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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/08/2026 has been entered.
Status of the Claims
The amendment filed 05/08/2026 has been entered. Claims 1-3 and 5-13 are pending and under consideration.
Response to Arguments
In response to the applicant’s argument with respect to 35 USC 103 rejections have been considered and are at least partially persuasive, but are moot in light of new rejection/interpretation.
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.
Claims 1-3, 5-9 and 11 rejected under 35 U.S.C. 103 as being unpatentable over Coogan (US 20220257426 A1) in view of Zeineh (US 20220062050 A1) and Knepshield et al (US 20170112676 A1).
Regarding claim 1, Coogan substantially teaches applicant’s claimed invention, and specifically discloses a device with every structural limitation of applicant’s claimed invention (except for the limitations shown in italics and grayed-out) including:
An eyelid seal (figure 1, eyelid closure patches 102) for maintaining lid closure for an eye of a patient, comprising:
a main section (figure 1 and [0014] main body 108 comprising a width and length sufficient to cover orbital area including an upper, an lower eyelid and length of the eye of the patient) of a width sufficient to cover an upper and lower eyelid of the patient and a length at least equal to a length of the eye of the patient, but wherein the width and length of the main section are limited such that the main section fits wholly within an orbit of the eye of the patient, and further wherein the main section comprises an asymmetric contour shape to conform to the orbit of the eye adnexa of the patient with a medial canthus of the eye narrower than a temporal canthus of the eye, and further wherein the main section is formed of a porous plastic material ([0031-0037 and 0060] the main body comprises semi-permeable membrane made of polymer, and the semi-permeable membrane comprises a porous network and/or a number of pores configured to allow ventilation thereby preventing a decrease in adhesion due to excessive moisture vapors Examiner’s note: the limitation below is directed to an intended use and functional result of providing porous plastic material rather than structural difference. As set forth in MPEP 2114, if prior art reference teaches the claimed structures, the prior art is considered to inherently posses the functionally defined limitations of the claimed apparatus. In the instant case, the prior art teaches the main section made of a porous plastic material, the claim is not patentably distinct from the prior art) configured to allow air through to reduce the activation of sudoriferous glands, thereby preventing a decrease in adhesion of the eyelid seal to the upper and lower eyelid that would otherwise occur, wherein adhesion is critical in order to control inadequate lid seal in the patient;
further wherein a lower side of the main section comprises an adhesive (figure 2 and [0017] adhesive 112) comprising sufficient stickiness to maintain complete lid closure for the eye of the patient during an entire night's sleep; and
at least one tab (figure 1 and [0059] non-adhesive tab 110) on an end of the main section, wherein a lower side of the tab is free of the adhesive.
Coogan does not expressly teach wherein the width and length of the main section are limited such that the main section fits wholly within an orbit of the eye of the patient.
In the same field of endeavor, Zeineh teaches an eye patch (figure 1, 100) having a width and length of the main section are limited such that the main section fits wholly within an orbit of the eye of the patient (see figure 6 and [0039], the size of eye patch 100 is limited such that the patch fit within an orbit of the eye excluding eyebrows 605).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Coogan to incorporate the teachings of Zeineh and provides the main section comprising claimed size, as one of skill in the art motivated to do so, for the purpose of keeping the adhesive from contacting eyebrows, as the adhesive damages easily damage them, as taught by Zeineh ([0004]).
The combination does not expressly teach wherein the main section comprises an asymmetric contour shape to conform to the orbit of the eye adnexa of the patient with a medial canthus of the eye narrower than a temporal canthus of the eye.
In the same field of endeavor, namely eyelid closure patch, Knepshield teaches wherein the main section (figures 6-9 [0037] main body 13) comprises an asymmetric contour shape (figures 6-9 [0037] main body 13 has an asymmetrical configuration) to conform to the orbit of the eye adnexa of the patient with a medial canthus of the eye narrower than a temporal canthus of the eye.
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Coogan, as modified by Zeineh, to incorporate the teachings of Knepshield and provide the main section as claimed for the purpose of providing desired coverage of the wearer's eye while minimizing potential discomfort to the wearer as taught by Knepshield ([0037]).
Regarding Claim 2, Coogan, as modified by Zeineh and Knepshield, teaches the eyelid seal of claim 1.
The combination does not expressly teach wherein the adhesive is a pressure- sensitive adhesive
In the same field of endeavor, namely eyelid closure patch, Knepshield teaches wherein the adhesive is a pressure- sensitive adhesive ([0033] pressure sensitive adhesive including a natural or synthetic hydrocolloid, gelatins, synthetic rubber, acrylate, silicone or soft silicone gel adhesive or any other suitable medical grade adhesive.)
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Coogan, as modified by Zeineh and Knepshield, to incorporate the teachings of Knepshield and provides the adhesive as claimed for the purpose of provide sufficient adhesiveness to secure adhere to delicate eyelid skin, while being easily removable with minimal discomfort ensuring high comfort for the patient during use as taught by Knepshield ([0009 and 0033]).
Regarding claim 3, Coogan, as modified by Zeineh and Knepshield, teaches the eyelid seal of claim 2.
The combination further teaches wherein the adhesive is a water-soluble gelatinous or hydrocolloidal adhesive (Knepshield; [0033]).
Regarding claim 5, Coogan, as modified by Zeineh and Knepshield, teaches the eyelid seal of claim 1.
The combination further teaches wherein the plastic is selected from the group consisting of polypropylene, polyethylene, an acrylic polymer and polyvinyl alcohol (Coogan; [0031-0037 and 0060] the main body is formed of acrylate film)
Regarding claim 6, Coogan, as modified by Zeineh and Knepshield, teaches the eyelid seal of claim 1.
The combination does not teach wherein the adhesive comprises a hydrogel.
In the same field of endeavor, namely eyelid closure patch, Knepshield teaches wherein the adhesive comprises a hydrogel ([0033] water soluble hydrocolloid is considered hydrogel)
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Coogan, as modified by Zeineh and Knepshield, to incorporate the teachings of Knepshield and provides the adhesive as claimed for the purpose of provide sufficient adhesiveness to secure adhere to delicate eyelid skin, while being easily removable with minimal discomfort ensuring high comfort for the patient during use as taught by Knepshield ([0009 and 0033]).
Regarding claim 7, Coogan, as modified by Zeineh and Knepshield, teaches the eyelid seal of claim 1.
The combination does not teach wherein the adhesive comprises a natural gum.
In the same field of endeavor, namely eyelid closure patch, Knepshield teaches wherein the adhesive comprises a natural gum ([0033] “Suitable synthetic and natural water soluble hydrocolloids and gelatins include karaya gum, guara gum, collagen, polysaccharide gum”)
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Coogan, as modified by Zeineh and Knepshield, to incorporate the teachings of Knepshield and provides the adhesive as claimed for the purpose of provide sufficient adhesiveness to secure adhere to delicate eyelid skin, while being easily removable with minimal discomfort ensuring high comfort for the patient during use as taught by Knepshield ([0009 and 0033]).
Regarding claim 8, Coogan, as modified by Zeineh and Knepshield, teaches the eyelid seal of claim 7.
The combination further teaches wherein the gum is a karaya gum, a guar gum, or a combination thereof (Knepshield; [0033] “Suitable synthetic and natural water soluble hydrocolloids and gelatins include karaya gum, guara gum, collagen, polysaccharide gum”)
Regarding claim 9, Coogan, as modified by Zeineh and Knepshield, teaches the eyelid seal of claim 8.
The combination further teaches wherein the adhesive comprises a polysaccharide gum (Knepshield; [0033] “Suitable synthetic and natural water soluble hydrocolloids and gelatins include karaya gum, guara gum, collagen, polysaccharide gum”)
Regarding claim 11, Coogan, as modified by Zeineh and Knepshield, teaches the eyelid seal of claim 1.
The combination further teaches the main section comprises a plurality of fenestrations (Coogan; [0037] “The semi-permeable membrane may comprise a porous network and/or a number of pores, holes, channels or perforations extending therethrough from one side or face to the other”) configured to reduce activation of sudoriferous and sebaceous grands wherein the eyelid seal may be worn by the patient for a full night of sleep with the eye closed (Coogan; [0037] pores, holes, channels or perforation capable of performing recited function above).
Claims 10, 12 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Coogan (US 20220257426 A1) in view of Zeineh (US 20220062050 A1) and Knepshield et al (US 20170112676 A1), and in further view of Bruhl (US 5004333 A).
Regarding Claim 10, Coogan, as modified by Zeineh and Knepshield, teaches the eyelid seal of claim 1.
The combination does not expressly teach the main section is hypoallergenic.
In the same field of endeavor, namely eyeshield, Bruhl teaches eyeshield (figure 2, 10) comprises hypoallergenic material (col 4 lines 62-63 “the border material is hypoallergenic”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Coogan, as modified by Zeineh and Knepshield, to incorporate the teachings of Bruhl and provide the hypoallergenic main section, and one of skill in the art motivated to do so, for the purpose of providing comfortable skin contact while reducing irritation, as taught by Bruhl (col 2 lines 45-61).
Regarding claim 12, Coogan, as modified by Zeineh and Knepshield, teaches the eyelid seal of claim 11.
The combination does not expressly teach wherein each of the plurality of fenestrations are arranged in a grid pattern on the main section.
In the same field of endeavor, namely eyeshield, Bruhl teaches eyeshield (figure 2, 10) wherein the eye seal comprises plurality of fenestrations, and each of the plurality of fenestrations are arranged in a grid pattern on the main section (Bruhl; see figure 2, apertures are distributed in grid pattern).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Coogan, as modified by Zeineh and Knepshield, to incorporate the teachings of Bruhl and provide the plurality of fenestrations as claimed, and one of skill in the art motivated to do so, for the purpose of providing uniform ventilation throughout a surface of the main body.
Regarding claim 13, Coogan, as modified by Zeineh and Knepshield, teaches the eyelid seal of claim 12.
The combination does not expressly teach wherein each of the plurality of fenestrations are spaced 1mm apart from one another.
However, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modified Coogan, as modified by Zeineh Knepshield to have the each of the fenestrations are spaced 1mm apart from one another as claimed, since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984) MPEP 2144.04 IV. In the instant case, one of skill in the art motivate to do so for the purpose of providing sufficient ventilation while preserving the structural integrity and adhesiveness of the eye cover. Furthermore, applicant has not shown unexpected result gleaming from the claimed dimension ([0024]), and therefore the claimed device is not patentably distinct from the prior art device.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SETH HAN whose telephone number is (571)272-2545. The examiner can normally be reached M-F 0900-1700.
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/SETH HAN/ Examiner, Art Unit 3781
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