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 .
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 04/22/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
The information disclosure statement (IDS) submitted on 12/04/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
The information disclosure statement (IDS) submitted on 03/17/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
The information disclosure statement (IDS) submitted on 12/24/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being 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.
Claims 1, 5 and 6 are rejected under 35 U.S.C. 102a1 as being anticipated by Beshay et al. (US 2020/0225220 A1 – hereafter ‘220).
‘220 discloses a lateral flow assay chip (Abstract) that includes the following limitations for claim 1:
“An assay cartridge that is used for immunochromatographic assay”: ‘220 discloses a cartridge for rapid immunochromatographic assay ([0019]) that is being interpreted as the immunochromatographic assay of the instant application.
“an assay strip that has, as an assay region for determining whether a sample is positive or negative, a plurality of kinds of assay regions each on which a plurality of kinds of binding substances that respectively specifically bind to a plurality of different kinds of test substances is immobilized, and that includes a strip-shaped carrier capable of performing an assay of a plurality of kinds of assay items depending on the number of different kinds of the assay regions”: ‘220 discloses a strip (Fig. 6; strip 302) that has an assay region that determines a positive or negative result that also includes a polarity of test regions (multiple detection lines 303 and 304; [0023])
“wherein in a case where a direction orthogonal to a longitudinal direction of the strip-shaped carrier is defined as a width direction”: ‘220 discloses that the test regions have a width that is orthogonal to the length of the strip (Fig. 3).
“the plurality of kinds of the assay regions has a length in the width direction of the strip-shaped carrier shorter than an entire width of the strip-shaped carrier”: ‘220 further discloses that the width of the test regions in the direction of the longitudinal axis of the strip are shorter than the width of the test region (Fig. 3; regions 303 and 304; [0023]).
For claim 5, ‘220 discloses that the detection regions are arranged such that they do not overlap in the longitudinal direction (Fig. 3).
For claim 6, the distance between the detection region would inherently be less than 2mm.
Therefore, ‘220 meets the limitations of claims 1, 5 and 6.
Claims 1 and 5-10 are rejected under 35 U.S.C. 102a1 as being anticipated by Nahm et al. (US 2005/0214951 A1 – hereafter ‘951).
‘951 discloses a lateral flow assay chip (Abstract) that includes the following limitations for claim 1:
“An assay cartridge that is used for immunochromatographic assay”: ‘951 discloses a cartridge that can be used for immunochromatography ([0006]; [0007]) that is being interpreted as the immunochromatographic assay of the instant application.
“an assay strip that has, as an assay region for determining whether a sample is positive or negative, a plurality of kinds of assay regions each on which a plurality of kinds of binding substances that respectively specifically bind to a plurality of different kinds of test substances is immobilized, and that includes a strip-shaped carrier capable of performing an assay of a plurality of kinds of assay items depending on the number of different kinds of the assay regions”: ‘951 discloses an assay strip with multiple test lines (lines 11; Fig. 2; [0135]) that indicate a positive or negative test result and include different substances immobilized on the lines.
“wherein in a case where a direction orthogonal to a longitudinal direction of the strip-shaped carrier is defined as a width direction”: ‘951 discloses that the test regions have a width that is orthogonal to the length of the strip (Fig. 2).
“the plurality of kinds of the assay regions has a length in the width direction of the strip-shaped carrier shorter than an entire width of the strip-shaped carrier”: ‘951 further discloses that the width of the test regions in the direction of the longitudinal axis of the strip are shorter than the width of the test region (Fig. 2; lines 11; [0135]).
For claim 5, ‘951 discloses that the detection regions are arranged such that they do not overlap in the longitudinal direction (Fig. 2).
For claim 6, the distance between the detection region are less than 2mm ([0167]).
For claim 7, ‘951 discloses the following limitations:
“coating step of applying a plurality of kinds of coating liquids each containing the plurality of kinds of the binding substances to form the plurality of kinds of the assay regions on a sheet-shaped carrier, the plurality of kinds of the coating liquids are applied in a mode in which an arrangement pattern of the plurality of kinds of the assay regions in the one strip-shaped carrier is periodically repeated”: ‘951 discloses coating the pad with the detector antibody ([0159]) to form the test lines where this arrangement results in the periodic distribution of each line.
“a cutting step of cutting the sheet-shaped carrier along a direction orthogonal to a repetition of the arrangement pattern.”: The sheet is cut to the desired width by a cutter ([0207]) where this would be in a direction orthogonal to the test lines.
For claim 8, the test lines are being interpreted as being arranged in a direction that is linear with the repetition direction ([0207]; Fig. 2).
For claim 9, the detector antibody is deposited such that a gap is formed between the test lines ([0167]) and the cutting would include cutting the gap. It should be noted that the cutting step does not preclude also cutting the test lines.
For claim 10, the coating of the test lines on the sheet are being interpreted as being formed in direction that is positionally shifted ([0167]; Fig. 2).
Therefore, ‘220 meets the limitations of claims 1, 5 and 6-10.
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.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Nahm et al. (US 2005/0214951 A1 – hereafter ‘951) in view of Watkins et al. (US 2019/0324040 A1 – hereafter ‘040).
‘951 (Nahm) discloses manufacturing a lateral flow assay chip, but does not explicitly disclose applying coatings or the test and control lines via ink jet.
‘040 (Watkins) discloses an assay system ([0010]) that for claim 12 includes using an ink jet process ([0193]) as a means for laying own the two test lines and a control line. This allows for a narrow strip to be applied to the substrate.
Therefore, it would have been obvious to one of ordinary skill in the at to employ the ink jet process of ‘040 within ‘951 in order to form test lines and a control line on a substrate of a lateral flow assay chip. The suggestion for doing so would have been in order to apply thin, narrow bands onto the test strip ([0193]).
Claims 2-4 are rejected under 35 U.S.C. 103 as being unpatentable over Nahm et al. (US 2005/0214951 A1 – hereafter ‘951) in view of O’Farrell et al. (US 2012/0184462 A1 – hereafter ‘462).
‘951 (Nahm) differs from claim 2 that the test areas are adjacent to one another.
‘462 (O’Farrell) discloses a lateral flow assay device (Abstract) that for claim 2 includes different test areas that are adjacent to one another across the width of the channel (Fig. 8; [0048]; [0049]). Thaks allows for the multiplexing of analyte detection.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to include the multiplexing of ‘462 within ‘951 in order to test multiple samples. The suggestion for doing so at the time would be to allow each channel to allow for the multiplexing of analytes ([0049]).
‘951 differs from the limitations of claim 3.
For claim 3, ‘462 discloses that the test areas are centered within the longitudinal direction of the strip carrier, coincide with each other and the widths are the same (Fig. 8).
Therefore, it would be obvious to one of ordinary skill in the art at the time of filing using the same reasoning as claim 2.
‘951 differs from the limitations of claim 4.
For claim 4, ‘462 discloses that the different assay regions are adjacent and also are deviated from one another. This is shown in Figure 8 of ‘462 where the row behind the first one has a test site that is deviated from the adjacent test site in the previous row.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing using the same reasoning as claim 2.
Allowable Subject Matter
Claims 11 and 13 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.
The following is a statement of reasons for the indication of allowable subject matter: For claim 11, the prior art taken either singly or in combination fails to teach or reasonably suggest the following limitation when taken in context of the claim as a whole a manufacturing method of an assay strip that includes the following steps: where a masking member including a plurality of opening portions linearly arranged along the repetition direction in a period in which a width of one strip-shaped carrier is defined as one period, in which a length of each of the opening portions in the repetition direction is the length of the assay region, is used, and the coating step includes a first coating step of placing the masking member at a first position on the sheet-shaped carrier and applying a first coating liquid that is one of the plurality of kinds of coating liquids on a first part that is exposed from the opening portion, and includes a second coating step of moving the masking member from the first position to a second position by shifting in the repetition direction within the one period and applying a second coating liquid that is another one of the plurality of kinds of coating liquids on a second part that is exposed from the opening portion at the second position and to which the first coating liquid is not applied.
For claim 13, the prior art taken either singly or in combination fails to teach or reasonably suggest the following limitation when taken in context of the claim as a whole a manufacturing method that further includes a marking step of providing, on the sheet-shaped carrier, a mark indicating a position to be cut in the cutting step where in the cutting step, the sheet-shaped carrier is cut based on the mark.
The closest prior art is Nahm et al. (US 2005/0214951 A1 ) which discloses an assay step, but does not teach the manufacturing steps of claims 11 and 12.
The next closest prior art is Nahm et al. (US 2005/0214951 A1) that discloses a lateral flow assay chip and method for manufacturing the chip, but Nahm does not teach or suggest the method steps of claims 11 and 13.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Hamad-Schifferli et al. (US 2017/0234866 A1) which discloses a multiplexed assay strip.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL L HOBBS whose telephone number is (571)270-3724. The examiner can normally be reached Variable, but generally 8AM-5PM M-F.
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/MICHAEL L HOBBS/Primary Examiner, Art Unit 1799
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