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 .
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “light supply unit” and “light transfer unit” in claim 6.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
Claims 4-5 are objected to because of the following informalities:
claim 4 recites “module 42” which should be amended to delete the reference number
claim 5 recites “mask unit m” which should be amended to delete “m”
claim 6 recites “the LED” which should be “the LEDs”
claim 7, in line 13 recites the “inner light-blocking member” which should be the “inner light-blocking unit”
claim 7 recites “the LED” which should be “the LEDs”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claims 3-5 are 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.
Regarding claim 3, the limitation “a distance between the combination LED module to be installed in the mask unit and the surface of the skin to be cared ensures that 50% of the light irradiation output is irradiated to the skin surface” lack sufficient written description. It is unclear how 50% of light irradiation output is irradiated to the skin surface based on the distance. This would depend on the other properties of the light irradiation including the beam angle. Presumably unless the distance is so great that light extend beyond the boundaries of the face 100% of the light would still reach the skin surface. In the claimed mask it does not appear possible for only 50% of the light to reach the skin.
Regarding claim 5, the limitation “wherein the combination LED modules are installed on the substrate at intervals of 14 to 20 mm from each other taking a curvature of a facial area into account while ensuring that the internal temperature of the mask unit does not exceed 41 to 43 °C” lacks sufficient written description. The original disclosure does disclose how the spacing interval alone would ensure that the mask unit does not exceed 41 to 43°C. The intensity of the LED modules and the skin type would also affect heat retention. The original disclosure also does no describe how the curvature of the facial area is taken into account when implementing the interval.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 6-9 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 6 positively requires a human face in the limitation “wherein the mask unit comprises an inner mask unit put on a user's face.” The examiner suggests amending to “configured to be put on a user’s face.”
Claims 7-9 depend from claim 6.
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.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lay et al. (US 2021/0370090).
[Claim 1] Lay discloses a light emitting diode (LED) mask for personal combination stimulation, comprising:
a mask unit (mask, #10) to be put on a face of a user [par. 0259]; and
a light irradiation unit (LED PCB assembly, Fig. 33 #22)installed in the mask unit and comprising a plurality of LEDs (Fig. 33 #36-1, 36-2) arranged on a substrate (substrate, Fig. 33 #38) [pars. 0259, 0297],
wherein the LEDs comprise multiple types of LED chips (first LED light sources, Fig. 33 #36-1 and second LED light sources, Fig. 33 #36-2) to emit light of different wavelengths [par. 0297], and the multiple types of LED chips are configured as a combination LED module in a single support structure and arranged on the substrate [pars. 0259, 0297].
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.
Claims 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Lay et al. (US 2021/0370090) as applied to claim 1 above.
[Claim 2] Lay discloses the combination LED module comprises a first LED chip for a wavelength of 625 to 635 nm (second light source emit light in the range of 610 nm to 630 nm), and a second LED chip for a wavelength of 845 to 855 nm (first light source emit light in the range of 840-860 nm), which are configured in the single support structure [par. 0297]. It would have been obvious to one of ordinary skill in the art before the effective filing date to select a wavelength of 625 to 635 nm and a wavelength of 845 to 855 nm because one in the art would have chosen from within the suitable operating wavelength range taught by Lay for providing light therapy.
[Claim 3] Lay discloses the first LED chip has a light irradiance output of 10 mW/cm2± 20% for a wavelength of 630 nm, and the second LED chip has a light irradiance output of 10 mW/cm2± 20% for a wavelength of 850 nm (each of the first and second radiant flux maybe in the range from 1 mW/cm2 to 60 mW/cm2 including 10 mw/cm2) [par. 0015, 0123], and the number of combination LED modules to be arranged ensures that the internal temperature of the mask unit rising due to heat generation caused by light emission does not exceed 41 to 43°C (thermal foldback protection may be provided at a threshold temperature (e.g., >42° Celsius) to prevent a user from experiencing bums or discomfort; thermal foldback protection may trigger a light-emitting device to terminate operation, reduce current, or change an operating state in response to receipt of a signal indicating an excess temperature condition) [par. 0168] and a distance between the combination LED module to be installed in the mask unit and the surface of the skin to be cared (the LEDs are spaced from the face)
Lay does not specifically disclose the number of LED modules causes the temperature to not exceed 41 to 43°C. However, it would have been obvious to one of ordinary skill in the art prior to the filing date of the invention that the disclosed thermal foldback protection that adjusts emission from the LED modules would take into account the number of LED modules to prevent exceeding the temperature limit for discomfort of 42°C. Lay also does not specifically disclose the distance between he LED module and skin surface ensures that 50% of the light irradiation output is irradiated to the skin surface. However, it would have been obvious to one of ordinary skill in the art before the effective filing date to select the emission parameters of LEDs and distance from the face to ensure a desired amount of light for a particular treatment reaches the face including at least 50%.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Lay et al. (US 2021/0370090) as applied to claim 3 above in view of Belkowski (US 2023/0010922).
[Claim 4] Lay does not disclose the combination LED module has a light irradiation angle of 120° and the distance between the combination LED module and the surface of the skin to be cared is 10 mm ± 10%.
Belkowski discloses an analogous light therapy device comprising LED light sources (#150). The LED light sources may emit with a beam angle between 120 and 135 degrees [pars. 0148, 0246]. The LED light sources may be various distances from the target including 0-1 cm (i.e. 10 mm) based on the intensity of light and the required target treatment parameters [par. 0151].
It would have been obvious to one of ordinary skill in the art before the effective filing date to use LEDs with a light irradiation angle (beam angle) of 120° and at a distance of 10 mm ± 10% in the mask of Lay as taught by Belkowski in order to provide the proper combination of angle, distance, and intensity to generate the light parameters required for treatment.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Lay et al. (US 2021/0370090) in view of Belkowski (US 2023/0010922) as applied to claim 4 above and further in view of Morita et al. (US 2020/0179711) and Moffat (US 2018/0353770).
[Claim 5] Lay in view of Belkowski discloses the combination LED modules are installed on the substrate taking a curvature of a facial area into account (see Fig. 33) while ensuring that the internal temperature of the mask unit does not exceed 41 to 43 °C (thermal foldback protection may be provided at a threshold temperature (e.g., >42° Celsius) to prevent a user from experiencing bums or discomfort; thermal foldback protection may trigger a light-emitting device to terminate operation, reduce current, or change an operating state in response to receipt of a signal indicating an excess temperature condition) [par. 0168]. Lay does not discloses the combination LED modules are installed on the substrate at intervals of 14 to 20 mm from each other.
Belkowksi discloses an analogous photodynamic therapy device comprising an array of LEDs (#15) with a pitch (center-to-center spacing) of 3 to 15 mm [par. 0049].
Moffat discloses an analogous photodynamic therapy device comprising LED arrays. Moffat discloses, as one of skill in the art would recognize, that the intensity of the LED array can be selected by adjusting various parameters of the array and associated components. For example, the intensity of the LED array can be increased by increasing the input energy delivered to the LEDs (e.g., by changing the power source or controls thereon), increasing the quantity of LEDs per unit area, decreasing the distance between the LEDs and the treatment area on the patient (e.g., 0-3 cm), decreasing the degree of light spreading of the lens(es) on the LEDs, and/or changing other features of the LED array that impact the radiation intensity. Conversely, the intensity of the LED array can be decreased by decreasing the level of energy delivered to the LEDs, decreasing the quantity of LEDs per unit area, increasing the distance between the LEDs and the treatment area on the patient, increasing the degree of light spreading of the lens(es) on the LEDs, and/or changing other features of the LED array that impact the radiation intensity [par. 0071].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combination LED modules of Lay to have an interval/pitch of 14 or 15 mm as taught by Belkowski in order to provide the desired intensity for therapy depending on the other parameters of combination LED modules as taught by Moffat. These are result effective variables.
Allowable Subject Matter
Claims 6-9 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 101 set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Regarding claim 6, Lay discloses the mask unit comprises an inner transmissive layer (light-transmissive element, #14) placed on the user’s face formed with an inner eye-exposure hole and an outer mask unit (housing, #12) coupled to the inner mask unit and formed with an outer eye-exposure hole communicating with the inner eye-exposure hole but does not disclose the light irradiation unit disposed on an outer surface. Lay has a plurality of standoffs (#31) that provide spacing between the light irradiation unit (LED PCB assembly, #22) and the inner transmissive layer [par. 0259]. Lay discloses a light-blocking member (eyepiece, #24) installed around the inner eye-exposure hole and the outer eye-exposure hole to prevent light from entering the eyes [par. 0259] but does not disclose a light transfer supply means installed in the inner mask unit to irradiate skin around the eyes with light, wherein the light transfer supply means comprises a light supply unit installed around the inner eye-exposure hole and formed of a light-transmitting material to make light enter and exit, and a light transfer unit arranged between the light supply unit and the LED to transfer light to the light supply unit.
Claims 7-9 depend from claim 6 and would also be allowable.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
(1) Molina (US 2005/0070977) discloses a light emitting face mask comprising an internal flexible printed circuit board (#32) containing LEDs (#36) to provide therapy to the face and a separate set of LEDs (#44) that direct therapy to the eyes within an inner eye patch (#42) located in through holes (#56).
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(2) Alexander et al. (US 5,913,883) discloses a therapeutic facial mask with a plurality of LEDs and eye holes.
(3) Chen (US 2007/0135869) discloses a face mask with an array of LEDs and eye through holes.
(4) Kim (US 2022/0152317) discloses a face mask with an array of LEDs on a central layer and eye through holes extending through an exterior mask layer.
(5) Bhardwaj (US 2007/0339462) discloses a phototherapy face mask with an array of LEDs and eye through holes.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATHAN J JENNESS whose telephone number is (571)270-5055. The examiner can normally be reached M-F 8:00-5:00 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Edward Lefkowitz can be reached at 571-272-2180. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NATHAN J JENNESS/Supervisory Patent Examiner, Art Unit 3733 10 July 2026
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