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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/29/2026 has been entered.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 33 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 33 is indefinite as to the phrase “further”. Claim 33 does not have any additional ingredients and it is within the scope of claim 20. Claims dependent on claim 33 are also rejected, since they have all the limitations of claim 33.
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(s) 20, 23, 26 and 29-36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kaye et al. (US 20130324574) in view of Aberg et al. (US 20170105987) and further in view of Shantha et al. (US 20110052678).
Kaye teaches a method of treating a subject suffering from an ocular inflammatory disease (OID), uveitis, bacterial conjunctivitis, viral conjunctivitis, an inflammation of the orbital tissue, the lacrimal apparatus, the eyelid, the cornea, the retina or the optic pathway. Kaye teaches a method for treating a subject suffering from an autoimmune disease-associated ocular inflammation comprising periodic ocular administration to the subject a therapeutically effective amount of laquinimod or a pharmaceutically acceptable salt, and an ocular pharmaceutical composition comprising laquinimod or a pharmaceutically acceptable salt thereof for use in treating an autoimmune disease-associated ocular inflammation. See the abstract. The method comprising periodic administration to the subject of a therapeutically effective amount of laquinimod or a pharmaceutically acceptable salt thereof effective to treat the subject. See para [0015]. The laquinimod or pharmaceutically acceptable salt thereof is administered topically or orally. See para [0020]. The use of an eye drop is taught in Para [0031]. The concentration of laquinimod or pharmaceutically acceptable salt thereof in the liquid or gel is 0.5% (5 mg/ml)-10.0% (100 mg/ml). See Para [0022]. The pH of 7.3-7.4 is taught in Para [0098]. The laquinimod in a gel or liquid form is taught in claim 9. The use of polymers, such as, carbomers, modified cellulose and their mixture is taught in Para [0037].
Kaye differs from the claimed composition in the presence of some of the secondary components. Aberg teaches the use of norketotifen for the treatment of intraocular pressure, Para [0008]. The use of EDTA is taught in Para [0022]. The concentration of the chelating agent is taught to be in amounts of about 0.01 wt. % to about 10 wt. %, specifically about 0.01 wt. % to 2.0 wt. %. See Para [0022]. The use of stabilizers and solubilizers is taught in Paras [0023] and [0024]. Aberg teaches that exemplary stabilizers include methylcellulose, edetate, chitosan, Hydroxypropyl methylcellulose and hydroxyethyl cellulose, para [0023]. Aberg teaches that stabilizers listed here are useful in concentrations of about 0.05 wt. % to about 4 wt. %, and are specifically used in concentrations of about 0.05 wt. % to about 2 wt. %. See Para [0023]. Aberg teaches that EDTA functions as a chelating agent and a stabilizer, Para [0023]. The use of solubilizers is taught in Para [0024]. The use of a buffering agent to keep the pH about 4-6 is taught in Para [0025]. Aberg teaches that the Tonicity-adjusting agents increase the effective osmolarity or effective osmolality of a formulation. Ocular compositions may contain a tonicity-adjusting agent in an amount sufficient to cause the final composition to have an ophthalmically acceptable osmolality (generally about 150 to about 450 mOsm and preferably about 230 to about 330 mOsm). Exemplary tonicity-adjusting agents to be used with norketotifen may be of ionic and/or non-ionic type. An example of ionic type tonicity enhancers is sodium chloride and examples of non-ionic tonicity enhancing agents are, for example sorbitol and propylene glycol, which are compatible with norketotifen. Thus, norketotifen formulations may include, for example sodium chloride, in amounts of about 0.1 wt. % to about 0.9 wt. %, sorbitol in amounts of about 0.1% to about 10%, or propylene glycol in amounts about 0.1 wt. % to about 10 wt. %. See Para. [0026]. Aberg teaches that Ophthalmic solutions may contain one or more viscosity-adjusting agents and have a viscosity of about 1.0 to about 100,000 cP, specifically about 2.0 to about 90,000 cP, and more specifically about 2.5 and about 75,000 cP. See Para. [0027]. Aberg teaches that Viscosity modifying agents include edetate, methylcellulose, carboxymethylcellulose, hydroxypropyl methylcellulose, hydroxyethyl cellulose, polyethylene glycol, propylene glycol alginate, chitosan, and tragacanth, Para. [0027]. Exemplary of the humectants include polyethylene glycol, sorbitol and propylene glycol. Humectants are used in amounts of about 0.05 wt. % to about 10 wt. %, specifically about 0.1 wt. % to about 4 wt. %, and more specifically about 0.1 wt. % to about 2 wt. %. See Para [0028]. The use of antioxidants is taught in Para [0029]. Exemplary lubricants that include methylcellulose, hydroxypropyl methylcellulose, hydroxyethyl cellulose, thiolated acrylic acid polymers, carbomer, carboxymethylcellulose sodium, chitosan, and polyisobutylcyanoacrylate When used, the amount of lubricant is about 0.1 wt. % to about 10%, specifically about 0.1 wt. % to about 4 wt. %, and more specifically about 0.1 wt. % to about 2 wt. %. See Para [0033]. The use of surfactants, such as polysorbates is taught in Para [0035]. The concentrations of the surfactants is taught to be in amounts of about 0.05 wt. % to about 4 wt. %, specifically about 0.1 wt. % to about 2 wt. %. See Para [0035]. The composition being in a gel, ointment and emulsion is taught in Para [0037]. The use of preservatives, such as benzalkonium chloride at the concentration of 0.0001% is taught in Para [0039] and [0040]. The treatment of patients having glaucoma is taught in Para [0055]. The use of a container is taught in Para [0039] and [0107]. The cumulative absorption tested in a bovine cornea is the property of a composition and not a composition itself. Aberg teaches that Intraocular hydrophobic ointments may contain norketotifen at concentrations of about 0.02 wt. % to about 1.0 wt. %. The intraocular hydrophobic ointments have a viscosity of about 1,000 to about 500,000 cP, specifically about 20,000 to about 200,000 cP. Ophthalmic hydrophobic ointments have tonicity of about 150 and about 450 mOsm, specifically about 230 and about 330 mOsm. The intraocular hydrophobic ointments can also contain other excipients, such as humectants, viscosity modifying agents, tonicity agents, chelating agents, buffers, surfactants, mucoadhesive, antioxidants and preservatives. The intraocular hydrophobic ointments and gels were designed for once-daily ocular administration or for repeated ocular administrations from two to five times daily to a mammal in need thereof. See Para [0092]. Aberg teaches that useful intraocular emulsions contained norketotifen at concentrations of about 0.02 wt. % to about 1.0 wt. %. The intraocular emulsions had a viscosity of about 1.0 to about 300,000 cP, specifically about 2.0 to about 90,000 cP, most specifically about 2.5 to about 75,000 cP. The intraocular emulsions had osmolality of about 150 to about 450 mOsm, specifically about 230 to about 330 mOsm. The intraocular emulsions had pH of about 4 to about 6.5.
Shantha teaches the treatment of macular degeneration with ophthalmic topical preparation using insulin and/or IGF-1 and other therapeutics agents in an ophthalmic topical preparation. See para [0099]. Shantha teaches that the penetration enhancers may include anionic surfactants, urea's, fatty acids, fatty alcohols, teARMDenes, cationic surfactants, nonionic surfactants, zwitterionic surfactants, polyols, amides, lactam, acetone, alcohols, and sugars. See para [0172]. The use of benzalkonium chloride is taught in Para [0177]. Shantha teaches the pH can be within a range which the pH is acceptable to ophthalmic preparations which the pH preferably is within a range from 4-6-7 to 8 most preferably 7.4. See Para [0202]. Shantha teaches that buffering ingredients, such as sodium borate, sodium acetates, gluconate buffers, and other conventional ingredients such as sorbitan monolaurate, triethanolamine, oleate, polyoxyethylene sorbitan monopalmitylate, dioctyl sodium sulfosuccinate, monothioglycerol, thiosorbitol, ethylenediamine tetracetic. Furthermore, appropriate ophthalmic vehicles can be used as carrier media for the current purpose. This includes conventional phosphate buffer vehicle systems which are isotonic boric acid vehicles, isotonic sodium chloride vehicles, and isotonic sodium borate. See para [0213]. The use of polysorbate is taught in Para [0216]. The use of glycerin and mannitol carboxy methylcellulose, hydroxyethyl cellulose, hydroxypropyl methylcellulose and polyvinyl alcohol at the concentration of 0.001% to about 10% is taught in Para [0217]. Shantha teaches that stabilizing agents are antioxidants, like bisulfites and ascorbate. The metal chelating agents like sodium EDTA and drug solubility enhancers which are the polyethylene glycols. See para [0218]. Shantha teaches that The ophthalmic compositions, which are intended for direct application to the eye, will be formulated to have a pH and tonicity which these are compatible with the eye. This will normally require a buffer to maintain the pH of the composition at or near physiologic pH (i.e., pH 7.4) which the buffer may require a tonicity agent to bring the osmolality of the composition to a level or near 210-320 millimoles per kilogram. See Para [0219]. The use of polysorbate is taught in Para [0224]. It would have been obvious to a person skilled in the art to add the claimed secondary components to the ophthalmic formulation of Kaye comprising laquinimod motivated by the teachings of Aberg and Shantha, which teach the use of the claimed secondary ingredients in ophthalmic formulations being used for treating glaucoma and conditions with excess neovascularization as old and well known. To house an ophthalmic formulation in a container is taught in Paras [0039] and [0107] of Aberg. Aberg and Shantha make clear that all the claimed secondary components have been previously used in ophthalmic formulations.
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
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