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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 03/06/2024 and 08/27/2024 have been made record of and considered by the examiner.
Specification
The disclosure is objected to because of the following informalities: [0054] references “network 204,” however, the network in claim 1 is labelled as #120. Appropriate correction is required.
Claim Objections
Claim 16 is objected to because of the following informalities: the limitation “(ii) a filter paper later” contains a typo, the examiner assumes that it should read “(ii) a filter paper layer.” Appropriate correction is required.
Claim 6 is objected to because it is grammatically ambiguous. Claim 6 follows the singular “the analyte” with a list that contains duplicates and multiple and’s. Clarification is respectfully requested.
Claim 9 is objected to because of the following informalities: the limitation “markers comprise an ArUco marker” contains a typo, the examiner assumes that it should read “markers comprises an ArUco marker.” Appropriate correction is required.
Claim 13 is objected to because of the following informalities: the limitation “The paper based microfluidic diagnostic device of claim 12, each of the” contains a typo, the examiner assumes that it should read “The paper based microfluidic diagnostic device of claim 12, wherein each of the.” Appropriate correction is required.
Consider claim 49, which, in comparison to claim 1, contains the additional limitations: “at least one of the top panel or the bottom panel comprises a plurality of image registration markers included on the top panel” and “to form a plurality of receptacles that are each configured to receive a lateral flow test strip.” The examiner respectfully suggests aligning the language of claim 49 with that of claims 1 and 15 to promote consistency and reduce ambiguity.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 49 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 49 recites the broad recitation “at least one of the top panel or the bottom panel comprises a plurality of image registration markers”, and the claim also recites “at least one of the top panel or the bottom panel comprises a plurality of image registration markers included on the top panel” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Appropriate correction is required.
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.
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.
Claims 1-3, 5-8, 11, 15-16, 18-19, 21-24, 26, 30, and 49 are rejected under 35 U.S.C. 103 as being unpatentable over Pulitzer (US 2021/0405043 A1), in further view of Lieberman (US 2015/0160245 A1), in further view of Adiri (US 2020/0126227 A1), and in further view of Wronko (US 2019/0111425 A1).
Consider claims 1 and 49, Pulitzer discloses a paper based microfluidic diagnostic device, comprising:
a top panel comprising a first plurality of cut regions (FIG. 17, FIG. 23A; ¶92, 93, 100; “The testing device 1700 includes a housing 1702 that forms the body of the testing device… The testing device 1700 may further have a plurality of sample wells 1706, each sample well having one of the plurality of immunoassay test pads 1704 disposed within); and
a bottom panel comprising a second plurality of cut regions (¶104, 109-119, FIGs. 23-27; “FIG. 23B, there is illustrated a bottom view of one embodiment of the two-sided flow through immunoassay device 2300. The bottom of the device 2300 includes a test results window 2308… ), wherein:
[Claim 49: the first and second plurality of cut regions are configured to form a plurality of receptacles that are each configured to receive a lateral flow test strip (¶62-66, 91, 112; “testing device 300 and other embodiments herein illustrate a lateral flow immunoassay device”), and]
the first and second plurality of cut regions are configured to form a plurality of diagnostic wells (¶100; “The top of the device 2300 includes a sample well 2302 having a plurality of orifices 2304. The sample well 2302 has a solid bottom, with the solid bottom have the plurality of orifices 2304 disposed therein”),
each of the plurality of diagnostic wells comprises a diagnostic paper layer positioned over a filter paper layer (¶107, FIG. 23C; reaction membrane 2322, blocking layer 2326),
the diagnostic paper layer comprises one or more diagnostic components for quantitative assessment of an analyte (¶77, 107; reaction membrane 2322, ¶104; “At step 1406, a mobile device application checks the biologic sample the testing device result to determine a quantitative result of the test to provide a correlative value for the condition being tested in the biologic sample.”), and
at least one of the top panel or the bottom panel comprises a (¶92; “The testing device 1700 may also have disposed on the surface of the housing a crosshair symbol 1712, used as an alignment target.”).
Pulitzer fails to explicitly disclose at least one of the top panel or the bottom panel comprises a plurality of image registration markers and a plurality of image calibration markers.
In related art, Lieberman discloses:
a top panel comprising a first plurality of cut regions (¶60-63; fabrication of the PAD and reaction zones); and
the first (¶60; reaction zones (8); ¶63; “cut and paste” method),
each of the plurality of diagnostic wells comprises a diagnostic paper layer (¶57; “As shown in FIG. 1, typically the analytical PAD (2) comprises a porous hydrophilic medium, which is preferably a paper such as a fast chromatography paper or an absorbent blotting paper… Examples of suitable materials for an analytical device such as a PAD (2) include but are not limited to nitrocellulose acetate, chromatography paper, cellulose acetate, cellulosic paper, filter paper…”),
the diagnostic paper layer comprises one or more diagnostic components for quantitative assessment of an analyte (¶69; “Once the composition has been applied to the reaction zones (8), the disposing of the solution into the reaction zones (8) typically causes a colorimetric change in each reaction zone as previously outlined in reaction equations (i)-(iv) that can be analyzed in order to quantify the amount of the targeted chemical.”), and
at least one of the top panel or the bottom panel comprises a plurality of image registration markers and a plurality of image calibration markers (¶72; “The saltPAD (2) contains at least one electronically readable information zone… As demonstrated in FIG. 1, such information can include an identification tag such as a two-dimensional bar code (e.g., a QR code) (4), a color calibration zone (6) and a plurality of fiducial (24) markers, ¶74; “the color calibration zone (6) depicted in FIG. 1 on the saltPAD (2), which consists of different colored sub-regions, including a white region and a black region.”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to incorporate the color calibration zone and plurality of fiducial markers of Lieberman into the testing device of Pulitzer to use the color intensities of the calibration zones to correct the color intensities read from reaction zones before comparison to a stored calibration curve (Lieberman ¶74). Further, each PAD has a plurality of fiducial marks printed on it, so as to allow image analysis Software to automatically orient the card image for processing (Lieberman ¶79).
Further, Pulitzer states “The customizability of the devices shown in FIGs. 23A-29E allows for both manufacturers and users of the devices to build custom immunoassay testing devices Manufacturers often have to build each immunoassay test strip, laminate them, and insert them into a housing to be sold as the device. However, the devices disclosed herein allow for uniform cassettes to be on hand that can have pods inserted to custom build the tests, and allowing for layers to be stacked, without having to painstakingly build each test strip. Users also benefit since pods could be sold as separate replacements, allowing a user to buy a single cassette, and periodically buy disposable pods to be used and then discarded after a test is complete, keeping the cassette for the next time the user needs to perform a test (Pulitzer ¶117).” Therefore, a further benefit would be providing a housing for the PAD, which may be marked with markers (Pulitzer ¶92, 117).
In related art, Adiri further supports: at least one of the top panel or the bottom panel comprises a plurality of image registration markers and a plurality of image calibration markers (Adiri ¶103; “the processing device may also identify in the image a plurality of position markers (e.g., high contrast elements 475) distinguished from the at least one pair of colored reference elements (e.g., colored reference elements 470”; ¶104; “the trained machine learning model may be used to analyze the image and identify the color reference elements”; ¶107; “The trained machine learning model may be used to calculate the normalized reagent test color from the color of the reagent pad”).
In related art, Wronko further supports: at least one of the top panel or the bottom panel comprises a plurality of image registration markers and a plurality of image calibration markers (Wronko ¶24).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to incorporate the position markers and colored reference elements of Adiri and Wronko into the testing device of Pulitzer, as modified by Lieberman, to provide image alignment and color correction as commonly known in the art (Pulitzer ¶66, Lieberman ¶74).
Claim 16 is similarly rejected.
Consider claim 16, Pulitzer discloses a method of detecting and quantifying a target analyte in a fluid sample, comprising the steps of:
(a) obtaining a fluid sample (¶62, 100-107; biologic sample);
(b) depositing the fluid sample onto a microfluidic diagnostic device comprising one or more diagnostic wells that each comprise (¶62, 100-107; biologic sample introduced to sample well(s)):
(i) a diagnostic paper layer that includes one or more diagnostic components provided thereon (¶107; reaction membrane #2322), and
(ii) a filter paper later (¶107; blocking layer #2326);
(c) capturing, using an image capture device, an image of a reacted microfluidic diagnostic device (¶77, 104-105; “an image of the testing device is taken by the mobile device camera”);
(d) identifying, based on image registration markers included in the image (¶77; crosshair marker), a region corresponding to a reacted diagnostic well of the microfluidic diagnostic device (¶77-78, 105; “At step 912, the mobile device application correlates line intensity with analyte concentrations to further determine test line strength”; “FIG. 23B, two out of three test results indicators are displaying results, these two being oriented on the left side of the test results window 2308 and a designated with a ‘T' near the area of the test results window 2308 where the two indicators appear”);
(e) normalizing, (¶94-96; “The captured pixels may be normalized into a single value for determining whether there is a likelihood of infection, pregnancy, or whatever else the test is designed to detect… For example, the shade of red in all the pixels may be averaged to reach a single RGB value”); and
(f) analyzing, (¶74, 78, 89, 94-96; “for determining whether there is a likelihood of infection…”).
Pulitzer fails to explicitly disclose: (e) normalizing, based on image calibration markers included in the image, a color of the region corresponding to the reacted diagnostic well to generate a normalized color; and
(f) analyzing, using a machine learning model, the normalized color to predict a diagnostic test result.
In related art, Lieberman discloses a method of detecting and quantifying a target analyte in a fluid sample, comprising the steps of:
(b) depositing the fluid sample onto a microfluidic diagnostic device comprising one or more diagnostic wells (Lieberman ¶68; “fortified salt is first dissolved and drops of the solution are applied onto the twelve rectangular reaction zones (8) on the saltPAD (2)”) that each comprise:
(i) a diagnostic paper layer that includes one or more diagnostic components provided thereon (Lieberman ¶69; “the disposing of the solution into the reaction zones (8) typically causes a colorimetric change in each reaction zone”), and
(ii) a filter paper later (Lieberman ¶57);
(c) capturing, using an image capture device, an image of a reacted microfluidic diagnostic device (Lieberman ¶76; “a camera device capturing an image of the PAD (2) that has reacted with the composition using the camera device”);
(d) identifying, based on image registration markers included in the image, a region corresponding to a reacted diagnostic well of the microfluidic diagnostic device (Lieberman ¶72-73, 76; “The saltPAD (2) contains at least one electronically readable information zone which provides information necessary for determining the outcome of the test performed on the saltPAD (2) based on images obtained by a camera device.”; “providing an image analysis software capable of using information provided by the information zone and the image of the test result in order to identify and quantify a colorimetric change within the test reaction zone (8) of the PAD (2) shown in the captured image.”);
(e) normalizing, based on image calibration markers included in the image, a color of the region corresponding to the reacted diagnostic well to generate a normalized color (Lieberman ¶74, 79-80; normalized PAD (2) image); and
(f) analyzing, (Lieberman ¶74; “the color content of specific regions of the PAD (2) can preferably be analyzed to automatically determine the test result.).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to incorporate the color calibration zone and plurality of fiducial markers of Lieberman into the testing device of Pulitzer to use the color intensities of the calibration zones to correct the color intensities read from reaction zones before comparison to a stored calibration curve (Lieberman ¶74). Further, each PAD has a plurality of fiducial marks printed on it, so as to allow image analysis Software to automatically orient the card image for processing (Lieberman ¶79).
Further, Pulitzer states “The customizability of the devices shown in FIGs. 23A-29E allows for both manufacturers and users of the devices to build custom immunoassay testing devices Manufacturers often have to build each immunoassay test strip, laminate them, and insert them into a housing to be sold as the device. However, the devices disclosed herein allow for uniform cassettes to be on hand that can have pods inserted to custom build the tests, and allowing for layers to be stacked, without having to painstakingly build each test strip. Users also benefit since pods could be sold as separate replacements, allowing a user to buy a single cassette, and periodically buy disposable pods to be used and then discarded after a test is complete, keeping the cassette for the next time the user needs to perform a test (Pulitzer ¶117).” Therefore, a further benefit would be providing a housing for the PAD, which may be marked with markers (Pulitzer ¶92, 117).
In related art, Adiri discloses: (e) normalizing, based on image calibration markers included in the image, a color of the region corresponding to the reacted diagnostic well to generate a normalized color (Adiri ¶107, 136, 217; “The trained machine learning model may be used to calculate the normalized reagent test color from the color of the reagent pad”); and
(f) analyzing, using a machine learning model, the normalized color to predict a diagnostic test result (Adiri ¶107; “the processing device may determine the extent of the chemical reaction on each of the plurality of reagent pads based on the uniform color associated with each of the plurality of reagent pads.”; ¶202-203; “The colorized test surface recorded concurrently with each image in a series may be used by the system to account for changes in color of the wound during the healing process”; ¶217; “the trained machine learning model may be used to analyze the image … and estimate the length, size, depth, and/or volume of a skin feature. Such training examples may include an image of a wound with a colorized surface …, color information associated with an image”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to incorporate the color normalization of Adiri into the testing device of Pulitzer, as modified by Lieberman, to provide color correction as commonly known in the art (Lieberman ¶74). Adiri states: “when the at least one reagent pad includes a plurality of reagent pads, the processing device may use one or more normalized reagent test colors to determine a uniform color for pixels associated with each of the depiction of plurality of reagent pads. Thereafter, the processing device may determine the extent of the chemical reaction on each of the plurality of reagent pads based on the uniform color associated with each of the plurality of reagent pads (Adiri ¶107).”
In related art, Wronko further supports: (f) analyzing, using a machine learning model, the normalized color to predict a diagnostic test result (Wronko ¶55-56; “unsupervised learning is executed to form clusters of colors inside a given panel… A given identified color may
correspond to one or two types of results, depending on the type of diagnostic test with which the color is associated. For example, for metabolic tests the colors are quantitative a certain collection of RGB values represents a single quantitative number. Alternatively, for a binary diagnostic test … the presence or absence of a color(s) can indicate a positive or negative result”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to incorporate the machine learning model of Wronko into the testing device of Pulitzer, as modified by Lieberman and Adiri, to automatically the color content of reacted regions and determine the test result (Lieberman ¶74).
Consider claim 2, Pulitzer, as modified by Lieberman, Adiri, and Wronko, discloses the claimed invention wherein each of the plurality of diagnostic wells is configured to receive a fluid sample from a side of the bottom panel such that the fluid sample flows vertically to the diagnostic paper layer via the filter paper layer (Pulitzer ¶91, 105, 109-110).
Consider claim 3, Pulitzer, as modified by Lieberman, Adiri and Wronko, discloses the claimed invention wherein the diagnostic paper is a single layer sheet of hydrophilic porous paper (Lieberman ¶57, 63).
Consider claim 5, Pulitzer, as modified by Lieberman, Adiri and Wronko, discloses the claimed invention wherein the one or more diagnostic components are selected from reagents, dyes, probes, stabilizers, catalysts, anti-coagulants, lysing agents, nanoparticles, diluents, and combinations thereof (Pulitzer ¶44, 71, 81, 102-103, Lieberman ¶64-65, 68; Adiri ¶96, 102, Wronko ¶27).
Consider claim 6, Pulitzer, as modified by Lieberman, Adiri and Wronko, discloses the claimed invention wherein at least one diagnostic component is capable of selectively associating with the analyte selected from aspartate transaminase, alkaline phosphatase, alanine aminotransferase, bilirubin, albumin, total serum protein, glucose, cholesterol, creatine, sodium, calcium, gamma glutamyl transferase, direct bilirubin, indirect bilirubin, unconjugated bilirubin, and lactate dehydrogenase, glucose, blood urea nitrogen, calcium, bicarbonate, chloride, creatinine, potassium, hematocrit and sodium (Lieberman ¶65, Wronko ¶36, Adiri ¶259).
Consider claim 7, Pulitzer, as modified by Lieberman, Adiri and Wronko, discloses the claimed invention, further comprising an identifying marker (Lieberman ¶72-73, Adiri ¶118, Wronko ¶24).
Consider claim 8, Pulitzer, as modified by Lieberman, Adiri and Wronko, discloses the claimed invention wherein the identifying marker comprises a QR code or barcode (Lieberman ¶72-73, Adiri ¶118, Wronko ¶78).
Consider claim 11, Pulitzer, as modified by Lieberman, Adiri and Wronko, discloses the claimed invention wherein the plurality of image calibration markers comprise a plurality of reference color markers (Lieberman ¶74, Adiri ¶78, Wronko ¶24).
Consider claim 15, Pulitzer, as modified by Lieberman, Adiri and Wronko, discloses the claimed invention, further comprising at least one slot for receiving a lateral flow reaction substrate (Pulitzer FIGs. 3, 5, ¶46, 91).
Consider claim 18, Pulitzer, as modified by Lieberman, Adiri, and Wronko, discloses the claimed invention wherein identifying the region corresponding to the reacted diagnostic well comprises:
identifying, in the image, one or more image registration markers (Pulitzer ¶91, 105; Lieberman ¶79);
determining, based on the image registration markers, a pose of the image capture device (Pulitzer ¶73-74, 77, 91);
using the pose of the image capture device to align the image with a template image corresponding to the diagnostic device (Pulitzer ¶72-76, 92, Lieberman ¶22, 73, 80); and
identifying the region corresponding to the reacted diagnostic well based on a location of a diagnostic well in the template image (Pulitzer ¶72-76, 92, Lieberman ¶22, 73, 80, 88; Wronko ¶54-55).
Consider claim 19, Pulitzer, as modified by Lieberman, Adiri, and Wronko, discloses the claimed invention further comprising identifying the template image corresponding to the diagnostic device based on an identification marker included in the image (Pulitzer ¶73-74; Lieberman ¶21, 72-74, 79, 99).
Consider claim 21, Pulitzer, as modified by Lieberman, Adiri, and Wronko, discloses the claimed invention wherein normalizing the color of the region corresponding to the reacted diagnostic well comprises performing a masking operation and a color transformation (Lieberman ¶61, 72-74, 80, Adiri ¶45, 217, Wronko ¶54-55).
Consider claim 22, Pulitzer, as modified by Lieberman, Adiri, and Wronko, discloses the claimed invention wherein performing the color transformation comprises performing white balancing of the image (Lieberman ¶72-74, 80).
Consider claim 23, Pulitzer, as modified by Lieberman, Adiri, and Wronko, discloses the claimed invention wherein performing the white balancing of the image comprises comparing an observed color value of a white colored image calibration marker to a known color value of the white colored image calibration marker (Lieberman ¶72-74, 80).
Consider claim 24, Pulitzer, as modified by Lieberman, Adiri, and Wronko, discloses the claimed invention wherein performing the color transformation comprises generating a global transformation function for transforming the image to a first normalized image (Lieberman ¶79-80, Wronko ¶56).
Consider claim 26, Pulitzer, as modified by Lieberman, Adiri, and Wronko, discloses the claimed invention further comprising reducing a dimensionality of the first normalized image to generate a reduced dimensionality image (Wronko ¶56).
Consider claim 30, Pulitzer, as modified by Lieberman, Adiri, and Wronko, discloses the claimed invention, further comprising identifying the machine learning model based on an identification marker included in the image (Pulitzer ¶89, 99, Wronko ¶47).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Pulitzer, in view of Lieberman, Adiri, and Wronko, as applied to claims 1-3, 5-8, 11, 15, 16, 18-19, 21-24, 26, 30, and 49 above, and further in view of Liang (‘Printed paper-based devices for detection of food-borne contaminants: New device design and new colorimetric image analysis methods’).
Consider claim 9, while disclosing a plurality of fiducial markers (Lieberman ¶79), Pulitzer, as modified by Lieberman, Adiri, and Wronko, fails to specifically disclose wherein each of the plurality of image registration markers comprise an ArUco marker.
In related art, Liang discloses wherein each of the plurality of image registration markers comprise an ArUco marker (Liang Introduction, Future Goals and Other Ideas).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to incorporate the ArUco markers of Liang into the testing device/method of Pulitzer, as modified by Lieberman, Adiri, and Wronko to automatically orient the test/testing device for image processing (Lieberman ¶79). Liang uses four distinct markers to uniquely identify corners. Liang states, “These Aruco markers can be identified from the picture, and their indexes are used to calculate the homography” (Liang Future Goals and Other Ideas).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Pulitzer, in view of Lieberman, Adiri, and Wronko, as applied to claims 1-3, 5-8, 11, 15, 16, 18-19, 21-24, 26, 30, and 49 above, and further in view of Patel (US 2017/0184506 A1).
Consider claim 12, Pulitzer, as modified by Lieberman, Adiri, and Wronko, fails to specifically disclose wherein the plurality of image calibration markers comprise 24 unique colors.
In related art, Patel discloses wherein the plurality of image calibration markers comprise 24 unique colors (Patel ¶55).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to incorporate the 24 unique colors of Patel into the testing device/method of Pulitzer, as modified by Lieberman, Adiri, and Wronko to use color intensities of the calibration zones to correct the color intensities read from reaction zones (Lieberman ¶74, Patel ¶55). Or, as stated by Adiri, “the colors of the reference elements depicted in the image and the known colors of the reference elements may be used to determine the correction factors , for example using any color calibration algorithm (Adiri ¶113).
Allowable Subject Matter
Claims 13 and 29 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Relevant Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 2024/0076714 A1 discloses paper-based microfluidic devices.
US 2021/0199651 A1 discloses a vertical flow molecular assay apparatus.
US 2021/0293805 A1 discloses machine vision techniques for diagnostic testing.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHLEY HYTREK whose telephone number is (703)756-4562. The examiner can normally be reached M-F 9:00-5:00.
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/ASHLEY HYTREK/Examiner, Art Unit 2665
/Stephen R Koziol/Supervisory Patent Examiner, Art Unit 2665