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 .
Applicants' arguments, filed 05/18/2026, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 Sanad et al (Formulation and in Vitro Evaluation of Moxifloxacin-Lidocaine Base as A Topical Hydrogel Dressing, Journal of Natural Science, Biology and Medicine, Vol 14, Iss 2, July-December 2023, published Aug 10, 2023) in view of Wong et al (US 2020/0368153) and Ladd et al (WO 2019/140167 A1).
Sanad et al discloses various hydrogels comprising 0.01% moxifloxacin dissolved in 1 ml distilled water (1mg/mL) moxifloxacin and 2% (or 20mg/mL) lidocaine dissolved in propylene glycol, some formulations with a citrate phosphate buffer (abstract, Table 1, and pg 152 Addition of drug to the formulas).
The instant limitation of “excipient” is read broadly based on the instant specification at ¶ 28 to include any inactive ingredients, such as the hydrogel components or the buffer.
While Sanad et al teaches the combination of the antibiotic and anesthetic, it is unclear what the volumetric ratio, as required by the instant claims, is for the formulation because the prior art discloses the concentration, but not the volume. Sanad et al also does not tach proparacaine HCl as the anesthetic or a preservative as an excipient.
Wong et al teaches moxifloxacin concentration in eye drops may vary from 10-30 wt% (¶ 86). Preservatives are well known to be added to maintain sterility once the container has been opened (¶¶ 25-26).
Ladd et al teaches eye drops with anesthetic, such as lidocaine or proparacaine, may have concentrations from 0.01% to about 35% by weight (pg 11, first full ¶). Preservatives are taught to be suitable as well (pg 13, first partial ¶).
It would have been obvious to one of ordinary skill in the art to modify the formulation of Sanad et al within range well known to be suitable for topical eye delivery, as taught by Wong et al and Ladd et al.
It would also have been obvious to vary components known to be obvious variants, such as the anesthetics of Ladd et al.
Finally, it would have been obvious to add known excipients, such as a preservative, as taught by Ladd, for its disclosed function, i.e. to provide preservative properties to the formulation.
Double Patenting
Claims 1-5 and 21-23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims of copending Application No. 18/537,780 (reference application) in view of Wong et al (US 2020/0368153) and Ladd et al (WO 2019/140167 A1). Although the claims at issue are no longer identical, they are not patentably distinct from each other because ‘780 is directed to an eyedrop comprising a fluoroquinolone class antibiotic, such as moxifloxacin (claim 5), a topical anesthetic such as proparacaine (claim 3), and an inactive portion, such as a preservative (claim 8). The combination reads on the instant claims, except for the missing ratio. As discussed above, Wong et al and Ladd et al teach varying the anesthetic and antibiotic in formulations, therefore it would have been obvious to optimize the formulation for the desired functional, i.e. to provide treatment in the eye.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana S. Kaup can be reached at (571) 272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BENJAMIN J PACKARD/ Primary Examiner, Art Unit 1612
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