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 .
Response to Amendment
This office action is in response to the amendment filed on 11/26/2025. As directed by the amendment, claims 16-17 and 19-23 have been amended. As such, claims 16-30 are pending in the instant application.
Response to Arguments
Applicant's arguments on pages 6-14 of Remarks filed 11/26/2025 have been fully considered but they are not persuasive.
Applicant argues “The devices of Linhart are handheld applicators that direct a plasma plume onto or into an exposed surface of the body. Notably, there is no mention of any aerosol stream, inhalation path, or microdroplet formulation in Linhart, and no motivation or reason to adapt the systems of Linhart for respiratory use.” However, the examiner respectfully disagrees. Crosbie (US 20150090261 A1) teaches creating cold plasma and nitric oxide using electric arcs and electrodes for treatment as seen in [0007] and [0076]. Linhart (US 20180103991 A1) teaches using cold plasma to treat tissue problems as seen in [0016] and the plasma is produced by a voltage between two electrodes (see [0061]) using with nitrogen, oxygen and/or their mixtures such as nitric oxide as seen in [0063] and [0071]. As such, both prior arts teach creating cold plasma using electrodes for medical/treatment purposes and thus are analogous in art.
Applicant further argues “…that there is no teaching or suggestion in the prior art that could lead to a combination of dielectric barrier discharge plasma generation with an aerosol guiding structure…” with the combination of Crosbie, Linhart and Chen, and “Hendrikse is directed to a method for providing in situ chemical transformation and ionization of an inorganic oxidizer of a sample via an analyte detection system, and there is no reason for one skilled in the art to modify Crosbie.” Furthermore, “Modifying Linhart according to Hendrikse to reach the specific requirements of claim 16 would require hindsight reasoning, picking and choosing only certain features to reconstruct the limitations of claim 16 without any reasonable supporting rationale from the cited references.” However, the examiner respectfully disagrees. Linhart teaches an outer ground electrode 111 and active electrode 112 creating a discharge generating plasma 108 as seen in Fig. 1B and [0070]. This is similar to Hendrikse (US 20160161379 A1) which teaches a first electrode 112 is a needle electrode (see [0015]) and the second electrode is a sleeve and/or outer electrode enclosing the needle electrode 112 (see [0016]). Hendrikse further teaches applying voltage to the first electrode to generate a low temperature plasma by creating an electric field in the gas as seen in Fig. 2B and [0018]. As such, Hendrikse also teaches creating low temperature plasma by creating an electric field using electrodes and thus is analogous in art. As such, it would be obvious to one of ordinary skill in the art to modify the device taught by modified Crosbie to have the first electrode be a needle electrode, the second electrode be a cylindrical electrode and to have a dielectric capillary between both electrodes and with the needle electrode in the dielectric capillary as taught by Hendrikse to use specific types of electrodes that will perform a similar function (of creating cold/non-equilibrium/low temperature plasma using an electric field), especially as Hendrikse teaches having a dielectric capillary that can help direct the plasma towards the direction/area it needs to go towards (see [0020]).
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 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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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) 16-17, 19, 21-24 and 26-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Crosbie (US 20150090261 A1) in view of Linhart (US 20180103991 A1), Chen (US 20200268655 A1) and Hendrikse (US 20160161379 A1).
Regarding claim 16, Crosbie teaches a device for user inhalation of gases (inhaler 10 and airway 220, see Figs. 1-3), the device comprising:
a gas guiding structure comprising an airflow channel configured to guide the gas stream (airway 220 can be a mask hose connecting the patient to a mechanical ventilation device or gas supply, which guides the gas from the gas source to the patient as seen in Fig. 1 and [0052]),
a plasma jet generator (spark chamber 205, spark gap 225 and pair of electrodes (not shown), see Fig. 3) adapted for generating a plasma plume of non-thermal plasma (Crosbie teaches a pair of electrodes within a spark chamber 205 forming a spark gap 225 between in Fig. 3 and [0054]. Crosbie further teaches when separating nitric oxide from air using electric arcs (spark and arc is used interchangeably as seen in [0051]), the electrodes are ionized resulting in cold plasma as seen in [0007]), the plasma jet generator comprising an outlet for exhausting the plasma plume in the gases (outlet 40, see Figs. 1-3; outlet 40 is placed in the patient’s airway for generating Nitric Oxide and/or plasma as seen in [0090] into the pathway 220 as seen in Figs. 1-3) but does not teach an aerosol device for user inhalation of an aerosol stream, the device comprising:
an aerosol guiding structure comprising an airflow channel configured to guide the aerosol stream comprising a plurality of microdroplets,
an aerosol generator configured to generate the aerosol stream in the aerosol guiding structure and
a non-thermal plasma jet generator,
wherein the plasma jet generator comprises a dielectric barrier discharge configuration which comprises a first electrode and a second electrode with dielectric material between the electrodes,
wherein the dielectric barrier discharge configuration comprises a capillary section, wherein the first electrode is a needle electrode and the second electrode is a cylindrical electrode enclosing the needle electrode with a capillary made of dielectric material in between both electrodes.
However, Linhart teaches a non-thermal plasma jet generator (“Plasma may be delivered by plasma source represented by plasma jet shown on exemplary FIG. 1B.” see [0070]; Linhart teaches using cold plasma to treat tissue problems as seen in [0016]) adapted for generating a plasma plume of non-thermal plasma (Linhart teaches using cold plasma to treat tissue problems as seen in [0016] and the plasma is produced by a voltage between two electrodes as seen in [0061]. Linhart further teaches an outer ground electrode 111 and active electrode 112 creating a discharge generating plasma 108 as seen in Fig. 1B and [0070]).
Crosbie teaches using air and an electric arc to produce plasma and nitric oxide (see [0007]). Linhart teaches plasma may be generated with nitrogen, oxygen and/or their mixtures such as nitric oxide as seen in [0063] and [0071]. Both Crosbie and Linhart teaches using electrodes powered by voltage to produce plasma. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device taught by Crosbie to replace the electrodes as taught by Linhart as an alternative method to create non-thermal plasma within the art.
However, Chen teaches an aerosol device for user inhalation of an aerosol stream (plasma aerosol inhalation device 200, see Fig. 3 and [0027]), the device comprising:
an aerosol guiding structure comprising an airflow channel configured to guide the aerosol stream comprising a plurality of microdroplets (Nebulization module 20 nebulizes the liquid L to aerosol G’, such that the droplet particle size is about 1˜20 μm (microdroplets) as seen in [0029]. There is an aerosol guiding structure guiding the aerosol stream G’ as it moves towards plasma treatment module 40 and treatment chamber 41 as seen in Fig. 3 and [0027] and [0030]),
an aerosol generator (nebulization module 20, see Fig. 3) configured to generate the aerosol stream in the aerosol guiding structure (“Step S1: nebulizing the liquid L to aerosol G′ using the nebulization module 20.” See [0029]), and
a plasma generator (plasma generating unit 43, see Fig. 3) adapted for generating a plasma (“…a plasma P was generated by the plasma generating unit 43 to process the aerosol G′ in the treatment chamber into a plasma aerosol G…” see [0027]), the plasma generator comprising an outlet for exhausting the plasma plume in the aerosol stream (plasma generator unit 43 comprises an outlet for exhausting the plasma into treatment chamber 41 where the aerosol is combined with the plasma to become plasma aerosol G).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device taught by Crosbie in view of Linhart to replace the mechanical ventilation device with a nebulization module to create aerosol for user inhalation of an aerosol stream as taught by Chen as only aerosol can carry radicals (reactive oxygen species and reactive nitrogen species) generated by plasma and deliver it to the respiratory system while minimizing the impact of the radical to other tissues or organs (see [0011]).
However, Hendrikse teaches wherein the plasma jet generator comprises a dielectric barrier discharge (first electrode 112, second electrode 114 and dielectric barrier 116 see Fig. 2B) configuration which comprises a first electrode (first electrode 112, see Fig. 2B) and a second electrode (second electrode 114, see Fig. 2B) with dielectric material between the electrodes,
wherein the dielectric barrier discharge configuration comprises a capillary section, wherein the first electrode is a needle electrode (“…the first electrode 112 is a needle electrode…” see [0015]) and the second electrode is a cylindrical electrode enclosing the needle electrode (“For example, the second electrode 114 is a counter electrode, a sleeve electrode, and/or an outer electrode 114.” See [0016]; the second electrode is a sleeve and/or outer electrode enclosing the needle electrode 112 as seen in Fig. 2B) with a capillary (dielectric barrier 116, see Fig. 2B; “…the dielectric barrier 116 is a glass tube that is open at both ends.” See [0017]; the dielectric barrier 116 is taken to be a dielectric capillary as it is tubular like a capillary) made of dielectric material in between both electrodes (dielectric barrier 116 separates the first electrode 112 and second electrode 114 as seen in Fig. 2B and [0017] with the needle electrode 112 being within the dielectric barrier 116 as seen in Fig. 2B and [0017]).
Linhart teaches an active electrode 112 and a second outer ground electrode 111 but does not specify what type of electrodes they are as seen in Fig. 1B. Linhart further teaches a gas inlet where gas enters as shown by arrows 113 (see Fig. 1B and [0070]) and a power supply 101 (see Fig. 1B). Hendrikse teaches a first needle electrode 112, a second sleeve electrode 114, a transport gas inlet port 106 and a power supply 118 in which the power supply 118 is to apply voltage to the first electrode to generate a low temperature plasma by creating an electric field in the gas as seen in Fig. 2B and [0018]. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device taught by modified Crosbie to include the computer system and have the first electrode be a needle electrode, the second electrode be a cylindrical electrode and to have a dielectric capillary between both electrodes and with the needle electrode in the dielectric capillary as taught by Hendrikse to use specific types of electrodes that will perform a similar function. Furthermore, having a dielectric capillary can help direct the plasma towards the direction/area it needs to go towards (see [0020]).
Regarding claim 17, modified Crosbie teaches the device according to claim 16, and further teaches wherein the outlet of the plasma jet generator is oriented such that, in operation, the plasma plume is oriented substantially in a direction of the aerosol stream (Modified Crosbie teaches an outlet 40 (taught by Crosbie) to be oriented in the same direction of the aerosol stream (taught by Chen and will have the same pathway as the airway path to patient in Fig. 1), as air enters through inlet 30 and exits through outlet 40 as a nitric oxide plasma as seen in Fig. 1 and [0007] and [0052]).
Regarding claim 19, modified Crosbie teaches the device according to claim 16, and Crosbie further teaches comprising one outlet in a center of the aerosol stream (Modified Crosbie teaches an outlet 40 (taught by Crosbie) is in a center of the aerosol stream (taught by Chen) as seen in Figs. 1-2).
Regarding claim 21, modified Crosbie teaches the device according to claim 16, and Hendrikse further teaches wherein the second electrode is isolated from the first electrode (second electrode 114 is isolated from first electrode 112 as seen in Fig. 2B), and wherein the first electrode and the second electrode are configured such that a gas can be introduced between the electrodes (Hendrikse teaches transport gas inlet port 106 in which transport gas flow 901 enters through and is introduced between first electrode 112 and second electrode 114 as seen in Fig. 2B and [0015], [0018] and [0027]).
Regarding claim 22, modified Crosbie teaches the device according to claim 21, and Hendrikse further teaches the needle electrode is in the capillary made of dielectric material ([71] of applicant’s specification recites “In embodiments of the present invention the capillary is made of dielectric material. It may for example be made of glass, quartz, and medical grade polymers.” Hendrikse teaches first electrode 112 is in dielectric barrier 116, wherein dielectric barrier 16 is a glass tube as seen in Fig. 2B and [0017]).
Regarding claim 23, modified Crosbie teaches the device according to claim 22, and Hendrikse further teaches wherein the capillary extends beyond the needle electrode (dielectric barrier 116 extends past needle electrode 112 as seen in Fig. 2B).
Regarding claim 24, modified Crosbie teaches the device according to claim 22, and Hendrikse further teaches wherein the capillary is a straight capillary (the dielectric barrier 116 is a straight capillary as seen in Fig. 2B).
Regarding claim 26, modified Crosbie teaches the device according to claim 21, and further teaches the aerosol device comprising a voltage generator (high voltage power supply 250, see Fig. 3 of Crosbie) adapted for applying a voltage between the first and second electrode (Crosbie teaches voltage power supply 250 to apply a voltage between the two electrodes (taught by Hendrikse) as seen in Fig. 3 and [0062]).
Regarding claim 27, modified Crosbie teaches the device according to claim 16, and Chen further teaches the aerosol device comprising an aerosol generator (nebulization module 20, see Fig. 3) adapted for generating the aerosol stream in the aerosol inhaler (“Step S1: nebulizing the liquid L to aerosol G′ using the nebulization module 20.” See [0029] and Figs. 3-4).
Regarding claim 28, modified Crosbie teaches the device according to claim 16, and further teaches the aerosol device comprising at least one controller adapted for monitoring and/or controlling the aerosol device (Crosbie teaches a controller 260 which directly or indirectly controls spark generator 222 and monitors the production of NO as seen in Fig. 3 and [0057]. Hendrikse further teaches a computer system that can perform procedure 500 of introducing gas into a dielectric barrier, and applying a voltage between a first and second electrode as seen in Fig. 5 and [0037] and [0040]-[0042]).
Regarding claim 29, modified Crosbie teaches the device according to claim 28, and further teaches wherein the at least one controller is adapted for controlling a gas flow generator (Crosbie teaches the controller 260 to program the inhaler 401, in which a treatment profile can be selected 405 as seen in Fig. 4 and [0076]. Modified Crosbie will teach a controller 260 to program the nebulizer module 20 taught by Chen) and for controlling a plasma discharge in this gas flow (Modified Crosbie teaches a controller 260 to program the spark 415 as shown in Fig. 4 and [0080]-[0083] of Crosbie and further teaches a computer system that can perform procedure 500 of introducing gas into a dielectric barrier, and applying a voltage between a first and second electrode as seen in Fig. 5 and [0037] and [0040]-[0042] of Hendrikse).
Regarding claim 30, modified Crosbie teaches the device according to claim 29, and further teaches wherein the at least one controller is adapted for monitoring whether or not an aerosol stream is flowing and for activating the plasma discharge only if the aerosol stream is flowing (“…the inhaler further comprises an air velocity sensor disposed to sense air velocity within the spark chamber, the air velocity sensor being coupled directly or indirectly to the controller, and the controller is being configured to adjust the spark energy responsive to the velocity of air within the spark chamber.” See [0029] of Crosbie; modified Crosbie teaches an air velocity sensor connected to a controller 260 to monitor the velocity of the aerosol stream flow and adjusting the plasma due to the velocity of the aerosol, such that if the velocity is at zero, the spark energy/voltage can be adjusted to have no spark/voltage).
Claim(s) 18 is/are rejected under pre-AIA 35 U.S.C. 103 as being unpatentable over Crosbie (US 20150090261 A1) in view of Chen (US 20200268655 A1), Linhart (US 20180103991 A1) and Hendrikse (US 20160161379 A1), as applied to claim 16 above, and further in view of Rontal (US 20130053762 A1).
Regarding claim 18, modified Crosbie teaches the device according to claim 16, but does not teach wherein the non-thermal plasma jet generator comprises a plurality of outlets.
However, Rontal teaches wherein the non-thermal plasma jet generator (Rontal teaches an apparatus for treating biofilms on internal organs by the direct or indirect application of cold plasma as seen in [0013] and further discusses a “cold plasma generator” seen in [0015]) comprises a plurality of outlets (Rontal teaches multiple channels showing on an insertable cold plasma applicator as seen in Fig. 6 and [0029] and [0058]),
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device taught by modified Crosbie to have multiple channels as taught by Rontal to have multiple channels/outlets as an alternative cold plasma outlet design.
Claim(s) 20 is/are rejected under pre-AIA 35 U.S.C. 103 as being unpatentable over Crosbie (US 20150090261 A1) in view of Chen (US 20200268655 A1), Linhart (US 20180103991 A1) and Hendrikse (US 20160161379 A1), as applied to claim 16 above, and further in view of Fridman (US 20120253265 A1).
Regarding claim 20, modified Crosbie teaches the device according to claim 16, and Crosbie further teaches wherein the non-thermal plasma jet generator comprises a hollow tube adapted for guiding the plasma towards the outlet (there is a hollow tube connected to outlet 40 which directs the nitric oxide and/or plasma from the spark chamber 205 to outlet 40 as seen in Figs. 1-3) but does not teach wherein the hollow tube is adapted for changing an orientation of the plasma plume.
However, Fridman teaches wherein the hollow tube (tube 102, see Fig. 1) is adapted for changing an orientation of the plasma plume (Applicant’s specification recites “In general, the hollow tube, may be a flexible tube. By bending this tube the orientation of the
plasma plume can be changed (see [76]).” Fridman teaches the need for tube 102 to be flexible and preferably be made out plastic as seen in [0045]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device taught by modified Crosbie to have the hollow tube be made out of plastic as taught by Fridman for a flexible tube (see [0045]) and therefore can be bent around obstacles.
Claim(s) 25 is/are rejected under pre-AIA 35 U.S.C. 103 as being unpatentable over Crosbie (US 20150090261 A1) in view of Chen (US 20200268655 A1), Linhart (US 20180103991 A1) and Hendrikse (US 20160161379 A1), as applied to claim 22 above, and further in view of Lu (US 20090188626 A1).
Regarding claim 25, modified Crosbie teaches the device according to claim 22 but does not teach wherein the capillary is a bended capillary.
However, Lu teaches wherein the capillary is a bended capillary (“The dielectric material 5 is in the form of a bent hollow tube…” see [0062] and Fig. 5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device taught by modified Crosbie to have a bended capillary as taught by Lu as an alternative design choice that will not affect the function of the device.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Tina Zhang whose telephone number is (571)272-6956. The examiner can normally be reached Monday - Friday 9:00AM-5:00PM.
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/TINA ZHANG/Examiner, Art Unit 3785