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 .
Election/Restrictions
Applicant’s election without traverse of Invention I (claims 1-11) in the reply filed on April 27th, 2026 is acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on June 19th, 2024 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.
Claims 1-3, 5, 7-8, and 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Qiu (US 2019/0179055) in view of Blum (US 2015/0290034).
Regarding claim 1, Qiu discloses a coated contact lens (Figs. 1-2, element 100) comprising:
an anterior surface (101) and an opposite posterior surface (102); and
a layered structural configuration (as shown in Fig. 1, 100 has multiple layers) which comprises, in a direction from the anterior surface to the posterior surface, an anterior outer hydrogel layer (101), an inner layer (110), and a posterior outer hydrogel layer (102, [0088], “an inner (or middle) layer (or lens bulk material) 110 and the anterior and posterior outer hydrogel layers 120”),
wherein the inner layer is a lens bulk material ([0088], ““an inner (or middle) layer (or lens bulk material) 110”), wherein the posterior outer hydrogel layer is a layer of a first non-silicone hydrogel material ([0088], “The anterior and posterior outer hydrogel layers 120 are substantially uniform in thickness and made of a hydrogel material substantially free of silicone (preferably totally free of silicone)”), wherein the anterior outer hydrogel layer is a layer of the first non-silicone hydrogel material ([0088], “The anterior and posterior outer hydrogel layers 120 are substantially uniform in thickness and made of a hydrogel material substantially free of silicone (preferably totally free of silicone)”), wherein the coated contact lens in fully-hydrated state has a water-break-up time of at least about 10 seconds as measured on the anterior and posterior surfaces of the coated contact lens ([0008], “a long-lasting surface hydrophilicity and wettability as characterized by having a water-break-up time (WBUT) of at least 10 seconds”).
Qiu does not specifically disclose the anterior outer hydrogel layer with imperfections distributed therein so that the posterior outer hydrogel layer has a surface lubricity higher than the surface lubricity of the anterior outer hydrogel layer.
However Blum, in the same field of endeavor because both teach a contact lens, teaches the anterior outer hydrogel layer (Figs. 17, 29-30, and 36-37, element 1734, [0279], “A sclera ring can be made of soft lens materials by way of example only, hydrogels”, [0347], “a scleral ring having an increased surface friction region(s)”) with imperfections distributed therein ([0363], “the widening effect of an area of increased surface friction results from an increase in surface friction (e.g., friction drag coefficient)”, examiner interprets this to mean the surface has imperfections for increased friction) so that the posterior outer hydrogel layer has a surface lubricity higher than the surface lubricity of the anterior outer hydrogel layer (as shown in Figs. 17, 29-30, and 36-37, the increased friction zone is present only on an anterior surface).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to have the contact lens of Qiu with the anterior outer hydrogel layer with imperfections distributed therein so that the posterior outer hydrogel layer has a surface lubricity higher than the surface lubricity of the anterior outer hydrogel layer as taught by Blum, for the purpose of increasing the aperture of a wearer’s eye ([0311-0312]).
Regarding claim 2, modified Qiu teaches as is set forth in claim 1 rejection above but does not specifically disclose wherein the imperfections comprise: (1) detaches that in top view have a ring shape, a curved line shape, and/or a straight line shape; (2) gaps that in top view have a circular shape, a triangular shape, a square shape, a rectangular shape, a hexagonal shape, a polygonal shape, and/or a star shape.
However Blum, in the same field of endeavor because both teach a contact lens, teaches wherein the imperfections (Fig. 30, element 3010, [0403], “Incremental thickness and increased surface friction region 3010”) comprise: (1) detaches that in top view have a ring shape, a curved line shape, and/or a straight line shape; (2) gaps that in top view have a circular shape, a triangular shape, a square shape, a rectangular shape, a hexagonal shape, a polygonal shape, and/or a star shape ([0403], “discontinuous partial rings or areas having incremental thickness and increased surface friction”, examiner interprets the partial rings to correspond to gaps having circular shape).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to have the contact lens of Qiu in view of Blum with the wherein the imperfections comprise: (1) detaches that in top view have a ring shape, a curved line shape, and/or a straight line shape; (2) gaps that in top view have a circular shape, a triangular shape, a square shape, a rectangular shape, a hexagonal shape, a polygonal shape, and/or a star shape as taught by Blum, for the purpose of increasing the aperture of a wearer’s eye ([0311-0312]).
Regarding claim 3, modified Qiu teaches as is set forth in claim 2 rejection above but does not specifically disclose wherein the imperfections on the anterior surface of the coated contact lens are arranged in a rotationally symmetric pattern with respect to the central axis of the coated contact lens.
However Blum, in the same field of endeavor because both teach a contact lens, teaches wherein the imperfections (Fig. 30, element 3010, [0403], “Incremental thickness and increased surface friction region 3010”) on the anterior surface of the coated contact lens (as shown in Fig. 30, 3010 are on an anterior surface of 3000) are arranged in a rotationally symmetric pattern with respect to the central axis of the coated contact lens ([0403], “Incremental thickness and increased surface friction region 3010 can be a continuous ring”, a ring is rotationally symmetric).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to have the contact lens of Qiu in view of Blum with the wherein the imperfections on the anterior surface of the coated contact lens are arranged in a rotationally symmetric pattern with respect to the central axis of the coated contact lens as taught by Blum, for the purpose of increasing the aperture of a wearer’s eye ([0311-0312]).
Regarding claim 5, modified Qiu teaches as is set forth in claim 2 rejection above but does not specifically disclose wherein the imperfections comprise at least three ditches in ring-shape in top view.
However Blum, in the same field of endeavor because both teach a contact lens, teaches wherein the imperfections (Fig. 30, element 3010, [0403], “Incremental thickness and increased surface friction region 3010”) comprise at least three ditches in ring-shape in top view (as shown in Fig. 30, there are at least three ditches between the ring-shaped sections 3010).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to have the contact lens of Qiu in view of Blum with the wherein the imperfections comprise at least three ditches in ring-shape in top view as taught by Blum, for the purpose of increasing the aperture of a wearer’s eye ([0311-0312]).
Regarding claim 7, modified Qiu teaches as is set forth in claim 2 rejection above but does not specifically disclose wherein the imperfections comprise gaps in circular shape in top view.
However Blum, in the same field of endeavor because both teach a contact lens, teaches wherein the imperfections (Fig. 30, element 3010, [0403], “Incremental thickness and increased surface friction region 3010”) comprise gaps in circular shape in top view (as shown in Fig. 30, there are at least three gaps between the circular shaped sections 3010).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to have the contact lens of Qiu in view of Blum with the wherein the imperfections comprise gaps in circular shape in top view as taught by Blum, for the purpose of increasing the aperture of a wearer’s eye ([0311-0312]).
Regarding claim 8, modified Qiu teaches as is set forth in claim 7 rejection above but does not specifically disclose wherein the gaps in circular shape in top view each are arranged in a rotationally symmetric pattern on the anterior surface of the coated contact lens.
However Blum, in the same field of endeavor because both teach a contact lens, teaches wherein the gaps in circular shape in top view (examiner interprets the sections between nearby 3010 to be the gaps in Fig. 30) each are arranged in a rotationally symmetric pattern on the anterior surface of the coated contact lens ([0193], “increased surface friction region (zone, area) for the prosthesis (being a contact lens or a scleral ring) can be one of: rotationally symmetric”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to have the contact lens of Qiu in view of Blum with the wherein the gaps in circular shape in top view each are arranged in a rotationally symmetric pattern on the anterior surface of the coated contact lens as taught by Blum, for the purpose of increasing the aperture of a wearer’s eye ([0311-0312]).
Regarding claim 10, modified Qiu teaches as is set forth in claim 2 rejection above and Qiu further discloses wherein the first non-silicone hydrogel materials is:
(1) a crosslinked polymeric material which comprises at least 25% by mole of repeating monomeric units of at least one hydrophilic vinylic monomer selected from the group consisting of (meth)acrylamide, N,N-dimethyl (meth)acrylamide, N-ethyl (meth)acrylamide, N,N-diethyl(meth)acrylamide, N-propyl (meth)acrylamide, N-isopropyl (meth)acrylamide, N-3-methoxypropyl (meth)acrylamide), N-2-dimethylaminoethyl (meth)acrylamide, dimethylaminoethyl (meth)acrylate, N-2-hydroxylethyl (meth)acrylamide, N,N-bis(hydroxyethyl)(meth)acrylamide, N-3-hydroxypropyl (meth)acrylamide, N-2-hydroxypropyl (meth)acrylamide, N-2,3-dihydroxypropyl (meth)acrylamide, N-tris(hydroxymethyl)methyl (meth)acrylamide, 2-hydroxyethyl (meth)acrylate, 3-hydroxypropyl (meth)acrylate, 2-hydroxypropyl (meth)acrylate, glycerol methacrylate (GMA), di(ethylene glycol)(meth)acrylate, tri(ethylene glycol)(meth)acrylate, tetra(ethylene glycol)(meth)acrylate, poly(ethylene glycol)(meth)acrylate having a number average molecular weight of up to 1500, poly(ethylene glycol)ethyl (meth)acrylamide having a number average molecular weight of up to 1500, N-vinyl pyrrolidone, N-vinyl-N-methyl acetamide, N-vinyl formamide, N-vinyl acetamide, N-vinyl isopropylamide, N-vinyl-N-ethyl acetamide, N-vinyl-N-ethyl formamide, 1-methyl-3-methylene-2-pyrrolidone, 1-ethyl-3-methylene-2-pyrrolidone, 1-methyl-5-methylene-2-pyrrolidone, 1-ethyl-5-methylene-2-pyrrolidone, 5-methyl-3-methylene-2-pyrrolidone, 5-ethyl-3-methylene-2-pyrrolidone, 1-n-propyl-3-methylene-2-pyrrolidone, 1-n-propyl-5-methylene-2-pyrrolidone, 1-isopropyl-3-methylene-2-pyrrolidone, 1-isopropyl-5-methylene-2-pyrrolidone, 1-n-butyl-3-methylene-2-pyrrolidone, 1-tert-butyl-3-methylene-2-pyrrolidone, ethylene glycol methyl ether(meth)acrylate, di(ethylene glycol)methyl ether(meth)acrylate, tri(ethylene glycol)methyl ether(meth)acrylate, tetra(ethylene glycol)methyl ether(meth)acrylate, C1-C4-alkoxy poly(ethylene glycol)(meth)acrylate having a weight average molecular weight of up to 1500, methoxy-poly(ethylene glycol)ethyl (meth)acrylamide having a number average molecular weight of up to 1500, allyl alcohol, ethylene glycol monoallyl ether, di(ethylene glycol) monoallyl ether, tri(ethylene glycol) monoallyl ether, tetra(ethylene glycol) monoallyl ether, poly(ethylene glycol) monoallyl ether, ethylene glycol methyl allyl ether, di(ethylene glycol)methyl allyl ether, tri(ethylene glycol)methyl allyl ether, tetra(ethylene glycol)methyl allyl ether, poly(ethylene glycol)methyl allyl ether, ethylene glycol monovinyl ether, di(ethylene glycol) monovinyl ether, tri(ethylene glycol) monovinyl ether, tetra(ethylene glycol) monovinyl ether, poly(ethylene glycol) monovinyl ether, ethylene glycol methyl vinyl ether, di(ethylene glycol)methyl vinyl ether, tri(ethylene glycol)methyl vinyl ether, tetra(ethylene glycol)methyl vinyl ether, poly(ethylene glycol)methyl vinyl ether, and combinations thereof ([0208], “the anterior and posterior outer hydrogel layers and the outer surface hydrogel layer independent of each other are a crosslinked polymeric material which comprises at least 25% by mole (preferably at least 35% by mole, more preferably at least 45% by mole, even more preferably at least 55% by mole) of repeating monomeric units of at least one hydrophilic vinylic monomer selected from the group consisting of alkyl (meth)acrylamides (any one described above)”);
(2) a crosslinked polymeric material which comprises at least 25% by mole of repeating monomeric units of at least one phosphorylcholine-containing vinylic monomer (condition 1 is satisfied above);
(3) a crosslinked polymeric material which comprises poly(ethylene glycol) chains, derived directly from (a) a pol(ethylene glycol) having one sole functional group of —NH2, —SH or —COOH, (b) a pol(ethylene glycol) having two terminal functional groups selected from the group consisting of —NH2, —COOH, —SH, and combinations thereof, (c) a multi-arm poly(ethylene glycol) having one or more functional groups selected from the group consisting of —NH2, —COOH, —SH, and combinations thereof, and (d) combinations thereof (condition 1 is satisfied above); or
(4) combinations thereof (condition 1 is satisfied above).
Regarding claim 11, modified Qiu teaches as is set forth in claim 10 rejection above and Qiu further discloses wherein the lens bulk material is a silicone hydrogel material that in fully hydrated has a water content of from about 10% to about 70% by weight or less ([0200], “silicone hydrogel material can also have an equilibrium water content of from about 10% to about 70%”), an oxygen permeability of at least about 50 barrers ([0200], “the silicone hydrogel material of the inner layer (or the lens bulk material) has an oxygen permeability of at least about 50”), and an elastic modulus of from about 0.25 MPa to about 1.5 MPa ([0200], “a bulk elastic modulus or bulk Young Modulus (hereinafter the terms, “softness,” “elastic modulus,” and “Young's modulus” are interchangeably used in this application to mean bulk elastic modulus if the term is not modified by the word “surface.”) of from about 0.3 MPa to about 1.8 MPa, preferably from 0.4 MPa to about 1.5 MPa, more preferably from about 0.5 MPa to about 1.2 MPa”).
Allowable Subject Matter
Claims 4, 6, and 9 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: with respect to the allowable subject matter, none of the prior art either alone or in combination disclose or teach of the claimed combination of limitations to warrant a rejection under 35 U.S.C. 102 or 103.
Specifically, with respect to claim 4, none of the prior art either alone or in combination disclose or suggest wherein the imperfections on the anterior surface of the coated contact lens are located in an annular zone having an inner diameter of from about 6.0 mm to about 9.0 mm and an outer diameter of from about 11.5 mm to about 14.5 mm and being concentric with respect to the central axis of the coated contact lens.
Specifically, with respect to claim 6, none of the prior art either alone or in combination disclose or suggest wherein the imperfections comprise at least eight ditches in curved-line shape or shape of straight lines radiating outward from a circle having a diameter of from about 6.0 mm to about 9.0 mm and being concentric with respect to the central axis of the coated contact lens.
Specifically, with respect to claim 9, none of the prior art either alone or in combination disclose or suggest wherein the gaps in circular shape in top view are arranged in a pattern of annular rings concentric with the central axis of the coated contact lens.
Conclusion
The prior art made of record and not relied upon are considered pertinent to applicant’s disclosure. Franklin (US 2017/0123231), Suzuki (US 2009/0059166), Wanders (US 2008/0013044), teach a coated contact lens comprising: an anterior surface and an opposite posterior surface, wherein the posterior outer hydrogel layer is a layer of a first non-silicone hydrogel material, wherein the anterior outer hydrogel layer is a layer of the first non-silicone hydrogel material with imperfections distributed therein so that the posterior outer hydrogel layer has a surface lubricity higher than the surface lubricity of the anterior outer hydrogel layer.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW Y LEE whose telephone number is (571)272-3526. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Pinping Sun can be reached at (571) 270 - 1284. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW Y LEE/Examiner, Art Unit 2872 16 June 2026
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