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 .
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 1 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 1 recites, “according to a predetermined volumetric ratio of the antibiotic and the excipient relative to the anesthetic, wherein the volumetric ratio is between about 5:1 and about 15:1.” As such, it appears the ratio is intended to be antibiotic + excipient : anesthetic. But that ratio would require the amount of anesthetic to be between 6-20% vol of the composition. Looking to the specification and claim 6, it appears this is not consistent with the claimed invention. It appears the ratio should be just antibiotic : anesthetic, without inclusion of the excipient.
For purposes of examination, Examiner will read the ranges of claim 6 to represent the desired ratios which appear to fall within the ranges that exclude the excipient.
Claim Rejections - 35 USC § 103
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 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.
Claims 1, 2, 5, and 6-16 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al (Journal Of Ocular Pharmacology And Therapeutics, 2022, 38:3, 232-239).
Zhang et al teaches formulations comprising proparacaine hydrochloride at 0.5% and proparacaine hydrochloride diluted to 0.05% with common ophthalmic antibiotics, such as polymyxin and trimethoprim, for treatment of corneal wounds in both in vitro and in vivo models where all formulations provide improved healing (Abstract and Discussion). Zhang recognizes, but does not explain, that preservatives in proparacaine can play a role in corneal healing (Discussion).
While the drops were applied in conjunction with each other and such coadministration could read on mixing the components, the reference does not specifically disclose the two with another excipient in a formulation or the specific amount of antibiotic.
It would have been obvious to one of ordinary skill in the art to combine the two formulations used in the prior art into a single formulation for purposes of administration. When combining, it would have been obvious to follow the direction of the prior art and use either regular 0.5% or diluted 0.05% proparacaine hydrochloride with an antibiotic. Then it would have been obvious to optimize the amount of the antibiotic based on its disclosed function, starting with the standard amount, as taught by the prior art.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al (Journal Of Ocular Pharmacology And Therapeutics, 2022, 38:3, 232-239) in view of Karolchyk et al (US 2015/0335704).
Zhang et al is discussed above but does not teach the use of moxifloxacin as the active, polymers for a gel, or storage in a bottle.
Karolchyk et al teaches well known antibacterial agents for ophthalmic compositions include moxiflocxacin which may be present from 0.01 mg/mL to about 50 mg/mL (¶ 73) when anesthetics are also present from 0.01 mg/mL to about 100 mg/mL (¶ 71). Ocular compositions may be present in a gel-like state due to inclusion of polymers (¶ 102-103). The compositions may be provided in bottle, vials, or syringes (paragraph 110).
Additional motivation to combine the antibacterial and anesthetics is provided by Karolchyk et al which teaches their combination, and further teaches the potential ranges for optimization. When preparing the composition, it would have been obvious to modify it into a gel and provide it in any known bottle.
Statutory Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 1-20 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims of copending Application No. 18/537,780 (reference application). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
Examiner notes that the ranges claimed in ‘780 appear to be the same as what is claimed by the instant ratios, as demonstrated by instant claim 6, and therefore there is no way to practice the invention of ‘780 without infringing on the instant claims. If this interpretation is incorrect, then this rejection will be construed as a non-statutory double patenting rejection where the ranges appear to at least overlap and would therefore be prima facia obvious.
Conclusion
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 (9am-6pm + 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