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 1/23/24 is being considered by the examiner.
Claim Status
Claims 1-20 are pending and are examined.
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.
Claims 1, 4, 5, 11, 13, 14, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Kuniavsky (US Pub 2018/0184976), in view of Beck (US Pub 2021/0255110).
Regarding Claim 1, Kuniavsky teaches a fluid safety device comprising:
a rectangular prism (Fig. 6C Smart container 610 can include a physical enclosure shaped like a rectangular prism having an opening 612.)
wherein the distal end comprises a reaction pad separated into at least a first section, a second section, a third section, and a fourth section, wherein each section comprises a detector, wherein each detector comprises a sensor and a color-changing indicator, and wherein each sensor is capable of detecting a contaminant in a test sample and activating the color-changing indicator ([0071] FIG. 6C illustrates an exemplary smart container, in accordance with an embodiment of the present invention. A number of sensors (e.g., sensor 614) can be printed onto the inner bottom surface of container 610. When a sample containing biological or chemical substances is dropped inside container 610 from opening 612, the sensors can detect the biological or chemical substances. In some embodiments, the sensor data can be processed by a processor attached to smart container 610, and processing results can be displayed by a display attached to smart container 610. Other than the rectangular prism, smart container 610 can have different shapes.).
Kuniavsky is silent to a proximal end, a body, and a distal end; and a standard color card, wherein the proximal end comprises a hand grip.
Beck teaches in the related art of detecting a sample. [0076] In certain embodiments, the test strip 100 of the invention comprises an extension 106, e.g. arm, designed to be held by a user when using the strip. [0046] (b) optionally, a color chart/a reference color card. [0080] The reaction with the reagent(s) in the pad(s) within the testing regions 112 results with a color differentiation that can be observed and compared to a color chart for analysis. This can be done manually or automatically using a computer-based program.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added a proximal end, a body, and a distal end; and a standard color card, wherein the proximal end comprises a hand grip, as taught by Beck, to the device of Kuniavsky, to allow for a hand held detection device and a color reference card for manual analysis of results [0080].
Regarding Claim 4, modified Kuniavsky teaches the fluid safety device of claim 1, wherein each section is separated by a channel comprised of a solid substrate, wherein the channel further comprises at least two axes, wherein a first axis is arranged perpendicularly to a base of the reaction pad and a second axis is arranged parallel to the base of the reaction pad to cross over the first axis, and wherein each section is arranged so that at least one side of each section touches at least side of another section ([0078] In certain embodiments, said transporting routs 110 are grooves, channels—open or closed, fibers, conductive material, or any other material or structure that can week and transport liquid from the reservoir 108 to said testing regions 112. The dimensions, i.e., the diameter, of the transporting routs 110 may vary depending on the desired flow rate.).
Regarding Claim 5, modified Kuniavsky teaches the fluid safety device of claim 1, wherein the reaction pad further comprises a channel, wherein the channel crosses the entire length of the reaction pad and moves upwardly from a bottom portion of the first section to an upper portion of the second, third, or fourth sections, wherein the channel has an opening that permit fluid communication between the channel and one or more of the sections, wherein the test sample is added to the first section in an amount sufficient to cover the reaction pad in the first section up to a point where the opening is present, and wherein the test sample flows through the opening in the channel into another section in sequence ([0078] In certain embodiments, said transporting routs 110 are grooves, channels—open or closed, fibers, conductive material, or any other material or structure that can week and transport liquid from the reservoir 108 to said testing regions 112. The dimensions, i.e., the diameter, of the transporting routs 110 may vary depending on the desired flow rate.).
Regarding Claim 11, modified Kuniavsky teaches the fluid safety device of claim 1, wherein the sensor of at least the first, second, third, or fourth section is comprised of a cellulosic substrate infused with a colorimetric solution ([0011] In a variation on this embodiment, the absorbent material includes one or more of: paper, cellulose fiber. [0095] FIG. 10A illustrates an exemplary absorber embedded with chromatographic indicators, in accordance with an embodiment of the present invention.).
Regarding Claim 13, modified Kuniavsky teaches the fluid safety device of claim 1, wherein the sensor of at least the first, second, third, or fourth section is a blotting paper comprising a triglyceride detecting mixture, and wherein the triglyceride detecting mixture comprises: an HCl buffer; an enzyme; a dye; and a diaphorase solution (([0161] Preparation 2: [0162] 1) preparing a solution from water (405 ml), TritonX100 (1 g), CHAPS (1 g), poly methyl vinyl ether (21 g), calcium chloride (0.2 g), Na-ATP (32 g), sucrose (25 g) and HPC (hydroxypropyl cellulose) foundation, and adjusting the pH to 5.7; [0163] 2) mixing in the prepared solution: lipoprotein lipase (625 U), G3P oxidase (glycerol-3-phosphate oxidase) (500 U), glycerol kinase (359 U) and horseradish peroxidase (100 U), with TMBZ (6.25 g) and 4-AAP (20 g) and EDTA (5 g)).).
Regarding Claim 14, modified Kuniavsky teaches the fluid safety device of claim 1, wherein the sensor of at least the first, second, third, or fourth section is a blotting paper applied with a triglyceride detecting mixture, and wherein the triglyceride detecting mixture comprises: a solution comprising water, a nonionic surfactant, a detergent, a poly methyl vinyl ether, calcium chloride, Na-ATP, sucrose, and HPC (hydroxypropyl cellulose); an enzyme; a chromogenic substrate; a horseradish peroxidase mixture; and EDTA ([0161] Preparation 2: [0162] 1) preparing a solution from water (405 ml), TritonX100 (1 g), CHAPS (1 g), poly methyl vinyl ether (21 g), calcium chloride (0.2 g), Na-ATP (32 g), sucrose (25 g) and HPC (hydroxypropyl cellulose) foundation, and adjusting the pH to 5.7; [0163] 2) mixing in the prepared solution: lipoprotein lipase (625 U), G3P oxidase (glycerol-3-phosphate oxidase) (500 U), glycerol kinase (359 U) and horseradish peroxidase (100 U), with TMBZ (6.25 g) and 4-AAP (20 g) and EDTA (5 g)).
Regarding Claim 17, modified Kuniavsky teaches the fluid safety device of claim 1, wherein the standard color card has a chart of colors which correlate to the presence of the contaminant in a test sample, and wherein a user can determine the presence of the contaminant in the test sample based on a color change of the reaction pad when contacted with a test sample and the standard color card ([0046] (b) optionally, a color chart/a reference color card. [0080] The reaction with the reagent(s) in the pad(s) within the testing regions 112 results with a color differentiation that can be observed and compared to a color chart for analysis. This can be done manually or automatically using a computer-based program.).
Claims 2, 9, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Kuniavsky (US Pub 2018/0184976) in view of Beck (US Pub 2021/0255110) as applied to claim 1 above, and further in view of Fish (US Pub 2015/0293069).
Regarding Claim 2, modified Kuniavsky teaches the fluid safety device of claim 1.
Modified Kuniavsky is silent to the sensor of at least one of the first, second, third, or fourth sections comprises a sulfonephthalein dye, wherein the sulfonephthalein dye is selected from the group consisting of bromophenol blue, bromocresol green, chlorophenol red, bromothymol blue, o-cresol red, and bromocresol purple, and
Fish teaches in the related art of sensors. [0020] The test strip includes a handle portion, an alkalizing pad, and an indicating pad. Preferably, the alkalizing pad is a soda lime pad used to adjust the pH of a confined test sample. The indicating pad is configured to provide the color change in a high pH environment. The indicating pad comprises a hydrophobic member with a coating. [0022] An indicator is configured to responsively and discriminatingly change color in the presence of ammonia. Depending upon the concentration of ammonia, gradients of color intensity can be achieved to indicate concentrations on a parts per million (ppm) level of ammonia. Suitable indicators include bromophenol blue, bromocresol green, sodium salt, and bromocresol purple as pH indicators.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added bromophenol blue, bromocresol green, or bromocresol purple, as taught by Fish, to the at least one sensor section in the device of modified Kuniavsky, to detect concentrations of ammonia.
Regarding Claim 9, modified Kuniavsky teaches the fluid safety device of claim 1, wherein the sensor of at least one of the first, second, third, or fourth sections comprises a soda lime pad, a hydrophobic membrane, and a pH indicator.
Fish teaches in the related art of sensors. [0020] The test strip includes a handle portion, an alkalizing pad, and an indicating pad. Preferably, the alkalizing pad is a soda lime pad used to adjust the pH of a confined test sample. The indicating pad is configured to provide the color change in a high pH environment. The indicating pad comprises a hydrophobic member with a coating. [0022] An indicator is configured to responsively and discriminatingly change color in the presence of ammonia. Depending upon the concentration of ammonia, gradients of color intensity can be achieved to indicate concentrations on a parts per million (ppm) level of ammonia. Suitable indicators include bromophenol blue, bromocresol green, sodium salt, and bromocresol purple as pH indicators.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added a soda lime pad, a hydrophobic membrane, and a pH indicator, as taught by Fish, to the sensor sections in the device of modified Kuniavsky, to allow for detecting a high pH environment and ammonia concentration.
Regarding Claim 10, modified Kuniavsky teaches the fluid safety device of claim 9, wherein the hydrophobic membrane is selected from the group consisting of a polymeric microfiltration membrane, a polyvinylidene difluoride (PVDF) membrane, a positively charged nylon transfer membrane, a polytetrafluoroethylene-supported (PTFE) membrane on polypropylene or polyester, a microporous PTFE membrane, and a polypropylene membrane ([0024] PVDF (polyvinylidene fluoride) membranes).
Claims 3, 7, 8, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Kuniavsky (US Pub 2018/0184976), in view of Beck (US Pub 2021/0255110), and further in view of Lange (US Patent 3,802,842).
Regarding Claim 3, Kuniavsky teaches the fluid safety device of claim 1.
Kuniavsky is silent of at least one of the first, second, third, or fourth sections is potassium-iodide starch paper.
Lange teaches reagent papers have been in use for a long time, pH indicator papers being the most widely used but other reagent papers are also employed: for example, curcuma paper is used for the detection of acids, potassium iodide-starch paper for the detection of oxidation agents. Col. 1, lines 6-12.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added to the sensor in the device of modified Kuniavsky of at least one of the first, second, third, or fourth sections is potassium-iodide starch paper, as taught by Lange, to allow for potassium-iodide starch paper, as taught by Lange, to allow for detecting strong oxidizing agents.
Regarding Claim 7, modified Kuniavsky teaches the fluid safety device of claim 1.
Modified Kuniavsky is silent to each section comprises a solid base with at least a first layer and a second layer stacked on the solid base, and wherein the first layer comprises the sensor and the second layer comprises the color-changing indicator.
Lange teaches in claim 1, Test strip for the detection of components in liquids comprising holding means and at least one indicator layer containing detection reagents, wherein one surface of the indicator layer lies on a portion of said holding means and the remainder of said indicator layer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have re-arranged the device, as taught by modified Kuniavsky, to be a solid base with at least a first layer and a second layer stacked on the solid base, and wherein the first layer comprises the sensor and the second layer comprises the color-changing indicator, as taught by Lange, to allow for the device to fit into a a standard optical instrument for analysis.
Regarding Claim 8, modified Kuniavsky teaches the fluid safety device of claim 1.
Modified Kuniavsky is silent to the detector of at least the first, second, third, or fourth section comprises a nanoporous polyacrylonitrile mat as the sensor, and wherein the nanoporous polyacrylonitrile mat is impregnated with a colorimetric substance as the color-changing indicator.
Lange teaches it is preferred to use synthetic resin fabrics of monofile or spun filaments which can consist of cellulose materials, for example cotton, cellulose, flax or sisal, proteinaceous materials, for example, wools or silk, or synthetic resins, for example polyamides, polyesters, polyethylene, polypropylene, polyvinyl chloride or polyacrylonitrile, or of a large variety of co-polymers. In some cases, it is also possible to use fine metallic fabrics. There are obtained mixed colors with the colors of the indicator layer, which can sometimes increase the contrast. In addition, it is also possible to impregnate the meshwork with reagents which only penetrate into the indicator layer upon wetting. Col. 4, lines 13-28..
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the colorimetric substance in the device, as taught by modified Kuniavsky, to nanoporous polyacrylonitrile, as taught by Lange, for better absorption of the colorimetric substance.
Regarding Claim 18, modified Kuniavsky teaches the fluid safety device of claim 1.
Modified Kuniavsky is silent to the distal end further comprises a reaction pad well having a bottom surface and four sides that form an enclosure capable of holding the test sample and having an open top, wherein the four sides are the same height as the detectors in each section, wherein the bottom surface of the reaction pad well is integrated into an outer surface of the distal end of the fluid safety device such that the reaction pad well retains the test sample when positioned horizontally.
Lange teaches a meshwork 1, which is of larger dimensions than the indicator layer 4, covers the surface area 6 of the indicator layer 4 which is not facing the holder, peripheral zones 8 of the meshwork 1 projecting beyond the indicator layer 4 and being firmly connected, by means of the adhesive layer 3, with the holder 2. The meshwork 1 preferably lies directly upon the indicator layer 4 so that the intermediate space between the meshwork 1 and the indicator layer 4 is kept as small as possible. See Col. 3, lines 28-34.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added a reaction pad well having a bottom surface and four sides that form an enclosure capable of holding the test sample and having an open top, wherein the four sides are the same height as the detectors in each section, wherein the bottom surface of the reaction pad well is integrated into an outer surface of the distal end of the fluid safety device such that the reaction pad well retains the test sample when positioned horizontally, as taught by Lange, in the device of modified Kuniavsky, to allow for a standard sample processing and analysis configuration.
Claims 6 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Kuniavsky (US Pub 2018/0184976), in view of Beck (US Pub 2021/0255110), and further in view of Upreti (US Pub 2010/0136607).
Regarding Claims 6 and 12, modified Kuniavsky teaches the fluid safety device of claim 1, wherein each section is an absorptive well comprising a sponge material, and wherein the sensor and the color-changing indicator are combined with the sponge material, and the colorimetric solution comprises a colorimetric substance and an alcohol, and wherein the colorimetric substance is selected from the group consisting of phenolphthalein, p-xylenolphthalein, and thymolphthalein.
Upreti teaches in the related art of a sensor device. [0073] In one embodiment the at least one acid-base indicator is selected from the group comprising Alizarin yellow R, Alizarin yellow GG, Alizarin CI58000, Thiazole yellow G, thymophthalein, phenolphthalein, phenolthymolphthalein, brilliant orange, Tropaeolin 000, Tropaeolin 00, Tropaeolin 0, and mixtures thereof. [0299] In one embodiment the carrier matrix is selected from the group comprising filter paper, chromatographic paper, porous membranes, sponge material, paper, cellulose, wood, woven or non-woven fabric, polymeric film, glass fibre, silica gel, alumina, and the like.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added thymophthalein, phenolphthalein, or phenolthymolphthalein and to have selected sponge material as a carrier matrix, as taught by Upreti, in the device, as taught by modified Kuniavsky to allow for an acid-base indicator and a common carrier material for strong absorption, as taught by Upreti, in [0073] and [0299].
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Kuniavsky (US Pub 2018/0184976), in view of Beck (US Pub 2021/0255110), and further in view of Wang (US Pub 2008/0277606).
Regarding Claim 15, modified Kuniavsky teaches the fluid safety device of claim 1.
Modified Kuniavsky is silent to the sensor of at least the first, second, third, or fourth section is a filter paper applied with a triglyceride detecting mixture, wherein the triglyceride detecting mixture comprises a dye solution, and wherein the dye solution comprises a lysochrome selected from the group consisting of an amino acid staining azo dye, an aromatic compound containing an azo group, and a diazo dye.
Wang teaches in the related art of biological analysis of a sample. [0030] For the purposes of this invention, the dye is a low fluorescent, photostable compound which allows transmission of energy at a required wavelength range and prevents transmission of energy at all other wavelengths. Preferably, the dye is a lysochrome dye (i.e. a fat soluble dye). Examples of such lysochrome dyes include azo dyes which have undergone molecular rearrangement and are no longer able to ionise. It will be appreciated that selection of the dye will determine the wavelength range at which energy can be transmitted and the width of the wavelength range.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added an azo dye, as taught by Wang, to the filter paper in the device of modified Kuniavsky, allowing the dye to be used to tune the composition to allow transmission at the required wavelength range with the required or desired degree of selectivity and sensitivity, as taught by Wang, in [0030].
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Kuniavsky (US Pub 2018/0184976), in view of Beck (US Pub 2021/0255110), and further in view of Roessler (US Pub 2011/0195469).
Regarding Claim 16, modified Kuniavsky teaches the fluid safety device of claim 1.
Modified Kuniavsky is silent to the sensor of at least the first, second, third, or fourth section is comprised of an octanoyl-CoA substrate.
Roessler teaches in the related art of a biological sample. [0093] Likewise, if octanol is the desired fatty alcohol product, it is preferable to introduce a gene that encodes an acyl-CoA reductase that can preferentially use octanoyl-CoA as a substrate.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added octanoyl-CoA substrate, as taught by Roessler, to the sensor sections, as taught by modified Kuniavsky, allowing for specificity that closely matches the range of fatty alcohols (or other desired fatty acid product) to be produced in the host organism, as taught by Roessler, in [0093].
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Kuniavsky (US Pub 2018/0184976), in view of Beck (US Pub 2021/0255110), Lange (US Patent 3,802,842), as applied to claim 18, and further in view of Clouse (US Pub 2021/0386198).
Regarding Claim 19, modified Kuniavsky teaches the device of claim 18.
Modified Kuniavsky is silent to the reaction pad well further comprises a retractable cover that seals the enclosure.
Clouse teaches in the related art of sensors. [0115] FIG. 8 illustrates an example retractable cover 153 for configured to cover an aperture to selectively block the sensor or camera in the sensor cavity 150. FIG. 9 illustrates an example cover switch 154 for the retractable cover 153. FIG. 10 illustrates a top view for the cover switch 154 for the retractable cover 153.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added a retractable cover, as taught by Clouse, to the reaction pad well in the device, as taught by modified Kuniavsky, allow for blocking the reaction pad well from external light.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Kuniavsky (US Pub 2018/0184976), in view of Beck (US Pub 2021/0255110), Lange (US Patent 3,802,842), Clouse (US Pub 2021/0386198), as applied to claim 19, and further in view of Aramayo (US Pub 2019/0031259).
Regarding Claim 20, modified Kuniavsky teaches the fluid safety device of claim 19.
Modified Kuniavsky is silent to the proximal end further comprises a retractable bipodal support extension wherein the bipodal support extension has a height such that the enclosure is level with a flat surface on which the fluid safety device is disposed, and wherein the distal end of the fluid safety device is oriented upwards at an angle of 10–30° from the axis of the body.
Aramayo teaches in the related art of a housing with a device. A robotic apparatus moveable between a bipod mode and a tripod mode includes a housing, a first leg and a second leg extending from the housing, and a retractable third leg positioned between the first leg and the second leg. The third leg is configured to extend from the housing in the tripod mode and retract at least partially into the housing in the bipod mode. The transmission system is configured to move the robotic apparatus between the bipod mode. See Abstract. A retractable third leg positioned between the first leg and the second leg, wherein the third leg is configured to extend from the housing in the tripod mode and retract at least partially into the housing in the bipod mode. See Claim 1.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added to the proximal end a retractable bipodal support extension, as taught by Aramayo, with a height such that the enclosure is level with a flat surface on which the fluid safety device is disposed, and the distal end of the fluid safety device is oriented upwards at an angle of 10–30° from the axis of the body, in the device of modified Kuniavsky, to allow for moveable parts of the device for sample access and removal.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACQUELINE BRAZIN whose telephone number is (571)270-1457. The examiner can normally be reached M-F 8-5.
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/JB/
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798
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