DETAILED ACTION
The following is a Non-Final Office Action on the merits.
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 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.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 5/9/2025 has been entered.
Response to Amendment
Acknowledgment is made to the amendment received 5/9/2025.
Applicant’s amendments are sufficient to overcome the claim objection set forth in the previous office action.
Applicant’s amendments are sufficient to overcome the 35 USC 112(b)/second paragraph claim rejections set forth in the previous office action.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “wherein the first electrode and the second electrode each respectively extend a distance distally beyond an extent of the first and second dielectric coatings” (claim 7) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 7-12 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 7 recites the limitation “wherein the first electrode and the second electrode each respectively extend a distance distally beyond an extent of the first and second dielectric coatings”. While the specification discusses “The distance between a first electrode and second electrode may be fixed or the distance may be adjustable, e.g., to retract one or both of a first electrode and a second electrode while the device is not being used to generate a non-equilibrium plasma”, there is no support for the first and second electrode to extend a distance distally beyond both the first and second dielectric coatings.
Claims 8-12 depend from claim 7 and are thus also rejected.
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.
Claim(s) 1, 3, 13, 15 & 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (2010/0125267) in view of Krasik et al. (2017/0354453).
Concerning claim 1, as illustrated in at least Fig. 1 & 5C, Lee et al. disclose a device for administering a non-equilibrium plasma to a subject (plasma gun 1 comprises plasma discharge unit 20; [0026], [0040]), comprising:
a unit comprising a lumen and an aperture (plasma gun 1 comprises a lumen and an aperture; [0025])
a first electrode and a second electrode carried within the lumen of the unit (first and second electrodes 26a,b are carried within the lumen), wherein the first electrode and the second electrode are capable of carrying a voltage of at least 1 kV (first and second electrodes 26a, b are capable of carrying the claimed voltage; [0027], [0040]);
a first dielectric coating disposed on the first electrode and a second dielectric coating disposed on the second electrode (a dielectric 27 may be formed on both of the inner surface of the first electrode 26a and the outer surface of the second electrode 26b by a coating or attaching process; [0040]), the first dielectric coating and the second dielectric coating each in respective electrical communication with the first electrode and the second electrode such that the first and second dielectric coatings are capable of spatially-orienting a non-equilibrium plasma in a liquid phase between the first electrode and the second electrode (plasma discharge unit 20 generates stable and reliable atmospheric plasma 30 using dielectric barrier discharge (i.e., DBD) under the atmospheric pressure condition; [0026]);
a first wire connected to the first electrode and a second wire connected to the second electrode, wherein the first wire and the second wire are capable of carrying an electric current, and the first wire and the second wire are disposed within the lumen of the unit (power source 40 applies high voltage to electrodes 26a, b via inherent wire leads within the lumen; [0027-0028]); and
at least one insulating sheath surrounding a length of the first wire and a length of the second wire (housing 10 surrounds wires; [0025]).
Lee fails to disclose the unit being a catheter comprising a lumen and an aperture, the first and second electrode carried within the lumen, the first and second wire disposed within the lumen. However, Krasik et al. disclose a plasma generating device (26) for administering plasma that can be configured as either a catheter (64) or stand-alone unit. At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Lee et al. to further comprise a catheter comprising a lumen and an aperture, the first and second electrode carried within the lumen, the first and second wire disposed within the lumen in order to provide the benefit of enabling application of plasma at a desired location such as in deep cavities or open cavities as taught by Krasik et al. ([0127-0131]; Fig. 4A-B).
Concerning claim 3, Lee discloses the at least one of the first dielectric coating or the second dielectric coating is a dielectric thin film comprising a glass or biocompatible polymer ([0033]; Fig. 5c).
Concerning claim 13, as illustrated in at least Fig. 1 & 5C, Lee et al. disclose a device for administering a non-equilibrium plasma to a subject (plasma gun 1 comprises plasma discharge unit 20; [0026], [0040]), comprising:
a unit comprising a lumen and an aperture (plasma gun 1 comprises a lumen and an aperture; [0025]);
an inner electrode and an outer electrode concentrically arranged and carried within the lumen of the catheter (first and second electrodes 26a,b are concentrically arranged within the lumen), wherein the inner electrode and the outer electrode are capable of carrying a voltage of at least 1 kV (first and second electrodes 26a, b are capable of carrying the claimed voltage; [0027], [0040]);
a first dielectric coating disposed on the inner electrode and a second dielectric coating disposed on the outer electrode (a dielectric 27 may be formed on both of the inner surface of the first electrode 26a and the outer surface of the second electrode 26b by a coating or attaching process; [0040]), the first dielectric coating and the second dielectric coating each in respective electrical communication with the inner electrode and the outer electrode such that the first and second dielectric coatings are capable of spatially-orienting a non-equilibrium plasma between the inner electrode and the outer electrode (plasma discharge unit 20 generates stable and reliable atmospheric plasma 30 using dielectric barrier discharge (i.e., DBD) under the atmospheric pressure condition; [0026]);
a first wire connected to the inner electrode and a second wire connected to the outer electrode, wherein the first wire and the second wire are capable of carrying an electric current, and the first wire and the second wire are disposed within the lumen of the unit (power source 40 applies high voltage to electrodes 26a, b via inherent wire leads within the lumen; [0027-0028]); and
at least one insulating sheath surrounding a length of the first wire and a length of the second wire (housing 10 surrounds wires; [0025]).
Lee fails to disclose the unit being a catheter comprising a lumen and an aperture, the first and second electrode carried within the lumen, the first and second wire disposed within the lumen. However, Krasik et al. disclose a plasma generating device (26) for administering plasma that can be configured as either a catheter (64) or stand-alone unit. At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Lee et al. to further comprise a catheter comprising a lumen and an aperture, the first and second electrode carried within the lumen, the first and second wire disposed within the lumen in order to provide the benefit of enabling application of plasma at a desired location such as in deep cavities or open cavities as taught by Krasik et al. ([0127-0131]; Fig. 4A-B).
Claim 15 is rejected upon the same rationale as provided for claim 3.
Concerning claim 20, Lee fails to disclose at least one optical fiber extending within the lumen, the at least one optical fiber adapted for fiber optic imaging. However, Krasik et al. further disclose a visual signal unit (32) configured to transmit light through an optical fiber (34) and receive visual input coming back through the fiber (34). At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Lee et al. to further comprise at least one optical fiber extending within the lumen, the at least one optical fiber adapted for fiber optic imaging in order to provide the benefit of enabling an operator to receive visual input about the location of the plasma generating unit as taught by Krasik et al. ([0078]; Fig. 1A).
Claim(s) 2, 14 & 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (2010/0125267) in view of Krasik et al. (2017/0354453), as applied to claims 1 & 13, in further view of Platt, Jr. et al. (6,213,999).
Concerning claims 2 & 14, Lee et al. in view of Krasik et al. fail to disclose the device lacking a gas line capable of fueling a gas plasma. However, Platt, Jr. et al. disclose a device for administering plasma (10, 29), the device comprising either a supply of ionizable gas (12) or lack of a supply of ionizable gas such that fluid is ionized in the region of the active electrode. At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Lee et al. in view of Krasik et al. such that the device lacks a gas line capable of fueling a gas plasma in order to provide the benefit of a plasma that is more spatially dispersed as taught by Platt, Jr. et al. and since Platt, Jr. et al. teach a gas supply line and lack of a gas supply line to be equivalents in the art for the purposes of treating tissue. (Col. 1, ll. 31-38, Col. 5, ll. 6-25 & 45-53, Col. 5-6, ll. 63-11; Fig. 1-2)
Concerning claim 19, Lee et al. in view of Krasik et al. fail to specifically disclose the outer electrode is formed form a mesh material. However, Platt, Jr. et al. further disclose an outer electrode (17) comprising a conductive mesh. At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Lee et al. in view of Krasik et al. such that the outer electrode is formed form a mesh material in order to provide the benefit producing a desired field characteristic by manipulation of the size, shape, and placement of the electrodes as taught by Platt, Jr. et al. (Col. 6, ll. 12-28)
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (2010/0125267) in view of Krasik et al. (2017/0354453), as applied to claim 1, in further view of Sartor et al. (2017/0224404).
Concerning claim 4, Lee et al. in view of Krasik et al. fail to disclose the at least one of the first dielectric coating or the second dielectric coating is a dielectric thin film comprising quartz, polytetrafluoroethylene, sapphire, ruby, garnet, silica, cerium(IV) oxide, yttria-stabilized zirconia, alumina, corundum, silicon carbide, boron nitride, polyurethane, or parylene. However, Sartor et al. disclose a device for administering a plasma comprising a dielectric coating, the dielectric coating comprising sapphire, zirconia, polytetrafluoroethylene (for example, TEFLON), and combinations thereof, selected for high temperature, high dielectric strength, and relatively high dielectric constant. At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Lee et al. in view of Krasik et al. such that the at least one of the first dielectric coating or the second dielectric coating is a dielectric thin film comprising quartz, polytetrafluoroethylene, sapphire, ruby, garnet, silica, cerium(IV) oxide, yttria-stabilized zirconia, alumina, corundum, silicon carbide, boron nitride, polyurethane, or parylene in order to provide the benefit of a dielectric material that is a suitable insulating material and capable of withstanding high-temperatures as taught by Sartor et al. ([0073]) and since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. See also Ballas Liquidating Co. v. Allied industries of Kansas, Inc. (DC Kans) 205 USPQ 331.
Claim(s) 5-6 & 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (2010/0125267) in view of Krasik et al. (2017/0354453), as applied to claims 1 & 13, in further view of Davison et al. (2001/0001314).
Concerning claims 5 & 17, Lee et al. in view of Krasik et al. fail to disclose the first wire and/or the second wire comprises tungsten or platinum. However, Davison et al. disclose a device for administering a plasma comprising first and second wires connected to first and second electrodes (420, 422), the first and second wires comprising platinum. At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Lee et al. in view of Krasik et al. such that the first wire and/or the second wire comprises tungsten or platinum in order to provide the benefit a material where heat production is minimized and there is more efficient transfer or energy as taught by Davison et al. ([0037], [0039], [0196]) and since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. See also Ballas Liquidating Co. v. Allied industries of Kansas, Inc. (DC Kans) 205 USPQ 331.
Concerning claims 6 & 18, Lee et al. in view of Krasik et al. fail to disclose the first wire and/or the second wire has a diameter of about 1 mm to about 1 mm. However, Davison et al. further disclose the first wire and/or the second wire has a diameter of about 1 mm to about 1 mm ([0173]). It would have been obvious to one having ordinary skill in the art at the time the invention the invention was effectively filed to modify the invention of Lee et al. in view of Krasik et al. such that the first wire and/or the second wire has a diameter of about 1 mm to about 1 mm as taught by Davison et al. is of whatever desired or expedient size, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Response to Arguments
Applicant’s arguments are moot in view of the new ground(s) of rejection.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Blankenship (2005/0211685) teaches mesh electrodes of a plasma device for the purpose of increasing the uniformity of the cold plasma discharge by making the conductive surfaces on both sides of the shielding gas passage from a fine wire mesh, as opposed to a solid metal electrode ([0004], [0015]). Merbahi et al. (2012/0141321) and Ward et al. (2018/0036059) teach a plasma generating device (Fig. 1). Fridman et al. (2012/0253265) teach first and second electrodes extending beyond a single dielectric coating (Fig. 1).
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/JAYMI E DELLA/Primary Examiner, Art Unit 3794
JAYMI E. DELLA
Primary Examiner
Art Unit 3794