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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 08/04/2022, 03/03/2023, 07/27/2023 and 06/05/2025 has been considered by the examiner.
Preliminary Amendment
Preliminary Amendment that was filed on 05/06/2024 is entered.
Claim Objections
The following claims are objected to because of the following informalities:The phrase "characterized by or in that" is generally not used in customary U.S. patent practice. Please consider revising this phrase throughout the claims.Claim 7. The contact lens of any one of claims 4-6 should read “The contact lens of claim 4” for proper claim dependency. Appropriate correction is required.
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 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.
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 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness. hydrophilic
Claims 1-5, 7-16 and 18-21 are rejected under 35 U.S.C. 103 as being unpatentable over Chabrecek et al. (US 6468667; herein after “Chabrecek”) in view of Turner et al. (US 6478423; herein after “Turner”).
Chabrecek and Turner disclose l contact lens substrate with a hydrophilic coating material. Therefore, they are analogous art.
Regarding claim 1, Chabrecek teaches a contact lens (see Abstract), characterized by comprising: a lens (a lens substrate); and a hydrophilic coating attached to a surface of the lens by hydrogen bonding, ionic bonding, or a combination thereof (i.e., a surface coating (hydrophilicity, see Abstract) obtainable by reacting the reactive groups of the bulk material surface with a functional group of the acceptor saccharide and before or after said covalent bonding (hydrogen/ionic bonding) column 3, lines 22-26, also see column 1, lines 25-31), wherein the hydrophilic coating comprises polyacrylic acid and carbohydrate (column 1, lines 35-39 (carbohydrate) and column 2, lines 16-24 (polyacrylic acid)), and the carbohydrate comprises monosaccharide, disaccharide, or a combination thereof (i.e., Suitable acceptor saccharides comprise mono- or oligosaccharides or suitable derivatives thereof. Throughout this application the term oligosaccharide is to be understood as meaning a carbohydrate having, for example, from 2 to 20 and preferably from 2 to 10 saccharide units, column 2, lines 45-49).
Chabrecek teaches all limitations except for explicit teaching of a hydrophilic coating attached to a surface of the lens by hydrogen bonding, ionic bonding.
However, in a related field of endeavor Turner teaches the coating selected must be capable first of adhering to the substrate. This can be via chemical bonding such as covalent or ionic bonding or it can be via physical attraction so long as the coating can be made to adhere to the substrate, column 3, lines 33-36.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Chabrecek such that the coating selected must be capable first of adhering to the substrate via ionic bonding as taught by Turner such that the coating must be capable of remaining affixed to the lens substrate throughout its useful life (storage time plus the time in which it will be in contact with a user's eye).
Regarding claim 2, Chabrecek teaches the carbohydrate comprises glyceraldehyde, dihydroxyacetone, erythrose, ribose, deoxyribose, arabinose, xylose, lyxose, idose, glucose, fructose, galactose, mannose, rhamnose, sedoheptulose, mannoheptulose, sucrose, trehalose, lactose, maltose, or combinations thereof (i.e., carbohydrates selected from the group consisting of galactose, mannose, fucose, galactosamine, N-acetyl galactosamine, N-acetyl glucosamine, ialic acid and an oligosaccharide comprising one or more of the afore-mentioned arbohydrates, column 1, lines 37-43).
Regarding claim 3, Chabrecek teaches a weight ratio of the polyacrylic acid to the carbohydrate is ranged from 1:0.01 to 1:10 (column 20, line 66-column 21, line 4).
Regarding claim 4, Chabrecek teaches a contact lens (see Abstract), characterized by comprising: a lens (a lens substrate); a first hydrophilic coating attached to a surface of the lens by hydrogen bonding, ionic bonding, or a combination thereof (i.e., a surface coating (hydrophilicity, see Abstract) obtainable by reacting the reactive groups of the bulk material surface with a functional group of the acceptor saccharide and before or after said covalent bonding (hydrogen/ionic bonding) column 3, lines 22-26, also see column 1, lines 25-31), wherein the first hydrophilic coating comprises polyacrylic acid (column 2, lines 16-24 (polyacrylic acid)); and a second hydrophilic coating disposed on the first hydrophilic coating (i.e., one or more hydrophilic macromonomers (e.g., coatings), column 22, lines 45-49), wherein, the second hydrophilic coating comprises polyvinylpyrrolidone, poloxamine, poloxamer, methylcellulose, hydroxypropyl methylcellulose, carboxymethyl cellulose, ascorbic acid, poly(2-methacryloyloxyethyl phosphorylcholine), hyaluronic acid, alginic acid, polyglutamic acid, carbohydrate, or combinations thereof (e.g., a hydrophilic group, for example a carboxy, carbamoyl, sulfate, sulfonate, phosphate, amine, ammonium, acetate or hydroxy group, column 2, lines 14-32), and the carbohydrate comprises monosaccharide, disaccharide, or a combination thereof (column 1, lines 35-42).
Chabrecek fails to teach the first hydrophilic coating is disposed between the lens and the second hydrophilic coating.
However, in a related field of endeavor Turner teaches It is also possible to use more than one layer of coating, column 3, line 40, and the coating conditions can be arranged such that the lens substrate is highly swollen, column 4, lines 15-17.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Chabrecek such that it is possible to use more than one layer of coating (second coating), and the coatings can be arranged accordingly as taught by Turner such that hydrophilic coatings will not swell so dramatically under any conditions.
Furthermore, it has been held that rearranging parts such as the arrangement of a first hydrophilic coating disposed between a lens and a second hydrophilic coating of an invention involves only routine skill in the art In re Japikse, 86 USPQ 70.
Regarding claim 5, Chabrecek teaches the carbohydrate comprises glyceraldehyde, dihydroxyacetone, erythrose, ribose, deoxyribose, arabinose, xylose, lyxose, idose, glucose, fructose, galactose, mannose, rhamnose, sedoheptulose, mannoheptulose, sucrose, trehalose, lactose, maltose, or combinations thereof (i.e., carbohydrates selected from the group consisting of galactose, mannose, fucose, galactosamine, N-acetyl galactosamine, N-acetyl glucosamine, ialic acid and an oligosaccharide comprising one or more of the afore-mentioned arbohydrates, column 1, lines 37-43).
Regarding claim 7, Chabrecek teaches the lens is selected from the group consisting of a rigid gas permeable lens, a hydrogel lens, and a silicone hydrogel lens (e.g., soft hydrogel lens surface column 25, lines 33-36).
Regarding claim 8, Chabrecek teaches a manufacturing method of a contact lens (see column 1, lines 25-31), characterized by comprising: soaking a lens (i.e., the bulk material (a lens substrate) is immersed in a solution of the double bond modified acceptor saccharide, column 12, lines 20-28) in an acidic solution to form a hydrophilic coating on a surface of the lens (column 2, lines 11-34), wherein the acidic solution comprises polyacrylic acid, carbohydrate, and a polar solvent (column 1, lines 35-39 (carbohydrate); column 2, lines 16-24 (polyacrylic acid); and column 12, lines 1-7 (polar solvent such as DMSO)), and the carbohydrate comprises monosaccharide, disaccharide, or a combination thereof (i.e., Suitable acceptor saccharides comprise mono- or oligosaccharides or suitable derivatives thereof. Throughout this application the term oligosaccharide is to be understood as meaning a carbohydrate having, for example, from 2 to 20 and preferably from 2 to 10 saccharide units, column 2, lines 45-49).
Chabrecek teaches all limitations except for explicit teaching of soaking a lens in an acidic solution to form a hydrophilic coating.
However, in a related field of endeavor Turner teaches solution coating processes in which the lens substrate is freely floating and the coating solution is isotropic and not diffusion limited are most preferred, column 5, lines 13-15; a tielayer or coupling agent can be used to adhere the hydrophilic coating to the substrate. A coating layer with a significant number of carbonyl groups could be bonded to a polyolefin substrate through the use of a diamine tielayer in such a scheme. Selections of compatible lens substrate, coating, and tielayer (if necessary) materials is well within the knowledge of one skilled in the art, column 3, lines 44-50.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to a have solution coating processes in which the lens substrate is freely floating for the hydrophilic coating to a substrate as taught by Turner such that the coating solution can all be used to select and combine materials which will display the proper relative expansion condition of the substrate and coating in a particular set of conditions (within certain ranges dependent upon the materials considered).
Regarding claim 9, Chabrecek teaches soaking the lens in the acidic solution is performed at a temperature of 20° C. to 90° C (i.e., amino group reaction 0° C. to 100° C, see column 8, line 64 to column 9, line 7).
Regarding claim 10, Chabrecek fails to teach a weight percentage of the polyacrylic acid in the acidic solution is from 0.05% to 5%.
However, in a related field of endeavor Turner teaches a dilute polymer solution of coating material such as a solution between about 0.1 and 6.0 wt % of PAA (polyacrylic acid), column 4, 55-58.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to a have a dilute polymer solution of coating material such as a solution between about 0.1 and 6.0 wt % of PAA (polyacrylic acid) as taught by Turner such that the coating solution can all be used to select and combine materials which will display the proper relative expansion condition of the substrate.
Regarding claim 11, Chabrecek teaches a weight percentage of the carbohydrate in the acidic solution is from 0.05% to 10% (e.g., a carbohydrate having, for example, from 2 to 20 and preferably from 2 to 10 saccharide units (0.02% to 0.2%, column 2, lines 45-49).
Furthermore, it has held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 12, Chabrecek teaches the carbohydrate comprises glyceraldehyde, dihydroxyacetone, erythrose, ribose, deoxyribose, arabinose, xylose, lyxose, idose, glucose, fructose, galactose, mannose, rhamnose, sedoheptulose, mannoheptulose, sucrose, trehalose, lactose, maltose, or combinations thereof (i.e., carbohydrates selected from the group consisting of galactose, mannose, fucose, galactosamine, N-acetyl galactosamine, N-acetyl glucosamine, ialic acid and an oligosaccharide comprising one or more of the afore-mentioned arbohydrates, column 1, lines 37-43).
Regarding claim 13, Chabrecek teaches the acidic solution has a pH of 1 to 6.9 (e.g., The pH of the solution is adjusted to pH=3 by addition of 1 molar hydrochloric acid, column 32, lines 65-66).
Regarding claim 14, Chabrecek teaches the polar solvent comprises water, alcohol, or a combination thereof (e.g., a more polar solvent such as DMSO, DMA, N-methylpyrrolidone or even a lower alcohol, column 12, 6-8).
Regarding claim 15, Chabrecek teaches the polar solvent comprises the water and the alcohol, and soaking the lens in the acidic solution is performed at a temperature of 20° C. to 90° C (i.e., amino group reaction 0° C. to 100° C, see column 8, line 64 to column 9, line 7).
Regarding claim 16, Chabrecek teaches a manufacturing method of a contact lens (see column 1, lines 25-31), characterized by comprising: soaking a lens (i.e., the bulk material (a lens substrate) is immersed in a solution of the double bond modified acceptor saccharide, column 12, lines 20-28) in an acidic solution to form a first hydrophilic coating on a surface of the lens (column 2, lines 11-34), wherein the acidic solution comprises polyacrylic acid and a first polar solvent (column 1, lines 35-39 (carbohydrate)); and soaking the lens having the first hydrophilic coating in a hydrophilic solution to form a second hydrophilic coating on the first hydrophilic coating (i.e., a surface coating (first hydrophilic coat), see Abstract) column 3, lines 22-26; and one or more hydrophilic macromonomers (e.g., second coatings), column 22, lines 45-49, also see column 1, lines 25-31), wherein the hydrophilic solution comprises polyvinylpyrrolidone, poloxamine, poloxamer, methylcellulose, hydroxypropyl methylcellulose, carboxymethyl cellulose, ascorbic acid, poly(2-methacryloyloxyethyl phosphorylcholine), hyaluronic acid, alginic acid, polyglutamic acid, carbohydrate, or combinations thereof (e.g., a hydrophilic group, for example a carboxy, carbamoyl, sulfate, sulfonate, phosphate, amine, ammonium, acetate or hydroxy group, column 2, lines 14-32), and a second polar solvent (e.g., polar solvent such as DMSO, column 12, lines 1-7), and the carbohydrate comprises monosaccharide, disaccharide, or a combination thereof (column 1, lines 35-42).
Chabrecek fails explicit teaching of a second hydrophilic coating.
However, in a related field of endeavor Turner teaches It is also possible to use more than one layer of coating, column 3, line 40, and the coating conditions can be arranged such that the lens substrate is highly swollen, column 4, lines 15-17.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Chabrecek such that it is possible to use more than one layer of coating (second coating), and the coatings can be arranged accordingly as taught by Turner such that hydrophilic coatings will not swell so dramatically under any conditions.
Regarding claim 18, Chabrecek teaches the hydrophilic solution comprises the carbohydrate, and a weight percentage of the carbohydrate in the acidic solution is from 0.05% to 10% (e.g., a carbohydrate having, for example, from 2 to 20 and preferably from 2 to 10 saccharide units (0.02% to 0.2%, column 2, lines 45-49).
Furthermore, it has held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 19, Chabrecek teaches the hydrophilic solution has a pH of 1 to 14 (e.g., a reaction mixture (hydrophilic solution) containing 45 mL Hepes buffer, 100 mM, pH=7.0, column 29, lines 34-35).
Regarding claim 20, Chabrecek teaches soaking the lens having the first hydrophilic coating in the hydrophilic solution is performed at a temperature of 20° C. to 90° C (i.e., after incubation (of the reaction mixture (hydrophilic solution) for 10 minutes at 37° C. the reaction is stopped by the addition of 1 mL H2O, column 29, lines 34-43).
Regarding claim 21, Chabrecek teaches the carbohydrate comprises glyceraldehyde, dihydroxyacetone, erythrose, ribose, deoxyribose, arabinose, xylose, lyxose, idose, glucose, fructose, galactose, mannose, rhamnose, sedoheptulose, mannoheptulose, sucrose, trehalose, lactose, maltose, or combinations thereof (i.e., carbohydrates selected from the group consisting of galactose, mannose, fucose, galactosamine, N-acetyl galactosamine, N-acetyl glucosamine, ialic acid and an oligosaccharide comprising one or more of the afore-mentioned arbohydrates, column 1, lines 37-43).
Allowable Subject Matter
Claims 6 and 17 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 6, the prior art does not teach, or renders obvious, regarding the second hydrophilic coating comprises the polyvinylpyrrolidone and the carbohydrate, and a weight ratio of the polyvinylpyrrolidone to the carbohydrate is ranged from 1:0.01 to 1:10.
Regarding claim 17, the prior art does not teach, or renders obvious, regarding the hydrophilic solution comprises the polyvinylpyrrolidone, and a weight percentage of the polyvinylpyrrolidone is ranged from 0.05% to 10%.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Lee et al. (US PUB 2012/0058355) teaches “a hydrophilic coating can be applied to virtually any surface to produce a long-lasting, durable antifog effect. The coating can be biocompatible. The coating includes a molecular-level blend of hydrophilic polymers. The coating can be assembled using a layer-by-layer assembly process. “, see Abstract.
Winterton et al. (US 6793973) teaches “a method of treating polymeric materials, such as biomedical devices and contact lenses. In particular, the present invention is directed to a method of altering the hydrophobic or hydrophilic nature of the polymeric surface of a biomedical device by applying a single-dip polyionic solution to form a layer-by-layer-like coating thereon”, see column 1, lines 8-14.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MUSTAK CHOUDHURY whose telephone number is (571)272-5247. The examiner can normally be reached on M-F 8AM-5PM EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ricky Mack can be reached on (571)272-2333. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MUSTAK CHOUDHURY/Primary Examiner, Art Unit 2872
February 28, 2026