Prosecution Insights
Last updated: October 01, 2026
Application No. 18/602,116

Oral Therapy Device

Final Rejection §102§103
Filed
Mar 12, 2024
Priority
Nov 10, 2023 — CN 2023230395654
Examiner
ROANE, AARON F
Art Unit
3792
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Shenzhen Kaiyan Medical Equipment Co. Ltd.
OA Round
2 (Final)
73%
Grant Probability
Favorable
3-4
OA Rounds
1y 3m
Est. Remaining
83%
With Interview

Examiner Intelligence

Grants 73% — above average
73%
Career Allowance Rate
657 granted / 895 resolved
+3.4% vs TC avg
Moderate +10% lift
Without
With
+9.7%
Interview Lift
resolved cases with interview
Typical timeline
3y 9m
Avg Prosecution
42 currently pending
Career history
923
Total Applications
across all art units

Statute-Specific Performance

§101
1.6%
-38.4% vs TC avg
§103
46.1%
+6.1% vs TC avg
§102
24.7%
-15.3% vs TC avg
§112
18.1%
-21.9% vs TC avg
Black line = Tech Center average estimate • Based on career data from 895 resolved cases

Office Action

§102 §103
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 Arguments Applicant's arguments filed 05/20/2026 have been fully considered but they are not persuasive. This unpersuasiveness is due to a new grounds of rejection (a new interpretation of the prior art of record) which in turn is due to Applicant’s amendments. On page 8, 2nd full paragraph Applicant asserts “Jablow does not disclose this three-component structure,” the three-component structure comprising “a housing container enclosing a plurality of stimulation elements, and a contact layer disposed upon the plurality of stimulation elements and configured to make contact with inner surfaces of the oral cavity.” The examiner disagrees as the rejections below show the three-component structure along with the contact layer disposed upon the plurality of stimulation elements as shown in figures 15 and 18. Next on page 8, last paragraph, Applicant asserts “there is no separate contact layer disposed upon the stimulation elements.” This argument is not strictly commensurate with the claim language since there is no recitation of “separate.” Additionally, this argument is contradicted by figures 15 and 18 of the prior art. Next on page 9, 1st full paragraph Applicant asserts “Jablow's device is not fully inserted into the oral cavity.” Again this argument is not strictly commensurate with the claim language since it is the “therapeutic unit configured to be located inside an oral cavity of a user” which comprises the housing, the plurality of stimulation elements and the contact layer, all of which the prior art disclose as configured to be located within the oral cavity of the user see figures 15, and 18-19 of the prior art of s. Next on page 10, 2nd full paragraph, Applicant asserts “Claim 18 further recites "the contact layer adheres to a predetermined region of the inner surfaces of the oral cavity due to a vacuum created by the concaved inwards shape of the contact layer." Jablow does not disclose any vacuum-based adhesion mechanism.” This is unpersuasive since the nature and shape (concave) of the mouthpiece creates a suction/vacuum in the oral cavity (mouth). The written description does not disclose a source for suction or vacuum other than the shape of the contact layer and since the prior art discloses a similarly disclosed and shaped contact layer, i.e., concave, the prior art of Jablow meets the claimed limitation. Next on page 10, the 3rd full paragraph Applicant asserts “Jablow in paragraph [0052] only discloses wire conduits 632, which are electrical conductors. There is no inner conduit for fluid transfer within an outer conduit in Jablow.” The examiner disagrees. Applicant admits on the record Jablow discloses wire conduits 632. There are two wire conduit elements 632 – one meets the wire and the other meets the conduit and the outer conduit is defined and recited as comprising one inner conduit and one electrical conductor and therefore this limitation is met. The remaining anticipation arguments (e.g., the fastener, etc. ) are moot since those elements have been reinterpreted due to Applicant’s amendments. Applicant’s arguments traversing the 103/obviousness rejections are moot since they are directed to: 1) clearly shown and clearly rebutted earlier arguments, or 2) disclosed subject matter from the prior art no longer relied upon due to Applicant’s amendment. Accordingly, this action is made FINAL. Claim Rejections - 35 USC § 102 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 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. Claims 1-2, 7-10, 12-13, 16, and 18-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jablow (U.S. Patent Application Publication 2020/0230432). Regarding claims 1-2, 7 and 12-13, Jablow discloses a device comprising: a therapeutic unit configured to be located inside an oral cavity of a user, the therapeutic unit comprising: a housing container (“mouthpiece 602,” see [0047] and the embodiment shown in figures 15-16, and other alternate/equivalent counterparts in other embodiments) enclosing a plurality of stimulation elements in the form of irradiation sources (“LEDs, configuration 302 and 304 which may mate with the dual cylindrical lens array 202 and 204,” see [0045] and figures 3-4, “light generating element 604, such as, for example an LED light source or plurality of LED light sources,” see [0047] and figures 5-12, for example and other alternate/equivalent counterparts in embodiments), and a contact layer (“inner border 606,” see [0047] and figures 5-19, and other alternate/equivalent counterparts in other embodiments like 2006 in figure 20) adjacent a plurality of stimulation elements and configured to and positioned such that stimulation energy propagates from the plurality of stimulation elements through the contact layer and onto biological tissue of the oral cavity of the user, the contact layer shaped as concaved inwards towards the housing container of the therapeutic unit; it should be noted the contact layer is disposed upon the plurality of stimulation elements (since the contact layer 606 is shown in figure 18 as contacting the printed circuit board 626 and “light generating element 604 that can include a plurality of light generating elements 624, e.g., LED lights. Light generating element 604 can be a printed circuit board (PCB) 626 that includes the plurality of light generating elements 624 disposed thereon such that the light generating elements 624 are wired such that they can be connect to wire conduits 632 that provide power to the light generating elements 624,” see [0049]), a control module (the internal elements of "control/power unit 608," see [0047] and figures 5-12) electrically connected to the therapeutic unit through an electrical conductor (one of “wire conduits 632,” see [0052] and figure 16); and an electrical power source (“power source 658 (e.g., a battery including a rechargeable battery),” see [0052] and figure 19) provided within the control module, the electrical power source configured to provide electrical power to the plurality of stimulation elements, wherein the control module is configured to regulate the supply of the electrical power to the plurality of stimulation elements to modify operational characteristics of the plurality of stimulation elements. Jablow also discloses the claimed fastening arrangement (the external shell-like portion of the "control/power unit 608," see [0047], [0052] and figures 5-19, especially figures 12, 17A-17B) coupled to the control module and disposed outside the oral cavity (see figure 19), the fastening arrangement configured to fasten the control module to a portion of the body of the user outside the oral cavity. Regarding claim 8, Jablow discloses the claimed irradiation sources are configured to emit electromagnetic radiation in a wavelength range of 300 nm to 1200 nm (see [0062]). Regarding claim 9, Jablow discloses the claimed device including wherein portions of the contact layer above the irradiation sources are diaphanous. In [0038] of U.S. Patent Application Publication 2025/0152962 for the present application, Applicant discloses "In the context of the specification, the phrase "diaphanous material" refers to a material that allows at least a portion of one or more forms of electromagnetic radiation (such as Infrared, Ultraviolet, X-rays, Visible Light, Microwaves, Radio Waves, etc.) to pass through them. The diaphanous materials can be transparent (allowing one or more forms of electromagnetic radiation to pass through with minimal scattering) or translucent (allowing one or more forms of electromagnetic radiation to pass through with appreciable diffusion or scattering). Diaphanous materials can be dense, like glass, or have an open structure, like wire mesh or a woven fabric. Accordingly, Jablow anticipates the invention since Jab low disclose "the embodiment of FIGS. 5-19 include the mouthpiece is made of a material that is substantially clear or substantially transmissive of the light generated by the light generating element 604 and can be made of flexible or elastomeric that would be comfortable when engaged with the teeth and mouth of a user," see [0048]. Regarding claims 10, and 16, Jablow discloses the claimed device including the control module further comprises a user interface(" on/off button 614," see [0052] and figures 5- 6, and 12 - for example "user interface 1506," see [0055] and figure 14) configured to receive control input signals from the user, for modifying the operational characteristics of the plurality of stimulation elements. Regarding claims 18-19, Jablow discloses a method comprising: providing the oral therapy device, the oral therapy device comprising: a therapeutic unit configured to be located inside an oral cavity of a user, the therapeutic unit comprising: a housing container (“mouthpiece 602,” see [0047] and the embodiment shown in figures 15-16, and other alternate/equivalent counterparts in other embodiments) enclosing a plurality of stimulation elements in the form of irradiation sources (“LEDs, configuration 302 and 304 which may mate with the dual cylindrical lens array 202 and 204,” see [0045] and figures 3-4, “light generating element 604, such as, for example an LED light source or plurality of LED light sources,” see [0047] and figures 5-12, for example and other alternate/equivalent counterparts in embodiments), and a contact layer (“inner border 606,” see [0047] and figures 5-19, and other alternate/equivalent counterparts in other embodiments like 2006 in figure 20) adjacent a plurality of stimulation elements and configured to and positioned such that stimulation energy propagates from the plurality of stimulation elements through the contact layer and onto biological tissue of the oral cavity of the user, the contact layer shaped as concaved inwards towards the housing container of the therapeutic unit; it should be noted the contact layer is disposed upon the plurality of stimulation elements (since the contact layer 606 is shown in figure 18 as contacting the printed circuit board 626 and “light generating element 604 that can include a plurality of light generating elements 624, e.g., LED lights. Light generating element 604 can be a printed circuit board (PCB) 626 that includes the plurality of light generating elements 624 disposed thereon such that the light generating elements 624 are wired such that they can be connect to wire conduits 632 that provide power to the light generating elements 624,” see [0049]), a control module (the internal elements of "control/power unit 608," see [0047] and figures 5-12) electrically connected to the therapeutic unit through an electrical conductor (one of “wire conduits 632,” see [0052] and figure 16); and an electrical power source (“power source 658 (e.g., a battery including a rechargeable battery),” see [0052] and figure 19) provided within the control module, the electrical power source configured to provide electrical power to the plurality of stimulation elements, wherein the control module is configured to regulate the supply of the electrical power to the plurality of stimulation elements to modify operational characteristics of the plurality of stimulation elements; wherein the claimed fastening arrangement (the external shell-like portion of the "control/power unit 608," see [0047], [0052] and figures 5-19, especially figures 12, 17A-17B) coupled to the control module and disposed outside the oral cavity (see figure 19), the fastening arrangement configured to fasten the control module to a portion of the body of the user outside the oral cavity. 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. Claims 3, 11, 15, 17, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Jablow (U.S. Patent Application Publication 2020/0230432) as applied to claims 1, 13, and 18 above, and further in view of Brawn et al. (U.S. Patent Application Publication 2019/0083202). Regarding claims 3, and 15, Jablow show device above, but fail to recite the fastening arrangement comprises a hook portion configured to conform with a shape of an ear of the user. Like Jablow, Brawn et al. disclose a lighting device for applying light to the mouth region internally and externally and applying light to teeth and teach attaching the therapeutic unit having a plurality of light elements to an eyeglasses-like frame 22 having a hook portion ("ear-engaging portions 24," see [0333] and figures 1-4) in order to provide a known and workable means of securing the therapeutic unit in place with the added benefit passive engagement with the patient. Therefore, at the time of the of invention it would have been obvious to one of ordinary skill in the art to modify the invention of Jablow, as taught by Brawn et al., to attaching the therapeutic unit having a plurality of light elements to an eyeglasses-like frame having a hook portion for engaging the ear of the patient in order to provide a known and workable means of securing the therapeutic unit in place with the added benefit passive engagement with the patient. Regarding claims 11, 17, and 20, Jablow show device above, but fail to recite: the control module further comprises a communication interface configured to receive control input signals from a user computing device, over a communication network, for modifying the operational characteristics of the plurality of stimulation elements {claims 11, and 17}, the step of regulating the power supply further comprises receiving, by the control module, control input signals from the user, through one or more of a user interface provided with the control module and a communication interface over a communication network, for modifying the operational characteristics of the plurality of stimulation elements {claim 20}. Like Jablow, Brawn et al. disclose a lighting device for applying light to the mouth region internally and externally and applying light to teeth and teach providing the device and method with a "programmable controller" 50 "in communication with another device, such as a computer, which can include a personal computer, server computer, or laptop computer" (see [0424]) over wired or wireless networks (see [0426]) in order to provide an known and workable means "to control the operation of light-therapy apparatus 20" (see [0423]) wherein the "controller can have controls that allow various parameters to be set, such as light wavelength, light intensity, light pulsing, light duty cycle, light frequency, or light duration, and can appropriately activate light emitters of one or more light sources 3 0 in response to an appropriate signal. A controller can control light emissions with any light characteristics" (see [0423]). Therefore, at the time of the of invention it would have been obvious to one of ordinary skill in the art to modify the invention of Jablow, as taught by Brawn et al., to providing the device and method with a "programmable controller" 50 "in communication with another device, such as a computer, which can include a personal computer, server computer, or laptop computer" over wired or wireless networks in order to provide a known and workable means "to control the operation of light-therapy apparatus 20" wherein the "controller can have controls that allow various parameters to be set, such as light wavelength, light intensity, light pulsing, light duty cycle, light frequency, or light duration, and can appropriately activate light emitters of one or more light sources 30 in response to an appropriate signal. A controller can control light emissions with any light characteristics." Claims 4-6, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Jablow (U.S. Patent Application Publication 2020/0230432) as applied to claims 1, and 13 above, and further in view of Beckman (U.S. Patent Application Publication 2022/0054243). Regarding claims 4-6, and 14, Jablow further discloses a device is used for teeth whitening and an outer conduit (the neck portion of the control housing located adjacent the mouthpiece, see figures 5-12) has disposed therein electrical conductors ( electrical conductors 632, see figure 12) but fails to explicitly recite: A1) an outer conduit connecting the control module with the therapeutic unit, the outer conduit comprising therewithin an inner conduit, wherein the control module further comprises a composition container configured to store therewithin a therapeutic composition, the inner conduit configured to transfer the therapeutic composition from the composition container and into the oral cavity of the user {claim 4}, A2) the control module further comprises a pump configured to pump the therapeutic composition from the composition container and into the inner conduit {claim 5}, A3) the therapeutic composition is selected from a group consisting of water, brine solution, pharmaceutical compositions, gels, emulsions, and combinations thereof {claim 6}, and/or A4) the control module comprises a composition container configured to store therewithin a therapeutic composition, the control module connected to the therapeutic unit through an outer conduit comprising therewithin an inner conduit and the electrical conductor. Like Jablow, Beckman discloses a mouthpiece device used for whitening teeth having treatment capabilities ("UV light," see [0088]) and delivering fluids/liquids to the mouthpiece and teaches providing the device with Al) an outer conduit ("guiding extension 1521," see [093] (also see [0094 ]-[0097]) and figure 15, and alternate/equivalent counterparts in other embodiments, see for example the embodiments in figures 11-14) connecting the control module with the therapeutic unit, the outer conduit comprising therewithin an inner conduit ("conduit(s)," see [0098] for example, and figure 15, and alternate/equivalent counterparts in other embodiments, see for example the embodiments in figures 11-14 ), wherein the control module further comprises a composition container ("oral care fluids within cartridge 1506," see [0098] and figure 15, and alternate/equivalent counterparts in other embodiments, see for example the embodiments in figures 11-14) configured to store therewithin a therapeutic composition, the inner conduit configured to transfer the therapeutic composition from the composition container and into the oral cavity of the user {claim 4}, ■ A2) the control module further comprises a pump ("pump 1123," see [0066], and alternate/equivalent counterparts in other embodiments, see for example the embodiments) configured to pump the therapeutic composition from the composition container and into the inner conduit ("conduits," see [0066], and alternate/equivalent counterparts in other embodiments, see for example the embodiments) {claim 5}, ■ A3) the therapeutic composition is selected from a group consisting of water ("water," see [0066]), brine solution, pharmaceutical compositions, gels, emulsions, and combinations thereof {claim 6}, and A4) the control module comprises a composition container ("oral care fluids within cartridge 1506," see [0098] and figure 15, and alternate/equivalent counterparts in other embodiments, see for example the embodiments in figures 11-14) configured to store therewithin a therapeutic composition, the control module connected to the therapeutic unit through an outer conduit ("guiding extension 1521," see [093] (also see [0094]-[0097]) and figure 15, and alternate/equivalent counterparts in other embodiments, see for example the embodiments in figures 11-14) comprising therewithin an inner conduit, in order to provide a known and workable device for delivering a liquid/fluid composition to a mouthpiece in order to whiten teeth. This combination provides for an outer conduit that contains both electrical conductors (Jablow) and inner conduits for fluid (Beckman). Therefore, at the time of the of invention it would have been obvious to one of ordinary skill in the art to modify the invention of Jablow, as taught by Beckman, to providing the device with Al) an outer conduit connecting the control module with the therapeutic unit, the outer conduit comprising therewithin an inner conduit, wherein the control module further comprises a composition container configured to store therewithin a therapeutic composition, the inner conduit configured to transfer the therapeutic composition from the composition container and into the oral cavity of the user, A2) the control module further comprises a pump configured to pump the therapeutic composition from the composition container and into the inner conduit, A3) the therapeutic composition is selected from a group consisting of water, brine solution, pharmaceutical compositions, gels, emulsions, and combinations thereof, and A4) the control module comprises a composition container configured to store therewithin a therapeutic composition, the control module connected to the therapeutic unit through an outer comprising therewithin an inner conduit, all in order to provide a known and workable device for delivering a liquid/fluid composition to a mouthpiece in order to whiten teeth, this combination has the added benefit of a single device that both applies the teeth whitening composition and the necessary LEDs for completely the whitening process. 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. 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 AARON F ROANE whose telephone number is (571)272-4771. The examiner can normally be reached generally Mon-Fri 8am-9pm. 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, Niketa Patel can be reached at (571) 272-4156. 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. /AARON F ROANE/Primary Examiner, Art Unit 3792
Read full office action

Prosecution Timeline

Mar 12, 2024
Application Filed
Feb 25, 2026
Non-Final Rejection mailed — §102, §103
May 20, 2026
Response Filed
Aug 13, 2026
Final Rejection mailed — §102, §103 (current)

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Prosecution Projections

3-4
Expected OA Rounds
73%
Grant Probability
83%
With Interview (+9.7%)
3y 9m (~1y 3m remaining)
Median Time to Grant
Moderate
PTA Risk
Based on 895 resolved cases by this examiner. Grant probability derived from career allowance rate.

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