DETAILED ACTION
Notice of AIA Status
The present application, filed on 1/28/2025, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
Claims 1-3, 5-6 and 8-10 are rejected.
Claims 4, 7 and 10 are objected.
Claim Objections
Claim 10 is objected to because of the following informalities: claim 10 recites “wherein a plurality of the inlets and a plurality of the inner flow passages are included”. For clarity, consider rephrasing to ‘further comprising:
a plurality of inlets including the inlet; and
a plurality of inner flow passages including the inner flow passage.
Appropriate correction is required.
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 1-2, 5-6 and 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Chang (US20210255178) in view of Fuchiwaki (WO2020045551A, mapped to US20210170398, cited in the Information Disclosure Statement IDS dated 2/12/24, which is the national stage application of PCT / JP2019 / 033846 (WO2020045551A)).
With respect to claim 1, Chang teaches an assay device (immunoassay device 300 in [0041], illustrated in Figs. 3A, 3B, 3C) comprising:
an inlet (port 306 in [0041], which recites “FIG. 3B illustrates test strip 302. Test strip 302 comprises a single sample zone 304, which is accessible via port 306 in the optional housing of FIG. 3A. Single sample zone 304 is common to and in fluid communication with a plurality of fluid flow channels”);
an inner flow passage (fluid flow channel 308 and fluid flow channel 320 in Fig. 3B) through which a liquid (liquid sample in [0020], which recites “a sample is a fluid sample, preferably a liquid sample”) injected from the inlet (port 306) flows (see Figs. 3A and 3B); and
a liquid absorbing material (absorbent pad 912 in [0068], illustrated in Figs. 9B) that absorbs the liquid (liquid sample) that has passed through the inner flow passage (fluid channel 308 and fluid flow channel 320) (see [068], which recites “fluid sample deposited on the sample zone to flow towards absorbent pad 912”), wherein
the inner flow passage (fluid flow channel 308 and fluid flow channel 320) includes
a microflow passage (fluid flow channel 308 in [0043], which recites “fluid flow channel also comprises a capture zone 318 positioned downstream from the channel entrance region 316 and upstream from a channel constriction zone, indicated in FIG. 3B generally across the plurality of fluid flow channels as 320 and in FIG. 3C as constriction 322 in fluid flow channel 308”) including an assay region (capture zone 318 in [0043]) (see [0049], which recites “conjugates specific to each assay … are printed onto capture lines in conjugate zone for each fluid flow channel separately, thus providing a test assay for multi-analyte detection”), and
a separating flow passage (fluid flow channel 320 in Fig. 3B) that is provided between the microflow passage (fluid flow channel 318) and the liquid absorbing material (absorbent pad 912);
the separating flow passage (fluid flow channel 320) has a narrowed width portion (constriction 322 in [0043]) where a flow passage width is narrowed (see [0043], which recites “the constriction in each fluid flow channel, such as constriction 322, has a width wcz and a length lcz. In embodiments where the width of the constriction varies along its length, width wcz corresponds to the smallest width along the length lcz.”).
Chang fails to explicitly teach a separating flow passage for separating the liquid inside the inner flow passage when injection of the liquid is stopped.
In the analogous art of assay devices, Fuchiwaki teaches a separating flow passage (separating space 3 in [0083]) for separating the liquid inside the inner flow passage when injection of the liquid is stopped (see [0083], which recites “After stopping supply of the first liquid L1, the flow of the first liquid L1 is narrowed in the separating space 3 to be away from the inner edges of the two ventilation spaces 3 c as being directed from the one end 1 a of the microflow passage 1 and the absorbing porous medium 2 toward the center therebetween in the flow direction, as shown in FIG. 6(c). The first liquid L1 is then divided by the separating space 3 into a part absorbed through the capillary force of the absorbing porous medium 2, and another part held in the microflow passage 1 as shown in FIG. 6(d).”)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the assay device disclosed by Chang such that the separating flow passage provided between the microflow passage and the liquid absorbing material is for separating the liquid inside the inner flow passage when injection of the liquid is stopped as disclosed by Fuchiwaki with a reasonable expectation of success for the benefit of improving control of liquid handlining and assay reliability by controlling residual liquid after cessation of sample introduction thereby promoting capillary-driven separation between liquid retained in the microflow passage and liquid absorbed by the absorbing porous medium (see [0083] of Fuckiwaki).
With respect to claim 2, Chang in view of Fuchiwaki teaches the assay device according to claim 1, wherein the narrowed width portion (constriction 322) is provided successively from or adjacent to the microflow passage (fluid flow channel 308) (see Fig. 3C of Chang, which illustrates narrowed width portion (constriction 322) disposed immediately adjacent to the fluid flow channel 308).
With respect to claim 5, Chang in view of Fuchiwaki teaches the assay device according to claim 1, wherein the inner flow passage (which corresponds to microflow passage 41 in [0110] of Fuchiwaki) is formed by an upper flow passage forming member (top-side core layer S3 in [0121] of Fuchiwaki, the top-side core layer 3 and associated upper limited layers shown in Fig. 12 together corresponds to the claimed upper flow passage forming member), a lower flow passage forming member (bottom-side core layer S5 in [0121] of Fuchiwaki and associated lower laminated layers shown in Fig. 12, corresponding to the claimed lower flow passage member), and an intermediate member (intermediate core layer S24 in [0121] of Fuchiwaki, positioned between the upper flow passage member and the lower member) being stacked (see Fig. 12 of Fuchiwaki), the inlet (which corresponds to inlet 45 in [0126]) and an upper wall portion (top portion 48 a in [0111] of Fuchiwaki) constituting an upper wall (microflow passage wall 48 in [0011] of Fuchiwaki, defining the upper wall of the microflow passage 41) of the inner flow passage (microflow passage 41) being formed in the upper flow passage forming member (top-side core layer S3), a lower wall portion (bottom portion 48 b in [0111]) constituting a lower wall (microflow passage wall 8 in [0111], defining the lower wall of the microflow passage 41) of the inner flow passage (microflow passage 41) being formed in the lower flow passage forming member (bottom-side core layer S5), the intermediate member (intermediate core layer S24) functioning as a spacer (see Fig. 12 of Fuchiwaki) between the upper flow passage forming member (top-side core layer S3), and the lower flow passage forming member (bottom-side core layer S5) (the intermediate member (intermediate core layer S24) being positioned between the upper flow passage member and the lower member so as to define a height of the microflow passage functioning as the claimed spacer, see Fig. 12 of Fuchiwaki).
With respect to claim 6, Chang in view of Fuchiwaki teaches the assay device according to claim 5, wherein
a pair of sideways spaces (two sideways ventilation passages in [0088] of Fuchiwaki) that are adjacent to and communicate with the microflow passage are provided on both sides of the microflow passage in a width direction (see the abstract of Fuckiwaki, which recites “two sideways ventilation passages 6,46 which are adjacent to both sides of the microflow passage, respectively in the width direction”),
a pair of openings (side holes 59 in [0118], including through sections 59 a and 59 b illustrated in Fig. 12) that are located above (side holes 59 and [0121], including through sections 59a and 59b are formed through the top-side core layer and intermediate core layer, see Fig. 12]) and communicate with the pair of sideways spaces (see [0118], which recites “the assay device includes two side holes 59 which communicate the two sideways ventilation passages 46”) are formed at the upper flow passage forming member (corresponding to the top-side core layer and associated top layers shown in Fig. 12 which, when assembled, form the upper portion of the laminated structure corresponding to the claimed upper flow passage forming member).
With respect to claim 9, Chang in view of Fuchiwaki teaches the assay device according to claim 1, wherein at least one assay reagent (reagent drops in [0010] of Chang, which recites “FIGS. 7A-7B illustrate test strips having conjugate zones and/or capture zones comprised of an array of reagent drops”) that reacts with a liquid or a sample (analyte in [0032] of Chang) contained therein is disposed in the assay region (capture zone 318) (see [0032] of Chang, which recites “capture zones include at least one immobilizable species that has chemical or physical affinity to at least a portion of the conjugate complexes formed between a mobilizable, detectable species and the analyte of interest or a control analyte”).
With respect to claim 10, Chang in view of Fuchiwaki teaches the assay device according to claim 1.
Chang in view of Fuchiwaki fails to teach that a plurality of the inlets and a plurality of the inner flow passages are included.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the assay device disclosed by Chang in view of Fuchiwaki by duplicating the inlet as a matter of mere duplication of parts performing the same function without any new or unexpected results and by duplicating the inner flow passage pairs as a matter of mere duplication of parts performing the same function without any new or unexpected results such that the assay device includes a plurality of the inlets and a plurality of the inner flow passages with a reasonable expectation for the benefit of increasing sample throughput by enabling simultaneous analysis of multiple samples in a single assay device (see MPEP 2144.04).
Claims 3 are rejected under 35 U.S.C. 103 as being unpatentable over Chang (US20210255178) in view of Fuchiwaki (WO2020045551A, mapped to US20210170398, cited in the Information Disclosure Statement IDS dated 2/12/24, which is the national stage application of PCT / JP2019 / 033846 (WO2020045551A)) in view of Eason (US20210055295).
With respect to claim 3, Chang in view of Fuchiwaki teaches the assay device according to claim 1.
Chang in view of Fuchiwaki fails to teach a tapered flow passage portion extending from a position at which the liquid injected from the inlet is able to be received toward the separating flow passage and having a flow passage width gradually narrowed at a greater distance away from the inlet.
In the analogous art of assay devices, Eason teaches a tapered flow passage portion (“narrowing of the cross sectional area” in [0032]) extending from a position at which the liquid injected from the inlet (inlet of the fluid flow channel 6 in [0054]) is able to be received toward the separating flow passage (see [0056], which recites “a constricted portion (marked Lc) of the fluid flow channel which has a smaller cross-sectional area than an initial portion of the channel 6”) and having a flow passage width gradually narrowed at a greater distance away from the inlet (see Fig. 2) (see [0032], which recites “fluid flow channel may have a fluid inlet for introducing fluid into the fluid flow channel. … an initial portion of the fluid flow channel disposed between the fluid inlet and the constriction portion may have a larger cross-sectional area than the constricted portion. It can be particularly advantageous to have a larger cross sectional area in the initial part of the fluid flow channel, before then reducing the cross sectional area at the entry to the constricted portion which contains the test site. This means the time taken to flow from the fluid inlet to the entry region of the constricted portion can be kept shorter by having a wider cross sectional area in the initial portion, so that the user can view the result of the test sooner than if the cross sectional area in the initial portion was smaller. Also, the narrowing of the cross sectional area at the entry to the constricted portion concentrates the amount of target analyte provided into a smaller area, increasing the concentration of the target analyte and hence the reaction rate with the analyte detection substance at the test site. Therefore, the limit of detection can be reduced without greatly slowing down the overall time to obtain a result”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the assay device disclosed by Chang in view of Fuchiwaki by incorporating the tapered flow passage portion disclosed by Eason between the inlet (port 306 in Chang) and the separating flow passage (fluid flow channel 320) with a reasonable expectation of success such that the microflow passage includes a tapered flow passage portion extending from a position at which the liquid injected from the inlet is able to be received toward the separating flow passage and having a flow passage width gradually narrowed at a greater distance away from the inlet for the benefit of improving fluid control, concentrating analyte entering the constricted area and increasing reaction efficiency and sensitivity (see [0032], of Eason).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Chang (US20210255178) in view of Fuchiwaki (WO2020045551A, mapped to US20210170398, cited in the Information Disclosure Statement IDS dated 2/12/24, which is the national stage application of PCT / JP2019 / 033846 (WO2020045551A)) in view of Saiyed (US20210222105).
With respect to claim 8, Chang in view of Fuchiwaki teaches the assay device according to claim 5, wherein
the upper flow passage forming member (top-side core layer S3) is transparent (see [0069] of Fuchiwaki), which recites “the top-side core layer S3 and the bottom-side core layer S5 may be transparent”) and the assay device further comprises an observation window (window portion 22 in [0067] of Fuchiwaki) that is provided above the assay region (which corresponds to the reaction porous medium 14 in Fuckiwaki) (see [0008] of Fuckiwaki, which recites “the assay region are constituted by the porous medium”) of the microflow passage (which corresponds to microflow passage 1, 41 in Fuckiwaki) for observing the assay region (reaction porous medium 14) from outside (see [0067] of Fuchiwaki), which recites “the assay device includes a window portion 22 configured to allow the reaction porous medium 14 in the microflow passage 1 to be visually observed from the outside of the assay device. The window portion 22 is transparent”).
Chang in view of Fuchiwaki fails to teach the lower flow passage forming member is formed to be white or black.
In the analogous art of devices, Saiyed teaches the bottom side of a microfluidic cartridge is black (see [0055], which recites “the bottom side of the microfluidic cartridge 100 is … black”). Under the broadest reasonable interpretation, the black bottom side of the microfluidic cartridge 100 of Saiyed reasonably corresponds to the lower low passage forming member because the lower flow passage forming member defines a bottom structural portion of the assay device.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the assay device disclosed by Chang in view of Fuchiwaki by forming the lower flow forming passage member to be black as disclosed by Saiyed with a reasonable expectation of success for the benefit of improving optical contrast during observation, thereby reducing background reflections and improving signal detection (see [0108] of Saiyed).
Allowable Subject Matter
Claims 4 and 7 are 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.
With respect to claim 4, Chang in view of Fuchiwaki in view of Eason teaches the assay device according to claim 3, wherein
Chang in view of Fuchiwaki in view of Eason fails to teach reasonably suggest a microflow passage including the tapered flow passage portion and a first straight flow passage portion extending from a distal end portion of the tapered flow passage portion, reaching the separating flow passage, and having a constant flow passage width,
the separating flow passage includes the narrowed width portion and a second straight flow passage portion extending from the narrowed width portion, reaching the liquid absorbing material, and having a constant flow passage width, which is narrower than the flow passage width of the first straight flow passage portion, and
the narrowed width portion is formed into a tapered shape having a flow passage width gradually narrowed from the flow passage width of the first straight flow passage portion to the flow passage width of the second straight flow passage width.
With respect to claim 7, Chang in view of Fuchiwaki teaches the assay device according to claim 5.
the upper flow passage forming member (top-side core layer S3) and the lower flow passage forming member (bottom side core layer S5) is transparent (see [0069] of Fuchiwaki, which recites “the top-side core layer S3 and the bottom-side core layer S5 may be transparent”);
the assay device further comprises:
an observation window (window portion 22 in [0067]) that is provided above the assay region of the microflow passage for observing the assay region from outside (see [0067] of Fuchiwaki).
Chang in view of Fuchiwaki fails to teach or reasonably suggest a white or black back plate that is disposed below the assay region of the microflow passage.
Conclusion
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/JONATHAN BORTOLI/Examiner, Art Unit 1797
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