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 .
Acknowledgments
This office action is in response to the reply filed on 11/24/25. In the reply, the applicant elected, without traverse, Species A, i; Claims 1-4, 7-13. Claims 1-17 are pending with claims 5-6 and 14-17 being withdrawn.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 5/3/24;6/29/23; 12/28/22 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 § 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 1-3, 9-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chen et al. (US 2014/0005606) (“Chen”). Chen discloses:
(claim 1) A method of manufacturing (Fig. 2) a particle-attached microneedle, the method comprising: first coating a microneedle 10 with an adhesive solution 60 to form an adhesive layer; and dipping the microneedle, on which the adhesive layer has been formed in a coating well 40 filled with solid-phase drug particles 12 to secondarily attach the solid-phase drug particles on the adhesive layer. [0042,0052,0051]
Claim 2: Chen further comprising disposing a film 30 on the coating well to disperse the solid-phase drug particles before filling the solid-phase drug particles in the coating well. [0050] (chitosan gel solution with added drug)
Claim 3: after secondarily attaching the solid-phase drug particles, controlling voids between the secondarily attached solid-phase drug particles. (Fig. 2, voids controlled via the individual support shafts 102)
Claim 9: the adhesive solution comprises a single-type curable material, and the single-type curable material is any one selected from the group consisting of polyethyleneglycol (PEG), polyethylene oxide (PEO), beeswax, triglyceride, silicone, epoxy, protein bioadhesive and a UV-curable medical-grade epoxy resin. [0042]
Claim 10: the adhesive solution comprises an adhesive material and a solvent, wherein the adhesive material is any one selected from the group consisting of sugar 2- 20%, glucose 25-50%, starch 1-4%, gelatin 1-4%, carboxymethylcellulose (CMC-Na) 1-4%, gum arabic 2-5%, cellulose derivative (hydroxypropyl cellulose (HPC), hydroxypropylmethylcellulose (HPMC)) 1-4%, methyl cellulose (MC), ethyl cellulose 0.5-2%), polyvinylpyrrolidone (PVP) 2- 5%, cyanoacrylate, a fibrin glue, a protein glue, a polyethylene glycol (PEG) hydrogel sealant, silicone, epoxy, protein bioadhesive and a mussel adhesive protein, and the solvent is water or an organic solvent. [0013,0042] (and water content in skin for the solvent)
Claim 11: a raw material of the microneedle 10 is one or more selected from biodegradable polymers and non-biodegradable/biocompatible polymers, wherein biodegradable polymers comprising poly(lactic acid), poly(L-lactic acid), poly(glycolic acid), poly(lactic-co-glycolic acid) and polycaprolactone, wherein non-biodegradable/biocompatible polymers comprising cyclic olefin copolymer, polycarbonate, nylon, polyethylene and polypropylene. [0040]
Claim 12: the microneedle has a length of 50 pm to 1,000 pm. [0014,0041]
Claim 13: an active material of the solid-phase drug particles comprise any one or more selected from the group consisting of interferon, erythropoietin (EPO), follicle-stimulating hormone (FSH), parathyroid hormone (PTH), granulocyte- macrophage colony-stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (FM-CSF), human chorionic gonadotropin, progesterone, calcitonin, glucagon, GNRH antagonist, insulin, human growth hormone (GHD), testosterone, lidocaine, diclofenac, oxybutynin, ketoprofen, alendronate, enapril maleate, phenylpropanolamine, cromolyn, isotretinoin, oxytocin, paroxetine, flurbiprofen, sertraline, venlafaxine, leuprolide, risperidone, galantamine, enoxaparin, etanercept, fentanyl, filgrastim, heparin, somatropin, and sumatriptan, or comprises any one selected from the group consisting of a vaccine containing any one of Hepatitis A, B, and C, HIV, influenza, diphtheria, tetanus, pertussis, Lyme disease, rabies, pneumococcus, yellow fever, cholera, vaccinia, tuberculosis, rubella, measles, mumps, rotavirus, botulism, and herpes virus, and a botox toxin. [0007,0015]
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 4, 7-8 rejected under 35 U.S.C. 103 as being unpatentable over Chen in view of Zvezdin et al. (US 2020/0398035) (“Zvezdin”).
Chen discloses the invention as substantially claimed (see above) but does not directly disclose treating with air blow to control voids between the solid-phase drug particles and increase adhesion between the particles and adhesive layer. Zvezdin, in the analogous art, teaches fabricating microneedles by blowing air through a meniscus separating a drop drawn out by two surfaces [0013] as a way to create voids, individual microneedles. 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 blow air between the drug and adhesive layers as taught by Zvezdin as a method to obtain the microneedles.
Zvezdin also teaches fabrication of the microneedles with PDMS and a curing agent [0100]. A weight ratio of the complex-type curable material and hardener comprised in the adhesive solution being 40:1 to 20:1 is a result effective variable. Since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233 (CCPA 1955).
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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/DEANNA K HALL/Primary Examiner, Art Unit 3783