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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on January 29th, 2024 and June 10th, 2024 are being considered by the examiner.
Priority
Acknowledgment is made of applicant’s claim for foreign priority in Application No. CN2023202605361 and GB23035660, filed on February 14th, 2024 and March 10th, 2023, respectively.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
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.
Claims 1-18 are rejected under 35 U.S.C. 103 as being unpatentable over by Nazarian et al. (US20230062185) in view of Ergas et al. (US20230033993).
Figure 7 contains additional annotations below to clearly map claim limitations.
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Regarding claim 1, Nazarian teaches a phototherapy mask comprising: ([Abstract] “mask system that includes … light therapy”) a backing layer having a rear face [i.e., inner layer] and a front face [i.e. outer layer] and one or more lateral faces ([Fig. 7 above] eye openings contain lateral faces; see also [0046] “the mask portion 12 is shaped to fit over a wearer's face and can include … nostril/nose”) extending between the front face and the rear face; ([0047] “three mask layers that include an inner layer 20, a middle layer 22 and an outer layer 24”) a translucent layer disposed on the rear face of the backing layer, the translucent layer covering the entire rear face [i.e., rest of users face] of the backing layer; and ([Fig. 2] inner layer (20); [0048] “the inner layer 20 can be made of silicone (other comfortable or rubber material)” where silicone comprises translucent layers which cover the entire rear face) a plurality of light emitters sandwiched between the rear face of the backing layer and the translucent layer; ([Fig. 2] LEDs (16) in between layers (20) and (24) and [0048] “the therapy layer 27 is secured between the inner and middle layers 20 and 22” where the inner layer is translucent)
wherein the backing layer and the translucent layer together form a flexible structure ([0048] “the inner layer 20 can be made of silicone (other comfortable or rubber material), the middle layer 22 can be made of a thermoplastic elastomer (TPE) or other material” where TPE and silicone are flexible)
Regarding claim 1, Nazarian does not explicitly teach wherein the backing layer and the translucent layer together form a flexible structure that adopts a form that is concave to the rear of the mask. However, in the same field of endeavor of phototherapy face masks, Ergas discloses a phototherapy mask 400 adapted to fold about the face of a user (Fig. 2; par. [0034]) for the purpose of increasing the LED’s proximity to high contour locations, increasing the light exposure, and improving overall therapy. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify, with a reasonable expectation of success, the device in the Nazarian reference to include a phototherapy mask that is adapted to fold about the face of a user, as taught and suggested by Ergas, for the purpose of increasing the LED’s proximity to high contour locations, increasing the light exposure and improving overall therapy [Nazarian 0005].
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Regarding claim 2, Nazarian - Ergas as a combination teaches all of the limitations of claim 1. Nazarian also teaches the phototherapy mask comprises a nose hole and a mouth hole, ([0046] “the mask portion 12 … can include eye, nostril/nose, mouth and/or ear openings 14”) the translucent layer extending to the edges of the holes such that light from the light emitters can be emitted laterally from the translucent layer at the nose and mouth holes. ([Fig. 2] inner layer (20) that spans across the outer layer; [0048] “the inner layer 20 can be made of silicone (other comfortable or rubber material)” where silicone comprises translucent layers which cover the entire rear face)
Regarding claim 3, Nazarian - Ergas as a combination teaches all of the limitations of claim 1. Nazarian also teaches in which the phototherapy mask comprises two eye holes ([0046] “the mask portion 12 … can include eye, nostril/nose, mouth and/or ear openings 14”) and the backing layer comprises a collar around each eye hole, each collar extending rearwardly. ([Fig. 15] eye portion (150) and removable eye cover (157) extends rearwardly)
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Fig. 15, above
Regarding claim 4, Nazarian - Ergas as a combination teaches all of the limitations of claim 3. Nazarian also teaches in which each collar has an interior lateral surface that faces the respective eye hole and an exterior lateral surface ([Fig. 15] eye portion (150) and removable eye cover (157) has dual facing lateral surfaces), and the translucent layer covers the exterior lateral surface of each collar. ([0065] “the removable eye cover 157 may be made of silicone”)
Regarding claim 5, Nazarian - Ergas as a combination teaches all of the limitations of claim 4. Nazarian also teaches in which the translucent layer [i.e., silicone layer (152)] extends to cover a rear facing portion of each collar. ([0065] “the removable eye cover 157 may be inserted in an area next to the silicone layer 152” where silicone layer (152) extends to rear facing eye covers)
Regarding claim 6, Nazarian - Ergas as a combination teaches all of the limitations of claim 1. Nazarian also teaches in which the translucent layer has a rear face and the shape of the rear face of the translucent layer conforms to the shape of the rear face of the backing layer. ([Fig. 2 above] layer (20) conforms to layer (24) and ([0048] “the inner layer 20 can be made of silicone (other comfortable or rubber material), the middle layer 22 can be made of a thermoplastic elastomer (TPE) or other material”)
Regarding claim 7, Nazarian - Ergas as a combination teaches all of the limitations of claim 4. Nazarian also teaches in which the translucent layer has a rear face and the shape of the rear face of the translucent layer conforms to the shape of the exterior lateral surface of each collar. ([Fig. 2 above] layer (20) conforms to layer (24)’s lateral contour; see alternatively [0065] “the removable eye cover 157 may be inserted in an area next to the silicone layer … the removable eye cover 157 may be made of silicone” where the silicone layer conforms to the eye cover)
For the purposes of applying art, Figure 4 and 6 of Ergas are listed below.
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[AltContent: textbox (mating step)]Ergas, Fig. 4
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Ergas, Fig. 6
Regarding claim 8, Nazarian-Ergas as a combination teaches a phototherapy mask as claimed in claim 1. Regarding claim 8, Nazarian is silent on the backing layer defining a step along the periphery of the rear face of the backing layer, and the translucent layer defines a locating feature shaped to mate with the step. However, in the same field of endeavor of phototherapy face masks, Ergas discloses a mating step [Fig. 4] and a locating feature that will mate the translucent layer (300) to the backing layer (100) [Fig. 6] for the purpose of increasing the LED’s proximity to high contour locations, increasing the light exposure, and improving overall therapy. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify, with a reasonable expectation of success, the device in the Nazarian reference to adopt a form that forms a press fit to the rear of the mask with a flexible structure, as taught and suggested by Ergas, for the purpose of increasing the LED’s proximity to high contour locations, increasing the light exposure and improving overall therapy [see Nazarian 0005].
Regarding claim 9, Nazarian-Ergas as a combination teaches all of the limitations of claim 8. Nazarian also teaches in which the translucent layer covers a peripheral lateral face of the backing layer. ([Fig. 2] layer (20) conforms to layer (24)’s lateral nose contour and [0048] “the inner layer 20 can be made of silicone (other comfortable or rubber material), the middle layer 22 can be made of a thermoplastic elastomer (TPE) or other material” where TPE and silicone are flexible)
Regarding claim 10, Nazarian-Ergas as a combination teaches all of the limitations of claim 1. Nazarian also teaches in which the phototherapy mask comprises a central plateau and cheek regions [i.e., silicone layer] extending rearwardly and laterally from the central plateau. ([0060] “the silicone layer 152 of the eye portion covers at least partially the area around the user's forehead, eyebrows, cheekbones, and/or temples.”)
Regarding claim 11, Nazarian-Ergas as a combination teaches all of the limitations of claim 10. Nazarian also teaches in which comprising attachment structures ([0071] “the strap 104 of the mask assembly 100”) at the rear of the cheek regions and one or more flexible straps attached to the attachment structures, ([0071] “the strap 104 may extend along a lateral plane or transverse plane of the user's head” is rear of the cheek region)
Regarding claim 11, Nazarian does not explicitly teach wherein the attachment structures are constituted by both the backing layer and the translucent layer. However, in the same field of endeavor of phototherapy face masks, Ergas discloses attachment structures using loops on the edge (450) for affixing straps (440) [Fig. 4 and 7] for the purpose of increasing the LED’s proximity to high contour locations, increasing the light exposure, and improving overall therapy. It would have been prima facie obvious to a person having ordinary skill in the art before the effective filing date to have to modify the device in the Nazarian reference to explicitly secure the face mask to a user with every layer in the mask, as taught and suggested by Ergas, for the purposes of managing poor fitting due to variance in human head shape [0005].
Regarding claim 12, Nazarian-Ergas as a combination teaches all of the limitations of claim 1. Regarding claim 12, Nazarian does not explicitly teach in which the backing layer and the translucent layer together form a flexible structure that adopts a human facial form. However, in the same field of endeavor of phototherapy face masks, Ergas discloses a phototherapy mask (400) adapted to fold about the face of a user (Fig. 2; par. [0034]) for the purpose of increasing the LED’s proximity to high contour locations, increasing the light exposure, and improving overall therapy. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify, with a reasonable expectation of success, the device in the Nazarian reference to include a phototherapy mask that is adapted to fold about the face of a user, as taught and suggested by Ergas, for the purpose of increasing the LED’s proximity to high contour locations, increasing the light exposure and improving overall therapy.
Regarding claim 13, Nazarian-Ergas as a combination teaches all of the limitations of claim 1. Nazarian also teaches in which the Shore A hardness of the translucent layer is in the range from 20 to 40 and the Shore A hardness of the backing layer is in the range from 30 to 50. ([Fig. 2] layer (20) conforms to layer (24)’s lateral nose contour and [0048] “the inner layer 20 can be made of silicone (other comfortable or rubber material), the middle layer 22 can be made of a thermoplastic elastomer (TPE) or other material” where TPE and silicone fall within ASTM’s standard Shore A hardness scale) MPEP 2144.05(I) states “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” [In re Wertheim, 541 F.2d 257]. There is no criticality of overlapping ranges of silicone or TPE hardness and Applicant has not indicated in the specification that different ranges would produce unexpectedly different results than from the prior art range. One of ordinary skill in the art would have recognized the ranges as obvious variants that could be achieved through routine optimization.
Regarding claim 14, Nazarian teaches a method for forming a phototherapy mask comprising: ([0011] “the specification … enable a person skilled in the pertinent art to make and use the disclosure” and [Abstract] “mask system that includes … light therapy”) forming a backing layer of a polymer material, ([0011] “drawings … enable a person skilled in the pertinent art to make and use the disclosure” and [0048] “layer 24 can be made of polycarbonate (PC)”) the backing layer having a rear face and a front face and one or more lateral faces extending between the front face and the rear face; ([Fig. 7 above] eye openings contain lateral faces; see also [0046] “the mask portion 12 is shaped to fit over a wearer's face and can include … nostril/nose”) disposing a plurality of light emitters over the rear face of the backing layer; ([Fig. 2] LEDs (16) in between layers (20) and (24) and [0048] “the therapy layer 27 is secured between the inner and middle layers 20 and 22” where the inner layer is translucent)
Regarding claim 14, Nazarian does not explicitly teach forming, separately to the formation of the backing layer, a translucent layer of a polymer material for covering the entire rear face of the backing layer; and attaching the translucent layer to the rear face of the backing layer so as to sandwich the light emitters between the translucent layer and backing layer. However, in the same field of endeavor of phototherapy face masks, Ergas discloses a third layer (300) containing a separate translucent layers of a polymer material that is formed separately [Figs. 4-6] and layers (100), (200), and (300) layered together in [Fig. 1]. Ergas also discloses “The electronic layer (200) includes … one or more light sources”, see [0028]. for the purpose of increasing the LED’s proximity to high contour locations, increasing the light exposure, and improving overall therapy. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify, with a reasonable expectation of success, the device in the Nazarian reference to explicitly form separately and then layer the light sources in between flexible structures, as taught and suggested by Ergas. This would have increased the LED’s proximity to high contour locations, increasing the light exposure and improving the overall therapy.
Regarding claim 15, Nazarian-Ergas as a combination teaches all of the limitations of claim 14. Nazarian is silent on, as taught by Ergas, wherein the backing layer defines a step around the periphery of the rear face of the backing layer ([Fig. 4] mating step) and the translucent layer defines a locating feature shaped to mate with the step, wherein attaching the translucent layer to the rear face of the backing layer comprises mating the locating feature with the step. ([Fig. 6] locating feature that will mate the translucent layer (300) to the backing layer (100); see also [Fig 1] for mating Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify, with a reasonable expectation of success, the device in the Nazarian reference to adopt a form that forms a press fit to the rear of the mask with a flexible structure, as taught and suggested by Ergas. This would have allowed for an adjustable mask that increases LED’s proximity to high contour locations for improving the overall therapy.
Regarding claim 16, Nazarian-Ergas as a combination teaches all of the limitations of claim 14. Nazarian is silent on, as taught by Ergas, wherein the backing layer and translucent layer each comprise two eye holes ([0046] “the mask portion 12 … can include eye, nostril/nose, mouth and/or ear openings 14”) and collars extending rearwardly around each eye hole ([Fig. 15] eye portion (150) and removable eye cover (157) extends rearwardly), wherein attaching the translucent layer ([0065] “the removable eye cover 157 may be made of silicone”) to the rear face of the backing layer comprises fitting each collar of the translucent layer around the corresponding collar of the backing layer. ([Fig. 15] removable eye cover (157) fits around the eye portion (150))
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Fig. 15, above
Regarding claim 17, Nazarian-Ergas as a combination teaches all of the limitations of claim 14. Nazarian is silent on, as taught by Ergas, wherein the backing layer and the translucent layer each comprise attachment structures at the peripheral edges of the mask for attaching to flexible straps ([Fig. 4 and 7] contains loops on the edge (450) of mask layers (100) and (500) for affixing straps (440)), wherein attaching the translucent layer to the rear face of the backing layer comprises attaching one of the flexible straps to a respective attachment structure in each layer. ([0036] “The facial treatment region 500 is adapted to releasably affix to the backing layer 100 by one or more fastening means 510”) Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify, with a reasonable expectation of success, the device in the Nazarian reference to secure the face mask to a user with every layer in the mask, as taught and suggested by Ergas. This secure attachment method would have helped manage poor fitting due to variance in human head shape [0005].
Regarding claim 18, Nazarian-Ergas as a combination teaches all of the limitations of claim 14. Nazarian is silent on, as taught by Ergas wherein the translucent layer is formed as one continuous piece of the polymer material. ([Fig. 6] layer (300) is continuous.) Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify, with a reasonable expectation of success, the device in the Nazarian reference to adopt a continuous layer of silicone that forms a press fit to the rear of the mask with a flexible structure, as taught and suggested by Ergas. This would have allowed for an adjustable mask that increases LED’s proximity to high contour locations for improving the overall therapy.
Claims 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over by Nazarian et al. (Pat. 12520929) in view of Ergas et al. (US20230033993). as applied to claims 1-18 above, and further in view of Su et al. (WO2018196310).
Regarding claim 19, Nazarian-Ergas as a combination teaches all of the limitations of claim 14. Regarding claim 19, Nazarian-Ergas as a combination does not explicitly teach wherein attaching the translucent layer to the rear face of the backing layer comprises applying an adhesive to one or both of the rear face of the backing layer and the translucent layer. However, in the same field of endeavor of phototherapy face masks, Su discloses ([page 6, lines 34-37] “The stretchable LED … is glued between the mask-like elastic outer layer and the translucent mask-like elastic inner layer, and the mask-like elastic outer layer and the mask-like elastic inner layer are integrally assembled to form a mask body.”) Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify, with a reasonable expectation of success, the device in the Nazarian and Ergas combination to explicitly adhering the layers of the mask together, as taught and suggested by Su. This secure attachment method would have helped manage poor fitting due to variance in human head shape [0005].
Regarding claim 20, Nazarian-Ergas-Su as a combination teaches all of the limitations of claim 19. Su also teaches further comprising pressing the translucent layer onto the backing layer to force the adhesive to fill the space between the backing layer and translucent layer. ([0032] “may be obtained by overmoulding during production a second transparent material alongside the backing layer” where overmolding comprises pressing the layers together to adhere the layers.) It would have been prima facie obvious to a person having ordinary skill in the art to have modified the Nazarian and Ergas combination with the teachings of Su by explicitly adhering the layers of the mask together. This secure attachment method would have helped manage poor fitting due to variance in human head shape [0005].
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Lay et al. (Pat. 11975215) discloses a therapeutic mask and method of treating skin.
Bhardwaj et al. (Pat. 12268893) discloses an LED mask with contours for forming a tight fit to a human face.
Lee (KR20210036225) discloses a LED therapy mask with variable wavelengths that uses a piezoelectric element to alter the light output.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT ANTHONY SKROBARCZYK whose telephone number is (571)272-3301. The examiner can normally be reached Monday thru Friday 7:30AM -5PM CST.
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/R.A.S/Examiner, Art Unit 3792
/ALLEN PORTER/Primary Examiner, Art Unit 3796
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