DETAILED ACTION
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 .
Information Disclosure Statement
The Information Disclosure Statement (IDS) filed on 10/27/2023 has been considered by the Examiner.
Claim Status
Claims 1 - 8 are pending in the application.
Claim Objections
Claim 7 is objected to because of the following informalities: missing an article before "eye drop formulation". Examiner suggests adding the article “an” before “eye drop formulation” to promote clarity. Appropriate correction is required.
Claim Interpretation
Claims 5 - 8 are drawn to a composition and the intended use of the composition. The recitation of an intended use of the claimed invention must result in a structural difference between the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Therefore, the intended use recited in claims 5 - 8, namely that the composition is for treating macular degeneration and is delivered to a vitreous body, a retina and/or a choroid when administered to a mammal, is not afforded patentable weight.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 4 recites the limitation "the eye drop formulation" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 4 depends from claim 1, which does not introduce an eye drop formulation. The phrase "eye drop formulation" is not mentioned until claim 3, therefore the Examiner suggests amending claim 4 to depend from claim 3 or otherwise amend the claims to provide proper antecedent basis for "the eye drop formulation" in claim 4.
Claim 6 recites the limitation of “the mammal” in line 3. There is insufficient antecedent basis for this limitation in the claim. Claim 6 depends from claim 5, which does not recite “a mammal”. The Examiner suggests amending the claims to provide proper antecedent basis for "the mammal" recited in claim 6.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
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 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over Inoguchi et al. (US11382925, Published Jul 12, 2022), in view of Park et al. (KR-20220079480-A, Published June 13, 2022).
Regarding claims 1 - 8, Inoguchi et al. teach a method for treating aged-related maculopathy using a therapeutically effective amount of SGLT-2 inhibitor (column 2 lines 5-13, claims 1 and 4) in mammals. Specifically, Inoguchi et al. demonstrated the use of SGLT-2 inhibitor Ipragliflozin in age-related macular degeneration (AMD) mouse models (column 6 lines 4-15). Furthermore, they provide examples of SGLT-2 inhibitors including: Canagliflozin, Ipragliflozin, Dapagliflozin, Luseogliflozin, Empagliflozin, and Tofogliflozin which are “active ingredients of existing SGLT-2 inhibitor agents” (column 3 lines 62-67, and column 4 lines 1-3). Inoguchi et al. also disclose the term "Canagliflozin" relates to a compound having the following Canagliflozin structure
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, and includes a pharmaceutical acceptable hydrate, alcohol adduct, amino acid adduct and it is the same for other SGLT-2 inhibitors such as "Ipragliflozin" (column 4 lines 4-30).
Inoguchi et al. differs from the claimed invention in (A) the use of the specific compound Enavogliflozin, (B) administration of Enavogliflozin via an eye drop formulation, and (C) the teaching of the eye drop formulation composition comprising of excipients.
With regard to limitation (A) Park et al. teaches the composition and use of the SGLT-2 inhibitor, Enavogliflozin (also written as Inabogliflozin), for the treatment and prevention of diabetic eye diseases in a subject (pg. 2 claims 1 – 3, and paragraphs [0009], [0011], [0012], and [0037] ) as required in Applicant’s claims 1 and 5. Park et al. teach the chemical structure of Enavogliflozin represented by:
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(paragraph [0015]) which is the same as the structure provided in Applicant’s specification.
With regard to the limitations of (B) Park et al. teach a composition including an SGLT-2 inhibitor administered as an eye drop (paragraph [0021] and [0022]). They note that a high drug concentration level was observed in the vitreous, retina, and choroid, and an excellent therapeutic effect was exhibited for diabetic eye disease (paragraph [0022] and Figures 3 and 4). These disclosures read on Applicant’s claims 2, 3, 6 and 7.
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With regard to the limitations of (C) Park et al. teach excipients for the eye drop formulations through disclosure of the compositions (paragraphs [0042] – [0045]) as required in Applicant’s claims 4 and 8. Specifically the composition teaches polyoxyl castor oil, polysorbate (Tween 80), and glycerin which are excipients selected from the group consisting of polyoxyl castor oil, polysorbate, D-a-tocopheryl polyethylene glycol succinate, and glycerin as recited in claims 4 and 8.
Enavogliflozin is thus, a known SGLT-2 inhibitor and would be expected to exhibit the same mechanism of action as the SGLT-2 inhibitors taught by Inoguchi et al. for treating age-related maculopathy. Additionally, Park et al. teaches administration of the eye drop formulation, representing a known and predictable method for delivering therapeutically active agents to ocular tissues. Accordingly, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed, to modify the teachings of Inoguchi et al. which taught the use of SGLT-2 inhibitors for the treatment of aged-related maculopathy with the teachings of Park et al. which discloses an eye drop formulation of the SGLT-2 inhibitor Enavogliflozin for diabetic eye diseases. In view of these teachings, one of ordinary skill in the art at the time would have had a reasonable expectation of success to achieve Applicant’s claims 1-8.
Conclusion
No claims are allowed in this action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAJESH JAIPRASHAD whose telephone number is (571)272-1049. The examiner can normally be reached Monday-Friday 8AM-5PM.
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/RAJESH JAIPRASHAD/Examiner, Art Unit 1691
/RENEE CLAYTOR/Supervisory Patent Examiner, Art Unit 1691