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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/20/2026 has been entered.
Response to Arguments
The amended claims, dated 05/08/2026, have overcome the rejection under 35 USC 101 as presented in the previous Office Action dated 03/05/2026, and the rejection is hereby withdrawn.
Applicant’s arguments, see Remarks filed 03/05/2026, with respect to the rejection(s) of claim(s) 1, 4, 8, and 10 under 35 USC 103 in view of Gross et al (US 20200305858 A1) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration as necessitated by the amended claims, a new ground of rejection is made in view of Gross et al (US 20200305858 A1) and Gelland (US 20130324810 A1). New grounds of rejection detailed below.
Information Disclosure Statement
The Information Disclosure Statement (IDS) filed 03/28/2023 has been considered by the Examiner.
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.
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, 4, 8, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Gross et al (US 20200305858 A1) in view of Gelland (US 20130324810 A1).
Regarding claim 1, Gross teaches an eyeball and eyelid protector (100) comprising:
an eyeball cover (ring 102 or alternatively surgical lens 318) configured to cover an eyeball (see Figs. 8a-c where central ring 102 covers a portion of the eyeball; it can be appreciated that under its broadest reasonable interpretation, the eyeball and eyelid protector does not need to cover the entirety of the eyeball to meet the structural limitation of the claim as covering a portion of the eyeball may be interpreted as ‘configured to cover an eyeball’);
an eyelid protection part (106) that is bent and extends from one side of the eyeball cover to protect any one of an upper eyelid and a lower eyelid (see Fig. 1, [0049]; first eyelid margin holder 106 extends from a first side of central ring 102),
an auxiliary eyelid protection part (108) bent and extending from the other side of the eyeball cover (see Fig. 1; second eyelid margin holder 108 extending from an opposite side of ring 102 as first eyelid margin holder 106) while having an interval from the eyelid protection part (106) to protect the other one of the upper eyelid or the lower eyelid (see Fig. 1, [0049]; first and second eyelid margin holders 106 and 108 are spaced apart from each other by an angle theta),
wherein the eyelid protection part (106) includes:
an eyelid insertion portion (118) extending from the one side of the eyeball cover to an inside of the eyeball cover (Fig. 2) and configured to be inserted into any one of a gap between the upper eyelid and the eyeball or a gap between the lower eyelid and the eyeball (see [0049]; lower portions 118 of the lid margin holders 106 and 108 can be curved to form a scoop-like shape to easily hold a patient's eyelids and eyelashes when the eyelid speculum 100 is inserted into an eye of a patient);
an eyelid accommodation portion (160) bent and extending from the eyelid insertion portion to an outside of the eyeball cover to accommodate any one of the upper eyelid or the lower eyelid (see [0049]; the central portion 160 separates the lower eyeball insertion portion 118 and the upper eyelash cover portion 116, so it can be appreciated that the central portion 160 is in contact with an eyelid when places in the eye as seen in Figs. 8b-c); and
an eyelash cover portion (116) extending from the eyelid accommodation portion to the outside of the eyeball cover to cover any one of an eyelash of the upper eyelid or an eyelash of the lower eyelid (see Figs. 8b-c where portions 116 cover a portion of an eyelash of the upper or lower eyelid, [0059]; at least a portion of the patient’s eyelashes 144 extending from the upper eyelid 140 are positioned between the upper portion 116 and the lower portion 118 of the first eyelid margin holder 106),
wherein a total height of the eyelid protection part (106), including the eyelid insertion portion (118), the eyelid accommodation portion (160), and the eyelash cover portion (116) is in a range of 4 mm to 8 mm (see Fig. 2, [0053]; H2 can have a height ranging from 3.8mm to 11.4mm),
wherein an inner surface of the eyelid insertion portion (118), an inner surface of the eyelid accommodation portion (160), and an inner surface of the eyelash cover portion (116) are continuously connected and form one arc-shaped inner surface (see Fig. 2 where insertion portion 118, eyelid accommodation portion 160, and eyelash cover portion 116 of eyelid protection part 106 form one continuous arc), and
the inner surface of the eyelid insertion portion (118), the inner surface of the eyelid accommodation portion (160), and the inner surface of the eyelash cover portion (116) have different curvature radii each other, and forms continuous curves with the different curvature radii (see Fig. 2 where portions 118, 160, and 116 form a continuous curve with each portion having a slightly varied curvature),
wherein the inner surface of the eyelid insertion portion (118) has a smaller radius of curvature than that of the inner surface of the eyelash cover portion (116, see annotated Fig. 2 below), and
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the inner surface of the eyelid accommodation portion (160) has a smaller radius of curvature than that of the inner surface of the eyelid insertion portion (118, see annotated Fig. 2 below),
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wherein the auxiliary eyelid protection part (108) includes:
an auxiliary eyelid insertion portion (118) extending from the other side of the eyeball cover (see Fig. 2; where eyelid margin holder 108 extends from the opposite side of central ring 102 as eyelid margin holder 106) to the inside of the eyeball cover and configured to be inserted into the other one of the gap between the upper eyelid and the eyeball or the gap between the lower eyelid and the eyeball (see [0049]; lower portions 118 of the lid margin holders 106 and 108 can be curved to form a scoop-like shape to easily hold a patient's eyelids and eyelashes when the eyelid speculum 100 is inserted into an eye of a patient);
an auxiliary eyelid accommodation (160) portion bent and extending from the auxiliary eyelid insertion portion (118) to the outside of the eyeball cover to accommodate any one of the upper eyelid or the lower eyelid (see [0049]; the central portion 160 separates the lower eyeball insertion portion 118 and the upper eyelash cover portion 116, so it can be appreciated that the central portion 160 is in contact with an eyelid when places in the eye as seen in Figs. 8b-c); and
an auxiliary eyelash cover portion (116) extending from the auxiliary eyelid accommodation portion (160) to the outside of the eyeball cover (102) to cover any one of the eyelash of the upper eyelid or the eyelash of the lower eyelid (see Figs. 8b-c, [0059]; at least a portion of the patient’s eyelashes 144 extending from the upper eyelid 140 are positioned between the upper portion 116 and the lower portion 118 of the first eyelid margin holder 106),
wherein an inner surface of the auxiliary eyelid insertion portion (118), an inner surface of the auxiliary eyelid accommodation portion (160), and an inner surface of the auxiliary eyelash cover portion (116) are continuously connected and form another arc-shaped inner surface (see Fig. 2 where insertion portion 118, eyelid accommodation portion 160, and eyelash cover portion 116 of auxiliary eyelid protection part 108 form one continuous arc),
wherein the inner surface of the auxiliary eyelid insertion portion (118) has a smaller radius of curvature than that of the inner surface of the auxiliary eyelash cover portion (116, see annotated Fig. 2 below), and
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the inner surface of the auxiliary eyelid accommodation portion (160) has a smaller radius of curvature than that of the inner surface of the auxiliary eyelid insertion portion (118, see annotated Fig. 2 below), and
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wherein an eyeball insertion portion (118) having a smaller thickness than those of the other portions (see Fig. 2; insertion portion 118 has a smaller thickness as compared to the rest of eyelid protection part 106/108) is formed in a circumference of the eyeball cover (see Fig. 1; eyelid insertion portions 118 are formed around a portion of the circumference of the eyeball cover 100; it can be appreciated that under its broadest reasonable interpretation, the eyelid insertion portion does not need to be formed around the entire perimeter of the eyeball cover and may meet the structural limitations by being formed in a circumferential manner about a portion or the whole of the eyeball cover), and a distal end of the eyeball insertion portion has a rounded shape (see Fig. 2; eyeball insertion portion 118 having a rounded edge).
Gross is silent regarding wherein the eyeball cover is configured to fully cover an eyeball, wherein the eyelid protection part has a thickness of 0.4 mm to 0.8 mm; and wherein the auxiliary eyelid protection part has a thickness of 0.4 mm to 0.8 mm. It can be appreciated that Gross does teach a variation in size of the eyelid and eyeball protector and its parts, including eyelid protection parts, based on the particular patient or procedure, ranging from newborns, toddlers, young adults, adults, or even large animals (Gross [0051]). It would have been an obvious matter of design choice to select a thickness of 0.4mm to 0.8mm for the eyelid protection part and auxiliary eyelid protection part, since such a modification would have involved a mere change in the size of a component, for which Gross discloses a motivation based on the particulars of the usage of the device. A change in size is generally recognized as being within the level of ordinary skill in the art. See MPEP 2144.04(IV)(A), In re Rose, 105 USPQ 237.
Gelland teaches an eyeball and eyelid protector (1) comprising an eyeball cover (2) configured to fully cover an eyeball (see Gelland Fig. 6, [0070]; corneal cap 1 having eyelid retractor portions 3 and contact lens portion 2 integrated or combined such that the eyelid retractor and contact lens portions are not readily distinguishable elements, [0043]; the contact lens portion is a thin, transparent plastic lens placed directly onto the surface of the cornea of a patient’s eye, covering more than the patient’s cornea, up to and including most if not substantially all of the sclera visible to an observed of the patient’s opened eye); an eyelid protection part (3) that is bent and extends from one side of the eyeball cover to protect any one of an upper eyelid and a lower eyelid (see Gelland Fig. 6, [0046-0047]; eyelid retractors protrude from the cup’s outer surface a distance sufficient to prevent eyelid closure, the retractor portion may be outwardly tapered).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify Gross’s eyeball and eyelid protector with the eyeball covering contact lens as taught by Gelland. One of ordinary skill in the art would have been motivated to make this modification in order to keep a patient’s eyelids in an open position even in an anesthetized state (Gelland [0047]) so that a clinician may have optical access to a desired portion of the patient’s eye including the cornea and retinal vasculature (Gelland [0041-0042]). The clear, transparent contact lens as taught by Gelland allows for light to pass through the eye to observe retinal vasculature, providing an unobstructed view of the desired portions of a patient’s eye, as desired by Gross (Gross [0049]).
Regarding claims 4 and 8, Gross in view of Gelland teaches the eyeball and eyelid protector of claim 1. They are silent regarding wherein a ratio of the radius of curvature of the inner surface of the eyelid insertion portion/auxiliary eyelid insertion portion to the radius of curvature of the inner surface of the eyelash cover portion/auxiliary eyelash cover portion is in a range of 1:0.4 to 1:0.6.
It can be appreciated as illustrated in the annotated figures as referenced in claim 1, that Gross does teach a difference in the radius of curvature of the eyelid insertion portion and the eyelash cover portion. Gross also discloses a motivation for adjusting the shape and size of the eyeball and eyelid protector based on the particular patient and procedure (Gross [0051]), so it can be appreciated that there is a basis for the change in relative structure, and therefore ratio of in the radius of curvature, of the eyelid insertion portion and the eyelash cover portion.
In this instance, a device having the claimed relative dimensions would not perform differently than the prior art device disclosed by Gross in combination with Gelland at least because both devices cover the eye and provide protection to at least a portion of one or more of the eyelids/eyelashes. Therefore, the claimed invention is obvious over and not patentably distinct from the prior art device.
See MPEP 2144.04(IV)(A), which states: In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit 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.
Regarding claim 10, Gross in view of Gelland teaches the eyeball and eyelid protector of claim 1. Gross is silent regarding wherein the eyeball cover has a dome-shaped when viewed in a vertical cross-sectional shape.
Gelland teaches an eyeball and eyelid protector wherein the eyeball cover has a dome-shaped when viewed in a vertical cross-sectional shape (see Gelland Fig. 6 where contact lens portion 2 has a dome-shaped cross section).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify Gross’s eyeball and eyelid protector with the dome-shaped eyeball covering contact lens as taught by Gelland. One of ordinary skill in the art would have been motivated to make this modification in order to configure the contact lens portion to be placed directly onto the surface of the cornea of a patient’s eye so that a clinician may have optical access to a desired portion of the patient’s eye including the cornea and retinal vasculature (Gelland [0041-0042]). The dome-shaped, clear, transparent contact lens as taught by Gelland allows for light to pass through the eye to observe retinal vasculature, providing an unobstructed view of the desired portions of a patient’s eye, as desired by Gross (Gross [0049]).
Conclusion
THIS ACTION IS MADE FINAL. 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 ALISHA J SIRCAR whose telephone number is (571)272-0450. The examiner can normally be reached Monday - Thursday 9-6:30, Friday 9-5:30 CT.
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/A.J.S./Examiner, Art Unit 3792
/ALLEN PORTER/Primary Examiner, Art Unit 3796
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