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
The Amendment filed 02/06/2026 has been entered.
Claims 1, 2, 4, 10, 15 and 19 have thereby been amended.
Claims 1-19 are being examined in this office action.
Drawings
New corrected drawings in compliance with 37 CFR 1.121(d) are required in this application for the following: Figs. 1D-F do not meet the 37 CFR 1.84(a) standards, in which all lines in the drawings must, ordinarily, be drawn with the aid of a drafting instrument and must be executed in black, uniformly thick and well-defined lines, or the 37 CFR 1.84(m) standards, in which spaced lines for shading are preferred. These lines must be thin, as few in number as practicable, and they must contrast with the rest of the drawings.
Claim Objections
Claims 9 and 15-19 are objected to because of the following informalities:
Claim 9 has an error, reciting “a the.”
Claims 15 and 19 recite “and/or.” The use of “and/or” makes it unclear if both the elements (being the middle ear and middle ear cavity for claim 15 and the surface of the eardrum and the middle ear for claim 19) must be included (as with “and”) or only one (as with “or”), or if the recited terms point to the same single structure. For the purposes of examination, “and/or” is interpreted as only “or.”
Additionally, claims 16-18 should be included in the objection because any claims that depend on an objected claim inherit the problems of their parent claims.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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.
Claim 19 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kim et al. (“Bacterial Inactivation of Wound Infection in a Human Skin Model by Liquid-Phase Discharge Plasma” PLoS ONE, 2011).
Regarding claim 19, Kim et al. discloses a method for biofilm treatment in the middle ear and middle ear cavity and the deactivation of bacteria responsible for human ear infections (Abstract, Principal Findings, sentence 1: findings show plasma treatment as successful for treating biofilm infections in human tissue; Introduction, sentence 3: the middle ear is disclosed as an example of human tissue needing effective methods of biofilm treatment), the method comprising generating microplasma and injecting the microplasma (Materials and Methods, Liquid Plasma Device and Setup: the plasma is injected using an electrode and tungsten needle) into an ear canal toward the eardrum (tympanic membrane), thereby producing reactive species such as oxygen or nitrogen-bearing molecular radicals that diffuse through the eardrum and into the middle ear space, at least-partially disrupting and deactivating a biofilm on the inner surface of the eardrum and/or in the middle ear and at least-partially deactivating the bacteria responsible for ear infections (page 5, col. 2, sentence 1: plasma deactivates the bacteria with reactive chemical species to the applied tissue/area; Introduction, sentence 3: the middle ear may be the location of the biofilm being treated).
Claim Rejections - 35 USC § 103
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-14 are rejected under 35 U.S.C. 103 as being unpatentable over Ahn (US 20120253166) in view of Shelton (US 20190142258) in further view of Laroussi (US 8460283).
Regarding claim 1, Ahn discloses a speculum (310) comprising plasma generation (200; page 1, para. [0020]) at its distal tip for treatment of the middle ear.
Ahn provides disclosure for the overall device and its functionality as claimed, but fails to disclose the structural details of the speculum body being configured for otoscope attachment or the structural configuration of the plasma generation elements that are claimed.
Shelton teaches a speculum body (Fig. 1A, 110 and 102; Fig. 7A: 610, 602) configured to attach to the otoscope (page 4, para. [0062], last two sentences); and an optically transparent central portion in the body to permit viewing of an eardrum by a practitioner (Fig. 1B: 120 and 122; Fig. 7B: the open central lumen shown by D18 and D13), and an array of radially situated microchannels within the speculum body (Fig. 7A, channels 664a-d), wherein the array of radially situated microchannels are arranged to deliver an array to the eardrum (Figs. 2C-E: the array of air/air vortexes delivered to the ear drum; para. [0079], sentences 7-11) through the apertures (Fig. 7A: air outlet 662; [0079], sentence 11) while maintaining a view to the eardrum through the optically transparent central portion (Fig. 7B: air delivered through 664a-d, see on the outer perimeter while the central lumen denoted by D18 and D13 remains open and transparent for viewing). Therefore, it would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the body of the Ahn speculum with the teachings of the Shelton speculum to ensure its capability of coupling with an otoscope in order to allow for improved visualization and diagnosis of the ear (Shelton: page 3, para. [0055], sentences 1-2).
This device resulting from the combination of Ahn and Shelton, however, fails to disclose the structural details and configuration of the tip and plasma generation components taught by Ahn.
Laroussi teaches an analogous plasma treatment device comprising an array of radially (Fig. 4B radial arrangement of array) situated microchannels within the body (Fig. 4A, channels 410, 420, 440) and respectively extending to a corresponding array of apertures in a distal end of the body (Fig. 4A, 432/442; the apertures correspond to proximal channels 420); a power electrode array within the body (Fig. 4A, 434 and 444) positioned with respect to the microchannels to excite plasma generation within the microchannels (col. 6, lines 52-61), the apertures in the distal end are arranged to deliver an array of microplasma through the apertures (Fig. 4A: plasma plumes 480 delivered through apertures 432/442). Therefore, it would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the plasma generation at the distal tip of Ahn with the arrangements of the elements for the plasma generation and output taught by Laroussi, in order to maintain the central opening at the distal end of the speculum (evidenced by Laroussi Fig. 4B). Upon this combination, it would directly follow that the microchannels taught by Shelton would feed into and correspond to the apertures taught by Laroussi, such that the resulting Ahn-Shelton-Laroussi device would deliver the plasma to the eardrum of the patient.
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Regarding claim 2, Ahn in view of Shelton and in further view of Laroussi teaches the speculum according to claim 1 as described above, wherein the material of the body isolates the power electrode array (Laroussi Fig. 4A, body material of channels 440 separates lumen of channel from electrodes 444) from the array of radially situated microchannels (Laroussi: Figs. 4A and 4B illustrating radial configuration of channels 440; Shelton: Fig. 7A illustrating radial configuration of microchannels 664a-d).
Regarding claim 3, Ahn in view of Shelton and in further view of Laroussi teaches the speculum according to claim 1 as described above, comprising inlets to the microchannels to receive a gas flow and contacts to the power electrode array (Laroussi: Fig. 4A, inlets 420 and 422).
Regarding claim 4, Ahn in view of Shelton and in further view of Laroussi teaches the speculum according to claim 3 as described above, operated on the otoscope to produce a micro jet output as the array of microplasma (Laroussi: array of microplasma 880; col. 10, lines 45-48), as a result of the combined teachings of the micro jet output of Laroussi with the speculum configured to fit with the otoscope of Shelton.
Regarding claim 5, Ahn in view of Shelton and in further view of Laroussi teaches the speculum according to claim 1 as described above, wherein the optically transparent central portion comprises an empty lumen (Shelton: Fig. 1B, 120 and 122).
Regarding claim 6, Ahn in view of Shelton and in further view of Laroussi teaches the speculum according to claim 1 as described above, wherein the power electrode array comprises an array of radially situated electrodes (Laroussi: Fig. 4B, radial array of 444 and; Fig. 4A, array of 434).
Regarding claim 7, Ahn in view of Shelton and in further view of Laroussi teaches the speculum according to claim 6 as described above, wherein the radially situated electrodes and the radially situated microchannels alternate in an electrode section of the speculum (Laroussi: Fig. 4A, 434 electrodes alternating with 440 channels).
Regarding claim 8, Ahn in view of Shelton and in further view of Laroussi teaches the speculum according to claim 7 as described above, wherein the microchannels extend beyond the electrodes toward the distal end of the speculum body (Laroussi: Figs. 4A and 4B, end 442 of channels 440 extend beyond electrodes 434 and 444).
Regarding claim 9, Ahn in view of Shelton and in further view of Laroussi teaches the speculum according to claim 1 as described above, wherein the microchannels extend beyond the power electrode array toward a the distal end of the speculum body (Laroussi: Figs. 4A and 4B, end 442 of channels 440 extend beyond electrodes 434 and 444 of the power electrode array).
Regarding claim 10, Ahn in view of Shelton and in further view of Laroussi teaches the speculum according to claim 1 as described above, comprising an adapter to connect to an otoscope (Shelton: adapter 150/650; page 4, para. [0062], last two sentences), the adapter comprising: a circumferential channel on one side of the adapter (Shelton: Figs. 7A and 7B, 660 on distal side of adapter); gas outlets on an opposite side (Shelton: Fig. 7A, 660 and 662), the gas outlets being in fluid communication with the circumferential gas channel and being sized any arranged to mate with the microchannels (Shelton: Fig. 7A; page 7, para. [0079], sentences 1-7); and positive engagement features to mate with the otoscope (Shelton, 152).
Regarding claim 11, Ahn in view of Shelton and in further view of Laroussi teaches the speculum according to claim 10 as described above, wherein the otoscope is a conventional otoscope and the adapter is sized and configured to mate with the conventional otoscope (Shelton: page 3, para. [0056], second sentence).
Regarding claim 12, Ahn in view of Shelton and in further view of Laroussi teaches the speculum according to claim 1 as described above, wherein the speculum is sized according to ear canal anatomy (Shelton: page 3, para. [0056], sentences 4-6).
Regarding claim 13, Ahn in view of Shelton and in further view of Laroussi teaches the speculum according to claim 12 as described above, wherein the speculum comprises a shape, material and tip to create a seal in the ear canal (Shelton: Figs. 6A-6B, sealing feature 560; page 6, para. [0076], sentence 6).
Regarding claim 14, Ahn in view of Shelton and in further view of Laroussi teaches the speculum according to claim 12 as described above, wherein the electrode array extends a length away from the distal end that keeps the electrode array outside of the ear canal (Laroussi: Figs. 4A and 4B, distance between end 442 of channels 440 and electrodes 434 and 444, and electrodes 444 extending beyond distal end 414).
Claims 15-18 is rejected under 35 U.S.C. 103 as being unpatentable over Truong (US 20130023914) in view of Shelton (US 20190142258) in further view of Ahn (US 20120253166) in further view of Laroussi (US 8460283).
Regarding claim 15, Truong discloses a method for treatment in the middle ear and middle ear cavity, the method comprising: inspecting the middle ear of a subject (page 13, claim 31, lines 3-7); actuating jets to extend into the ear canal from a speculum (page 13, claim 31, lines 8-9); continuing to actuate the jets for a period of time sufficient (page 7, para. [0112], second sentence) in the middle ear and/or the middle ear cavity (page 7, para. [0112], fourth sentence).
However, Truong fails to disclose that the speculum used in this method is attached to an otoscope for viewing, and also fails to teach that the method is for plasma/biofilm treatment for the purpose of killing bacteria.
Shelton teaches an analogous speculum and treatment of the ear, with the speculum attached to the otoscope (page 4, para. [0062], last two sentences) wherein the speculum comprises an array of radially situated microchannels within the speculum body (Fig. 7A, channels 664a-d) and respectfully extending to apertures at a distal end of the speculum body (Fig. 7A: air outlet 662; [0079], sentences 7-11). Therefore, it would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the speculum of the Truong method with the teachings of the Shelton speculum to ensure its capability of coupling with an otoscope in order to allow for improved visualization and diagnosis of the ear (Shelton: page 3, para. [0055], sentences 1-2). However, Truong in view Shelton fails still to explicitly teach plasma and plasma jets for the treatment to the ear.
Ahn teaches an analogous plasma treatment for the ear to permit molecular radicals produced by the interaction of plasmas from the plasma jets with room air to diffuse through the eardrum of the subject and the inner surface of the eardrum (paras. [0064] - [0065]), teaching a device structure specifically for delivering plasma into the middle ear of a patient (Fig. 3; 200; page 1, para. [0020]). However, Ahn does not disclose specific structures of the plasma generation tip.
Laroussi teaches a plasma treatment device with plasma jets (Laroussi: Fig. 4A, 480), to inactivate or kill a bacterial biofilm (Laroussi: col. 2, lines 11-13), and microchannels extending to a corresponding array of apertures in a distal end (Fig. 4A, 432/442; the apertures correspond to proximal channels 420), wherein the plasma jets are emitted from the apertures (Fig. 4A: plasma plumes 480 delivered through apertures 432/442). Therefore, it would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of treatment with the speculum and otoscope features taught by the Truong-Shelton combination, in order to use the method to treat infections in the ear (Laroussi: col. 2, lines 1-7 in the ear when combined with Truong and Shelton). Upon this combination, it would directly follow that the microchannels taught by Shelton would feed into and correspond to the apertures taught by Laroussi, such that the resulting Truong-Shelton-Ahn-Laroussi method would deliver the plasma to the eardrum of the patient.
Regarding claim 16, Truong in view of Shelton and in further view of Ahn in further view of Laroussi teaches the method of claim 15 as described above, further comprising creating a seal in the ear canal with a tip of the speculum prior to the actuating of the plasma jets (Truong: page 9, para. [0138], sentence 5. Truong teaches this method for the actuation of the irrigation jets seen in Fig. 31, but upon combination with Laroussi the actuation is of the plasma jets).
Regarding claim 17, Truong in view of Shelton and in further view of Ahn in further view of Laroussi teaches the method of claim 15 as described above, repeated on a single patient over a period of time (Truong: page 5, para. [0088], sentences 1-3; pulsatile flow provides repeated rounds of treatment).
Regarding claim 18, Truong in view of Shelton and in further view of Ahn in further view of Laroussi teaches the method of claim 15 as described above, wherein the speculum comprises: a speculum body configured to attach to the otoscope (Shelton: page 4, para. [0062], last two sentences); an array of radially situated microchannels within the speculum body and extending to apertures in a distal end of the speculum body (Truong: channel 50, and Shelton: Fig. 7A, channels 664a-d); a power electrode array within the speculum body positioned with respect to the microchannels to excite plasma generation within the microchannels (Laroussi: Fig. 4A, 434 and 444; col. 6, lines 52-61); and an optically transparent central portion in the body to permit viewing of an eardrum by a practitioner (Truong: lenses 63 and 67; Shelton: Fig. 1B, 120 and 122).
Response to Arguments
Applicant's arguments filed 02/06/2026 regarding claims 1-19 have been fully considered but they are not persuasive.
Applicant argues that none of the prior art references recognize that “molecular radicals produced by the interaction of the plasmas with room air are able to diffuse through the eardrum and deactivated a biofilm located on the inner surface of the eardrum in the middle ear”. However, this limitation, found in recited in amended claim 15 as “molecular radicals produced by the interaction of plasmas from the plasma jets with room air to diffuse through the eardrum of the subject and inactivate or kill a bacterial biofilm”, is an intended outcome limitation. In other words, the method of claim 15 explicitly claims a time period that the plasma jets must be actuated for, that and that the plasma must be delivered to the eardrum/middle ear of the patient to treat a bacterial biofilm. However, the free radicals being produced from the interaction of the plasma with the surrounding air in the room is an intended outcome of delivering the plasma in the ear. There are no limitations claimed in claim 15 that specify any specific structures required to allow for free radicals to be produced when the plasma is emitted in an environment. Therefore, it is assumed by a person of ordinary skill in the art that any device/method having the same structures and steps as claimed would be capable of producing the same results as intended by the claimed invention. In this case, the Truong-Shelton-Laroussi method described as well as the Ahn-Shelton-Laroussi device have all the necessary components to deliver plasma to the eardrum/middle ear of a patient for biofilm treatment. Furthermore, Shelton explicitly discloses in para. [0079] cited above that the structures of the inlets and outlets around the microchannels do not seal off the inside of the ear from the air in the room around it. Therefore, one of ordinary skill in the art would recognize that the described combinations above read on all limitations as they are currently claimed, and that they would be capable of producing the same intended outcomes of the claimed invention as well.
Regarding claim 19, Applicant argues that Kim fails to disclose the plasma treatment being used to treat biofilm in the middle ear of a patient. However, although the experimental steps disclosed by Kim apply the plasma treatment to a human skin model as Applicant points out, Kim does disclose the purpose of that treatment to be used in various areas on patients including for infections in the middle ear, as disclosed in the Introduction. Therefore, Kim’s teachings of this application teach the limitations and also motivations for applying the plasma treatment within the ear of a patient, as described by the Ahn-Shelton-Laroussi device combination, as claimed.
Regarding claims 1-14, Applicant argues that “not one of [the cited] references directs microplasma via the array of microchannels and apertures.” However, Examiner does not rely on any single reference to teach this, but rather the combination of them, even though, as cited, Laroussi does in face disclose microplasma being emitted through microchannels and apertures. Examiner relies upon Shelton to teach the microchannel structures through the body and body structure of the Ahn plasma-generating speculum, and Laroussi to teach the plasma generation mechanism and apertures at the tip of the Ahn plasma-generating speculum. Applicant also argues that Ahn fails to teach a transparent inner portion of the speculum. However, as described above, Examiner relies upon the combination with Shelton to teach that specific structure of the body. In other words, Ahn acts as a bridge to motivate the combination of the Shelton speculum body with the plasma generation structures of Laroussi. Applicant additionally argues that Ahn fails to make a “provision for electrical safety in generating plasma,” however, that argument is not drawn to any limitations of the claims as they are currently written. Examiner maintains that Ahn in view of Shelton in further view of Laroussi reads on all limitation of the 02/06/2026 claims 1-14 as they are currently written.
Applicant also argues that Shelton (or any of the other references) does not explicitly mention that the channels referenced are “microchannels.” However, the claims or even the specification do not disclose a required range of dimensions that define or constitute “microchannels”. The disclosure provides an example in Fig. 1E showing the microchannel having a diameter of 225um, but again, no range to define what a microchannel must be is required in any of the claims as they are currently written. Still, Shelton discloses the space separating the central shaft lumen (Fig. 3B: 220) as little as 0.5 mm (para. [0068], sentence 1) which is the same as the embodiment discloses in Figs. 7A-B. Shelton further discloses the diameter of the gas vortex created as small at 0.5 mm. Therefore, according to these teachings and the channel structures of 664a-d shown in Figs. 7A-B, it is obvious to one of ordinary skill in the art that the channels disclosed can be less than a fraction of a mm in diameter and are in fact microchannels. Applicant cited a Wikipedia definition stating that “microchannel in microtechnology is a channel with a hydraulic diameter below 1 mm, usually 1-99 um.” As the microchannel diameters disclosed by the claimed invention in Fig. 1E are 225 um, it is unclear what range Applicant asserts a “microchannel” must fall within, other than anything less than 1 mm.
Regarding claims 15-18, Applicant argues that Truong fails to disclose plasma jets. However, as seen in the rejection above, Examiner does not rely upon Truong to teach the plasma jets. Rather, Examiner relies upon Truong to teach the overall method of actuation of flow into the ear for treatment, and relies upon Ahn and Laroussi to teach that flow as plasma and plasma jets.
Therefore, for all the reasons above, Examiner maintains that claims 1-19 stand rejected by Ahn in view of Shelton and Laroussi, or Truong in view of Ahn, Shelton and Laroussi, as cited above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATERINA ANNA WITTLIFF whose telephone number is (703)756-4772. The examiner can normally be reached M-Th: 9-7ET.
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/K.A.W./Examiner, Art Unit 3783
/NATHAN R PRICE/Primary Examiner, Art Unit 3783