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 § 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) 19, 21, 39, 41, and 43 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rontal (US 20150038790 A1) in view of Laroussi (US 20090121637 A1) and Hancock (US 20160113700 A1).
Regarding claim 19, Rontal teaches a plasma delivery tip of a medical-grade plasma generating device (Fig 1; disposable distal section generally indicated at 12), comprising: a gas delivery lumen having a proximal-to-distal axis ([0040] gas flowing through the tube 16), and along which a flow of ionization gas flows distally to an exit aperture of the gas delivery lumen ([0040] The hand-held member 14 also connects to a laser 34 through a fiber 36 which then passes through the output tube 16); and a discharge electrode, located in said lumen, for intraluminal creation of plasma ([0045] A tubular high voltage RF or pulsed electrode 86, which terminates shortly before the channel 84, and has gas flowing through it and out the end, is disposed in the channel 84), electrically isolated from the flow of ionization gas by a dielectric barrier layer ([0045] The channel 84 has a dielectric tubular liner 88, which covers the electrode 86. The dielectric tubular liner 88 may cover only the outer surface of electrode 86, or it may cover all surfaces of electrode 86. A plasma stream 90 is generated at the end of the electrode 86 and flows out of the endoscope), and which transmits a high voltage gradient into the flow of ionization gas when attached to a high voltage source, the gradient acting to generate free electrons alongside the discharge electrode and generate a flow of cold plasma by dielectric barrier discharge ([0045] FIG. 4 illustrates the distal end of an embodiment of the invention in which the plasma is generated at the distal end by a dielectric barrier discharge (DBD) or other conventional technique to form a plasma jet); wherein said plasma delivery tip is suitable for intraluminal delivery using a sheath or working channel and has an outer diameter of less than 7mm ([0058] The present invention contemplates insertable plasma applicators that can be added to any therapeutic endoscopic device or small diameter integrated endoscopes for the paranasal sinuses, where space is a premium. These insertable devices should have a diameter of less than about 2.5 millimeters). It would have been obvious to one having ordinary skill in the art at the time the invention was made to include wherein said plasma delivery tip is suitable for intraluminal delivery using a sheath or working channel and has an outer diameter of less than 7mm, 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.
Rontal fails to fully teach wherein the exit aperture of the gas delivery lumen is oriented to direct a cold plasma plume exiting the gas delivery lumen, in an oblique direction oriented away from the proximal-to-distal axis; and wherein said discharge electrode comprises a central conductor of a coaxial cable comprising said central conductor and an outer conductor, and the central conductor extends distally past said outer conductor and transmits said high voltage gradient.
However, Laroussi teaches wherein the exit aperture of the gas delivery lumen is oriented to direct a cold plasma plume exiting the gas delivery lumen, in an oblique direction oriented away from the proximal-to-distal axis (Fig 3; [0060] When the plasma pencil 300 is in use, plasma plumes 380 extend from each of the apertures 348. It should be appreciated that these plasma plumes 380 may extend in a direction perpendicular to the main axis of the plasma pencil 300. Alternatively, the plasma plumes 380 may extend in a direction that is at an obtuse angle to the main axis of the plasma pencil 300. In still other exemplary embodiments, the plasma plumes 380 may extend in a direction that is at an acute angle to the main axis of the plasma pencil 300). 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 Rontal to include wherein the exit aperture of the gas delivery lumen is oriented to direct a cold plasma plume exiting the gas delivery lumen, in an oblique direction oriented away from the proximal-to-distal axis. Doing so allows for the plasma to be applied in any direction necessary for the treatment.
Further, Hancock teaches wherein said discharge electrode comprises a central conductor of a coaxial cable ([0088] FIGS. 3A and 3B shown a first embodiment of an electrosurgical instrument 300 according to the invention. The instrument 300 comprises an elongate probe made up of a central coaxial cable 302 surrounded by a tubular sleeve 304) comprising said central conductor (Fig 3; inner conductor 312) and an outer conductor (Fig 3; outer conductor 310), and the central conductor extends distally past said outer conductor and transmits said high voltage gradient ([0089] the inner conductor 312 continues through the insulating element 308 and protrudes beyond the insulating element 308 for a length selected (using simulations) to give best impedance match for deep coagulation). 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 Rontal to include wherein said discharge electrode comprises a central conductor of a coaxial cable comprising said central conductor and an outer conductor, and the central conductor extends distally past said outer conductor and transmits said high voltage gradient. Doing so allows the conductor to extend beyond the sheath for deeper treatment into the target site.
Regarding claim 21, Rontal teaches the plasma delivery tip of claim 19, wherein said discharge electrode extends circumferentially around said gas lumen (Fig 4; [0045] The channel 84 has a dielectric tubular liner 88, which covers the electrode 86. The dielectric tubular liner 88 may cover only the outer surface of electrode 86, or it may cover all surfaces of electrode 86), but fails to fully teach wherein said gas lumen comprises a plurality of exit apertures oriented in an oblique direction away from said axis including said exit aperture.
However, Laroussi teaches wherein said gas lumen comprises a plurality of exit apertures oriented in an oblique direction away from said axis including said exit aperture (Fig 3; [0060] When the plasma pencil 300 is in use, plasma plumes 380 extend from each of the apertures 348. It should be appreciated that these plasma plumes 380 may extend in a direction perpendicular to the main axis of the plasma pencil 300. Alternatively, the plasma plumes 380 may extend in a direction that is at an obtuse angle to the main axis of the plasma pencil 300. In still other exemplary embodiments, the plasma plumes 380 may extend in a direction that is at an acute angle to the main axis of the plasma pencil 300). 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 Rontal to include wherein said gas lumen comprises a plurality of exit apertures oriented in an oblique direction away from said axis including said exit aperture. Doing so allows for the plasma to be applied in any direction necessary for the treatment.
Regarding claim 39, Rontal teaches the plasma tip of claim 19, wherein the outer conductor includes a distal extension of a flexible ([0042] Forces imposed on the tube guide wires by motion of the trigger 17 cause the flexible end section 18 to bend relative to the primary tube 16. The entire length of the tube 16 and its flexible extension 18 may be in the range of 13 centimeters and the diameters of the tubes are preferably 4 millimeters or less. This allows for maneuvering through the nasal passages).
Rontal fails to fully teach comprising: an outer insulating layer of the coaxial cable surrounding the outer conductor of a coaxial cable, and stripped from a distal portion of the central conductor; conducting electrical shielding layer from the distal portion of the coaxial cable comprising a stiffened electrical shielding layer; and an insulator insulating the central conductor with a dielectric barrier layer where it extends distally past the outer conductor.
However, Hancock teaches comprising: an outer insulating layer of the coaxial cable (Fig 12; [0126] An insulating liner 522 is mounted around the inside surface of the conductive terminal tube 518 along a distal length thereof) surrounding the outer conductor of the coaxial cable (Fig 12A), and stripped from a distal portion of the central conductor ([0122] The outer conductor 506 is exposed around at the outside surface of the coaxial cable 502); conducting electrical shielding layer (Fig 4; sleeve 304) from the distal portion of the coaxial cable comprising a stiffened electrical shielding layer (Fig 4; insulating tube 330 (e.g. made of quartz, ceramic or the like)); and an insulator insulating the central conductor (Fig 4; insulating element 308) with a dielectric barrier layer where it extends distally past the outer conductor ([0089] The protruding length is surrounded by a cylindrical ceramic (or other suitable dielectric or magnetic material) cap 314). 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 Rontal to include comprising: an outer insulating layer of the coaxial cable surrounding the outer conductor of a coaxial cable, and stripped from a distal portion of the central conductor; conducting electrical shielding layer from the distal portion of the coaxial cable comprising a stiffened electrical shielding layer; and an insulator insulating the central conductor with a dielectric barrier layer where it extends distally past the outer conductor. Doing so separates the conducting portions from each other to limit unwanted interaction.
Regarding claim 41, Rontal teaches the plasma tip of claim 39, wherein the coaxial cable has an outer diameter of less than 4 mm ([0058] The present invention contemplates insertable plasma applicators that can be added to any therapeutic endoscopic device or small diameter integrated endoscopes for the paranasal sinuses, where space is a premium. These insertable devices should have a diameter of less than about 2.5 millimeters). It would have been obvious to one having ordinary skill in the art at the time the invention was made to include wherein said plasma delivery tip is suitable for intraluminal delivery using a sheath or working channel and has an outer diameter of less than 7mm, 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 43, Rontal teaches the plasma delivery tip of claim 19, provided together with the plasma generating device, and operable to generate plasma ([0063] The plasma generator shown in FIG. 4 represents the distal end of an endoscope and the gas flow tube and electrode may be of an insertable design. FIG. 7 illustrates the manner of insertion of a DBD plasma generator 100, like that of FIG. 4, into an endoscope 102, from the proximal end, in accordance with the present invention, but the generator can alternatively be inserted from the distal end).
Claim(s) 22-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rontal (US 20150038790 A1) in view of Laroussi (US 20090121637 A1) and Hancock (US 20160113700 A1), further in view of Kalghatgi (US 20160121134 A1).
Regarding claim 22, Rontal teaches the plasma delivery tip of claim 19, but fails to fully teach comprising: at least one gas return channel extending along the gas delivery lumen, through which the ionization gas returns proximally after exiting the gas delivery lumen.
However, Kalghatgi teaches comprising: at least one gas return channel extending along the gas delivery lumen, through which the ionization gas returns proximally after exiting the gas delivery lumen ([0031] In some embodiments vacuum suction is effectuated by air drawn from a suction outlet connected or connectable to the plasma generation module 204 near the proximal end of the module. In some embodiments the air, gas, vapor, mist or the like are drawn through internal suction tube 238 within tube 226, and drawn from a suction inlet 240 at the distal end of the suction tube 238. The enclosure 202, which surrounds the larger tube 238, also surrounds the suction inlet 240). 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 Rontal to include comprising: at least one gas return channel extending along the gas delivery lumen, through which the ionization gas returns proximally after exiting the gas delivery lumen. Doing so would allow the extra gas to be returned to the chamber and would control the plasma generation site.
Regarding claim 23, Rontal teaches the plasma delivery tip of claim 22, but fails to teach wherein the at least one gas return channel extends helically around the gas delivery lumen.
However, Kalghatgi teaches wherein the at least one gas return channel extends helically around the gas delivery lumen (Fig 3 and 4; [0029] The enclosure 202, which surrounds the outer tube 238, also surrounds the gas outlet 236). 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 Rontal to include wherein the at least one gas return channel extends helically around the gas delivery lumen. Doing so would allow the extra gas to be returned to the chamber and would control the plasma generation site.
Regarding claim 24, Rontal teaches the plasma delivery tip of claim 22, but fails to teach wherein the gas return channel is provided with a connector to allow attachment to a source of negative pressure.
However, Kalghatgi teaches wherein the gas return channel is provided with a connector to allow attachment to a source of negative pressure ([0031] In some embodiments vacuum suction is effectuated by air drawn from a suction outlet connected or connectable to the plasma generation module 204 near the proximal end of the module). 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 Rontal to include wherein the gas return channel is provided with a connector to allow attachment to a source of negative pressure. Doing so would allow the extra gas to be returned to the chamber and would control the plasma generation site.
Regarding claim 25, Rontal teaches the plasma delivery tip of claim 22, but fails to teach wherein the gas return channel is open to a pressure lower than a pressure developed negative pressure.
However, Kalghatgi teaches wherein the gas return channel is open to a pressure lower than a pressure developed negative pressure ([0031] In some embodiments vacuum suction is effectuated by air drawn from a suction outlet connected or connectable to the plasma generation module 204 near the proximal end of the module). 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 Rontal to include wherein the gas return channel is open to a pressure lower than a pressure developed negative pressure. Doing so would allow the extra gas to be returned to the chamber and would control the plasma generation site.
Regarding claim 26, Rontal teaches the plasma delivery tip of claim 22, wherein the plasma is thermally non-damaging ([0014] In a preferred embodiment of the present invention, the non-thermal plasma (cold plasma)).
Claim(s) 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rontal (US 20150038790 A1) in view of Laroussi (US 20090121637 A1) and Hancock (US 20160113700 A1), further in view of Hancock (2) (US 20170014184 A1).
Regarding claim 40, Rontal teaches the plasma tip of claim 39, but fails to fully teach comprising an outer insulating layer added to extend over the stiffened electrical shielding layer.
However, Hancock (2) teaches comprising an outer insulating layer added to extend over the stiffened electrical shielding layer ([0077] To avoid damaging the distal end of the device as it is inserted along the instrument channel of an endoscope, a slidable tubular cover 344 is mounted at the distal end of the sheath 304). 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 Rontal to include comprising an outer insulating layer added to extend over the stiffened electrical shielding layer. Doing so would insulate the outer portion of the stiffened electrical shielding layer for protection against damages.
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