DETAILED ACTION
Applicant’s amendment dated 1 December 2025 is hereby acknowledged. Claims 1, 2, 4-14, and 16-22 as amended are pending. All outstanding objections and rejections made in the previous Office Action, and not repeated below, are hereby withdrawn.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior office action.
New grounds of rejection set forth below are necessitated by applicant’s amendment filed on 1 December 2025. For this reason, the present action is properly made final.
Claim Rejections - 35 USC § 103
Claim(s) 1, 2, 5-8, 10-14, 16-19, 21, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over JP 2013-235034 A (“Motoyama”).
A partial machine translation is enclosed.
As to claims 1 and 16, Motoyama teaches a molded body, in particular a contact lens (para. 0002) with a surface treatment of bringing a substrate into contact with a solution containing hydrophilic monomer and polymerizing.
Motoyama teaches the use of an initiator (para. 0016). Motoyama does not discuss adsorbing the initiator on the lens. However, Motoyama teaches immersing the lens in a solution with monomer and initiator (0033, 0092). Since the method of the specification adsorbs initiator by soaking the lens in an initiator solution, it is reasonable to expect that the process of Motoyama results in adsorption of monomer on the lens.
Motoyama does not explicitly state the hydrophilic polymer and lens forming in interpenetrating polymer network. However, the process of Motoyama provides that the hydrophilic monomer penetrates the base material (lens), thus promoting fixability (para. 0091). This suggests that the polymerized monomer and lens are interpenetrating.
Motoyama does not exemplify the recited hydrophilic monomers. However, Motoyama teaches numerous such monomers (paras. 0037, 0038), including N-vinylformamide, N-vinylacetamide, N-vinyl-N-methylacetamide, and N-vinylcaprolactam (para. 0038). The monomers of claim 16 are optional under claim 1. As such, the use of Motoyama, including the recited monomers is an obvious modification suggested by Motoyama.
As to claim 2, Motoyama teaches the use of thermal polymerization initiators, including azobisisobutyronitrile, 2,2-azobis(2,4-dimethylvaleronitrile), 2,2’-azobis[2-(2-imidzolin-2-yl)propane] dihydrochloride as particularly preferable thermal initiators (para. 0102), and thus the use of such initiator is an obvious modification suggested by Motoyama.
As to claim 5, Motoyama teaches that the hydrophilic monomer may be used in combination of two or more, thus three. Motoyama teaches monomers of the listed types (paras. 0033-0035), and therefore the use of at least one of these monomers in combination with two others is an obvious modification suggested by Motoyama.
As to claim 6, Motoyama teaches the lens is preferably silicone hydrogel (para. 0091).
As to claims 7 and 8, Motoyama teaches a molded body, in particular a contact lens (para. 0002) with a surface treatment of bringing a substrate into contact with a solution containing hydrophilic monomer and polymerizing.
Motoyama teaches the use of an initiator (para. 0016). Motoyama does not discuss adsorbing the initiator on the lens. However, Motoyama teaches immersing the lens in a solution with monomer and initiator (0033, 0092). Since the method of the specification adsorbs initiator by soaking the lens in an initiator solution, it is reasonable to expect that the process of Motoyama using a solution of the initiator along with monomer results in adsorption of monomer on the lens.
Motoyama does not explicitly state the hydrophilic polymer and lens forming in interpenetrating polymer network. However, the process of Motoyama provides that the hydrophilic monomer penetrates the base material (lens), thus promoting fixability (para. 0091). This suggests that the polymerized monomer and lens are interpenetrating.
Motoyama does not exemplify the recited hydrophilic monomers. However, Motoyama teaches numerous such monomers (paras. 0037, 0038), including N-vinylformamide, N-vinylacetamide, N-vinyl-N-methylacetamide, and N-vinylcaprolactam (para. 0038). As such, the use of Motoyama, including the recited monomers is an obvious modification suggested by Motoyama.
As to claim 10, Motoyama teaches soaking the lens in a solution with monomer and initiator (para. 0033, 0092). Since the method of the specification adsorbs initiator by soaking the lens in an initiator solution, it is reasonable to expect that the process of Motoyama using a solution of the initiator along with monomer results in adsorption of monomer on the lens. Motoyama teaches heating the lens and monomer solution (para. 0108-113).
As to claim 11, Motoyama teaches a polymerization temperature of preferably 50 to 80 degrees C (para. 0113), which includes temperatures in the recited range. Motoyama teaches the temperature should be high enough to provide polymerization without decreasing oxygen permeability or causing deformation.
As to claims 12 and 13, Motoyama teaches polymerizing in a most preferred range of 5 to 40 minutes (para. 0112), which is within the range of claim 12, and substantially overlaps the range of claim 13. This time is selected to provide wettability without decreasing oxygen permeability, and therefore, polymerization time within the range of claims 12 and 13 is an obvious modification suggested by Motoyama.
As to claim 14, Motoyama teaches the use of thermal polymerization initiators, including azobisisobutyronitrile, 2,2-azobis(2,4-dimethylvaleronitrile), 2,2’-azobis[2-(2-imidzolin-2-yl)propane] dihydrochloride as particularly preferable thermal initiators (para. 0102), and thus the use of such initiator is an obvious modification suggested by Motoyama.
As to claims 17, 18, and 21, Motoyama teaches combinations of hydrophilic monomers, including 2,3-dihydroxypropyl methacrylate and N,N-dimethylacrylamide (para. 0038). While the ratio of these is not discussed by Motoyama, Motoyama teaches that N,N-dimethylacrylamide is a preferred monomer for wettability (para. 0094), and that other monomers may be added such as those used for forming a base material (para. 0095). Given that dimethylacrylamide is a preferred monomer for wettability, the use of such monomer in excess of another monomer such as 2,3-dihydroxypropyl methacrylate is an obvious modification. Depending on the composition of the base substrate, the use of 2,3-dihydroxypropyl methacrylate for compatibility with the lens is an obvious modification. Again, while the relative ratios of these monomers are not provided, it would be obvious to provide ratios of these monomers, including in the recited range of claims 17, 18, and 21, to optimize wettability and provide permeability into the lens substrate as required by the specific lens.
As to claims 19 and 22, Motoyama teaches hydrophilic monomers may include combinations, including N-vinylpyrrolidone (para. 0038), and the addition of such monomer is an obvious modification suggested by Motoyama.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over JP 2013-235034 A (“Motoyama”) in view of US 2017/0146823 (“Lee”).
As to claim 4, Motoyama teaches combinations of monomers, but does not discuss the ratio. Lee teaches similar hydrophilic coatings for contact lens, and teaches the use of 0.001 to 0.1 mol of the crosslinking agent to 1 mol of hydrophilic monomer, which overlaps the recited range when converted to weight ratio, since EGDMA has higher molecular weight than, for example, N,N-dimethylmethacrylamide. As such, the use of a second hydrophilic monomer, including in the recited range, is an obvious modification suggested by Lee.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over JP 2013-235034 A (“Motoyama”) in view of US 2022/0026601 (“Lin”).
Motoyama does not suggest the recited amount of initiator in solution. However, Lin teaches a similar hydrophilic coating for contact lens by polymerizing hydrophilic monomers in the presence of initiator. Lin teaches that the initiator may be applied in a separate step prior to the polymerization with the monomer solution (para. 0039-0040), causing adsorption by the lens body, followed by treatment with hydrophilic monomer solution (para. 0043). Lin teaches the use of initiator in the recited concentration (para. 0042). Lin teaches that this method provides improvements in surface modifications (para. 0050). As such, the use of initiator solution of the recited concentration prior to hydrophilic monomer treatment is a known technique for providing hydrophilic coating on contact lens.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over JP 2013-235034 A (“Motoyama”) as applied to claim 1, further in view of US 6,169,127 (“Lohmann”).
As to claim 20, Motoyama teaches providing hydrophilic coating, but does not discuss the hysteresis angle. Lohmann teaches hydrophilic coatings on contact lenses, including those from recited monomers, and teaches that such coatings can provide recited hysteresis angles (24:10-25), and as such, providing a hysteresis angle in the recited range is an obvious modification known to be in the range for similar hydrophilic coatings.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 2, 4-14, and 16-22 have been considered but are moot because the new ground of rejection does not rely on any combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/KREGG T BROOKS/ Primary Examiner, Art Unit 1764