DETAILED ACTION
Previous Rejections
Applicant’s arguments, filed May 21, 2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Status
Claims 6 – 16 are newly added.
Claims 1 – 16 are examined here-in.
Claim Objections
Claim 9 is objected to because of the following informalities:
Claim 9 does not include units for molecular weight.
Appropriate correction is required.
Claim Rejections - 35 USC § 103 (New, Necessitated by Amendment)
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 non-obviousness.
Claims 1 – 16 are rejected under 35 U.S.C. 103 as being unpatentable over Matsumura (US 2018/0161438 A1).
Matsumura teaches an aqueous ophthalmic composition which contains a vinyl-based polymer to reduce ocular discomfort by increasing fluids on the eye surface (abstract, paragraphs 0007 – 0008, 0010, 0012).
Matsumura teaches polyvinylpyrrolidone as vinyl-based polymer, with polyvinylpyrrolidone K25 and K90 being most preferred (paragraphs 0021, 0053 – 0054).
Matsumura teaches the inclusion of saccharides such as cellulose, cellulose polymers, hyaluronic acid, chondroitin sulfate, or their salts (paragraphs 0020, 0059 – 0060, 0070 – 0072). For cellulose-based polymer compounds, Matsumura teaches methyl cellulose, ethyl cellulose, hydroxyethyl cellulose, and others (paragraphs 0062 – 0066).
Matsumura teaches the inclusion of inorganic salt zinc chloride (paragraph 0024).
Matsumura teaches the total amount of vinyl-based polymer, saccharide, and inorganic salt is from 0.0000001 to 25 w/v % of the total composition (paragraph 0051). Matsumura teaches polyvinylpyrrolidone in an amount from 0.001 to 25 w/v % of the total composition (paragraph 0056 – 0057). Matsumura teaches the content of mucopolysaccharide in the composition is from 0.0001 to 5 w/v % (paragraphs 0073 – 0075). Matsumura teaches the content of zinc chloride inorganic salt is from 0.00001 to 0.1 w/v % (paragraph 0121).
Matsumura teaches the composition also includes a buffer, which may be a borate buffer including boric acid and borax (paragraphs 0015, 0160 - 0162). Matsumura teaches inclusion of buffer in the amount of 0.001 to 10 w/v % of the total solution (paragraphs 0164 – 0165).
Matsumura teaches the aqueous ophthalmic composition reduces eye dryness (paragraphs 0199 – 0201).
Claims 1 – 16 are rendered prima facie obvious over the teachings of Matsumura, because it is prima facie obvious to combine prior art elements according to known methods, in order to yield predictable results. In the instant case, all the claimed elements (e.g., zinc chloride, polyvinyl pyrrolidine, saccharides, buffers) were known in the prior art (e.g., ophthalmic compositions) and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results (e.g., an ophthalmic composition that relieves dry eye) to one of ordinary skill in the art (MPEP 2143(i)(a)).
Matsumura’s teaching for an ophthalmic composition with inorganic salt zinc chloride, a vinyl-based polymer, and mucopolysaccharides (abstract, paragraphs 0007 – 0008, 0010, 0012, 0020 - 0021, 0024, 0051, 0053 – 0054, 0059 – 0060, 0070 – 0072) reads on instant claim 1. Matsumura does not teach the composition contains rebamipide, therefore a person of ordinary skill in the art would be motivated not to include rebamipide.
Matsumura’s teaching for polyvinylpyrrolidone as vinyl-based polymer, with polyvinylpyrrolidone K25 and K90 being most preferred (paragraphs 0021, 0053 – 0054) reads on instant claims 2 and 4.
Matsumura’s teaching for polyvinylpyrrolidone in an amount from 0.001 to 25 w/v % of the total composition (paragraph 0056 – 0057) reads on instant claims 3 and 10 which recite 0.001 to 5 and 0.0001 to 10 w/v%, respectively. Claimed ranges that overlap teachings of the prior art are prima facie obvious according to MPEP 2144.05(i).
Matsumura’s teaching that the aqueous ophthalmic composition reduces eye dryness (paragraphs 0199 – 0201) reads on instant claim 5.
Matsumura’s teaching for mucopolysaccharides such as hyaluronic acid, chondroitin sulfate, or their salts (paragraphs 0020, 0070 – 0072) reads on instant claim 6.
Matsumura’s teaching for mucopolysaccharide in the composition in the amount of 0.0001 to 5 w/v % (paragraphs 0073 – 0075) overlaps with the instantly claimed range of 0.001 to 5 w/v % as recited in claim 7. Claimed ranges that overlap teachings of the prior art are prima facie obvious according to MPEP 2144.05(i).
Within Matsumura’s teaching for mucopolysaccharide in the composition in the amount of 0.0001 to 5 w/v % (paragraphs 0073 – 0075) and for zinc chloride inorganic salt in an amount of 0.00001 to 0.1 w/v % (paragraph 0121) there is a range of weight ratios, including most simply a ratio of 0.0001 mucopolysaccharide to 0.00001 parts zinc chloride, which is a ratio of 10:1. This ratio falls within the claimed range of 0.0002 to 2000000 parts mucopolysaccharide to 1 part zinc chloride recited in claim 8.
Matsumura does not teach a specific molecular weight for polyvinyl-based polymer compound, however, a person of ordinary skill in the art would recognize that polymer molecular weight depends on the number of repeats of monomer units, and can be easily modulated by changing the amount of unit repeats. For example, in the case of polyvinylpyrrolidone, the monomer unit is vinylpyrrolidone which has an empirical formula of C6H9NO and molar mass of 111 g/mol. A polymer with a low amount of monomer repeats, such as 25 would therefore have a molecular weight of 2,775 g/mol. A polymer with 90 monomer repeats would have a molecular weight of 9,990 g/mol. A person of ordinary skill in the art would also recognize that a polymer with a greater molecular weight would have a greater viscosity than a polymer of lower molecular weight. With this expertise, a person of ordinary skill in the art would be able to choose a polyvinyl-based polymer with a molecular weight between 5,000 and 5,000,000 as recited in instant claim 9. A person of ordinary skill in the art would be motivated to identify an appropriate polymer molecular weight via routine experimentation to ensure that the viscosity of an ophthalmological composition is sufficiently flowable so that it is easy to apply and would be guided by Matsumura’s teachings regarding polymer K values to starting molecular weights (i.e. PVP K90 has a MW of approximately 360,000 g/mol). Optimization through routine experimentation is prima facie obvious according to MPEP 2144.05(ii)(a).
Within Matsumura’s teaching for polyvinylpyrrolidone in an amount from 0.001 to 25 w/v % of the total composition (paragraph 0056 – 0057) and for zinc chloride inorganic salt in an amount of 0.00001 to 0.1 w/v % (paragraph 0121) there is a range of weight ratios, including most simply a ratio of 0.001 polyvinylpyrrolidone to 0.00001 parts zinc chloride, which is a ratio of 100:1. This ratio falls within the claimed range of 0.002 to 2000000 parts polyvinylpyrrolidone to 1 part zinc chloride recited in claim 11.
Matsumura’s teaching that the composition also includes a buffer, which may be a borate buffer including boric acid and borax in an amount of 0.001 to 10 w/v % of the total solution (paragraphs 0015, 0160 – 0162, 0164 – 0165) reads on instant claims 12 – 14. Matsumura’s teaching for 0.001 to 10 w/v% overlaps on the instantly claimed range of 0.0001 to 10 w/v% recited in claim 14.
Matsumura’s teaching the composition includes cellulose-based polymer compounds such as methyl cellulose, ethyl cellulose, hydroxyethyl cellulose, and others (paragraphs 0062 – 0066) reads on instant claims 15 and 16.
Examiner’s Reply to Attorney Arguments Dated May 21, 2026
Applicant’s arguments have been considered but are moot because the new ground of rejection addresses the claims as presently amended and does not rely on references that were previously applied in the prior rejection of record.
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 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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Toriana N. Vigil whose telephone number is (571)270-7549. The examiner can normally be reached Monday - Friday 9:00 a.m. - 5:00 p.m. EST.
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/TORIANA N. VIGIL/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
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