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 .
DETAILED ACTION
Claim status
Claims 1-21 are pending
Claims 15-21 are withdrawn
Claims 1-14 are under examination
Election/Restrictions
Applicant’s election of the following invention in the reply filed on 3/26/2026 is acknowledged.
Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.03(a)).
The requirement is still deemed proper and is therefore made FINAL.
Group I, claims 1-14, drawn to a composition comprising moxifloxacin.
Claims 15-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable linking claim.
Claim Rejections - 35 USC § 112(b)
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 13 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 pre-AIA the applicant regards as the invention.
Claim 13 recites the limitation "The" corneal storage solution. There is insufficient antecedent basis for this limitation because Claim 13 is an independent claim. In light of the specification, and for the sake of compact prosecution, Claim 13 is being examined as being dependent on Claim 1. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 and 3 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Kuhn et al., (US 6,916,484, filed 7/25/2000, patented 7/12/2005).
With respect to claims 1 and 3, Khun claims an aqueous pharmaceutical composition comprising from 0.02-2.4% by weight moxifloxacin, and a working Example of 0.2% by weight moxifloxacin (Example 1, and see Claims 1 and 2 of Kuhn).
Although, Kuhn does not use the composition for corneal storage, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In instant case, the composition of Kuhn is an aqueous solution at a physiological osmolarity, can be used clinically and/or as a preservative (col 6, 2nd & 3rd para.). Thus, the composition of Kuhn is capable of storing cornea.
Accordingly, Kuhn anticipates instant claims.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1-7 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Lindstrom et al. (US 5,104,787, filed 3/05/1990, patented 4/14/1992), in view of Kuhn et al., (US 6,916,484, filed 7/25/2000, patented 7/12/2005) and Wagner et al. (Clin Opth, 2010, 4:41-45)
In regard to claims 1-7 and 13, Lindstrom teaches an claims a corneal storage solution comprising:
-An aqueous electrolyte solution (e.g., MEM and TC199),
-glycosaminoglycan (e.g., chondroitin sulfate),
-deturgescent agent (e.g,, dextran),
-energy source (e.g., sodium pyruvate),
-buffer system (e.g., HEPES),
-nutrient supplements (e.g., vitamin B12 and non-essential amino acids), and
-antimycotic agent (e.g., amphotericin B at about 0.1 mg/ml (i.e., 0.00010 % w/v)),
(col 7, Description of the Preferred Embodiments, Table I, Formula A, see also Claims 1 and 2). In regard the concentration of amphotericin B as per claim 13, 0.00010 % w/v is about 0.00025% w/v, and MPEP 2144.05(I) states that a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close.
However, although Lindstrom teaches the presence of an antibiotic such as gentamicin, they are silent to the antibiotic moxifloxacin.
With respect to instant claims, Khun claims an aqueous pharmaceutical composition comprising about 0.02% by weight moxifloxacin (see Claims 1 and 2 of Kuhn).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art at the time of filing to prepare the storage composition comprising an antibiotic as taught by Lindstrom and substitute moxifloxacin as the antibiotic as taught by Khun with a reasonable expectation of success. The ordinary skilled artisan would have been motivated to do so as taught by Wagner because moxifloxacin is more effective at killing bacteria from the eye than gentamicin (Abstract, p.43, Table 1 and Figs. 1-4).
Hence, the claimed invention as a whole was prima facie obvious in the absence of evidence to the contrary.
Claims 1, 3, 5-12, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Sundaresan et al. (Ind J Ophthal, 2019, 67:1579-84), in view of Kuhn et al., (US 6,916,484, filed 7/25/2000, patented 7/12/2005) and Wagner et al. (Clin Opth, 2010, 4:41-45),
In regard to claims 1, 3, 5-12, and 14, Sundaresan teaches the corneal storage solution of Cornisol (Abstract, Fig. 1). Although Sundaresan does not disclose the components, Applicant’s specification in Table 1 evidences that Cornisol comprises:
-An aqueous electrolyte solution (e.g., 0.4% MEM and 0.15% Medium-199),
-glycosaminoglycan (e.g., 2.5% chondroitin sulfate),
-deturgescent agent (e.g,, 1% dextran-40),
-energy source (e.g., 0.111% sodium pyruvate),
-buffer system (e.g., 0.8% HEPES),
-nutrient supplements (e.g., 0.000136% v/v vitamin B12),
- Glutamax (i.e., 1% l-alanyl-L-glutamine-dipeptide), and
-recombinant human insulin at 0.0006% v/v.
However, although Sundaresan teaches the presence of an antibiotic such as gentamicin, they are silent to the antibiotic moxifloxacin.
With respect to instant claims, Khun claims an aqueous pharmaceutical composition comprising about 0.02% by weight moxifloxacin (see Claims 1 and 2 of Kuhn). In regard the concentration of moxifloxacin as per claim 12, 0.02 % w/v is about 0.025% w/v, and MPEP 2144.05(I) states that a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close.
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art at the time of filing to prepare the storage composition comprising an antibiotic as taught by Sundaresan and substitute moxifloxacin as the antibiotic as taught by Khun with a reasonable expectation of success. The ordinary skilled artisan would have been motivated to do so as taught by Wagner because moxifloxacin is more effective at killing bacteria from the eye than gentamicin (Abstract, p.43, Table 1 and Figs. 1-4).
Hence, the claimed invention as a whole was prima facie obvious in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARTHUR S LEONARD whose telephone number is (571)270-3073. The examiner can normally be reached on Mon-Fri 9am-5pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James Doug Schultz can be reached on 571-272-0763. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ARTHUR S LEONARD/Examiner, Art Unit 1631
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