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 .
Status of the Claims
Claims 1-19 and 25 are pending.
Claims 5-6, 8, 10, 19 and 25 are withdrawn (see restriction/election).
Priority
Applicant’s claim for benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged. This application is a national stage entry of and claims priority to PCT/US2021/062643 filed on 12/09/2021 and further claims priority to provisional application number 63/127,087, filed 12/17/2020.
Information Disclosure Statement
All references from IDS(s) received on 6/09/2023, 12/23/2024, and 10/17/2025 have been considered unless marked with a strikethrough.
Election/Restrictions
Applicant’s election of the following below without traverse in the reply filed on 2/20/2026 is acknowledged. Claims 6, 10, and 25 are withdrawn as not reading on the elected species.
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No anticipatory art was found on the elected species of sodium alginate and where ketorolac is in the same composition as the rest. The Examiner expanded this species to poly(oxyethylene-co-oxypropylene) block copolymer and ibuprofen. Therefore, claims 5, 8, and 19 are also withdrawn as not reading on the expanded species. Claims 1-5, 7, 9, and 11-18 will be examined on their merits.
Anticipatory art was found on some of the elected species as well as expanded species. See 102 analysis below.
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.
Claims 17-18 are 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.
Regarding claims 17-18, the phrase "substantially" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention.
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.
(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 1-4, 7, 9, and 11-15 are rejected under 35 U.S.C. 102(a)(1)/(2) as being anticipated by HARROW (US20200155450A1; published 05/21/2020; “Harrow”).
Harrow teaches an ophthalmological pharmaceutical composition for use in topical administration (Example 3) comprising a mydriatic agent, including phenylephrine and tropicamide (Claim 18) as required by instant claims 1-3, a carrier polymer including is poly(oxyethylene-co-oxypropylene) block copolymer (Claim 23) as required by instant claims 1, 7, and 9, an NSAID including ibuprofen (claim 6) as required by instant claims 1 and 4, an anesthetic agent including lidocaine (Claim 5) as required by instant claims 11-12, an antibiotic including moxifloxacin (Claim 8) as required by instant claims 13-14, and finally the composition including an aqueous carrier (Claim 1) and ethylenediaminetetraacetic acid (Claim 14) as required by instant claims 1 and 15.
Therefore claims 1-4, 7, 9, and 11-15 are anticipated by Harrow.
Examiner wants to also point out that phrase “suitable for” is considered intended use language. Here the composition of the art is capable of performing the intended use.
During examination, statements in the preamble reciting the purpose or intended use of the claimed invention must be evaluated to determine whether or not the recited purpose or intended use results in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art. If so, the recitation serves to limit the claim. See, e.g., In re Otto, 312 F.2d 937, 938, 136 USPQ 458, 459 (CCPA 1963) (The claims were directed to a core member for hair curlers and a process of making a core member for hair curlers. The court held that the intended use of hair curling was of no significance to the structure and process of making.); In re Sinex, 309 F.2d 488, 492, 135 USPQ 302, 305 (CCPA 1962) (statement of intended use in an apparatus claim did not distinguish over the prior art apparatus). To satisfy an intended use limitation which is limiting, a prior art structure which is capable of performing the intended use as recited in the preamble meets the claim. See, e.g., In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed. Cir. 1997) (anticipation rejection affirmed based on Board’s factual finding that the reference dispenser (a spout disclosed as useful for purposes such as dispensing oil from an oil can) would be capable of dispensing popcorn in the manner set forth in appellant’s claim 1 (a dispensing top for dispensing popcorn in a specified manner)) and cases cited therein. See MPEP 2111.02.
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 1-4, 7, 9, and 11-18 are rejected under 35 U.S.C. 103 as being unpatentable over HARROW (US20200155450A1; published 05/21/2020; “Harrow”).
Harrow teaches an ophthalmological pharmaceutical composition for use in topical administration (Example 3) comprising a mydriatic agent, including phenylephrine and tropicamide (Claim 18) as required by instant claims 1-3, a carrier polymer including is poly(oxyethylene-co-oxypropylene) block copolymer (Claim 23) as required by instant claims 1, 7, and 9, an NSAID including ibuprofen (claim 6) as required by instant claims 1 and 4, an anesthetic agent including lidocaine (Claim 5) as required by instant claims 11-12, an antibiotic including moxifloxacin (Claim 8) as required by instant claims 13-14, and finally the composition including an aqueous carrier (Claim 1) and ethylenediaminetetraacetic acid (Claim 14) as required by instant claims 1 and 15.
Harrow fails to explicitly teach the EDTA is a disodium ededate, as required by instant claim 16, or that the composition is “substantially” free of preservatives or sulfites, as required by instant claims 17-18.
With respect to claims 17-18, the instant application does not specify a list of preservatives or sulfites. It does mention benzalkonium chloride as an example of a preservative. Harrow does not explicitly teach the addition of preservatives or sulfites, including benzalkonium chloride. Since Harrow doesn’t teach them in the list of ingredients this would meet the substantially free limitation of the instant claims. Therefore, it would be obvious to a person skilled in the art that the composition taught by Harrow would not include a significant amount of preservatives or sulfites.
With respect to claim 16, Harrow does not explicitly teach the EDTA is a disodium ededate. However, Harrow does teach EDTA as a keratopathy agent and further teaches the term “keratopathy agent” refers to substances or compounds that can be used for treating any noninflammatory disease of the cornea (para. 0029). A person skilled in the art could reasonably figure that the pharmaceutical salt of EDTA would fall in this category the same as EDTA does. Therefore, claims 16-18 would be obvious to a person skilled in the art at the time.
The Supreme Court in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper "functional approach" to the determination of obviousness as laid down in Graham.
Examples of rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement
to yield predictable results;
(E) "Obvious to try" – choosing from a finite number of identified, predictable solutions, with a
reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same
field or a different one based on design incentives or other market forces if the variations are
predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of
ordinary skill to modify the prior art reference or to combine prior art reference teachings to
arrive at the claimed invention.
Applying KSR example rationale (E), it would have been prima facie obvious to extract the teachings of Harrow and use a pharmaceutically acceptable salt of EDTA. Therefore, claims 1-4, 7, 9, and 11-18 would be obvious to a person skilled in the art at the time.
Conclusion
Claims 1-4, 7, 9, and 11-18 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICOLA MARIA BAUER whose telephone number is (703)756-1269. The examiner can normally be reached Monday-Friday 7:30-5 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clint Brooks can be reached at (571) 270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/N.M.B./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
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