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 claims 1-16 in the reply filed on 05/18/2026 is acknowledged.
Claims 17-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected method, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/18/202.
Claim Rejections - 35 USC § 112
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.
Claims 1-16 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 pre-AIA the applicant regards as the invention.
Claims 1 and 9 recite the limitation “(c) at least one free-radical initiator (photoinitiator or thermal initiator).” The limitation renders the claim indefinite because the examples and preferences may lead to confusion over the intended scope of the claim since it is not clear whether the claimed narrower range is a limitation. For compact prosecution, the limitation is interpreted as --(c) at least one free-radical initiator--. Claims 2-8 and 10-16 which depend from claims 1 and 9 are similarly rejected.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Bassampour (US-20230004023-A1) in view of Iwata (US-20120252925-A1).
Regarding claim 1, Bassampour teaches a method for producing embedded hydrogel contact lenses, comprising the steps of:(1) obtaining a female mold half, a first male mold half and a second male mold half, wherein the female mold half has a first molding surface defining the anterior surface of a contact lens to be molded and also the front surface of an insert to be molded, wherein the first male mold half has a second molding surface defining the back surface of the insert to be molded, wherein the second male mold half has a third molding surface defining the posterior surface of the contact lens to be molded, wherein the first male mold half and the female mold half are configured to receive each other such that an insert-molding cavity is formed between the second molding surface and a central portion of the first molding surface when the female mold half is closed with the first male mold half, wherein the second male mold half and the female mold half are configured to receive each other such that a lens- molding cavity is formed between the first and third molding surfaces when the female mold half is closed with the second male mold half (¶0172); (2) dispensing an amount of an insert-forming composition on the central portion of the first molding surface of the female mold half (¶0172); (3) placing the first male mold half on top of the insert-forming composition in the female mold half and closing the first male mold half and the female mold half to form a first molding assembly comprising the insert-forming composition within the insert-molding cavity (¶0172); (4) curing the insert-forming composition in the insert-molding cavity of the first molding assembly to form a molded insert made of a crosslinked polymeric material formed from the insert-forming composition (¶0172); (5) separating the first molding assembly obtained in step (4) into the first male mold half and the female mold half with the molded insert that is adhered onto the central portion of the first molding surface (¶0172); (6) dispensing a lens-forming composition in the female mold half with the molded insert adhered thereon in an amount sufficient for filling the lens-molding cavity (¶0172); (7) placing the second male mold half on top of the lens-forming composition in the female mold half and closing the second male mold half and the female mold half to form a second molding assembly comprising the lens-forming composition and the molded insert immersed therein in the lens-molding cavity (¶0172); (8) curing the lens-forming composition in the lens-molding cavity of the second molding assembly to form an embedded hydrogel contact lens precursor that comprise a bulk hydrogel material formed from the lens-forming composition and the insert embedded in the bulk material (¶0172); (9) separating the second molding assembly obtained in step (8) into the second male mold half and the female mold half, with the embedded hydrogel contact lens precursor adhered on a lens-adhered mold half which is one of the female and second male mold halves (¶0172); (10) removing the embedded hydrogel contact lens precursor from the lens-adhered mold half (¶0172); and (11) subjecting the embedded hydrogel contact lens precursor to post-molding processes including one or more processes selected from the group consisting of extraction, hydration, surface treatment, packaging, sterilization, and combinations thereof (¶0174-0179).
While Bassampour teaches a method comprising dispensing a lens-forming composition in the female mold half with the molded insert adhered thereon in an amount sufficient for filling the lens-molding cavity, wherein the lens-forming composition comprises (a) at least one non-silicone vinylic crosslinking agent which capable of swelling the molded insert by a first swelling degree, (b) a non-reactive organic solvent for dissolving all polymerizable components in the lens-forming composition, and (c) at least one free-radical initiator, wherein the non-reactive organic solvent is capable of swelling the molded insert by a second swelling degree (¶0160-0164,0172), Bassampour does not specify wherein the method further comprises (a) from about 0.1% to about 5% by weight of at least one non-silicone vinylic crosslinking agent, (b) from about 10% to about 35% by weight of a non-reactive organic solvent, and wherein the first and second swelling degrees independent of each other are from about 12.5% to about 25% as instantly claimed.
However, in the same field of endeavor, methods of making contact lens, Iwata teaches a mold method in which a monomer mixture is filled into a mold, followed by a radical polymerization by the known method, or by a spin casting method in which a monomer mixture is fed in a rotatable hemisphere mold, followed by a polymerization (¶0108). Iwata teaches that in these cases, polymerization of a solution of monomer mixture added with solvents in a mold may be utilized to adjust the degree of polymerization or lens swelling ratio (¶0108). Iwata further teaches that if a solvent is included, solvents which dissolve the monomers effectively are advantageously used (¶0108).
Iwata teaches that adjusting the degree of polymerization or lens swelling ratio is recognized as result-effective variable (¶0108). Since this particular parameter is recognized as result-effective variable, i.e. a variable which achieves a recognized result, the determination of the optimum or workable ranges of said variable can be characterized as routine experimentation. MPEP 2144.05(II).
One of ordinary skill in the art before the effective filing date of the invention would have found it obvious to modify the method disclosed in Bassampour via routine optimization such that the method further comprises (a) from about 0.1% to about 5% by weight of at least one non-silicone vinylic crosslinking agent, (b) from about 10% to about 35% by weight of a non-reactive organic solvent, and wherein the first and second swelling degrees independent of each other are from about 12.5% to about 25% to yield an expected result. MPEP 2144.05(II).
Regarding claim 9, Bassampour teaches a method for producing embedded hydrogel contact lenses, comprising the steps of: (1) obtaining a first female mold half, a male mold half and a second female mold half, wherein the first female mold half has a first molding surface defining the front surface of an insert to be molded, wherein the male mold half has a second molding surface defining the posterior surface of a contact lens to be molded and also the back surface of the insert to be molded, wherein the second female mold half has a third molding surface defining the anterior surface of the contact lens to be molded, wherein the first female mold half and the male mold half are configured to receive each other such that an insert-molding cavity is formed between the first molding surface and a central portion of the second molding surface when the male mold half is closed with the first female mold half, wherein the male mold half and the second female mold half are configured to receive each other such that a lens- molding cavity is formed between the second and third molding surfaces when the male mold half is closed with the second female mold half; (2) dispensing an amount of an insert-forming composition in the first female mold half; (3) placing the male mold half on top of the insert-forming composition in the first female mold half and closing the male mold half and the first female mold half to form a first molding assembly comprising the insert-forming composition within the insert-molding cavity; (4) curing the insert-forming composition in the insert-molding cavity of the first molding assembly to form a molded insert made of a crosslinked polymeric material formed from the insert-forming composition; (5) separating the first molding assembly obtained in step (4) into the first female mold half and the male mold half with the molded insert that is adhered onto the central portion of the second molding surface; (6) dispensing a lens-forming composition in the second female mold half in an amount sufficient for filling the lens-molding cavity; (7) placing the male mold half with the molded insert adhered thereonto on top of the lens-forming composition in the second female mold half and closing the male mold half and the second female mold half to form a second molding assembly comprising the lens-forming composition and the molded insert immersed therein in the lens-molding cavity; (8) curing the lens-forming composition in the lens-molding cavity of the second molding assembly to form an embedded hydrogel contact lens precursor that comprise a bulk hydrogel material formed from the lens-forming composition and the insert embedded in the bulk material; (9) separating the second molding assembly obtained in step (8) into the male mold half and the second female mold half, with the embedded hydrogel contact lens precursor adhered on a lens-adhered mold half which is one of the male and second female mold halves; (10) removing the embedded hydrogel contact lens precursor from the lens-adhered mold half; and (11) subjecting the embedded hydrogel contact lens precursor to post-molding processes including one or more processes selected from the group consisting of extraction, hydration, surface treatment, packaging, sterilization, and combinations thereof to obtain an embedded hydrogel contact lens (¶0172, 0174-0179).
While Bassampour teaches a method comprising dispensing a lens-forming composition in the female mold half with the molded insert adhered thereon in an amount sufficient for filling the lens-molding cavity, wherein the lens-forming composition comprises (a) at least one non-silicone vinylic crosslinking agent which capable of swelling the molded insert by a first swelling degree, (b) a non-reactive organic solvent for dissolving all polymerizable components in the lens-forming composition, and (c) at least one free-radical initiator, wherein the non-reactive organic solvent is capable of swelling the molded insert by a second swelling degree (¶0160-0164,0172), Bassampour does not specify wherein the lens-forming composition comprises (a) from about 0.1% to about 5% by weight of at least one non-silicone vinylic crosslinking agent which capable of swelling the molded insert by a first swelling degree, (b) from about 10% to about 35% by weight of a non-reactive organic solvent, wherein the non-reactive organic solvent is capable of swelling the molded insert by a second swelling degree, wherein the first and second swelling degrees independent of each other are from about 12.5% to about 25%.
However, in the same field of endeavor, methods of making contact lens, Iwata teaches a mold method in which a monomer mixture is filled into a mold, followed by a radical polymerization by the known method, or by a spin casting method in which a monomer mixture is fed in a rotatable hemisphere mold, followed by a polymerization (¶0108). Iwata teaches that in these cases, polymerization of a solution of monomer mixture added with solvents in a mold may be utilized to adjust the degree of polymerization or lens swelling ratio (¶0108). Iwata further teaches that if a solvent is included, solvents which dissolve the monomers effectively are advantageously used (¶0108).
Iwata teaches that adjusting the degree of polymerization or lens swelling ratio is recognized as result-effective variable (¶0108). Since this particular parameter is recognized as result-effective variable, i.e. a variable which achieves a recognized result, the determination of the optimum or workable ranges of said variable can be characterized as routine experimentation. MPEP 2144.05(II).
One of ordinary skill in the art before the effective filing date of the invention would have found it obvious to modify the method disclosed in Bassampour via routine optimization such that the method further comprises (a) from about 0.1% to about 5% by weight of at least one non-silicone vinylic crosslinking agent which capable of swelling the molded insert by a first swelling degree, (b) from about 10% to about 35% by weight of a non-reactive organic solvent, wherein the non-reactive organic solvent is capable of swelling the molded insert by a second swelling degree, wherein the first and second swelling degrees independent of each other are from about 12.5% to about 25% to yield an expected result. MPEP 2144.05(II).
Claims 2 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Bassampour (US-20230004023-A1) in view of Iwata (US-20120252925-A1), as applied to claims 1 and 9, and in further view of Matsuzawa (US-20080073804-A1).
Regarding claims 2 and 10, as applied to claims 1 and 9, Bassampour in view of Iwata do not disclose a method wherein the first male mold half comprise an overflow groove which surrounds the second molding surface and into which any excess insert-forming material is pressed when the first molding assembly is closed securely, wherein any flushes formed from the excess insert-forming material during step (5) can be stuck on the first male mold half during step of separating the first molding assembly, thereby removing the flushes.
However, in the same field of endeavor, methods of producing contact lenses, Matsuzawa teaches that it is conventional for mold halves to have means for allowing overflow of insert-forming materials ([0003]). Matsuzawa teaches the use of such an overflow groove with a female mold half ("overflow" (11), [0044]) and that the overflow groove can alternatively be located on a male mold half ([0079]) (known technique applicable to the base method).
One of ordinary skill in the art before the effective filing date of the invention would have found it obvious to modify the method disclosed in Bassampour in view of Iwata by applying the known technique of using an overflow groove with a female mold half or a male mold half as disclosed in Matsuzawa to the method disclosed in Bassampour in view of Iwata such that the first male mold half comprises an overflow groove which surrounds the second molding surface and into which any excess insert-forming material is pressed when the first molding assembly is closed securely, wherein any flushes formed from the excess insert-forming material during step (5) can be stuck on the first male mold half during step of separating the first molding assembly, thereby removing the flushes with predictable results and resulting in an improved method. MPEP 2143(D).
Claims 3-8 and 11-16 are rejected under 35 U.S.C. 103 as being unpatentable over Bassampour (US-20230004023-A1) in view of Iwata (US-20120252925-A1) and in further view of Matsuzawa (US-20080073804-A1), as applied to claims 2 and 10, and in further view of Suzuki (US-20250205983-A1).
Regarding claims 3-6, as applied to claims 2 and 10, Bassampour in view of Iwata and Matsuzawa do not disclose wherein the method further comprises, before step (2), a step of treating a central circular area of the first molding surface is carried by using a vacuum UV, wherein the central circular area has a diameter equal to or smaller than the diameter of the insert to be molded; wherein the method further comprises, before step (2), a step of treating a central circular area of the first molding surface is carried by using a corona plasma, wherein the central circular area has a diameter equal to or smaller than the diameter of the insert to be molded; wherein the method further comprises a step of surface-treating the back surface of the molded insert adhered onto the central portion of the first molding surface with a corona or Argon plasma or with a vacuum UV; nor wherein the central circular area has a diameter that is about 90% or smaller of the diameter of the insert.
However, Suzuki, which is within the contact lens manufacturing art, teaches that during contact lens manufacturing, the circular surfaces of the mold halves can be modified with "surface property adjustment treatments such as plasma treatment, UV irradiation, corona discharge [and] laser discharge" for the result effective means of modifying the degree of adhesion between the molding materials and the mold halves ([0216]).
A person of ordinary skill in the art would readily understand that changes in adhesion between the molding material (including that of the insert) and the mold half would only be relevant to such parts of the mold half that come into contact with the molding material, such parts representing an area of 100% or smaller of the diameter of the insert to be molded (which overlaps with the claimed range of 90% or smaller) and the amount of area of the mold half receiving a surface treatment represents a result- effective variable for modifying the degree of adhesion between the mold half and the insert, and it has been held that discovering an optimum value of a result effect variable involves only routine skill in the art (see MPEP 2144.05(II)).
Regarding claims 7 and 15, as applied to claims 6 and 14, Bassampour in view of Iwata and Matsuzawa and Suzuki teach a method wherein said at least one non-silicone vinylic crosslinking agent comprises ethyleneglycol dimethacrylate (Bassampour, ¶0151).
Regarding claims 8 and 16, as applied to claims 6 and 14, Bassampour in view of Iwata and Matsuzawa and Suzuki teach a method wherein the insert-forming composition comprises at least one silicone-containing aryl vinylic monomer (Bassampour, ¶0072).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Cheng (US-20220326412-A1) – teaches that the crosslinked polymeric material of the rigid hydrophobic insert comprises an aryl vinylic monomer (¶0088).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JaMel M Nelson whose telephone number is (571)272-8174. The examiner can normally be reached 9:00 a.m. to 5:00 p.m..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Galen Hauth can be reached on (571) 270-5516. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAMEL M NELSON/Primary Examiner, Art Unit 1743
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