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 .
Examiner Note
In view of the amendments and applicant's remarks filed on 06/01/2026 pages 1-2 have been considered and are persuasive thereby claim objections are hereby withdrawn.
Response to Arguments
Applicant's arguments filed 06/01/2026 have been fully considered but they are not persuasive.
Applicant’s substantive arguments are as follows:
(1) Applied art Chabrecek fails to disclose "a hydrophilic coating comprising polyacrylic acid and carbohydrate that are attached to a surface of the lens by hydrogen bonding, ionic bonding, or a combination thereof' recited in claims 1 and 8 of the present disclosure.
(2) It can be seen from column 2, lines 11-28, of Chabrecek that the bulk material (the Office Action corresponds it to the claimed lens) can include polyacrylic acid, and therefore the polyacrylic acid of Chabrecek cannot be seen as a "coating layer" on the surface of the bulk material. Accordingly, Chabrecek fails to disclose the hydrophilic coating comprising polyacrylic acid and carbohydrate recited in claims 1 and 8 of the present disclosure.
(3) Dependent claims are allowable because they directly or indirectly depend from an allowable base claim.
The examiner respectfully disagrees with applicants’ arguments regarding independent claim(s) 1 and 8.
Examiner’s responses to Applicant’s arguments are as follows:
It is respectfully pointed out that the applied prior art is considered to meet all of Applicant’s limitations per rejections below. Most responses to arguments are addressed in rejections below.
(1) Further, for clarification and support examiners position, applicant’s attention is respectfully requested to Chabrecek reference which also teaches “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.
(2) Chabrecek reference further teaches “covalently linking to the material surface specific carbohydrates which mimic a biological surface appropriate for cell attachment and, especially in case of contact lenses, provide high wettability, lubricity, water retention, on-eye comfort. column 1, lines 26-34 and “The hydrophilic groups are inherently present in the bulk material and therefore also at the surface of a ophthalmic device manufactured therefrom. Such materials are known to the skilled artisan and comprise for example polyhydroxyethyl acrylate, polyhydroxyethyl methacrylate (HEMA), polyvinyl pyrrolidone (PVP), polyacrylic acid,” column 2, lines 16-24.
(3) Dependent claims are not allowable because they directly or indirectly depend from rejected base claim.
Therefore, one of ordinary skill in the art would recognize that the teachings of Chabrecek in view of Turner substantially satisfy the limitations of claims 1 and 8. Thus, in view of the above reasons, Examiner maintains rejections.
The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
While the amendments to claims 1 and 8 as presented do not present allowable subject matter, in the interest of compact prosecution, examiner feels that a further interview may help to expedite prosecution of the application.
Examiner is available for an interview at Applicant's convenience at the number below should Applicant wish to discuss the case further.
Cited prior art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. U.S. Pre Grant Publication No. 2002/0086160; Qiu et al. teaches “a coating process is provided that can be utilized to deposit polyionic materials onto a substrate to form polymeric tie layers having functional groups thereon so that additional active agents can be attached thereto. In one embodiment, for example, a process of the present invention allows the deposition of a bicomponent polyionic solution to a biomaterial substrate, such as a contact lens”., paragraph 0016.
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.
Claims 1-3 and 8-15 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), comprising: a lens (e.g., an ophthalmic lens substrate, see Abstract); and a hydrophilic coating comprising polyacrylic acid and carbohydrate (column 1, lines 35-39 (carbohydrate) and column 2, lines 16-24 (polyacrylic acid)) that are 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 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 covalent bonding, however fails explicit teaching of hydrogen bonding, ionic bonding, or a combination thereof.
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 carbohydrates, 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 8, Chabrecek teaches a manufacturing method of a contact lens (see column 1, lines 25-31), 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)), 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), hydrophilic coating comprising polyacrylic acid and carbohydrate (column 1, lines 35-39 (carbohydrate) and column 2, lines 16-24 (polyacrylic acid)) that are 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).
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).
Chabrecek teaches covalent bonding, however fails explicit teaching of hydrogen bonding, ionic bonding, or a combination thereof.
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 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 in view of Turner 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).
Allowable Subject Matter
Claims 4-7 and 16-21 are allowed.
The following is an examiner's statement of reasons for allowance: The closest prior art Chabrecek taken either singularly or in a combination fails to anticipate or fairly suggest the limitations of the independent claims, in such a manner that rejection under 35 U.S.C. 102 or 103 would be proper. The prior art fails to teach a combination of all the claimed features as presented in independent claims 4 and 16, for example:
Claim 4 relates to “a first hydrophilic coating attached to a surface of the lens by hydrogen bonding, ionic bonding, or a combination thereof, wherein the first hydrophilic coating comprises polyacrylic acid; and a second hydrophilic coating disposed on the first hydrophilic coating and attached to the first hydrophilic coating by hydrogen bonding, ionic bonding, or a combination thereof”.
Claim 16 relates to “soaking the lens having the first hydrophilic coating in a hydrophilic solution to form a second hydrophilic coating on the first hydrophilic coating, the second hydrophilic coating attached to the first hydrophilic coating by hydrogen bonding, ionic bonding, or a combination thereof.”
Claims 3-7 and 17-21 depend from either allowable claim 4 or 16 are also allowed.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance”.
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 extension fee 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 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 5712722333. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MUSTAK CHOUDHURY/Primary Examiner, Art Unit 2872
July 21, 2026
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