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 .
DETAILED ACTION
Election/Restrictions
1. Applicant's election of Group II, claims 9-15, without traverse, filed December 30, 2025 is acknowledged and has been entered. Applicant also elected species (1) viral antigen as target substance, (2) nasal aspirate as specimen, (3) EDTA 10-150 mM as chelating agent, and (4) antigen-antibody reaction. Claims 9-15 read on the elected species in (1) to (4). Claims 1-8 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being claims drawn to a non-elected invention. Accordingly, claims 1-15 are pending. Claims 9-15 are under examination.
Priority
2. Receipt is acknowledged of certified copies of foreign priority papers required by 37 CFR 1.55, which papers have been placed of record in the file.
3. Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d) or (f), 365(a) or (b) or 386(a). Based on the filing receipt, the effective filing date of this National Stage application, which is a 371 of PCT/JP2021/027337 filed 07/21/2021, is July 27, 2020 which is the filing date of Foreign Application JAPAN 2020-126241 filed 07/27/2020 from which the benefit of foreign priority is claimed.
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.
4. Claims 9-15 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 9 is vague and indefinite in reciting “A method for detecting, by utilizing an antigen-antibody reaction or reaction between substances… wherein detection is performed with signal reduction suppressed by previously contacting the specimen with a chelating agent” because it recites the use of “antigen-antibody reaction or a reaction between substances” and “signal reduction suppressed by previously contacting the specimen with a chelating agent” but, since the claim does not set forth any steps involved in the method/process, it is unclear what method/process Applicant is intending to encompass. A claim is indefinite where it merely recites a use without any active, positive steps delimiting how this use is actually practiced.
Claim Rejections - 35 USC § 102
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.
5. Claims 9-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hideki et al. (JP 2016 099131).
Hideki et al. disclose an immunochromatography method for detecting a target substance which is specifically a virus antigen (microorganism) present in a specimen using an immunochromatographic device to detect antigen-antibody reaction signal; wherein signal reduction is detected as suppressed by a chelating agent that is contacted with the specimen. The method comprises combining the specimen with a specimen extracting solution which comprises an enzyme and a surfactant, and also contains a chelating agent; and adding or dispensing the resultant mixture to the immunochromatographic device. The specimen extracting solution containing the chelating agent may be impregnated onto a portion of the immunochromatographic device. The specimen extracting solution contains the chelating agent at a concentration of 1 mM to 100 mM (encompassed within 8 mM to 300 mM in claim 13 and within 25 mM to 300 mM in claim 14); wherein the chelating agent is ethylenediaminetetraacetic acid (EDTA). See entire document; especially paragraphs [0017, 0018, 0021-0024] and Example 2. Accordingly, Hideki et al. appears to read on Applicant’s claimed invention.
6. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GAILENE R. GABEL whose telephone number is (571)272-0820. The examiner can normally be reached Monday, Tuesday, and Thursday 5:30 AM to 4:00 PM.
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/GAILENE GABEL/Primary Examiner, Art Unit 1678
February 6, 2026