DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s amendment and response filed on 4/23/2026 have been received and entered into the case. Claims 4-5, 9, 14-16, 21-24, 28-29, 31, and 40-49 have been canceled. Claims 1-3, 6-8, 10-13, 17-20, 25-27, 30, and 32-39 are pending, Claims 26-27, 30 and 32-39 have been withdrawn, and Claims 1-3, 6-8, 10-13, 17-20, and 25 have been considered on the merits, insofar as they read on the elected species of ranpirnase, oxymetazoline, viral conjunctivitis, and human adenovirus B. All arguments have been fully considered.
Withdrawn Rejections
Rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, are withdrawn in view of applicant’s amendments.
Rejections under 35 U.S.C. 101 are withdrawn in view of applicant’s amendments.
Rejections of Claims 1-2, 10-13, 17-18, and 20 under 35 U.S.C. 102(a)(1)/(2) as being anticipated by Strem (US 2017/0087223 A1; 3/30/2017.) are withdrawn in view of applicant’s amendments.
Rejections of Claims 3-4, 6-8 and 25 under 35 U.S.C. 103 as being unpatentable over Strem (US 2017/0087223 A1; 3/30/2017.) in view of Terrie (Pharmacy Times. 2009;1-5.) are withdrawn in view of applicant’s amendments.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 of this title, 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 1-3, 6-8, 10-13, 17-20, and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Strem (US 2017/0087223 A1; 3/30/2017.) in view of Nayak et al (Indian Journal of Ophthalmology. 1987;35(4):190-193.) and NDA (https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050541s024lbl.pdf. 2017;1-2.).
The instant claims recite a product combination that inhibits or slows an ocular infection, wherein the product combination comprises: a therapeutically effective amount of one or more ribonuclease (RNase); and a therapeutically effective amount of one or more additional therapeutic agent, wherein the one or more additional therapeutic agent is oxymetazoline and tobramycin; wherein the ocular infection is a bacterial infection, a viral infection, or both.
Strem teaches a pharmaceutical composition comprising ranpirnases for treating a viral conjunctivitis (para 0006), or delaying or preventing in an individual the onset of a clinical symptom of a viral conjunctivitis (para 0095), wherein the viral conjunctivitis is an epidemic keratoconjunctivitis, a pharyngoconjunctival fever, a nonspecific sporadic follicular conjunctivitis, or a chronic papillary conjunctivitis, caused by a Human adenovirus B (para 0006). Ranpirnases can be co-formulated with immunomodulatory drugs or antibiotics to increase the overall therapeutic effect of the treatment (para 0139). Use of said ranpirnases is in an amount sufficient to treats the viral conjunctivitis (para 0055), the actual effective amount of ranpirnases can be determined by a person of ordinary skill in the art, variations in dosage levels can be adjusted using standard empirical routines of optimization, which are well-known to a person of ordinary skill in the art (para 0057, 0129). The pharmaceutical composition may include a pharmaceutically-acceptable carrier (para 0086). The formulation may be a simple one or as part of a more complex drug delivery system, said ranpirnases may be formulated by itself in a pharmaceutical composition, or may be formulated together with one or more other therapeutic compounds in a single pharmaceutical composition (para 0089). The pharmaceutical composition is formulated using an ophthalmic route of administration (para 0088, 0126). Ranpirnases is in an amount of 25 µM (para 0227).
Strem does not teach the claimed additional therapeutic agent being oxymetazoline and tobramycin (claim 1) as well as the claimed amount of ranpirnases, oxymetazoline and tobramycin (claims 3, 6-8 and 25), and the RNase and the additional therapeutic agent are formulated in a single formulation (claim 18).
However, Strem does teach the pharmaceutical composition is used for treating a viral conjunctivitis, the actual symptoms associated with the viral conjunctivitis are well known and include ocular itching, burning eyes, and increased tear production. Strem does teach the pharmaceutical composition may be combined with other supplementary active ingredients, agents or drugs (para 0053). Nayak teaches that 0.01% oxymetazoline demonstrates significant improvement in the conjunctival symptoms viz itching, foreign body sensation, watering the burning sensation (Abstract). In addition, NDA teaches 0.3% tobramycin is an ophthalmic antibiotic formulation that is active against a wide variety of gram-negative and gram-positive ophthalmic pathogens (p.1 para 1 & 3), and 0.3% tobramycin has been used in the treatment of external infections of the eye (p.1 para 9).
Thus, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to combine ranpirnases, oxymetazoline and tobramycin into a pharmaceutical composition as a single formulation, since Strem discloses a pharmaceutical composition comprises ranpirnases that is useful for treating a viral conjunctivitis, the actual symptoms associated with the viral conjunctivitis include ocular itching, burning eyes, and increased tear production, the pharmaceutical composition may be combined with other supplementary active ingredients, agents or drugs, Nayak discloses that 0.01% oxymetazoline demonstrates significant improvement in the conjunctival symptoms viz itching, foreign body sensation, watering the burning sensation, and NDA discloses that 0.3% tobramycin has been used in the treatment of external infections of the eye. In addition, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to optimize the concentration of ranpirnases, oxymetazoline and tobramycin, since Strem discloses ranpirnases is in an amount of 25 µM, and that variations in dosage levels can be adjusted using standard empirical routines of optimization, which are well-known to a person of ordinary skill in the art, Nayak discloses 0.01% oxymetazoline significantly improves the conjunctival symptoms viz itching, foreign body sensation, watering the burning sensation, and NDA discloses that 0.3% tobramycin has been used in the treatment of external infections of the eye. Generally, differences in concentration will not support patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. (MPEP 2144.05 II) Moreover, before the effective filing date of the claimed invention, one of ordinary skill in the art would have been motivated by the cited references and routine practice to combine an optimized amount of ranpirnases, oxymetazoline and tobramycin with a reasonable expectation for successfully obtaining a pharmaceutical composition.
References cited above do not teach the one or more RNase is in a first composition and the one or more additional therapeutic agent is in a second composition, and wherein the first composition is separate from the second composition (claim 19).
However, Strem does teach the formulation may be a simple one or as part of a more complex drug delivery system, said ranpirnases may be formulated by itself in a pharmaceutical composition, or may be formulated together with one or more other therapeutic compounds in a single pharmaceutical composition (para 0089).
Thus, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to separate ranpirnases in a first composition from an additional therapeutic agent in a second composition, since Strem discloses that the formulation comprises ranpirnases and additional therapeutic agents, and ranpirnases can be formulated by itself. Moreover, before the effective filing date of the claimed invention, one of ordinary skill in the art would have been motivated by the cited reference to separate ranpirnases in a first composition from an additional therapeutic agent in a second composition with a reasonable expectation of success.
Response to Arguments
Applicant argues that cited references do not teach or reasonably suggest the one or more additional therapeutic agent is oxymetazoline and tobramycin as amended in claim 1. However, these arguments are moot since those rejections are withdrawn in view of applicant’s amendments.
Conclusion
No claims are 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 extension fee 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.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNN Y FAN whose telephone number is (571)270-3541. The examiner can normally be reached on M-F 7am-4pm.
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/Lynn Y Fan/
Primary Examiner, Art Unit 1759
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