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 .
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” or more specifically “This application describes” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The disclosure is objected to because of the following informalities:
Abstract, L2-3: cavity of a first molding assembly comprising an insert mold half
Appropriate correction is required.
Drawings
The drawings are objected to as Figures 3-4 are new drawings that have not been previously presented. Applicant is reminded of the need to comply with 37 C.F.R. 1.121. Any replacement sheet of drawings shall include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is amended. Any new sheet of drawings containing an additional figure must be labeled in the top margin as "New Sheet." All changes to the drawings shall be explained, in detail, in either the drawing amendment or remarks section of the amendment paper.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: 351 on p.14-15. Additionally the drawings are objected to because they include the following reference character(s) not mentioned in the description: 310. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to because the arrows indicating relative movements between component 304 to 302, 306 to 302, 401 to 404 and 404 to 402 aren’t clear as to which direction the components are moving, lines indicating different surfaces on the same component (for example on 304) are nearly illegible, and both pages of Replacement Drawings have a superfluous tag of “PAT059191-US-NP”. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 3-7, 9, and 11-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bassampour et al. (US20230004023) (of record) in view of applicant’s specification, Matsuzawa et al. (US20080073804) (of record) and Suzuki et al. (US20250205983) (of record).
Regarding claim 1, Bassampour discloses a method for producing embedded silicone hydrogel contact lenses, comprising the steps of:
(1) obtaining a female mold half, a first male 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 a front surface of an insert to be molded ([0172] in that the insert is “partially embedded” and therefore not completely surrounded by the contact lens), wherein the first male mold half has a second molding surface defining the back surface of an 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]);
(3) dispensing an amount of an insert-forming composition on the central portion of the first molding surface of the female mold half ([0172]);
(4) 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]);
(5) 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]);
(6) separating the first molding assembly obtained in step (5) 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]);
(7) 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 of the female mold half ([0172]), wherein the lens-forming composition comprises
at least one polysiloxane acrylic crosslinker ([0133]),
at least one photoinitiator ([0160]-[0162]);
(8) 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]);
(9) actinically curing the lens-forming composition in the lens-molding cavity of the second molding assembly to form an embedded silicone hydrogel contact lens precursor that comprise a bulk silicone hydrogel material formed from the lens- forming composition and the insert embedded in the bulk silicone hydrogel material ([0172]);
(10) separating the second molding assembly obtained in step (9) into the second male mold half and the female mold half, with the embedded silicone hydrogel contact lens precursor adhered on a lens-adhered mold half which is one of the female and second male mold halves ([0172]);
(11) removing the embedded silicone hydrogel contact lens precursor from the lens-adhered mold half ([0172]); and
(12) subjecting the embedded silicone 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 does not explicitly teach 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 excess insert-forming material during step (6) can be stuck on the first male mold half during step of separating the first molding assembly and that step (3) comprises dispensing enough insert-forming composition to fill the molding cavity with excess, it would have been obvious to one of ordinary skill in the art prior to the earliest effective priority date of the instant application to do so, given that
a1) Matsuzawa, which is within the contact lens molding art, teaches that it is conventional for mold halves to have means for allowing overflow of insert-forming materials ([0003]);
a2) Matsuzawa teaches the use of such an overflow groove with a female mold half (“overflow” (11), [0044]); and
a3) Matsuzawa teaches that the overflow groove can alternatively be located on a male mold half ([0079]); and
b) Matsuzawa teaches that it is conventional to use an surplus amount of insert-forming composition as to cause overflow ([0003]).
While Bassampour does not explicitly teach that the method further comprises a step (2) of treating a circular area in the central circular portion of the first molding surfaces by using a vacuum UV or a corona plasma, it would have been obvious to one of ordinary skill in the art prior to the earliest effective priority date of the instant application to do so, given that 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 benefit of modifying the degree of adhesion between the molding materials and the mold halves ([0216]).
While Bassampour does not explicitly disclose that the lens-forming composition comprises from about 10 to about 35 weight part units of at least one N,N-dialkylacrylamide having a 1-octanol-water partition coefficient Log(Pow) of from about 0.7 to about 2.1, about 30 to about 40 weight part units of at least one hydrophilic (meth)acrylamido monomer having a Log(Pow) of less than about 0.5, about 30 to about 40 weight part units of at least one polysiloxane acrylic crosslinker, and about 20 to about 30 weight part units of at least one non-reactive diluent, wherein the lens-forming composition is free of siloxane-containing vinylic monomer having a tris(trialkylsilyloxy)silyl or bis(trialkylsilyloxy)silyl group or a polysiloxane segment having 3 to 15 consecutive siloxane units, wherein the sum of the amounts of components comprising at least one N,N-dialkylacrylamide, at least one hydrophilic (meth)acrylamido monomer, at least one polysiloxane acrylic crosslinker and at least one photoinitiator is at least 90% by weight relative to total amount of all polymerizable components in the lens-forming composition, it would have been obvious to one of ordinary skill in the art prior to the earliest effective priority date of the instant application to do so, given that:
a1) Bassampour teaches that the lens-forming composition can comprise of "N,N-diethyl (meth)acrylamide" ([0135], [0033] in that “(meth)acrylamide” refers to both “methacrylamide” and “acrylamide”), which is within the list of preferred N,N-dialkylacrylamides in applicant’s specification that has a 1-octanol-water partition coefficient Log(Pow) of from about 0.7 to about 2.1 (p.26); and
a2) Bassampour teaches that the lens-forming composition can comprise of "N-2-hydroxylethyl (meth)acrylamide" ([0136]), which is within the list of preferred hydrophilic (meth)acrylamido monomers in applicant’s specification that has a Log(Pow) of less than about 0.5 (p.26);
a3) Bassampour teaches that the lens-forming composition can comprise of “suitable solvents” including “propylene glycol n-propyl ether” ([0164]), which is within the list of suitable solvents “used as non-reactive diluents” in applicant’s specification (p.30); and
a4) case law holds that where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established (see MPEP 2112.01);
b1) of the 5 components of the lens-forming composition as taught in Bassampour and applicant’s specification, the solvent is non-reactive and does not become part of the final formed product;
b2) the amount of photoinitiator relative to the rest of the components is minor (in Table 2, only 1 weight part unit);
b3) the remaining 99 weight part unit would be divided between the at least N,N-dialkyacrylamide, at least one hydrophilic (meth)acrylamido monomer and at least one polysiloxane acrylic crosslinker, and as such, a person of ordinary skill in the art would immediately envisage a 1:1:1 ratio of the monomers embracing using 33 wt% of each, which overlaps with the claimed ranges as set forth above;
c1) given that Bassampour teaches that the N-2-hydroxylethyl (meth)acrylamide is a acrylic monomer ([0136]), with “acrylic monomer” defined, in part, as a type of vinylic monomer in [0028], and “vinylic monomer” defined, in part, as a compound that “is soluble in a solvent” in [0023], and for a compound to be “soluble” includes that “the compound or material can be dissolved in the solvent to give a solution with a concentration of at least about 0.5% by weight” in [0024]; and
c2) Bassampour teaches that use of solvents or mixtures with a solvent in lens-forming compositions is “known to a person skilled in the art” ([0160]);
c3) the determination of the amount of solvent to achieve a minimum concentration of about 0.5% represents a case of discovering the optimum or workable ranges where the general conditions of a claim are disclosed in the prior art and involves only routine skill in the art (see MPEP 2144.05(II)), one would have been motivated to set the amount of at least one non-reactive diluent to be from about 20 to about 30 weight part units for the purpose of effectively dissolving the lens-forming composition;
d) Bassampour teaches that the use of bis(trialkylsilyloxy)alkylsilyl group or a tris(trialkylsilyloxy)silyl groups is not required to practice the taught invention (claim 1, in that it does not list bis(trialkylsilyloxy)alkylsilyl group or a tris(trialkylsilyloxy)silyl group as a required component, and [0146], wherein the inclusion of such as groups as “a second silicone-containing vinylic monomer” is optional), meaning the composition can be made so as to be free of siloxane-containing vinylic monomer having a tris(trialkylsilyloxy)silyl or bis(trialkylsilyloxy)silyl group or a polysiloxane segment having 3 to 15 consecutive siloxane units; and
e) given that the teachings of Bassampour include a composition where the polymerizable components comprise of just N,N-diethyl (meth)acrylamide [(0135)], N-2-hydroxylethyl (meth)acrylamide ([0136]), at least one polysiloxane acrylic crosslinker ([0133]) and at least one photoinitiator ([0163]-[0164]) (with the non-reactive diluent not being considered part of “polymerizable components” as it does not react/polymerize) (claim 12), such a composition would be 100% by weight relative to a total amount of all polymerizable components in the lens-forming composition (which is within the claimed range of at least 90%).
While not relied upon for the basis of a rejection, examiner notes the current disclosure does not support the criticality of limitations regarding the Log(POW) of at least one N,N-dialkylacrylamide and the log (POW) of at least one hydrophilic (meth)acrylamido monomer with sufficient specificity as to render the claimed range non-obvious over the prior art, as p.14 of the original disclosure comprises general statements about the supposed benefits and the experimental data shown in Table 2 represents only one composition relying on only one species from the claimed genus’s (based on Example 2 of the cited US9315669 reference) with an appropriate Log(POW) with no further examples both within and outside of the claimed range and to establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range (see MPEP 716.02(d)(II)). Additionally, the current disclosure does not support the criticality of the limitation regarding the sum of components comprising at least one N,N-dialkylacrylamide, at least one hydrophilic (meth)acrylamido monomer, at least one polysiloxane acrylic crosslinker and at least one photoinitiator being at least 90% by weight relative to a total amount of all polymerizable components in the lens forming composition, as the examples in Table 2 are all within the claimed range of at least 90% with no examples outside of said range and to establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range (see MPEP 716.02(d)(II)). Furthermore, examiner notes that the current disclosure does not support the criticality of the limitation regarding the lens-forming composition is free of siloxane-containing vinylic monomer having a tris(trialkylsilyloxy)silyl or bis(trialkylsilyloxy)silyl group or a polysiloxane segment having 3 to 15 consecutive siloxane units with sufficient specificity as to render the claimed range non-obvious over the prior art, as there is only one experimental data point (2-4, with 0 TRIS-MA) within said claimed range and three experimental data points with the same amount outside of the claimed range (2-1, 2-2 and 2-3 with 15 TRIS-MA) with the explanation for the difference between the two possible values being “only the embedded SiHy contact lenses obtained from Formulation 2-4 are not deformed (i.e., having round shape)” and to establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range (see MPEP 716.02(d)(II)).
Regarding claim 3, modified Bassampour teaches all limitations of claim 1 as set forth above. While Bassampour does not explicitly teach that the circular area has a diameter that is about 90% or smaller of the diameter of the insert to be molded, it would have been obvious to one of ordinary skill in the art prior to the earliest effective priority date of the instant application to do so, given that:
a) Suzuki 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]);
b) 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 (including 90% or less than a diameter of the insert to be molded) of a result effective variable involves only routine skill in the art (see MPEP 2144.05(II)).
Regarding claim 4, modified Bassampour teaches all limitations of claim 3 as set forth above. Additionally, Suzuki teaches that the central circular area of the first molding surface is carried out by using the vacuum UV ([0216]).
Regarding claim 5, modified Bassampour teaches all limitations of claim 3 as set forth above. Additionally, Suzuki teaches that the central circular area of the first molding surface is carried out by using the corona plasma ([0216]).
Regarding claim 6, modified Bassampour teaches all limitations of claim 3 as set forth above. Additionally, Bassampour teaches that the insert-forming composition comprises at least one silicone-containing aryl vinylic monomer ([0087]-[0090]) and at least one silicone-containing aryl vinylic crosslinker ([0091]).
Regarding claim 7, modified Bassampour teaches all limitations of claim 6 as set forth above. Additionally, Bassampour teaches that said at least one non-reactive diluent comprises ethylene glycol butyl ether ([0289]), propylene glycol, 1-propanol, isopropanol, sec-butanol, tert-butyl alcohol, tert-amyl alcohol, or mixtures thereof ([0164]).
Regarding claim 9, Bassampour discloses a method for producing an embedded silicone hydrogel “SiHy” contact lenses, comprising the steps of:
(1) obtaining a first female mold half, a male 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 first female mold half is closed with the male mold half, wherein the second female mold half and the male 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 second female mold half is closed with the male mold half ([0173]);
(2) dispensing an amount of an insert-forming composition in the first female mold half ([0173]);
(4) 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 ([0173]);
(5) 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 ([0173]);
(6) 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 ([0173]);
(7) dispensing a lens-forming composition in the second female mold half in an amount sufficient for filling the lens-molding cavity ([0173]), wherein the lens-forming composition comprises
at least one polysiloxane acrylic crosslinker ([0133]), and
at least one photoinitiator ([0160]-[0162]),
(8) placing the male mold half with the molded insert that is adhered onto the central portion of the second molding surface 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 ([0173]);
(9) actinically curing the lens-forming composition in the lens-molding cavity of the second molding assembly to form an embedded SiHy contact lens precursor that comprise a bulk SiHy material formed from the lens-forming composition and the insert embedded in the bulk silicone hydrogel material ([0173]);
(10) separating the second molding assembly obtained in step (8) into the second female mold half and the male mold half, with the embedded silicone hydrogel contact lens precursor adhered on a lens-adhered mold half which is one of the second female mold [[half]] and male mold halves ([0173]);
(11) removing the embedded silicone hydrogel contact lens precursor from the lens- adhered mold half ([0173]); and
(12) subjecting the embedded silicone 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 does not explicitly teach that the first female mold half comprises an overflow groove which surrounds the first 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 excess insert-forming material during step (6) can be stuck on the first female mold half during step of separating the first molding assembly and that step (3) comprises dispensing enough insert-forming composition to fill the molding cavity with excess, it would have been obvious to one of ordinary skill in the art prior to the earliest effective priority date of the instant application to do so, given that
a1) Matsuzawa, which is within the contact lens molding art, teaches that it is conventional for mold halves to have means for allowing overflow of insert-forming materials ([0003]);
a2) Matsuzawa teaches the use of such an overflow groove with a female mold half (“overflow” (11), [0044]); and
b) Matsuzawa teaches that it is conventional to use an surplus amount of insert-forming composition as to cause overflow ([0003]).
While Bassampour does not explicitly teach that the method further comprises a step (2) of treating a circular area in the central circular portion of the second molding surfaces by using a vacuum UV or a corona plasma, it would have been obvious to one of ordinary skill in the art prior to the earliest effective priority date of the instant application to do so, given that 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]);
While Bassampour does not explicitly disclose that the lens-forming composition comprises from about 10 to about 35 weight part units of at least one N,N-dialkylacrylamide having a 1-octanol-water partition coefficient Log(Pow) of from about 0.7 to about 2.1, about 30 to about 40 weight part units of at least one hydrophilic (meth)acrylamido monomer having a Log(Pow) of less than about 0.5, about 30 to about 40 weight part units of at least one polysiloxane acrylic crosslinker, and about 20 to about 30 weight part units of at least one non-reactive diluent, wherein the lens-forming composition is free of siloxane-containing vinylic monomer having a tris(trialkylsilyloxy)silyl or bis(trialkylsilyloxy)silyl group or a polysiloxane segment having 3 to 15 consecutive siloxane units, wherein the sum of the amounts of components comprising at least one N,N-dialkylacrylamide, at least one hydrophilic (meth)acrylamido monomer, at least one polysiloxane acrylic crosslinker and at least one photoinitiator is at least 90% by weight relative to total amount of all polymerizable components in the lens-forming composition, it would have been obvious to one of ordinary skill in the art prior to the earliest effective priority date of the instant application to do so, given that:
a1) Bassampour teaches that the lens-forming composition can comprise of "N,N-diethyl (meth)acrylamide" ([0135], [0033] in that “(meth)acrylamide” refers to both “methacrylamide” and “acrylamide”)), which is within the list of preferred N,N-dialkylacrylamides in applicant’s specification that has a 1-octanol-water partition coefficient Log(Pow) of from about 0.7 to about 2.1 (p.25-26);
a2) Bassampour teaches that the lens-forming composition can comprise of "N-2-hydroxylethyl (meth)acrylamide" ([0136]), which is within the list of preferred hydrophilic (meth)acrylamido monomers in applicant’s specification that has a Log(Pow) of less than about 0.5 (p.26);
a3) Bassampour teaches that the lens-forming composition can comprise of “suitable solvents” including “propylene glycol n-propyl ether” ([0164]), which is within the list of suitable solvents “used as non-reactive diluents” in applicant’s specification (p.30); and
a4) it has been held that “a reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments” (see MPEP 2123), which includes the use of components listed;
b1) of the 5 components of the lens-forming composition as taught in Bassampour and applicant’s specification, the solvent is non-reactive and does not become part of the final formed product;
b2) the amount of photoinitiator relative to the rest of the components is minor (in Table 2, only 1 weight part unit);
b3) the remaining 99 weight part unit would be divided between the at least N,N-dialkyacrylamide, at least one hydrophilic (meth)acrylamido monomer and at least one polysiloxane acrylic crosslinker, and as such, a person of ordinary skill in the art would immediately envisage a 1:1:1 ratio of the monomers embracing using 33 wt% of each, which overlaps with the claimed ranges as set forth above;
c1) given that Bassampour teaches that the N-2-hydroxylethyl (meth)acrylamide is an acrylic monomer ([0136]), with “acrylic monomer” defined, in part, as a type of vinylic monomer in [0028], and “vinylic monomer” defined, in part, as a compound that “is soluble in a solvent” in [0023], and for a compound to be “soluble” includes that “the compound or material can be dissolved in the solvent to give a solution with a concentration of at least about 0.5% by weight” in [0024]; and
c2) Bassampour teaches that use of solvents or mixtures with a solvent in lens-forming compositions is “known to a person skilled in the art” ([0160]);
c3) the determination of the amount of solvent to achieve a minimum concentration of about 0.5% represents a case of discovering the optimum or workable ranges where the general conditions of a claim are disclosed in the prior art and involves only routine skill in the art (see MPEP 2144.05(II)), one would have been motivated to set the amount of at least one non-reactive diluent to be from about 20 to about 30 weight part units for the purpose of effectively dissolving the lens-forming composition;
d) Bassampour teaches that the use of bis(trialkylsilyloxy)alkylsilyl group or a tris(trialkylsilyloxy)silyl groups is not required to practice the taught invention (claim 1, in that it does not list bis(trialkylsilyloxy)alkylsilyl group or a tris(trialkylsilyloxy)silyl group as a required component, and [0146], wherein the inclusion of such as groups as “a second silicone-containing vinylic monomer” is optional), meaning the composition can be made so as to be free of siloxane-containing vinylic monomer having a tris(trialkylsilyloxy)silyl or bis(trialkylsilyloxy)silyl group or a polysiloxane segment having 3 to 15 consecutive siloxane units; and
d) given that the teachings of Bassampour include a composition where the polymerizable components comprise of just N,N-diethyl (meth)acrylamide [(0135)], N-2-hydroxylethyl (meth)acrylamide ([0136]), at least one polysiloxane acrylic crosslinker ([0133]) and at least one photoinitiator ([0163]-[0164]) (with the non-reactive diluent not being considered part of “polymerizable components” as it does not react/polymerize) (claim 12), such a composition would be 100% by weight relative to a total amount of all polymerizable components in the lens-forming composition (which is within the claimed range of at least 90%).
While not relied upon for the basis of a rejection, examiner notes the current disclosure does not support the criticality of limitations regarding the Log(POW) of at least one N,N-dialkylacrylamide and the log (POW) of at least one hydrophilic (meth)acrylamido monomer with sufficient specificity as to render the claimed range non-obvious over the prior art, as p.14 of the original disclosure comprises general statements about the supposed benefits and the experimental data shown in Table 2 represents only one composition relying on only one species from the claimed genus’s (based on Example 2 of the cited US9315669 reference) with an appropriate Log(POW) with no further examples both within and outside of the claimed range and to establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range (see MPEP 716.02(d)(II)). Additionally, the current disclosure does not support the criticality of the limitation regarding the sum of components comprising at least one N,N-dialkylacrylamide, at least one hydrophilic (meth)acrylamido monomer, at least one polysiloxane acrylic crosslinker and at least one photoinitiator being at least 90% by weight relative to a total amount of all polymerizable components in the lens forming composition, as the examples in Table 2 are all within the claimed range of at least 90% with no examples outside of said range and to establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range (see MPEP 716.02(d)(II)). Furthermore, examiner notes that the current disclosure does not support the criticality of the limitation regarding the lens-forming composition is free of siloxane-containing vinylic monomer having a tris(trialkylsilyloxy)silyl or bis(trialkylsilyloxy)silyl group or a polysiloxane segment having 3 to 15 consecutive siloxane units with sufficient specificity as to render the claimed range non-obvious over the prior art, as there is only one experimental data point (2-4, with 0 TRIS-MA) within said claimed range and three experimental data points with the same amount outside of the claimed range (2-1, 2-2 and 2-3 with 15 TRIS-MA) with the explanation for the difference between the two possible values being “only the embedded SiHy contact lenses obtained from Formulation 2-4 are not deformed (i.e., having round shape)” and to establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range (see MPEP 716.02(d)(II)).
Regarding claim 11, modified Bassampour teaches all limitations of claim 1 as set forth above. While Bassampour does not explicitly teach that the circular area has a diameter that is about 90% or smaller of the diameter of the insert to be molded, it would have been obvious to one of ordinary skill in the art prior to the earliest effective priority date of the instant application to do so, given that:
a) Suzuki 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]);
b) 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 (including 90% or less than a diameter of the insert to be molded) of a result effective variable involves only routine skill in the art (see MPEP 2144.05(II)).
Regarding claim 12, modified Bassampour teaches all limitations of claim 11 as set forth above. Additionally, Suzuki teaches that the central circular area of the first molding surface is carried out by using the vacuum UV ([0216]).
Regarding claim 13, modified Bassampour teaches all limitations of claim 11 as set forth above. Additionally, Suzuki teaches that the central circular area of the first molding surface is carried out by using the corona plasma ([0216]).
Regarding claim 14, modified Bassampour teaches all limitations of claim 11 as set forth above. Additionally, Bassampour teaches that the insert-forming composition comprises at least one silicone-containing aryl vinylic monomer ([0087]-[0090]) and at least one silicone-containing aryl vinylic crosslinker ([0091]).
Regarding claim 15, modified Bassampour teaches all limitations of claim 14 as set forth above. Additionally, Bassampour teaches that said at least one non-reactive diluent comprises ethylene glycol butyl ether ([0289]), propylene glycol, 1-propanol, isopropanol, sec- butanol, tert-butyl alcohol, tert-amyl alcohol, or mixtures thereof ([0164]).
Response to Arguments
Applicant's arguments filed 1 June 2026 have been fully considered but they are not persuasive.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., that “the treatment of only a partial molding surface” in claims 1 and 9) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In response to applicant's argument that the prior art does not recognize the benefits of the claimed composition comprising two different types of (meth)acrylamido monomer, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). Furthermore, examiner notes that the current claim limitations do not explicitly require “two different types of (meth)acrylamido monomers” as mentioned in the remarks but rather “at least one N,N-dialkyacrylamide having a 1-octanol-water partition coefficient Log(POW) of from about 0.7 to about 2.1” and “at least one hydrophilic (methy)acrylamido monomer having a Log(POW) of less than about 0.5”.
Regarding p. 14 of applicant’s remarks, applicant argues that the prior art of record does not teach the amended compositions of claim 1 and 9. Examiner disagrees, noting that as set forth above in the 35 U.S.C. 103 rejections, the prior art is considered to teach the amended language.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDER D BOOTH whose telephone number is 571-272-6704. The examiner can normally be reached M-Th 7:00-4:30.
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/ALEXANDER D BOOTH/Examiner, Art Unit 1749
/SEDEF E PAQUETTE/Primary Examiner, Art Unit 1749
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