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 .
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.
Response to Amendment
The preliminary amendments to the claims and specification filed 07/22/2025 have been reviewed and accepted by the examiner.
Claim Rejections - 35 USC § 103
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.
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.
Claims 16-26 are rejected under 35 U.S.C. 103 as being unpatentable over Huang (US-20170166673) in view of Qian (US-20170165932).
Regarding claim 16, Huang teaches:
A coated silicone hydrogel contact lens ([0126]), comprising: a bulk silicone hydrogel material ([0002]); and a layer of a non-silicone hydrogel material thereon ([0101]), wherein the bulk silicone hydrogel material comprises (a) repeating units of at least one hydrophilized polysiloxane vinylic crosslinker ([0010]), (b) optionally repeating units of hydroxyethyl methacrylate ([0010] and [0100]), (d) from about 2% to about 10% by weight of carboxyl-containing repeating units of at least one carboxyl-containing (meth)acryloxy monomer ([0010] and [0100]), and (e) optionally repeating units of at least one polymerizable component selected from the group consisting of a non-silicone vinylic crosslinker, a UV-absorbing vinylic monomer, a polymerizable UV/high-energy-violet-light absorbing compound, a polymerizable photochromic compound, a polymerizable tinting agent, and combinations thereof, provided the amount of the component (e) is less than 10% by weight relative to the total weight of the bulk silicone hydrogel material in dry state ([0121]), wherein the sum of the amounts of components (a) to (e) present in the bulk silicone hydrogel material is at least 90% by weight ([0010]),
wherein the coated silicone hydrogel contact lens has a water-break-up-time (WBUT) of at least 5 seconds ([0235]), an oxygen permeability (Dk) of at least 50 barrers ([0010] and [0235]), an elastic modulus of from about 0.2 MPa to about 1.8 MPa ([0139]), an equilibrium water content of from about 20% to about 75% by weight (i.e., when being fully hydrated) ([0139]), a friction rating of about 3.0 or lower ([0078]), an average water contact angle of about 90 degrees or lower by sessile drop ([0078]).
Huang does not teach:
the bulk silicone hydrogel material also comprises (c) repeating units of at least one C1-C2 alkoxyethyl (meth)acrylate; and
wherein the layer of the non-silicone hydrogel material is covalently attached to the bulk silicone hydrogel material through the carboxyl groups of the carboxyl-containing repeating units on and/or near the surface of the bulk silicone hydrogel material.
However, Qian, in a similar field of endeavor, coated silicone contact lenses, teaches:
the bulk silicone hydrogel material also comprises (c) repeating units of at least one C1-C2 alkoxyethyl (meth)acrylate ([0012] – [0015], [0072], and [0086]); and
wherein the layer of the non-silicone hydrogel material is covalently attached to the bulk silicone hydrogel material through the carboxyl groups of the carboxyl-containing repeating units on and/or near the surface of the bulk silicone hydrogel material ([0012] – [0015], [0072], and [0130]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the coated silicone hydrogel contact lens of Huang to incorporate the teachings of Qian and include repeating units of at least one C1-C2 alkoxyethyl (meth)acrylate and wherein the layer of the non-silicone hydrogel material is covalently attached to the bulk silicone hydrogel material through the carboxyl groups of the carboxyl-containing repeating units on and/or near the surface of the bulk silicone hydrogel material. The purpose, as stated by Qian, being with such stable base coating formed in a water-based coating process, a durable non-silicone hydrogel coating on the silicone hydrogel contact lens can be formed by covalently attaching a partially-crosslinked hydrophilic polymeric material according to thermally-induced reaction mechanism ([0072]).
Regarding claim 17, Huang in view of Qian teaches the limitations of claim 16, which claim 17 depends on. Huang further teaches:
wherein said at least one hydrophilized polysiloxane vinylic crosslinker comprises at least about 1.50 milliequivalent/gram ("meq/g") of hydrophilic moieties, which are hydroxyl groups (-OH), carboxyl groups (-COOH), amino groups (-NHRN1 in which RN1 is H or C1-C2 alkyl), amide moieties (-CO-NRN1RN2 in which RN1 is H or C1-C2 alkyl and RN2 is a covalent bond, H, or C1-C2 alkyl), N-C1-C3 acylamino groups, urethane moieties (-NH-CO-O-), urea moieties (-NH-CO-NH-), a polyethylene glycol chain of 4C2H4i in which n is an integer of 2 to 20 and T1 is H, methyl or acetyl or a phosphorylcholine group, or combinations thereof ([0008] and [0039]). While Huang is silent as to the exact moieties, these are factors that would be easily discoverable to one of ordinary skill in the art through routine experimentation and therefore do not lend patentability in the absence of a showing of criticality or unexpected results.
In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. It would have been obvious to one having ordinary skill in the art to have determined the optimum values of the relevant process parameters through routine experimentation in the absence of a showing of criticality.
Regarding claim 18, Huang in view of Qian teaches the limitations of claim 17, which claim 18 depends on. Huang further teaches:
wherein said at least one hydrophilized polysiloxane vinylic crosslinker a polysiloxane vinylic crosslinker that comprises (1) a polysiloxane segment comprising dimethylsiloxane units and hydrophilized siloxane units each having one methyl substituent and one monovalent C4-C40 organic radical substituent having 2 to 6 hydroxyl groups and (2) two terminal (meth)acryloyl groups ([0134]).
Regarding claim 19, Huang in view of Qian teaches the limitations of claim 18, which claim 19 depends on. Huang further teaches:
wherein said at least one hydrophilized polysiloxane vinylic crosslinker comprises a polysiloxane vinylic crosslinker of formula (1)H3OouI -R3-Xo1-C-=CH2(1)H3 in which:ul is an integer of from 30 to 500 and col is an integer of from 1 to 75, provided that co1/u1 is from about 0.035 to about 0.15;Xo1 is O or NRn in which Ra is hydrogen or C1-C10-alkyl;Ro is hydrogen or methyl;R2 and R3 independently of each other are a substituted or unsubstituted alkylene divalent radical or a divalent radical of -R5-O-R6- in which R5 and R6 independently of each other are a substituted or unsubstituted C1-C10 alkylene divalent radical;R4 is a monovalent radical of any one of formula (2) to (7)CH2-X3-RO2 (2)2%m3 X4- 4 (3)OH (4) H (5) CH2-OH (6) CH3 (7) p1 is zero or 1; m1 is an integer of 2 to 4; m2 is an integer of 1 to 5; m3 is an integer of 3 to 6; m4 is an integer of 2 to 5; R7 is hydrogen or methyl; R$ is a C2-C hydrocarbon radical having (m2+1) valencies; R9 is a C2-C hydrocarbon radical having (m4+1) valencies; R10 is ethyl or hydroxymethyl; R1 is methyl or hydroxymethyl; Ri2 is hydroxyl or methoxy; X3 is a sulfur linkage of -S- or a tertiary amino linkage of -NR13- in which R13 is C1-C1 alkyl, hydroxyethyl, hydroxypropyl, or 2,3-dihydroxypropyl; X4 is an amide linkage of -or--NR14- in which Ri4 is hydrogen or Ci-Cialkyl; Lpc is a divalent radical of ~CH2-CHRo-R15~-C2H4-C2H4-,or R17- in which q1 is an integer of 1 to 20, Ri5 is a linear or branched alkylene divalent radical, Ri6 is a linear or branched C3-C10 alkylene divalent radical, and R17 is a direct bond or a linear or branched C1-C4 alkylene divalent radical ([0063] – [0080]).
Regarding claim 20, Huang in view of Qian teaches the limitations of claim 19, which claim 20 depends on. Huang further teaches:
wherein the non- silicone hydrogel material is a crosslinked polymeric material which comprises at least 25% by mole of repeating monomeric units of at least one hydrophilic vinylic monomer selected from the group consisting of N,N-dimethyl (meth)acrylamide, N-ethyl (meth)acrylamide, N,N-diethyl (meth)acrylamide, N-propyl (meth)acrylamide, N- isopropyl (meth)acrylamide, N-3-methoxypropyl (meth)acrylamide, N-2- dimethylaminoethyl (meth)acrylamide, dimethylaminoethyl (meth)acrylate, N-2- hydroxylethyl (meth)acrylamide, N,N-bis(hydroxyethyl) (meth)acrylamide, N-3- hydroxypropyl (meth)acrylamide, N-2-hydroxypropyl (meth)acrylamide, N-2,3- dihydroxypropyl (meth)acrylamide, N-tris(hydroxymethyl)methyl (meth)acrylamide, 2- hydroxyethyl (meth)acrylate, 3-hydroxypropyl (meth)acrylate, 2-hydroxypropyl (meth)acrylate, glycerol methacrylate (GMA), di(ethylene glycol) (meth)acrylate, tri(ethylene glycol) (meth)acrylate, tetra(ethylene glycol) (meth)acrylate, poly(ethylene glycol) (meth)acrylate having a number average molecular weight of up to 1500, poly(ethylene glycol)ethyl (meth)acrylamide having a number average molecular weight of up to 1500, N-vinylpyrrolidone, N-vinyl-3-methyl-2-pyrrolidone, N-vinyl-4-methyl-2- pyrrolidone, N-vinyl-5-methyl-2-pyrrolidone, N-vinyl-6-methyl-2-pyrrolidone, N-vinyl-3- ethyl-2-pyrrolidone, N-vinyl-4,5-dimethyl-2-pyrrolidone, N-vinyl-5,5-dimethyl-2- pyrrolidone, N-vinyl-3,3,5-trimethyl-2-pyrrolidone, N-vinyl piperidone, N-vinyl-3-methyl- 2-piperidone, N-vinyl-4-methyl-2-piperidone, N-vinyl-5-methyl-2-piperidone, N-vinyl-6- methyl-2-piperidone, N-vinyl-6-ethyl-2-piperidone, N-vinyl-3,5-dimethyl-2-piperidone, N- vinyl-4,4-dimethyl-2-piperidone, N-vinyl caprolactam, N-vinyl-3-methyl-2-caprolactam, N-vinyl-4-methyl-2-caprolactam, N-vinyl-7-methyl-2-caprolactam, N-vinyl-7-ethyl-2- caprolactam, N-vinyl-3,5-dimethyl-2-caprolactam, N-vinyl-4,6-dimethyl-2-caprolactam, N-vinyl-3,5,7-trimethyl-2-caprolactam, N-vinyl-N-methyl acetamide, N-vinyl formamide, N-vinyl acetamide, N-vinyl isopropylamide, N-vinyl-N-ethyl acetamide, N-vinyl-N-ethyl formamide, 1-methyl-3-methylene-2-pyrrolidone, 1-ethyl-3-methylene-2-pyrrolidone, 1- methyl-5-methylene-2-pyrrolidone, 1-ethyl-5-methylene-2-pyrrolidone, 5-methyl-3- methylene-2-pyrrolidone, 5-ethyl-3-methylene-2-pyrrolidone, 1-n-propyl-3-methylene-2- pyrrolidone, 1-n-propyl-5-methylene-2-pyrrolidone, 1-isopropyl-3-methylene-2- pyrrolidone, 1-isopropyl-5-methylene-2-pyrrolidone, 1-n-butyl-3-methylene-2- pyrrolidone, 1-tert-butyl-3-methylene-2-pyrrolidone, ethylene glycol methyl ether (meth)acrylate, di(ethylene glycol) methyl ether (meth)acrylate, tri(ethylene glycol) methyl ether (meth)acrylate, tetra(ethylene glycol) methyl ether (meth)acrylate, C1-C4- alkoxy poly(ethylene glycol) (meth)acrylate having a weight average molecular weight of up to 1500, methoxy-poly(ethylene glycol)ethyl (meth)acrylamide having a number average molecular weight of up to 1500, ethylene glycol monovinyl ether, di(ethylene glycol) monovinyl ether, tri(ethylene glycol) monovinyl ether, tetra(ethylene glycol) monovinyl ether, poly(ethylene glycol) monovinyl ether, ethylene glycol methyl vinyl ether, di(ethylene glycol) methyl vinyl ether, tri(ethylene glycol) methyl vinyl ether, tetra(ethylene glycol) methyl vinyl ether, poly(ethylene glycol) methyl vinyl ether, and combinations thereof ([0095]).
Regarding claim 21, Huang in view of Qian teaches the limitations of claim 19, which claim 21 depends on. Qian further teaches:
the non-silicone hydrogel material is a crosslinked polymeric material which comprises at least 25% by mole of repeating monomeric units of at least one phosphrylcholine-containing vinylic monomer ([0120] - [0122]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the non-silicone hydrogel material of Huang in view of Qian to further incorporate the teachings of Qian and include a crosslinked polymeric material which comprises at least 25% by mole of repeating monomeric units of at least one phosphrylcholine-containing vinylic monomer. The purpose, as stated by Qian, being that most preferably, the hydrophilicity-enhancing agent as a hydrophilicity-enhancing agent is PEG-N ([0122]).
Regarding claim 22, Huang in view of Qian teaches the limitations of claim 19, which claim 22 depends on. Huang further teaches:
wherein the non- silicone hydrogel material is a crosslinked polymeric material which comprises poly(ethylene glycol) chains ([0103] – [0104] and [0117]).
Regarding claim 23, Huang in view of Qian teaches the limitations of claim 22, which claim 23 depends on. Huang further teaches:
wherein the poly(ethylene glycol) chains each are derived directly from (a) a pol(ethylene glycol) having one sole functional group of -NH2, -SH or -COOH, (b) a pol(ethylene glycol) having two terminal functional groups selected from the group consisting of -NH2, - COOH, -SH, and combinations thereof, (c) a multi-arm poly(ethylene glycol) having one or more functional groups selected from the group consisting of -NH2, -COOH, - SH, and combinations thereof, and (d) combinations thereof ([0103] – [0104] and [0117]).
Regarding claim 24, Huang in view of Qian teaches the limitations of claim 17, which claim 24 depends on. Huang further teaches:
wherein the coated silicone hydrogel contact lens has an oxygen permeability (Dk) of at least about 60 barrers ([0092]), a an elastic modulus of from about 0.3 MPa to about 1.2 MPa ([0092]), an equilibrium water content of from about 35% to about 65% by weight ([0092]), and an average water contact angle of about 80 degrees or lower ([0052]).
Qian further teaches:
wherein the coated silicone hydrogel contact lens has a water-break-up-time (WBUT) of at least about 15 seconds ([0078]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the coated silicone hydrogel contact lens of Huang in view of Qian to further incorporate the teachings of Qian and have a WBUT of at least 15 seconds. The purpose, as stated by Qian, being wherein the crosslinked hydrophilic coating exhibits a water-break-up-time (WBUT) of at least about 5 seconds (preferably at least about 10 second, more preferably at least about 15 second, even more preferably at least about 20 seconds) ([0078]).
Regarding claim 25, Huang in view of Qian teaches the limitations of claim 24, which claim 25 depends on. Huang further teaches:
wherein the sum of the amounts of components (a) to (e) present in the bulk silicone hydrogel material is at least 92% by weight ([0010]).
Regarding claim 26, Huang in view of Qian teaches the limitations of claim 25, which claim 26 depends on. Huang further teaches:
wherein the amount of component (a) present in the bulk silicone hydrogel material is from about 30% to about 65% by weight ([0010]).
Claims 27-31 are rejected under 35 U.S.C. 103 as being unpatentable over Huang (US-20170166673) in view of Qian (US-20170165932), as applied to claim 26 above, and further in view of Liu (US-20110085128).
Regarding claim 27, Huang in view of Qian teaches the limitations of claim 26, which claim 27 depends on, but does not teach wherein the sum of the amounts of components (b) and (c) present in the bulk silicone hydrogel material is from about 30% to about 65% by weight. However, Liu, in a similar field of endeavor, a coated silicone hydrogel contact lens, teaches:
wherein the sum of the amounts of components (b) and (c) present in the bulk silicone hydrogel material is from about 30% to about 65% by weight ([0026], [0066], and [0090] – [0093]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the coated silicone hydrogel contact lens of Huang in view of Qian to incorporate the teachings of Liu and make the sum of amounts of components (b) and (c) a specific % by weight. The purpose, as stated by Liu, being straightforwardly manufacture the present contact lenses without subjecting the contact lenses to plasma treatment and/or to treatment with a polymerizable swelling agent after the lens body is formed ([0006]).
Regarding claim 28, Huang in view of Qian and Liu teaches the limitations of claim 27, which claim 28 depends on. Huang further teaches:
wherein the amount of component (d) present in the bulk silicone hydrogel material is from about 3% to about 9% by weight ([0010] and [0100]).
Regarding claim 29, Huang in view of Qian and Liu teaches the limitations of claim 28, which claim 29 depends on. Huang further teaches:
wherein said at least one hydrophilized polysiloxane vinylic crosslinker a polysiloxane vinylic crosslinker that comprises (1) a polysiloxane segment comprising dimethylsiloxane units and hydrophilized siloxane units each having one methyl substituent and one monovalent C4-C40 organic radical substituent having 2 to 6 hydroxyl groups and (2) two terminal (meth)acryloyl groups ([0134]).
Regarding claim 30, Huang in view of Qian and Liu teaches the limitations of claim 29, which claim 30 depends on. Huang further teaches:
wherein said at least one hydrophilized polysiloxane vinylic crosslinker comprises a polysiloxane vinylic crosslinker of formula (1)H3o H2C= -Xo1-R2- -R3-Xo1- =CH2 (1) H3 in which:u1 is an integer of from 30 to 500 and o1 is an integer of from 1 to 75, provided that o1/u1 is from about 0.035 to about 0.15;Xo1 is O or NRn in which Ra is hydrogen or C1-C10-alkyl;Ro is hydrogen or methyl;R2 and R3 independently of each other are a substituted or unsubstituted alkylene divalent radical or a divalent radical of -RS-O-R6- in which R5 and R6 independently of each other are a substituted or unsubstituted C1-C10 alkylene divalent radical;R4 is a monovalent radical of any one of formula (2) to (7) -CH2P CH2-X3- 2 (2)H)m (3) -CH2- OH (4) H (5) CH2-OH (6) -LPc-O-CH2-CH2-CH3 (7) p1 is zero or 1; m1 is an integer of 2 to 4; m2 is an integer of 1 to 5; m3 is an integer of 3 to 6; m4 is an integer of 2 to 5; R7 is hydrogen or methyl; R$ is a C2-C6 hydrocarbon radical having (m2+1) valencies; R9 is a C2-C hydrocarbon radical having (m4+1) valencies; R10 is ethyl or hydroxymethyl; R1 is methyl or hydroxymethyl; Ri2 is hydroxyl or methoxy; X3 is a sulfur linkage of -S- or a tertiary amino linkage of -NR13- in which Ri3 is C1-C1 alkyl, hydroxyethyl, hydroxypropyl, or 2,3-dihydroxypropyl; X4 is an amide linkage of ~or-NR14~ in which R14 is hydrogen or alkyl; Lpc is a divalent radical of -CH2-CHRo-R15--C2H4-, or n which q1 is an integer of 1 to 20, Ri5 is a linear or branched alkylene divalent radical, Ri6 is a linear or branched C3-C10 alkylene divalent radical, and R17 is a direct bond or a linear or branched C1-C4 alkylene divalent radical ([0063] – [0080]).
Regarding claim 31, Huang in view of Qian and Liu teaches the limitations of claim 30, which claim 31 depends on. Huang further teaches:
wherein the coated silicone hydrogel contact lens has a friction rating of about 1.5 or lower ([0200] and [0235]) and an average water contact angle of about 70 degrees or lower ([0052]).
Conclusion
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/A.B./Examiner, Art Unit 1741 /JACOB T MINSKEY/Primary Examiner, Art Unit 1748
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