Prosecution Insights
Last updated: April 19, 2026
Application No. 17/846,892

ADJUSTMENT METHOD FOR ADJUSTING A SETUP FOR AN ANALYTICAL METHOD

Final Rejection §102§112§Other
Filed
Jun 22, 2022
Examiner
KWAK, DEAN P
Art Unit
1798
Tech Center
1700 — Chemical & Materials Engineering
Assignee
Roche Diabetes Care Inc.
OA Round
2 (Final)
58%
Grant Probability
Moderate
3-4
OA Rounds
4y 1m
To Grant
97%
With Interview

Examiner Intelligence

Grants 58% of resolved cases
58%
Career Allow Rate
380 granted / 650 resolved
-6.5% vs TC avg
Strong +38% interview lift
Without
With
+38.3%
Interview Lift
resolved cases with interview
Typical timeline
4y 1m
Avg Prosecution
58 currently pending
Career history
708
Total Applications
across all art units

Statute-Specific Performance

§101
0.6%
-39.4% vs TC avg
§103
34.6%
-5.4% vs TC avg
§102
34.9%
-5.1% vs TC avg
§112
26.5%
-13.5% vs TC avg
Black line = Tech Center average estimate • Based on career data from 650 resolved cases

Office Action

§102 §112 §Other
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 Newly submitted claim 18 is directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: claim 18 represents a distinct standard measuring mode, please see the 05/21/2025 Restriction Requirement. Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 18 has been withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03. To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention. Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention. Claims 1-11 and 17 are being examined. Claim Rejections - 35 USC § 112 The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action. Claims 8-10 are 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 “most recent measurement attempts [...] most recent logged rejection events” in claim 8 is a relative term which renders the claim indefinite. The term “most recent” 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. The term “most often over all rejection events or logged most recently” in claim 9 is a relative term which renders the claim indefinite. The term “most often [...] most recently” 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. The term “most often over all rejection events or logged most recently” in claim 10 is a relative term which renders the claim indefinite. The term “most often [...] most recently” 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. Claim Rejections - 35 USC § 102 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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action. Claim(s) 1-11 & 17 is/are rejected under 35 U.S.C. 102a1/a2 as being anticipated by Pulitzer et al. (US 2019/0384890). Regarding claim 1, Pulitzer et al. teach: 1. A method of adjusting a setup, the method being used when determining a concentration of an analyte in a body fluid based on a color formation reaction in an optical test strip, with a mobile device having a camera, a processor and a memory, wherein the method comprises: a) carrying out a plurality of analyte measurement attempts with the mobile device (e.g., 802) set in a standard measuring mode (e.g., steps 908, 910+; steps 1106, 1108+; steps 1406, 1408+; step 2606; steps 3708, 3710+; steps 4008, 4010+), wherein each of the plurality of analyte measurement attempts comprises: capturing (e.g., step 908; step 1106; step 1406; step 2606; step 3708; step 4008), by using the camera (see ¶ 0076-0077, ¶ 0086+), one or more images (see i.e., Referring now to FIGS. 8A and 8B, there is illustrated a diagrammatic view of one embodiment of a process 800 for a mobile device application for testing device image capture and image processing. The mobile device application allows for an image of a testing device, such as testing device 300, to be captured using a camera installed on a mobile device 802 having a screen 804. [...] In FIG. 8B, there is shown the result of a successful alignment of the outline 806 with the testing device 300 and successful alignment of the crosshair graphic 808 with the crosshair 310 on the testing device 300. As shown in FIG. 8B, once aligned, a success indicator 812 may appear, such as a check mark or other positive status symbol, on the aligned image. Successful alignment causes the camera on the mobile device 802 to capture the current image of the testing device 300. Other checks may occur, including ensuring that the image is focused before the image is saved. This image is then processed to determine a result based on the severity of the reaction occurring on the test strip. The mobile device application performs an analysis of the test line captured in the image, counting the number of colored pixels, as well as determining the intensity of the color. The mobile device may then compare this number and color intensity to that in the control line, providing a mathematical evaluation of the test line. ¶ 0077-0078; see also At step 1106, a mobile device is used to capture an image of the testing device after testing is complete. ¶ 0086) of at least a part of an optical test strip (e.g., 100, 300) having a test field (e.g., test strips 304), checking, by the processor (the mobile device 802 inherently comprises a processor ¶ 0077+), capable for fulfillment of one or more measurement rejection criteria (see discussion below; see also i.e., alignment, focused image, color accuracy and determination ¶ 0077-0078, 0121+; color values corresponding to test results Abstract+; rating threshold ¶ 0087+) stored in the memory (a software application stored on a mobile device inherently includes a memory, see Abstract+), and rejecting, by the processor, the measurement attempt when one or more measurement rejection criteria are fulfilled, and logging the one or more rejection events in the memory (see i.e., In FIG. 8B, there is shown the result of a successful alignment of the outline 806 with the testing device 300 and successful alignment of the crosshair graphic 808 with the crosshair 310 on the testing device 300. As shown in FIG. 8B, once aligned, a success indicator 812 may appear, such as a check mark or other positive status symbol, on the aligned image. Successful alignment causes the camera on the mobile device 802 to capture the current image of the testing device 300. Other checks may occur, including ensuring that the image is focused before the image is saved. This image is then processed to determine a result based on the severity of the reaction occurring on the test strip. The mobile device application performs an analysis of the test line captured in the image, counting the number of colored pixels, as well as determining the intensity of the color. The mobile device may then compare this number and color intensity to that in the control line, providing a mathematical evaluation of the test line. ¶ 0077; At decision block 1110, it is determined whether the ratings for each condition exceed a certain threshold for that condition. ¶ 0087; When the mobile application described herein captures an image of the testing device, in some embodiments each pixel that makes up the test line captured in the image is processed to place it on a color gradient scale. ¶ 0097; FIG. 36 is a top view of a mobile device 3600 using an application for testing device image capture and image processing. The mobile device application allows for an image of a testing device, such as testing device 3500, to be captured using a camera installed on mobile device 3600 having a screen 3604. While the mobile device 3600 displays on the screen 3604 the scene captured by the camera, the mobile device application may also display a graphic on the screen 3604 in the form of a boxed outline 3608, similar or identical to outline 806 of FIG. 8A, the outline corresponding to the size of the testing device 3600. Also displayed on the screen of the mobile device 3600 is an alignment graphic 3608. A user of the mobile device 3600 aligns the outline with the borders of the testing device 3500 and also aligns the alignment graphic 3608 with the alignment target 3510 on the testing device 3500 until the outline and the alignment graphic 3608 are superimposed upon the test device 3500 and alignment target 3510 as illustrated. As described in connection with FIG. 8B, a success indicator may appear, such as a check mark or other positive status symbol, on the aligned image when the alignment is successful. In one embodiment, successful alignment causes the camera on the mobile device 3600 to capture the current image of the testing device 3500. Other checks may occur including ensuring that the image is focused before the image is saved. The captured image of testing device 3500 also includes color mosaic 3515. The mobile device application recognizes color mosaic 3514 based upon its position in the captured image and/or other criteria, such as the arrangement of color tiles 3516 or a code imprinted with the color mosaic. The inclusion of the color mosaic in the captured image provides a means of calibrating and interpreting the results of the test. ¶ 0129-0130), and b) analyzing, by the processor, one or more of the logged rejection events in an error analysis and based on the result of the error analysis (see discussion below; and e.g., image process and analysis; steps 910, 912 & ¶ 0133 for example), adjusting the setup by placing the device in a measuring mode different from the standard measuring mode (see e.g., color shift factor or correction of test results ¶ 0123+, ¶ 0134-0135; see also ¶ 0098-0100; steps 3712, 3716, 3724, 3726, 3730 for example). Regarding the limitation “rejection criteria”, the Examiner notes that the claim does not require specific criteria, define the term “rejection”, or specify steps involved in the rejection; it is therefore sufficiently broad to have properly read on Pulitzer et al. (see i.e., alignment, focused image, color accuracy and determination ¶ 0077-0078, 0121+; color values corresponding to test results Abstract+; rating threshold ¶ 0087+; When the mobile application described herein captures an image of the testing device, in some embodiments each pixel that makes up the test line captured in the image is processed to place it on a color gradient scale. In some embodiments, this placement may be done by examining the RGB color values of the pixel. For any given test, there may be a visual color indicator (such as a test line) presented to the user of the test to indicate whether a reaction occurred. The color that is to be presented is known for the given test. Additionally, in some embodiments, the strength of the reaction will affect the strength of the color indicator. ¶ 0097; There can be seen an origin point 1902 on the chart 1900, wherein the RGB color value is (255, 255, 255) or white. This may represent a no reaction state for the test strip, since the test line on the strip may only appear as a white blank space if no reaction has occurred. [...] If a pixel has less red than a 255 value, the pixel would be plotted away from the diagonal line 1908 in relation to whichever color is more predominant. For instance, if the pixel has RGB color values of (127, 50, 205), a shade of purple, the pixel would be plotted somewhere in the lower right quadrant of the chart 1900. ¶ 0098; 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. This may be done in various ways. For example, the shade of red in all the pixels may be averaged to reach a single RGB value. Outliers may be left out so that the average is not heavily skewed, especially when there are few outliers present. This RGB value may then be given a value, such as a risk rating, ranging from 0 to 100. For example, an RGB value of (255, 255, 255) would be given a rating of 0. An RGB value of (255, 0, 0) would be given a rating of 100. An RGB value of (205, 150, 75) may be given a rating of 70, and so on. This normalized value may then be used to compare the user of the test to users of past tests to determine a risk level. In some embodiments, the control line and the test line may be captured and the results compared, as well. In addition, the real results of risk levels may also be used to adjust the stored normalized value. For instance, if a particular RGB value that seems to indicate a strong reaction repeatedly was found to not indicate an infection, this value may be adjusted to provide a lower risk rating. For instance, if a physician who saw a patient who had a (205, 150, 75) RGB value later reported to the operator of the server 1206 that further testing showed no infection was present, and if this trend continued substantially as reported by other physicians or medical organizations, subsequent test results by other test users that were near the RGB value of (205, 150, 75) may be given a lower rating. ¶ 0099; Chart 2000 illustrates how past tests results may be collected and used to determine the risk of a current test user. A y axis 2002 represents a risk level rating, ranging from 0 at the origin to 100. An x axis 2004 represents time, wherein a plurality of normalized test results is plotted on the chart 2000. The chart 2000 is further divided into sections across the y axis 2002, indicating various risk level thresholds. For instance, and as illustrated in the chart 2000, there may be at certain rating levels different thresholds of risk labeled as low, moderate, above average, and high risk levels. These thresholds may be moved over time as more data is accumulated via users conducting tests and the mobile application storing the data on the tests. When a user conducts a test, the user's normalized rating can be plotted similarly to past test results and weighed against them in order to provide a risk level for the user. ¶ 0100). The limitation “error analysis” is similarly broad to read on Pulitzer et al. (see e.g., color shift factor or correction of test results ¶ 0123+; i.e., After comparison, the differences between the color values of the captured image of the color mosaic and the known color values may be checked to determine if the differences are within a predetermined acceptable range at 3724. For example, if the red, green and blue values (RGB) for the different color tiles 3516 of the color mosaic in the captured image were all within a range of −5 to +5 of the known values, the color values of the captured image may be determined to be acceptable in which case, no color correction is necessary and the process skips to 3728. ¶ 0134; If the color values of the color matrix of the captured image are not within an acceptable range when compared to the known values, a color shift factor or correction may be determined at 3726. The color shift factor may be determined with an algorithm that uses the differences between the color values of the color mosaic of the captured image and the known color values to determine a color shift factor or factors. ¶ 0135). Regarding claim 1, Applicants’ preamble recites “the method being used when determining a concentration of an analyte in a body fluid based on a color formation reaction in an optical test strip, with a mobile device having a camera, a processor and a memory”. A preamble is generally not accorded any patentable weight where it merely recites the purpose of a process or the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the process steps or structural limitations are able to stand alone. See In re Hirao, 535 F.2d 67, 190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187 F.2d 150, 152, 88 USPQ 478, 481 (CCPA 1951). With regard to limitations in claims 1-3, 5-8, 11 (e.g., … for fulfillment of one or more measurement rejection criteria stored in the memory …, etc.), these claim limitations do not specify active method steps. It has been held that to be entitled to weight in method claims, the recited structure limitations therein must affect the method in a manipulative sense, and not to amount to the mere claiming of a use of a particular structure. It is advised to set forth the claims in conventional terminology positively reciting active method steps. Regarding claims 2-11 & 17, Pulitzer et al. teach: 2. The method according to claim 1, wherein step a) comprises checking by the processor for the fulfillment of one or more measurement rejection criteria stored in the memory based on an analysis of the one or more images captured (see ¶ 0077 for example). 3. The method according to claim 1, further comprising, in step a), obtaining sensor data (e.g., wavelengths, color value) by using at least one sensor (e.g., CMOS, CCD) of the mobile device and checking for the fulfillment of one or more measurement rejection criteria stored in the memory based on one or more of the obtained sensor data (¶ 0077-0078). 4. The method according to claim 1, wherein the one or more measurement rejection criteria comprise at least one of insufficient image sharpness, insufficient region of interest (ROI) saturation, insufficient ROI size, insufficient ROI homogeneity, insufficient steadiness, and insufficient orientation (¶ 0077-0078, 0087, 0121+). 5. The method according to claim 1, further comprising determining and providing, by the processor, an analytical measurement result value by using the one or more images captured in step a) when the measurement attempt was not rejected (e.g., negative test result step 4028, Fig. 40 & ¶ 0144). 6. The method according to claim 1, wherein step a) comprises capturing, by using the camera, at least one image of at least a part of an optical test strip having a test field before and at least one image of at least a part of an optical test strip after sample application (see ¶ 0103-0104 for example), and step a) further comprises checking, by the processor, for the fulfillment of one or more measurement rejection criteria stored in the memory based on an analysis of the at least two captured images, and when one or more measurement rejection criteria are fulfilled, rejecting, by the processor, the measurement attempt and logging the one or more rejection events in the memory (¶ 0077), and step a) further comprises determining, by the processor, an analytical measurement result value by using at least one of the at least two images and providing the analytical measurement result value to the user when the measurement attempt was not rejected based on the analysis of the at least two images (see e.g., steps 4026, 4028 in Fig. 40 & ¶ 0144). 7. The method of adjusting according to claim 1, wherein step b) comprises analyzing only the one or more rejection events logged from measurement attempts conducted when the mobile device was set in the standard measuring mode (see step 3724 for example). 8. The method according to claim 1, wherein the analyzed one or more logged rejection events are the one or more logged rejection events from one or more of: a predefined number of measurement attempts; a predefined number of logged rejection events; and a predefined timespan (see ¶ 0098-0100 & Fig. 20 for example). 9. The method according to claim 1, wherein the error analysis comprises determining the rejection event logged over all rejection events or logged (see e.g., color shift factor or correction of test results ¶ 0123+, ¶ 0134-0135; see also ¶ 0077, 0098-0100). 10. The method according to claim 1, wherein the measuring mode different from the standard measuring mode is a reduced measuring mode wherein one or more of the measurement rejection criteria are deactivated and wherein the one or more deactivated measurement rejection criteria are different from the measurement rejection event logged over all rejection events or as determined in the error analysis (see i.e., if the red, green and blue values (RGB) for the different color tiles 3516 of the color mosaic in the captured image were all within a range of −5 to +5 of the known values, the color values of the captured image may be determined to be acceptable in which case, no color correction is necessary and the process skips to 3728. ¶ 0134; see also The plurality of test functions 2102 may be buttons that can be selected by a user to switch between tests within the mobile application. ¶ 0101). 11. The method according to claim 1, further comprising: c) carrying out at least one analyte measurement attempt with the mobile device set in the reduced measuring mode, the analyte measurement attempt in the reduced measuring mode comprising: capturing, by using the camera, one or more images of at least a part of an optical test strip having a test field before and after sample application or of a dummy test strip (see ¶ 0098, 0103-0104; 0130-0133 for example), checking, by the processor, for the fulfillment of one or more measurement rejection criteria stored in the memory that are not deactivated (see i.e., steps 3718-3732 in Fig. 37; steps 4018-4028 in Fig. 40), and when one or more measurement rejection criteria which are not deactivated are fulfilled rejecting, by the processor, the measurement attempt (see i.e., steps 3718-3732 in Fig. 37; steps 4018-4028 in Fig. 40; see also If the color values of the color matrix of the captured image are not within an acceptable range when compared to the known values, a color shift factor or correction may be determined at 3726. The color shift factor may be determined with an algorithm that uses the differences between the color values of the color mosaic of the captured image and the known color values to determine a color shift factor or factors. ¶ 0135; The plurality of test functions 2102 may be buttons that can be selected by a user to switch between tests within the mobile application. ¶ 0101). 17. The method according to claim 1, wherein the measuring mode different from the standard measuring mode is a reduced measuring mode wherein one or more of the measurement rejection criteria are deactivated (see i.e., if the red, green and blue values (RGB) for the different color tiles 3516 of the color mosaic in the captured image were all within a range of −5 to +5 of the known values, the color values of the captured image may be determined to be acceptable in which case, no color correction is necessary and the process skips to 3728. ¶ 0134; see also The plurality of test functions 2102 may be buttons that can be selected by a user to switch between tests within the mobile application. ¶ 0101). Response to Arguments Applicant's arguments filed 01/29/2026 have been fully considered but they are not persuasive. 35 USC § 112 rejections have been revised. In response to the Applicant's argument that “Pulitzer fails to teach or suggest logging rejection events and the subsequent analysis of the logged rejected events in an error analysis. Clearly, Pulitzer also fails to adjust the setup by placing the device in a measuring mode different from the standard measuring mode based upon the result of the error analysis as called for in claim 1”, Examiner disagrees. Pulitzer et al. teach, among other things, rejecting, by the processor, the measurement attempt when one or more measurement rejection criteria are fulfilled, and logging the one or more rejection events in the memory (see i.e., In FIG. 8B, there is shown the result of a successful alignment of the outline 806 with the testing device 300 and successful alignment of the crosshair graphic 808 with the crosshair 310 on the testing device 300. As shown in FIG. 8B, once aligned, a success indicator 812 may appear, such as a check mark or other positive status symbol, on the aligned image. Successful alignment causes the camera on the mobile device 802 to capture the current image of the testing device 300. Other checks may occur, including ensuring that the image is focused before the image is saved. This image is then processed to determine a result based on the severity of the reaction occurring on the test strip. The mobile device application performs an analysis of the test line captured in the image, counting the number of colored pixels, as well as determining the intensity of the color. The mobile device may then compare this number and color intensity to that in the control line, providing a mathematical evaluation of the test line. ¶ 0077; At decision block 1110, it is determined whether the ratings for each condition exceed a certain threshold for that condition. ¶ 0087; When the mobile application described herein captures an image of the testing device, in some embodiments each pixel that makes up the test line captured in the image is processed to place it on a color gradient scale. ¶ 0097; FIG. 36 is a top view of a mobile device 3600 using an application for testing device image capture and image processing. The mobile device application allows for an image of a testing device, such as testing device 3500, to be captured using a camera installed on mobile device 3600 having a screen 3604. While the mobile device 3600 displays on the screen 3604 the scene captured by the camera, the mobile device application may also display a graphic on the screen 3604 in the form of a boxed outline 3608, similar or identical to outline 806 of FIG. 8A, the outline corresponding to the size of the testing device 3600. Also displayed on the screen of the mobile device 3600 is an alignment graphic 3608. A user of the mobile device 3600 aligns the outline with the borders of the testing device 3500 and also aligns the alignment graphic 3608 with the alignment target 3510 on the testing device 3500 until the outline and the alignment graphic 3608 are superimposed upon the test device 3500 and alignment target 3510 as illustrated. As described in connection with FIG. 8B, a success indicator may appear, such as a check mark or other positive status symbol, on the aligned image when the alignment is successful. In one embodiment, successful alignment causes the camera on the mobile device 3600 to capture the current image of the testing device 3500. Other checks may occur including ensuring that the image is focused before the image is saved. The captured image of testing device 3500 also includes color mosaic 3515. The mobile device application recognizes color mosaic 3514 based upon its position in the captured image and/or other criteria, such as the arrangement of color tiles 3516 or a code imprinted with the color mosaic. The inclusion of the color mosaic in the captured image provides a means of calibrating and interpreting the results of the test. ¶ 0129-0130), and b) analyzing, by the processor, one or more of the logged rejection events in an error analysis and based on the result of the error analysis (see discussion below; and e.g., image process and analysis; steps 910, 912 & ¶ 0133 for example), adjusting the setup by placing the device in a measuring mode different from the standard measuring mode (see e.g., color shift factor or correction of test results ¶ 0123+, ¶ 0134-0135; see also ¶ 0098-0100; steps 3712, 3716, 3724, 3726, 3730 for example). Regarding the limitation “rejection criteria”, the Examiner notes that the claim does not require specific criteria, define the term “rejection”, or specify steps involved in the rejection; it is therefore sufficiently broad to have properly read on Pulitzer et al. (see i.e., alignment, focused image, color accuracy and determination ¶ 0077-0078, 0121+; color values corresponding to test results Abstract+; rating threshold ¶ 0087+; When the mobile application described herein captures an image of the testing device, in some embodiments each pixel that makes up the test line captured in the image is processed to place it on a color gradient scale. In some embodiments, this placement may be done by examining the RGB color values of the pixel. For any given test, there may be a visual color indicator (such as a test line) presented to the user of the test to indicate whether a reaction occurred. The color that is to be presented is known for the given test. Additionally, in some embodiments, the strength of the reaction will affect the strength of the color indicator. ¶ 0097; There can be seen an origin point 1902 on the chart 1900, wherein the RGB color value is (255, 255, 255) or white. This may represent a no reaction state for the test strip, since the test line on the strip may only appear as a white blank space if no reaction has occurred. [...] If a pixel has less red than a 255 value, the pixel would be plotted away from the diagonal line 1908 in relation to whichever color is more predominant. For instance, if the pixel has RGB color values of (127, 50, 205), a shade of purple, the pixel would be plotted somewhere in the lower right quadrant of the chart 1900. ¶ 0098; 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. This may be done in various ways. For example, the shade of red in all the pixels may be averaged to reach a single RGB value. Outliers may be left out so that the average is not heavily skewed, especially when there are few outliers present. This RGB value may then be given a value, such as a risk rating, ranging from 0 to 100. For example, an RGB value of (255, 255, 255) would be given a rating of 0. An RGB value of (255, 0, 0) would be given a rating of 100. An RGB value of (205, 150, 75) may be given a rating of 70, and so on. This normalized value may then be used to compare the user of the test to users of past tests to determine a risk level. In some embodiments, the control line and the test line may be captured and the results compared, as well. In addition, the real results of risk levels may also be used to adjust the stored normalized value. For instance, if a particular RGB value that seems to indicate a strong reaction repeatedly was found to not indicate an infection, this value may be adjusted to provide a lower risk rating. For instance, if a physician who saw a patient who had a (205, 150, 75) RGB value later reported to the operator of the server 1206 that further testing showed no infection was present, and if this trend continued substantially as reported by other physicians or medical organizations, subsequent test results by other test users that were near the RGB value of (205, 150, 75) may be given a lower rating. ¶ 0099; Chart 2000 illustrates how past tests results may be collected and used to determine the risk of a current test user. A y axis 2002 represents a risk level rating, ranging from 0 at the origin to 100. An x axis 2004 represents time, wherein a plurality of normalized test results is plotted on the chart 2000. The chart 2000 is further divided into sections across the y axis 2002, indicating various risk level thresholds. For instance, and as illustrated in the chart 2000, there may be at certain rating levels different thresholds of risk labeled as low, moderate, above average, and high risk levels. These thresholds may be moved over time as more data is accumulated via users conducting tests and the mobile application storing the data on the tests. When a user conducts a test, the user's normalized rating can be plotted similarly to past test results and weighed against them in order to provide a risk level for the user. ¶ 0100). The limitation “error analysis” is similarly broad to read on Pulitzer et al. (see e.g., color shift factor or correction of test results ¶ 0123+; i.e., After comparison, the differences between the color values of the captured image of the color mosaic and the known color values may be checked to determine if the differences are within a predetermined acceptable range at 3724. For example, if the red, green and blue values (RGB) for the different color tiles 3516 of the color mosaic in the captured image were all within a range of −5 to +5 of the known values, the color values of the captured image may be determined to be acceptable in which case, no color correction is necessary and the process skips to 3728. ¶ 0134; If the color values of the color matrix of the captured image are not within an acceptable range when compared to the known values, a color shift factor or correction may be determined at 3726. The color shift factor may be determined with an algorithm that uses the differences between the color values of the color mosaic of the captured image and the known color values to determine a color shift factor or factors. ¶ 0135). Applicant is thanked for their thoughtful amendments to the claims. Conclusion Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a). A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action. Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEAN KWAK whose telephone number is (571)270-7072. The examiner can normally be reached M-TH, 4:30 am - 2:30 pm EST. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, CHARLES CAPOZZI can be reached at (571)270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /DEAN KWAK/Primary Examiner, Art Unit 1798 DEAN KWAK Primary Examiner Art Unit 1798
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Prosecution Timeline

Jun 22, 2022
Application Filed
Aug 30, 2025
Non-Final Rejection — §102, §112, §Other
Jan 29, 2026
Response Filed
Mar 05, 2026
Final Rejection — §102, §112, §Other (current)

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

3-4
Expected OA Rounds
58%
Grant Probability
97%
With Interview (+38.3%)
4y 1m
Median Time to Grant
Moderate
PTA Risk
Based on 650 resolved cases by this examiner. Grant probability derived from career allow rate.

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