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) submitted on 2/1/24 is in compliance with the provisions of 37 CFR 1.97(b). Accordingly, the IDS is being considered by the Examiner.
Claim Rejections - 35 USC § 102
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 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.
Claims 1-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chen et al. (US 10,028,905) (“Chen”). Chen discloses:
(claim 1) An implantable microneedle comprising: a shape having a cylindrical body and a conical tip (Figs. 6a-c, C6L35-42); and a swellable polymer-based coating layer 33,13 covering all of the tip surface and a portion of the cylindrical body, wherein the coating layer is removable from the microneedle in a body environment, wherein coating layer is capable of being separated from the microneedle and implanted in the body environment when the microneedle is inserted into and removed from the body environment, wherein the coating layer has an asymmetrical structure with respect to a central axis of the microneedle, and wherein the coating layer has one portion thicker than the other portion thereof. C9L20-48
Claim 2: the swellable polymer includes at least one selected from gelatin, chitosan, collagen, hyaluronic acid, or chondroitin sulfate. C6L43-49
Claim 3: the swellable polymer is crosslinked to a degree such that at least a portion of an interface or a surface thereof is dissolved in moisture. C7L38-41
Claim 4: the implantable microneedle further comprises a sacrificial layer 32,12 disposed between the surface of the tip of the microneedle and the swellable polymer-based coating layer, wherein the sacrificial layer covers at least a portion of the tip surface of the microneedle, wherein the sacrificial layer has been dissolved in moisture before the swellable polymer based coating layer has been dissolved in moisture, and wherein the coating layer covers at least a portion of the sacrificial layer. C14L15-28, Figs. 5, 6c, C7L34-41, C8L16-31
Claim 5: the sacrificial layer is made of at least one of a monosaccharide or a water-soluble polymer having a molecular weight lower than 10k. C5L50-62
Claim 6: the coating layer contains a drug (S1) therein.
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 8:30am- 4:30pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at 571-272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DEANNA K HALL/Primary Examiner, Art Unit 3783
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