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
Applicant’s amendments to claims 1, 2, 12, 13, and 16 and the cancellation of claims 10, 21, and 22, in the response filed March 21, 2025, are acknowledged by the Examiner.
Claims 1-5, 8, 9, and 11-20 are pending.
Group I (claims 1 and dependents), Species A1 (Fig 2-4), and Species B1 (Fig 1 and 7) remain elected. Claim 11 and claim 20 remain withdrawn.
Claims 1-5, 8, 9, and 12-19 are under consideration.
Response to Arguments
In response to “REJECTIONS UNDER 35 U.S.C. § 112”
The cancellation of claim 10 renders the corresponding 112 rejection moot, it is withdrawn.
Applicant’s amendments to claim 16 have overcome the 112 rejections, it is withdrawn.
In response to “REJECTIONS UNDER 35 U.S.C. § 102” and “REJECTIONS UNDER 35 U.S.C. § 103”
With respect to claim 1, Applicant argues that Durette does not meet each limitation of the amended claim. As necessitated by the amendments, new grounds of rejection have been made.
Applicant’s arguments to the rejections of the dependent claims are directed to claim 1, discussed above.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 line 14-15 is suggested to recite “wherein the thermal insulating layer is a thermal poor conductor with a porous structure and soft texture, or a thermal poor conductor with a film-like structure and soft texture;”
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.
Claim 16 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 16 recites “wherein the width of the eyelash protective layer is 3-15 mm” which is not supported but the instant application Specifications. The Specifications [21] recite: the edge area of the medical adhesive layer not covered by the eyelash protective layer has an enough width to fix the paste on the skin, the width is usually in a range of 3-15 mm, preferably 5 mm. The width detailed in the Specifications is the width of the edge area of the medical adhesive layer, not the eyelash protection layer as claimed. For the sake of compact prosecution, Examiner will interpret the limitation to be directed to the width of the edge area of the medical adhesive layer.
Claim Rejections - 35 USC § 112b
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 1-5, 8, 9, and 12-19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
With respect to claim 1, claim 1 line 2 requires “an optional medical adhesive layer” rendering the claim indefinite. “Optional” implies that the medical adhesive is present and a user has the ability to elect to use the adhesive or not, but it is not clear how a user may do this. The specifications do introduce an alternative to the medical adhesive layer- “[16] In some embodiments, the thermal insulating layer has a dual structure composed of a smooth foam layer and a hydrogel layer, the smooth foam layer is in contact with the shading layer, and the hydrogel layer replaces the medical adhesive layer to adhere to the skin” (emphasis added), but it is not clear how a user themselves would replace the adhesive layer with the hydrogel layer to make the medical adhesive layer “optional.” Instead, the Specifications- in light of the elected species- support an alternative embodiments in which either the medical adhesive is present or the hydrogel is present. The medical adhesive is required for the other elements of the device, so the Examiner will interpret the claim to only have the medical adhesive.
Claim 1 line 15-18 requires “the thermal insulating layer has a dual structure composed of a smooth foam layer with poor thermal conductivity and a hydrogel layer with large specific heat capacity, the smooth foam layer is in contact with the shading layer, and the hydrogel layer adheres to the skin;” rendering the claim indefinite. While the Applicant may claim the configuration with either the medical adhesive or the hydrogel as supported by instant application [16], there is not support for the elected embodiment to have both. The limitation of claim 1 below each require the medical adhesive:
Line 2- an optional medical adhesive layer (optional, but must be present in order to be optional to a user)
Lines 8-9- the medical adhesive layer being located inside the thermal insulating layer and used for sticking and fixing on the skin around eyes (claimed as present and required for the device to function)
Lines 10-14- the eyelash protective layer being located inside the medical adhesive layer and used for protecting eyelashes from sticking off by the medical adhesive layer (the medical adhesive layer is required as another element requires it as a reference point)
Lines 11-13- and the isolation layer being located inside the medical adhesive layer and the eyelash protective layer, and is used for protecting unused medical adhesive layer (the medical adhesive layer is required as another element requires it as a reference point)
Lines 19-20- and wherein the eyelash protective layer is located at the center of the medical adhesive layer, and has a smaller surface area than that of the medical adhesive layer, the edge area of the medical adhesive layer not covered by the eyelash protective layer has an enough width to fix the paste on the skin (the medical adhesive layer is required as another element requires it as a reference point)
The medical adhesive is required for the other elements of the device, so the Examiner will interpret the claim to only have the medical adhesive.
As stated above, the hydrogel layer, in the elected embodiment of Fig 1 and Fig 7, is an alternative to the medical adhesive, so in lines 15-18 it is unclear if the adhesive layer is now a part of the thermal layer or is a separate layer. Lines 15-18 imply the hydrogel is in the thermal layer, but then “the medical adhesive layer being located inside the thermal insulating layer” as required by line 8 is not possible.
Should the Applicant wish to claim the hydrogel as the adhesive, Examiner suggests using “adhesive layer” throughout the claim instead of “medical adhesive layer” and clarifying whether the hydrogel as the adhesive layer is a part of the thermal layer or separate therefrom.
Examiner notes that the embodiment that has both the adhesive and the hydrogel is embodiment of Fig 9, which was not elected. Claims drawn to both a medical adhesive and a hydrogel would be drawn to an unelected embodiment and be withdrawn.
Claims 2-5, 8, 9, and 12-19 are rejected in light of a rejected claim above.
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.
Claims 1, 2, 8, 9, 12, and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2001/0051165 (“Lenz”).
With respect to claim 1, Lenz discloses A light-proof eye protection paste (Fig 1, [0001]), comprising a decorative layer ([0040], Fig 1, skin colored top layer 1), a shading layer (Fig 1, [0040], black layer 2), a thermal insulating layer ([0013], foamed inner layer 3, foam material identified has insulation properties), an optional medical adhesive layer (Fig 1, [0047], adhesive 4), an eyelash protective layer (Fig 1, eyelash protection layer is pad 5) and an isolation layer from outside to inside (Fig 1, [0022], protective covering is an isolation later), the decorative layer being compounded at an outermost layer (Fig 1, outermost layer is decorative layer 1), the shading layers being compounded inside the decorative layer and used for blocking light and preventing light from penetrating to hurt the skin ([0030], shading layer 2 formed and applied inside the decorative layer 1, “compounded” interpreted as applied during manufacturing in light of steps recited in the instant application Specifications [49]), the thermal insulating layer being compounded inside the shading layer and used for absorbing strong light energy transmitted to the shading layer ([0031], [0035], insulation later 3 applied to the shading layer 2, system is light blocking), the medical adhesive layer being located inside the thermal insulating layer and used for sticking and fixing on the skin around eyes (Fig 1, medical adhesive 4 inside thermal layer 3), the eyelash protective layer is being located inside the medical adhesive layer and used for protecting eyelashes from sticking off by the medical adhesive layer (Fig 1, eyelash layer 5 inside the adhesive layer 4, by not being adhesive it would protect against eyelash sticking), and the isolation layer being located inside the medical adhesive layer and the eyelash protective layer, and is used for protecting unused medical adhesive layer (Fig 1, [0022], protective covering); wherein the thermal insulating layer is a thermal poor conductor with porous structure and soft texture, or a thermal poor conductor with film-like structure and soft texture ([0016]-[0018], polyurethane (“PU”) is a thermal poor conductor and with the density and thickness detailed would be soft); and the thermal insulating layer has a dual structure composed of a smooth foam layer with poor thermal conductivity and a hydrogel layer with large specific heat capacity (hydrogel limitation omitted, see 112b rejection above; [0013], [0018], foamed insulating layer 3), the smooth foam layer is in contact with the shading layer ([0013], [0018], foamed insulating layer 3 is coated to the shading layer where it dries and is a universal thickness so it would be smooth), and the hydrogel layer adheres to the skin (omitted, see 112b rejection above); wherein the strong light is a light having an energy density of 100mw- 200mw/cm2 ([0045], [0016], PU foam is an insulator and absorbs light energy, it is capable of absorbing at least some of the claimed light; Examiner notes that the device is capable of absorbing light, the claim does not dictate time nor amount of light needed to be absorbed, further the light is not a part of the invention nor is the device exposed to the light in a method claim, so the claimed limitation is met through capability of the prior art material); and wherein the eyelash protective layer is located at the center of the medical adhesive layer ([0033], centrally applied protective layer 5), and has a smaller surface area than that of the medical adhesive layer ([0033], protective layer 5 is smaller than the adhesive layer 4), the edge area of the medical adhesive layer not covered by the eyelash protective layer has an enough width to fix the paste on the skin ([0013], adhesive to be applied to the skin).
With respect to claim 2, Lenz discloses The light-proof eye protection paste according to claim 1, wherein the decorative layer is a film with a thickness in a range of 0.01-0.5 mm ([0018], layer thickness of 0.2-2.0 mm).
With respect to claim 8, Lenz discloses The light-proof eye protection paste according to claim 1, wherein a material of the thermal insulating layer is selected from one of PU, EPDM, EPP, EVA and XPE/IXPE foam, with a thickness of 0.1-1.5 mm ([0018], PU foam layer thickness of 0.2-2.0 mm).
With respect to claim 9, Lenz discloses The light-proof eye protection paste according to claim 1, wherein the thermal insulating layer is made of a non-transparent material ([0014], occlusive), which configured to participate in blocking light at the same time of heat insulation ([0016], light block and low thermal transfer material), during LED or blue light treatments with low/no heat ([0045], visible light opaque), the shading layer can be removed and the thermal insulating layer is used directly to block light ([0016], layers are each material that would prevent light and insulate, material is capable of somehow being separated).
With respect to claim 12, Lenz discloses The light-proof eye protection paste according to claim 1, wherein the decorative layer film and the thermal insulating layer are fixed on both sides of the shading layer by laminating process ([0028]-[0031], layer are combined into a single device).
The claimed phrase “by laminating process” is being treated as a product by process limitation; that is, that the layers are connected of the apparatus are done by a laminating process. As set forth in MPEP 2113, product by process claims are NOT limited to the manipulations of the recited steps, only to the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 U.S.C. 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. See MPEP 2113.
With respect to claim 13, Lenz discloses The light-proof eye protection paste according to claim 1, wherein the decorative layer and the thermal insulating layer are compounded on both sides of the shading layer by the following steps: 1) keeping the film of the decorative layer and the materials of the shading layer even and non-folding under proper tension conditions; 2) coating a polyurethane adhesive on the surface of the decorative layer, after natural drying for 1-3 minutes, and compounding the decorative layer with the shading layer under the extrusion of a pressure roller; 3) repeating the above steps 1) and 2), and compounding the thermal insulating layer on the other side of the shading layer; 4) curing the polyurethane adhesive between the decorative layer, the shading layer and the thermal insulating layer for 5-36 hours under conditions of temperature 35-60 °C and humidity 35-60% to complete the compounding process ([0028]-[0031], layer are combined into a single device).
The claimed phrase “by the following steps” is being treated as a product by process limitation; that is, that the layers are connected of the apparatus are done by a laminating process. As set forth in MPEP 2113, product by process claims are NOT limited to the manipulations of the recited steps, only to the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 U.S.C. 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. See MPEP 2113.
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 3 is rejected under 35 U.S.C. 103 as being obvious over Lenz in view of US 2017/0027757 (“Durette”).
With respect to claim 3, Lenz discloses The light-proof eye protection paste according to claim 1.
Lenz is silent on wherein the shading layer is a metal foil, and the metal foil fully covers the thermal insulating layer; and wherein the metal foil is an aluminum foil or a copper foil.
Durette teaches an analogous shading layer in between other layers wherein the shading layer is a metal foil, and the metal foil fully covers the thermal insulating layer; and wherein the metal foil is an aluminum foil or a copper foil ([0022], Fig 7, layer of aluminum foil).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the shading layer of Lenz to be foil as taught by Durette in order to allow the eye cover to be used in a variety of procedures (Durette [0022]).
Claims 4, 5, 14-19 are rejected under 35 U.S.C. 103 as being obvious over Lenz in view of US 7,584,754 (“Pellegrini et al”).
With respect to claim 4, Lenz discloses The light-proof eye protection paste according to claim 1.
Lenz is silent on wherein the shading layer is a metallized film.
Pellegrini teaches an analogous shading layer between other layers for an eye protector wherein the shading layer is a metallized film (col 5 l 15-20).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the shading layer of Lenz to be a metalized film as taught by Pellegrini in order to better block intense light (Pellegrini col 5 ll 5-10).
With respect to claim 5, Lenz discloses The light-proof eye protection paste according to claim 1.
Lenz is silent on wherein the shading layer has a thickness in a range of 0.01-0.2 mm.
Pellegrini teaches an analogous shading layer that has a thickness in a range of 0.01-0.2 mm (col 5 ll 10-15, 0.001-1mm thick).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the shading layer material and thickness of Durette to be the thickness as taught by Pellegrini in order to ensure the eye cover is comfortable but effective (Pellegrini col 2 ll 00-05).
With respect to claim 14, Lenz discloses The light-proof eye protection paste according to claim 1.
Lenz is silent on wherein the medical adhesive layer comprises a safe, hypoallergenic and biocompatible medical adhesive, which can be one of medical hot-melt pressure-sensitive adhesive, acrylic pressure-sensitive adhesive and silicone gel.
Pellegrini teaches an analogous eye cover with layers, including a medical adhesive, wherein the medical adhesive layer comprises a safe, hypoallergenic and biocompatible medical adhesive, which can be one of medical hot-melt pressure-sensitive adhesive, acrylic pressure-sensitive adhesive and silicone gel (col 4 l 65-col 5 l 5, col 2 ll 60-65, hypoallergenic and biocompatible medical adhesive).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the adhesive of Lenz to be the adhesive as taught by Pellegrini in order to ensure safe use with a variety of users (Pellegrini col 4 l 65-col 5 l 5).
With respect to claim 15, Lenz discloses The light-proof eye protection paste according to claim 1.
Lenz is silent on wherein the eyelash protective layer is a soft, non-sticky, oval or round, biocompatible material with a thickness of 0.01-0.2 mm.
Pellegrini teaches an analogous eye cover with an eyelash protective layer is a soft, non-sticky, oval or round, biocompatible material with a thickness of 0.01-0.2 mm (col 2 ll 45-55, oval biocompatible foamed plastic, thickness of 0.1-5.0 mm)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the protective layer material and thickness of Lenz to be the thickness and material as taught by Pellegrini in order to ensure the eye cover is comfortable (Pellegrini col 2 ll 00-05).
With respect to claim 16, Lenz discloses The light-proof eye protection paste according to claim 1.
Lenz is silent on wherein the width of the eyelash protective layer is 3-15 mm.
Pellegrini teaches an analogous eye cover with an adhesive and a central protective layer, wherein the width of the edge area of the medical adhesive layer is 3-15 mm (col 3 ll 30-35, 5mm peripheral portion of adhesive 13).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the size of the adhesive layer and eye protection layer of Lenz to be as detailed in Pellegrini in order to ensure the system can adhere around the eyes (Pellegrini col 3 ll 25-35).
With respect to claim 17, Lenz discloses The light-proof eye protection paste according to claim 1.
Lenz is silent on wherein the isolation layer is selected from one of silicone oil release paper, non-silicon release paper, fluorinated PET film, silicone oil PET film and PET film.
Pellegrini teaches an analogous eye cover with layers, including an isolation layer, wherein the isolation layer is selected from one of silicone oil release paper, non-silicon release paper, fluorinated PET film, silicone oil PET film and PET film (col 3 ll 55-60, wax paper is a non-silicon release paper).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to change the isolation layer material of Lenz to be the material as taught by Pellegrini in order to ensure the layer will properly release (Pellegrini col 3 ll 55-60).
With respect to claim 18, Lenz discloses The light-proof eye protection paste according to claim 1.
Lenz is silent on wherein the paste has a shape conforming to the structure and physiological characteristics of the eyes, and can be selected from one of symmetrical rain drop shape, bean sprout shape, oval shape, dolphin shape or conjoined glasses frame shape.
Pellegrini teaches an analogous eye cover wherein the paste has a shape conforming to the structure and physiological characteristics of the eyes, and can be selected from one of symmetrical rain drop shape, bean sprout shape, oval shape, dolphin shape or conjoined glasses frame shape (col 2 ll 45-55, oval).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the shape of the patch of Lenz to be oval as taught by Pellegrini in order to better fit the eye (Pellegrini col 2 ll 55-60).
With respect to claim 19, Lenz discloses The light-proof eye protection paste according to claim 1.
Lenz is silent on wherein the light-proof eye protection paste is symmetrically arranged and adhered on the rectangular isolation layer.
Pellegrini teaches an analogous eye protection system that is symmetrically arranged and adhered on the rectangular isolation layer (col 3 ll 60-65, symmetrical with respect to other protectors and shown symmetrical on sheet 12).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to duplicate and organize the paste of Lenz as taught by Pellegrini in order to alloform easy dispensing (Pellegrini col 3 ll 60-70).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ADAM D BAKER whose telephone number is (571)270-3333. The examiner can normally be reached Monday-Friday 9:30-5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rachael E Bredefeld can be reached on (571)270-5237. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ADAM BAKER/Primary Examiner, Art Unit 3786