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 .
Claim Status
Applicants’ amendments and arguments filed 10/08/2025 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
Claims 8, 16, and 25 remain withdrawn.
Claims 2, 7, 10, 15, 18-19 and 24 remain cancelled.
Claims 1, 9, and 17 are amended.
Claims 1, 3-6, 9, 11-14, 17, and 20-23 are under current examination.
New Rejections Necessitated by Claim Amendments
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.
Claims 1 and 3-6 are rejected under 35 U.S.C. 103 as being unpatentable over Haruna et al. (JP2003146891A, published 05/21/2003, hereafter Haruna) in view of Akayi et al. (Ayaki, Masahiko & Iwasawa, Atsuo & Niwano, Yoshimi. (2011). Cytotoxicity assays of new artificial tears containing 2-methacryloyloxyethyl phosphorylcholine polymer for ocular surface cells. Japanese journal of ophthalmology. 55. 541-6. 10.1007/s10384-011-0073-8., hereafter Ayaki).
Haruna teaches a safe cleaning agent for the eye and nose mucous membrane, having a high cell-protecting effect and easy to use (abstract; according to the claim limitations of the instant claim 1). Haruna further teaches the cleaning agent for the eye or nose mucous membrane is characterized by zinc or a zinc salt (abstract; according to the claim limitations of the instant claim 1). Haruna disclose zinc salts such as zinc sulfate and zinc lactate have astringent and anti-inflammatory effects as their main effects, and are widely used in eye drops as astringents and anti-inflammatory agents (paragraph 0006; according to the claim limitations of the instant claim 1). Furthermore, Haruna teaches a cleansing agent for ocular mucosa or nasal mucosa, characterized by containing zinc or a zinc salt and a surfactant, in which the zinc salt is selected from one or more zinc gluconate, zinc citrate, zinc 2-oxoglutarate, and zinc acetate and in addition to a second a zinc salt containing zinc sulfate, zinc lactate, zinc chloride (paragraph 0006; according to the claim limitations of the instant claim 1). The amount of the zinc salt or the like used in the detergent of the present invention varies depending on the mode of the composition, the method of application, the type of compound, etc., but is usually in the range of 0.0001 to 5% (paragraph 0007; according to the claim limitations of the instant claim 1). Specifically, from the aspect of local irritation and astringent action of zinc salt, in in the case of an eye wash, 0.0001 to 5%, preferably 0.0005 to 2% (paragraph 0007; according to the claim limitations of the instant claim 1). Haruna teaches that the pH or osmotic pressure can be adjusted using a buffer, preferably borate buffers, phosphate buffers, carbonate buffers, and citrate buffers (paragraph 00043; according to the claim limitations of the instant claim 1). Haruna further teaches the composition of the present invention contains various components (including a pharmacologically active ingredient and a physiologically active ingredient) in addition to the above-mentioned zinc salt, a surfactant and a cooling agent, as long as the effects of the present invention are not impaired and in which the ingredients may be contained in combination (paragraph 0022; according to the claim limitations of the instant claim 4). The type of such components is not particularly limited, and examples include decongestant components, α-adrenergic agonist components, anti-inflammatory drug components, vitamins (paragraph 0022; according to the claim limitations of the instant claim 4). For example, vitamin A [e.g. retinal, retinol pharmacologically acceptable salts thereof], Vitamin Bs [thiamine hydrochloride, thiamine nitrate, bisthiamine nitrate, thiamine disulfide, thiamine dicetyl nitrate ester salt, dicetiamine hydrochloride, fursultiamine hydrochloride, octotiamine, shicothiamine, bis-ibutyamine, bisbentiamine, fursultiamine, pro Sultiamine, benfotiamine, flavin adenine dinucleotide sodium, riboflavin, sodium riboflavin phosphate, riboflavin butyrate, pyridoxine hydrochloride, pyridoxal phosphate, hydroxocobalamin hydrochloride, hydroxocobalamin acetate, cyanocobalamin, hydroxocobalamin, nicotinic acid, nicotinic acid amide, vitamin C [ascorbic acid and its derivatives, erythorbic acid and its derivatives, and pharmacologically acceptable salts thereof (e.g., sodium ascorbate, sodium erythorbate, etc.]], vitamin D [Erg ergocalciferol, cholecalciferol, hydroxycholecalciferol, dihydroxycholecalciferol, dihydrotaki Sterols and pharmaceutically acceptable salts thereof, etc.], vitamin Es [e.g. tocopherol and its derivatives, ubiquinone derivatives and pharmaceutically acceptable salts thereof (tocopherol acetate, tocopherol nicotinate, tocopherol succinate) , Tocopherol calcium succinate, etc.) (paragraph 0026; according to claim limitations of the instant claim 4). Haruna teaches the amounts of these components in the cleansing agent of the present invention are appropriately selected depending on the type of formulation, the type of active ingredient, etc., and the amounts of various components in the cleansing agent for eye mucous membranes and nasal mucosa are known in the art (paragraph 0031; according the claim limitations of the instant claim 4-5). Haruna teaches the Vitamins: For example, 0.0001-1%, preferably 0.0001-0.5% (paragraph 0032; according to the claim limitations of the instant claims 4-6). Lastly, Haruna teaches the addition of hyaluronic acid as a thickener, a polysaccharide, and a sugar additives (paragraphs 0028, 0030, and 0035; according to the claim limitations of the instant claim 1). Lastly, Haruna teaches concentration of polysaccharide or derivative thereof to be 0.0001-2% ([0032]; according to the claim limitations of the instant claim 1).
Although Haruna teaches the addition of hyaluronic acid fails to explicitly teach the addition of a hydrophilic substance, such as a substance comprising 2-methacryloyloxyethyl phosphorylcholine or polymers of phosphorylcholine or a combination thereof as in the instant claim 1. Further, although Haruna teaches the concentration of polysaccharide, it fails to explicitly teach the concentration range of a hydrophilic substance comprising 2-methacryloyloxyethyl phosphorylcholine or polymers of phosphorylcholine or a combination thereof as in the instant claim 1.
Ayaki teaches the cytotoxicity of new artificial tears containing 2-methacryloyloxyethyl phosphorylcholine polymer (MPC) (title and abstract). Ayaki teaches the MPC polymer-containing eye drops are the first such ophthalmic product to be commercially available and they contain approximately 0.1% Lipidure-PMB (copolymer of MPC and butyl methacrylate) (abstract). Further, Ayaki teaches MPC eye drops were tolerable to ocular surface cells, and comparable to single doses of clinically approved drugs containing sodium hyaluronate (page 541, conclusion).
One skilled in the art before the effective filing date of the claimed invention would claim an ophthalmic composition comprising a buffer solution, a zinc salt comprising zinc sulfate and zinc lactate, and a vitamin as outlined by Haruna with the ready improvement of adding a hydrophilic substance, such as MPC as outlined by Ayaki, as claimed by the instant claim 1. As outlined by Ayaki, one skilled in the art would be motivated to add the improvement of MPC as it is more tolerable to the ocular surface in ophthalmic products than other approved drugs. Haruna further teaches a concentration of zinc salt that overlaps the ranges that are claimed by instant claim 1. Therefore, it would be obvious to claim a composition comprising a buffer solution, a zinc salt comprising zinc sulfate and zinc lactate at the desired concentration, with the ready improvement of a hydrophilic substance comprising hyaluronic acid and PEG 400 as claimed in instant claim 1 as it would yield predictable results. Furthermore, Haruna discloses the addition of a vitamin, specifically vitamin A and its derivatives, vitamin B3 and its derivatives, vitamin B12 and its derivatives, vitamin C and its derivatives, and vitamin E and its derivatives, or combinations, therefore making it of obvious to claim this addition to an ophthalmic solution as in instant claims 4 and 5. Additionally, Haruna discloses a concentration of the additional vitamin that is encompassed by the instant claim 6 thus making it obvious to claim. Lastly, Ying teaches a concentration of MPC that lies within the range of instant claim 1 thus making it of obviousness to claim.
Claims 9, 11-14, 17, and 20-23 are rejected under 35 U.S.C. 103 as being unpatentable over Haruna et al. (JP2003146891A, published 05/21/2003, hereafter Haruna), in view of Akayi et al. (Ayaki, Masahiko & Iwasawa, Atsuo & Niwano, Yoshimi. (2011). Cytotoxicity assays of new artificial tears containing 2-methacryloyloxyethyl phosphorylcholine polymer for ocular surface cells. Japanese journal of ophthalmology. 55. 541-6. 10.1007/s10384-011-0073-8., hereafter Ayaki), and in view of Mizutare et al. (US20170105934A1, published 04/20/2017, hereafter Mizutare).
As mentioned above Haruna in view of Ayaki teaches an ophthalmic composition comprising a buffer solution, a zinc salt at the desired concentration, a vitamin or combination of vitamins at the desired concentration, and a hydrophilic substance comprising MPC at the desired concentration.
Although Haruna discloses the addition of B vitamins as mentioned above, both Haruna and Ayaki do not expressly disclose including a vitamin B2 species such as flavin mononucleotide. Mizutare remedies this deficiency.
Mizutare discloses an aqueous ophthalmic composition is provided comprising at least one component which is selected from the group consisting of a polysaccharide, a monosaccharide, at least one vitamin component selected from the group consisting of vitamin B12, vitamin B2, vitamin A (abstract; according to the claim limitations of the instant claims 9, 11-14, 17, and 20-23). Mizutare teaches an aqueous ophthalmic composition refers to all aqueous compositions related to ophthalmology such as eye drops (having the same significance as ophthalmic liquid or ophthalmic pharmaceutical agent), eye wash (having the same significance as eye-washing liquid or eye-washing pharmaceutical agent), liquid for wearing contact lenses, liquid for washing contact lenses, liquid for storing contact lenses, and disinfectant liquid for contact lenses (paragraph 0022; according to the claim limitations of the instant claims 9, 11-14, 17, and 20-23). Mizutare discloses in the aqueous ophthalmic composition, it is possible to use, as the (A) component, at least one kind which is selected from the group consisting of a polysaccharide; a monosaccharide; at least one vitamin selected from the group consisting of vitamin B.sub.12, vitamin B2, vitamin A, and panthenol (paragraph 0023; according to the claim limitations of the instant claims 9, 11-14, 17, and 20-23). The water-soluble vitamin may be, for example, at least one kind selected from the group consisting of vitamin B2 such as riboflavin, flavin mononucleotide, flavin adenine dinucleotide, riboflavin butyrate, riboflavin tetrabutyrate, riboflavin 5′-phosphate sodium, riboflavin tetranicotinate, and salts thereof ([0030]). Mizutare teaches the total content of the vitamin relative to the total amount of the aqueous ophthalmic composition is suitably set in accordance with the kinds of the (A) components and the kinds and content of other blended components (paragraph 0054; according to the claim limitations of the instant claims 9, 11-14, 17, and 20-23). From the viewpoint of producing the effects more conspicuously, the total content of the vitamin is preferably from 0.00001 w/v % to 1.6 w/v % (paragraph 0054; according to the claim limitations of the instant claims 9, 11-14, 17, and 20-23). Mizutare et al disclose the buffering agent of the (B) component may be either an inorganic buffering agent or an organic buffering agent (paragraph 0067; according to the claim limitations of the instant claims 9, 11-14, 17, and 20-23). The inorganic buffering agent of the (B) component of the present invention is preferably boric acid or a salt of boric acid (paragraph 0068; according to the claim limitations of the instant claims 9, 11-14, 17, and 20-23).
One skilled in the art before the effective filing date of the claimed invention would claim an ophthalmic composition comprising a buffer solution, a zinc salt comprising zinc sulfate and zinc lactate, and a vitamin as outlined by Haruna with the ready improvement of adding a hydrophilic substance comprising MPC as outlined by Ayaki with the simple substitution of B2 and its derivatives as outlined in the ophthalmic composition disclosed by Mizutare. Haruna teaches the addition of B vitamins, therefore the simple substitution of B2 and its derivatives for the vitamin, specifically the vitamin B would be a functional equivalent as demonstrated by Haruna, Ayaki, and Mizutare. Therefore, it would be obvious to claim a composition comprising a buffer solution, a zinc salt comprising zinc sulfate and zinc lactate, vitamins to include B2 and its derivatives, and a hydrophilic substance comprising hyaluronic acid and PEG 400 as in instant claims 9, 11-14, 17, and 20-23.
Response to Applicant’s Arguments
Applicants’ arguments filed 02/09/2026 have been fully considered. Applicant’s amendments have necessitated new grounds of rejection, therefore the previous rejections have been withdrawn.
Conclusion
No claims allowed.
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.
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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
/A.N.I./ Examiner, Art Unit 1611
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