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 .
Election/Restrictions
Applicant’s election without traverse of Claims 9-18 in the reply filed on 11/25/2025 is acknowledged.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 9-18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claim 9 recites determining a level of urine parameters after calculating a normalized color value using regression analysis.
The limitation of “conducting a regression analysis by determining least-squares of the reference values in accordance with said prestored set of values” is a process that under its broadest reasonable interpretation, relates a predicted value to a measured value which is merely organizing information through mathematical correlations, which falls under the “Mathematical Concepts” grouping of abstract ideas. If a claim limitation recites a relationship that requires calculating using mathematical methods to determine a variable or number, it falls under the Mathematical Concepts grouping of abstract ideas.
This judicial exception is not integrated into a practical application. The claim recites the additional elements of a urine strip, a mobile device, and a remote server, but the processor of the server in both steps is recited at a high-level of generality (i.e., as a generic processor performing a generic computer function of calculating a linear fit for a set of data) such that it amounts no more than mere instructions to apply the exception using a generic computer component. Further, the prior art reference of Burg (US 20160048739 A1) teaches a system comprising a urine test strip, mobile device, and remote server (see [0065] and [0094]). Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. Further, the elements are conventional, routine, and well-known in the prior art. The claim is directed to an abstract idea.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element of using a processor to perform both the extracting and determining steps amounts to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. The claim is not patent eligible.
Claim 10 does not further incorporate the abstract idea into a practical application as it is an example of a mathematical calculation (using a formula to convert coordinates into natural numbers) and is therefore not deemed patent eligible because it does not incorporate the judicial exception into a practical application.
Claim 11 refers to the step of applying a color transformation matrix to the obtained color values which is merely a data gathering step required to obtain and apply the correlation, and does not add a meaningful limitation to the method as it is insignificant extra-solution activity.
Claims 12-14 refers to the step of applying a correction matrix to the obtained color values which is merely a data gathering step required to obtain and apply the correlation, and does not add a meaningful limitation to the method as it is insignificant extra-solution activity.
Claims 15-16 do not clarify or use the steps of determining the relationship between the reference and test values and deriving an item of quality information of claim 9 and are therefore not deemed patent eligible because they do not incorporate the judicial exception into a
practical application.
Claims 17-18 are drawn to the storage of data following analysis which is considered insignificant extra-solution activity as it does not add any meaningful limitation to the determining step of claim 1. Further, capturing an image for machine learning is merely a nominal or token extra-solution component of the claim, and is nothing more than an attempt to generally link the product of nature to a particular technological environment.
Priority
The Applicant’s claims the benefit of a prior-filed application US Application 17/052,533, now abandoned.
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of the first paragraph of 35 U.S.C. 112. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551,32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 17/052,533, fails to provide adequate support or enablement in the manner provided by the first paragraph of 35 U.S.C. 112 for one or more claims of this application.
Since claims 9-18 contain language that does not appear to be supported by App. No. 17/052,533, these claims do not receive the earlier filing date and will be examined based on the filing date of the present application.
Claim 9 recites “wherein said remote server further includes processing unit configured for: extracting, from each reference region, reference values representative of at least one detected color in said reference region; extracting, from each reacting area, color values representative of a detected color of said reacting area; conducting a regression analysis by determining least-squares of the reference values in accordance with said prestored set of values; determining a color correction model by calculating root polynomial expansion of said least-squares; applying said color correction model on said color values by calculating root polynomial expansion of said color values to obtain normalized values; and determine level of said urine parameters in accordance with normalized values.”
Claim 10 recites “ [the] processing unit is further configured for converting said reference values to floating point values.”
Claim 11 recites “[the] processing unit is further configured for conducting a regression analysis includes multiplying reference matrix including said reference values with an inverse of an expected matrix including said prestored set of values to obtain correction matrix representative of said color correction model.”
Claim 12 recites “wherein said correction matrix is calculated as:
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x
p
(
M
t
)
T
*
(
M
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)
-
1
where
M
t
is a matrix of said reference values and where
M
r
is a matrix of said prestored set of values”.
Claim 13 recites “wherein applying said color correction model includes multiplying said correction matrix with root polynomial expansion of said color values, wherein said color values are RGB values and said root polynomial expansion is defined as:
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.”
Claim 14 recites “wherein applying said color correction model is calculated as:
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x
p
(
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)
T
)
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where
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x
p
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is a matrix of root polynomial expansion of said color values and where
M
c
is said correction matrix.”
Claim 15 recites “[the] plurality of reference regions includes between five and thirty reference regions.”
Claim 16 recites “wherein said strip include a background having a dark or black color.”
Claim 17 recites “wherein said server is further configured neural networks training including comparing said normalized values with stored values and determining probability-weighted association between said normalized values and a predicted value of said urine parameters.”
Claim 18 recites “wherein said server includes an image database including a plurality of classified images of said reacting area classified by levels of said of said urine parameters, said server is configured to extract characterizing features of said classified images and to determine level of said urine parameter in accordance with said characterizing features.”
Prior filed App. No. 17/052,533 does not provide support for the server being configured to calculate a regression analysis and root polynomial expansion. ‘533 discloses “the urinalysis results of the user can be submitted to another mobile communication device (4), a server, (p. 9, lns. 15-24).
Because the parent document preceding this application does not disclose the features recited supra as set forth in the claims of the instant invention, applicant only has priority for claims 9-18 back to the filing date the instant application filed on 08/24/2022 and US20210208081 (Pg Pub of App. No. 17/052,533) qualifies as prior art under 35 U.S.C. 102(a)(1) against the claims, and is considered out of the grace period. See Exparte DesOrmeaux, 25 U.S.P.Q. 2d 2040 (Bd. Pat. App. & Inter. 1992) and In re Chu, 36 U.S.P.Q. 2d 1089 (Fed. Cir. 1995) where parent patents were deemed to be prior art against examined applications despite a claim of priority to those parent patents.
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 16 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.
The term “dark” in claim 16 is a relative term which renders the claim indefinite. The term “dark” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear how “dark” the background of the strip is, or whether it just dark compared to the white color of the test strip.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 9-11, 13-16 are rejected under 35 U.S.C. 103 as being unpatentable over Burg (US 20160048739 A1) as applied above, and further in view of Lings et al. (US 20120288195 A1).
Regarding claim 9, Burg teaches a system for conducting a urinalysis (system for colorimetric analysis of urine test strips, see [0081] – [0082]), the system comprising:
a urine strip having a plurality of reacting areas configured to react with a predetermine urine parameter (diagnostic instrument 600 with colorimetric test pads (CTPs) 112, see Fig. 6 and [0117]) , and a plurality of reference regions each having a designated color (reference color bar 601 with known color values, see [0122])
a mobile device (220) configured to obtain an image of said urine strip and transmit said image (smartphone used to capture and relay an image of the test strip, see [0094]);
a remote server (211) configured for receiving said image from said mobile device (phone 220 relays data to remote cloud server 211, see [0093]);
wherein said remote server includes a database including prestored set of values corresponding to expected colors of each reference region (the server comprises a memory 1312 containing a predetermined color object, see [0058] – [0060] and [0072]);
wherein said remote server further includes processing unit (1311, see [0072], used to store processed images from mobile device) configured for:
extracting, from each reference region, reference values representative of at least one detected color in said reference region (the reference color bar illumination is extracted from the image 711, see Fig. 8);
extracting, from each reacting area, color values representative of a detected color of said reacting area (CTP color values are extracted 303, see Fig. 8);
applying said color correction model on said color values by calculating root polynomial expansion of said color values to obtain normalized values (the formula obtained for the illumination is applied to the color values to obtain normalization, see [0129]); and
determine level of said urine parameters in accordance with normalized values (concentration of each analyte is determined after normalization, see [0129]).
However, Burg does not explicitly teach that the remote server includes a processing unit for conducting a regression analysis by determining least-squares of the reference values in accordance with said prestored set of values and determining a color correction model by calculating root polynomial expansion of said least-squares.
However, in the analogous art of using mobile devices to determine color changes using regression analysis, Lings et al. teaches a processing unit for conducting a regression analysis by determining least-squares of the reference values in accordance with said prestored set of values and determining a color correction model by calculating root polynomial expansion of said least-squares (the detection of the color change of the test strip is obtained by calculating the least squares between stored reference values and obtained reference colors and determining a color correction model using a polynomial curve fit, see [0097] and [0111]- [0117]).
While Burg does not teach that the processor specifically uses least squares and polynomial expansion claimed by the instant invention, the reference does teach the use of an expanded quadratic to correct for illumination in a captured image. Therefore, the modification to include the least squares analysis to determine the root polynomial solution to the second-order polynomial function would have been obvious to a person possessing ordinary skill in the art before the effective filing date of the instant application as exemplified by Lings et al. (see First Embodiment of Lings et al.).
It would have been obvious to a person possessing ordinary skill in the art before the effective filing date of the instant application to have modified the invention of Burg to include the second order polynomial and least squares regression analysis of Lings et al. for the benefit of adapting the calibration process to account for variations in brightness and in setting. The modification of the invention of Burg to incorporate the function of Lings et al. further would have resulted in the predictable result of facilitating regression analysis in a server to provide a prediction model that is fit to stored data.
Regarding claim 10, modified Burg teaches the system according to claim 9 wherein said processing unit is further configured for converting said reference values to floating point values (the server is used to convert the RCB to color values, see [0128] and [0132] – [0133]).
Regarding claim 11, modified Burg teaches the system according to claim 9 wherein said processing unit is further configured for conducting a regression analysis includes multiplying reference matrix including said reference values with an inverse of an expected matrix including said prestored set of values to obtain correction matrix representative of said color correction model (see Claim 3, where normalization includes multiplying the inverse matrix of the stored values to the measured color values).
Regarding claim 13, Burg teaches the system according to claim 11 wherein applying said color correction model includes multiplying said correction matrix (the color transform is calculated using regression, see [0149], where the regression uses the multiplication of a second-order (quadratic) equation, see [0153]), but does not teach that the color correction model includes multiplying the matrix specifically with the root polynomial expansion of said color values, wherein said color values are RGB values and said root polynomial expansion is defined as:
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.
However, in the analogous art of using mobile devices to determine color changes using regression analysis, Lings et al. teaches a device wherein the color correction model includes multiplying the matrix specifically with the root polynomial expansion of said color values, wherein said color values are RGB values and said root polynomial expansion is defined as:
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(see Fig. 7 and [0112] – [0117], where the matrix of measured values is RGB and a second-order polynomial is used to calculate normalized color values, see [0057]).
While Burg does not teach that the processor specifically uses RGB and the specific polynomial expansion claimed by the instant invention, the reference does teach the use of an expanded quadratic to correct for illumination in a captured image. Therefore, the modification to include the root polynomial solution to the second-order polynomial function would have been obvious to a person possessing ordinary skill in the art before the effective filing date of the instant application as exemplified by Lings et al. (see First Embodiment of Lings et al.).
It would have been obvious to a person possessing ordinary skill in the art before the effective filing date of the instant application to have modified the invention of Burg to include the second order polynomial of Lings et al. for the benefit of adapting the calibration process to account for variations in brightness and in setting. The modification of the invention of Burg to incorporate the function of Lings et al. further would have resulted in the predictable result of facilitating regression analysis in a server to provide a prediction model that is fit to stored data.
Regarding claim 14, modified Burg teaches the system according to claim 13 wherein applying said color correction model is calculated as:
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c
*
e
x
p
(
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G
B
)
T
)
T
where
e
x
p
(
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G
B
)
is a matrix of root polynomial expansion of said color values and where
M
c
is said correction matrix (see First Embodiment of Lings et al.).
Regarding claim 15, modified Burg teaches the system according to claim 9 wherein said plurality of reference regions includes between five and thirty reference regions (8 reference regions are included on the test paddle, see Fig. 6).
Regarding claim 16, modified Burg teaches the system according to claim 9 wherein said strip include a background having a dark (the machine readable code is darker than the color test pads, see Fig. 1B, where the code is part of the test strip).
Regarding claim 18, modified Burg teaches the system according to claim 9 wherein said server includes an image database including a plurality of classified images of said reacting area classified by levels of said of said urine parameters (the server contains images of test strips sorted by analyte concentration/titration, see [0071] – [0075]), said server is configured to extract characterizing features of said classified images and to determine level of said urine parameter in accordance with said characterizing features (the server retrieves parameters of an image to determine concentration under different illumination conditions, see [0071] – [0075]).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Burg (US 20160048739 A1) as applied above, and further in view of Lings et al. (US 20120288195 A1) and Satoh et al. (US 20130208289 A1).
Regarding claim 12, Burg teaches the system according to claim 11 wherein a correction matrix is calculated (the measured reference values are multiplied against an inverse matrix of stored color values, see [0129] and 61/973,208, incorporated by reference).
However, the prior art reference of modified Burg does not teach that the correction matric is calculated as
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x
p
(
M
t
)
T
*
(
M
r
T
)
-
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where
M
t
is a matrix of said reference values and where
M
r
is a matrix of said prestored set of values.
In the analogous art of detecting color changes using matrix values, the Satoh et al. teaches a device wherein the reference values are transformed into a linear matrix and then multiplied by the inverse matrix of previously stored values to obtain a set of color values used to normalization (see [0222]-[0227]).
The linearization of a matrix followed by the multiplication of the matrix with an inverse matrix was known and common in the art in the art before the effective filing date of the instant invention as evidenced by Satoh et al. Therefore, it would have been obvious to a person possessing ordinary skill in the art before the effective filing date of the instant application to have modified the color normalization step of previously modified Burg to implement the steps of linearization and inversion of the predicted color values for the benefit of selecting points in a neighboring space with high accuracy, which improves the accuracy of a neighboring point calculation, see [0222] in Satoh et al. Additionally, the modification of the apparatus of Burg to implement the additional normalization steps included within Satoh et al. would have resulted in the expected result of correcting a colorimetric assay under a multitude of lighting conditions.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Burg (US 20160048739 A1) as applied above, and further in view of Lings et al. (US 20120288195 A1) and Pulitzer et al. (US 2019/0027251 A1).
Regarding claim 17, modified Burg teaches the system according to claim 9 wherein said server is further configured neural networks training including comparing said normalized values with stored values (normalized values are compared to stored values of the chemical test pads to determine a predicted concentration of the target analyte, see [0071] – [0075]), but does not teach that the neural network also configured to determine a probability-weighted association between said normalized values and a predicted value of said urine parameters.
However, in the analogous art of using a mobile device to diagnose a user based on a test strip, Pulitzer et al. teaches a mobile device application wherein a server contains a neural network used to assign probability-weighted outcomes to a potential color value that is used to detect glucose levels, proteins, bacteria, and infectious markers within urine, see [0074] and [0097] – [0101]. While the neural network of Burg does not explicitly contain a predicted value of urine parameters, it is used to determine predicted color values under different lighting conditions and that would not exclude the use of predicting a color change after analyte exposure.
Therefore, it would have been obvious to a person possessing ordinary skill in the art before the effective filing date of the instant application to have modified the neural network of Burg to implement the diagnostic step within the neural network as exemplified by Pulitzer et al. with no deviation to the structure of the invention and for the benefit of diagnosing a user of the mobile application and test strip with a higher degree of certainty as the neural network compares the captured image to previously stored and accurate color values, see [0101] [0102] in Pulitzer et al. Furthermore, the integration of the neural network of Pulitzer et al. within the device of Burg would have had the expected result of providing a point-of-care diagnostic platform within a smartphone, as is stated by the instant invention.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEA MARTIN whose telephone number is (571)272-5283. The examiner can normally be reached M-F 10AM-5:00PM (EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel can be reached at (571)270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.N.M./Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758