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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 05/22/2026 has been entered.
Detailed Action
Applicants’ response, dated 05/22/2026, is acknowledged. Applicant has canceled claim 8 and added claim 25, no new matter was added. Claims 1, 3, 5, 7, 9-20, 22-23 and 25 are pending and are now evaluated on its merits.
Priority
This application claims domestic benefit to U.S. provisional application 63/364,914, dated 05/18/2022.
Response to Arguments
Applicants’ arguments, see Page 1, filed 05/22/2026, with respect to the rejections of claims 1, 3, 5, 7-17, 19 and 22-23 under Russ (WO 2009024346 A2) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Musunuri et al. (US 10555947 B2), Chadwick et al. (US 20190365629 A1), Bucks et al. Uptake of Two Zwitterionic Surfactants into Human Skin in Vivo, Toxicol and Applied Pharma, June 1993, Pages 224-227 and Chowhan et al. (U.S. 5741817 A).
Applicants’ argument (Pages 2-3) in respect to the teachings of Ostrow et al. (US 20150366854 A1) not qualified as prior art to claimed invention as Ostrow fails to teach an oil-in-water emulsion have been fully considered and are persuasive.
Musunuri teaches an oil-in-water emulsion system topical ophthalmic cream composition to treat eye disorders such as dry eye syndrome, blepharitis and glaucoma comprising. The teachings of Musunuri in view of Chadwick et al. (US 20190365629 A1), Bucks et al. Uptake of Two Zwitterionic Surfactants into Human Skin in Vivo, Toxicol and Applied Pharma, June 1993, Pages 224-227 and Chowhan et al. (U.S. 5741817 A) reads to claimed limitations of Zwitterion mM concentrations and viscosity of the topical cream formulation.
Claim Objections
Claim 14 is objected to because of the following informalities: a “t” after ophthalmic and before topical. Appropriate correction is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 7, 9, 12, 14, 16-20, 22-23 and 25 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Musunuri et al. (US 10555947 B2).
Regarding claims 1, 7, 9, 12, 14, 16-20, 22-23 and 25, Musunuri teaches a method for the treatment of eye disorder such as dry eye syndrome, blepharitis and glaucoma (relevant to claim 23) (Pg. 4, last para-Pg. 5) comprising administration of a topical cream composition comprising a corticosteroid of loteprednol at 0.01% to about 0.5 w/w (relevant to claim 20), an alpha 2 adrenergic agonist and pharmaceutically acceptable excipients which includes a zwitterionic surfactant, in an oil-in-water emulsion system (relevant to claim 1) (Pg. 4, 2nd para; Pg. 6, 1st para; and Pg. 7, 1st para.). The composition further comprises a buffering agent from a list of agents which consist of histidine to maintain the composition at a pH of 5-8 (relevant to claims 7, 9, 12, 14, 19 and 22-23) (Pg. 18, 4th para.). The excipients taught by Musunuri comprises viscosity modifier of Carbopol at 0.05% w/w, polymeric surfactant of polysorbate 80 and Pemulen (relevant to claims 16-18) (Pg. 10, 1st para. and Pg. 26, 1st para.). Musunuri additionally teaches the composition to be administrated to a patient’s entire eye structure or a tissue or gland in or around the eye such as the ocular tissue, eyelids, margin of the eyelid of the subject or ocular surface (relevant to claim 25).
Of a particular embodiment Musunuri teaches example Tables 1-3 for the formulation of the ophthalmic composition comprising the above ingredients.
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 3 is rejected under 35 U.S.C. 103 as being unpatentable over Musunuri et al. (US 10555947 B2) in view of Bucks et al. Uptake of Two Zwitterionic Surfactants into Human Skin in Vivo, Toxicol and Applied Pharma, June 1993, Pages 224-227.
The teachings of Musunuri for the above 102 rejections of claims 1, 7, 9, 12, 14, 16-20, 22-23 and 25 are incorporated herein by reference. Musunuri additionally teaches the formulation comprising a surfactant in which any type of surfactant can be used including, anionic, cationic, amphoteric, zwitterionic, nonionic, as well as a mixture of two or more thereof (Pg. 18, 3rd para.). In an example of a topical ophthalmic combination formulation the surfactant in the formulation was about 0.2%-2% by weight (Pg. 25, 3rd para.)
Musunuri fails to teach the zwitterion as an amino acid, a peptide, a protein, a phosphatidylcholine or a betaine wherein the zwitterion has a concentration of about 5 mM to about 600 Mm.
Bucks teaches the potential risk associated with the uptake of N,N-dimethyl-N-dodecylglycine (dodecylbetaine, C12BET) and N,N-dimethyl-N-hexadecylglycine (hexadecylbetaine. C16BET) into human skin. Bucks evaluated in aqueous solution (C12BET concentrations 16, 100, and 800 mM; C16BET concentrations 0.14, 1.0, and 5.4 mM) to the dorsal upper arms of male volunteers for 30 min. After administration and washing off no betaine-induced effects on the stratum corneum were observed, concluding the betaines are safe to use in personal care products (abstract).
Therefore, it would have been obvious to someone of ordinary skill in the art at the time of filing to have produced the ophthalmic topical cream formulation taught by Musunuri wherein the surfactant is a zwitterion of C12BET or C16BET with concentration of about 5 mM to about 600 mM. One would have been motivated to do so because Bucks teaches the zwitterion surfactants of C12BET or C16BET at concentrations within claimed range is safe for topical administration. There is a reasonable expectation of producing the topical cream formulation taught by Musunuri wherein the surfactant is C12BET or C16BET with concentration of about 5 mM to about 600 mM.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Musunuri et al. (US 10555947 B2) in view of Chadwick et al. (US 20190365629 A1).
The teachings of Musunuri for the above 102 rejections of claims 1, 7, 9, 12, 14, 16-20, 22-23 and 25 are incorporated herein by reference.
Musunuri fails to teach the composition comprising a viscosity of about 25,000 cPs to about 400,000 cPs.
Chadwick teaches methods and compositions useful as eye creams as oil-in-water emulsion solutions wherein the viscosity of the cream ranges from about 1 cps to well over 1 million cps (abstract, para. 0013).
Therefore, it would have been obvious to someone of ordinary skill in the art at the time of filing to have administered the composition taught by Musunuri wherein the viscosity ranges from about 25,000 cPs to about 400,000 cPs. One would have been motivated to do so from the teachings of Chadwick of eye cream oil-in-water solutions, which is known in the art of having a viscosity within the desired range. Additionally, one would test the composition to obtain optimal viscosity to produce a safe, tolerable and effective topical eye cream to a patient in need. There is a reasonable expectation of success in developing the composition taught by Musunuri wherein the viscosity of the topical cream is about 25,000 cPs to about 400,000 cPs.
Claims 10-11, 13 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Musunuri et al. (US 10555947 B2) in view of Chowhan et al. (U.S. 5741817 A).
The teachings of Musunuri for the above 102 rejections of claims 1, 7, 9, 12, 14, 16-20, 22-23 and 25 are incorporated herein by reference. Musunuri additionally teaches a buffering agent known to those skilled in the art is used including, but not limited to, acetate, borate, tris, carbonate, citrate, histidine, succinate, and phosphate (Pg. 18, 4th para.).
Musunuri fails to teach the buffers of lysine and/or arginine at a concentration of about 10 mM to about 500 mM.
Chowhan teaches the use of glycine and other low molecular weight amino acids of histidine, lysine and arginine in a concentration of from about 0.01 to about 7.5 % w/v enhance the efficacy of antimicrobial preservatives and act as chelating agents, buffers and tonicity agents in ophthalmic compositions (abstract, Page 2).
Therefore, it would have been obvious to someone of ordinary skill in the art at the time of filling to have used arginine or lysine as a ph buffer in a concentration of about 10 mM to about 500 Mm for the ophthalmic topical cream formulation taught by Musunuri. One would have been motivated to do so as Musunuri teaches histidine and other well known pH buffers can be used in the formulation and Chowhan teaches amino acids of histidine, lysine and arginine are known to be incorporated in ophthalmic formulations as pH buffers.
One would also have the buffer at a concentration of about 10 mM to about 500 Mm as Chowhan teaches the amino acids in a concentration of from about 0.01 to about 7.5 % w/v, thus taking the molecular weight of lysine at 146.19 g/mol the mM will be 0.68 to 513.03 mM. The mM of arginine would produce 0.57 mM to 430.54 mM and .064 mM to 483.37 mM for histidine. There is a reasonable expectation of interchanging the histidine buffer taught by Musunuri with lysine o arginine at a concentration of about 10 mM to about 500 Mm from the teachings of Chowhan.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MIKHAIL O'DONNEL ROBINSON whose telephone number is (571)270-0777. The examiner can normally be reached Monday-Friday 7:30am-5:30pm.
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MIKHAIL O'DONNEL. ROBINSON
Examiner
Art Unit 1627
/MIKHAIL O'DONNEL ROBINSON/Examiner, Art Unit 1627
/Kortney L. Klinkel/Supervisory Patent Examiner, Art Unit 1627
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