DETAILED ACTION
1. This office action is in response to the communicated dated 10 March 2026 concerning application number 18/662,858 effectively filed on 13 May 2024.
Notice of Pre-AIA or AIA Status
2. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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.
Status of Claims
3. Claims 1-29 are pending, of which claims 1, 15-16, and 21-25 have been amended; and claims 1-29 are under consideration for patentability.
Response to Arguments
4. Applicant’s arguments dated 10 March 2026, referred to herein as “the Arguments”, have been fully considered, but they are not persuasive in view of the new grounds of rejection necessitated by Applicant’s amendments to the claims.
Applicant argues that the prior art of record does not explicitly teach the amended limitations of claims 1 and 16 that recites the photobiomodulation device being retained by a patient at least partially within an oral cavity of the patient for a treatment session wherein at least one LED light emitter is mounted within a distal end of the insertion portion to illuminate tissue including a tongue of the patient having one or more blood vessels within the illuminated tissue (pages 7-8 of the Arguments). The Examiner respectfully disagrees as Brawn-202 teaches a light therapy apparatus 3600 comprising a mouthpiece 3610 having a plurality of light emitters 3644-3645 (e.g., LEDs) that are configured to deliver light within the oral cavity to provide a photobiomodulation treatment (e.g., osteoblast proliferation and/or photobiomodulation enhanced orthodontic tooth movement) [0810, 0812, 0818, 1393]) Meanwhile, Altshuler teaches a light emitting mouthpiece 24 comprising an optical radiation source 18 (e.g., LED) that delivers light at the blood and/or lymph vessels of the patient’s tongue ([0040, 0067, 0084, 0109, FIG. 3]). Specifically, Altshuler illustrates the optical radiation source 18 being disposed at the distal end of the mouthpiece 24 ([FIG. 3]). Thus, the Examiner respectfully maintains that Brawn-202 in view of Altshuler suggests the amended limitation that recites the photobiomodulation device being retained by a patient at least partially within an oral cavity of the patient for a treatment session wherein at least one LED light emitter is mounted within a distal end of the insertion portion to illuminate tissue including a tongue of the patient having one or more blood vessels within the illuminated tissue.
Applicant argues that Streeter does not explicitly teach the limitation of claim 23 that recites a processor being mounted on the head worn device (page 8 of the Arguments). The Examiner respectfully disagrees, as Streeter teaches a light therapy apparatus 10 comprising a wearable cap 60 having a light source 40 ([0097, 0100, 0124-0125, 0129]). Furthermore, Streeter teaches that the light source 40 may comprise the programmable controller 126 ([0139]). Thus, the Examiner respectfully maintains that Streeter teaches a processor mounted on the head worn device.
Applicant argues that neither Streeter or Berman teach the head worn device to illuminate vascular tissue to treat a neurological condition as recited in claim 23 (page 8 of the Arguments). The Examiner respectfully disagrees, as Streeter teaches the light source 40 comprising a plurality of LEDs that are configured to transmit light through the skull to at least one target area of the brain ([0088, 0090, 0100, 0125]). Furthermore, the light may be transmitted to a blocked vessel within the brain to increase to increase blood flow ([0210]). Specifically, the light therapy is configured to treat a neurological or neurodegenerative disease, such as Parkinson’s disease ([0019, 0090, 0209-0210]). Therefore, the Examiner respectfully maintains that Streeter teaches the head worn device to illuminate vascular tissue to treat a neurological condition.
Applicant argues that Mackellar fails to address the use of audio information as a stimulus in combination with photobiomodulation within claims 24-25 (page 8 of the Arguments). The Examiner respectfully submits that Mackellar is not relied upon for teaching a combination of photobiomodulation (e.g., light therapy) and an audio stimulus (e.g., linguistic input). Instead, Streeter and Berman were relied upon for teaching the light therapy as illustrated within the rejection of claim 23. Furthermore, the rejection of claim 24 introduces Mackellar to teach the head worn device comprising a transceiver that receives a linguistic input from an external user device (please refer to the rejection below and the explanation of paragraphs [0078, 0080-0081]). Specifically, Mackellar is analogous to Streeter and Berman, as Mackellar’s head worn device is also utilized by patients having a neurological disorder impairment. Thus, the Examiner respectfully submits that Streeter, Berman, and Mackellar are considered to be a valid prior art combination for suggesting claims 24-25.
Applicant argues that Dougal does not address mounting control and power on the headset within claim 26. The Examiner respectfully submits that claim 26 does not recite that specific limitation. However, Dougal was relied upon for teaching the limitation of claim 26 that recites wherein the plurality of LEDs are mounted on a plurality of circuit boards, wherein an intensity of the transmitted light comprising a therapeutic dose of light to treat autism. In this case, Dougal teaches a transcranial wearable device comprising a plurality of modules D that include a printed circuit board (PCB) having a light source or series of light sources ([abstract, 0060, FIG. 7A]). Specifically, each of the PCBs may be flexible to ensure close approximation of the light sources to the scalp to treat autism ([0060, 0089]). Thus, the Examiner respectfully maintains the combination of Streeter, Berman, and Dougal for suggesting claim 26.
Claim Rejections - 35 USC § 103
5. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
6. Claims 1-2, 6-13, 15-17, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Brawn et al. (US 2019/0083202 A1, referred to herein as “Brawn-202”) in view of Altshuler et al. (US 2004/0193236 A1).
Regarding claim 1, Brawn-202 teaches a photobiomodulation device (the light therapy apparatus 3600 comprises a mouthpiece 3610 having a plurality of light emitters 3644-3645 (e.g., LEDs) that are configured to provide light therapy or photobiomodulation within the patient’s oral cavity [0810, 0818, 1393, FIGS. 138-139]. For example, the light therapy apparatus 3600 is configured to emit infrared light or near-infrared light within the oral cavity to provide a photobiomodulation treatment (e.g., osteoblast proliferation and/or photobiomodulation enhanced orthodontic tooth movement) [0810, 0812, 0818, 1393]), comprising:
one or more light emitting diode (LED) light emitters mounted on an a photobiomodulation device housing wherein an insertion portion of the photobiomodulation device is sized and shaped to be retained by a patient at least partially within an oral cavity of the patient for a treatment session (the light therapy apparatus 3600 comprises a mouthpiece 3610 having a plurality of light emitters 3644-3645 (e.g., LEDs) that are configured to provide light therapy or photobiomodulation within the patient’s oral cavity [0810-0811, 0818, 1393, FIGS. 138-139]. Specifically, the mouthpiece 3610 is configured to be retained within the patient’s oral cavity [0810-0811, 0817-0818]); and
a controller in the photobiomodulation device housing and connected to the one or more light emitting diodes (the mouthpiece 3610 may comprise an extra-oral housing portion that extends outside of the mouthpiece 3610 [0784, 0810]. Furthermore, the extra-oral housing portion of the mouthpiece 3610 may be similar or identical to the extra-oral housing 2560 within the embodiment of figure 84 [0664, 0784, 0810, FIG. 84, FIGS. 138-139]. Specifically, the extra-oral housing portion of the mouthpiece 3610 contains electronic circuitry that is coupled to a controller which controls the light emitters 3644-3645 [0664, 0784, 0810]) and a battery (the electronic circuitry or controller is coupled to a battery (e.g., power source) to provide power to the light emitters 3644-3645 to produce the desired light [0810]), the controller configured to control an emission of light having a pulse rate and duty cycle from the one or more LED light emitters that illuminate tissue within the oral cavity during the treatment session (the electronic circuitry or controller is configured to control the emission of light (e.g., wavelength, intensity, and/or frequency) from the light emitters 3644-3645 that illuminate tissue within the oral cavity during the treatment session [0810, 0812]. Furthermore, the controller may adjust the duty cycle (e.g., about 10%, 20%, or 30%) and the frequency (e.g., pulse rate) of the pulses emitted from the light emitters 3644-3645 [0243, 0810]).
Brawn does not explicitly teach wherein at least one of the LED emitters is mounted within a distal end of the insertion portion to illuminate tissue including a tongue of the patient having one or more blood vessels within the illuminated tissue.
The prior art by Altshuler is analogous to Brawn-202, as they both teach the use of a light emitting mouthpiece ([0114-0115]).
Altshuler teaches wherein at least one of the LED emitters is mounted within a distal end of the insertion portion to illuminate tissue including a tongue of the patient having one or more blood vessels within the illuminated tissue (the light emitting mouthpiece 24 comprises an optical radiation source 18 (e.g., LED) that delivers light at the blood and/or lymph vessels of the patient’s tongue [0040, 0067, 0084, 0109, FIG. 3]. Specifically, figure 3 illustrates the optical radiation source 18 being disposed at the distal end of the mouthpiece 24 [FIG. 3]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify Brawn-202’s photobiomodulation device to illuminate the blood vessels of the patient’s tongue, as taught by Altshuler. The advantage of such modification will increase microcirculation within the blood and/or lymph vessels of the tongue (see paragraphs [0109, 0114-0115, 0125] by Altshuler).
Regarding claim 2, Brawn-202 in view of Altshuler suggests the device of claim 1. Brawn-202 teaches an alternate embodiment comprising a transceiver on the device housing (the apparatus 2500 comprises a transmitter 2576 (e.g., transceiver) that is disposed in the bill or extra-oral housing portion 2560 of the mouthpiece 2510 [0632, 0682, FIG. 84]);
a memory in communication with the transceiver (the microcontroller 2572 would inherently require a memory to store the data and/or transmit the stored data to an external device [0682]. Specifically, the microcontroller 2572 utilizes a transmitter 2576 (e.g., transceiver) to communicate data between the memory and the external device [0682, 0690]), the controller (the microcontroller 2572 communicates with the memory which stores the data [0682, 0690]), and storing instructions, that when executed, to cause the photobiomodulation device to initiate the treatment session (the memory of the microcontroller 2572 is configured to store instructions which executes the algorithm 2640 to initiate the administration of the light therapy session based upon a capacitance threshold [0682, 0690]).
The Examiner respectfully submits that each of Brawn-202’s embodiments are drawn to devices that are configured to illuminate tissue within the oral cavity (the mouthpiece 2510 and the mouthpiece 3610 is configured to provide illumination to the tissue within the oral cavity [0632, 0638, 0682, 0810-0811]). Thus, it would have been obvious to combine each of Brawn-202’s embodiments to arrive at an overall device similar to the one claimed. Specifically, this modification will provide a memory that is communicates with a transceiver, the controller, and stores instructions to cause the photobiomodulation device to initiate the treatment session. The advantage of such modification will allow the photobiomodulation device to communicate with an external device and store instructions to initiate the light therapy session based upon a capacitance threshold ([0632, 0682, 0690]).
Regarding claim 6, Brawn-202 teaches wherein the one or more LED light emitters emit light having at least one of a red or infrared wavelength (the light emitters 3644-3645 (e.g., LEDs) of the light therapy apparatus 3600 are configured to emit infrared light within the oral cavity to provide a photobiomodulation treatment (e.g., osteoblast proliferation and/or photobiomodulation enhanced orthodontic tooth movement) [0810, 0812, 0818, 1393]).
Regarding claim 7, Brawn-202 teaches wherein the device housing includes an external layer that encapsulates a light emission surface of at least one LED light emitter (the external layer (e.g., molded silicone) is configured encapsulate the plurality of light emitters 3644-3645 (e.g., LEDs) [0810, 0817]).
Regarding claim 8, Brawn-202 teaches wherein the device housing further comprises a silicone material (the mouthpiece 3610 of the light therapy apparatus 3600 may comprise a silicone material [0810, 0817]).
Regarding claim 9, Brawn-202 teaches wherein the device housing further comprises a plastic material (any embodiment of a light-therapy apparatus (e.g., the light therapy apparatus 3600) may be constructed from a plastic material [0341, 0541, 0784, 0810]).
Regarding claim 10, Brawn-202 teaches wherein the controller is mounted on a circuit board in an external portion of the device housing (the mouthpiece 3610 may comprise an extra-oral housing portion that extends outside of the mouthpiece 3610 [0784, 0810]. Furthermore, the extra-oral housing portion of the mouthpiece 3610 may be similar or identical to the extra-oral housing 2560 within the embodiment of figure 84 [0664, 0784, 0810, FIG. 84, FIGS. 138-139]. Specifically, the extra-oral housing portion of the mouthpiece 3610 contains electronic circuitry that is coupled to a controller [0664, 0784, 0810]).
Regarding claim 11, Brawn-202 teaches wherein the one or more LED light emitters are mounted on one or more circuit boards, respectively (the light emitters 3644 and 3645 (e.g., LEDs) are physically coupled to the flexible circuit boards 3646 and 3647, respectively [0810]).
Regarding claim 12, Brawn-202 in view of Altshuler suggests the device of claim 1. Brawn-202 teaches wherein the one or more LED light emitters comprises a plurality of LED light emitters (the plurality of light emitters 3644-3645 (e.g., LEDs) [0810]).
Furthermore, Brawn-202 teaches an alternate embodiment wherein the controller is configured to control a light emission pattern by the plurality of LED light emitters (the mouthpiece 3810 comprises a plurality of light emitters 3844 having a light emission pattern or sequence that is controlled by a controller [0846, 0848, 0853]).
The Examiner respectfully submits that each of Brawn-202’s embodiments are drawn to devices that are configured to illuminate tissue within the oral cavity (the mouthpiece 3610 and the mouthpiece 3810 is configured to provide illumination to the tissue within the oral cavity [0810-0811, 0846, 0848, 0853]). Thus, it would have been obvious to combine each of Brawn-202’s embodiments to arrive at an overall device similar to the one claimed. The advantage of such modification will allow the controller to control multiple zones of the light emitting diodes in a predetermined sequence and/or pattern ([0848, 0853]).
Regarding claim 13, Brawn-202 teaches an LED status light indicator on the device housing (as stated previously in claim 1, the extra-oral housing portion of the mouthpiece 3610 may be identical to the extra-oral housing 2560 within the embodiment of figure 84 [0708, 0784, 0810, FIG. 84, FIGS. 138-139]. In this case, the extra-oral housing portion of the mouthpiece 3610 includes an indicator light which is identical to the indicator light 2578 of the extra-oral housing 2560 [0708, 0784, 0810, FIG. 84, FIGS. 138-139]).
Regarding claim 15, Brawn-202 teaches wherein the controller is configured to control a pulse rate ([0243]) and a length of the treatment session ([0328]).
Regarding claim 16, Brawn-202 teaches a method for photobiomodulation of an oral cavity (the light therapy apparatus 3600 comprises a mouthpiece 3610 having a plurality of light emitters 3644-3645 (e.g., LEDs) that are configured to provide light therapy or photobiomodulation within the patient’s oral cavity [0810, 0818, 1393, FIGS. 138-139]. For example, the light therapy apparatus 3600 is configured to emit infrared light or near-infrared light within the oral cavity to provide a photobiomodulation treatment (e.g., osteoblast proliferation and/or photobiomodulation enhanced orthodontic tooth movement) [0810, 0812, 0818, 1393]), the method comprising:
positioning a photobiomodulation device in an oral cavity of a patient wherein the patient holds the photobiomodulation device in the oral cavity during treatment of a condition of the patient (the light therapy apparatus 3600 comprises a mouthpiece 3610 having a plurality of light emitters 3644-3645 (e.g., LEDs) that are configured to provide light therapy or photobiomodulation within the patient’s oral cavity [0810, 0818, 1393, FIGS. 138-139]. The Examiner respectfully submits that the patient holds the mouthpiece 3610 within the oral cavity by biting the bite tray 3612 [0786, 0810]), the photobiomodulation device including a light emitting device connected to a controller (the extra-oral housing portion of the mouthpiece 3610 contains electronic circuitry that is coupled to a controller which controls the light emitters 3644-3645 [0784, 0810]) and a battery (the electronic circuitry or controller is coupled to a battery (e.g., power source) to provide power to the light emitters 3644-3645 to produce the desired light [0810]); and
emitting a wavelength of light from the light emitting device having a pulse rate and duty cycle and positioned such that emitted light illuminate a tissue within the oral cavity for a treatment period (the electronic circuitry or controller is configured to control the emission of light (e.g., wavelength, intensity, and/or frequency) from the light emitters 3644-3645 that illuminate tissue within the oral cavity during the treatment session [0810, 0812]. Furthermore, the controller may adjust the duty cycle (e.g., about 10%, 20%, or 30%) and the frequency (e.g., pulse rate) of the pulses emitted from the light emitters 3644-3645 [0243, 0810]).
Brawn-202 does not explicitly teach wherein the light emitting device is positioned within a distal end of an insertion portion of the photobiomodulation device contacting tissue with the oral cavity;
wherein the tissue includes a blood flow that is illuminated with a selected dose of the emitted light.
The prior art by Altshuler is analogous to Brawn-202, as they both teach the use of a light emitting mouthpiece ([0114-0115]).
Altshuler teaches wherein the light emitting device is positioned within a distal end of an insertion portion of the photobiomodulation device contacting tissue with the oral cavity (the light emitting mouthpiece 24 comprises an optical radiation source 18 (e.g., LED) that delivers light at the blood and/or lymph vessels of the patient’s tongue [0040, 0067, 0084, 0109, FIG. 3]. Specifically, figure 3 illustrates the optical radiation source 18 being disposed at the distal end of the mouthpiece 24 which contacts the patient’s tongue [FIG. 3]).
wherein the tissue includes a blood flow that illuminated with a selected dose of the emitted light (the mouthpiece may emit light within the oral cavity to increase the lymph and blood flow within a tissue [0114-0115, 0125]. Specifically, a controller 43 is used to regulate or select the light treatment parameters [0099]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify Brawn-202’s photobiomodulation device to illuminate the blood vessels of the patient’s tongue, as taught by Altshuler. The advantage of such modification will increase microcirculation within the blood and/or lymph vessels of the tongue (see paragraphs [0109, 0114-0115, 0125] by Altshuler).
Regarding claim 17, Brawn-202 in view of Altshuler suggests the method of claim 16. Brawn teaches controlling an operation of the light emitting device with a controller, the light emitting device including one or more light emitting diodes (LEDs) (the extra-oral housing portion of the mouthpiece 3610 contains electronic circuitry that is coupled to a controller which controls the light emitters 3644-3645 [0784, 0810]).
Furthermore, Brawn-202 teaches an alternate embodiment that includes a sensor to sense the operating condition of the device (the mouthpiece 2510 comprises a capacitance sensor 2549 that is configured to detect operational data (e.g., change in capacitance) to determine the operating condition (e.g., ready status 2620 or paused status 2664) of the apparatus 2500 [0669, 0671, 0674, 0690, 0695]) and a memory to store the operational data within the device housing (the microcontroller 2572 would inherently require a memory to register or store the operational data (e.g., capacitance change) that is detected by the capacitance sensor 2549 [0671, 0674]. Specifically, the microcontroller 2572 registers the operational data (e.g., capacitance change) and executes an algorithm to indicate the operating condition (e.g., ready status 2620 or paused status 2664) of the apparatus 2500 [0669, 0671, 0674, 0690, 0695]).
The Examiner respectfully submits that each of the embodiments are drawn to devices that are configured to illuminate tissue within the oral cavity (the mouthpiece 2510 and the mouthpiece 3610 is configured to provide illumination to the tissue within the oral cavity [0632, 0638, 0682, 0810-0811]). Thus, it would have been obvious to combine each of the embodiments to arrive at an overall device similar to the one claimed. Specifically, this modification will provide the device with a sensor that is configured to sense the operating condition of the device (the capacitance sensor 2549 [0669, 0671, 0674, 0690, 0695]) and a memory that is configured to store the operational data within the device housing (the microcontroller 2572 has a memory that registers the sensed operational data (e.g., capacitance change) to execute an algorithm which indicates the operating condition (e.g., ready status 2620 or paused status 2664) [0669, 0671, 0674, 0690, 0695]). This modification is beneficial, as it will allow for controlling the device based on the data that is sensed by the capacitance sensor (see paragraphs [0669, 0671, 0674, 0690, 0695] by Brawn-202).
Regarding claim 19, Brawn-202 in view of Altshuler suggests the method of claim 16. Brawn-202 teaches communicating treatment parameters to the controller from an external computing device that comprises a tablet or phone having a touch actuated display (the external device (e.g., smartphone) includes software that is configured to program the LEDs of a light therapy apparatus (e.g., light therapy apparatus 3600) from any embodiment of the invention [0810, 1063, 1066]), the external computing device having stored thereon a software module configured to store the treatment parameters in a memory (the external device (e.g., smartphone) includes software that is configured to receive, store, and analyze data relating to the light therapy regimen [1063, 1066]), the treatment parameters including delivering a power of 30-150 mW of light to the patient during a treatment session (as stated previously above, the external device (e.g., smartphone) includes software that is configured to program the LEDs of a light therapy apparatus (e.g., light therapy apparatus 3600) from any embodiment of the invention [0810, 1063, 1066]. Specifically, the external device may program the LEDs to deliver a power of 30 mW to about 150 mW [0873-0874, 1066]).
Brawn-202 and Altshuler do not explicitly teach delivering a power of 100-150 mW of light to the patient during the treatment session.
However, Applicant’s claimed power range of 100-150 mW lies entirely within Brawn-202’s power range of 30-150 mW ([0873-0874, 1066]). Therefore, a prima facie case of obviousness exists. Based on the overlapping range, a person having ordinary skill in the art would have found it obvious to deliver a power of 100-150 mW of light to the patient during the treatment session (MPEP 2144.05). The advantage of such modification may increase the rate of tooth movement (see paragraphs [0873-0874, 1066, 1393] by Brawn-202).
Regarding claim 20, Brawn-202 teaches delivering a therapeutic dose of light to the patient to increase production adenosine triphosphate (ATP) (the light treatment can provide additional adenosine-5’-triphosphate (ATP) energy to the tissue cells [0904]).
7. Claims 3-5, 14, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Brawn-202 in view of Altshuler et al., further in view of Sentis et al. (US 2017/0333728 A1).
Regarding claim 3, Brawn-202 in view of Altshuler suggests the device of claim 1. Brawn-202 teaches a portable communication device that communicates with the photobiomodulation device (a light therapy apparatus according to the embodiments of the invention (e.g., the light therapy apparatus 3600) can be electronically linked or paired with an external communication device (e.g., smartphone, tablet, computer, or a portable electronic device) [0810, 1063]. As stated previously in claim 1, the light therapy apparatus 3600 is configured to emit infrared light or near-infrared light within the oral cavity to provide a photobiomodulation treatment (e.g., osteoblast proliferation and/or photobiomodulation enhanced orthodontic tooth movement) [0810, 0812, 0818, 1393]).
Brawn-202 and Altshuler do not explicitly teach wherein the device comprises a pacifier.
The prior art by Sentis is analogous to Brawn-202, as they both teach a light treatment device that is configured to emit light within the oral cavity ([0036, 0039]).
Sentis teaches wherein the devices comprises a pacifier (the pacifier 10 [abstract, 0039]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify the device suggested by Brawn-202 in view of Altshuler to comprise a pacifier, as taught by Sentis. The advantage of such modification will provide a light treatment to heal an infant’s gums or a child’s gums (see the [abstract] and paragraph [0039] by Sentis).
Regarding claim 4, Brawn-202 in view of Altshuler suggests the device of claim 1. Brawn-202 and Altshuler do not explicitly teach wherein the photobiomodulation device housing comprises a pacifier having an external portion outside the oral cavity.
However, Sentis teaches wherein the photobiomodulation device housing comprises a pacifier (the pacifier 10 [abstract, 0039]) having an external portion outside the oral cavity (the pacifier 10 includes a light diffusing member 18 (e.g., nipple) that is inserted into the oral cavity [0039]. Furthermore, the mouth shield 50 is an external portion that is configured to prevent the infant or child from inserting the pacifier 10 entirely into the oral cavity [abstract, 0039, FIG. 1]. Specifically, figure 1 illustrates an external housing 36 that extends from the mouth shield 50 [0039, FIG. 1]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify the photobiomodulation device suggested by Brawn-202 in view of Altshuler to comprise a pacifier having an external portion outside the oral cavity, as taught by Sentis. This modification is beneficial, as the light-diffusing member (e.g., nipple) of the pacifier can be inserted into an infant’s oral cavity or a child’s oral cavity to provide a light treatment (see the [abstract] and paragraph [0039] by Sentis). Furthermore, the external portion (e.g., mouth shield) of the pacifier will prevent the infant or child from inserting the pacifier entirely into the oral cavity ([0039]).
Regarding claim 5, Sentis teaches wherein the insertion portion of the pacifier is configured to be inserted into the oral cavity of a child (the pacifier 10 is configured to be inserted within the oral cavity of an infant or child [abstract, 0039]. Specifically, the light-diffusing member 18 (e.g., nipple) of the pacifier 10 is inserted into the oral cavity [0039]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify the pacifier suggested by Branw-202 in view of Altshuler and Sentis to be inserted into the oral cavity of a child, as further taught by Sentis. This modification is beneficial, as the pacifier can be inserted into an infant’s oral cavity or a child’s oral cavity to provide a light treatment (see the [abstract] and paragraph [0039] by Sentis).
Regarding claim 14, Brawn-202 in view of Altshuler suggests the device of claim 1. Brawn-202 and Altshuler do not explicitly teach a switch on the device housing to actuate operation of the device.
However, Sentis teaches a switch on the device housing to actuate operation of the device (figure 1 illustrates the housing 36 comprising a press switch 60 that is configured to control the operation of the LEDs 2 [0039 0041, FIG. 1]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify the device housing suggested by Brawn-202 in view of Altshuler to include a switch to actuate the operation of the device, as taught by Sentis. The advantage of such modification will allow the user to manually control the power of LEDs to prevent unnecessary battery drain (see paragraph [0041] by Sentis).
Regarding claim 18, Brawn-202 in view of Altshuler suggests the method of claim 16. Brawn-202 and Altshuler do not explicitly teach positioning the device includes inserting a pacifier into the oral cavity and further comprising operating the light emitting device with the controller that is positioned in an external portion of the device.
The prior art by Sentis is analogous to Brawn-202, as they both teach a light treatment device that is configured to emit light within the oral cavity ([0036, 0039]).
Sentis teaches positioning the device includes inserting a pacifier into the oral cavity and further comprising operating the light emitting device with the controller that is positioned in an external portion of the device (the pacifier 10 includes a light diffusing member 18 (e.g., nipple) that is inserted into the oral cavity [0039]. Furthermore, the external mouth shield 50 is configured to prevent the infant or child from inserting the pacifier 10 entirely into the oral cavity [abstract, 0039, FIG. 1]. Specifically, figure 1 illustrates an external housing 36 that extends from the external mouth shield 50 [0039, FIG. 1]. Lastly, the external housing 36 includes a light radiation controller 16 [0039, FIG. 1]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify the device suggested by Brawn-202 in view of Altshuler to comprise a pacifier having an external portion that is configured to house the controller, as taught by Sentis. This modification is beneficial, as the light-diffusing member (e.g., nipple) of the pacifier can be inserted into an infant’s oral cavity or a child’s oral cavity to provide a light treatment (see the [abstract] and paragraph [0039] by Sentis). Furthermore, this modification will allow the user to access the controller from the external housing of the pacifier to adjust the parameters (e.g., wavelength) of the LEDs (see paragraph [0039] by Sentis).
8. Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Brawn-202 in view of Altshuler et al., further in view of Brawn et al. (WO 2020118449 A2, with citations to the corresponding US Publication No. 2022/0118274 A1 and referred to herein as “Brawn-274”).
Regarding claim 21, Brawn-202 in view of Altshuler suggests the method of claim 16. Brawn-202 and Altshuler do not explicitly teach wherein the treatment session comprises treating a developmental delay of a child.
The prior art by Brawn-274 is analogous to Brawn-202, as they both teach a device that is configured to administer light to the oral cavity ([abstract, 0152, 0412]).
Brawn-274 teaches wherein the treatment session comprises treating a developmental delay of a child (the intra-oral apparatus is configured to deliver light within the patient’s oral cavity to a treat a neurodegenerative disease or a developmental cognitive impairment [0174, 0176, 0412]. Specifically, the patient may be a child or an adult [0145]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify the treatment suggested by Brawn-202 in view of Altshuler to consist of treating a developmental delay of a child, as taught by Brawn-274. The advantage of such modification will allow the device to provide light to a child’s oral cavity to treat a developmental cognitive impairment, such as dementia or Parkinson’s disease (see paragraphs [0145, 0174, 0176, 0412] by Brawn-274).
9. Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Brawn-202 in view of Altshuler et al., further in view of Huttermann et al. (US 2011/0066213 A1).
Regarding claim 22, Brawn-202 in view of Altshuler suggests the method of claim 16. Brawn and Altshuler do not explicitly teach at least one of an EEG measurement of the patient and measuring a mitochondrial function of the patient.
The prior art by Huttermann is analogous to Brawn, as they both teach light treatment device comprising a mouthpiece that is configured to emit light within the oral cavity to treat a dental or gum disorder ([0039]).
Huttermann teaches measuring a mitochondrial function of the patient (the light treatment (e.g., infrared light) is configured to modulate the mitochondrial function of a human patient [0014-0016, 0031, 0039-0040]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify the method suggested by Brawn-202 in view of Altshuler to measure the mitochondrial function of the patient, as taught by Huttermann. This modification is beneficial, as the mitochondrial function can be monitored to determine if there was a reduction in the reactive oxygen species (see paragraphs [0014-0016, 0031, 0039-0040] by Huttermann).
10. Claims 23 and 28-29 are rejected under 35 U.S.C. 103 as being unpatentable over Streeter et al. (US 2011/0144723 A1) in view of Berman et al. (US 2016/0235983 A1).
Regarding claim 23, Streeter teaches a device for therapeutic illumination of brain tissue (the light therapy device 10 is configure to treat a patient’s brain 20 [0019, 0097]), the device comprising:
a plurality of light emitting diodes (LEDs) on a head worn device (the light therapy device 10 comprises a cap 60 having a light source 40 that includes a plurality of light emitting diodes [0100, 0124-0125, 0129, FIG. 1]) configured such that at least one transcranial LED is configured to transmit light through a cranium of a patient to illuminate a blood vessel in vascular tissue of the patient within different regions of brain tissue within the cranium (the light source 40 comprises a plurality of LEDs that are configured to transmit light through the skull to different portions of the brain [0088-0089, 0090, 0100, 0125]. Furthermore, the light may be transmitted to a blocked vessel within the brain to increase to increase blood flow [0210]. Specifically, this will result in the treatment of the blocked vessel [0210]);
one or more processors (the programmable controller 126 [0139, 0143]) and a battery mounted on a frame of the head worn device (the power supply or battery is directly coupled to the light source 40 which is disposed on the cap 60 [0100, 0139, FIG. 1]. Furthermore, the light source 40 may comprise the programmable controller 126 [0139]);
at least one processor controlling a pulse rate and duty cycle of light illuminating the vascular tissue for a treatment period (the programmable controller 26 is configured to control the duty cycle and the frequency (e.g., pulse rate) of the pulses during the treatment period [0139, 0242-0243, 0254]), wherein the battery provides power to each of the LEDs (the power supply or battery is directly coupled to the light source 40 which consist of LEDs [0125, 0139])
a memory mounted on the head worn device and communicating with the one or more processors, the memory storing instructions that, when executed, cause the head worn device to (as stated previously above, the cap 60 includes a light source 40 comprising the programmable controller 126 [0100, 0139]. Specifically, the programmable controller 126 would inherently require a memory that stores instructions (e.g., instructions for light parameters) for the programmable controller 126 to execute [0139, 0143]):
determine, by the one or more processors mounted on the head worn device, a pulse rate of light to be emitted by the at least one transcranial LED during the treatment period (the programmable controller 126 can program the LEDs of the light source 40 to have a pulse rate or frequency [0125, 0139, 0227, 0242]. As stated previously above, the LEDs of the light are configured to transmit light through the skull to at least one target area of the brain [0088, 0090, 0100, 0125]); and
emit, by the plurality of LEDs, light at a wavelength for a programmed treatment period to treat a neurological condition of the patient ([0019, 0090, 0124-0126]).
Streeter does not explicitly teach wherein the plurality of LEDs emit light at a wavelength in at least one of a red and infrared spectrum.
The prior art by Berman is analogous to Streeter, as they both teach a device that is configured to emit light through the cranium and into the brain ([0039, 0069, 0073]).
Berman teaches wherein the plurality of LEDs emit light at a wavelength in an infrared spectrum ([0039, 0069, 0073])
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify Streeter’s LEDs to emit light in an infrared spectrum, as taught by Berman. The advantage of such modification will allow for treating dementia without over-stimulating depression, tinnitus, or PTSD (see paragraphs [0012, 0039, 0069, 0073] by Berman).
Regarding claim 28, Berman teaches an EEG sensor configured to be attached to the patient to measure brain activity during or after a light emission therapy session (the biometric measurement device 111 (e.g., EEG) is configured to be attached to the patient to measure brain activity before, during, or after the predetermined directed energy therapy (e.g., light therapy) [0040, 0043-0044]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify the device suggested by Streeter in view of Berman to include an EEG sensor that is attached to the patient to the patient to measure brain activity during or after a light emission therapy session, as further taught by Berman. This modification is beneficial, as the EEG data may help determine if the light parameters need to be adjusted for an effective treatment (see paragraphs [0040, 0043-0045]).
Regarding claim 29, Streeter teaches determining the wavelength of light for the at least one tissue LED comprises selecting a wavelength to stimulate production of adenosine triphosphate (ATP) in tissue within the cranium ([0095]).
11. Claims 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Streeter et al. in view of Berman et al. further in view of Mackellar et al. (US 2019/0246982 A1).
Regarding claim 24, Streeter in view of Berman suggests the device of claim 23. Streeter and Berman do not explicitly teach a wireless transceiver mounted on the head worn device that receives linguistic input from an external user device.
The prior art by Mackellar is analogous to Streeter, as they both teach a wearable device that is utilized by a patient having neurological disorder or a cognitive impairment ([0064, 0078]).
Mackellar teaches a transceiver in the head worn device that receives linguistic input from an external user device (the user devices may include a biomonitoring neuroheadset, a user device (e.g., a mobile computing device, a computer, etc.) in communication with the biomonitoring neuroheadset (e.g., wireless communication via transceivers), and other suitable mobile devices [0078, 0080, FIG. 1]. Specifically, the user devices may communicate audio and/or bioelectrical signal datasets to each other [0078, 0080-0081]. Specifically, the audio signal datasets may include linguistic or speech recognition approaches [0078, 0080-0081]. The Examiner respectfully submits that speech recognition is known to utilize linguistics [0081]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify the head worn device suggested by Streeter in view of Berman to include a transceiver that receives a linguistic input from an external user device, as taught by Mackellar. The advantage of such modification will provide the head worn device with the capability of speech recognition (see paragraphs [0078, 0080-0081] by Mackellar).
Regarding claim 25, Mackellar teaches one or more headphones that emit the linguistic input (as stated previously above, Specifically, the user devices (e.g., a mobile computing device and a biomonitoring neuroheadset) may communicate audio and/or bioelectrical signal datasets to each other [0078, 0080-0081]. Specifically, the audio signal datasets may include linguistic or speech recognition approaches [0078, 0080-0081]. [0081]). Furthermore, the user devices (e.g., biomonitoring neuroheadset) may include in-ear headphones or on-ear headphones to emit the audio and bioelectric signal datasets [0078, 0080-0081, 0104]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify the head worn device suggested by Streeter in view of Berman and Mackellar to include headphones that emit the linguistic input, as further taught by Mackellar. The advantage of such modification will provide the head worn device with the capability of speech recognition (see paragraphs [0078, 0080-0081] by Mackellar).
12. Claim 26 are rejected under 35 U.S.C. 103 as being unpatentable over Streeter et al. in view of Berman et al. further in view of Dougal (US 2012/0046716 A1).
Regarding claim 26, Streeter in view of Berman suggests the device of claim 23. Berman teaches each transcranial LED having a lens to couple emitted light onto the cranium of the patient such that the light at a transmission wavelength is transmitted through the cranium and into a portion of brain tissue of the patient (each of the plurality of energy portals 113 (e.g., LEDs) may include a lens 117 that emits the infrared (IR) radiation through the skull and into a portion of the brain tissue [0009, 0039-0040, 0052]).
Streeter and Berman do not explicitly teach wherein the plurality of LEDs are mounted on a plurality of circuit boards, wherein an intensity of the transmitted light comprising a therapeutic dose of light to treat autism.
The prior art by Dougal is analogous to Streeter, as the they both teach a wearable light emitting device that is configured to treat various neurological conditions ([abstract, 0001]).
Dougal teaches wherein the plurality of LEDs are mounted on a plurality of circuit boards (each of the modules D includes a printed circuit board (PCB) having a light source or a series of light sources [0060, FIG. 7A]. Specifically, the each of the PCBs may be flexible ensuring the close approximation of the light sources to the scalp [0060]), wherein an intensity of the transmitted light comprising a therapeutic dose of light to treat autism (the emitted light has an intensity that is configured to treat autism [0001, 0041, 0089]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify the LEDs suggested by Streeter in view of Berman to be mounted on a plurality of printed circuit boards. This modification is beneficial, as each of the printed circuit boards (PCBs) may be flexible to ensure close approximation of the light sources to the scalp (see paragraphs [0001, 0060] by Dougal). Furthermore, it would have been obvious to a person having ordinary skill in the art to modify the LEDs suggested by Streeter in view of Berman to emit a light intensity that is configured to treat autism, as taught by Dougal. This modification beneficial, as it will increase the number of neurological conditions that the device can treat (see paragraphs 0001, 0041, 0089] by Dougal). In other words, this will allow the device to be utilized by a wide variety of patients having different neurological conditions (e.g., Alzheimer’s disease, Parkinson’s Disease, or autism).
13. Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Streeter et al. in view of Berman et al. further in view of Lim (WO 2019/053625 A1, with citations to the corresponding US Publication No. 2020/0360715 A1) and Mackellar et al.
Regarding claim 27, Streeter in view of Berman suggests the device of claim 23. Streeter and Berman do not explicitly teach a touchscreen tablet that communicates with the head worn device, the tablet having a further data processor and a further memory wherein the further data processor is configured to operate a light emission module, a linguistic therapy module, a patient data entry module and an electronic medical record module.
The prior art by Lim is analogous to Streeter, as they both teach light emitting devices that are configured to emit light into the brain ([abstract]).
Lim teaches a touchscreen tablet that communicates with the head worn device (the tablet 170 has an interface or touch screen 172 to control the parameters of light irradiation units 110, 112, 114, 116, 118, 120, and 130 on the transcranial headset 102 [0147, 0149-0150]), the tablet having a further data processor and a further memory (the computing devices (e.g., the tablet 170) comprises a processor and a storage component (e.g., memory) [0123-0124, 0149-0150]) wherein the further data processor is configured to operate a light emission module (the tablet 170 has an interface or touch screen 172 to control the parameters of light irradiation units 110, 112, 114, 116, 118, 120, and 130 on the transcranial headset 102 [0147, 0149-0150]), a patient data entry module (the computing device (e.g., tablet 170) may be used to collect patient data relating to brain function [0123, 0149-0150]), and an electronic medical record module (the computing device (e.g., tablet 170) may collect data relating to patient data relating to the patient’s treatment or medical history [0128]).
The prior art by Mackellar is analogous to Streeter, as they both teach a wearable device that is utilized by a patient having neurological disorder or a cognitive impairment ([0064, 0078]).
Mackellar teaches wherein the data processor of the touchscreen tablet is configured to operate a linguistic therapy module (the user devices (e.g., tablet, smartphone, or biomonitoring neuroheadset) may include a linguistic or speech recognition module that analyzes the audio datasets [0020, 0078, 0081]. The Examiner respectfully submits that speech recognition is known to utilize linguistics [0081]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify the head worn device suggested by Streeter in view of Berman to communicate with a tablet that operates a light emission module, patient data entry module, and electronic medical record module, as taught by Lim. The advantage of such modification will allow the tablet to control the light parameters, collect patient data during the treatment, and store data relating to the patient’s medical or treatment history (see paragraphs [0123, 0128, 0147, 0149-0150] by Lim). Furthermore, it would have been obvious to a person having ordinary skill in the art to modify the tablet suggested by Streeter in view of Berman and Lim to include a linguistic therapy module, as taught by Mackellar. The advantage of such modification will provide the tablet a linguistic or speech recognition module that analyzes the audio datasets (see paragraphs [0020, 0078, 0081] by Mackellar).
Statement on Communication via Internet
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Conclusion
15. 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.
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/J.B.S./Examiner, Art Unit 3792
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792
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