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 .
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because of the use of legal phraseology, such as “said,” used to describe elements of the device. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Interpretation
The instant Claims contain a large amount of functional language (ex: "configured for"). However, functional language does not add any further structure to an apparatus beyond a capability. Apparatus claims must distinguish over the prior art in terms of structure rather than function (see MPEP 2114 and 2173.05(g)). Therefore, if the prior art structure is capable of performing the function, then the prior art meets the limitation in the claims.
Claim Objections
Claim 1 is objected to because of the following informalities: “at a location along said path” in line 6 of the claim. Within claim 1 and proceeding claims “path” is referred to as “flow path” and appropriate correction is required to maintain claim language consistency. Examiner recommends amending the claim to recite “at a location along said flow path” or an equivalent thereof.
Claim 7 is objected to because of the following informalities: “arrayed on said path” in line 2 of the claim. Within the claim and preceding claims “path” is referred to as “flow path” and appropriate correction is required to maintain claim language consistency. Examiner recommends amending the claim to recite “arrayed on said flow path” or an equivalent thereof.
Claim 16 is objected to because of the following informalities: “thereby to cause said concentration localization to occur…” in lines 3-4 of the claim. In other preceding claims the “concentration localization” is referred to as “localized concentration” and appropriate correction is required to maintain claim language consistency. Examiner recommends amending the claim to recite “thereby to cause said localized concentration to occur” or an equivalent thereof.
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.
Claims 5-6, 11-13, 16, and 18-20 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 5 recites the limitation “wherein said at least two membranes” in line 1 of the claim. It is unclear whether the “said at least two membranes” are the same membranes as the membranes in the “at least one pair of membranes” as recited in claim 1. Based on the disclosure of the present application, Examiner believes the “at least two membranes” are the same membranes as the “at least one pair of membranes” and recommends amending the claim to recite “wherein said at least one pair of membranes” or an equivalent thereof.
Claims 6 and 11-13 are rejected based on their dependence to claim 5.
Claim 13 recites the limitations "configured to allow digital-like manipulations of multiple plugs containing different preconcentrated particles/molecules” in lines 2-3. It is unclear of the “multiple plugs” are the same or different from the “at least one preconcentrated biological plug” of claim 11 from which claim 13 depends. Examiner recommends amending the claim to recite "configured to allow digital-like manipulations of the at least one preconcentrated biological plug and a second biological plug containing…” or an equivalent thereof.
Claim 13 recites the limitations "difference preconcentrated particles/molecules” in line 2 of the claims. In other preceding claims, only particles/bioparticles are recited. The use of the slash between particles and molecules leaves the scope of the claim unclear as the slash can be interpreted to mean either particles OR molecules, or particles AND molecules, or if particles is the same as molecules. Examiner recommends amending the claim to recite "difference preconcentrated particles” or an equivalent thereof.
Claim 16 recites the limitation "net flow in said microchannel" in line 2. There is insufficient antecedent basis for this limitation in the claim as neither claim 1 nor claim 15 recited a microchannel, only a (flow) path. Examiner recommends amending the claim to recite “net flow in said flow path” or an equivalent thereof.
Claim 16 additionally recites the limitation “a depletion layer is generated…” in lines 2-3 of the claim. Claim 15, from which claim 16 is dependent, recites “a depletion layer” and it is unclear if the depletion layers in claim 15 and claim 16 are the same or different depletion layers. Examiner believes the depletion layer of claim 16 is the same depletion layer of claim 15 and will be examined as such. Examiner recommends amending the claim to recite “said depletion layer is generated” or an equivalent thereof.
Claim 18 recites the limitation "said concentration plugs" in line 7 of the claim. There is insufficient antecedent basis for this limitation in the claim as only “a first localized concentration plug” is recited previously in the claim. There is a lack of antecedent bases for multiple concentration plugs. Examiner recommends amending the claim to recite “said (first) concentration plug” or an equivalent thereof.
Claims 19-20 are rejected based on their dependence to claim 18.
Claim Rejections - 35 USC § 102
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, 3, 7, 9-10, 14-15, and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lee, et. al. (US 20190331563 A1).
Regarding claim 1, Lee teaches a preconcentration kit coupled to a lateral flow assay assembly (Abstract) for detection of biomarkers at low concentrations (par. 0009) (device for concentration of bioparticles for identification). Lee teaches the lateral flow device 100 comprises (Fig. 1a):
A test pad 160 (flow path) connected to a sample pad 120 (inlet) through a conjugate pad 150 (flow path) and support 110, wherein a sample is applied to the sample pad 120 (par. 0047). In line with other lateral flow assay devices, one of ordinary skill in the art understands the flow path of a lateral flow device will start where the sample is deposited (the inlet) and extend by capillary action through all pads that make up the lateral flow device. Therefore, a sample pad will have a portion where a sample is deposited (reading on an inlet) and the sample pad will have other portions where the sample moves downstream to the test pad and conjugate pad; this path the sample takes makes up the flow path (at least one capillary flow path from an inlet). Examiner notes Lee is silent to the bioparticle sample not explicitly being in a buffer solution. In line with other lateral flow assay devices, one of ordinary skill in the art understands that lateral flow assays are performed on liquid samples and therefore the sample must be in a liquid solution, like a buffer solution. Further, bioparticles and the buffer solution, or specifically, “bioparticles in a buffer solution” are not positively recited elements of the apparatus, but an element which the apparatus acts upon. Because Lee teaches a lateral flow assay kit and lateral flow assays are performed on liquid samples, the lateral flow assay kit with a pre-concentration kit 13 as taught by Lee is more than capable of being used “for advection of said bioparticles in a buffer solution” as required by the apparatus of claim 1.
A preconcentration kit 13 comprising two strips of an ion permeable membrane 130 (one pair of membranes) with a power supply 140 (electrical powering) wherein the membranes are fluidically downstream the sample pad 120 and upstream the conjugate pad 140 (par. 0048-0049) (at least one pair of membranes along said flow path). Each membrane (of the two membranes making up the pair) are equipped with thin film electrodes, the electrodes being connected to external power supplies (par. 0049). Because each membrane of the pair has their own electrodes to connect the membrane to the power supply, the membranes can be individually selectable through their own respective electrodes(the membranes being individually selectable for electrical powering).
Lee teaches the membranes 130 are connected to an external power supply by thin film electrodes creating a potential difference at both ends (par. 0049) so that the biomaterial can be preconcentrated at a certain region along the channel (par. 0050). Examiner notes this preconcentration region can be seen in the dashed circle in Fig. 1a. Examiner additionally notes Lee refers to membrane 130 as a singular element, but when referring to par. 0057 of Lee, it is understood that “the selective ion permeable membrane (130) includes nanochannels (nanoporous membranes) made up of selective ion permeable materials that selectively pass ions.” (thereby to controllably set up a region subject to a voltage gradient at a location along said path, said region causing localized concentration of said bioparticles into at least one preconcentrated bioparticles plug).
The test pad 160 further comprising a detection region 162 (along said flow path) where the sample binds with analytes in the sample (par. 0047) through (but not limited to) ligands (detection surface immobilized molecular probes) (par. 0078). Specifically, the detection region is configured to contain at least one captor for capturing desired analytes (par. 0098-0099)(detection surface immobilized molecular probes located along said flow path to detect said bioparticles following said localized concentration).
Regarding claim 3, Lee teaches the lateral flow assay strip 100 is paired with the preconcentration kit 13 (Fig. 1a; par. 0048) at a front end (wherein said device is a concentrator) and terminates in an absorption pad 170 (outlet) with the test pad 160 in between (configured with an outlet with said localized concentration). Lee teaches absorption pad 170 draws the sample from the sample pad 120 by capillary action when aligned on support 110 with the preconcentration kit 13 on the lateral flow device 100 (Fig. 1a; par. 0047) (said outlet configured for extracting said localized concentration of bioparticles when said outlet is aligned to the inlet of a lateral flow device).
Regarding claim 7, Lee teaches a linear (one-dimensional) flow path that starts where the sample is deposited on the sample pad 120m moves through the preconcentration kit 13 area to the test pad 160 where the analyte of interest is detected at the detection region 162, and finally to the absorption pad 170 (Fig. 1a; par. 0047) (wherein said flow path comprises a one-dimensional path and said membranes are arrayed on said path).
Regarding claim 9, Lee teaches the preconcentration kit 13 comprises selective ion permeable membranes 130 (par. 0048) (wherein said membranes comprise ion-permselective membranes).
Regarding claim 10, Lee teaches the device comprises a lateral flow assay strip 100 wherein the pads are a porous medium like cellulose or nitrocellulose (par. 0047) (wherein said flow path comprises a paper-based lateral flow assay).
Regarding claim 14, Lee teaches the membranes 130 are connected to an external power supply by thin film electrodes creating a potential difference at both ends (par. 0049) so that the biomaterial can be preconcentrated at a certain region along the channel (par. 0050) (comprising individual electrodes to respective ones of said membranes, therethrough to selectively electrically power said membranes).
Regarding claim 15, Lee teaches the membranes 130 are connected to an external power supply by thin film electrodes creating a potential difference at both ends (par. 0049) so that the biomaterial can be preconcentrated at a certain region along the channel (par. 0050) wherein the cathode membrane creates a depletion zone and the anode membrane creates an enrichment zone (par. 0077) (configured to differentially electrify said membranes to generate either an enrichment layer or a depletion layer).
Regarding claim 17, Lee teaches the lateral flow assay has a preconcentration kit 13 comprising two strips of an ion permeable membrane 130 connected to the power supply 140 by thin film electrodes creating a potential difference at both ends (par. 0049) (individually addressable membranes) with a channel between the membranes so that the biomaterial can be preconcentrated at a certain region along the channel (par. 0050). This preconcentration region can be seen in the dashed circle in Fig. 1a and reads on at least one intermembrane spacing. Lee teaches the device can comprise additional selective ion permeable membranes beyond the two membranes and are “patterned and attached on a straight line” (par. 0075), with additional membranes operating in the same way as membrane pair 130 (par. 0076) (comprising a serial array of at least three individually addressable membranes). As seen in Figure 1a, a linear flow path is created from the sample pad 120, through the membranes 130, to the test pad 160 (within a respective straight flow path). It is understood that a spacing will be in between additional membranes as the space in between the membranes is where the pre-concentrated plugs are generated therefore require multiple intermembrane spacings including the intermembrane spacing as seen in Fig. 1a (individually addressable membranes, and intermembrane spacings, embedded within a respective straight flow path).
Claims 1, 4-7, 9, 15-16, and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Slouka, et. al. (US 20170108485 A1).
Regarding claim 1, Slouka teaches an integrated ion-exchange membrane microfluidic biochip platform for diagnostic detection in samples (Abstract) (device for concentration of bioparticles for identification). Slouka teaches a device comprising (Fig. 19, 20):
A chip with at least one inlet for introducing a sample (par. 0033) and one fluidic channel (Fig. 19, see path leading from inlet to outlet) (at least one capillary flow path from an inlet for advection of said bioparticles). Examiner notes Slouka is silent to the bioparticle sample explicitly being in a buffer solution. In line with other microfluidic devices, one of ordinary skill in the art understands that microfluidic devices require liquid samples and therefore the sample must be in a liquid solution (par. 0081), like a buffer solution. Further, bioparticles and the buffer solution, is or specifically, “bioparticles in a buffer solution” are not a positively recited elements of the apparatus, but an element which the apparatus acts upon. Because Slouka teaches microfluidic device and microfluidic devices require liquid samples, the device as taught by Slouka is more than capable of being used “for advection of said bioparticles in a buffer solution” as required by the apparatus of claim 1
A pre-concentration unit, downstream the inlet, comprising at least two cation exchange membranes (CEM) (auxiliary membrane and pre-concentration membrane) that work together to hold a preconcentrated slug in place (par. 0160-0162), when a voltage is applied to the membranes (par. 0035, 0161) (at least one pair of membranes along said flow path, the membranes being individually selectable for electrical powering, thereby to controllably set up a region subject to a voltage gradient at a location along said path, said region causing localized concentration of said bioparticles into at least one preconcentrated bioparticles plug).
A sensor unit downstream the inlet and between a pre-concentration unit (seen in Fig. 19), comprising probes on which target molecules hybridize (par. 0084), the probes being attached to a membrane of the sensor unit (par. 0121) (detection surface immobilized molecular probes located along said flow path to detect said bioparticles following said localized concentration).
Regarding claim 4, Slouka teaches the device can detect multiple targets through a plurality of methods, one such method being the division of the main channel into several channels, another method being several integrated chips with each with a unique sensor as seen in Figure 19 (note the plurality of inlets and membranes) (par. 0145) (wherein said flow path comprises a microfluidic network of microfluidic channels).
Regarding claim 5, Slouka teaches the pre-concentration unit, comprising at least two cation exchange membranes (CEM) (auxiliary membrane and pre-concentration membrane) at set locations surrounding the sensor unit (Fig. 19) (wherein said at least two membranes comprise an array of membranes), that work together to hold a preconcentrated slug in place (par. 0160-0162), when a voltage is applied to the membranes (par. 0035, 0161) (each membrane being individually selectable for electrical powering).
Regarding claim 6, Slouka when a voltage is applied to the membranes, the pre-concentrated slug moves partially based on the voltage applied to the membranes (par. 0161) (configured such that changing a selection of powered membranes in said array maneuvers said localized concentration).
Regarding claim 7, Slouka teaches a microfluidic path wherein the inlet, pre-concentration unit, and sensing unit are all aligned in a linear pathway (Fig. 19) (wherein said flow path comprises a one-dimensional path and said membranes are arrayed on said path).
Regarding claim 9, Slouka teaches the pre-concentration unit uses at least two CEMs (par. 0162) (wherein said membranes comprise ion-permselective membranes).
Regarding claim 11, Slouka teaches the position of the pre-concentrated slug is controlled by the applied voltage and fine-tuning of the voltage fine-tunes the placement of the slug (par. 0161) (configured such that said selecting of electrical powering on said membranes performs digital-like microfluidic operations on said at least one preconcentrated bioparticles plug).
Regarding claim 12, Slouka teaches the fine-tuning of the applied voltage moves the pre-concentrated slug up and downstream as needed for detection (par. 0161) (wherein said digital-like microfluidic operations comprise one or more of: down and up-stream translations).
Regarding claim 15, Slouka teaches the CEMs created a region depleted of all ions downstream the concentration slug (par. 0161) (configured to differentially electrify said membranes to generate… a depletion layer).
Regarding claim 16, Slouka teaches in addition to the applied voltage, a flow rate also influences the formation and location of the slug (par. 0161) (the face of background net flow in said microchannel). Therefore, the combined applied voltage and flow rate allow for a slug to form creating an enrichment region; in other words, when two CEMs are used, the slug is between the two CEMs (par. 0160). Therefore, if the preconcentrated slug is between the two CEMs (downstream from at least one CEM) and the depleted region is formed downstream at least one CEM (a depletion layer is generated from the interface of the downstream membrane) and downstream and adjacent to the concentrated plug (par. 0160-0161) the device is configured such that, upon the application of a voltage drop between two of said membranes in the face of background net flow in said microchannel, a depletion layer is generated from the interface of the downstream membrane, thereby to cause said concentration localization to occur at an edge of said depletion layer because the slug must be between the two membranes (par. 0160) and the depletion region is downstream the slug (par. 0161).
Regarding claim 18, Slouka teaches an integrated ion-exchange membrane microfluidic biochip platform device and method for diagnostic detection in samples (Abstract) (a method of identifying bioparticles/biomolecules). Slouka teaches a device comprising and undergoing the following method (Fig. 19, 20):
A chip with at least one inlet and one fluidic channel, wherein a sample is introduced through the inlet to a main channel (par. 0033), wherein the sample comprises a nucleic acid from a variety of sources (par. 0014) and be in a variety of sample matrices (par. 0017). Slouka teaches a pre-treatment unit that filters the sample (par. 0034) and further mix the sample with lysing buffers (par. 0180) upstream a preconcentration unit (Fig. 19). Slouka further teaches the device is capable of handling “raw samples” like blood and urine (par. 0019), both blood and urine are buffered solutions. If a raw sample of blood for example is analyzed, then the blood sample is going to comprise nucleic acid (bioparticles/biomolecules) in a buffered solution (a method of identifying bioparticles/biomolecules in a buffer fluid) (inserting the bioparticles/biomolecules and buffer fluid into a microfluidic network, the microfluidic network forming at least one capillary flow path).
A sensor unit downstream the inlet and between a pre-concentration unit (seen in Fig. 19), comprising probes on which target molecules hybridize (par. 0084), the probes being attached to a membrane of the sensor unit and to detect electrical potential across the membrane to detect the target analyte (par. 0036-0038, 0121) (detection molecular probes)
A pre-concentration unit, downstream the inlet and surrounding the sensor unit (Fig. 19), comprising at least two cation exchange membranes (CEMs) (auxiliary membrane and pre-concentration membrane) that work together to hold a preconcentrated slug in place (par. 0160-0162), when a voltage is applied to the membranes (par. 0035, 0161) (differentially electrifying individually addressable membranes embedded into said flow path of said microfluidic network, to cause a concentration of said bioparticles/biomolecules into a first localized concentration plug) (changing said electrifying of said membranes to hold or maneuver said concentration plugs around detection molecular probes).
Claim Rejections - 35 USC § 103
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 2 is rejected under 35 U.S.C. 103 as being unpatentable over Lee, et. al. (US 20190331563 A1) as applied to claim 1, and in further view of Han, et. al. (KR 101718951 B1; as cited in and with citations corresponding to document provided with IDS dated 01 January 2025).
Regarding claim 2, Lee teaches the device comprises a lateral flow assay strip 100 wherein the pads are a porous medium like cellulose or nitrocellulose (par. 0047) with a detection region 162 on the test pad 160 (Fig. 1a) (wherein said device is a paper-based lateral flow device having at least one test line).
Lee is silent to the assay strip being configured such that said localized concentration occurs at said test line.
Han teaches a biomolecule concentration device (par. 0001) comprising a porous membrane between two selective ion permeable membranes (par. 0012). Han teaches the concentration device 100 comprises two strips of selective ion permeable membranes 30 spaced apart from one another and porous membranes 40 atop substrate 10 (Fig. 1; par. 0031). Han teaches porous membranes 40 are cellulose paper or an equivalent capable of passive capillary force (par. 0032) (paper-based lateral flow device). Porous membranes further comprise buffer membranes 41, 42 at terminal ends of the device 100 (on outer edges of the permeable membranes 30) and a reaction membrane 45between the two permeable membranes 30 (Fig. 1, ; par. 0031). Han teaches a sample is applied to the reaction membrane 45 and upon activation the target particle is concentrated between the permeable membranes 30 (see concentration line in Fig. 4, label 420) and unwanted sample material moves to buffer reservoir 41, 42 (par. 0038-0040, 004-0047) (configured such that said localized concentration occurs at said test line). Han teaches this configuration allows for detection and interpretation of the analysis to easily be performed with the human eye even in sample with low target material concentration (par. 0048).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to modify the location of the permeable membranes from the beginning of the assay strip of Lee to instead be on either side of the test line as taught by Han because doing so would make the detection and interpretation of the analysis to easily be performed with the human eye at low concentrations (Han, par. 0048) with reasonable expectation of success. MPEP 2143(I)(G).
Claims 8, 13, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Slouka, et. al. (US 20170108485 A1) as applied to claim 1 (for claim 8), claim 12 (for claim 13), and claim 18 (for claims 19-20), in further view of Ko, et. al. (US 20110220498 A1).
Regarding claim 8, Slouka teaches the device can detect multiple targets through a plurality of methods, one such method being the division of the main channel into several channels, another method being several integrated chips with each with a unique sensor as seen in Figure 19 (note the plurality of inlets and membranes) (par. 0145) (wherein said flow path comprises a two-dimensional network).
However, Slouka is silent to said membranes [being] arrayed over said two-dimensional network (specifically the CEMs responsible for creating the pre-concentrated slug).
Ko teaches the device comprises a microchannel that divides into a plurality of microchannels (par. 0018) in with an electrode applies an electric field (par. 0017) (wherein said flow path comprises a two-dimensional network). The device further comprises a plurality of ion-selective membranes (par. 0018), such as cation exchange membrane Nafion (par. 0019). As seen in Figure 4a, a singular cation exchange membrane can extend over a plurality of the microchannels to create a plurality of plugs (par. 0040-0041) (said membranes are arrayed over said two-dimensional network). Ko teaches extending the membrane across a plurality of channels allows for a plurality of plugs to be formed allowing for high-throughput analysis (par. 0016) through parallelization (par. 0020).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to modify the membrane strips of Slouka to extend across a plurality of microchannels as taught by Ko because doing so allows for parallelization of the plug-creation process which further allows for high-throughput analysis of bioparticles (Ko, par. 0016, 0020) with reasonable expectation of success. MPEP 2143(I)(G).
Regarding claim 13, Slouka teaches the position of the pre-concentrated slug is controlled by the applied voltage and fine-tuning of the voltage fine-tunes the placement of the slug (Slouka, par. 0161) (configured to allow digital-like manipulations (of a slug)). Slouka further teaches the device can detect multiple targets through a plurality of methods, one such method being several integrated chips with each with a unique sensor as seen in Figure 19 that depicts multiple inlets (see circular projections at the far left end of device in top figure of Fig. 19) (par. 0145) (different preconcentrated particles/molecules from samples introduced via separate inlets).
Slouka is silent to the manipulations of multiple plugs containing different preconcentrated particles/molecules.
Ko teaches a microfluidic device that creates a concentration interface across a plurality of microchannels (Abstract). Ko teaches the device comprises a microchannel that divides into a plurality of microchannels (par. 0018) in with an electrode applies an electric field (par. 0017). The device further comprises a plurality of ion-selective membranes (par. 0018), such as Nafion (par. 0019), specifically created in parallel (par. 0020) extended over a plurality of the microchannels to create a plurality of plugs (par. 0040-0041) (manipulations of multiple plugs). Ko teaches extending a plurality of membranes across a plurality of channels allows for a plurality of plugs to be formed allowing for high-throughput analysis through parallelization (par. 0020).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to modify device with that manipulates a singular plug of Slouka to include membranes extending over multiple channels to form and manipulated multiple plugs taught by Ko because doing so allows for parallelization of the plug-creation process which further allows for high-throughput analysis of bioparticles (Ko, par. 0016, 0020) with reasonable expectation of success. MPEP 2143(I)(G).
Regarding claim 19, Slouka teaches the pre-concentration unit, comprising at least two cation exchange membranes (CEM) (auxiliary membrane and pre-concentration membrane), that work together to hold a preconcentrated slug in place (par. 0160-0162), when a voltage is applied to the membranes (par. 0035, 0161) (further configured to carry out further changing of said electrifying). Slouka further teaches the device can detect multiple targets through a plurality of methods, one such method being several integrated chips with each with a unique sensor as seen in Figure 19 (note the plurality of inlets and membranes) (par. 0145).
Slouka, however, is silent to the changing of said electrifying to generate at least one additional concentrated plug.
Ko teaches a microfluidic device that creates a concentration interface across a plurality of microchannels (Abstract). Ko teaches the device comprises a microchannel that divides into a plurality of microchannels (par. 0018) in with an electrode applies an electric field (par. 0017). The device further comprises a plurality of ion-selective membranes (par. 0018), such as cation exchange membrane Nafion (par. 0019), specifically created in parallel (par. 0020) extended over a plurality of the microchannels to create a plurality of plugs (par. 0040-0041) (further configured to carry out further changing of said electrifying to generate at least one additional concentrated plug). Ko teaches extending a plurality of membranes across a plurality of channels allows for a plurality of plugs to be formed allowing for high-throughput analysis through parallelization (par. 0020).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to modify the electrifying process of the membrane strips of a singular flow path of Slouka to extending the electrifying process of the membrane strips across a plurality of microchannels as taught by Ko because doing so allows for parallelization of the plug-creation process which further allows for high-throughput analysis of bioparticles (Ko, par. 0016, 0020) with reasonable expectation of success. MPEP 2143(I)(G).
Regarding claim 20, modified Slouka teaches when a voltage is applied to the membranes, the pre-concentrated slug moves partially based on the voltage applied to the membranes (Slouka, par. 0161), and if the voltage changes, the pre-concentrated slug will move the slug up- or down-stream (comprising further changing said electrifying to carry out digital-like manipulation of said first…plug).
Modified Slouka is silent to further changing said electrifying to carry out digital-like manipulation of said at least one additional plug.
Ko teaches a plurality of ion-selective membranes (par. 0018), such as cation exchange membrane Nafion (par. 0019), specifically created in parallel (par. 0020) extended over a plurality of the microchannels to create a plurality of plugs (par. 0040-0041). Ko teaches such that when an electrical potential is applied across the membrane, the preconcentration process in each channel to form the slugs in each channel (par. 0037) (further changing said electrifying to carry out digital-like manipulation of… said at least one additional plug). Ko teaches extending a plurality of membranes across a plurality of channels allows for a plurality of plugs to be formed allowing for high-throughput analysis through parallelization (par. 0020).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to modify the electrifying process for manipulating a first plug of modified Slouka to extending the electrifying process across a plurality of microchannels to manipulate at least one additional plug as taught by Ko because doing so allows for parallelization of the plug-creation process which further allows for high-throughput analysis of bioparticles (Ko, par. 0016, 0020) with reasonable expectation of success. MPEP 2143(I)(G).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Kim, et. al. (“Battery operated preconcentration assisted lateral flow assay” 2017) teaches a lateral flow assay device with a preconcentration enhancement (Abstract). Examiner notes this NPL corresponds with the apparatus described in Lee, et. al. (US 20190331563 A1).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MADISON T HERBERT whose telephone number is (571)270-1448. The examiner can normally be reached Monday-Friday 8:30a-5:00p.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel can be reached at (571) 270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.T.H./Examiner, Art Unit 1758
/HENRY H NGUYEN/Primary Examiner, Art Unit 1758
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