DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. 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
2. Applicant’s election without traverse of Group II in the reply filed on June 8, 2026 is acknowledged.
Information Disclosure Statement
3. The information disclosure statements (dated August 9, 2024 and June 3, 2024) were in compliance with the provisions of 37 CFR 1.97 and 37 CFR 1.98. The statements were considered. Signed copies of form 1449 are enclosed herewith.
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.
4. Claim(s) 1-3, 8-19 and 21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20190008837. The reference has a publication date of January 10, 2019 which antedates the present claims having a filing date of March 29, 2024 and priority claim to provisional application dated March 31, 2023.
The reference teaches the administration of pergolide to the eye to treat an ophthalmic condition which includes disorders that can result from trauma to the eye or cornea, for example, neurotrophic keratopathy, dry eye, etc. (present claim 1, 2, 11). The administration is in form of a topical eye drop – claim 19 (present claim 3). The administration can be 1-3 times a day – claim 18 (present claim 10). The dosage amount that is administered at each time point can be about 10 – 20 mL or 50 – 60 mL – page 5 (present claim 4 and 5). The composition that is administered includes various additional ingredients, for example, hyaluronic acid – claim 7 (present claim 19), water – claim 9, propylene glycol – claim 8, phosphate buffer – page 9 (present claim 21) and ascorbate – page 11 (present claim 18). The administration is to a population that did not receive previous ocular nerve grafting (present claim 17). The properties claim in present claim 8, 9 and 12-16 are inherently anticipated because the properties are inseparable from the product and administration thereof.
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.
5. Claim(s) 6 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20190008837. The reference has a publication date of January 10, 2019 which antedates the present claims having a filing date of March 29, 2024 and priority claim to provisional application dated March 31, 2023.
Determining the scope and contents of the prior art
The reference teaches the administration of pergolide to the eye to treat an ophthalmic condition which includes disorders that can result from trauma to the eye or cornea, for example, neurotrophic keratopathy, dry eye, etc. (present claim 1, 2, 11). The administration is in form of a topical eye drop – claim 19 (present claim 3). The administration can be 1-3 times a day – claim 18 (present claim 10). The dosage amount that is administered at each time point can be about 10 – 20 mL or 50 – 60 mL – page 5 (present claim 4 and 5). The composition that is administered includes various additional ingredients, for example, hyaluronic acid – claim 7 (present claim 19), water – claim 9, propylene glycol – claim 8, phosphate buffer – page 9 (present claim 21) and ascorbate – page 11 (present claim 18). The administration is to a population that did not receive previous ocular nerve grafting (present claim 17). The properties claim in present claim 8, 9 and 12-16 are inherently anticipated because the properties are inseparable from the product and administration thereof. .
Ascertaining the differences between the prior art and the claims at issue
The difference between the present claims and the prior art is the amount of pergolide that is administered.
Resolving the level of ordinary skill in the pertinent art - considering objective evidence present in the application indicating obviousness
MPEP 2144.05 provides guidelines for the examination of applications for obviousness of similar and overlapping ranges, amounts, and proportions. MPEP 2144.05 II states “that where 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.” Thus, the general administration of pergolide as claimed is taught in the prior art. The skilled artisan may arrive by routine experimentation at different amounts of administration. For this reason, the present claims are determined to be prima facie obvious over the prior art.
Conclusion
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/SUN JAE YOO/Primary Examiner, Art Unit 1621
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