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 statements (IDS) submitted on 07/17/2024 and 10/14/2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Status
Claims 1-20 are pending with claims 1-20 being examined.
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 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over Wilding et al (US 20060223166 A1; hereinafter “Wilding”) in view of Scrivens (US 6819408 B1; hereinafter “Scrivens”).
Regarding claim 1, Wilding teaches an assay device (Wilding; fig. 1. 10) comprising:
a planar substrate (Wilding; fig. 1. 14) having a top surface (Wilding; fig. 1. 12) and a bottom surface (Wilding; fig. 1. 14 (the bottom portion of the substrate);
a first flow channel of a first size disposed within the planar substrate and extending between the top surface and the bottom surface (Wilding; fig. 6. 20a), and a second flow channel (Wilding; fig. 6. 20b and [0011] “microfabricating flow channels into the surface of the substrate and then adhering a cover”).
Wilding fails to teach the second flow channel of a second size disposed within the planar substrate and extending between the top surface and the bottom surface, the second size being larger than the first size; and
the first flow channel configured to receive a liquid sample and allow a first flow of the liquid sample within the first flow channel whereby a first analyte of the liquid sample is distributed within the first flow channel as a first monolayer;
the second flow channel configured to receive the liquid sample and allow a second flow of the liquid sample within the second flow channel whereby a second analyte of the liquid sample is distributed within the second flow channel as a second monolayer, and the first analyte having a higher population density within the liquid sample compared to the second analyte.
However, Scrivens teaches the analogous art of an apparatus for analyzing blood (Scrivens; Abstract) that includes a substrate (Scrivens; fig. 1. 4) and a second flow channel of a second size disposed within the planar substrate and extending between the top surface and the bottom surface, the second size being larger than the first size (Scrivens; Col. 4 lines 33-35 “two channels having different sizes”. Channel 7 is sized to allow only particles smaller… “); the first flow channel configured to receive a liquid sample and allow a first flow of the liquid sample within the first flow channel whereby a first analyte of the liquid sample is distributed within the first flow channel as a first monolayer; the second flow channel configured to receive the liquid sample and allow a second flow of the liquid sample within the second flow channel (Scrivens; Col. 4 lines 34-42) whereby a second analyte of the liquid sample is distributed within the second flow channel as a second monolayer (Scrivens; Col. 3 lines 66-67 to Col. 4 lines 1-3), and the first analyte having a higher population density within the liquid sample compared to the second analyte (Scrivens; Col. 4 lines 33-37, channel 7 allows particles to pass (which have a population density) while channel 8 allows liquid to pass (which would have no particle density)).
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Wilding’s planar substrate to include a second flow channel of a second size disposed within the planar substrate and extending between the top surface and the bottom surface, the second size being larger than the first size; and the first flow channel configured to receive a liquid sample and allow a first flow of the liquid sample within the first flow channel whereby a first analyte of the liquid sample is distributed within the first flow channel as a first monolayer; the second flow channel configured to receive the liquid sample and allow a second flow of the liquid sample within the second flow channel whereby a second analyte of the liquid sample is distributed within the second flow channel as a second monolayer, and the first analyte having a higher population density within the liquid sample compared to the second analyte as taught by Scrivens because Scrivens teaches an apparatus for analyzing blood (Scrivens; Abstract) that includes a substrate (Scrivens; fig. 1. 4) and a second flow channel of a second size disposed within the planar substrate and extending between the top surface and the bottom surface, the second size being larger than the first size (Scrivens; Col. 4 lines 33-35 “two channels having different sizes”. Channel 7 is sized to allow only particles smaller… “); the first flow channel configured to receive a liquid sample and allow a first flow of the liquid sample within the first flow channel whereby a first analyte of the liquid sample is distributed within the first flow channel as a first monolayer; the second flow channel configured to receive the liquid sample and allow a second flow of the liquid sample within the second flow channel (Scrivens; Col. 4 lines 34-42) whereby a second analyte of the liquid sample is distributed within the second flow channel as a second monolayer (Scrivens; Col. 3 lines 66-67 to Col. 4 lines 1-3), and the first analyte having a higher population density within the liquid sample compared to the second analyte (Scrivens; Col. 4 lines 33-37, channel 7 allows particles to pass (which have a population density) while channel 8 allows liquid to pass (which would have no particle density)).
The modification allows the channels can be sized appropriately to exclude any desired cell or particle sizes, the additional channels of a size different from those shown could be placed to control the ratio of more than one species of cell or particle (Scrivens; Col. 4 lines 37-43).
Regarding claim 2, modified Wilding teaches the assay device of claim 1 (see above), further comprising: a first inlet fluidly coupled to the first flow channel; a first vent fluidly coupled to the first flow channel and configured to facilitate the first flow of the liquid sample through the first flow channel; a second inlet fluidly coupled to the second flow channel; and a second vent fluidly coupled to the second flow channel and configured to facilitate the second flow of the liquid sample through the second flow channel (Wilding; fig. 14. 22A-c and 140 and [0080]).
Regarding claim 3, modified Wilding teaches the assay device of claim 2 (see above), wherein each of the first inlet and the second inlet is disposed in the top surface (Wilding; fig. 17B. 16).
Regarding claim 4, modified Wilding teaches the assay device of claim 1 (see above), wherein the planar substrate is formed by a single material (Wilding; fig. 17A. 14 and [0066] “silicon substrate 14”).
Regarding claim 5, modified Wilding teaches the assay device of claim 1 (see above), wherein the bottom surface of the planar substrate is formed by a first material layer which defines bottom surfaces and sidewall surfaces of the first flow channel and the second flow channel (Wilding; [0011] “silicon”, “flow channels and detection regions”), and the top surface of the planar substrate is formed by a second material layer defining upper surfaces of the first flow channel and the second flow channel (Wilding; [0011] “transparent glass cover”).
Regarding claim 6, modified Wilding teaches the assay device of claim 5 (see above), wherein the first material layer and the second material layer are composed of different materials or composed of a same material (Wilding; [0011]).
Regarding claim 7, modified Wilding teaches the assay device of claim 1 (see above), wherein the bottom surface of the planar substrate is formed by a first material layer which defines bottom surfaces of the first flow channel and the second flow channel (Wilding; [0011] “silicon substrate”), the top surface of the planar substrate is formed by a second material layer defining upper surfaces of the first flow channel and the second flow channel (Wilding; [0011] “glass cover”), and a third material layer interposed between the first material layer and the second material layer defining sidewall surfaces of the first flow channel and the second flow channel (Wilding; other materials can be used such as “polymeric materials”).
Regarding claim 8, modified Wilding teaches the assay device of claim 7 (see above), wherein the first, second and third material layers are composed of different materials or composed of a same material (Wilding; [0011] “polymeric materials”).
Regarding claim 9, modified Wilding teaches the assay device of claim 7 (see above), wherein the first material layer and the second material layer are composed of a first material (Wilding; [0011] ‘the flow system and the flow channels are fabricated from polymeric materials”), and the third material layer is composed of a second material (Wilding; [0011] “glass cover”).
Regarding claim 10, modified Wilding teaches the assay device of claim 1 (see above), wherein an upper surface of the planar substrate disposed over at least one of the first flow channel or the second flow channel is transparent or semi-transparent (Wilding; [0014] “transparent section of the substrate”, and [0053] “translucent window”).
Regarding claim 11, modified Wilding teaches the assay device of claim 1 (see above), wherein the bottom surface of the planar substrate is transparent or semi-transparent (Wilding; [0014] “transparent section of the substrate”).
Regarding claim 12, modified Wilding teaches the assay device of claim 1 (see above), wherein the liquid sample is a bodily fluid (Wilding; [0012] “biological fluid such as blood”).
Regarding claim 13, modified Wilding teaches the assay device of claim 1 (see above), wherein the liquid sample is selected from the group consisting of amniotic fluid, aqueous humour, vitreous humour, blood, whole blood, fractionated blood, 50plasma, serum, breast milk, cerebrospinal fluid (CSF), cerumen (earwax), chyle, chime, endolymph, perilymph, feces, breath, gastric acid, gastric juice, lymph, mucus (including nasal drainage and phlegm), pericardial fluid, peritoneal fluid, pleural fluid, pus, rheum, saliva, exhaled breath condensates, sebum, semen, sputum, sweat, synovial fluid, tears, vomit, prostatic fluid, nipple aspirate fluid, lachrymal fluid, perspiration, cheek swabs, cell lysate, gastrointestinal fluid, biopsy tissue and urine (Wilding; [0012] “urine”).
Regarding claim 14, modified Wilding teaches the assay device of claim 1 (see above), wherein the liquid sample is whole blood (Wilding; [0012] “blood”).
Regarding claim 15, modified Wilding teaches the assay device of claim 14 (see above) wherein the first flow channel is configured to generate a substantially uniform distribution of red blood cells within an imaging area of the first flow channel, and the second flow channel is configured to generate a substantially uniform distribution of at least one of white blood cells or platelets within an imaging area of the second flow channel.
Modified Wilding teaches a first and second flow channel (see claim 1 above), and an imaging area (Wilding; [0052] “detection region with translucent window”). What the first and second flow channels are used for is a matter of intended use.
Claims 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Takayama (US 20050229696 A1; hereinafter “Takayama”) in view of Scrivens (US 6819408 B1; hereinafter “Scrivens”).
Regarding claim 16, Takayama teaches a roll of multiple assay devices (Takayama; fig. 27. 1G), each assay device in the roll comprising:
a planar substrate (Takayama; fig. 2a. 9) having a top surface (Takayama; fig. 2a. 2) and a bottom surface (Takayama; fig. 2a. 4); a first flow channel of a first size disposed within the planar substrate and extending between the top surface and the bottom surface (Takayama; fig. 2b. 2, 5, 9).
Takayama fails to teach the assay device roll comprises a second flow channel of a second size disposed within the planar substrate and extending between the top surface and the bottom surface, the second size being larger than the first size; and the first flow channel configured to receive a liquid sample and allow a first flow of the liquid sample within the first flow channel whereby a first analyte of the liquid sample is distributed within the first flow channel as a first monolayer; the second flow channel configured to receive the liquid sample and allow a second flow of the liquid sample within the second flow channel whereby a second analyte of the liquid sample is distributed within the second flow channel as a second monolayer, and the first analyte having a higher population density within the liquid sample compared to the second analyte.
However, Scrivens teaches the analogous art of an apparatus for analyzing blood (Scrivens; Abstract) that includes a substrate (Scrivens; fig. 1. 4) and a second flow channel of a second size disposed within the planar substrate and extending between the top surface and the bottom surface, the second size being larger than the first size (Scrivens; Col. 4 lines 33-35 “two channels having different sizes”. Channel 7 is sized to allow only particles smaller… “); the first flow channel configured to receive a liquid sample and allow a first flow of the liquid sample within the first flow channel whereby a first analyte of the liquid sample is distributed within the first flow channel as a first monolayer; the second flow channel configured to receive the liquid sample and allow a second flow of the liquid sample within the second flow channel (Scrivens; Col. 4 lines 34-42) whereby a second analyte of the liquid sample is distributed within the second flow channel as a second monolayer (Scrivens; Col. 3 lines 66-67 to Col. 4 lines 1-3), and the first analyte having a higher population density within the liquid sample compared to the second analyte (Scrivens; Col. 4 lines 33-37, channel 7 allows particles to pass (which have a population density) while channel 8 allows liquid to pass (which would have no particle density)).
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Takayama’s planar substrate to include a second flow channel of a second size disposed within the planar substrate and extending between the top surface and the bottom surface, the second size being larger than the first size; and the first flow channel configured to receive a liquid sample and allow a first flow of the liquid sample within the first flow channel whereby a first analyte of the liquid sample is distributed within the first flow channel as a first monolayer; the second flow channel configured to receive the liquid sample and allow a second flow of the liquid sample within the second flow channel whereby a second analyte of the liquid sample is distributed within the second flow channel as a second monolayer, and the first analyte having a higher population density within the liquid sample compared to the second analyte as taught by (Scrivens because Scrivens teaches an apparatus for analyzing blood (Scrivens; Abstract) that includes a substrate (Scrivens; fig. 1. 4) and a second flow channel of a second size disposed within the planar substrate and extending between the top surface and the bottom surface, the second size being larger than the first size (Scrivens; Col. 4 lines 33-35 “two channels having different sizes”. Channel 7 is sized to allow only particles smaller… “); the first flow channel configured to receive a liquid sample and allow a first flow of the liquid sample within the first flow channel whereby a first analyte of the liquid sample is distributed within the first flow channel as a first monolayer; the second flow channel configured to receive the liquid sample and allow a second flow of the liquid sample within the second flow channel (Scrivens; Col. 4 lines 34-42) whereby a second analyte of the liquid sample is distributed within the second flow channel as a second monolayer (Scrivens; Col. 3 lines 66-67 to Col. 4 lines 1-3), and the first analyte having a higher population density within the liquid sample compared to the second analyte (Scrivens; Col. 4 lines 33-37, channel 7 allows particles to pass (which have a population density) while channel 8 allows liquid to pass (which would have no particle density)).
The modification allows the channels can be sized appropriately to exclude any desired cell or particle sizes, the additional channels of a size different from those shown could be placed to control the ratio of more than one species of cell or particle (Scrivens; Col. 4 lines 37-43).
Regarding claim 17, modified Takayama teaches the roll of claim 16 (see above), wherein the liquid sample is whole blood (Takayama; [0679] “blood”), and wherein the first flow channel is configured to generate a substantially uniform distribution of red blood cells within an imaging area of the first flow channel, and the second flow channel is configured to generate a substantially uniform distribution of at least one of white blood cells or platelets within an imaging area of the second flow channel.
Modified Takayama teaches a first and second flow channel (see claim 16 above), to a detection area that includes a camera (imaging area) (Takayama; [0261]), wherein the substance (blood) is within the imaging area (Takayama; [0423]).
What the flow channels are configured to do is a matter of intended use.
Regarding claim 18, modified Takayama teaches the roll of claim 16 (see above), wherein the multiple assay devices are organized into a plurality of detachable cards (Takayama; fig. 13. 10, and [0358] “disposable chips 301, and fig. 28, 300, 301, [0358] “unit base 300 supports chip 301).
Regarding claim 19, modified Takayama teaches the roll of claim 18 (see above), wherein each detachable card of the plurality of detachable cards comprises three assay devices.
Takayama teaches assay devices organized into a plurality of cards (see claim 18 above) that includes 2 assay devices (Takayama; fig. 28. 300, 301).
Takayama does not teach the plurality of detachable cards comprises three assay devices.
It would have been obvious to include 3 assay devices on each detachable card to perform various operations simultaneously (Takayama; [0355]).
Regarding claim 20, modified Takayama teaches the roll of claim 16 (see above), formed by multiple layers (Takayama; fig. 11. 2, 8, 9, 4) comprising at least a pressure sensitive adhesive release liner layer, a pressure sensitive adhesive layer, a polycarbonate film layer, or a polycarbonate film release layer (Takayama; [0187], [0202] “organic film that can bind with the substrate”).
Conclusion
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/A.R./Examiner, Art Unit 1798
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798
