DETAILED ACTION
Claims 1-9 are pending.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 04/25/2024 and 01/03/2025 have been 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.
(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 1-5 and 8 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Wada et al., (US10520497B2) (IDS filed on 04/25/2024).
Wada teaches an assay cartridge that is used for immunochromatographic assay (see figure 1 of ‘497), the assay cartridge comprising:
an assay strip that has, on a surface, an assay region in which a color development state changes depending on whether a sample is positive or negative (see column 11 lines 3-8 “The amplification label region L3 is a region which includes a substance being reacted with the second amplification liquid 46, is reacted with the second amplification liquid 46 and thus produces or changes color…”, see column 13 line 67 and column 14 lines 1-5 “The presence or absence of the test substance and the concentration thereof can be confirmed from the discoloration of the inspection region L1, and whether or not inspection for measuring the test substance is succeeded can be confirmed from the discoloration of the confirmation region L2”, see column 1 lines 50-55 “By visually determining the presence or absence or a degree of a signal generated by the sensitized labeled microparticles trapped at the reaction site, it is possible to measure presence or absence or an amount of the test substance in the sample”);
an accommodating part that accommodates an amplifying liquid which amplifies color development of the assay region (see column 4 lines 58-63 “The intermediate member 30 has a first pot accommodation portion 32 which accommodates the first pot 40 and includes on the bottom surface an amplification liquid-filling hole for adding the first amplification liquid 41 dropwise onto the insoluble carrier 2.”, see column 2 lines 37-41 “a first pot and a second pot each including a surface having a sheet member, a first amplification liquid and a second amplification liquid being sealed, respectively, in the first pot and 40 the second pot in order to amplify a detection signal in the inspection region…”); and
an absorber that absorbs at least a part of the amplifying liquid which is supplied from the accommodating part, flows on the surface of the assay strip toward the assay region, and passes through the assay region (see column 5 lines 40-43 “an absorption pad accommodation portion 22 in which an absorption pad 6 is mounted is provided on the downstream side of the insoluble carrier accommodation portion”, see column 13 lines 30-34 “whereby a complex body of the test substance and the label substance is formed through the first substance, and the complex body is spread toward the absorption pad 6 side together with the specimen liquid due to the suctioning force of the absorption pad 6 and capillarity”, see figure 3) (instant claim 1).
Wada teaches wherein the absorber is arranged on a downstream side of the assay region in a flow direction of the amplifying liquid, and the absorber is not overlapped with the assay region in the flow direction (see column 6 lines 5-8 “In addition, in the present specification, as illustrated in FIG. 3, the liquid-sending pad 4 side is defined as an upstream side and the absorption pad 6 side is defined as a downstream side”, see figure 3 where 6 is the absorption pad, 22 is the absorption pad accommodation portion, 2 is the insoluble carrier, 3 is the holding pad, and 4 is the pad) (instant claim 2). Wada teaches wherein in a case where a direction intersecting the flow direction of the amplifying liquid is defined as a width direction, the absorber is arranged on at least one of both sides of the assay strip in the width direction (see figures 2-3) (instant claim 3). Wada teaches the absorber is arranged on both sides of the assay strip in the width direction (see figure 3 where 6 is the absorber) (instant claim 4) and where at least part of the absorber is arranged at a position facing the surface of the assay strip (see figure 3 where 6 is the absorber) (instant claim 5). Wada teaches wherein in the assay strip, a spotting region on which the sample is spotted is arranged on a downstream side of the assay region in a flow direction of the amplifying liquid (see figure 1 where 18 is the observation window, see column 5 lines 32-36 “In addition, the upper case 10 includes an observation window 18 for visually checking the three regions L1 to L3 at positions corresponding to the flow path-forming member 35 of the intermediate member 30”) (instant claim 8).
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 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Wada et al., as it pertains to claims 1-5 and 8 above.
The teachings of Wada as it pertains to claims 1-5 and 8 is discussed in the 35 USC 102 rejection above.
Wada teaches an assay cartridge that comprises an assay strip that has a assay region in which a color develops and/or changes depending on the presence or absence of a sample, an accommodating part, and an absorber (see figure 3, see column 11 lines 3-8, see column 13 line 67 and column 14 lines 1-5, see column 1 lines 50-55, see column 4 lines 58-63, see column 2 lines 37-41, see column 5 lines 40-43, see column 13 lines 30-34). Wada teaches the absorber being arranged on both sides of the assay strip in the width direction and a part of the absorber being positioned facing the surface of the assay strip (see figure 3).
Wada does not explicitly teach the location of the absorber being an interval between the assay strip at 0.3 mm or more and 1 mm or less.
It would have been obvious to one of ordinary skill in the art to optimize such parameters based on the requirements of the particular assay. Selection of such parameters would have been an obvious matter of choice absent evidence of unexpected results tied to said parameters (instant claims 6-7).
It would have been obvious to one of ordinary skill in the art at the time of filing to optimize such parameters based on the requirements of the particular assay. One of ordinary skill in the art would have been motivated to optimize the location of the absorber being an interval between the assay strip at 0.3 mm or more and 1 mm or less based on the success of Wada’s assay cartridge device. Thus, claims 6-7 are obvious to one of ordinary skill in the art at the time of filing, especially in the absence of evidence to the contrary.
Allowable Subject Matter
Claim 9 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
No claim is allowed.
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/MCKENZIE A DUNN/Examiner, Art Unit 1678
/GREGORY S EMCH/Supervisory Patent Examiner, Art Unit 1678
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