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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on July 23, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The disclosure is objected to because of the following informalities:
The bolded in “In conclusion, the microfluidic detection device of the present disclosure has a recess set between a control region and a test region on a base, and a protrusion set on a lid corresponding to the recess that enable the sample flowing through the test region longer, and the impurities and unwanted substances deposited at the bottom of the recess, thereby improving the color development.” in Paragraph 0016 should instead read “and a protrusion set on a lid corresponding to the recess that enable the sample flowing through the test region for a longer time, and the impurities and unwanted substances are deposited at the bottom of the recess”
Appropriate correction is required.
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.
Claim 10 is 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 10 recites the limitation "the upper surface of the base to the lower surface of the base" in Line 2-3. There is insufficient antecedent basis for this limitation in the claim.
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 1, 2, 5, 9, 11, 13, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Park et al. (US 20210402396 A1) in view Cuppoletti et al. (WO 2016209900 A1) and Dirckx et al. (US10279345B2) (Cited in 892).
Regarding claim 1, Park et al. teaches a microfluidic detection device (abstract), comprising:
a base (lower plate 12, See annotated FIG. 2) with a microfluidic channel structure formed on the base (channels 111, 121, and 131, See annotated FIG. 1), wherein the microfluidic channel structure comprises:
a sample well (first storage 110, FIG. 2) for loading the sample (para. [0052]);
a detection well (well array 130, FIG. 2);
a channel connecting the sample well and the detection well (channels 111, 121, FIG. 2);
wherein the detection well (well array 130, FIG. 2) has a recess deeper than the channel (feature 121 and 131, FIG. 2);
a lid (upper plate 11, FIG. 2) covering the base (lower plate 12, FIG. 2)
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Park et al. fails to teach the following limitations:
A first reagent in the detection well for reacting with the sample in the detection well
A protrusion corresponding to the recess to form a space between the protrusion and the recess on the lid.
Regarding limitation I, Cuppoletti et al. teaches a detection chamber (See annotated FIG. 1A - array chamber 110) which includes a first reagent for reacting with the sample (para. [0077]). Cuppoletti et al. also teaches that
a suitable substrate/reagent can be pre-loaded into the detection chamber 110, such that the capture molecule reacts with the substrate/reagent to generate light (e.g., ultraviolet, visible, or infrared light) for detection (para. [0077]).
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It would have been obvious of one of ordinary skill in the art to use Cuppoletti et al.’s teaching of a first reagent (detection reagent) in Park et al.’s detection well because using a first reagent would allow the capture molecule to react with the reagent to generate light for detection. This method of improving Park et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Cuppoletti et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Cuppoletti et al. and Park et al. to obtain the invention as specified in claim 1.
Regarding limitation II, Dirckx et al. teaches that fluidic devices can include structural (e.g., an elongated indentation or protrusion) and/or physical or chemical characteristics (e.g., hydrophobicity vs. hydrophilicity that can exert a force (e.g., a containing force) on a fluid (Description, para. 115). Dirckx et al. also teaches that these characteristics facilitate control over fluid transport in the microfluidic device (Description, para. 115).
It would have been obvious of one of ordinary skill in the art to add a protrusion as shown by Dirckx et al. on the lid of Park et al. because using a structural characteristics like protrusions would facilitate control over fluid transport in the microfluidic device. This method of improving Park et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Dirckx et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Dirckx et al. and Park et al. to obtain the invention as specified in claim 1.
Regarding claim 2, modified Park et al. teaches the microfluidic detection device of claim 1. Park et al. also teaches that the recess in their detection well is along the direction from an upper surface of the base to a lower surface of the base (Park et al., See annotated FIG. 2 below).
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Regarding claim 5, modified Park et al. teaches the microfluidic detection device of claim 1. Modified Park et al. also teaches the presence of detection reagents - such as intercalating dyes, fluorescently tagged probes, among other suitable detection molecules, which allow for measurement and quantification of the amplification of targets – in the detection chamber (Cuppoletti et al., para. [00145]). Detection reagents – like fluorescent tagged probes – increase the signal for measurement (boost the signal). The structure resulting from a combination of modified Park et al. and Cuppoletti et al. would encompass a first reagent comprising a signal booster absent clear evidence otherwise.
Regarding claim 9, modified Park et al. teaches the microfluidic detection device of claim 1. Park et al. also teaches a microfluidic channel structure (see FIG. 1, Park et al.) that further comprises a reaction well (Second storage, 120) between the sample well (first storage, 110) and the detection well (array 130). Park et al. also teaches that the reaction well may contain at least one reactant for each target material (which is inside the sample) (para. [0057]). Park et al. also teaches wherein the sample well, the reacting well, and the detection well are connected by the channel. (FIG. 1 of Park et al., elements 111, 121)
Regarding claim 11, modified Park et al. teaches the microfluidic detection device of claim 9. Park et al. also teaches a branched microfluidic channel structure, with each branch of the microfluidic channel structure comprising the reaction well and the detection well (See FIG 1. of Park et al, branching of channels 111, 121).
Regarding claim 13, modified Park et al. teaches the device of claim 9. Park et al. fails to teach specifically that the second reagent comprises of antibody-colloidal gold conjugates. Dirckx et al. teaches in their fluidic device that one of the stored reagents may include a solution of metal colloid (e.g., a gold conjugated antibody) (Dirckx et al. – Page 57, Line 27-29). Dirckx et al. also teaches that these antibody-colloidal gold conjugates specifically bind to the antigen to be detected. (Dirckx et al. – Page 57, Line 27-29).
It would have been obvious of one of ordinary skill in the art to use Dirckx et al.’s teaching of using antibody-colloidal gold conjugates as a reagent in modified Park et al.’s second reagent because antibody-colloidal gold conjugates bind to the antigen, which can allow detection to occur. This method of improving modified Park et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Dirckx et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Dirckx et al. and modified Park et al. to obtain the invention as specified in claim 13.
Regarding claim 15, modified Park et al. teaches the microfluidic detection device of claim 9. Modified Park et al. also teaches of a reagent for nucleic acid amplification through the usage of primer oligonucleotides for amplification of the target (Cuppoletti et al., primer oligonucleotides – para. [0074]). Modified Park et al. also teaches that oligonucleotides are specifically used as primers for a nucleic acid amplification reaction (Cuppoletti et al., para. [0065]). The structure resulting from a combination of Park et al. and Cuppoletti et al. would encompass a second reagent (the primer oligonucleotides) comprising a reagent for nucleic acid amplification.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Park et al. (already referenced), Cuppoletti et al. (already referenced), Dirckx et al. (already referenced) as applied to claim 1 above, and in further view of Anderson et al. (US 9840732 B2) (Cited in 892).
Regarding claim 3, modified Park et al. teaches the device of claim 1. Modified Park et al. fails to teach that recess and protrusion are arc-shaped. Anderson et al. teaches that physical barriers disposed in a microfluidic device include recesses or protrusions extending into the passage (Col. 20, Para. 1). Anderson et al. also teaches that physical barriers can be concaved in shape to facilitate particle capture (Col 23, Para. 3).
It would have been obvious of one of ordinary skill in the art to use Anderson et al.’s teaching of the shape of recesses/protrusions in modified Park et al. because arc-shaped protrusions and recesses facilitate particle capture. This method of improving modified Park et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Anderson et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Anderson et al. and modified Park et al. to obtain the invention as specified in claim 3.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Park et al. (already referenced), Cuppoletti et al. (already referenced), Dirckx et al. (already referenced), Anderson et al. (already referenced) as applied to claim 3 above, and in further view of Fowler et al. (WO2013130714A1) (Cited in 892).
Regarding claim 4, modified Park et al. teaches the device of claim 3. Modified Park et al. fails to teach that recess and protrusion forms a curved channel. Fowler et al. teaches that surface contours (including recesses and protrusions) and curved paths structures within fluid passages (para. [0097)]. Fowler et al. also teaches that these fluid passage structures can be used to manipulate fluid and particle movement (para. [0097)].
It would have been obvious of one of ordinary skill in the art to use Fowler et al.’s teaching of surface contours and curved paths structures in modified Park et al. because surface contours (recesses and protrusions) and curved paths can be used to manipulate fluid and particle movement. This method of improving modified Park et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Fowler et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Fowler et al. and modified Park et al. to obtain the invention as specified in claim 4.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Park et al. (already referenced), Cuppoletti et al. (already referenced), Dirckx et al. (already referenced) as applied to claim 1 above, and in further view of Fang et al. (CN 108435266 B and corresponding attached machine translation) (Cited in 892).
Regarding claim 6, modified Park et al. teaches the microfluidic detection device of claim 1. Modified Park et al. fails to teach that the lid further has at least one air hole corresponding to the microfluidic channel structure. Fang et al. teaches a microfluidic detection device with a lid (See annotated FIG. 2 – 10 Upper Layer) with at least one air hole (FIG. 2 – 103 Vent Hole) corresponding to the microfluidic channel structure. Fang et al. also teaches that the air holes improve fluidity of the sample solution (para. [0063] of MT).
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It would have been obvious of one of ordinary skill in the art to use Fang et al.’s teaching of an air hole in modified Park et al. because air holes would improve fluidity of the sample solution in the device. This method of improving modified Park et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Fang et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Fang et al. and modified Park et al. to obtain the invention as specified in claim 6.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Park et al. (already referenced), Cuppoletti et al. (already referenced), Dirckx et al. (already referenced) as applied to claim 1 above, and in further view of Kim In Wook (KR 20110088746 A and corresponding attached machine translation) (Cited in 892).
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Regarding claim 7, modified Park et al. teaches the microfluidic device of claim 1. Modified Park et al. fails to teach that the detection well has a control region and a test region. Kim In Wook teaches a microfluidic device with a detection region (420) that has a control region (See annotated FIG. 6 above, 440) and a test region (FIG. 6, 430) in holder 410. Kim In Wook also teaches that the target substance moves to the analysis chamber 400 and binds to the capture conjugate permanently immobilized in the test region and the control region through competitive inhibition (Page 24 of MT).
It would have been obvious of one of ordinary skill in the art to use Kim In Wook’s teaching of a control region and a test region in modified Park et al. because using a test region and control region allows for analysis of whether the analyte is directly or indirectly immobilized from the competitive inhibition. This method of improving modified Park et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Kim in Wook. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Kim in Wook’s and modified Park et al. to obtain the invention as specified in claim 7.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Park et al. (already referenced), Cuppoletti et al. (already referenced), Dirckx et al. (already referenced) as applied to claim 1 above, and in further view of Zhou et al. (CN112858710A and corresponding machine translation) (Cited in 892).
Regarding claim 8, modified Park et al. teaches the microfluidic detection device of claim 1. Park et al. fails to teach a lid with a sample through hole corresponding to the sample well. Zhou et al. teaches a lid (See annotated FIG. 2 below, chip cover plate 2) with a sample through hole corresponding to the sample well (FIG. 2, sample loading hole - feature 7). Zhou et al. also teaches that using a sample through hole contributes to quick and convenient detection (para. [0007 and 0008] of MT).
It would have been obvious of one of ordinary skill in the art to use Zhou et al.’s teaching of a sample hole in the lid in modified Park et al. because using a sample hole would ease loading of the sample into the device, contributing to quick and convenient detection. This method of improving modified Park et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Zhou et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Zhou et al. and modified Park et al. to obtain the invention as specified in claim 8.
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Park et al. fails to teach a detection window corresponding to the detection well in the lid. Zhou et al. teaches a detection window present in their cover plate (detection window (FIG. 2, feature 8). Zhou et al. teaches using a detection window contributes to quick and convenient detection (para. [0007 and 0008] of MT).
It would have been obvious of one of ordinary skill in the art to use Zhou et al.’s teaching of a detection window in the lid in modified Park et al. because using a detection window hole would ease viewing the detection result of the sample in the device, contributing to quick and convenient detection. This method of improving modified Park et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Zhou et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Zhou et al. and modified Park et al. to obtain the invention as specified in claim 8.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Park et al. (already referenced), Cuppoletti et al. (already referenced), Dirckx et al. (already referenced) as applied to claim 9 above, and in further view of Pinto et al. (WO 2019207150 A1) (Cited in 892).
Regarding claim 10, modified Park et al. teaches the microfluidic detection device of claim 9. Modified Park et al. fails to explicitly teach that the reaction well is deeper than the channel along the direction from the upper surface of the base to the lower surface of the base. Pinto et al. teaches a base layer (See annotated FIG. 2 - feature 5) with a reaction chamber (FIG. 2, feature 8) wherein “depth of the reaction chamber can be used to control the flow rate and hence the residence time of the fluidic sample in the reaction chamber. A deeper chamber will result in a much slower flow rate, and a longer residence time” (Page 21, Line 28-30).
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It would have been obvious of one of ordinary skill in the art to use Pinto et al.’s teaching of deeper chambers (well) in modified Park et al. because a deeper chamber (well) allows control over flow rate and residence time of the sample. This method of improving modified Park et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Pinto et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Pinto et al. and modified Park et al. to obtain the invention as specified in claim 10.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Park et al. (already referenced), Cuppoletti et al. (already referenced), Dirckx et al. (already referenced) as applied to claim 11 above, and in further view of Ram et al. (WO 2012092489 A1) (Cited in 892).
Regarding claim 12, modified Park et al. teaches the microfluidic detection device of claim 11. Modified Park et al. fails to teach a gate disposed between the reaction well and the detection well to control the flow of fluid from the reaction well to the detection well. Ram et al. teaches a microfluidic detection device that may include a gate mechanism (para. [00073]). Ram et al. also teaches that gate mechanisms control flow, and can be included in the reaction chamber prior to the detection chamber to allow a required incubation period to be achieved (para. [00073]).
It would have been obvious of one of ordinary skill in the art to use Ram et al.’s teaching of using gate mechanisms in modified Park et al. because the gate structure would control the flow between the reaction chamber and detection chamber, allowing a desired incubation period to be achieved first. This method of improving modified Park et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Ram et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Ram et al. and modified Park et al. to obtain the invention as specified in claim 12.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Park et al. (already referenced), Cuppoletti et al. (already referenced), Dirckx et al. (already referenced) as applied to claim 13 above, and in further view of Neethirajan et al. (US 20170341077 A1) (Cited in 892).
Regarding claim 14, modified Park et al. teaches the microfluidic detection device of claim 13 with antibody-colloidal gold conjugates. Modified Park et al. fails to teach that test paper is disposed on the reaction well. Neethirajan et al. teaches a microfluidic detection device embodiment with chromatography paper coated with a predetermined amount of a probe composition that is then placed in the reaction well. (para. [0055]). Neethirajan et al. also teaches these coated papers are then analyzed for fluorescence intensity (para. [0106]).
It would have been obvious of one of ordinary skill in the art to use Neethirajan et al.’s teaching of coated papers disposed on the reaction well in modified Park et al.’s antibody-colloidal gold conjugates because the chromatography paper coated with the probe composition would allow analysis for fluorescence intensity. This method of improving modified Park et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Neethirajan et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Neethirajan et al. and modified Park et al. to obtain the invention as specified in claim 14.
Claim 16, 17, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Park et al. (already referenced), Cuppoletti et al. (already referenced), Dirckx et al. (already referenced), and in further view of Broughton et al. (WO 2020257356 A2) (Cited in 892).
Regarding claim 16, modified Park et al. teaches the microfluidic detection device of claim 15. Modified Park et al. fails to explicitly teach the nucleic acid amplification technique selected. Broughton et al. teaches that nucleic acid-sequence-based amplification (NASBA) as an amplification technique used in their microfluidic detection device (para. [0381]). Broughton et al. also teaches that nucleic acid amplification of the sample can improve at least one of sensitivity, specificity, or accuracy of the detection the target RNA (para. [0381]).
It would have been obvious of one of ordinary skill in the art to use Broughton et al.’s teaching of a specific nucleic acid amplification technique in Park et al. because nucleic acid amplification can improve sensitivity, specificity, or accuracy of the detection the target RNA. This method of improving Park et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Broughton et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Broughton et al. and Park et al. to obtain the invention as specified in claim 16.
Regarding claim 17, modified Park et al. teaches the microfluidic detection device of claim 1. Modified Park et al. fails to explicitly teach a method for rapid diagnostic testing. Broughton et al. teaches a method for rapid lab testing (para. [0318]) comprising: obtaining a sample from a subject in need thereof (“providing a sample from a subject”, para. [0034])); loading the sample to the microfluidic detection device (“adding the sample to a microfluidic cartridge”, para. [0034]); and detecting a biochemical value or a disease pathogen by the microfluidic detection device (“correlating a detectable signal to the presence or absence of a target nucleic acid; and optionally quantifying the detectable signal, thereby quantifying an amount of the target nucleic acid present in the sample” para. [0034]). Broughton et al. also discloses that this method is specifically used in detecting a target nucleic acid (para. [0034]).
It would have been obvious of one of ordinary skill in the art to use Broughton et al.’s teaching of a rapid diagnostic testing in Park et al. because using Broughton’s method (rapid testing) would allow for detection of a target nucleic acid. This method of improving Park et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Broughton et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Broughton et al. and Park et al. to obtain the invention as specified in claim 17.
Regarding claim 18, modified Park et al. teaches the method of claim 17. Modified Park et al. fails to explicitly teach the disease pathogen selected. Broughton et al. teaches that the target nucleic acid can be from a virus (para. [0342]). Broughton et al. also teaches that the sample can be used in identifying a disease status of a subject (para. [0342]).
It would have been obvious of one of ordinary skill in the art to use Broughton et al.’s teaching in Park et al. because using a target nucleic acid from a virus would allow for identification of a disease status of a subject. This method of improving Park et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Broughton et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Broughton et al. and Park et al. to obtain the invention as specified in claim 18.
Conclusion
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/JULIUS FRANCIS YOH/Examiner, Art Unit 1799
/MICHAEL A MARCHESCHI/Supervisory Patent Examiner, Art Unit 1799