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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/17/2025 has been entered.
Status of Claims
Claims 1-2, 4-7, and 9-16 are currently pending and under examination. Claims 3 and 8 are canceled. As per the amendments filed on 12/17/2025, claim 1 is amended and claims 12-16 are newly added.
Priority
Acknowledgment is made of applicant's claim for domestic priority based on provisional applications 63/630,396 (filed on 01/31/2024) and 63/738,896 (filed on 12/26/2024).
• Claims 1-2, 4-7, and 9-16 are not sufficiently described in provisional application 63/630,396 to receive the provisional application’s filing date. This provisional application does not disclose
the 400-470 nm range in claim 1 (a narrower 410-455 nm range is described in the provisional application, which could have an impact on device usage), optical arrays placed up the nostrils and attached to adjustable arms (claims 1, 7, 9, 12-13), a dome-shape (Claim 2), the regions of the brain being targeted (claim 6 and 9), or the wireless communication setup (claims 14-16).
• Claims 1-2, 4-7, and 9-16 are sufficiently described in provisional application 63/738,896 to receive this provisional application’s filing date.
Therefore, Claims 1-2, 4-7, and 9-16 will be evaluated with an effective filing date of 12/26/2024.
Response to Arguments
Applicant’s arguments, see Remarks pages 6-8 (Rejections under 35 U.S.C. § 103), filed 12/17/2025, with respect to the 35 U.S.C. § 103 rejections of claims 1-2 and 4-11 over Medendorp (US PG Pub 2017/0028216 A1) in view of Nuytkens (US PG Pub 2021/0393977 A1) and Sun (KR 100987729 B1) have been fully considered. Claims 3 and 8 are canceled. Regarding claim 1, Applicant argues:
Turning to the primary reference, Medendorp is directed to "phototherapy devices for treatment of dermatological disorders of the scalp." The outstanding Office Action cited paragraph 17 of Medendorp as describing a target "wavelength of about 400nm to 470nm" as was previously recited in claim 8.
However, Applicant respectfully submits that Medendorp fails to teach or suggest each of
the features of amended claim 1. Specifically, Medendorp fails to teach or suggest "wherein each of the plurality of optical emitters and the another plurality of optical emitters are configured to selectively produce optical emissions of light at a target wavelength of about 400nm to 470nm to the first target area and second target area of the recipient to treat a brain disorder in the recipient" as currently recited in amended claim 1. (12/17/2025 Remarks, pages 7-8)
This argument is not persuasive. The 08/13/2025 office action (rejection of claim 1, pages 4-8) argues the combination of Medendorp (which provides an untethered helmet-like structure with a built-in control interface for irradiation of the scalp) and Nuytkens (which provides a helmet-like structure and nasal structure for irradiation of the brain through the skull and nose) irradiates the first (through the skull) and second (through the nasal passages) target areas. With respect to the 400-470 nm blue light applied to both target areas: (1) Medendorp teaches blue light within the claimed range is applied to the targeted tissue to provide a bactericidal effect ([0155]) where the targeted tissue can include nervous tissue ([0007]) and (2) Nuytkens teaches blue light within the claimed range is applied to the brain via the helmet emitters ([0169]) and nasal emitters ([0177]). Therefore, the combination of Medendorp and Nuytkens would apply the blue light to the brain via both target areas.
Applicant also argues:
Additionally, Applicant respectfully submits that each of the cited references are completely silent regarding "a light emitting diode driver that is connected to the controller, said LED driver delivering an electrical output of about 200ma at a frequency of 25hz-35hz to the plurality of optical emitters and the another plurality of optical emitters," as is also currently recited in amended claim 1. Accordingly, Applicant respectfully submits that claim 1 and all claims depending therefrom patentably define over the cited reference. Thus, withdrawal of the rejection of the claims under 35 U.S.C. § 103 is respectfully requested. (12/17/2025 Remarks, page 8)
This argument is persuasive. While Medendorp, Nuytkens, or Sun recognize that a current is necessary to operate emitters, all these references are silent with respect to specific current settings for irradiation of the brain through the skull. Regarding the 25-35 Hz frequency, Nuytkens teaches entrainment with optical stimulation at frequencies relevant to specific brain waves ([0154], [0182]). Both beta ([0153] – “Beta waves are neural oscillations in the frequency range of about 12-30 Hz and occur when a patient is awake and conscious ( e.g., alert)”) and gamma waves ([0153] – “Gamma waves are neural oscillations in the frequency range of about 30-140 Hz (e.g., 40 Hz) and occur when a patient has heightened perception”) would occur within the claimed ranged of 25-35 Hz. Therefore, because of the specific current level limitation, the rejections of claims 1-2 and 4-11 are withdrawn. However, upon further consideration, new 35 U.S.C. § 103 rejections in view of Sverdlov (US PG Pub 2021/0205634 A1) are added (see “Claim Rejections - 35 USC § 103” section). Due to cumulative amendments changing the scope of the original claims, prior art rejections are adjusted to make Nuytkens the primary prior art reference (i.e. now claims 1-2, 4-7, and 9-11 are rejected under 35 USC § 103 over Nuytkens in view of Sverdlov and Sun).
Newly added claims 12-16 are evaluated in light of the above arguments and rejected under 35 U.S.C. § 103 over Nuytkens in view of Sverdlov and Sun (see “Claim Rejections - 35 USC § 103” section).
Summary: The 35 U.S.C. § 103 rejections of claims 1-2 and 4-11 over Medendorp in view of Nuytkens and Sun are withdrawn. New 35 U.S.C. § 103 rejections for claims 1-2, 4-7, and 9-11 over Nuytkens in view of Sverdlov and Sun are added. 35 U.S.C. § 103 rejections for newly added claims 12-16 are added (see “Claim Rejections - 35 USC § 103”).
Claim Objection
The following claims are objected to because of the following informalities:
• Claim 1: The abbreviation for milliamperes would be better represented as “mA” instead of “ma.”
• Claim 1: The inconsistent use of “light emitting diode driver” and “LED driver” in claim 1, namely without defining the acronym and spelling out “light emitting diode” in the rest of the claims, should be addressed.
Appropriate correction is required.
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:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue
Resolving the level of ordinary skill in the pertinent art.
Considering objective evidence present in the application indicating obviousness or non-obviousness.
Claims 1-2, 4-7, and 9-16 are rejected under U.S.C 103 as being unpatentable over Nuytkens (US PG Pub 2021/0393977 A1, see previously cited) in view of Sverdlov (US PG Pub 2021/0205634 A1, see “Notice of References Cited”) and Sun (KR 100987729 B1, see previously cited). Note a machine translation via Espacenet (https://worldwide.espacenet.com) was used to interpret the disclosure in Sun (KR 100987729 B1 - see previously attached copy of the Description translation with line numbers added by the Examiner for the purpose of citing selections within the reference).
Regarding Claim 1, Nuytkens discloses a blue light therapy device ([0169] – light therapy device which can emit in the blue spectrum), comprising:
• a main body having an inside surface and an outside surface (Figure 2 – inside surface diagram of helmet-like structure, Figure 3 - outside surface of helmet-like structure, [0156]);
• a pair of fixed optical arrays each having a plurality of optical emitters ([0169] – at least two light emitter arrays are disclosed) that are positioned along the inner surface of the main body (Fig. 2, [0169] – the emitters 230 and 232 are placed along the inner surface of the helmet-like portion), said pair of fixed optical arrays being configured to be oriented toward a first target area of a recipient to be treated (Fig. 2, [0169] – the emitters 230 and 232 are placed along the inner surface of the helmet-like portion in order to irradiate the brain through the skull as discussed in [0008]);
adjustable arm positioned along the main body (Fig. 1, [0177] – arm connects the main body of the apparatus to the nosepiece and can be moved: “Nosepiece 260 can be coupled to flexible PCB 214 and disposed below an underside of headpiece 210 to be in line with the nostrils of patient 102”);
an adjustable optical array having another plurality of optical emitters that are connected along the adjustable arm (Fig. 2., [0244] – each nostril has an emitter array), said adjustable optical array being configured to be selectively oriented toward a second target area of the recipient to be treated (Fig. 2, [0244] – fourth emitter arrays shine on the brain through the nostrils);
a user interface (180, [0161])
a controller (170 processor), said controller being in communication with each of the user interface, the pair of fixed optical arrays and the adjustable optical array ([0160-0161]);
a light emitting diode driver ([0141]) that is connected to the controller ([0188]), said LED driver delivering an electrical output at a frequency of 25hz-35hz to the plurality of optical emitters and the another plurality of optical emitters ([0154], [0182] – entrainment with optical stimulation at frequencies relevant to specific brain waves within the 25-35 hz range; [0153] – “Beta waves are neural oscillations in the frequency range of about 12-30 Hz and occur when a patient is awake and conscious ( e.g., alert)”), “Gamma waves are neural oscillations in the frequency range of about 30-140 Hz (e.g., 40 Hz) and occur when a patient has heightened perception”), wherein each of the plurality of optical emitters and the another plurality of optical emitters are configured to selectively produce optical emissions of light at a target wavelength ([0143-0144] – variable power settings based on required depth and entrainment frequency) of about 400nm to 470nm to the first target area and second target area of the recipient to treat a brain disorder in the recipient ([0169] – helmet emitters can emit blue light within the claimed range, [0177] – nasal emitters can emit blue light within the claimed range). MPEP 2144.05 states “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” There is no evidence of an “unexpected result or criticality” on the analysis from the discussed range interpretations for frequency or wavelength.
Nuytkens does not disclose:
a user interface that is positioned along the outside surface of the main body;
a controller that is positioned along the main body,
a pair of adjustable arms
an adjustable optical array having another plurality of optical emitters that are connected along a distal end of each of the pair of adjustable arms
said LED driver delivering an electrical output of about 200ma
Sverdlov, in the same field of endeavor of a photobiomodulation device worn over the head to irradiate the brain ([0013]), teaches ranges of parameters governing LED emissions based on producing the necessary illumination to cross the skull and irradiate the brain (Fig. 15, [0143]). The table in Figure 15 presents maximum pulsed LED current as varying between 20-700 mA, which would include a setting at 200 mA, depending on other LED settings (such as duty cycle and irradiance power/area). MPEP 2144.05 states “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” There is no evidence of an “unexpected result or criticality” on the analysis from the discussed range interpretations.
Additionally, Sverdlov teaches a user interface positioned on the head wearable device where parameters can be manually adjusted (Fig. 18, [0149] – “the head wearable device 800 has light emitting devices 810 at spaced locations around the head of the patient connected by a cable 812 to a circuit housing having a first portion with an on/off switch 802 and a second portion with one or more control buttons or actuators 804 to manually select operating modes of the device as described herein”). The controller board is positioned along the main body of the photobiomodulation device ([0068-0070] – see controller board 260).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Nuytkens’ light therapy device irradiating the brain via a helmet-like structure placed over the head by incorporating the helmet-like structure with variable LED electrical settings and a built-in controller/interface in Sverdlov. This would have been obvious because both Nuytkens and Sverdlov discuss irradiating via a headpiece to provide therapy to the brain and Sverdlov provides a solution/improvement to modulate the current to LEDs for irradiating the brain based on desired treatment power or biological properties of the patient such as skull thickness and a controller/interface setup on the headpiece so that settings can be adjusted in the absence of an external computing device. Therefore, a person of ordinary skill in the art would be motivated to improve the device of Nuytkens by incorporating the helmet-like structure with variable LED electrical settings and a built-in controller/interface in Sverdlov.
Sun, in the same field of providing light therapy (Page 1, Lines 18-20), teaches two separate arm structures each with a distal end positioned in a nostril to irradiate blue and red light (Fig. 1; Page 5, lines 12-17 – “The above main body (110) is configured in a form that can be inserted into both nostrils of a patient, and its interior is equipped with an LED light source (111), a control unit (112) that controls the LED light source (111), a communication unit (113), and a window (114) that allows light to pass through to the outside. The above LED light source (111) is composed of a blue LED (111a) and a red LED (112)”).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Nuytkens light therapy device irradiating the brain via a helmet-like structure placed over the head and single nosepiece placed in the nostrils by incorporating the nostril irradiators and separate connecting arms in Sun. At the time, there would have been a recognized need to implement light therapy which can be applied to the nostrils in order to stimulate structures best accessible through the nasal cavity. The particular designs of the nosepieces in Nuytkens (one connected nosepiece for both nostrils) and Sun (two separate pieces, one for each nostril) both irradiate the nasal cavities via two emitter units placed in the nostrils and would be seen as obvious variations in design. A person of ordinary skill in the art would have a reasonable expectation of successfully using the nosepiece arms in Sun as part of the apparatus in Nuytkens.
Therefore, Claim 1 is obvious over Nuytkens in view of Sverdlov and Sun.
Regarding Claim 2, the blue light therapy device in Claim 1 is obvious over Nuytkens in view of Sverdlov and Sun, as indicated hereinabove. Nuytkens further discloses wherein the main body includes a dome-shape and is configured to be positioned about a head of the recipient to be treated (Fig. 1, [0164] – the helmet-like headpiece 210 is depicted as dome-shaped in order to be placed over the top of the head).
Therefore, Claim 2 is obvious over Nuytkens in view of Sverdlov and Sun.
Regarding Claim 4, the blue light therapy device in Claim 2 is obvious over Nuytkens in view of Sverdlov and Sun, as indicated hereinabove. Nuytkens discloses wherein the pair of fixed optical arrays includes a first array of optical emitters that is positioned along a first side of the main body, and a second array of optical emitters that is positioned along a second side of the main body
([0170-0171] – LEDs used in optical arrays, first and second light emitting arrays, in the helmet-like structure). Nuytkens further discloses: “In some embodiments, one or more first light emitters 234 can be enclosed by first electrodes 224 of first electrode array 222. For example, as shown in FIG. 2A, first light emitter 234 can be embedded and/or disposed within a hollow cavity of first electrode 224” ([0170]) and “In some embodiments, one or more second light emitters 238 can be enclosed by second electrodes 228 of second electrode array 226” ([0171]). The fixed radial fingers covering the inner surface area of helmet-like structure, as displayed in Figure 2, are coupled to the electrodes and light emitters ([0166]). Given the distribution of the electrodes and light arrays on these fingers, light arrays would be positioned on at least a first and second side of the main body in order to irradiate different portions of the head.
Therefore, Claim 4 is obvious over Nuytkens in view of Sverdlov and Sun.
Regarding Claim 5, the blue light therapy device in Claim 4 is obvious over Nuytkens in view of Sverdlov and Sun, as indicated hereinabove. Nuytkens further discloses wherein the first array of optical emitters is configured to engage the head of the recipient at a location above a right ear, and the second array of optical emitters is configured to engage the head of the recipient at a location above a left ear (Fig. 2 – optical emitter arrays are placed above the ears). LEDs are used in optical arrays, first and second light emitting arrays, in the helmet-like structure ([0170-0171]). Nuytkens further discloses: “In some embodiments, one or more first light emitters 234 can be enclosed by first electrodes 224 of first electrode array 222. For example, as shown in FIG. 2A, first light emitter 234 can be embedded and/or disposed within a hollow cavity of first electrode 224” ([0170]) and “In some embodiments, one or more second light emitters 238 can be enclosed by second electrodes 228 of second electrode array 226” ([0171]). The fixed radial fingers covering the inner surface area of helmet-like structure, as displayed in Figure 2, are coupled to the electrodes and light emitters ([0166]). Given the distribution of the electrodes and light arrays on these fingers, light arrays would be positioned on at least a first and second side of the main body corresponding to positions above the ears.
Therefore, Claim 5 is obvious over Nuytkens in view of Sverdlov and Sun.
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Nuytkens – Figures 2 and 3 (Modified by the Examiner in red to show positioning of light emitter arrays above the ears)
Regarding Claim 6, the blue light therapy device in Claim 5 is obvious over Nuytkens in view of Sverdlov and Sun, as indicated hereinabove. Nuytkens discloses the device provides light therapy to the brain ([0083]) via headpiece 210 ([0164]). However, Nuytkens does not specifically disclose the first target area comprises a hippocampus and an entorhinal cortex of a brain of the recipient to be treated. It should be noted that MPEP 2115 (II) states:
Claim analysis is highly fact-dependent. A claim is only limited by positively recited elements. Thus, "[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims." In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963); see also In re Young, 75 F.2d 996, 25 USPQ 69 (CCPA 1935).
Both Nuytkens ([0064]) and the Instant Application ([0041]) disclose emissions of light being directed toward the surface of the head. The specific targets of the phototherapy are not relevant to an assessment of patentability as the claims relate to the structural elements of a light-emitting device placed on the head. Nuytkens applies blue light ([0169] – light therapy device which can emit in the blue spectrum) to various locations in the head under headpiece 210 (Fig. 1, [0164]) in order to provide therapy to the brain ([0083]). Therefore, Nuytkens could be used to target the specific brain regions in the claim language (hippocampus and entorhinal cortex) via the LED arrays positioned underneath the helmet-like structure.
Therefore, Claim 6 is obvious over Nuytkens in view of Sverdlov and Sun.
Regarding Claim 7, the blue light therapy device in Claim 1 is obvious over Nuytkens in view of Sverdlov and Sun, as indicated hereinabove. Nuytkens further discloses wherein each of the plurality of optical emitters ([0170-0171] – LEDs used in optical arrays, first and second light emitting arrays, in the helmet-like structure) and the another plurality of optical emitters comprise a light emitting diode ([0177] – LEDs used in optical arrays, fourth light emitting arrays, placed in the nostrils).
Therefore, Claim 7 is obvious over Nuytkens in view of Sverdlov and Sun.
Regarding Claim 9, the blue light therapy device in Claim 1 is obvious over Nuytkens in view of Sverdlov and Sun, as indicated hereinabove. Nuytkens discloses wherein the adjustable arm is configured to position the adjustable optical array within a nostril of the recipient to be treated (Fig. 1, [0177] – the nose piece is depicted as placing the optical arrays up the nostrils to illuminate the brain regions accessible via the nasal cavities, Fig. 2 – optical arrays (marked as 262, 264) placed up both nostrils). Nuytkens discloses at least one arm which connects the main body of the apparatus to the nosepiece (Fig. 1, [0177]). For stability, the design could be assumed to have an arm to support both ends of the nosepiece, but only one is visible in Figure 1 and the text does not elaborate further on the connection. Therefore, Nuytkens does not explicitly disclose a pair of adjustable arms.
Sun, in the same field of providing light therapy to the nasal passages (Page 1, Lines 18-20), teaches two separate arm structures each with a distal end positioned in a nostril to irradiate blue and red light (Fig. 1; Page 5, lines 12-17 – “The above main body (110) is configured in a form that can be inserted into both nostrils of a patient, and its interior is equipped with an LED light source (111), a control unit (112) that controls the LED light source (111), a communication unit (113), and a window (114) that allows light to pass through to the outside. The above LED light source (111) is composed of a blue LED (111a) and a red LED (112)”).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Nuytkens light therapy device irradiating the brain via a helmet-like structure placed over the head and single nosepiece placed in the nostrils by incorporating the nostril irradiators and separate connecting arms in Sun. At the time, there would have been a recognized need to implement light therapy which can be applied to the nostrils in order to stimulate structures best accessible through the nasal cavity. The particular designs of the nosepieces in Nuytkens (one connected nosepiece for both nostrils) and Sun (two separate pieces, one for each nostril) both irradiate the nasal cavities via two emitter units placed in the nostrils and would be seen as obvious variations in design. A person of ordinary skill in the art would have a reasonable expectation of successfully using the nosepiece arms in Sun as part of the apparatus in Nuytkens.
Therefore, Claim 9 is obvious over Nuytkens in view of Sverdlov and Sun.
Regarding Claim 10, the blue light therapy device in Claim 9 is obvious over Nuytkens in view of Sverdlov and Sun, as indicated hereinabove. Nuytkens discloses the device provides light therapy to the brain ([0083]) via shining on brain structures via the nasal cavities ([0177]). However, Nuytkens does not specifically disclose the second target area comprises: a trigeminal pathway and frontal lobe of a brain of the recipient to be treated. It should be noted that MPEP 2115 (II) states:
Claim analysis is highly fact-dependent. A claim is only limited by positively recited elements. Thus, "[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims." In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963); see also In re Young, 75 F.2d 996, 25 USPQ 69 (CCPA 1935).
Nuytkens ([0177]) and the instant Specification ([0043]) disclose light applied to the nasal cavity via the nostrils to affect the brain. The specific targets of the phototherapy are not relevant to an assessment of patentability as the claims relate to the structural elements of a light-emitting device placed in the nostrils. Nuytkens is able to apply blue light therapy within the nostrils ([0177]), although not specifying particular regions of the brain or nearby nerves. Therefore, Nuytkens’ apparatus could be used to target the regions in the claim language (a trigeminal pathway and frontal lobe of a brain) accessible via the nasal passages as well.
Therefore, Claim 10 is obvious over Nuytkens in view of Sverdlov and Sun.
Regarding Claim 11, the blue light therapy device in Claim 1 is obvious over Nuytkens in view of Sverdlov and Sun, as indicated hereinabove. Nuytkens discloses an eye shield that is positioned along the main body at a location adjacent to the adjustable arm (Fig. 1 – the eyepiece 240 is connected to the main body of the headpiece 210 and positioned above the nosepiece 260). Nuytkens discloses the “eyepiece 240 can be coupled to flexible PCB 214 and disposed below an underside of headpiece 210 to be in line with the eyes of patient 102” ([0173]). While Nuytkens describes “eyepiece 240 can be configured to dynamically emit warm white light radiation (e.g., broadband) based on measured transcranial EEG signals of patient 102 (e.g., local EEG signal 130 shown in FIG. 1A, local EEG signal 140 shown in FIG. 1B) for treatment of a neurological abnormality of patient 102” ([0173]), the structure itself could form an optical or physical shield with the plain meaning of “eye shield.” The eyepiece in Nuytkens can be considered an extension of the PCB structure covering the scalp ([0166] – “In some embodiments, flexible PCB 214 can extend beyond a perimeter of headpiece 210 to form eyepiece 240, earpiece 250, and/or nosepiece 260”), where the eyes would be covered to contain optical stimulation in the same manner as the headpiece (Figs. 3-4). Nuytkens discloses at least one arm which connects the main body of the apparatus to the nosepiece (Fig. 1, [0177]). For stability, the design could be assumed to have an arm to support both ends of the nosepiece, but only one is visible in Figure 1 and the text does not elaborate further on the connection. Therefore, Nuytkens does not explicitly disclose a pair of adjustable arms.
Sun, in the same field of providing light therapy to the nasal passages (Page 1, Lines 18-20), teaches two separate arm structures each with a distal end positioned in a nostril to irradiate blue and red light (Fig. 1; Page 5, lines 12-17 – “The above main body (110) is configured in a form that can be inserted into both nostrils of a patient, and its interior is equipped with an LED light source (111), a control unit (112) that controls the LED light source (111), a communication unit (113), and a window (114) that allows light to pass through to the outside. The above LED light source (111) is composed of a blue LED (111a) and a red LED (112)”).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Nuytkens light therapy device irradiating the brain via a helmet-like structure placed over the head and single nosepiece placed in the nostrils by incorporating the nostril irradiators and separate connecting arms in Sun. At the time, there would have been a recognized need to implement light therapy which can be applied to the nostrils in order to stimulate structures best accessible through the nasal cavity. The particular designs of the nosepieces in Nuytkens (one connected nosepiece for both nostrils) and Sun (two separate pieces, one for each nostril) both irradiate the nasal cavities via two emitter units placed in the nostrils and would be seen as obvious variations in design. A person of ordinary skill in the art would have a reasonable expectation of successfully using the nosepiece arms in Sun as part of the apparatus in Nuytkens.
Therefore, Claim 11 is obvious over Nuytkens in view of Sverdlov and Sun.
Regarding Claim 12, the blue light therapy device in Claim 1 is obvious over Nuytkens in view of Sverdlov and Sun, as indicated hereinabove. Nuytkens discloses at least one arm which connects the main body of the apparatus to the nosepiece (Fig. 1, [0177]). For stability, the design could be assumed to have an arm to support both ends of the nosepiece, but only one is visible in Figure 1 and the text does not elaborate further on the connection. Therefore, Nuytkens does not explicitly disclose wherein the pair of adjustable arms comprises: a first elongated array arm having a first end that is connected to the main body and a second end that extends outward therefrom; and a second elongated array arm having a first end that is connected to the main body and a second end that extends outward therefrom, wherein the first elongated array arm and the second elongated array arm are discrete and nonconnected components that are each configured to independently move and flex from each other.
Sun, in the same field of providing light therapy to the nasal passages (Page 1, Lines 18-20), teaches two separate arm structures each with a distal end positioned in a nostril to irradiate blue and red light (Fig. 1; Translation: Page 5, lines 12-17 – “The above main body (110) is configured in a form that can be inserted into both nostrils of a patient, and its interior is equipped with an LED light source (111), a control unit (112) that controls the LED light source (111), a communication unit (113), and a window (114) that allows light to pass through to the outside. The above LED light source (111) is composed of a blue LED (111a) and a red LED (112)”) and a second end connected to an apparatus body on the head (Fig. 1, Translation: Page 3, lines 16-21).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Nuytkens light therapy device irradiating the brain via a helmet-like structure placed over the head and single nosepiece placed in the nostrils by incorporating the nostril irradiators and separate connecting arms in Sun. At the time, there would have been a recognized need to implement light therapy which can be applied to the nostrils in order to stimulate structures best accessible through the nasal cavity. The particular designs of the nosepieces in Nuytkens (one connected nosepiece for both nostrils) and Sun (two separate pieces, one for each nostril) both irradiate the nasal cavities via two emitter units placed in the nostrils and would be seen as obvious variations in design. A person of ordinary skill in the art would have a reasonable expectation of successfully using the nosepiece arms in Sun as part of the apparatus in Nuytkens.
Therefore, Claim 12 is obvious over Nuytkens in view of Sverdlov and Sun.
Regarding Claim 13, the blue light therapy device in Claim 12 is obvious over Nuytkens in view of Sverdlov and Sun, as indicated hereinabove. Nuytkens discloses the another plurality of optical emitters ([0177] – fourth light emitter arrays via shining on brain structures via the nasal cavities) comprises: a first group of two to four individual light emitting diodes that are positioned along the end of first nostril nosepiece; and a second group of two to four individual light emitting diodes that are positioned along the end of second nostril nosepiece (Figs. 2 – two arrays depicted, one for each nostril, [0177] – at least two light emitters in each array: “nosepiece 260 can include fourth light emitter array 262 having a plurality of fourth light emitters 264” where light emitters are described as being LEDs).
Nuytkens discloses at least one arm which connects the main body of the apparatus to the nosepiece (Fig. 1, [0177]). For stability, the design could be assumed to have an arm to support both ends of the nosepiece, but only one is visible in Figure 1 and the text does not elaborate further on the connection. Therefore, Nuytkens does not explicitly disclose light emitters on the second end of the first elongated array arm and second end of the second elongated array arm.
Sun, in the same field of providing light therapy to the nasal passages (Page 1, Lines 18-20), teaches two separate arm structures each with a distal end positioned in a nostril to irradiate blue and red light (Fig. 1; Translation: Page 5, lines 12-17 – “The above main body (110) is configured in a form that can be inserted into both nostrils of a patient, and its interior is equipped with an LED light source (111), a control unit (112) that controls the LED light source (111), a communication unit (113), and a window (114) that allows light to pass through to the outside. The above LED light source (111) is composed of a blue LED (111a) and a red LED (112)”) and a second end connected to an apparatus body on the head (Fig. 1, Translation: Page 3, lines 16-21). Note Sun also discloses multiple LED’s (111a and 111b) at the end of main body 110 being able to be contained within each nostril using the separate arm design (Fig 2, translation: page 5, lines 16-21).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Nuytkens light therapy device irradiating the brain via a helmet-like structure placed over the head and single nosepiece placed in the nostrils by incorporating the nostril irradiators and separate connecting arms in Sun. At the time, there would have been a recognized need to implement light therapy which can be applied to the nostrils in order to stimulate structures best accessible through the nasal cavity. The particular designs of the nosepieces in Nuytkens (one connected nosepiece for both nostrils) and Sun (two separate pieces, one for each nostril) both irradiate the nasal cavities via two emitter units placed in the nostrils and would be seen as obvious variations in design. A person of ordinary skill in the art would have a reasonable expectation of successfully using the nosepiece arms in Sun as part of the apparatus in Nuytkens.
Therefore, Claim 13 is obvious over Nuytkens in view of Sverdlov and Sun.
Regarding Claim 14, the blue light therapy device in Claim 1 is obvious over Nuytkens in view of Sverdlov and Sun, as indicated hereinabove. Nuytkens discloses further comprising: a wireless transceiver that is in communication with the system controller ([0159], [0190] - a wireless communications controller is coupled to a transceiver to enable wireless data transfer to control the apparatus).
Therefore, Claim 14 is obvious over Nuytkens in view of Sverdlov and Sun.
Regarding Claim 15, the blue light therapy device in Claim 14 is obvious over Nuytkens in view of Sverdlov and Sun, as indicated hereinabove. Nuytkens discloses the wireless transceiver is configured to receive operating instructions from an external device ([0159] – a wirelessly connected smart device can be used to control the system using a transceiver).
Therefore, Claim 15 is obvious over Nuytkens in view of Sverdlov and Sun.
Regarding Claim 16, the blue light therapy device in Claim 15 is obvious over Nuytkens in view of Sverdlov and Sun, as indicated hereinabove. Nuytkens discloses further comprising: a mobile application that is configured to operate on a processor enabled device, wherein the mobile application includes functionality for communicating with the controller and for sending operating instructions to the controller to selectively operate each of the plurality of optical emitters ([0190] – a wireless communication controller can enable communication between the processor 170, which controls the stimulation apparatus, and smart device 180, which uses a control app as a user interface to visualize data and input controls commands). Four types of optical emitter arrays are controlled in Nuytkens, most pertinently first and second light emitting arrays in the helmet-like structure ([0170-0171]) and fourth light emitting arrays placed in the nostrils ([0177]).
Therefore, Claim 16 is obvious over Nuytkens in view of Sverdlov and Sun.
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/Benjamin A. Schmitt/
Examiner
Art Unit 3796
/ALLEN PORTER/Primary Examiner, Art Unit 3796