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 .
Status of the Claims
Claims 3, 5-6, and 13-14 have been cancelled. Claims 1-2, 4, 7-12, and 15-16 are pending and examined herein.
Priority
This application, filed 02/16/2023, is a 371 of PCT/JP2021/032953, filed 09/08/2021, which claims benefit of JAPAN 2020-150743, filed 09/08/2020. This priority is acknowledged and the claims examined herein are treated as having an effective filing date of 09/08/2020.
Information Disclosure Statement
The Information Disclosure Statement filed 12/30/2025 is acknowledged and has been considered.
Withdrawn Rejections/Objections
The rejection of claim 3 under 35 U.S.C. 112 is withdrawn in response to Applicant’s cancellation of the claims.
The rejection of claim 9 under 35 U.S.C. 112 is withdrawn in response to Applicant’s amendments to the claims.
The rejection of claims 1-8 under 35 U.S.C. 102 is withdrawn in response to Applicant’s amendments to the claims.
The rejection of claims 9-16 under 35 U.S.C. 103 is withdrawn in response to Applicant’s amendments to the claims.
New 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, 4, and 7-8 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by US 2007/0196884 A1, “METHOD FOR THE DETECTION OF COLIFORMS AND IN PARTICULAR ESCHERICHIA COLI” (published 08/23/2007, referred to herein as Bodini).
If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. In order words, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2111.02 II.
Regarding claim 1, “which is used for detecting a target substance in a specimen utilizing antigen-antibody-reactions” and “a non-specific-reaction-suppressing component for suppressing false positives” are considered intended uses that do not convey any structural specificity to the claimed reagent. Regarding claim 2, “which is an immunochromatographic test reagent”, i.e. is a test reagent used for immunochromatography, is considered an intended use that does not convey any structural specificity to the claimed reagent.
Regarding claim 1, Bodini teaches a reagent comprising tryptophan (para. 0041, lines 10-12).
Regarding claim 4, Bodini teaches a tryptophan concentration up to 80mM (para. 0041, lines 10-12). Tryptophan has a molecular weight of 204.23 g/mol; therefore, a concentration of up to 80 mM is equivalent to up to about 16%, which anticipates the claimed range of 0.1-10%.
Regarding claim 7, Bodini teaches that the reagent further comprises all the other natural 20 amino acids (para. 0041, lines 17-18), which includes arginine and lysine.
Regarding claim 8, Bodini teaches the reagent comprises sodium chloride (para. 0041, lines 23-25).
New 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 9-12 and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over US 2021/0080455 A1, “ORGANIC COLORED MICROPARTICLES, DIAGNOSTIC REAGENT KIT, AND IN VITRO DIAGNOSIS METHOD” (priority to JP 2017-183472, filed 09/25/2017, referred to herein as Horii).
Regarding claims 9 and 15-16, Horii teaches a method of detecting protein antigen in plasma, i.e. plasma proteins (para. 0068, lines 1-5), comprising introducing the specimen to a specimen-extracting solution (para. 0066, lines 7-11), i.e. a specimen pretreatment liquid (para. 0067, lines 4-9), brining into the solution an antibody (para. 0065, lines 1-4), and detecting the target substance using antigen-antibody reactions (para. 0061, lines 1-5). Horii teaches that the pretreatment liquid contains a component that suppresses non-specific reactions (para. 0067, lines 6-9), such as false positive reactions. Horii teaches that the pretreatment liquid can contain water-soluble amino acids such as tryptophan, phenylalanine, arginine, and lysine (para. 0067, lines 24-28). Horii teaches that the addition of various, i.e. multiple, water-soluble amino acids is preferable (para. 0067, lines 15-19). Horii teaches that using amino acids as an additive improves background (para. 0031, lines 10-12), such as false-positive reactions. Horii teaches a pretreatment solution containing phosphate buffered solution, PBS, which contains sodium chloride (para. 0130, lines 1-3).
However, Horii does not teach all of these components in a single solution.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the claimed components into a single pretreatment solution, as taught by Horii. An artisan would have been motivated and had a reasonable expectation of success in making using these components because they would be used for their intended purposes, as taught by Horii.
Regarding claim 10, Horii teaches that this method is for use in immunochromatography (para. 0014, lines 1-5).
Regarding claim 11, Horii teaches applying the specimen to a test device comprising a site impregnated with the pretreatment solution containing the non-specific-reaction-suppressing component (para. 0064, lines 1-5).
Regarding claim 12, Horii teaches a pretreatment solution comprising 2% non-specific-reaction-suppressing-component, BSA (para. 0130, lines 1-4).
However, Horii does not specifically teach one of the claimed compounds in the claimed concentration range.
It would have been obvious to one of ordinary skill in the art to substitute an amino acid, such as tryptophan or phenylalanine, for BSA at the same 10% concentration in the pretreatment buffer taught by Horii. An artisan would have been motivated to make this change and have a reasonable expectation of success because Horii teaches that these amino acids and BSA can be used for the same purpose, i.e. as the component that suppresses non-specific reactions in the pretreatment liquid (para. 0067).
Response to Arguments
Applicant’s arguments with respect to claims 1-16 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant’s argument with respect to the rejection of claim 3 under 35 U.S.C. 112 is withdrawn in response to Applicant’s cancellation of the claims.
Applicant’s argument with response to the rejection of claim 8 under 35 U.S.C. 112 is withdrawn in response to Applicant’s amendment.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/C.E./Examiner, Art Unit 1677
/BAO-THUY L NGUYEN/Supervisory Patent Examiner, Art Unit 1677 May 7, 2026
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