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 06/17/2026 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.
Please see MPEP 1503.02.
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 an outward facing surface of 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), and wherein the speculum body comprises a shape to seal molecular radicals generated by the array of microplasmas in the ear canal (Figs. 6A-6B, sealing feature 560; page 6, para. [0076], sentence 6). 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), wherein the array of radially situation microchannels and the apertures in the distal end are dispersed so as to approximate a cone (see annotated Figure below, the apertures approximating a cone shape as shown by the orientations of 440 that contain 442); 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 microplasmas 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.
PNG
media_image1.png
604
710
media_image1.png
Greyscale
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 microplasmas (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 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 and 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 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 (page 7, para. [0112], second sentence) in the middle ear or in the middle ear cavity (page 7, para. [0112], fourth sentence). Although Truong does not explicitly disclose that the jets are actuated for at least 3 minutes, it would have been obvious for one of ordinary skill in the art to run the jet actuation for at least 3 minutes as a matter of routine optimization since it has been held that “where general conditions of a claim are disclosed in prior art, it is not inventive to discover the optimum or workable ranges by routine optimization.” (See MPEP 2144.05(II)).
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), and sealing the molecular radicals in the ear canal (Figs. 6A-6B, sealing feature 560; page 6, para. [0076], sentence 6). 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 generate molecular radicals 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).
Regarding claim 20, Truong in view of Shelton and in further view of Ahn in further view of Laroussi teaches the method of claim 1 as described above, comprising a sealing membrane on the outside of the speculum body to seal the molecular radicals generated by the array of microplasmas in the ear canal (Shelton: Figs. 6A-B: sealing feature is a membrane “lip” 562).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (“Bacterial Inactivation of Wound Infection in a Human Skin Model by Liquid-Phase Discharge Plasma” PLoS ONE, 2011) in view of Shelton (US 20190142258).
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 in a gas mixture; 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 an outer surface of the eardrum (tympanic membrane), thereby producing gaseous reactive species such as oxygen or nitrogen-bearing molecular radicals, diffuse through the eardrum and into the middle ear space, at least-partially disrupting and deactivating a biofilm on one or both of the inner surface of the eardrum and in the middle ear cavity, 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). Although Kim et al. does not explicitly disclose maintaining the injection for at least 3 minutes, it would have been obvious for one of ordinary skill in the art to run the jet actuation for at least 3 minutes as a matter of routine optimization since it has been held that “where general conditions of a claim are disclosed in prior art, it is not inventive to discover the optimum or workable ranges by routine optimization.” (See MPEP 2144.05(II)).
Kim et al. fails, however, to explicitly disclose that a seal is formed with the ear canal during the injection, as Kim also fails to disclose all the structures of the devices used. Shelton teaches a speculum structure for using in a patient’s ear, which forms a seal with the ear canal during use (Figs. 6A-6B, sealing feature 560; page 6, para. [0076], sentence 6). 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 Kim et al. by incorporating the use of a speculum device which delivers the microplasmas, having a body structure as taught by Shelton to create a seal with the ear canal, in order to contain the microplasmas within the canal for effective treatment.
Response to Arguments
Applicant's arguments filed 06/17/2026 regarding the drawing objections and prior art rejections of claims 1-12, 14-18 and 20 have been fully considered but are not persuasive.
Regarding the drawing objection, Applicant argues against the objection due to a previous round of prosecution. However, Examiner directs Applicant to MPEP section 1503.02 for the requirements of the drawings regarding their lines and shading.
Applicant’s arguments regarding the limitations of “at least 3 minutes” in claims 15 and 19 are not persuasive as the claimed time frame would have been obvious to one of skill in the art as a matter of routine optimization (see the rejections above and MPEP section 2144.05(II).
Regarding Applicant’s arguments of the “molecular radicals generated by the array” for claim 1, Examiner points to this as functional language, citing back to Laroussi which teaches the generation of the plasma plumes, and molecular radicals being a fundamental aspect of generated plasma, as Laroussi teaches.
Applicant’s arguments regarding the prior art rejection of claim 19 is considered moot in light of the amendments to claim 19 filed 06/17/2026 for which there is a new ground of rejection. Kim is no longer solely relied upon to teach all limitations of claim 19, as it is now combined with the taught structures of Shelton to teach sealing with the ear canal.
For these reasons, claims 1-12 and 14-20 stand rejected as recited above.
Conclusion
THIS ACTION IS MADE FINAL. 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 KATERINA ANNA WITTLIFF whose telephone number is (703)756-4772. The examiner can normally be reached M-Th: 9-7ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, MICHAEL TSAI can be reached at 571-270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/K.A.W./Examiner, Art Unit 3783
/NATHAN R PRICE/Primary Examiner, Art Unit 3783
Prosecution Insights