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 Group I, claims 1-16 in the reply filed on 5 January 2026 is acknowledged.
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 “The invention provides” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the molds used and the movement of both the molds used and the materials formed from said molds must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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 Interpretation
Regarding claim 1, L17-18 recites the limitation “(2) dispensing an amount of an insert-forming composition on the central portion of the first molding surface of the female mold half”, an amount being a non-zero quantity with no further clarification, while L29-31 recites the limitation “(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 of the female mold half” (underline for emphasis), an amount that must be at least enough to fill the lens-molding cavity of the female mold half. For purposes of interpretation, claim 1 L17-18 will be interpreted as though the amount dispensed for the insert-forming composition must be at least enough to fill an insert-molding cavity.
Regarding claim 9, language similar that set forth above appears on L16 and L27-28 and will be interpreted similarly.
Claim Objections
Claims 1, 2, 4, 5, 9 10, 12 and 13 are objected to because of the following informalities:
Claim 1, L4-5: has a first molding surface defining [[the]] an anterior surface
Claim 1, L6: second molding surface defining [[the]] a back surface
Claim 1, L8-9: a third molding surface defining [[the]] a posterior surface of the contact lens
Claim 1, L38: siloxane units, wherein [[the]] a sum of the amounts
Claim 1, L39: at least 90% by weight relative to a total amount of
Claim 2, L1: wherein the first male mold half comprises an overflow groove
Claim 2, L5: during the step of separating
Claim 4: is carried out by using [[a]] the vacuum UV.
Claim 5: is carried out by using [[a]] the corona plasma.
Claim 9, L 1: a method for producing embedded silicone hydrogel (SiHy) contact lenses
Claim 9, 4-5: has a first molding surface defining [[the]] a front surface
Claim 9, L5-6: second molding surface defining [[the]] a posterior surface of a contact lens to be molded and also [[the]] a
Claim 9, L8: third molding surface defining [[the]] an anterior surface of the contact lens
Claim 9, L36-37: wherein [[the]] a sum of the amounts of components (a) to (d) is at least at least 90% by weight relative to a total amount of
Claim 9, L45-46: form an embedded SiHy contact lens precursor that comprises
Claim 10, L1: the first female mold half comprises
Claim 10, L5: during the step of separating
Claim 12: is carried out by using [[a]] the vacuum UV.
Claim 13: is carried out by using [[a]] the corona plasma.
Appropriate correction is required.
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 3-8 and 11-16 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 3 recites the limitation "the diameter of the insert to be molded". There is insufficient antecedent basis for this limitation in the claim.
As claims 4-8 are directly/indirectly dependent on claim 3, they stand as rejected for similar reasons.
Claim 11 recites the limitation "the diameter of the insert to be molded". There is insufficient antecedent basis for this limitation in the claim.
As claims 12-16 are directly/indirectly dependent on claim 3, they stand as rejected for similar reasons.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
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 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.
Claim(s) 1 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Bassampour et al. (US20230004023) (of record) in view of applicant’s specification.
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, 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]);
(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 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]);
(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) 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]);
(9) separating the second molding assembly obtained in step (8) 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]);
(10) removing the embedded silicone hydrogel contact lens precursor from the lens-adhered mold half ([0172]); and
(11) 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 disclose that the lens-forming composition comprises at least one N,N-dialkylacrylamide having a 1-octanol-water partition coefficient Log(Pow) of from about 0.7 to about 2.1, at least one hydrophilic (meth)acrylamido monomer having a Log(Pow) of less than about 0.5, 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]), 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” (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;
b) 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
c) 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), 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 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]);
(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 ([0173]);
(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 ([0173]);
(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 ([0173]);
(6) 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]),
(7) 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]);
(8) 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]);
(9) 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]);
(10) removing the embedded silicone hydrogel contact lens precursor from the lens- adhered mold half ([0173]); and
(11) 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 disclose that the lens-forming composition comprises at least one N,N-dialkylacrylamide having a 1-octanol-water partition coefficient Log(Pow) of from about 0.7 to about 2.1, at least one hydrophilic (meth)acrylamido monomer having a Log(Pow) of less than about 0.5, 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]), 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” (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;
b) 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
c) 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), 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)).
Claim(s) 2 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Bassampour et al. (US20230004023) (of record) and applicant’s specification as set forth in the claim 1 and 9 rejections above and further in view of Matsuzawa et al. (US20080073804) (of record).
Regarding claim 2, modified Bassampour teaches all limitations of claim 1 as set forth above. While Bassampour does not explicitly teach that the first male mold half comprises an overflow groove which surrounds the 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 (5) can be stuck on the first male mold half during step of separating the first molding assembly, thereby removing the flushes, 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,
a) given that 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]),
b) Matsuzawa teaches the use of such an overflow groove with a female mold half (“overflow” (11), [0044]); and
c) Matsuzawa teaches that the overflow groove can alternatively be located on a male mold half ([0079]).
Regarding claim 10, modified Bassampour teaches all limitations of claim 9 as set forth above. While Bassampour does not explicitly teach that the first female mold half comprises an overflow groove which surrounds the 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 (5) can be stuck on the first female mold half during step of separating the first molding assembly, thereby removing the flushes, 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,
a) given that Matsuzawa, which is within the molding art, teaches that it is conventional for mold halves to have means for allowing overflow of insert-forming materials ([0003]),
b) Matsuzawa teaches the use of such an overflow groove with a female mold half(“overflow” (11), [0044]); and
c) Matsuzawa teaches that the overflow groove can alternatively be located on a male mold half ([0079]).
Claim(s) 3-8 and 11-16 are rejected under 35 U.S.C. 103 as being unpatentable over Bassampour et al. (US20230004023) (of record) and applicant’s specification as set forth in the claim 1 and 9 rejections above and further in view of Suzuki et al. (US20250205983).
Regarding claim 3, modified Bassampour teaches all limitations of claim 1 as set forth above. While Bassampour does not explicitly teach that the method further comprises, before step (2), a step of treating a central circular area of the first molding surfaces by using a vacuum UV or a corona plasma, wherein the central 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, 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]);
b) 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);
c) 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 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 8, modified Bassampour teaches all limitations of claim 7 as set forth above. While Bassampour does not explicitly teach that the lens-forming composition comprises: (a) 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; (b) from about 10 to about 35 weight part units of at least one hydrophilic (meth)acrylamido monomer having a Log(Pow) of less than about 0.5; and (c) from about 30 to about 40 weight part units of at least one polysiloxane acrylic crosslinker, it would have been obvious to one of ordinary skill in the art prior to the earliest effective of the instant application date to do so, given that
a) of the 5 components of the lens-forming composition as taught in Bassampour, the solvent is non-reactive and does not become part of the final formed product;
b) the amount of photoinitiator relative to the rest of the components is minor (in Table 2, only 1 weight part unit);
c) 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.
While not relied upon as the basis of a rejection, examiner notes that the current disclosure does not support the criticality of the claimed ranges above as to render it unobvious over the claimed prior art, given that the originally submitted specification only gives a general statement for the claimed weight ranges in p.34 and with regards to the formulations of Table 2, wherein the change of relative amounts of at least one N,N-dialkylacrylamide (“DEA”) and of at least one hydrophilic (meth)acrylamido monomer (“DMA”) across formulations 2-1, 2-2, and 2-3 had little to no impact on the amount of delamination or deformity as compared to the removal of TRIS-MA in formulation 2-4 based on the description on p.57. To establish unexpected results over a claimed range and claim criticality, 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 9 as set forth above. While Bassampour does not explicitly teach that the method further comprises, before step (2), a step of treating a central circular area of the first molding surfaces by using a vacuum UV or a corona plasma, wherein the central 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, 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]);
b) a person of ordinary skill in the art would readily understand that the change 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);
c) 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
d) it has been held that discovering an optimum value 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]).
Regarding claim 16, modified Bassampour teaches all limitations of claim 14 as set forth above. While Bassampour does not explicitly teach that the lens-forming composition comprises: (a) 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; (b) from about 10 to about 35 weight part units of at least one hydrophilic (meth)acrylamido monomer having a Log(Pow) of less than about 0.5; and (c) from about 30 to about 40 weight part units of at least one polysiloxane acrylic crosslinker, it would have been obvious to one of ordinary skill in the art prior to the earliest effective of the instant application date to do so, given that
a) of the 5 components of the lens-forming composition as taught in Bassampour, the solvent is non-reactive and does not become part of the final formed product;
b) the amount of photoinitiator relative to the rest of the components is minor (in Table 2, only 1 weight part unit);
c) 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.
While not relied upon as the basis of a rejection, examiner notes that the current disclosure does not support the criticality of the claimed ranges above as to render it unobvious over the claimed prior art, given that the originally submitted specification only gives a general statement for the claimed weight ranges in p.34 and with regards to the formulations of Table 2, wherein the change of relative amounts of at least one N,N-dialkylacrylamide (“DEA”) and of at least one hydrophilic (meth)acrylamido monomer (“DMA”) across formulations 2-1, 2-2, and 2-3 had little to no impact on the amount of delamination or deformity as compared to the removal of TRIS-MA in formulation 2-4 based on the description on p.57. To establish unexpected results over a claimed range and claim criticality, 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)).
Conclusion
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