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 .
Receipt is acknowledged of certified copies of the foreign application TW 111150218 papers required under 37 CFR 1.55.
Applicants have not filed a translation of the foreign application TW 111150218 to which they are claiming foreign priority.
Information Disclosure Statement
Information disclosure statement (IDS) filed on 06/05/2024 is compliant and has been considered by the examiner.
Claim Objections
Claims 2-4 are objected to because of the following informalities: the term claim in claims 2-4 start with capital letter “C”. The upper-case C should be lower-case c.
Appropriate correction is required.
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 is rejected under 35 U.S.C. 103 as being unpatentable over Filios et al. 2014 (Journal of Biological Chemistry, 289:36275-36283, “Filios”), Singh et al. 2019 (Diabetes, 68:2175-2190, “Singh”), and Xu et al. 2014 (Wound Repair and Regeneration, 22: A69, abstract only, “Xu”).
With respect to claim 1, Filios et al teaches expression of Zeb-1 is decreased in insulinoma-1 (INS-1) cells in culture as well as in INS-1 cells of diabetic mouse model after transfection of miR-200b (see figure 5). Furthermore, Filios teaches that expression of E-cadherin, a regulator of epithelial-mesenchymal transition (EMT), is increased in INS-1 cells along with an increase in miRNA-200b. Filios also teaches the sequence of miRNA-200b that is 100% identical to SEQ ID NO:2 recited in claim 1 as shown below.
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Thus, Filios teaches relationship of increased miRNA-200b expression with reduced Zeb-1 expression and increased E-cadherin expression in and diabetes. Filios also teaches the sequence of SEQ ID NO 2 as claimed instantly.
However, Filios does not teach administering miRNA-200b to a diabetic subject for improving wound healing.
Singh teaches diabetic wound healing was improved in diabetic mice subjected to Zeb1 gene knockout (see abstract and figure 5F). Singh teaches that under diabetic condition, arrest of endothelial ZEB1 has the potential to rescue vascular and wound closure complications (see “ZEB1 Knockout Rescued Diabetic Endothelial Dysfunction and Improved Wound Closure” section of result). Furthermore, Singh teaches that the expression level of E-cadherin goes down after creating cutaneous wounding (see figure 1A) in the diabetic mouse.
Xu hypothesized that abnormal miRNA-200b expression may be responsible for the impaired EMT seen in diabetic wounds and contributed to the diabetic wound healing impairment. Using diabetic mice, they showed that miRNA-200b was significantly down regulated in wounds. Decrease in miRNA-200b levels correlated with increased expression of Zeb1. Xu further taught that down regulating the expression of miRNA-200b in diabetic wounds might be responsible for the abnormal EMT seen in diabetic mouse and may contribute to the wound healing impairment.
In view of the combined teachings of Filios, Singh et al and Xu, it would have been obvious to administer miRNA-200b to the wound of a diabetic subject for improving healing of the wound of the subject with a reasonable expectation of success. An artisan would have been motivated to administer miRNA-200b to the diabetic wound because Xu teaches that miRNA 200b is decreased in wound of diabetic mouse and, a decrease in miRNA-200b levels is associated with impaired wound healing in diabetic mouse.
Claim(s) 2-4 are rejected under 35 U.S.C. 103 as being unpatentable over Filios, Singh, and Xu as applied to claim 1 above, and further in view of US pre-grant publication (US-PGPUB) number US 20170298353 published in 10/19/2017 “US2017”.
Teachings of Filios, Singh, and Xu as applicable to claim 1 have been described above.
With respect to claim 2, US2017 teaches a method of promoting wound healing, e.g., in subjects with or without diabetes by administering an inhibitory nucleic acid that targets miR-26a to the wound. In exemplary embodiments, the wound is an ulcer, e.g., a foot ulcer, in a diabetic subject (see paragraph 0028)
With respect to claim 3 and 4, US2017 teaches that the compositions are formulated with a pharmaceutically acceptable carrier. The pharmaceutical compositions and formulations can be administered parenterally, topically, orally or by local administration, such as by injection, topical application (e.g., of a lotion, cream, gel, or spray), or other dermal or transdermal application (see paragraph 0086).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to administer miRNA-200b to diabetic ulcer and wound of a diabetic subject by different methods of application/administration such as parenteral or topical with a reasonable expectation of success. One would have been motivated to do so with a reasonable expectation of success because US20147 teaches administration of miRNA-200b to diabetic wound and/or ulcer by parenteral and topical routes.
Conclusion
No claim is allowed.
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Suraj Sapkota
Patent Examiner
AU 1635
/RAM R SHUKLA/ Supervisory Patent Examiner, Art Unit 1635
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