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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/16/2025 and 09/04/2024. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of invention (1) and species (1) drawn to claims 1, 2 and 5-14, and withdrawn claims 3, 4 and 15-17 from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/24/2026.
Examiner respectfully notes that claim 15 is withdrawn from consideration as in it depends on originally withdrawn claim 4.
Claim Objections
Claim 1 is objected to because of the following informalities: the phrase “placed so that” in line 2 should be amended to read --configured to be placed on--. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: the phrase “outer surfaces” in line 13 should be amended to read –the outer surfaces--. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: the phrase “a conductive material” in line 2 should be amended to read –the conductive material--. 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.
Claims 1, 2 and 5-14 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.
Claim 1 recite the limitation “one surface of the sensor panel” in lines 2, 3, 9-10 and 12-13, and claim 2 recite the limitation “one surface of the sensor panel” in line 2, this limitation is not defined by the claims, which renders the claims indefinite. One with ordinary skill in the art would not be able to know if the claimed limitation “one surface” is the same surface and/o different surfaces of the sensor panel. The scope of the claim remains indeterminate because of the claimed “one surface of the sensor panel”.
Claim 1 recite the limitation “exposed to outside” in line 5 and claim 5 recite the limitation “outside” in line 3, this limitation is not defined by the claims, which renders the claims indefinite. One with ordinary skill in the art would not be able to know the claimed limitation “outside” refers to outside of which structure and/or exposed to outside of the environment. As broadly as claimed the scope of the claim is indeterminate with respect to the claimed “exposed to outside”.
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.
Claim(s) 1, 2, 5, 6 and 14 is/are rejected under 35 U.S.C. 103 as being obvious over Perking University (CN 218793374 U in IDS# 6 mailed on 12/16/2025, hereinafter Perking et al) in view of The Regents of The University of California (KR 10-2014-0078644 A in IDS #7 mailed on 12/16/2025, hereinafter California et al)(an English translated version is being used herein).
As to claims 1, 6 and 14, Perking teaches microneedle sensor (microneedle sensor in fig1 and 8, pages 2-4), comprising:
a sensor panel placed so that one surface thereof is in contact with skin of a body (substrate 21, page 3, fig.1 and 8);
a plurality of hollow microneedles that are formed on one surface of the sensor panel to protrude in form of micrometer-scale needles (array of microneedles 22 protruding from substrate 21 to be inserted/penetrate the skin, page 3-5, par.51, fig.1 and 8),
wherein a hollow hole with one side exposed to outside is provided inside the hollow microneedle (microneedle array 22 having hollow needles 221 having holes to be injected with a drug, pages 3-4, par.51-52, fig.1 and 8);
a reference electrode of a conductive material applied to a first region formed on one surface of the sensor panel and applied to outer surfaces of hollow microneedles located on the first region, wherein the reference electrode is formed of any one of standard hydrogen electrode (SHE), calomel (Hg/Hg.sub.2Cl.sub.2), and silver-silver chloride (Ag/AgCl) (reference electrode 234 made from silver-silver chloride, placed at the right-side region on substrate 21, page 6, par.69, as best seen in fig.8); and
a counter electrode of a conductive material applied to a second region formed on one surface of the sensor panel and applied to outer surfaces of hollow microneedles located on the second region, wherein the counter electrode is formed of any one of gold (Au), platinum (Pt), silver (Ag), carbon (C), copper (Cu), palladium (Pd), and stainless steel. (counter electrode 233 made from gold, platinum or carbon, placed at the middle region on substrate 21, page 6, par.69).
Still, as to claims 1, 6 and 14, Perking teaches the invention substantially as claimed above, but failed to explicitly teach a reaction electrodes of a conductive material each inserted into the hollow holes of the hollow microneedles and configured to be inserted into an interior of the skin along with the hollow microneedles, wherein the reaction electrodes are formed of any one of gold (Au), platinum (Pt), silver (Ag), carbon (C), copper (Cu), palladium (Pd), and stainless steel, wherein the hollow hole is configured to extend long from an inside of the hollow microneedle to penetrate the sensor panel, and the reaction electrodes are formed as wires that penetrate the sensor panel and are inserted into the hollow holes.
However, California teaches an analogous microneedle sensor for detecting blood analyte (microneedle array 100, microneedle array 100 includes an array of microscale-sized hollow needles 101, abstract, page 6, fig.1-2), wherein the microneedle comprises: a reaction electrodes of a conductive material each inserted into the hollow holes of the hollow microneedles and configured to be inserted into an interior of the skin along with the hollow microneedles (probes/electrodes 102, wherein protruding needle structure having an opening at a terminal end of the needle structure and a probe 102 formed in the outer wall and one or more chemical or biological materials in contact with the probe 102 through the opening, And a probe that interacts to generate a probe signal (e.g., a sense signal), page 6, fig.1-2),
wherein the reaction electrodes are formed of any one of gold (Au) (gold, page 11), platinum (Pt) (platinum probes/electrodes page 8,9 and 11), silver (Ag), carbon (C), copper (Cu), palladium (Pd), and stainless steel,
wherein the hollow hole is configured to extend long from an inside of the hollow microneedle to penetrate the sensor panel (as best seen in fig.1 and 2, microneedles are having side holes extending from inside of the needle, page 6), and the reaction electrodes are formed as wires that penetrate the sensor panel and are inserted into the hollow holes (probes/electrodes 102 are formed of wires extending from lower substrate to holes in microneedles 101, page 6, fig.1-2).
Since reference electrodes extending through microneedles for detecting blood analytes are well-known in the art, so it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to include reference electrodes into hollow microneedle taught by Perking’s invention, as probes/electrodes 12 taught by California’s invention, for the same purpose of detecting blood analytes, as taught by California’s invention (pages 3-6).
As to claim 2, Perking teaches the microneedle sensor, wherein the first region and the second region are provided at positions spaced apart from each other on one surface of the sensor panel, and the hollow microneedles are disposed in both the first and second regions (as best seen in fig.8, reference electrode 234 is placed at the right-side region on substrate 21 and counter electrode 233 is placed at the middle region on substrate 21, wherein right side region and middle region are spaced apart from each other and microneedle array 22 is disposed on both the right and middle regions of substrate 21, pages 5-6).
As to claim 5, Perking teaches the microneedle sensor, wherein, on one side of the hollow microneedle, an opening is formed by cutting the one side of the hollow microneedle, and the one side of the hollow hole is exposed to outside through the opening (as best seen in fig.1 and 2, hollow microneedles 221 having an upper cut/hole that is exposed to the outside/environment/contact media, page 3, par.43-44 and page 4, par.45-46).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAY A ABOUELELA whose telephone number is (571)270-7917. The examiner can normally be reached 8-5.
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/MAY A ABOUELELA/Primary Examiner, Art Unit 3791
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