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 Arguments
Applicant’s arguments in combination with amendments, see remarks and claims, filed 04/08/2026, with respect to the rejection(s) of claim(s) under 35 USC 112b have been fully considered and are persuasive. Therefore, the 112b rejection has been withdrawn.
Applicant’s arguments in combination with amendments, see remarks and claims, filed 04/08/2026, with respect to the rejection(s) of claim(s) under 35 USC 103 have been fully considered and are persuasive.
The claims as written do not recite any details regarding the inner main body. As written and under its broadest reasonable interpretation, any component provided inside the housing can be considered to be the inner main body. Hwang discloses the light source and providing a plurality of light-inducing groves formed outside the housing so as to emit light (para 0038) and in figures 2 and 4 shows having a gap between the light inducing grooves 112 and the lamp 122 (i.e., light source). As such, the shell could be considered to be the surface of the housing 110 which encloses the “inner main body” and “light source”, and separating them from the oral cavity. This would create an “air gap that separates both the inner main body and the light source from the shell (see fig. 2, para 0029-0030; space provided between lamps 122 and light inducing grooves 113”, para 0032, see figs 2 and 4) for improving delivery of the emitted light to the pharyngeal tissue (this limitation is the result of operation of the device; therefore, it is understood to be non-functional language and not given any patentable weight.)
However, to advance prosecution, the applicant’s arguments are considered persuasive and it is accepted that Hwang fails to explicitly disclose the shell and the air gap. However, Van, from a similar field of endeavor teaches an illumination device having a deformable light guide (para 0045; i.e., “shell”) enclosing the support circuitry coupled to each of the light sources (para 0050; i.e., “inner main body and the light source”), configured to guide the light produced by the light source 34 to a specified location (e.g., a target tissue area) via a primary emission surface (para 0045, fig. 3, i.e., “separating the inner main body and the light source from the oral cavity”); wherein the deformable light guide is configured to conform to a target tissue of a user when in contact with the tissue.
Claim(s) 1-3, 8-11, 15-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Pat Pub No. 20220040495 to Hwang et al. (previously presented) in view of US Pat Pub No. 20220288413 to Van de Ven.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hwang in view of Van as applied to claims 1-3, 8-11, 15-19 above, and further in view of US Pat Pub No. 20210228900 to Kothari et al. (previously presented).
Claim(s) 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hwang in view of Van as applied to claims 1-3, 8-11, 15-19 above, and further in view of US Pat Pub No. 20040116985 to Black (previously presented).
Claim(s) 5, 12-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hwang in view of Van as applied to claims 1-3, 8-11, 15-19 above, and further in view of US 20220226667 A1 to Kothari et al. (previously presented).
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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Claim(s) 1-3, 8-11, 15-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Pat Pub No. 20220040495 to Hwang et al. (hereinafter “Hwang”) in view of US Pat Pub No. 20220288413 to Van de Ven (Hereinafter “Van”).
Regarding claim 1. (Original) Hwang discloses a phototherapy device (para 0025, “stomatitis treatment device 1”) for delivering phototherapy to an oral cavity (para 0001-0003, 0011, 0018, 0026, etc.), the phototherapy device including: a main body configured to be receiving within the oral cavity (para 0025-0026, “body 10”, figs. 1-4); a light source configured to emit light and mechanically supported by an inner main body (para 0026, 0031 “cell restoration lamp 122”, and any components holding the lamps; see figs 2 and 4), such that when the main body is positioned within the oral cavity the inner main body and the light source are located within the oral cavity and inner main body directs light emitted from the light source to illuminate tissues of the oral cavity (fig. 4);
Hwang discloses the light source and providing a plurality of light-inducing groves formed outside the housing so as to emit light (para 0038) and in figures 2 and 4 shows having a gap between the light inducing grooves 112 and the lamp 122 (i.e., light source). As such, the shell could be considered to be the surface of the housing 110 which encloses the “inner main body” and “light source”, and separating them from the oral cavity. This would create an “air gap that separates both the inner main body and the light source from the shell (see fig. 2, para 0029-0030; space provided between lamps 122 and light inducing grooves 113”, para 0032, see figs 2 and 4) for improving delivery of the emitted light to the pharyngeal tissue (this limitation is the result of operation of the device; therefore, it is understood to be non-functional language and not given any patentable weight.)
In arguendo, even if Hwang fails to explicitly disclose the shell and the air gap as recited, Van, from a similar field of endeavor teaches an illumination device having a deformable light guide (para 0045; i.e., “shell”) enclosing the support circuitry coupled to each of the light sources (para 0050; i.e., “inner main body and the light source”), configured to guide the light produced by the light source 34 to a specified location (e.g., a target tissue area) via a primary emission surface (para 0045, fig. 3, i.e., “separating the inner main body and the light source from the oral cavity”); wherein the deformable light guide is configured to conform to a target tissue of a user when in contact with the tissue. It would have been obvious before the filing date of the claimed invention to modify the disclosure of Hwang with the teachings of Van, because doing so would allow for having a deformable section, providing the predictable result of conforming to a target tissue of a user when in contact with the tissue.
Regarding “for improving delivery of the emitted light to the pharyngeal tissue. This limitation is the result of operation of the device; therefore, it is understood to be non-functional language and not given any patentable weight.). Hwang discloses the device is configured to emit light outward from the uvula evasion portion 115 to provide treatment to uvula and tonsils (para 0032). As such, it is understood that at least a portion of the light is at least capable of reaching the pharyngeal tissue. Van also teaches that the treatments may include one or more tissues of the upper respiratory tract, including the nasal cavity, ostium from paranasal sinus cavities, and the pharynx, including the nasopharynx and the oropharynx (para 0043).
Regarding claim 2. (Original) Hwang as modified by Van renders obvious the phototherapy device of claim 1, wherein: the main body further includes an upper portion (para 0025, “body 10”), a lower portion (para 0025, “coupling module 20”), a connecting portion joining the upper portion and the lower portion (para 0033, 0034, etc., “coupling groove 114”), and a channel located between the upper portion and the lower portion (fig. 2, para 0034); the channel is shaped to receive a tongue when inserted into the oral cavity (fig. 2, para 0034);; the upper portion is shaped to overlie the tongue when the tongue is received in the channel (fig. 2, para 0027, 0034); and the lower portion is shaped to underlie the tongue when the tongue is received in the channel (fig. 2, para 0034).
Regarding claim 3. (Currently Amended) Hwang as modified by Van renders obvious the phototherapy device of claim 1
Regarding claim 8. (Currently Amended) Hwang as modified by Van renders obvious the phototherapy device of claim 1, wherein the light source includes light emitters for generating the emitted light (para 0031 “a light emitting diode (LED)”).
Regarding claim 9. (Original) Hwang as modified by Van renders obvious the phototherapy device of claim 8, wherein: the light emitters include distal light emitters and lateral light emitters (fig. 2); the distal light emitters are positioned along a distal end of the main body, such that light emitted by the distal light emitters illuminates the pharyngeal tissues when the main body is positioned within the oral cavity (see rejection of claim 1); and the lateral light emitters are positioned along lateral walls of the main body, such that light emitted by the lateral light emitters illuminates buccal tissues of the oral cavity when the main body is positioned within the oral cavity (para 0032, fig 1; it is understood that at least a portion of the light could be emitted “laterally”).
Regarding claim 10. (Currently Amended) Hwang as modified by Van renders obvious the phototherapy device of claim 1, wherein: the main body includes a proximal end having a top bite location located along a top surface of the main body (fig. 4, para 0005, 0034), and a bottom bite location located along a bottom surface of the main body (fig. 4, para 0005, 0034); the top bite location is configured to interact with top teeth of the oral cavity when the main body is located within the oral cavity (fig. 4, para 0005, 0034); and the bottom bite location is configured to interact with bottom teeth of the oral cavity when the main body is located within the oral cavity (fig. 4, para 0005, 0034).
Regarding claim 11. (Original) Hwang as modified by Van renders obvious the phototherapy device of claim 4, wherein light emitted from the light source via the lateral walls of the main body is configured to illuminate buccal tissues of the oral cavity via an opening between the upper teeth and the lower teeth formed by the main body portion being located between the upper teeth and the bottom teeth of the oral cavity (para 0017, 0032).
Regarding claim 15. (Currently Amended) Hwang as modified by Van renders obvious the phototherapy device of claim 1, wherein the main body includes a protrusion extending from a top surface of the main body, such that: the protrusion interacts with a roof of the oral cavity when the main body is positioned within the oral cavity; and a gag reflex caused by the main body being positioned within the oral cavity is reduced (para 027, at least a portion of the top surface that is at the peak of the “convex upward” is understood to be the “protrusion”, providing the same functionality and benefit).
Regarding claim 16. (Currently Amended) Hwang as modified by Van renders obvious the phototherapy device of claim 1, wherein the main body includes tongue protrusions extending from a bottom surface of the main body, such that when the main body is positioned within the oral cavity the tongue protrusions depress a tongue of the oral cavity (para 0011-0013, 0027 “a first lower portion 112 formed to be concave downward to be mounted on a top side of a tongue”).
Regarding claim 17. (Currently Amended) Hwang as modified by Van renders obvious the phototherapy device of claim 1, wherein the main body comprises a memory forming material configured to conform to a shape of the oral cavity when positioned within the oral cavity (para 0029 “flexible material” See MPEP 2143 “(B) Simple substitution of one known element for another to obtain predictable results;”).
Regarding claim 18. (Currently Amended) Hwang as modified by Van renders obvious the phototherapy device of claim 1, wherein: the main body includes location features comprising irregularities in a surface of the main body; the location features are configured to, when the main body is located within the oral cavity: engage with at least one of the teeth, lips, or palate; and ensure that the main body is placed in a particular position and orientation within the oral cavity when the location features are positioned adjacent the corresponding structures of the oral cavity (figs. 1 and 4, any portion of the device could be considered as the “irregularities” that engage the teeth, lips, palate).
Regarding claim 19. (Currently Amended) Hwang as modified by Van renders obvious the phototherapy device of claim 1, further comprising processor circuitry mechanically supported by the main body, wherein the processor circuitry is configured to control emission of the light by the light source (para 0042 “control panel”).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hwang in view of Van as applied to claims 1-3, 8-11, 15-19 above, and further in view of US Pat Pub No. 20210228900 to Kothari et al. (hereinafter “Kothari ‘900”).
Regarding claim 4. (Currently Amended) Hwang as modified by Van renders obvious the phototherapy device of claim 1:wherein the main body includes lateral walls and a distal end located between the lateral walls (fig 1, side walls and uvula evasion portion 115); but fails to disclose further comprising a camera located along the distal end configured to image tissues of the oral cavity being illuminated by the emitted light when the main body is inserted into the oral cavity.
Kothari ‘900, from a similar field of endeavor teaches having a camera to distinguish different tissues in the oral cavity (para 0082). It would have been obvious before the filing date of the claimed invention to modify the disclosure of Hwang as modified by Van with the teachings of Kothari to provide the predictable result of distinguish different tissues in the oral cavity.
Claim(s) 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hwang in view of Van as applied to claims 1-3, 8-11, 15-19 above, and further in view of US Pat Pub No. 20040116985 to Black.
Regarding claim 6. (Currently Amended) Hwang as modified by Van renders obvious the phototherapy device of claim 1, Hwang discloses the body to be flexible which would allow it to bend and deform as desired but fails to disclose wherein: the main body is articulable along a point of articulation to form an angle of articulation between a proximal plane of the main body and a distal plane of the main body , such that a portion of the emitted light is targeted onto the pharyngeal tissues; the proximal plane extends between lateral walls of the main body, a proximal end of the main body, and the point of articulation; and the distal plane extends between the lateral walls of the main body, a distal end of the main body, and the point of articulation.
Black from a similar field of endeavor teaches using a material that are bendable and formable to provide a pre-arranged angle or bendable or formable material(s) is (are) used then the user could manipulate the element to create any desired angle of the element (para 0006). It would have been obvious before the filing date of the claimed invention to modify the disclosure of Hwang as modified by Van with the teachings of Black to provide the predictable result of allowing the user to manipulate the element to create any desired angle of the element to provide the desired treatment.
Regarding claim 7. (Currently Amended) Hwang as modified by Van renders obvious the phototherapy device of claim 1, Hwang discloses the body to be flexible which would allow it to bend and deform as desired but fails to disclose wherein: the main body is articulable along a distal point of articulation and a proximal point of articulation, such that a portion of the emitted light is targeted onto the pharyngeal tissues the distal point of articulation is configured to form a distal angle of articulation between a central plane of the main body and a distal plane of the main body; the proximal point of articulation is configured to form a proximal angle of articulation between a central plane of the main body and a proximal plane of the main body; the proximal plane extends between lateral walls of the main body, a proximal end of the main body, and the proximal point of articulation; the central plane extends between the lateral walls of the main body, the distal point of articulation, and the proximal point of articulation; and the distal plane extends between the lateral walls of the main body, a distal end of the main body, and the distal point of articulation.
Black from a similar field of endeavor teaches using a material that are bendable and formable to provide a pre-arranged angle or bendable or formable material(s) is (are) used then the user could manipulate the element to create any desired angle of the element (para 0006). It would have been obvious before the filing date of the claimed invention to modify the disclosure of Hwang as modified by Van with the teachings of Black to provide the predictable result of allowing the user to manipulate the element to create any desired angle of the element to provide the desired treatment.
Claim(s) 5, 12-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hwang in view of Van as applied to claims 1-3, 8-11, 15-19 above, and further in view of US 20220226667 A1 to Kothari et al. (hereinafter “Kothari”).
Regarding claim 5. (Currently Amended) Hwang as modified by Van renders obvious the phototherapy device of claim 1, wherein: the shell includes lateral walls and a distal end located between the lateral walls (fig 1, side walls and uvula evasion portion 115); but fails to disclose the distal end includes lensing configured to alter a trajectory of the emitted light, such that the pharyngeal tissues are illuminated by the emitted light.
Kothari, from a similar field of endeavor, teaches a having lenses to alter the distribution of light exiting the distal surface (para 0077, fig. 20). It would have been obvious before the filing date of the claimed invention to modify the disclosure of Hwang as modified by Van with the teachings of Kothari to provide the predictable result of altering the distribution of light exiting the distal surface and improving treatment.
Regarding claim 12. (Currently Amended) Hwang as modified by Van renders obvious the phototherapy device of claim 1, but fails to disclose further comprising side wings located adjacent the lateral walls of the main body, wherein: the side wings each include a light emitting surface configured to emit light; when the main body is located within the oral cavity the side wings are positioned relative to the main body, such that: the side wings are located between teeth and buccal tissues of the oral cavity; the light emitting surface of the side wings faces the buccal tissues; and the light emitted from the light emitting surfaces illuminates the buccal tissues.
Kothari, from a similar field of endeavor, teaches a having side wings to emit light and bite pads for engagement by teeth of the patient to secure the side wings 14 in place when the main body portion 12 is inserted into the oral cavity of the patient (para 0052, 0056, 0064, 0077). It would have been obvious before the filing date of the claimed invention to modify the disclosure of Hwang as modified by Van with the teachings of Kothari to provide the predictable result of further securing the device when the device is inserted into the oral cavity of the patient.
Regarding claim 13. (Currently Amended) Hwang as modified by Van renders obvious the phototherapy device of claim 1, but fails to disclose wherein the main body includes a breathing channel comprising an opening extending between the distal end and the proximal end of the main body, such that when positioned within the oral cavity the breathing channel extends between the oral cavity and an external environment allowing for exchange of air between the oral cavity and the external environment.
Kothari, from a similar field of endeavor, teaches a having breathing tube to provide air path to improve patient breathing during treatment (para 0007, 0041, 0072-0074). It would have been obvious before the filing date of the claimed invention to modify the disclosure of Hwang as modified by Van with the teachings of Kothari to provide the predictable result of improving patient breathing during treatment.
Regarding claim 14. (Currently Amended) Hwang as modified by Van and Kothari renders obvious the phototherapy device of claim 13, further comprising a breathing apparatus mechanically supported by an exterior surface of the main body, wherein: the breathing channel includes an oral cavity opening, an external environment opening, and a breathing channel extending between the oral cavity opening and the external environment opening, such that when positioned within the oral cavity the breathing channel extends between the oral cavity and an external environment allowing for exchange of air between the oral cavity and the external environment (para 0007, 0041, 0072-0074).
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 SANA SAHAND whose telephone number is (571)272-6842. The examiner can normally be reached M-Th 8:30 am -5:30 pm; F 9 am-3 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer S McDonald can be reached at (571) 270- 3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SANA SAHAND/Examiner, Art Unit 3796
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