyond a distal end of the sleeve. Doing so allows the plasma tip to be deployable when it is in the correct position for ease of insertion.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHLEIGH LAUREN KERN whose telephone number is (703)756-4577. The examiner can normally be reached 7:30 am - 4:30 pm.
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/ASHLEIGH LAUREN KERN/Examiner, Art Unit 3794
/ADAM Z MINCHELLA/Primary Examiner, Art Unit 3794