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 .
Claims 26-40 and 42-54 are presented for examination.
The amendments and remarks filed on 04/18/2025 have been received and entered. Applicant in his remarks
Response to arguments
Applicant’s arguments and remarks have been noted. Applicant in his remarks argues that “Karavas teaches various components claimed in claims 26-40. The pending claims are neither taught nor suggested by Karavas. Applicant notes that the pending claims all require a composition comprising a demulcent, an oil, and hyaluronic acid or a salt thereof, none of which is claimed or suggested in Karavas. I in addition, pending claims 49-54 require specific ingredients in specific amounts, which are not taught or suggested by Karavas”. It is the examiner’s position that applicant attacks the reference individually and argues that the reference does not teach all the components of the claimed invention. Applicant’s attention is drawn to In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981), wherein the court stated “one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references”. The secondary references are relied upon to teach the secondary and the concentrations of each component. Applicant in his remarks further argues that “According to the Office Action, Singh teaches various components claimed in claims 26-
40. The pending claims are neither taught nor suggested by Singh. Currently pending claims 26- 40 and 42-48 all require a specific oil component, which may be flaxseed oil, sea buckthorn seed oil, sea buckthorn pulp oil, perilla seed oil, chia seed oil, pecan nut oil, macadamia nut oil, rosehip seed oil, and anchovy oil, and combinations thereof. None of these oils are taught or suggested by Singh. Singh teaches ophthalmic formulations containing mycophenolic acid or salts or derivatives thereof, in general. (Singh, { [0011].) Although Singh lists myriad excipients that can be used in ophthalmic formulations, there is nothing in Singh pointing to the formulations claimed in the present application that enhance ocular health and improve eye comfort by combining the specific oils with demulcents and specified surfactant”. It is the examiner’s position that the rejection is an obviousness rejection and not anticipation. Applicant is combining all the components used in ophthalmic formulations. Such components are taught by the combination of the relied upon references. Applicant in his remarks further argues that “According to the Office Action, Mizutare teaches various components claimed in claims 26-40. The pending claims are neither taught nor suggested by Mizutare. For example, currently pending claims 26-40 and 42-48 require that the formulations are preservative-free. By contrast, Mizutare specifically teaches ophthalmic compositions including a preservative (Mizutare, Abstract, [0010], | [0011]). Nothing in Mizutare teaches that such compositions would be safe for use without including a preservative, and a person of ordinary skill in the art would not be motivated to modify the compositions of Mizutare to omit a preservative, since an error in preservation of an ophthalmic formulation could result in an unsafe product. In addition, currently pending claims 26-40 and 42-48 all require a specific oil component, which may be flaxseed oil, sea buckthorn seed oil, sea buckthorn pulp oil, perilla seed oil, chia seed oil, pecan nut oil, macadamia nut oil, rosehip seed oil, and anchovy oil, and combinations thereof. None of these oils are taught or suggested by Mizutare”. It is the examiner’s position that applicant attacks each reference individually and argues that the reference does not have all the components of the claimed composition. Karavas and Singh were relied upon that the ophthalmic formulations can be prepared without a preservative. Mizutare teaches all the components of the claimed composition other than certain fatty acids that are taught by core et al. The substitution of Mizutare oil for the claimed oil would have been obvious to a person skilled in the art in the absence of evidence to the contrary. Saebo teaches pecan and anchovies are source of omega fatty acids. It would have been obvious to a person skilled in the art to use the composition of Mizutare preservative free, considering that Karavas and Singh teach that ophthalmic formulation can be prepared in a preservative free formulation. Applicant’s arguments regarding Gore have been noted. Applicant in his remarks argues that “Gore explicitly teaches away from the claimed formulations. The compositions in Gore require antioxidants selected from butylated hydroxyanisole (BHA) or butylated hydroxytoluene (BHT) to stabilize the oils in the formulations. (Gore, {[ [O005].) According to Gore, different antioxidants, “such as Vitamin E acetate, ascorbyl palmitate and alpha-tocopherol led to degradation of omega-3 oil along with a change in physical appearance of the emulsions.” The examiner directs applicant’s attention to US 2010/0305045, which is incorporated by reference by Gore. Such references in Para [0107] teaches that in one embodiment anti-oxidants are added to preserve the solutions stability as well as to reduce ocular surface free radial damage. Suitable non-limiting examples include vitamin C, vitamin E, vitamin A and butylhydroxytoluene (BHT). Furthermore, Mizutare teaches the use of tocopherols as antioxidants in combination with other claimed components in ophthalmic formulations. Saebo is relied upon to show pecan and anchovies as a source of omega-3 fatty acids for improving vison. Applicant argues that Saeb does not teach the use of such oils in ophthalmic formulations. It is the examiner’s position that the use of anchovies as a source of fatty acids in ophthalmic formulation is taught by Gore. Additionally, the substitution of one oil for another would have been obvious to a person skilled in the art in the absence of evidence to the contrary.
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.
Claim(s) 26-30, 33-36, 41-50 is/are rejected under 35 U.S.C. 103 as being unpatentable over Karavas (WO 2017182138) in view of Singh et al. (US 20230144779) and further in view of Mizutare et al. (US 20170105934), Gore et al. (US 20160143977) and Saebo (US 20110244052).
Karavas et al. teach a preservative-free ophthalmic composition for the reduction of elevated intraocular pressure containing Latanoprost or a combination of Latanoprost and Timolol and to a process for preparing such compositions. See the abstract. Karavas et al. teach that although providing effective biocidal properties with well tolerated short-term use at low concentrations, preservatives can cause serious inflammatory effects on the eye with long-term use in chronic conditions, such as glaucoma or potentially ocular allergies. Antimicrobial preservatives are not found in single use vials of ophthalmic solutions since they are manufactured aseptically or are sterilized and the products are used once and the dispenser is thrown away. Karavas et al. teach that tonicity plays an important role in successful administration of an aqueous solution and it refers to the osmotic pressure exerted by salts in the solution. A solution acceptable for ophthalmic administration is required to be isotonic to lacrimal fluid. Tonicity agents used can be selected from, but are not limited to, sodium chloride, mannitol, dextrose, glycerin, potassium chloride, calcium chloride, magnesium chloride, propylene glycol and glycerol. See Page 6, lines 25-30. Therefore, the use of mannitol and dextrose as claimed herein is taught by Karavas et al. Karavas et al. Teach that the pH is adjusted to 6. Suitable buffering agents include, but are not limited to, sodium dihydrogen phosphate dihydrate, anhydrous disodium phosphate, hydrochloric acid, sodium hydroxide, sodium hydrogen carbonate. Karavas et al. teach that Solubilizing agents can be selected from, but are not limited to, polyoxyl 40 hydrogenated castor oil (Cremophor RH- 40), polyoxyl 35 castor oil (Cremophor EL), poloxamer 407, polysorbate 20, benzalkonium chloride, cyclodextrins, lecithin, benzyl alcohol, benzyl benzoate. See page 7, lines 18-25 and claims 2-3.
Karavas et al. differs from the claimed invention in the presence of amino acids, tromethamine, cellulose derivatives, povidone, trisodium citrate and the concentrations of certain ingredients.
Singh et al. teach an ophthalmic formulation having trisodium citrate and tromethamine as
buffering agents. See Para [0064]. The use of carbomer and povidone is taught in Para [0065].
The use of carboxymethyl cellulose is taught in Para [0065]. The use of tocopherol is taught in
para [0066]. The use of surfactants, such as polyoxyl 40 castor oil and polyoxyl 35 castor oil is
taught in Para [0069]. The use of lanolin is taught in Para [0074] and [0124]. The use of
hyaluronic acid is taught in Paras [0070] and [0234]. The use of the salts of ascorbic acid is
taught in Paras [0217] and [0232]. The pH of 4-7 is taught in claim 7. The concentrations of
surfactants is taught in Paras[0097] and [0236]. The concentrations of pH modifiers is taught to
be 0.005 to5% w/v. See Para [0092]. The concentrations of humectant is taught in Para
[0098]. The use of microemulsions is taught in Para [0280]. The single use containers is taught
in para [0310]. Mizutare et al. teach an aqueous ophthalmic composition 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 and panthenol, at least one oil component selected from the group consisting of a plant oil, an animal oil and a mineral oil, at least one surfactant selected from the group consisting of polyoxyethylene castor oil,
polyoxyethylene hydrogenated castor oil, polyoxyethylene polyoxypropylene glycol and polyoxyl stearate. See the abstract. The use of carboxymethyl cellulose is taught in para [0010]. The use of sesame oil and castor oil is taught in Paras [0011] and [0034]. The use of polyoxyl stearate is taught in Para[0021]. The use of water is taught in Para [0022]. The use of povidone is taught in Para [0043]. The concentration of sesame oil is taught to be 0.00001 w/v % to 5 w/v %. See Para [0057]. The concentration of castor oil is taught to be 0.00001 w/v % to5 w/v %. The use of sorbitol is taught in Para [0096]. The use of hydrochloric acid as a pH adjusting agent is taught in para [0098]. The use of palmitic acid and amino acids, such as, aspartic and glutamic is taught in Para [0104]. The use of hyaluronic acid is taught in Para [0026]-[0028]. The use of mannitol is taught in Para [0044]. The use of citrate is taught in Para [0107] and table 18. The use of tocopherol is taught in tables 7 and 18.
Core et al. teach stabilized ophthalmic compositions containing omega-3 oils. Among other things, the compositions are useful as artificial tears and as ophthalmic compositions to diagnose, treat, or prevent dry eye syndrome or keratoconjunctivitis in a human or other mammal in need of such diagnosis treatment, or prevention. See Para [0002]. Core teaches that wherein the omega-3 oil is selected from the group consisting of flaxseed oil, chia oil, kiwifruit oil, perilla oil, lingonberry oil, camelina oil, purslane oil, black raspberry oil, cod liver oil, salmon oil, anchovy oil and tuna oil. See claim 3. The concentrations of castor and flaxseed oil is taught in claim 18. Saebo teaches a composition for improving vision using omega-3 fatty acids. Pecans and anchovies is taught to be as a source of omega fatty acids. See Para [0008] and claim 3. It would have been obvious toa person skilled in the art to add the secondary components to the composition of Karavas and use it in an ophthalmic formulation motivated by the teachings of Singh, Mizutare, Gore and Saebo, which teach the use of the secondary components in ophthalmic formulations as old and well known. Karavas makes clear that the ophthalmic formulation can be prepared in a single use formulations without having a preservative. Singh, teaches that the claimed components can be prepared in a single use formulations. Therefore, it would have been obvious toa person skilled in the art to prepare the claimed ophthalmic formulations without a preservative in a single use vial. The use of ascorbyl palmitate instead of general teachings of ascorbate salts taught by the prior art would have been obvious to a person skilled in the art in the absence of evidence to the contrary. The determination of optimum amounts or proportions are considered to be within the skill of artisan in the absence of evidence to the contrary. Applicant’s attention is drawn to In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA1955), where the court stated that “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation”.
Claims 31, 32, 27, 38, 39 and 40 are objected to as being dependent on rejected claims.
Claims 51-54 at present time are considered to be allowable.
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 ZOHREH A FAY whose telephone number is (703)756-1800. The examiner can normally be reached Monday-Friday 9:30AM-6:00.
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/ZOHREH A FAY/Primary Examiner, Art Unit 1617