DETAILED ACTION
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 .
Applicant's request for reconsideration of the finality of the rejection of the last Office action is persuasive and, therefore, the finality of that action is withdrawn. Examiner agrees that the hydrogel cited does not read on the claim limitation of being a solution.
Applicants' arguments, filed 08/27/2026, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-5 and 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al (Effects of Regular/Dilute Proparacaine Anesthetic Eye Drops in Combination with Ophthalmic Antibiotics on Corneal Wound Healing. Journal of Ocular Pharmacology and Therapeutics. 2022;38(3):232-239. doi:10.1089/jop.2021.0116) in view of Dana et al (US 20110206620).
Zhang teaches the benefits of administering anesthetic eye drops in conjunction with antibiotics, where the study used regular (0.5% solution) and diluted proparacaine (0.05% solution) eye drops with common ophthalmic antibiotics (Abstract, Purpose). The antibiotic eye drops included polymyxin B sulfate and trimethoprim (Methods, Proparaine preparation and administration). While the authors conclude that the combination can produce an additive negative effect, the lower concentration of anesthetic produces fewer negative effects when combined with antibiotic therapy and for short term, the diluted combination is preferred. Zhang recognizes preservatives are present in proparaine, thought it is unclear the role they play in corneal healing (Discussion, second to last paragraph).
Zhang does not teach the specifically claimed ratio, that the two components are in a single eye drop, or that the antibiotic is moxifloxacin.
Dana et al teaches composition for the treatment of dry eye which may include commonly known antibiotics, including polymyxin B, moxifloxacin, and trimethoprim, among others (¶ 17). Dana further teaches the addition of known excipients, such as conventional preservatives to maintain sterility (¶ 193).
With regards to claims 1,5 and 22, when practicing the method of Zhang, it would have been obvious to use diluted proparacaine in combination varying amounts of the antibiotic to provide optimized pain relief with reduced infection rates. The amount of antibiotic would also be directly related to the specific antibiotic chosen, and the amount varied based on the desired efficacy. See MPEP 2144.05.
Additionally, it would have been obvious to combine the two into a single eye drop, given they are administered concurrently.
With regards to claim 2, Zhang teaches administration of proparacaine at a concentration of 0.5%.
With regards to claims 3-4, it would have been obvious to use any known ocular antibiotic to provide short term pain relief and antibiotic protection, including the obvious variants taught by Dana et al. See MPEP 2144.06.
With regards to claim 21, Zhang teaches administration of proparacaine at a concentration of 0.05%.
With regards to claim 23, Zhang recognizes that preservatives are in the anesthetic composition, and Dana et al further teaches the benefits of preservatives in solutions.
Conclusion
Applicant's amendment to the claim amendments prior to the withdrawn Final Rejection necessitated the new ground(s) of rejection presented in this Office action. In other words, this Office Action is construed as following the last Non-Final 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN J PACKARD whose telephone number is (571)270-3440. The examiner can normally be reached Mon 2-6pm and Tues-Fri 9:30am-6:30pm + mid-day flex.
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/BENJAMIN J PACKARD/ Primary Examiner, Art Unit 1612
