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 statements (IDS) submitted on 2/22/23;1/26/23 are in compliance with the provisions of 37 CFR 1.97(b). Accordingly, the IDSs are being considered by the Examiner.
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.
Claims 1-7, 10-23 are rejected under 35 U.S.C. 103 as being unpatentable over Hydrogel Doped with Nanoparticles for Local Sustained Release of siRNA in Breast Cancer, Adv. Healthcare Mater (2014) DOI: 10.1002/adhm.201400235, Nathaly Segovia et al. (“Segovia”) in view of Kang et al. (US 11,801,371) (“Kang”).
(claims 1, 18, 22) Segovia discloses an adhesive hydrogel scaffold (claim 15) embedded (well dispersed, claim 17) with (a polyplex formed in a polymeric complex, claims 19-21; see Segovia Fig. 1) PBAE/nucleic acid (siRNA) nanoparticles (claims 10-11) for sustained release, see introduction (2nd column and 1st column of pg. 2), §2.2.1. Segovia, does not directly disclose the adhesive hydrogel scaffold being a microneedle patch with the base and the plurality of microneedles formed from crosslinked gelatin methacryloyl (GelMA). Kang, in the analogous art, teaches a GelMA microneedle patch as another substitute bioabsorbable scaffold material. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the PAMAM dextran hydrogel of Segovia with the GelMA microneedle patch as taught by Kang to similiarly deliver the siRNA in a biodegradable hydrogel as a substitution of one adhesive biodegradable hydrogel for another.
(claims 2, 22-23) Upon application of the patch on living tissue (skin tissue, mucosal tissue, heart tissue, blood vessels, ocular tissue, gastrointestinal tissue, buccal tissue, muscle tissue, vaginal tissue) the plurality of microneedles release PBAE/nucleic acid nanoparticles into the living tissue C5L51-59 (Kang)
(claim 3) the nanoparticles comprise a ratio of PBAE to nucleic acid of between about 60/1 and about 80/1 on a weight basis is an obvious design choice over the combined art, above. (see pg. 8 Segovia).
(claims 4-6) The microneedles are biodegradable (C6L59-C7L11); with sustained release of the PBAE/nucleic nanoparticles over a period of 100 hours or more (see Segovia §2.2.1 pg. 3-4)
(claims 7,12-14) the plurality of microneedles have substantially the same lengths (Kang C4L60-C5L13); length of less than about 1.5mm; length within the range of about 10 microns to about 1500 microns; diameter or width at a point of contact with the base that is less than about 500 microns (see Kang Fig. 5A)
(claim 16) the microneedles have a shape or configuration of a pyramid, cone, cylindrical, tapered tip, conical, square base, or pentagonal base conical tip (Kang C5L14-27)
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEANNA K HALL whose telephone number is (571)272-2819. The examiner can normally be reached M-F 9:00am-5:30pm est.
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/DEANNA K HALL/Primary Examiner, Art Unit 3783