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 1-15 and 18-20 are pending
Claim 14-15 and 18-20 are withdrawn from examination as being drawn to a nonelected specie.
Claims 1-13 are under consideration in the instant office action.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-13) and the following species in their response dated 04/06/2026 is acknowledged.
Specie 1: Metformin as the active ingredient
Specie 2: carboxymethyl cellulose (CMC) as the ionic macromolecule
Upon further consideration, the specie election is withdrawn and the claims are examined for all the species they encompass.
Examination of the claims are conducted to the extent they read on the elected invention. Claims 14-15 and 18-20 are withdrawn from examination as being drawn to a nonelected specie.
Claims 1-13 are under examination and the requirement for restriction is made final.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/24/2023 and 04/06/2026 complies with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609. Accordingly, it has been placed in the application file and the information therein has been considered as to the merits. See attached copy of the PTO-1449.
Priority
This application is a U.S. national stage application under 35 U.S.C. Q 371 of International Application No. PCT/CN2021/134150, filed internationally on November 29, 2021, which claims the benefit of priority to Chinese Application No. 202110091088.2, filed on January 22, 2021,
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 4-7 are rejected under 35 U.S.C. 102 (a) (1) and under 35 U.S.C 102(a)(2) as being anticipated by Horn et al. (WO 2019/0224120)
Instant claims are drawn an aqueous ophthalmic preparation for eye drop administration, comprising an active pharmaceutical ingredient and an ophthalmic preparation carrier or adjuvant; wherein the active pharmaceutical ingredient comprises at least one selected from the group consisting of an adenylate-activated protein kinase activator and[[/or]] an anti-inflammatory active ingredient; and wherein the ophthalmic preparation carrier or adjuvant comprises a surfactant, an ionic macromolecule, and a solvent.
Horn et al. discloses topical drug compositions for ophthalmological use (abstract). Comprising a steroid anti-inflammatory drug or a nonsteroid anti-inflammatory drug or an antibiotic [0075-0076] . Their composition comprises 2.0% to about 6.0% w/v of one or more nonionic surfactants, preferably the one or more nonionic surfactants is selected from the group consisting of polysorbates, poloxamers, polyoxyl castor oils, and cyclodextrins, more preferably selected from the group consisting of polysorbate 80, poloxamer 407, poloxamer 188, polyoxyl castor oil and hydroxypropyl gamma cyclodextrin ([0021-0022][0034], claim 33). They disclose the inclusion of an ionic macromolecules or 0.5-2% w/v of viscosity agent selected from the group consisting of cellulose derivatives, carbomers, gums, dextrans, polyvinyl alcohol, polyacrylic acids, povidone, polyethylene glycol, propylene glycol, chitosans, hyaluronates, hyaluronic acids and combinations thereof, preferably wherein the composition has a viscosity from about 1 to about 1,000 centipoise and the cellulose derivative carboxymethyl cellulose at a concentration from about 0.01% to about 1.5% w/v.[0034, 0040, 0065]. They further disclose a composition comprising an active agent selected from the group consisting of diquafosol, bimatoprost, cyclosporine-A, GLC, prednisolone forte, ketorolac, gentamycin, polytrim, ciprofloxacin, moxifloxacin, gatifloxacin, lifitegrast, besifloxacin, pilocarpine, brimonidine, timolol, dexmedetomidine, timoptic, dorzolamide, latanoprost, acetylsalicylic acid and a combination thereof, preferably cyclosporine-A, one or more nonionic surfactants and at least one excipient selected from the group consisting of one or more viscosity enhancers, a polyol and an electrolyte, wherein micelles having an average diameter from about 12 to about 20 nanometers are formed, preferably from about 15 to about 20 nanometers and more preferably about 16 nanometers [0647].
Therefore the composition disclosed by Horn et al. fully anticipates instant claims 1 and 4-7.
Claims 1 and 4-7 are rejected under 35 U.S.C. 102 (a) (1) and under 35 U.S.C 102(a)(2) as being anticipated by Mizutare et al. (US 2017/015934).
Mizutare et al. discloses a aqueous ophthalmic compositions which comprises an anti-inflammatory or anti-bacterial agents (abstract), at least one surfactant which include Poloxamer 407, polyoxyethylene (200) polyoxypropylene (70) glycol, polyoxyethylene hydrogenated castor oil 40, polyoxyethylene hydrogenated castor oil 60, polyoxyethylene castor oil 3, polyoxyethylene castor oil 10, polyoxyethylene castor oil 35, polyoxyl 40 stearate and polyoxyl 140 stearate are preferable, and Poloxamer 407, polyoxyethylene hydrogenated castor oil 60, polyoxyethylene castor oil 10, polyoxyethylene castor oil 35, and polyoxyl 40 stearate [0037-0039]. They disclose the inclusion of thickening agents and the preferred agents are cellulose based polymers such as carboxymethyl cellulose, carboxymethyl cellulose sodium and methyl cellulose [0043]. They disclose the use of acidic polysaccharides in their formulation which includes chondroitin sulfate, hyaluronic acid, xanthan gum, gellan gum, alginic acid, or a salt thereof, and is particularly preferably sodium chondroitin sulfate, sodium hyaluronate, alginic acid, or gellan gum[0027]. They disclose the total amount of active ingredient in their composition to be 0.001- 0.01 w/v%[0049], the polysaccharide component to be between 0.0001 w/v% to 6 w/v% [0050], surfactant 0.001 w/v% to 5 w/v% [0059]. Mizutare et al describes in detail all the different active agents and additives that can be used in ophthalmologic solutions and in their inventive compositions [0085-0102]
Therefore the composition disclosed by Mizutare et al. fully anticipates instant claims 1 and 4-7.
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 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 2-3 and 8-11 are rejected under 35 U.S.C. 103(a) as being unpatentable over by Mizutare et al. (US 2017/0105934) in view of Makley et al. (US 2018/0250313).
Mizutare et al. teaches as recited above in the anticipation rejection as applied to claims 1 and 4-7 and are applied here in the same way/
Mizutare et el. does not specifically recite the ratios between the different components in the composition as instantly claimed in claims 2-4, however, they disclose the total amount of active ingredient in their composition to be 0.001- 0.01 w/v%[0049], the polysaccharide component to be between 0.0001 w/v% to 6 w/v% [0050], surfactant 0.001 w/v% to 5 w/v% [0059]. Mizutare et al describes in detail all the different active agents and additives that can be used in ophthalmologic solutions and in their inventive compositions [0085-0102]. It would have been obvious to a person of ordinary skill in the art to optimize the concentrations of these agents with guidelines provided by Mizutare et al. and arrive at the instantly claimed ratio’s. These ranges yield a range of ratios that overlap with those instantly claimed, thereby rendering the claimed ranges obvious. “in the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed.Cir. 1990)" (see MPEP 2144.05).
Mizutare et al. fails to disclose the instantly claimed active agents as recited in claims 9-10 and the ophthalmic preparation as nanospheres comprising nanobodies having a particle size 10-2000 nm
However, Makley et al. discloses ophthalmic formulations for treatment of ocular conditions such as cataract (abstract). They disclose compounds of formula (IIIC) in their composition which can be used in combination with an anti-apoptotic compounds such as lipoic acid [0278] or other anti-inflammatory compounds [0282] or antibiotic agents such as doxycycline and tetracycline [0283]. They disclose their compositions to comprise of surfactants such as sorbitan ether esters at a concentration of 0.05 wt % to about 0.3 wt % of surfactant such as polysorbate -80 [0179] and a viscosity increasing agents which includes carboxymethylcellulose also disclose the use of their compositions as nanosuspension [0186] comprising nano particles of 50 nm droplets( [0153], [0301]).
The references above discloses that their pharmaceutical compositions comprise ophthalmologically acceptable preservatives, surfactants, viscosity enhancers, penetration enhancers, buffers, sodium chloride, and water to form an aqueous, sterile ophthalmic suspension or solution. They teach the key excipients that goes into an ophthalmic formulations which are instantly claimed , the surfactant and the ionic macromolecule, the solvent and the active agents. Further, excipients used in the ophthalmic compositions and formulation of ophthalmic compositions are well known in the pharmaceutical arts. As such it would have been prima facia obvious to a person of ordinary skill in the art to arrive at the instant claims motivated and guided by teachings of Boss et al. and what is well known in the art.
Further it is recognized that pharmaceutical excipients may perform more than one function, and are therefore characterized as having different uses depending on the particular application. While the use of an excipient in the context of a particular formulation may determine the function of the excipient, the inclusion of any particular excipient into any one or more category as set forth above is not meant to limit the function of that excipient
The references above provides a clear motivation and suggestions to formulate an ophthalmic composition with the instantly claimed compound suitable for administration to the eyes for the purpose it serves. The amount of a specific ingredient in a composition is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient needed to achieve the desired results. Thus, absent some demonstration of unexpected results from the claimed parameters, the optimization of ingredient amounts would have been obvious at the time of applicant's invention. With regards to the amount of each of the excipient added to the composition. it would be within the skill of an ordinary artisan to be able to optimize the concentrations of each of the excipient to maximize its effect and utility in the composition. It is noted that "[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). An ordinarily skilled artisan would arrive at the instantly claimed concentration while conducting routine optimization testing to achieve this goal. As such a person of ordinary skill in the art would be imbued with a reasonable expectation of success in formulating the instantly claimed composition , absence of evidence to the contrary.
Conclusion
Claims 1-13 are rejected. No claims are allowed
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAVITHA RAO whose telephone number is (571)270-5315. The examiner can normally be reached on Mon-Fri 7 am to 4 pm..
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Renee Claytor can be reached on (571) 272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SAVITHA M RAO/ Primary Examiner, Art Unit 1691
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