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 .
Election/Restrictions
The rejections of record have been withdrawn below. The Markush search has been extended to Trichostatin A.
The election of species reads on claims 1-17.
Current Status of 18/073,181
This Office Action is responsive to the amended claims of 05/18/2026.
Claims 1-17 are examined on the merits.
Priority
This application is a continuation in part of PCT/US2021/035344, PCT/US2021/036741, PCT/US2021/036614, PCT/US2021/036738, PCT/US2021036628, and PCT/US2021/036617. These PCTs claim priority to US provisional applications 63/033,291, 63/037,920, 63/037,891, 63/037,918, 63/037,910, and 63/037,901.
The instant claims find support from these applications. The effective filing date is 6/2/2020.
Response to Arguments
Applicants’ claim amendments and Remarks of 05/18/2026 are acknowledged and have been considered.
Any rejection and/or objection not specifically addressed or modified below is herein withdrawn.
Claims 1, 15, and 17 are amended.
In regard to the 102 rejection, this rejection is withdrawn. Applicants deleted levocabastine hydrochloride as an option of active drug compounds in claims 1 and 17.
In regard to the 103 rejection, this rejection is withdrawn due to claim amendments.
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.
Claim(s) 1, 4, 8, and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by OKAMOTO (JP2007191398A). Examiner is citing the machine translation which is provided to Applicants.
OKAMOTO anticipates treating eye diseases including myopia (paragraph [0009], [0005], [0017]) with a composition containing trichostatin A as an active ingredient (paragraph [0005]). This anticipates claim 1.
OKAMOTO anticipates the composition was administered once a day (paragraph [0017]). This anticipates claim 4.
OKAMOTO anticipates administering trichostatin A in an eye drop (paragraph [0008]). This anticipates claim 8.
There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference. Chemical properties are inherent to their compounds. See MPEP 2112 (II). Products of identical chemical composition can not have mutually exclusive properties. A chemical compound of claim 1, and its properties, efficacy, penetration, stability, bioavailability and side effects, are inseparable. See MPEP 2112.01 (II). This anticipates claim 15.
Claim(s) 16 and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by BOBBA (WO 2018193367).
BOBBA anticipates a method of treating ophthalmic disorders including myopia (page 4) with pharmaceutical composition comprising combination of Alcaftadine and Nepafenac (page 1). This anticipates claims 16-17.
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.
Claim(s) 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over OKAMOTO (JP2007191398A) in view of Chehab (US 2014/0036225, previously cited) and in view of TAN (US20200138801, previously cited).
Claim(s) 1, 4, 8, and 15 are taught above by OKAMOTO.
Tan teaches a method of treating myopia by administering a very low concentration of atropine (paragraph [0047], another myopia treatment. Tan additionally teaches that “a patient who can benefit from atropine treatments as disclosed herein can be of any age group” (paragraph [0048]). This helps teach claims 2-3.
Tan also teaches that treatment with the atropine may last for 5-10 years (paragraph [0068]). Tan teaches that administration can be intermitted (paragraph [009]) or continuously (paragraph [0068]). This helps teach claim 6.
The artisan would have found it obvious to combine trichostatin A, which is known to be a myopia treatment (OKAMOTO), with atropine, another known myopia treatment. It is prima facie obvious to combine one myopia treatment with another in order to form a treatment to be used for the very same purpose (treating myopia). In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). See MPEP 2144.06(I). This helps teach claims 2-3 and 6.
Furthermore, OKAMOTO teaches that the amount/percentage of trichostatin A in the therapeutic agent can vary depending on the type of eye disease, administration route, dose, and patient, and can be appropriately determined by those skilled in the art (paragraph [0008]). This teaches a motivation that the artisan would have been expected to vary the dosage (1-3 times a week) from claims 5-6 and route of administration (claims 9-14).
Examiner understands that the subject is monitored for the suppression of myopia and the dosage is adjusted depending on the degree of suppression. This teaches claim 7.
Therefore, the artisan would have been motivated to optimize the dosing schedule of trichostatin A. OKAMOTO teaches varying dose (amount and timing) would be expected (paragraph [0008]). Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. See MPEP 2144.05(II)A. Examiner has reviewed the instant specification and claims and has not found evidence that the dosage is critical. Thus, the artisan would be motivated and expected to optimize the dosage schedule of Trichostatin A. In order to confirm the success of dosing amount/schedule, the artisan would be further motivated and expected to monitor the patient. This teaches claims 5-7.
Chehab teaches delivering the therapeutic agents through the contact lens (paragraph [0030]). This teaches claim 8.
Chehab teaches that the contact lens is a multi-focal lens (paragraph [0033]. This teaches claim 10.
Chehab teaches that the composition is loaded on the entire volume of the contact lens (“The lenses in the blister package uptake the drug over a period of time” paragraph [0032]). This teaches claim 11.
Chehab teaches the contact lens is made of a hydrogel material (paragraph [0011]). This teaches claims 9, 12 , and 13 (gel).
Chehab teaches the therapeutic agent further comprises atropine, which prevents or treats myopia (paragraph [0030]). This teaches claim 14.
The artisan would have been motivated to vary the route of admisntration (OKAMOTO paragraph [0008]). The artisan would have been motivated to use a known route of administration, for example Chehab’s contact lenses (paragraphs [0030, 0033, 0032, and 0011]). The artisan would have expected that the contact lens to be effective at delivering therapeutic agents (paragraph [0030]). This teaches claims 9-14.
The artisan would be motivated to administer OKAMOTO’s method (administering Trichostatin A and atropine) to any aged patient. Tan teaches that a patient who can benefit from atropine treatments (treatments for myopia) can be of any age group (paragraph [0048]). Furthermore, it is obvious to administer OKAMOTO’s method to any myopia patient, including a sub-population of claims 2 and 3, because nothing precludes them from the treatment. This teaches claims 2 and 3.
Conclusion
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.
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/G.A.H./Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625
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