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 .
Response to Arguments
Claims 47, 51, 59, 63, and 67-82 are pending
Applicant’s arguments with respect to amended claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claims 59, 63, 73, 47, 51, 68, 77, and 80 are rejected under 35 U.S.C. 103 as being unpatentable over Tsai et al., US 20130267032 A1 (hereinafter “Tsai”), in view of Front et al., WO 2013179279 A2 (hereinafter “Front”).
Regarding claim 59, Tsai discloses a system, comprising:
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a camera (fig. 2, imaging device 208) configured to capture a plurality of digital color images of a reagent dipstick (fig. 2, test strip 200 including reaction area 202) over a time period, the reagent dipstick including a reagent test pad exposed to a biological sample, wherein a color of the first reagent test pad changes over the time period in response to a concentration of an analyte in the biological sample (paragraph 35, “Specimen test strip 200 includes a reaction area 202 to receive a specimen sample. Reaction area 202 includes reagents to chemically react with the analyte in the specimen sample and produce one or more color parameters that are proportional to the value of a characteristic of the analyte in the specimen sample. In some embodiments, the one or more color parameters includes the color or both the color and the color intensity of reaction area 202. In one example, the color is the hue of reaction area 202 and the color intensity is the lightness of reaction area 202. The hue and the lightness are color components in the hue, saturation, and lightness (HSL) color space, which are determined from the red, green, and blue (RGB) values of pixels captured by a camera. For convenience, color and color intensity may be collectively referred to as color. The reagents may be analyte specific and may include one or more enzymes, one or more antibodies, and/or one or more dyes. For example, reagents for testing glucose in blood may include glucose oxidase, heteropoly acid, and tetradecyl ammonium nitrate”, fig. 10, block 1002 paragraphs 62-64, capturing at least two images of test strip in a time window having a time difference, “In block 1002, computing device 210 captures at least two images 212 of specimen test strip 200 in time window 908. Images 212 may be images taken in a rapid succession (e.g., in a continuous or rapid-fire mode) or frames from a video. For example, a first image 212 is captured at a first time and a second image 212 is captured at a second time. The time difference between the first and the second time is calculated as a time window (e.g., time window 908 shown in FIG. 9). Each image 212 includes reaction area 202 on specimen test strip 200”), and wherein each of the images includes multiple reference colors (paragraph 36, “In one example, specimen test strip 200 includes a color calibration area 204 that is part of specimen test strip 200. In one example, color calibration area 204 is used to determine the color of reaction area 202 under different lighting conditions. In such an example, color calibration area 204 may be a color chart having an arrangement of known color samples. In another example, color calibration area 204 is used to correct the detected color of reaction area 202 to remove the effects of the light condition”); and
a processor, configured to:
(paragraph 39, “Using an imaging device 208 on computing device 210, a user captures an image 212 of reaction area 202 and at least one of color calibration area 204 and temperature calibration area 206. Imaging device 208 may be a camera, a scanner, or another similar device, and computing device 210 may be a smart phone, a tablet computer, a laptop computer, a desktop computer, or another similar device. Computing device 210 runs a diagnostic application that analyzes image 212 to determine the analyte characteristic from the color of reaction zone 202”, it is required a computing device including a processor)
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determine a captured color of the reagent test pad from the captured plurality of digital color images of the reagent dipstick (fig. 10, block 1004, 1006, “computing device 210 determines a change in color intensity of reaction area 202 from images 212. Block 1006 may be followed by block 1008”); and
compare the captured color of the reagent test pad to the reference colors (paragraph 40, “In one example, the diagnostic application determines the color of reaction area 202 using color calibration area 204 in image 212. When color calibration area 204 is a color chart, the diagnostic application matches the color of the entire or part of reaction area 202 to one of the known color samples of color calibration area 204 to determine the color of reaction area 202. Alternatively the diagnostic application may manipulate image 212 until color chart 204 matches its known colors and then reads all or part of the color of reaction area 202. When color calibration area 204 is a gray card, the diagnostic application manipulates image 212 until gray card 204 in image 212 has the proper white balance and then reads the color of reaction area 202”) and
determine the concentration of the analyte in the biological sample based on the comparison (fig. 10, block 1008, paragraphs 62-67, “The rate of the change in a color parameter in reaction area 202 may depend on the analyte characteristic value. For each analyte characteristic value, the rate of the change in the color parameter may be plotted as a curve over time. FIG. 9 is a chart 900 illustrating three curves 902, 904, and 906 plotting the change in a color parameter (e.g., color intensity) over time for three analyte characteristic values (e.g., three glucose levels). Each curve has a different slope in a time window (e.g., time window 908) that is unique to the corresponding analyte characteristic value. Thus the difference between at least two values of the color parameter and the difference between when the two values are captured may be used to identify the corresponding analyte characteristic value”; “In block 1008, computing device 210 correlates the change in color intensity to an analyte characteristic value. Computing device 210 may use chart 900, or the mathematical representation of chart 900, to determine the analyte characteristic value. Specifically, computing device 210 moves time window 908 along curves 902, 904, and 906. When the intensity change of a curve in the time window matches the intensity change of reaction area 202, then reaction area 202 has the analyte characteristic value of that curve”, paragraph 98, “The test strips, systems and methods disclosed herein may be used to test for the presence and/or concentration of certain analytes, such as but not limited to glucose, cholesterol, uric acid, troponin I, ketone, protein, nitrite and leukocyte. Various fluids may be tested, such as but not limited to blood, interstitial fluid, urine, saliva, and other bodily fluids”).
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Tsai does not disclose in particular:
obtain, over the Internet, information regarding the reference colors;
compare the captured color of the reagent test pad to the reference colors with a correction based on the obtained information.
The concept of obtaining from Internet calibration information via reference such as a code or barcode, however, is known in the art, such as disclosed by Front, which discloses method for analyzing biological sample in which calibration data is to be downloaded from Internet via a barcode (page 22, lines 6-28: “When the analysis is executed by the data processor, the analysis typically, but not necessarily, comprises piecewise histogram normalization of signal received from sample region 16 based on signal received from reference region 18. … The normalization can be according to calibration data that describes the relation between a concentration of substance 20 and the signal affected by the label(s) responsively to substance 20. … The calibration data can also be provided in the form of downloadable data, wherein the kit packaging includes device 10 (optionally and preferably encapsulated by encapsulation 22) and a code or a barcode or any other type of permission for downloading the calibration data from the internet”).
Both Tsai and Front disclose system and method for analyzing biological sample, with reference/calibration data provided for analysis, Front further disclose calibration data may be downloaded from the Internet via barcode. It would have been obvious to one or ordinary skill in the art at the time of filing to incorporate the concept of providing barcode to download additional calibration from the Internet, such as disclosed by Front, into the reference chart of Tsai, such that the color analysis system of Tsai may obtain additional reference information, to constitute: obtain, over the Internet, information regarding the reference colors; compare the captured color of the reagent test pad to the reference colors with a correction based on the obtained information, such is incorporation of known concept into known device to yield predictable result, the result would have been predictable and would provide benefit such as providing most up-to-date reference information and expanded reference information storage over Internet.
Regarding claim 63, Tsai in view of Front discloses the system of claim 59, further comprising the reagent dipstick, wherein each of the images includes the reference colors by virtue of the reagent dipstick including a color reference bar (see Tsai, fig. 2, paragraphs 35-36, each image captured by the system include image of test strip / reagent dipstick with reference color area 204 having thereon reference colors).
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Regarding claim 73, Tsai in view of Front discloses the system according to claim 47, wherein the processor is configured to obtain the information via a bar code located near the reference colors (see combination as made in rejection of claim 47, Front, page 22, line 20-28, “The calibration data can also be provided in the form of downloadable data, wherein the kit packaging includes device 10 (optionally and preferably encapsulated by encapsulation 22) and a code or a barcode or any other type of permission for downloading the calibration data from the internet”.
Regarding claim 47, this is a method claim counterpart of device claim 59, both reciting substantially similar subject matter. Accordingly, claim 47 is rejected for the same reasons as claim 59.
Regarding claim 51, this is a method claim counterpart of device claim 63, both reciting substantially similar subject matter. Accordingly, claim 51 is rejected for the same reasons as claim 63.
Regarding claim 68, this is a method claim counterpart of device claim 73, both reciting substantially similar subject matter. Accordingly, claim 68 is rejected for the same reasons as claim 73.
Regarding claim 77, this is a Beauregard claim (i.e., "non-transitory machine-readable medium") counterpart of system claim 59, both reciting substantially similar subject matter. Accordingly, claim 77 is rejected for the same reasons as claim 59.
Regarding claim 80, this is a Beauregard claim (i.e., "non-transitory machine-readable medium") counterpart of system claim 73, both reciting substantially similar subject matter. Accordingly, claim 80 is rejected for the same reasons as claim 73.
Claims 72, 67, and 79 are rejected under 35 U.S.C. 103 as being unpatentable over Tsai in view of Front, as applied in claims 59, 47, and 77 above, and in further view of Hamsici et al., US 20130308852 A1 (hereinafter “Hamsici”).
Regarding claim 72, Tsai in view of Front discloses the system according to claim 59.
Tsai in view of Front does not specifically require verbatim wherein the captured color is a final stable color of the reagent test pad.
However, it is well known in biological sample test that it is beneficial to wait until test process finish to obtain a final, stable test color, such as disclosed by Hamsici (paragraph 4, “in the use of color-based measuring devices, and other colorimetric systems, it may be important to accurately measure colors. For example, in a paper-based microfluidic device that is used to diagnose diseases, it may be important that the color of the final samples, and thus a concentration estimate of the samples be measured accurately”, see also reference cited but not relied upon: Purdie et al., US 20020160519 A1, paragraph 117, for color reaction, “when batching samples for assay, care must be taken to ensure that the final color is stable beyond the endpoint time”, Kritzman et al., US 20120003685 A1, paragraph 254, “An indicator reagent shows a color change … Observation of a visible stable color at the end of the reaction indicates that the ammonium concentration is greater than the pre-set threshold.”).
It would have been obvious to one of ordinary skill in the art at the time of filing to incorporate the concept of waiting until color reaction to stabilize and capture final stable color of test sample, such as disclosed by Hamsici, into the system of Tsai in view of Front, to constitute wherein the captured color is a final stable color of the reagent test pad, such is incorporation of a known concept into known device to yield predictable result, the result would have been predictable and would allow accurate and stable measurement of analyte concentration.
Regarding claim 67, this is a method claim counterpart of device claim 72, both reciting substantially similar subject matter. Accordingly, claim 67 is rejected for the same reasons as claim 72.
Regarding claim 79, this is a Beauregard claim (i.e., "non-transitory machine-readable medium") counterpart of system claim 72, both reciting substantially similar subject matter. Accordingly, claim 79 is rejected for the same reasons as claim 72.
Claims 74, 69, and 78 are rejected under 35 U.S.C. 103 as being unpatentable over Tsai in view of Front, as applied in claims 59, 47, and 77 above, and in further view of Agarwal et al., US 20130322750 A1 (hereinafter “Agarwal”)
Regarding claim 74, Tsai in view of Front discloses the system according to claim 59, further comprising a color chart that includes the reference colors (Tsai, fig. 2, reference color region 204).
Tsai in view of Front does not disclose in particular wherein each of the images includes the reference colors by virtue of the reagent dipstick being placed next to a color chart that includes the reference colors.
The difference between pending claimed feature and Tsai in view of Front is that Tsai discloses instead the reference color chart is integrated into reagent dipstick / test strip (Tsai, fig. 2, reference 204), while pending claim discloses a separate reference color chart placed next to reagent dipstick.
The concept of having separate reference color chart placed next to color to be identified and capturing reference color with identification target in same image however, is known in the art, such as disclosed by Agarwal, which disclose system and method for evaluation color of a sample (see abstract) by virtue of color sample being placed next to a color chart that includes the reference colors (paragraphs 16-18, fig. 1, calibration strip including reference colors placed next to color sample to be captured in a same image by camera 114, “the imaging booth 102 houses a sample positioning mechanism such as a sample tray or pedestal 112 designed to support a sample to be measured (e.g., a fabric swatch) and a color calibration strip (e.g., a strip including a plurality of color swatches of known spectral reflectance) and/or a gray card. In one embodiment, reference color data for the colors displayed on the calibration strip is pre-measured (e.g., using a spectrophotometer).”).
It would have been obvious to one of ordinary skill in the art at the time of filing to incorporate the concept of placing reference color chart next to color sample to be captured, such as disclosed by Agarwal, into the system of Tsai in view of Front, such that reference color chart of Tsai in view of Front is separate and disposed adjacent to reagent test strip, to constitute wherein each of the images includes the reference colors by virtue of the reagent dipstick being placed next to a color chart that includes the reference colors, such is replacement of a known technique (integrated reference color chart) with another known technique (separate reference color chart) to yield same predictable result, the predictable result of allowing color sample to be measured against a reference color would have been the same, and allow same reference chart to be used for multiple color samples.
Regarding claim 69, this is a method claim counterpart of device claim 74, both reciting substantially similar subject matter. Accordingly, claim 69 is rejected for the same reasons as claim 74.
Regarding claim 78, this is a Beauregard claim (i.e., "non-transitory machine-readable medium") counterpart of system claim 74, both reciting substantially similar subject matter. Accordingly, claim 78 is rejected for the same reasons as claim 74.
Claims 75, 76, 70, 71, 81 and 82 are rejected under 35 U.S.C. 103 as being unpatentable over Tsai in view of Front, as applied in claims 47, 59, and 77 above, and in further view of Baker et al, US 20070058859 A1 (hereinafter Baker), and Bhatti et al., US 20070071314 A1 (hereinafter “Bhatti”).
Regarding claims 75 and 76, Tsai in view of Front discloses the method according to claim 59.
Tsai in view of Front does not disclose specifically (from claim 75) wherein the processor is configured to compare the capture the captured color of the reagent test pad to the reference colors comprises: correcting the captured color based on the obtained information; and comparing the corrected captured color to the reference colors, and
(from claim 76) wherein the processor is configured to correct the captured color by: computing an inverse transformation matrix based on the obtained information, and correcting the captured color using the inverse transformation matrix.
In similar field of endeavor of comparing colors, Baker discloses a white balancing process and concept of analyzing color to convey true color of a subject, such that an image can be captured in a first lighting condition with a reference color, and, using the reference color and a control reference color set containing the same color as the reference color, image in first light condition may be transformed to corresponding colors under second lighting conditions using an inverse transform matrix that links the colors of first image under first lighting condition to corresponding colors under second lighting conditions.
In particular, see Baker paragraph 4, motivation: “ambient lighting conditions present when a image is captured can distort overall coloration of an image. For example, if a picture is taken indoors, the light radiated by lighting fixtures may be weighted in a particular range of color spectrum. For example, fluorescent lighting emits light with a slightly bluish tint. Thus, a picture taken in the presence of fluorescent lighting will be distorted by the ambient light and will depict the subject with more blue tones than may actually present”, paragraphs 24-26, process of capturing an image with a reference color, and “compares reference color 202 a with control color 203 a to determine how the colors of imaged reference color set 202 have been transformed due to the ambient lighting conditions and the image processing parameters of image capture device 201. Color correction component 204 then generates a color correction function (e.g., 210) which eliminates the discrepancy between reference color 202 a and control color 203 a”, “applicator 205 applies the color correction function 210 generated by color correction component 204 to an image (e.g., 206) to create a modified image 207. In so doing, the combined effects of the ambient lighting conditions at the location at which image 206 is captured as well as device characteristics and the image processing capabilities of image capture device 201 are eliminated from modified image 207.” fig. 1-3A, paragraphs 4, 5, 20-43, detailed description of capturing image and a reference color set in unknown light condition, having previously determined color value of color in reference color set under a second known light condition, and applying transform function to correct color of captured image to a second known light condition. It is required that in order to correct from a first unknown lighting condition to a second known light condition that the color value of reference color set to be captured. Baker utilize an inverse transform matrix to perform color correction, paragraph 53: “upon determining that the imaged reference color set 202 is a valid copy, color correction component 204 then estimates the color transformation, also referred to as a “transform function”, between the color space of imaged reference color set 202 and the control reference color set 203 to determine color correction function 210. In one embodiment of the present invention, a least-squares estimation is used to derive a color correction function F in the form of 3×4 matrix, that maps measured patch mean colors M (e.g., from one or more of color patches 301-324) from imaged reference color set 204 to corresponding control color values R in control reference color set 203. In other embodiments, the measured patch mean color values may be processed through an inverse-gamma function to remove the effects of device non-linear contrast adjustment. The matrix results in a transform function F a 3×3 color transformation matrix plus an additive per-color-component offset”.
Tsai in view of Front discloses a process of color matching color of reagent test sample to colors on reference chart, wherein color accuracy is critical and both the color on reagent dipstick and color of reference chart may be captured under a second unknown lighting condition. Baker discloses a process of improving color accuracy by color correction of all colors in an image captured, by having known reference color set from captured image in a second unknown lighting condition corrected to a known reference color set in a first known lighting condition previously captured. It would have been obvious to one of ordinary skill in the art at the time of filing, to incorporate the known concept of capturing a color of image from an unknown lighting condition and color correcting the color of image captured to a different lighting condition, such as disclosed by Baker, into the known process of Tsai in view of Front, to capture a reference color set under two different lighting conditions (known and unknown) and perform color calibration, such that the color sample of reagent test pad of Tsai in view of Front and the colors on reference chart for use in analysis of Tsai in view of Front can be captured in different lighting conditions and color corrected to match each other with color correction performed by transform function applied to image captured, the result would have been predictable and would constitute (from claim 75) wherein the processor is configured to compare the capture the captured color of the reagent test pad to the reference colors comprises: correcting the captured color based on the obtained information; and comparing the corrected captured color to the reference colors, and would result in a method of color analysis that increase user flexibility by allowing colors to be captured under different lighting condition while ensuring accuracy of color analysis.
The combination made with Tsai in view of Front and Baker does not specifically outline (from claim 76) wherein the processor is configured to correct the captured color by: computing an inverse transformation matrix based on the obtained information, and correcting the captured color using the inverse transformation matrix.
In other words, Tsai in view of Front discloses the concept of capturing color sample along with a reference color chart (Tsai, fig. 2) in a first lighting condition, and Baker discloses the concept of linking reference color chart captured in the first lighting condition with reference color chart captured in a second lighting condition via inverse transformation matrix to provide color calibration. Tsai in view of Front and Baker only does not specifically outline that the color calibration is applied to the color sample.
In similar field of endeavor of linking color reference chart in one lighting condition with color reference chart in another lighting condition, Bhatti disclose the concept of capturing image of a test subject of a first color sample (fig. 2, subject 203) along with an image reference color chart (fig. 2, reference color set, paragraphs 34, 35, “FIG. 2 shows an exemplary image capture system 200 used in conjunction with embodiments of the present invention. In embodiments of the present invention, system 200 comprises an image capture device 201 for capturing an image 202 comprising a subject (e.g., 203) and a imaged reference color set 204. It is noted that in embodiments of the present invention, subject 203 may be a test subject as described above with reference to FIG. 1”, “Typically, the quality and spectral characteristics of light falling on a given subject affect the subject's appearance to a camera and thus on the image generated by the camera. The camera itself, through physical characteristics of its design and fabrication of its sensor, and also through internal processing characteristics of the camera, introduces further alteration in the perceived skin coloration of the subject. These effects combine to make skin coloration metrics of the image highly dubious. By viewing a set of reference colors captured along with the image of the subject, image analysis system 205 may facilitate determining a transformation from the observed color space of the image to a reference or “true” color space that is independent of the ambient lighting conditions and image processing capabilities of the camera which captures the image”), wherein a transformation matrix is calculated linking the captured reference chart to a reference chart under controlled lighting condition (paragraph 36, “the true color space is represented by a control reference color set 208. By comparing the characteristics of control reference color set 208 with the characteristics of the reference color set 204 captured in the image, image analysis system 205 can determine a transformation, or “color correction function,” which accounts for the discrepancy between the characteristics of imaged reference color set 204 and control reference color set 208. This color correction function directly compensates for the combined effect of the ambient lighting in the room and the color transformation of the acquiring camera”, paragraph 69, “upon determining that the imaged reference color set 204 is a valid copy, color correction component 401 then estimates the color transformation between the color space of image 202 and the control reference color set 208 to determine color correction function 411. In one embodiment of the present invention, a least-squares estimation of a 3×4 matrix to derive a color correction function F(, also referred to as a “transform function” that maps measured patch mean colors M(e.g., from one or more of color patches 301-324) from imaged reference color set 204 to a corresponding control color values R in control reference color set 208”, paragraph 71, “color correction component 401 determines a color correction function F((e.g., 411) which substantially eliminates discrepancies between the imaged reference color set 204 and the control reference color set 208.”) to generate a color correction function, and the color correction function is applied to the captured first color sample in order to provide accurate comparison of first color sample to a second color sample in reference chart under controlled lighting condition (paragraph 79, “applicator 405 receives color correction function 411 from color correction component 401 and the color descriptions (e.g., 412) of the skin pixels selected by skin pixel selection component 402 as being representative of the skin color of subject 203. In one embodiment, applicator 405 then applies color correction function 411 to the color descriptions 412 and outputs modified color description 209 as a result”, see also paragraph 41-43, 46, “In so doing, a modified color description of that skin pixel is created which compensates for the effects of ambient lighting and image processing capabilities of the image capture device at the time the image was captured. This facilitates accurately estimating the natural skin color of the subject in the image”, “compares a color description of the skin color estimate 413 generated by image analysis system 205 with a color description of the classification colors described above with reference to FIG. 1 to determine which classification color or classification colors most closely matches the skin coloration of subject 203”).
Tsai in view of Front and Baker disclose the concept of capturing color sample on reagent test pad along with reference colors and generating inverse transformation matrix linking reference color chart under a first lighting condition to reference chart under second lighting condition, Bhatti additionally disclose the concept of capturing color of test subject along with reference colors, generating color correction function with transformation matrix linking reference color chart captured along with color of test subject to controlled reference color set, and applying color correction function to the captured test subject color in order to compare test subject color with second colors in controlled reference color set to obtain accurate color description. It would have been obvious to one of ordinary skill in the art to incorporate the technique of Bhatti of performing color correction on color of captured test subject (i.e. first color color sample), into the method of comparing first color sample with second color sample of Tsai in view of Front and Baker, such that the first color of captured regent test pad in Tsai in view of Front and Baker captured under a first lighting condition is transformed to color space of controlled reference chart under a second lighting condition by having an inverse transformation matrix applied to the first color sample, in order to achieve the benefit of allowing an accurate color comparation of first color sample under the first lighting condition with second color sample in reference test chart under the second lighting condition, such is incorporation of a known technique into a known method to yield predictable result, the result would have been predictable and would constitute (from claim 76) wherein the processor is configured to correct the captured color by: computing an inverse transformation matrix based on the obtained information, and correcting the captured color using the inverse transformation matrix, while performing the intended function providing precise analysis of analyte level via captured image of reagent test pads.
Regarding claim 70, this is a method claim counterpart of device claim 75, both reciting substantially similar subject matter. Accordingly, claim 70 is rejected for the same reasons as claim 75.
Regarding claim 71, this is a method claim counterpart of device claim 76, both reciting substantially similar subject matter. Accordingly, claim 71 is rejected for the same reasons as claim 76.
Regarding claim 81, this is a Beauregard claim (i.e., "non-transitory machine-readable medium") counterpart of system claim 75, both reciting substantially similar subject matter. Accordingly, claim 81 is rejected for the same reasons as claim 75.
Regarding claim 82, this is a Beauregard claim (i.e., "non-transitory machine-readable medium") counterpart of system claim 76, both reciting substantially similar subject matter. Accordingly, claim 82 is rejected for the same reasons as claim 76.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Purdie et al., US 20020160519 A1, paragraph 117, for color reaction, “when batching samples for assay, care must be taken to ensure that the final color is stable beyond the endpoint time”,
Kritzman et al., US 20120003685 A1, paragraph 254, “An indicator reagent shows a color change … Observation of a visible stable color at the end of the reaction indicates that the ammonium concentration is greater than the pre-set threshold.”
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
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/PEIJIE SHEN/Examiner, Art Unit 2622
/PATRICK N EDOUARD/Supervisory Patent Examiner, Art Unit 2622
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