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
Applicant’s election without traverse of Levaocabastine hydrochloride in the reply filed on 12/31/2025 is acknowledged.
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 12/31/2025.
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.
Information Disclosure Statement
The information disclosure statements (IDS), submitted on 12/01/2022 and 12/12/2022, are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 15 is objected to because of the following informalities: Claim 15 has two “and/or”s; this is awkward. Examiner recommends removing one of them for a more parallel list. 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.
Claim(s) 1, 4-5, and 7-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chehab (US 2014/0036225).
Chehab anticipates a contact lens comprising myopia control optics and selective or non-selective muscarinic agents (paragraph [0008]).
Chehab anticipates a method of preventing or treating (“effectively slow or stop myopia progression”) myopia in a subject by a contact lens (paragraph [0030]).
Chehab anticipates levocabastine hydrochloride (paragraph [0066]) administered in the contact lenses as an additional agent.
This anticipates claims 1, 16 and 17.
Chehab anticipates that the lens are worn every one to three days (paragraph [0034]). This anticipates claims 4 and 5.
Chehab anticipates that the drug release kinetics are adjusted to give therapeutically relevant concentrations (paragraph [0058]). Examiner understands that the subject is monitored for the suppression of myopia and the dosage is adjusted depending on the degree of suppression. This anticipates claim 7.
Chehab anticipates delivering the therapeutic agents through the contact lens (paragraph [0030]). This anticipates claim 8.
Chehab anticipates that the contact lens is a multi-focal lens (paragraph [0033]. This anticipates claim 10.
Chehab anticipates 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 anticipates claim 11.
Chehab anticipates the contact lens is made of a hydrogel material (paragraph [0011]). This anticipates claims 9, 12 , and 13 (gel).
Chehab anticipates the therapeutic agent further comprises atropine, which prevents or treats myopia (paragraph [0030]). This anticipates claim 14.
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 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) 1-17 are rejected under 35 U.S.C. 103 as being unpatentable over Chehab (US 2014/0036225) in view of TAN (US20200138801).
Claim(s) 1, 4-5, and 7-17 are taught above by Chehab.
Chehab does not disclose any age of patients.
Tan teaches a method of treating myopia by administering a very low concentration of atropine (paragraph [0047], same as the method of Chehab. 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 teaches claim 6.
The artisan would be motivated to administer Chehab’s method (administering a combination therapy of atropine and levocabastine hydrochloride (paragraph [0030] and [0066]) 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 Chehab’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
No claims are allowed as written.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GILLIAN A HUTTER whose telephone number is (571)272-6323. The examiner can normally be reached M-F 7:30-5.
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/G.A.H./ Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625