DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant's arguments in Remarks filed 06/03/2026 have been fully considered regarding the assertion, on pg. 3, that “no new matter has been added.” The Examiner respectfully disagrees. The Examiner notes that the following features are not supported by the instant specification: “a frontal wear fixation assembly coupled to the internal chassis and external chassis”; “a lateral wear fixation assembly extending from the frontal wear fixation assembly”; and “a lateral adjustment rotation assembly rotatably connecting the lateral wear fixation assembly to the frontal wear fixation assembly.” Although Fig. 9 shows these features labeled as 40, 50, and 80, respectively, and para. [0064] recites a “frontal wear fixation assembly (40),” “a lateral wear fixation assembly (50),” and “a lateral adjustment rotation assembly (80),” Fig. 9 and para. [0064] does not support where the frontal wear fixation assembly is “coupled to the internal chassis and external chassis,” where the lateral wear fixation assembly is “extending from the frontal wear fixation assembly,”, or where the lateral adjustment rotation assembly is “connecting the lateral wear fixation assembly to the frontal wear fixation assembly.” Fig. 9 and para. [0064] do not adequately disclose each underlined limitation. Therefore, new matter has been added to the specification.
Applicant’s arguments, see pg. 6 of Remarks, filed 06/03/2026, with respect to Specification Objections have been fully considered and are persuasive. The Objection of the Specification has been withdrawn.
Applicant’s arguments, see pg. 6 of Remarks, filed 06/03/2026, with respect to Specification Objections have been fully considered and are persuasive. The Objection of the Specification has been withdrawn.
Applicant’s arguments, see pg. 6-7 of Remarks, filed 06/03/2026, with respect to the rejection of claims 2, 4, and 10 under 35 USC 112(b) have been fully considered and are persuasive. The rejection of claims 2, 4, and 10 under 35 USC 112(b) have been withdrawn.
Applicant’s arguments, see pg. 6-7 of Remarks, filed 06/03/2026, with respect to the rejection of claims 2, 4, and 10 under 35 USC 112(b) have been fully considered and are persuasive. The rejection of claims 2, 4, and 10 under 35 USC 112(b) have been withdrawn.
Applicant’s arguments, see pg. 8-10 of Remarks, filed 06/03/2026, with respect to the rejection of claim 1, have been fully considered and are persuasive. The Examiner agrees that the amendments to the claims overcomes the rejection of claim 1 under 35USC 102 and 103 in view of the prior art. The Rejection of claim 1 has been withdrawn. However, the amendment to the claims necessitates new grounds for rejection (see “Response to Amendment” section below). The Examiner respectfully disagrees that Barron does not teach the limitations of claim 1 as amended. The rejection of claim 1 under 35 USC 102 is outlined below.
Response to Amendment
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 1 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 1 recites, “a frontal wear fixation assembly coupled to the internal chassis and the external chassis; a lateral wear fixation assembly extending from the frontal wear fixation assembly; and a lateral adjustment rotation assembly rotatably connecting the lateral wear fixation assembly to the frontal wear fixation assembly.” There is inadequate support disclosed in the instant specification to support the subject matter of amended claim 1. Although para. [0064] discloses a frontal wear fixation assembly (40), a lateral wear fixation assembly (50), and a lateral adjustment rotation unit (80), the instant specification does not disclose the underlined subject matter (“coupled to the internal chassis and the external chassis” (line 9); “extending from the frontal wear fixation assembly”(line 10); “rotatably connecting the lateral wear fixation assembly to the frontal wear fixation assembly” (lines 11-12)). Further, Fig. 9 discloses each claimed element of the new subject matter introduced in claim 1 (40, 50, and 80 are all shown to be labeled in the figure). However, is inadequate to show where the frontal wear fixation assembly is coupled to the internal and external chassis; where the lateral wear fixation assembly is extending from the frontal wear fixation assembly; and where the lateral adjustment rotational assembly is rotatably connecting the lateral wear fixation assembly to the frontal wear fixation assembly. Fig. 9 does not clearly show the disclosed elements, and it is not clear what each labeled element is pointing to in the figure.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
10. Claims 1, 2, and 10 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Barron et al. (US 20210275827 A1, “Barron”).
Regarding claim 1, Barron teaches a photobiomodulation (PBM) system (abstract; “light therapy unit”; Fig. 1). Barron also discloses where the system is used for treating a wide variety of psychiatric disorders, and that the system may improve sleep (para. [0089]: “Light therapy also would appear promising in this regard, at least insofar as it can likely improve sleep and mood problems.”). Barron further teaches where the system comprises: a light source having at least one light emitting diode (LED) element configured for light irradiation (para. [0010]; “a plurality of LEDs disposed on said chassis”); a controller for adjusting an output of light from the light source (para. [0010]; “a controller which controls the operation of said LEDs”); an internal chassis on which a plurality of light sources and control units are installed (Abstract; “…a light therapy unit comprising (a) a chassis, (b) a plurality of LEDs disposed on said chassis, and (c) a controller which controls the operation of said LEDs.”; Fig. 3; inward-facing surface 106); and an external chassis (Fig. 3; outward-facing surface 108) on which a charging cable connector and connection terminals are installed (Fig. 3 and 4 (Fig. 4 is a more detailed drawing of the remote (113) disposed on the external chassis shown in Fig. 4); para. [0028]; “The remote control 113 is further equipped with a headset audio plug-in port 211 for connecting a wired headset 212 to the remote control 113, and a power plug-in port 213 for connecting a power cord 214 to the remote control 113. The power cord 214 may be utilized to power the remote control 113 or to recharge one or more internal batteries contained within the device”); a frontal wear fixation assembly (Fig. 3; the surface that mates the internal (106) and external chassis (108) together) coupled to the internal chassis and the external chassis; a lateral wear fixation assembly (Fig. 3; The surface where the frontal wear fixation assembly joints with the lateral portion of the device) extending from the frontal wear fixation assembly; and a lateral adjustment rotation assembly (Fig. 3; See labeling below) rotatably connecting the lateral wear fixation assembly to the frontal wear fixation assembly.
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Regarding claim 2, Barron teaches the PBM system according to claim 1 (see above), wherein the light source is configured to irradiate light of a near-infrared wavelength ranging from 650 nm to 1100 nm to a cranium of a user. (para. [0024: “Various LEDs 109 or other light sources which emit at various wavelengths may be utilized in the devices and methodologies disclosed herein. However, the use of light sources which emit at wavelengths in the red, infra-red and blue-turquoise regions of the spectrum are preferred, and the use of light sources which emit at about 470 nm, 670 nm and 870 nm are especially preferred. In a preferred mode of operation, these light sources are made to oscillate or flicker in the theta or gamma band.”).
Regarding claim 10, Barron teaches the PBM system according to claim 1 (see above), wherein the controller (para. [0010]; “a controller which controls the operation of said LEDs”) is configured to adjust a light wavelength (para. [0015]: “a controller which controls the operation of said LEDs; and operating the plurality of LEDs at a plurality of distinct wavelengths of light such that the light emitted by the LEDs impinges on the subject, and such that the intensity of at least one of the plurality of distinct wavelengths of light is modulated at a frequency within the range of about 20 Hz to about 60 Hz.”), an irradiation intensity (abstract: “and such that the intensity of at least one of the plurality of distinct wavelengths of light is modulated at a frequency within the range of about 20 Hz to about 60 Hz.”), and a duration of irradiation of the light source (para. [0026]: “The particular wavelength(s) of emission of the LED array 109, the duration of those emissions, the frequency of oscillation (if any), the intensity of the emitted light, the selection of accompanying audio tracks or files (if any), and/or the oscillation of any accompanying audio tracks, files or component(s) thereof, may be selected to achieve a desired physiological or psychological effect.”).
Claim 1 is rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Min et al. (US 20140316492 A1, “Min”).
Regarding claim 1, in the interest of compact prosecution regarding the amended claim 1, Min teaches a photobiomodulation (PBM) system (Fig. 1-6; Abstract: "an LED phototherapy apparatus"). Min does not disclose that the apparatus is used for sleep. However, since Min discloses all of the particular elements of claim 1, absent evidence in the contrary, Min’s system could be used for inducing sleep. Min further discloses where the system comprises a light source (Fig. 1; LED 324) having at least one light emitting diode (LED) element ((Fig. 1; LED 324) configured for light irradiation (para. [0042]: " It is preferable that the LED 324 be a monochromatic LED or an RGB LED emitting multicolored light."); a control unit controller for adjusting an output of light from the light source (Abstract: "a control circuit part adapted for supplying electric power to the light emitting member and controlling light intensity and irradiation time."); an internal chassis (Fig. 2; inner cover 22) on which the light source (Fig. 2; 324); para. [0041]: "an LED (Light Emitting Diode) 324 formed on the front side of the PCB 32.") and the controller (Fig. 2; PCB 32)) are installed (Fig. 2 shows where the components are assembled on inner cover 22); an external chassis (outer cover 24) on which a charging cable connector and connection terminals are installed (para. [0045]: " The control circuit part has a power supply part to supply electric power. The power supply part is embedded in the supporter, and may be a rechargeable battery which is usable for a predetermined period of time in a charged state or a power cable which is directly connected to an external power supply socket so as to supply commercial electricity."); a frontal wear fixation assembly (see circled in figure 2 below. The circled figures show assemblies for mating 22 and 24) coupled to the internal chassis and the external chassis (see part circled in Fig. 2 below. The circled parts are where the outer cover 24 and inner cover 22 are mated together); a lateral wear fixation assembly extending from the frontal wear fixation assembly (Fig. 2; support part 1; para. [0053]: "a finishing cover 16 is joined to the outside of the side plate portion 114 of the base 11 of the support part 1, and a power source part 18 is joined between the side plate portion 114 and the finishing cover 16." The entire assembly 1 is attached to the lateral side of the system); and a lateral adjustment rotation assembly (Fig. 2; rotational shaft member 15) rotatably connecting the lateral wear fixation assembly to the frontal wear fixation assembly (para. [0048]-[0049]: "The angle-regulating means includes: a rotary shaft member 15 protrudingly formed on the side plate portion 114 of the support part 1 and having a guide plate 152 which has a plurality of through holes 153 formed radially; rotational holders 26 formed at both sides of the rotation part 2 and joined to the rotary shaft member 15; and ball plungers respectively formed on the rotational holders 26 and selectively joined to the plural through holes 153 of the guide plate 152. The rotary shaft member 15 is joined to the rotational holder 26 of the rotation part 2, and a coil spring 156 is joined to the outside of the rotary shaft member 15 such that the rotational holder 26 gets in contact with the guide plate 152. The coil spring 156 pushes one side of the rotational holder 26 so as to provide a strong bearing power, such that the contact state between the rotational holder 26 and the guide plate 152 can be kept.")
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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.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Barron et al. (US 20210275827 A1, “Barron”) in view of Lim (US 20200360715 A1, “Lim”).
Regarding claim 4, Barron teaches the PBM system according to claim 2 (see above). Although Barron teaches an adjustable wavelength output from the LED (para. [0024]: “Various LEDs 109 or other light sources which emit at various wavelengths may be utilized in the devices and methodologies disclosed herein. However, the use of light sources which emit at wavelengths in the red, infra-red and blue-turquoise regions of the spectrum are preferred, and the use of light sources which emit at about 470 nm, 670 nm and 870 nm are especially preferred. In a preferred mode of operation, these light sources are made to oscillate or flicker in the theta or gamma band.”), Barron does not expressly disclose where the near-infrared wavelength is 850nm.
Lim, in the same field of endeavor of photobiomodulation, discloses a system for irradiating the brain with LED lights of different output wavelengths. Lim discloses wherein the near-infrared wavelength can range from 620-780nm and 780-1400 nm (para. [0101]), and that these wavelengths can be used for biomodulation (title).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to experiment with varying the wavelengths of the LED, as disclosed by Lim, until arriving at the optimal wavelength for PBM. One of ordinary skill in the art would have recognized that the wavelengths in the range disclosed by Lim could be experimentally tried until arriving at an optimal value for achieving a desired effect. Therefore, to achieve optimal therapeutic effect, it would have been obvious to include an LED for generating the claimed wavelength, as disclosed by Lim, in the system of Barron. This would have been an obvious improvement to the device of Barron since it would improve optimize the biomodulation capabilities for producing therapeutic effects.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OWEN LEWIS MARSH whose telephone number is (571)272-8584. The examiner can normally be reached 7:30am – 5pm (M-Th) and 8am – noon (F).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached at (571) 270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/O.L.M./Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796
Prosecution Insights