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 .
Priority
The effective filing date is the actual filing date – May 12, 2023.
Status
Claims 1, 3-24 are pending. Applicant amended independent claims 1 and 19.
Rejections not reiterated in this office action are withdrawn.
New Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 19-22 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor at the time the application was filed, had possession of the claimed invention.
Applicant amended the claim to include a numerical range limitation with of “from 23 ppm to 45 ppm”. Applicant stated the following regarding support for the amendment:
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the examiner could not locate support for such a new limitation at the cited portions or elsewhere in the disclosure, nor does there appear to be a written description of the limitation in the application as filed. See Hyatt v. Dudas, 492 F.3d 1365, 1370, 83 USPQ2d 1373, 1376 (Fed. Cir. 2007) (holding that "[MPEP] § 2163.04 (I)(B) as written is a lawful formulation of the prima facie standard for a lack of written description rejection."). There is no literal support for the added limitation and one of skill in the art would not recognize that Applicant possessed the claim scope.
New 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, 3-18, 24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tada et al. (US11376262, published Jul 5, 2022).
Tada teaches a clobetasol ophthalmic nanosuspension comprising clobetasol propionate, sodium chloride (physiologically acceptable salt), glycerin, hydrogenated soybean lecithin, and anhydrous citric acid (col 43, line 1, to col 45, line 28; claims 1-9) having particle diameters (col 43, line 20-24, “mean particle diameter (Dv) of 132 nm, … (D90) of 184 nm”). Tada teaches the composition is useful for treating eye inflammation from surgical treatments including “anterior chamber paracentesis” and “cataract surgery” (col 22, lines 29-43). Tada teaches “treating … post-surgery infections of cornea, … post-surgery infections of anterior chamber … comprising administering a pharmaceutical composition comprising an aqueous suspension to a subject in need thereof in an effective amount” (claim 1). Thus, claim 1 is anticipated.
Regarding claim 3, Tada teaches treating ocular inflammation (col 5, lines 37-54: “treating … ocular inflammatory or infectious diseases”).
Regarding claim 4, Tada teaches cataract surgery which includes uncomplicated cataract surgery (col 22, line 41; claim 1).
Regarding claim 5, Tada teaches comprising 0.01 wt% (col 44, line 32, “Clobetasol Priopionate 0.01”; col 43, line 1, to col 45, line 28).
Regarding claim 6, Tada teaches the administration every day (col 24, lines 9-12: “applicable every day … after a topical inflammatory or infectious disease is developed”).
Regarding claims 7-8, Tada teaches application every day after the procedure (col 22, lines 26-56; col 24, lines 1-19: “applicable every day … after a topical inflammatory or infectious disease is developed”).
Regarding claim 9, Tada teaches daily administration for two weeks (col 24, lines 1-19).
Regarding claim 10, Tada teaches forming the nanosuspension by mixing the ingredients acid (col 43, line 1, to col 45, line 28).
Regarding claims 11-17, Tada teaches polyvinyl alcohol and poloxamer as ingredients which correspond to the claims surface, dispersion, and viscosity modifiers (col 43, line 1, to col 45, line 28; claims 1-9).
Regarding claim 18, Tada teaches administration as an eye drop (claim 9).
Regarding claim 24, Tada is silent regarding ACC count, however, the property of reducing ACC count would inherent in the Tada method when practiced. The technical reasoning supporting inherency is that the administration of the same composition to the same patient in the same manner would have the same effect and nothing in the claim distinguishes the method from that of the prior art. MPEP 2112.
New 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, 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.
Claims 1, 3-23 are rejected under 35 U.S.C. 103 as being unpatentable over Tada et al. (US11376262, published Jul 5, 2022) in view of Kikuchi et al. (International Journal of Pharmaceutics 290 (2005) 83–89).
Tada teaches as in the 35 USC 102 rejection of claims 1, 3-18 above and incorporated herein which also renders these claims obvious.
Regarding claim 19, Tada teaches formulation with boric acid (col 14, lines 9-18) and benzalkonium chloride 0.001% (equivalent to 10ppm) (col 43, line 1, to col 45, line 28), benzalkonium chloride as an agglomeration inhibitor in a range of 0.001 to 10% (col 10, lines 20-30) and all of the elements of claim 1 as detailed above, but does not specifically teach EDTA or the specific ppm amount of benzalkonium chloride.
Kikuchi teaches formulations that enhance the corneal penetration of an active agent through the synergistic combination of EDTA and boric acid (title, abstract).
One of ordinary skill in the art following the teaching of Tada would have considered formulating with boric acid and EDTA because of the success of Kikuchi and because these formulation elements are routinely used in such formulations. One of ordinary skill in the art would have considered routine the optimization of the amount of benzalkonium chloride within the amounts taught by Tada as a agglomeration inhibitor or preservative and arrived at the claimed invention. One of ordinary skill in the art would consider such formulation optimization steps as routine in the art and would arrive at the claimed invention with a reasonable expectation of success.
Similarly with claims 20 and 21, each of these elements are taught by the combined prior art and would be part of routine optimization of the formulation. One of ordinary skill in the art would need to select from the components and using their high level of experience in the art would arrive at the claimed values in the course of routine experimentation. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); MPEP 2144.05.
Regarding claim 22, Tada in view of Kikuchi teaches the same composition and same method of use such that one of ordinary skill in the art would arrive at the claimed invention.
Regarding claim 23, Tada teaches that the invention is useful in treating inflammation and pain (col 1, line 35) such that one of ordinary skill in the art would have considered the administering the composition in the same manner and arrive at the claimed invention.
With each of the above claims, the level of skill in the art is very high such that one of ordinary skill in the art would consider routine the combination of elements from the teaching of the art in the same field of endeavor. One of ordinary skill in the art would have recognized that the results of the combination would be predictable due to the well-known nature and optimizations routinely performed in the art. Thus, one of ordinary skill in the art would have arrived at the invention as claimed with a reasonable expectation of success.
In the alternative, claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Tada et al. (US11376262, published Jul 5, 2022) in view of Kikuchi et al. (International Journal of Pharmaceutics 290 (2005) 83–89) as applied to claims 1, 3-23 above and further in view of Formosa (“Efficacy and Safety of APP13007 for Treatment of Inflammation and Pain After Cataract Surgery” ClinicalTrials.gov ID NCT04739709, available online at https://clinicaltrials.gov/study/NCT04739709 version published 2021-02-03).
Regarding claim 24, Tada teaches the composition is useful for treating eye inflammation from surgical treatments including “anterior chamber paracentesis” and “cataract surgery” (col 22, lines 29-43) and “treating … post-surgery infections of cornea, … post-surgery infections of anterior chamber … comprising administering a pharmaceutical composition comprising an aqueous suspension to a subject in need thereof in an effective amount” (claim 1), but does not teach reducing anterior chamber cell (ACC) count.
Formosa teaches a clinical trial for treating inflammation and pain following cataract surgery by administering eye drops and assessing ACC count (p. 9/14: “Primary Outcome Measures”). Formosa is in the same field of endeavor as Tada of treating ocular inflammation subsequent to cataract surgery. One of ordinary skill in the art would have considered assessing ACC count as was well-known in the art and in the same manner as taught by Formosa and arrived at the claimed invention with a reasonable expectation of success.
Response to Applicant Remarks
Applicant filed a response on 11/20/25 and a supplemental response on 12/11/25 including two 132 declarations. The examiner has fully considered the responses, including the 132 declarations.
The declaration of Chen provided data regarding the effect of benzalkonium chloride (BAK) as an anti-bacterial across concentrations.
The declaration of Co provided data regarding the ACC count and pain grade following cataract surgery in patients receiving a placebo.
In the 12/11/25 remarks providing the declarations Applicant states that “the declarations are submitted to support Applicant’s contentions in the Amendment filed 20 November 2025 at pages 9 and 11 respectively” without further explanation. The examiner interprets the declarations as providing an evidentiary basis for the data included in the 11/20/25 remarks. Subsequent reference to Applicant remarks pertain to the 11/20/25 response.
Applicant argues on page 5 that two of the operative complications arising from cataract surgery of high ACC count and pain can be effectively treated by administering the claimed composition post-operatively.
This argument is not persuasive because Tada teaches that the administration of the composition is expected to treat inflammation and pain and as in the 102 and 103 rejections above the ACC count reduction is inherent or in the alternative well-known (as also shown by Applicant’s citation to Liu, Kuchle, Li, etc.) to be a measure of treating inflammation and pain. Thus, weighing the evidence of record, the alleged unexpected result is expected.
Applicant next argues on page 6 that Tada only describes prevention of infection by administration of the pharmaceutical composition before surgery, not after.
This argument is not persuasive because Tada teaches “treating … post-surgery infections of cornea, … post-surgery infections of anterior chamber … comprising administering a pharmaceutical composition comprising an aqueous suspension to a subject in need thereof in an effective amount” (claim 1) and “applicable every day … after a topical inflammatory or infectious disease is developed” (col 24, lines 9-12).
Applicant also argues that based on Tada, “it also does not follow that Tada’s pharmaceutical composition would necessarily be useful in treating pain after cataract surgery.”
This is not persuasive as Tada teaches that the composition includes treating pain and furthermore, one of ordinary skill in the art would have reasonably considered that treating eye inflammation would reduce pain in a subject.
Applicant next argues that “one skilled in the art would not expect a drug that prevents a disease to also treat it” and analogizes to fiber and diabetes.
This argument is not persuasive as one of ordinary skill in the art would have a reasonable expectation of Tada’s teaching of the composition “for treating or preventing inflammatory diseases of the eye” (Abstract), that treating and preventing are within the scope of the composition’s utility.
Applicant also argues that that “corticosteroids like clobetasol propionate are known to increase intraocular pressure in some patients, complicating cataract surgery” without any factual support or citation.
The argument is not persuasive as it appears to be unsupported attorney argument and regardless Tada does teach post-surgery administration.
Applicant next argues that the claimed range of BAK is critical as antibacterial while avoiding adverse effects.
This argument is not persuasive because BAK is specifically taught as a preferred antibacterial agent ([0061]: “Benzalkonium chloride is preferable.”) and one of ordinary skill in the art would have considered routine optimization of the ingredient as an antibacterial without adverse effects.
Conclusion
No claims allowed.
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 ROBERT H HAVLIN whose telephone number is (571)272-9066. The examiner can normally be reached 9am - 6pm.
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, Kortney Klinkel can be reached at (571) 270-5293. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROBERT H HAVLIN/Primary Patent Examiner, Art Unit 1626