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 .
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim(s) 1-16 is/are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 1 lines 14-16 recites “an adhesive layer … is extended to be directly attached to the skin”, which positively recites the skin. Examiner suggests Applicant to amend claim 1 as “an adhesive layer that covers the contact support surface and is configured to be extended to be directly attached to a skin”.
Claims 2-16 are rejected by virtue of depending on claim 1.
Claim 2 lines 2-3 recites “the microneedle penetrates into the skin and release the drug as it dissolves within the skin”, which positively recites the skin. Examiner suggests Applicant to amend claim 2 as “the microneedle is configured to penetrate into the skin and configured to release the drug as it dissolves within the skin”.
Claim 8 lines 2-3 recites “the drug … is absorbed into the body through the micropores in the skin formed by microneedles”, which positively recites the body and the skin. Examiner suggests Applicant to amend claim 8 as “the drug released due to the gelation of the drug support layer is configured to be absorbed into the body through the micropores in the skin formed by microneedles”.
Claim 12 lines 2-5 recites “the occlusive backing layer film prevents loss of moisture evaporated from the skin, so that the micropores of the skin formed by the microneedle are kept open while the microneedle patch is attached to the skin”, which positively recites the skin.
Claim 13 lines 2-5 recites “the micropores of the skin are maintained in an open state, and the drug released due to the gelation of the drug support layer is continuously absorbed into the skin”, which positively recites the skin.
Claim Objections
Claim(s) 1, 8 is/are objected to because of the following informalities:
Claim 1, line 16, “the skin” should be amended to “a skin”.
Claim 8, line 3, “the body” should be amended to “a body”.
Appropriate correction is required.
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(s) 1 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, the phrase "a drug" in line 5 renders the claim indefinite because it is unclear whether this limitation is the same as or different from “a drug” limitation recited in line 3.
Regarding claim 1, the phrase "a drug" in line 9 renders the claim indefinite because it is unclear whether this limitation is the same as or different from “a drug” limitation recited in line 3.
Claims 2-16 are rejected by virtue of depending on claim 1.
Regarding claim 2, the phrase "the drug" in line 3 renders the claim indefinite because it is unclear whether this limitation refers to “a drug” of the microneedle or “a drug” of the drug support layer.
Regarding claim 6, the phrase "a drug" in line 2 renders the claim indefinite because it is unclear whether this limitation is the same as or different from “a drug” of the drug support layer recited previously in claim 1.
Regarding claim 6, the phrase "a drug can be gelated by moisture evaporated from the skin" in lines 2-3 renders the claim indefinite. It is unclear if the limitation “be gelated by moisture evaporated from the skin” is positively recited in claim 6 since claim 6 uses the word “can”.
Claims 7-8 are rejected by virtue of depending on claim 6.
Regarding claim 11, the phrase "promotes gelation of the drug support layer" in lines 3-4 renders the claim indefinite because it is unclear how the drug support layer being gelated. Claim 11 depends on claim 10 and claim 10 depends on claim 1, wherein claim 1 only recites the drug support layer containing a drug. Since claim 6 recites how the drug support layer being gelated, Examiner suggests Applicant to change the dependency of claim 10.
Claims 12-13 are rejected by virtue of depending on claim 11.
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.
Claim(s) 1-3, 9-10, 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over KR101878414 (Examiner notes: see the attached NPL for the translation of KR 101878414) in view of JP2016189844 (Examiner notes: see the attached NPL for the translation of JP2016189844).
Regarding claim 1, KR101878414 discloses
A microneedle patch (20’, figs. 2 and 4) comprising the following components:
a microneedle (21’, figs. 2 and 4) comprising a drug (10, figs. 2 and 4. Examiner notes: see par. 0053 of the translation for microneedle patch 20’ comprising a plurality of biodegradable microneedles 21’, see par. 0054 of the translation for the plurality of biodegradable microneedles 21’ comprising an allergen 10, and see par. 0042 of the translation for allergen being a drug);
a drug support layer (23’, figs. 2 and 4) supporting the microneedle on one surface (see figs. 2 and 4) and containing a drug (Examiner notes: see par. 0053 of the translation for layer 23’ being allergen applied layer, see also par. 0059 for more detail of layer 23’);
a support (22’, figs. 2 and 4) provided in contact with a surface opposite to the surface of the drug support layer on which the microneedle is supported (see figs. 2 and 4 for 21’ positioned on one side of 23’ and 22’ positioned on an opposite side of 23’) and not containing a drug (see figs. 2 and 4 for 22’ not containing drug 10).
KR101878414 also discloses the microneedle patch attached to the skin of a human body for a period of time so that the microneedles are biodegraded (par. 0097 of the translation) and the microneedle patch being removed after the microneedles are almost biodegraded (par. 0109 of the translation).
KR101878414 is silent about an occlusive backing layer film provided in contact with a surface opposite to the surface of the support to which the drug support layer is in contact, wherein the occlusive backing layer film further includes an adhesive layer that covers the contact support surface and is extended to be directly attached to the skin.
However, JP2016189844 teaches a microneedle patch (10, fig. 1) comprising an occlusive backing layer film (14, fig. 1) provided in contact with a surface opposite to the surface of the support to which the drug support layer is in contact (see fig. 1 for microneedles 11 being on one side of support 12 and film 14 being on the opposite side of support 12, see also par. 0002 of the translation for the adhesive sheet laminated on the side opposite to the side on which the microneedles are arranged), wherein the occlusive backing layer film (14) further includes an adhesive layer (see par. 0017 of the translation for 14 being adhesive sheet) that covers the contact support surface (see fig. 1 for 14 covering surface of 12) and is extended to be directly attached to the skin (see fig. 1).
It would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify KR101878414 by adding an occlusive backing layer film/ an adhesive layer such that the layer covers the device and extends to be directly attached to the skin, as taught by JP2016189844, for the purpose of stably holding the microneedle on the skin until the dissolution of the microneedles is completed (par. 0003 of JP2016189844 translation).
Regarding claim 2, KR101878414 in view of JP2016189844 discloses the microneedle patch according to claim 1,
KR101878414 further discloses wherein the microneedle (21’, figs. 2 and 4) penetrates into the skin and release the drug as it dissolves within the skin (see par. 0054 of KR101878414 translation).
Regarding claim 3, KR101878414 in view of JP2016189844 discloses the microneedle patch according to claim 1,
KR101878414 further discloses wherein the microneedle (21’) is formed of a mixture of at least one selected from the group consisting of hyaluronic acid (see par. 0055 of KR101878414 translation), polyvinylpyrrolidone (PVP) (see par. 0056 of KR101878414 translation), polyvinyl alcohol (PVA) (see par. 0056 of KR101878414 translation), sodium carboxymethyl cellulose, and saccharide.
Regarding claim 9, KR101878414 in view of JP2016189844 discloses the microneedle patch according to claim 1,
KR101878414 further discloses wherein the drug support layer is formed of a mixture of at least one selected from the group consisting of hyaluronic acid (see par. 0055 of KR101878414 translation), polyvinylpyrrolidone (PVP) (see par. 0056 of KR101878414 translation), polyvinyl alcohol (PVA) (see par. 0056 of KR101878414 translation), sodium carboxymethyl cellulose (NaCMC),ooloxamer, carbomer, hypromellose, hydroxypropyl cellulose (HPC) (see par. 0056 of KR101878414 translation), hydroxyethyl cellulose (HEC) (see par. 0056 of KR101878414 translation), sodium alginate, saccharide, glycerin, propylene glycol (see par. 0056 of KR101878414 translation), polyethylene glycol 400, and sorbitol (SB) (Examiner notes: see fig. 4 for both of drug support layer 23’ and microneedles 21’ being formed from viscous composition 30).
Regarding claim 10, KR101878414 in view of JP2016189844 discloses the microneedle patch according to claim 1,
JP2016189844 further teaches wherein the occlusive backing layer film (14) is semi- permeable or moisture-proof to moisture evaporated from the skin (Examiner notes: see fig. 1 for 14 without through-holes, see fig. 2 for 14 with through-holes, see fig. 3 for 14 with smaller thickness, and see fig. 4 for 14 with some recessed parts. See also pars. 0010-0013 of the JP2016189844 translation for 14 having property of transmitting moisture to improve the feeling of use).
It would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to further modify KR101878414 such that the occlusive backing layer film/ an adhesive layer has a property of transmitting moisture, as taught by JP2016189844, for the purpose of improving the feeling of use (par. 0013 of JP2016189844).
Regarding claim 15, KR101878414 in view of JP2016189844 discloses the microneedle patch according to claim 1,
KR101878414 further discloses wherein the microneedle has one or more shapes selected from the group consisting of a circular cone shape (see figs. 2 and 4, see also par. 0019 of the translation), a quadrangular pyramid shape (see figs. 2 and 4, see also par. 0019 of the translation), and a triangular pyramid shape.
Regarding claim 16, KR101878414 in view of JP2016189844 discloses the microneedle patch according to claim 1,
KR101878414 further discloses wherein the support (22’) is formed of at least one selected from the group consisting of biocompatible polymers, ceramics, and metals (Examiner notes: see par. 0058 of the translation for 22’ including biodegradable materials similar to microneedles 21’, and see par. 0056 of the translation for the biodegradable materials listed for microneedles 21’).
Claim(s) 4-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over KR101878414 in view of JP2016189844 in further view of Wanichwecharungruang et al. (US 2022/0249820).
Regarding claims 4 and 5, KR101878414 in view of JP2016189844 discloses the microneedle patch according to claim 3, as set forth above, except for (claim 4) wherein the saccharide is at least one selected from the group consisting of monosaccharides, disaccharides, and polysaccharides; and (claim 5) wherein the monosaccharide is at least one selected from the group consisting of fructose, galactose, glucose and mannose; the disaccharide is at least one selected from the group consisting of sucrose, lactose, maltose, trehalose, turanose and cellobiose; and the polysaccharide is at least one selected from the group consisting of dextran, diethylamino ethyl- dextran, dextrin, cellulose and B-glucans
However, Wanichwecharungruang teaches a microneedle patch comprising needles (101, fig. 2) wherein the needles are made of water-soluble material that are non-biotoxic and bio-absorbable and bio-compatible (par. 0024) and wherein the needles are formed of a mixture of at least one selected from the group consisting of hyaluronic acid (par. 0024), polyvinylpyrrolidone (par. 0024), polyvinyl alcohol (par. 0024), saccharide such as fructose, galactose, glucose, sucrose, maltose (par. 0024).
It would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify the microneedles of KR101878414 to be made of water-soluble materials, as taught by Wanichwecharungruang, for the purpose of providing non-biotoxic and bio-absorbable and bio-compatible microneedles to be used in a user’s skin (par. 0024 of Wanichwecharungruang).
Claim(s) 6-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over KR101878414 in view of JP2016189844 in further view of Xu (US 2008/0051695).
Regarding claims 6, 7, and 8, KR101878414 in view of JP2016189844 discloses the microneedle patch according to claim 1, as set forth above, except for (claim 6) wherein the drug support layer containing a drug can be gelated by moisture evaporated from the skin, (claim 7) wherein the drug contained in the drug support layer is released due to the gelation of the drug support layer, and (claim 8) wherein the drug released due to the gelation of the drug support layer is absorbed into the body through the micropores in the skin formed by microneedles.
However, Xu teaches a microneedle patch with a gel containing active component (par. 0034) wherein the gel containing active component can be dissolved by moisture evaporated from skin and the active substance can diffusion into skin through conduits opened along the interface of skin and microneedles (par. 0034).
It would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify the drug support layer of KR101878414 to be a gel containing active layer, as taught by Xu, for the purpose of allowing the active substance on the layer being diffused into skin through conduits opened along the interface of skin and microneedles (par. 0034 of Xu).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over KR101878414 in view of JP2016189844 in further view of Spector (US 2020/0289330).
Regarding claim 14, KR101878414 in view of JP2016189844 discloses the microneedle patch according to claim 1, as set forth above, except for wherein the microneedle patch further includes a protective layer to protect an adhesive layer before being used on the skin.
However, Spector teaches a microneedle patch (fig. 4 and par. 0033) comprising a protective layer (25, par. 0033) to protect an adhesive layer before being used on the skin (par. 0033 and fig. 4).
It would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify KR101878414 by adding a protective layer, as taught by Spector, for the purpose of providing a layer on the bottom of the microneedles to protect the adhesive layer as well as prevent the drug from leaking out of the needles prior to use (par. 0033 of Spector).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO 892 form.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DUNG T ULSH whose telephone number is (571)272-9894. The examiner can normally be reached Monday-Friday 9am-6pm.
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/DUNG T ULSH/Examiner, Art Unit 3783
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