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 .
DETAILED ACTION
Claims 1-10 are pending. Note that, Applicant’s amendment and arguments filed June 23, 2026, have been entered.
Objections/Rejections Withdrawn
The following objections/rejections as set forth in the Office action mailed 5/19/26 have been withdrawn:
None.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
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.
Claim 1-6 and 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Barniak et al (US2022/0290072) in view of CN109562183.
With respect to independent, instant claim 1, Barniak et al teach a contact lens treating solution includes (a) about 0.005 to about 2 wt. %, based on the total weight of the contact lens treating solution, of hyaluronic acid or a salt thereof; (b) about 0.01 to about 1 wt. %, based on the total weight of the contact lens treating solution, of erythritol; (c) one or more nonionic surfactants; (d) sodium chloride, potassium chloride or any combination thereof; and (e) one or more buffers. See Abstract. The one or more buffers are present in a contact lens treating solution disclosed herein in an amount ranging from about 0.1 to about 10% (w/w). In another illustrative embodiment, the one or more buffers are present in a contact lens treating solution disclosed herein in an amount ranging from about 0.5 to about 5% (w/w). See para. 33. In general, hyaluronic acid or a salt thereof such as sodium hyaluronate and potassium hyaluronate can have from about 2 to about 1,500,000 disaccharide units. In an embodiment, hyaluronic acid or a salt thereof can have a weight average molecular weight ranging from about 10,000 to about 3,000,000 Daltons (Da) in which the lower limit is from about 10,000, about 20,000, about 30,000, about 40,000, about 50,000, about 60,000, about 70,000, about 80,000, about 90,000, about 100,000, about 200,000, about 300,000, about 400,000, about 500,000, or about 600,000 Da, and the upper limit is about 200,000, about 300,000, about 400,000, about 500,000, about 600,000, about 700,000, about 800,000, about 900,000, about 1,000,000, or about up to 2,800,000 Da, where any of the lower limits can be combined with any of the upper limits. See para. 18. The contact lens treating solution disclosed herein contains one or more antimicrobial agents. Various antimicrobial agents are known for use as preservatives in ophthalmic compositions. See para. 18 and para. 34.
The type of lens to be contacted with the contact lens treating solutions disclosed herein is not critical and any lens is contemplated. Representative examples of such lenses include, but are not limited to, soft contact lenses, e.g., a soft, hydrogel lens; soft, non-hydrogel lens and the like, hard contact lenses, e.g., a hard, gas permeable lens material and the like, rigid gas permeable (RGP) lenses, intraocular lenses, overlay lenses, and the like. See para. 72. The contact lens treating solution disclosed herein may further contain one or more comfort or cushioning components. The comfort component can enhance and/or prolong the cleaning and wetting activity of the surfactant component and/or condition the lens surface rendering it more hydrophilic (less lipophilic) and/or to act as a demulcent on the eye. The comfort component is believed to cushion the impact on the eye surface during placement of the lens and serves also to alleviate eye irritation. Suitable comfort components include, for example, water soluble natural gums, cellulose-derived polymers and the like. Useful natural gums include guar gum, gum tragacanth and the like. Useful cellulose-derived comfort components include cellulose-derived polymers, such as hydroxypropyl cellulose, hydroxypropylmethyl cellulose, carboxymethyl cellulose, methyl cellulose, hydroxyethyl cellulose and the like. Some non-cellulose comfort components include propylene glycol or glycerin. The comfort components can be present in the solution in an amount ranging from about 0.01% to about 1% (w/w). See para. 65-66. The pH of the contact lens treating solutions and/or compositions disclosed herein may be maintained within the range of pH of about 4.0 to about 9.0, or about 5.0 to about 8.0, or about 6.0 to about 8.0, or about 6.5 to about 7.8. In an embodiment, pH values of greater than or equal to about 7 at most. See para. 78. The composition may also contain amphoteric surfactants, chelating agents, viscosity modifying agents, etc. Se para. 59.
Barniak et al do not teach the use of the specific hydrolyzed hyaluronic acid derivative as recited by formula (I) or a composition containing a salt of hyaluronic acid, the specific hydrolyzed hyaluronic acid derivative as recited by formula (I), and the other requisite components of the composition in the specific amounts as recited by independent, instant claim 1 and the respective dependent claims.
‘183 teaches a liquid preparation for soft contact lenses, more particularly hydrogel contact lenses or silicone hydrogel contact lenses. The liquid preparation according to the present invention for contact lenses comprises a hydrolyzed hyaluronic acid derivative which has a monoether of a linear or branched alkyl or alkenyl group carrying 6-20 carbon atoms, inclusive, with glycerol in a side chain. The liquid preparation according to the present invention for soft contact lenses may comprise one or more kinds of cationic bactericides selected from the group consisting ofalexidine salt-based, chlorohexidine salt-based, polyhexamethylene biguanide salt-based and quaternary ammonium salt-based cationic bactericides. The liquid preparation according to the present invention for soft contact lenses can inhibit the adsorption of the cationic bactericide(s) on a soft contact lens and prevent the onset of corneal staining in a wearer. See Abstract. The contact lens liquid preparation of the present invention ls an aqueous liquid preparation is characterized in that it contains a hydrolyzed hyaluronic acid derivative with a specific structure as a moisturizer, which is the same as recited by the instant claims. The hydrolyzed hyaluronic acld derivative (alkylglycerol hydrolyzed hyaluronate) of a specific structure used invention can exert a higher hydrophilicity-imparting effect than hyaluronic acid, and can also inhibit the adsorption of cationic bactericides on contact lenses. Preferably, the content of the hydrolyzed hyaluronlc acid derivative in the solvent for contact lens of the present invention is 5 ppm or more and 5000 ppm or less. See paras. 19-22.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to use the specific hydrolyzed hyaluronic acid derivative as recited by the instant claims in the composition taught by Barniak et al, with a reasonable expectation of success, because ‘183 teaches that the use of the specific hydrolyzed hyaluronic acid derivative as recited by the instant claims in a similar composition provides moisturizing benefits and can inhibit the absorption of cationic bactericides on contact lenses and further, such properties would be desirable in the composition taught by Barniak et al.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to formulate a composition containing a salt of hyaluronic acid, the specific hydrolyzed hyaluronic acid derivative as recited by formula (I), and the other requisite components of the composition in the specific amounts as recited by independent, instant claim 1 and the respective dependent claims, with a reasonable expectation of success and similar results with respect to other disclosed components, because the broad teachings of Barniak et al in view of ‘183 suggest a composition containing a salt of hyaluronic acid, the specific hydrolyzed hyaluronic acid derivative as recited by formula (I), and the other requisite components of the composition in the specific amounts as recited by independent, instant claim 1 and the respective dependent claims.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Barniak et al (US2022/0290072) in view of CN109562183 as applied to claims 1-6 and 8-10 above, and further in view of WO2024/058212.
Barniak et al are relied upon as set forth above. However, Barniak et al do not teach the use of alginic acid in addition to the other requisite components of the composition as recited by the instant claims.
‘212 teaches a contact lens solution that imparts surface hydrophilicity and anti-fouling properties to a contact lens. See para. 1. The contact lens solution may contain an additive in amounts from 0.01% to 5% by weight, wherein suitable additives include thickeners, inorganic salts, stabilizers, etc. Suitable thickeners include alginic acid, etc. See paras. 16-19.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to use alginic acid in the composition taught by Barniak et al, with a reasonable expectation of success, because ‘212 teaches the use of alginic acid as a thickener in a similar composition and further, Barniak et al teach the use of viscosity modifying agents (i,e., thickeners) in general.
Response to Arguments
With respect to the rejection of the instant claims under 35 USC 103 using Barniak et al in view of CN109562183, Applicant states that the problems to be solved by Barniak et al and CN' 183 are both different from those of this present application, and neither Barniak et al nor CN' 183 teaches or suggests contact lens packaging solutions containing both hyaluronic acid salts and hydrolyzed hyaluronic acid derivatives, and a weight ratio of the salt of hyaluronic acid and the hydrolyzed hyaluronic acid derivative is in the range of 1:4 to 4:1 as recited by the instant claims. Additionally, Applicant states that ‘183 discloses that "a hydrolyzed hyaluronic acid derivative with a specific structure (low molecular weight hyaluronic acid derivative) has a higher hydrophilicity imparting effect compared with hyaluronic acid, and can also inhibit the adsorption of commonly used bactericides on soft contact lenses, thereby completing the present invention” and that ‘183 not only fails to explicitly describe or substantially imply the suggestion of using hydrolyzed hyaluronic acid derivatives to replace hyaluronic acid to increase the wetness of contact lenses disclosed by Barniak et al, but also teaches away to use hyaluronic acid in the liquid preparation for contact lenses.
In response, note that, the Examiner asserts that ‘183 teaching that a hydrolyzed hyaluronic acid derivative has a higher hydrophilicity imparting effect compared with hyaluronic acid, and can also inhibit the adsorption of commonly used bactericides on soft contact lenses, does not constitute a teaching away from hyaluronic acid, and rather implies that the hyaluronic acid derivative is more preferred than hyaluronic acid. The Examiner asserts that ‘183 is merely teaching that a hydrolyzed hyaluronic acid derivative has some beneficial properties that may exceed some of the properties of hyaluronic acid. Note that, the Examiner asserts that ‘183 is analogous prior art relative to the claimed invention and Barniak et al since it is drawn to the same field of endeavor and that one of ordinary skill in the art clearly would have looked to the teachings of ‘183 to cure the deficiencies of Barniak et al. ‘183 is a secondary reference relied upon for its teaching of the specific hydrolyzed hyaluronic acid derivative as recited by formula (I). Note that, Barniak et al is the primary reference which clearly teaches the use of hyaluronic acid. The Examiner asserts that one of ordinary skill in the art clearly would have been motivated to use the specific hydrolyzed hyaluronic acid derivative as recited by the instant claims in the composition taught by Barniak et al, with a reasonable expectation of success, because ‘183 teaches that the use of the specific hydrolyzed hyaluronic acid derivative as recited by the instant claims in a similar composition provides moisturizing benefits and can inhibit the absorption of cationic bactericides on contact lenses and further, such properties would be desirable in the composition taught by Barniak et al. Note that, ‘183 suggests, for example, 0.1% (i.e., 1000ppm) of the specific hydrolyzed hyaluronic acid derivative, and Barniak et al suggest, for example, 0.1% by weight of a salt of hyaluronic acid, which would result in a weight ratio of salt of hyaluronic acid to specific hydrolyzed hyaluronic acid derivative of 1:1 and fall within the scope of the instant claims. Thus, the Examiner asserts that the teachings of Barniak et al in view of ‘183 are sufficient to render the claimed invention obvious under 35 USC 103.
With respect to the rejection of instant claim 7 using Barniak et al in view of CN109562183, further in view of WO2024/058212, Applicant states that the teachings of Barniak et al in view of ‘183 are not sufficient to suggest the claimed invention and that the teachings of ‘212 are not sufficient to remedy the deficiencies of Barniak et al in view of ‘212. In response, note that, the Examiner asserts that the teachings of Barniak et al in view of ‘183 are sufficient to suggest the claimed invention for the reasons set forth above. Additionally, the Examiner asserts that ‘212 is analogous prior art relative to the claimed invention and Barniak et al and that one of ordinary skill in the art clearly would have looked to the teachings of ‘212 to cure the deficiencies of Barniak et al in view of ‘183 with respect to instant claim 7. ‘212 is a secondary reference relied upon for its teaching of alginic acid. The Examiner asserts that one of ordinary skill in the art clearly would have been motivated to use alginic acid in the composition taught by Barniak et al, with a reasonable expectation of success, because ‘212 teaches the use of alginic acid as a thickener in a similar composition and further, Barniak et al teach the use of viscosity modifying agents (i,e., thickeners) in general. Thus, the Examiner assets that the teachings of Barniak et al in view of CN109562183, further in view of WO2024/058212, are sufficient to render the claimed invention obvious under 35 USC 103.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GREGORY R DEL COTTO whose telephone number is (571)272-1312. The examiner can normally be reached M-F, 8:30am-6:00pm, EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Angela Brown-Pettigrew can be reached at (571) 272-2817. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/GREGORY R DELCOTTO/Primary Examiner, Art Unit 1761
/G.R.D/August 25, 2026
Prosecution Insights