DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendment filed on 02/16/2026 has been entered. Claim 1-12, 14, 18-21, and 23-27 remain pending in the application. Applicant’s amendment to the Claims have overcome each and every 112(b) and 112(d) rejection previously set forth in the Non-final Office Action mailed on 09/19/2025.
Response to Arguments
Applicant's arguments filed 02/16/2026 have been fully considered but they are not persuasive.
Claim Interpretation:
Applicant's arguments/remarks concerning Claim 12 and 19 under 112(f) have been fully considered and are persuasive. The 112(f) interpretation is withdrawn.
Rejection under 35 U.S.C § 112:
The previous rejection of Claim 9 under 112(b) is withdrawn in view of the amendment to the claims.
The previous rejection of Claim 26 and 27 under 112(d) is withdrawn in view of the amendment to the claims.
Rejection under 35 U.S.C § 102 and 103:
Applicant's arguments/remarks concerning the § 102 and 103 have been fully considered but are not persuasive. Applicant argues that Kothari (1) “does not disclose or suggest treatment of the skin between the sternocleidomastoid muscle”, and (2) “does not disclose or suggest a device configured so that the emitters located within a define anatomical location emit at a higher optical intensity than emitters outside that region based solely on anatomical location, rather than responsive to tissue properties or distance”. The Examiner respectfully disagrees.
Concerning argument (1), the claimed device is structured to target a specific anatomical region of the throat between the sternocleidomastoid muscle and Kothari disclose or suggest treatment area to include this anatomical location, for example, Kothari disclose “the anatomical location includes at least one of a mouth or a neck” and “the anatomical location 18 may comprise a lower portion of a face of a patient 20 including the mouth (e.g., including the area around the mouth, cheeks, and a neck of the patient 20). In the embodiment shown in FIG. 2, the anatomical location includes the area under the chin”. Kothari’s disclosure of anatomical location to include a neck would cover the claimed region between the sternocleidomastoid muscle. Also referring to the Images on page 13 of Applicant’s Remark, Kothari’s anatomical location is clearly in between the sternocleidomastoid muscle.
Concerning argument (2), applicant remarks that Kothari determines the location of illumination based on tissue characteristics and distance to target region, rather than the emitters located within a define anatomical location emit at a higher optical intensity than emitters outside that region based solely on anatomical location. However, Kothari disclose that "The phototherapy device includes a mask shaped to conform to an anatomical location when placed against the anatomical location. The phototherapy device also includes an illumination source comprising an array of light sources configured to emit light to illuminate target regions when the mask is placed against the anatomical location. The phototherapy device further includes circuitry configured to: receive from the tissue sensor tissue properties. The received tissue properties affect delivery of light to the target regions" and “The mask 12 may be held in place relative to the anatomical location 18 using straps (FIGS. 1 -8), adhesive, or using any suitable means. Alternatively, or additionally, the mask 12 may be handheld by a user to maintain a position of the mask 12 relative to the anatomical location 18”. The mask is placed at the anatomical location of targeted regions to illuminate, the tissue properties further affect the light delivery but does not rely exclusively on the tissue properties or measured distance to determine illumination.
Kothari further disclose that “an array of light sources 22 configured to emit light 28 to illuminate the target regions 22 when the mask 12 is placed against the anatomical location 22” and “The controller may focus on the tissue of interest by modulating the intensity of light emitted by each of the separate light sources (e.g., by increasing or decreasing power to the separate light sources individually). That is, the circuitry 16 may control the regions illuminated by the illumination source 14, such that the target regions 24 are preferentially illuminated by the illumination source 14. For example, the target regions may be preferentially illuminated by the illumination source such that an optical power of light 28 received by the target regions is at least two, three, or five times higher than an optical power of light 28 received by non-target regions".
As such, Kothari clearly teaches the “treatment of the skin between the sternocleidomastoid muscle” and “intensity variation is based solely on anatomical location where emitters emitting higher optical intensity in a defined anatomical region than emitters outside that region”.
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 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.
Claim(s) 1-8, 11-12, 14, 18-21, and 23-27 are rejected under 35 U.S.C. 103 as being unpatentable over Pomar et al (WO2018193426A1); hereinafter Pomar in view of Kothari et al (WO2019222492A1); hereinafter Kothari.
Regarding Claims 1 and 25, Pomar teaches a phototherapy device for treating a medical condition by delivering phototherapy to an anatomical treatment arca of a patient via a skin surface of the patient (abstract - device for stimulating comprises a cap and a plurality of light-emitting diodes), the system comprising:
a light source configured to emit electromagnetic radiation (abstract - light-emitting diodes);
and a pad configured to support the light source (fig. 2 - inner surface of the device, second inner layer part 9), such that positioning the pad adjacent to the skin surface causes the electromagnetic radiation output by the light source to be received by the skin surface as treatment electromagnetic radiation and to interact with the anatomical treatment area ([56] expose the arrays 30 of the LEDs 3 towards the eyelids and the periocular areas);
wherein the light source includes multiple light emitters located at different positions on the pad, such that a treatment property of the treatment electromagnetic radiation varies spatially based on medical properties of the anatomical treatment area (fig. 2 shows multiple light sources);
wherein the light emitters are located on the pad, such that when the pad is placed over a throat of the patient, the light emitters are preferentially located between sternocleidomastoid muscles of the patient ([12] describes how the positioning of the lights are aligned to the anatomical structures of concern);
and wherein the medical properties include at least one of anatomical structures or the medical condition ([12] describes how the positioning of the lights are aligned to the anatomical structures of concern);
Pomar fails to teach positioning the light emitters in specific locations. Kothari teaches the light emitters located between sternocleidomastoid muscles of the patient preferentially emit the treatment electromagnetic radiation, such that the optical intensity of the electromagnetic radiation emitted by the light emitters located between sternocleidomastoid muscles of the patient is higher than the optical intensity of the electromagnetic radiation (the circuitry is configured to affect the light emitted by the array of light sources in the target regions by at least one of: increasing the intensity) emitted by the light emitters not located between sternocleidomastoid muscles of the patient (the circuitry is configured to affect the light emitted by the array of light sources in the target regions by at least one of: decreasing an intensity) (The controller may focus on the tissue of interest by modulating the intensity of light emitted by each of the separate light sources (e.g., by increasing or decreasing power to the separate light sources individually). That is, the circuitry 16 may control the regions illuminated by the illumination source 14, such that the target regions 24 are preferentially illuminated by the illumination source 14. For example, the target regions may be preferentially illuminated by the illumination source such that an optical power of light 28 received by the target regions is at least two, three, or five times higher than an optical power of light 28 received by non-target regions).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify Pomar with Kothari because there is some teaching, suggestion, or motivation to do so. Kothari teaches that due to varying tissue thickness and optical properties, each location requires a different light intensity to deliver the phototherapy deep into the tissues.
Regarding Claim 2, Pomar further teaches the treatment property that varies spatially comprises at least one of wavelength, optical intensity, or optical dose ([62] The LEDs 3 distributed on the mask 2 can exhibit different features, e.g., they can be suitable for the emission of a red light beam to stimulate the production of collagen, or a blue beam to counteract the bacterial acne or a yellow beam to stimulate the lymphatic system and the nervous system, or even an infrared beam. Preferably, LEDs 3 having different features arc combined in the same mask 2 to perform mixed treatments.).
Regarding Claim 3, Pomar further teaches the light emitters include at least one first type of light emitter and at least one second type of light emitter (fig. 2 - the emitters appear to be different types, see part 3 compared to part 11 for example); the treatment property of the electromagnetic radiation emitted by the first type of light emitter differs from the treatment property of the electromagnetic radiation emitted by the second type of light emitter ([62] Preferably, LEDs 3 having different features are combined in the same mask 2 to perform mixed treatments.);
and at least one of a total number or a position of the at least one first type of light emitter differs from that of the at least one second type of light emitter, such that the treatment property of the treatment electromagnetic radiation varies spatially ([62] The LEDs 3 distributed on the mask 2 can exhibit different features).
Regarding Claim 4, Pomar further teaches the at least one first type of light emitter is configured to emit a first wavelength range of electromagnetic radiation ([62] The LEDs 3 distributed on the mask 2 can exhibit different features, e.g., they can be suitable for the emission of a red light beam to stimulate the production of collagen) ;
the at least one second type of light emitter is configured to emit a second wavelength range of electromagnetic radiation ([62] or a blue beam to counteract the bacterial acne or a yellow beam to stimulate the lymphatic system and the nervous system, or even an infrared beam);
and the first wavelength range differs from the second wavelength range ([62] Preferably, LEDs 3 having different features are combined in the same mask 2 to perform mixed treatments).
Regarding Claim 5, Pomar further teaches processor circuitry configured to control the emission of the electromagnetic radiation by the light source by separately controlling the first type of light emitters from the second type of light emitters ([44] the LEDs 3 are connected to appropriate electrical circuits, known per se and, therefore, not shown, which allow to manage the power supply and the correct operation of the diodes. The LED circuits 3 are electrically connected to a control and/or power supply unit 4 of the device).
Regarding Claim 6, Pomar further teaches the processor circuitry is configured to control the first type of light emitters and the second type of light emitters based on the medical condition being treated ([27] Advantageously, said light-emitting diodes are electrically connected to an external control and/or power supply unit.).
Regarding Claim 7, Pomar further teaches a positioning of the multiple light emitters varies spatially, such that the optical dose of the treatment electromagnetic radiation varies spatially (fig. 2).
Regarding Claim 8, Pomar teaches the device of claim 1. Pomar fails to teach controlling the different arrays separately. Kothari teaches the light emitters include at least a first group of light emitters and a second group of light emitters;
further comprising processor circuitry configured to control the emission of the electromagnetic radiation by the light source by separately controlling the first group of light emitters from the second group of light emitters (modulating an optical dosage delivered to targeted tissues extraorally based on measured tissue properties, such that the targeted tissues receive a particular dose of optical power).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify Pomar with Kothari because there is some teaching, suggestion, or motivation to do so. Kothari teaches that due to varying tissue thickness and optical properties, each location requires a different light intensity to deliver the phototherapy deep into the tissues.
Regarding Claim 11, Pomar teaches the device of claim 1. Pomar fails to teach a pad contoured to the skin surface. Kothari teaches the pad is contoured based on a shape of the skin surface, such that an inner surface of the pad is adjacent to the skin surface when the pad is pressed against the skin surface (the array of light sources 22 may be located adjacent a surface of the mask 12 opposite a skin surface of the user when the mask is positioned against the anatomical location 22). It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify Pomar with Kothari because there is some teaching, suggestion, or motivation to do so. Kothari teaches that due to varying tissue thickness and optical properties, each location requires a different light intensity to deliver the phototherapy deep into the tissues.
Regarding Claim 12, the combination of Pomar and Kothari teaches the device of claim 11. Pomar further teaches the pad includes a fastener, a proximal edge, a distal edge, and an inner surface; the fastener is configured to maintain a position of the distal end relative to the proximal end, such that the inner surface of the pad forms a channel shaped to receive at least a portion of a throat of the patient ([59] openings 12,13 passing through the first layer 8 and the second layer 9 are realized on the mask in order to allow a suitable air circulation to the user and thus increase his/her well-being during the treatment).
Regarding Claim 14, Pomar teaches the device of claim 1. Pomar fails to teach multiple connected pads. Kothari teaches the pad comprises multiple pads and each of the multiple pads includes at least one of the multiple light emitters; and further comprising a fastener configured to maintain a position of at least one of the multiple pads relative to the skin surface (fig. 5 shows 2 pads connected). It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify Pomar with Kothari because there is some teaching, suggestion, or motivation to do so. Kothari teaches that due to varying tissue thickness and optical properties, each location requires a different light intensity to deliver the phototherapy deep into the tissues.
Regarding Claim 18, Pomar further teaches the pad includes air passages configured to permit airflow across at least a portion of the skin surface; and the air passages include at least one of:
contours on an inner surface of the pad such that the inner surface of the pad does not make physical contact with the at least a portion of the skin surface; or passages between the inner surface of the pad and an exterior surface of the pad located opposite the inner surface of the pad ([73] mask is arranged in front of the user's face, at an appropriate distance, therefore the user is irradiated by the light beam of the LEDs without the need to directly contact the user's skin with the energy source).
Regarding Claim 19, Pomar teaches the device of claim 1. Pomar fails to teach a pad with articulating structures. Kothari teaches the pad includes articulating structures configured to enable the pad to bend at a 90-degree angle (fig. 6-8 parts 12a-12b are connected allowing the pads to bend at a 90-degree angle). It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify Pomar with Kothari because there is some teaching, suggestion, or motivation to do so. Kothari teaches that due to varying tissue thickness and optical properties, each location requires a different light intensity to deliver the phototherapy deep into the tissues.
Regarding Claim 20, Pomar further teaches each of the multiple light emitters is at least one of a light emitting diode (LED) or a laser diode ([42] light sources 3 of the light-emitting diodes).
Regarding Claim 21, Pomar teaches the device of claim 1. Pomar fails to teach the pad acting as a light guide. Kothari teaches the pad acts as a light guide by receiving at least a portion of the electromagnetic radiation emitted by the light source and transmitting the received electromagnetic radiation via total internal reflection to a light emitting surface of the pad, such that received electromagnetic radiation is emitted from the light emitting surface and interacts with the tissue (intraoral component may comprise a light guide (e.g., made from silicone, acrylic, etc.) configured to transmit light from the one or more light sources to deliver phototherapy to target regions). It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify Pomar with Kothari because there is some teaching, suggestion, or motivation to do SO. Kothari teaches that due to varying tissue thickness and optical properties, each location requires a different light intensity to deliver the phototherapy deep into the tissues.
Regarding Claim 23, Pomar teaches the device of claim 1. Pomar fails to teach a pad with a thermal sensor. Kothari teaches the pad includes a thermal sensor configured to monitor a surface temperature of the probe; and further comprising processor circuitry configured to control emission of the electromagnetic radiation by the light source, such that emission of electromagnetic radiation by the light source is reduced when the thermal sensor detects a temperature greater than a predetermined level (the phototherapy device also includes one or more temperature sensors positioned to detect a temperature of a contacting surface of the mask).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify Pomar with Kothari because there is some teaching, suggestion, or motivation to do so. Kothari teaches the predetermined level may be a threshold temperature (e.g., determined to cause tissue damage, damage to a part of the phototherapy device 10, or discomfort to a patient).
Regarding Claim 24, Pomar further teaches the light source is configured to emit both therapeutic light and infrared or near infrared light, such that penetration of the therapeutic light into the anatomical treatment area is improved ([62] infrared beam).
Regarding Claim 26, Pomar teaches the method of claim 25. Pomar fails to teach a specific medical condition from the list. Kothari teaches the medical condition comprises at least one of radiation dermatitis, dysphagia, delayed swallow reflex, pharyngeal peristalsis abnormality, esophageal mucositis, pharyngeal mucositis (Phototherapy can be utilized for treating and providing pain relief for various conditions, including a condition called Oral Mucositis (OM)), dysarthria, lymphedema, radiation fibrosis, neuralgia, or dysesthesia. It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify Pomar with Kothari because there is some teaching, suggestion, or motivation to do so. Kothari teaches that due to varying tissue thickness and optical properties, each location requires a different light intensity to deliver the phototherapy deep into the tissues.
Regarding Claim 27, Pomar teaches the method of claim 25. Pomar fails to teach a specific medical condition from the list provided. Kothari teaches the medical condition comprises at least one of radiation dermatitis, xerostomia, radiation fibrosis, dysarthria, neuralgia/dysesthesia (providing pain relief for various conditions), or osteoradionecrosis of the jaw. It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify Pomar with Kothari because there is some teaching, suggestion, or motivation to do so. Kothari teaches that due to varying tissue thickness and optical properties, each location requires a different light intensity to deliver the phototherapy deep into the tissues.
Claim(s) 9 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pomar and Kothari in view of Tapper et al (US 20160051834 A1); hereinafter Tapper.
Regarding Claim 9, the combination of Pomar and Kothari teaches the device of claim 8. Kothari teaches where the first type of medical condition and second type of medical condition are each selected from the group consisting of: dysphagia, delayed swallow reflex, pharyngeal peristalsis abnormality (PPA), voice disorder (larynx), esophageal mucositis, pharyngeal mucositis (Phototherapy can be utilized for treating and providing pain relief for various conditions, including a condition called Oral Mucositis (OM)), dysarthria, head and neck cancer, radiation dermatitis, lymphedema (neck), radiation fibrosis, neuralgia/dysesthesia (providing pain relief for various conditions), and neck surgery.
The combination fails to teach treating a second type of medical condition. Tapper teaches the first group of light emitters are positioned to treat a first type of medical condition; and the second group of light emitters are positioned to treat a second type of medical condition ([0161] simultaneous treatment of multiple skin conditions). It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify the combination of Pomar and Kothari with Tapper because there is some teaching, suggestion, or motivation to do so. Tapper teaches that this allows one to custom tailor the LED treatment regimen ([0161]).
Regarding Claim 10, the combination of Pomar, Kothari, and Tapper teaches the device of claim 9. Tapper further teaches the processor circuitry is configured to control the first group of light emitters and the second group of light emitters based on the medical condition being treated ([0161] allowing the user to program which arcas of their face require specific treatments).
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.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Patel Niketa can be reached at (571) 272-4156. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/I.J./ Examiner, Art Unit 3792
/JOHN R DOWNEY/ Primary Examiner, Art Unit 3792
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