DETAILED CORRESPONDENCE
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 1/3/24, 10/30/24 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Status
Claims 1-19 are pending.
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 1-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim 1 is rejected based on the following analysis:
Step 2A, Prong One: Identify the law of nature/natural phenomenon/abstract ideas.
Claim 1 recites the abstract ideas of “processor configured to perform a main determination” in lines 6-8 and 14-16, which are mental processes.
Although a processor is used, MPEP 2106.04(a)(2)III is clear that using a computer/controller to perform the abstract idea does not preclude the steps from being considered an abstract idea.
Step 2A Prong Two: Has the abstract idea been integrated into a particular practical application?
No. Once the determination is made then no action is taken and therefore there is no application.
The claim also recites an assay apparatus with a loading part and an imaging unit to image the assay region. However, this is just using the assay apparatus and imaging unit to gather data to be used in the abstract idea. However, data gathering to be used in the abstract idea does not integrate the judicial exception into a practical application because data gathering is insignificant extra-solution activity, and not a particular practical application. See MPEP 2106.05(g). Additionally, this is recited at such a high level of generality that it amounts to just generally applying the abstract idea per MPEP 2106.05(f), and/or also is just generally linking the abstract idea to a field of use per MPEP 2106.05(h), which are not particular practical applications.
The abstract idea is performed by a computer/controller/processor, but performing the abstract idea on a general-purpose computer is not enough to integrate the exception into a practical application (MPEP 2106.05(b)I.).
Step 2B: Does the claim recite any elements which are significantly more than the abstract idea?
The claim recites the additional elements of an assay apparatus with a loading part and an imaging unit. These additional elements do not amount to significantly more as they are well-understood, routine, and conventional (WURC) in the art as evidenced by Ding et al (WO 2021092595 where US 20220404342 is used as the corresponding document; hereinafter “Ding”) and Uchida et al (US 20110244590; hereinafter “Uchida”; already of record). Ding discusses an assay apparatus with a loading part and an imaging unit; [7, 221-225, 236-239], Fig. 2. Uchida discusses an assay apparatus with a loading part and an imaging unit; [64, 72-73], Fig. 1-2.
The dependent claims 2-19 undergo a similar analysis and do not appear to resolve any of the above issues, and are therefore similarly rejected. Claims 2-3 describe “selecting” which is an abstract idea under step 2A prong one, where there is no application under step 2A prong two. Claims 4-5 describe “deriving” which is math and/or a mental process and “determining” which are abstract ideas under step 2A prong one, where there is no application under step 2A prong two. Claim 6 further describes the imaging device which is still used to gather data under step 2A prong two, and where the imaging device with an image sensor is WURC as evidenced by the cited references above. Claim 6 also describes generating a profile which is a mental step as it could be done by the computer or with pencil and paper under step 2A prong one, and even if this were displaying then this does not integrate the exception into a practical application because notifying is insignificant post-solution activity and not a particular practical application, similar to the alarm in Parker v. Flook. See MPEP 2106.04(d) and 2106.05(g). Claim 7 further describes dividing the image and determining which are both abstract ideas under step 2A prong one, where there is no application under step 2A prong two. Claims 8-12, 14, 18 describe the abstract ideas of “determining” and/or “deriving” in more detail under step 2A prong one, where there is no application under step 2A prong two. As best understood, claim 13 also recites details the abstract ideas of “determining” under step 2A prong one, where there is no application under step 2A prong two, and even if this were displaying then this does not integrate the exception into a practical application because notifying is insignificant post-solution activity and not a particular practical application, similar to the alarm in Parker v. Flook. See MPEP 2106.04(d) and 2106.05(g). Claims 15, 16, 17, 19 recite details the abstract ideas of “presenting” which could be a determining step (as best understood) under step 2A prong one, where there is no application under step 2A prong two, and even if this were displaying then this does not integrate the exception into a practical application because notifying is insignificant post-solution activity and not a particular practical application, similar to the alarm in Parker v. Flook. See MPEP 2106.04(d) and 2106.05(g).
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.
Claims 1-19 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 pre-AIA the applicant regards as the invention.
As to claim 1, it is unclear what high density pixels is attempting to define in the second to last line of the claim. What defines “high” density? This seems subjective and it is unclear what would or would not be high density. Further, it is unclear what high-density pixels is even describing. What would a high-density pixel be defined by? An imager would produce a plurality of pixels and the data in each of those pixels should be the same. How are some of the pixels different in density from other pixels?
Regarding claim 1, it is unclear what plural “columns” applicants are attempting to describe in the last two lines of the claim. Previously, the assay region is described as having a line-shaped region in the column direction, and there is a two-dimensional matrix forming the pixels. However, this does not mean there are multiple columns. Specifically, there could be a single line/column of pixels and multiple rows of pixels. It is unclear whether or not multiple columns of pixels is required? Further, it is unclear if the multiple columns of pixels are separate assay regions or within the same assay region. Are multiple assay regions required? A potential infringer would not understand whether a single column or multiple columns are required by the claims. Several dependent claims also recite plural columns, and are rejected similarly (non-limiting examples including claims 4, 5, 6, 7, 12)
Claims 2-19 are rejected based on further claim dependency.
As to claim 14, it is unclear how the main determination could not be performed as recited in the last two lines. Specifically, claim 1 requires the main determination to be present. Therefore, it is unclear how claim 14, which requires all the limitations of claim 1 (including the main determination) would then not perform the main determination. This creates conflicting ambiguity and a potential infringer would not understand whether or not an invention that did not perform the main determination would infringe on claim 14.
Regarding claim 16, it is unclear how the processor presents the assay region, and what this language is intending to describe. Is the processor “determining” or “displaying”. If the processor presenting is intended to be a display to a user, then the claims should be clarified to reflect this because a processor alone cannot “present” things as currently interpreted. If the processor is just making determinations, then the language should be clarified to accurately reflect applicants’ intent. Claims 17 and 19 are similarly rejected because they recite similar limitations.
Appropriate correction and/or clarification is required.
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 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 1 is rejected under 35 U.S.C. 102a1 as being anticipated by Baker et al (Baker Alexander et al; “Lateral flow glycol-assays for the rapid and low-cost detection of lectins-polymeric linkers and particle engineering are essential for selectivity and performance”; Advanced Healthcare Materials; vol. 11, issue 4, published 11/17/21; already of record; hereinafter “Baker”).
As to claim 1, Baker teaches an immunochromatographic assay apparatus (Baker; Fig. 2, and page 10 of 11) comprising: a loading part in which a cartridge including a carrier having a spotting region on which a sample is spotted and an assay region in which a color development state changes depending on whether the sample is positive or negative, is attachably and detachably loaded; an imaging unit that images the assay region; and a processor configured to perform a main determination, which is a determination of whether the sample is positive or negative, based on an assay region image of the assay region imaged by the imaging unit, wherein in a case where a development direction of the sample in the carrier is a row direction and a direction intersecting the row direction is a column direction, the assay region is a line-shaped region extending along the column direction, the assay region image is an image in which a plurality of pixels are two-dimensionally arranged in a matrix form, and the processor is configured to perform the main determination using residual pixels excluding one or more high-density pixels having a relatively high density in each of the columns of the assay region image (The examiner notes that the carrier and the assay regions are not positively recited as they are not part of the claimed apparatus, and are related to intended use of the loading part. Baker teaches a strip in figure 2 which is loaded into an imaging device; page 10 of 11 and section 4. Baker teaches that noise was removed/excluded and that pixels contributing to the signal peak was excluded; section 4).
Note: The instant Claims contain a large amount of functional language (ex: “configured to…”). However, functional language does not add any further structure to an apparatus beyond a capability. Apparatus claims must distinguish over the prior art in terms of structure rather than function (see MPEP 2114 and 2173.05(g)). Therefore, if the prior art structure is capable of performing the function, then the prior art meets the limitation in the claims.
Claim Rejections - 35 USC § 103
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.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-19 are rejected under 35 U.S.C. 103 as being unpatentable over Ding et al (WO 2021092595 where US 20220404342 is used as the corresponding document; hereinafter “Ding”) alone or alternatively in view of Georgescu et al (US 20180260609; hereinafter “Georgescu”).
As to claim 1, Ding teaches an immunochromatographic assay apparatus (Ding; Figs. 1-2, [54]) comprising: a loading part in which a cartridge including a carrier having a spotting region on which a sample is spotted and an assay region in which a color development state changes depending on whether the sample is positive or negative, is attachably and detachably loaded; an imaging unit that images the assay region; and a processor configured to perform a main determination, which is a determination of whether the sample is positive or negative, based on an assay region image of the assay region imaged by the imaging unit, wherein in a case where a development direction of the sample in the carrier is a row direction and a direction intersecting the row direction is a column direction, the assay region is a line-shaped region extending along the column direction, the assay region image is an image in which a plurality of pixels are two-dimensionally arranged in a matrix form, and the processor is configured to perform the main determination using residual pixels excluding one or more low-density pixels having a relatively low density in each of the columns of the assay region image (Ding teaches a VFA/LFA strip that is carrier with bars/lines/columns for analytes in figure 1; [29, 42]. Ding teaches an imaging device with an adapter/slider/holder as the loading part to connect the carrier to the imager; [7, 221-225, 236-239], Fig. 2. Ding teaches a processor, where the processor determines the presence or absence of the sample/analyte; [91, 249, 304, 332, 344, 348, 352]. Ding teaches dividing up each of the imaged assay region into subregions, which create a heatmap/matrix of the pixels and determine highest and lowest pixel values; [6, 275, 282-286, 293]. Ding teaches removing the highest pixel values from the heatmap/matrix to help in the determination; [284-285]. As best understood, the examiner notes that a larger pixel value correlates to a lower pixel density, while a smaller pixel value correlates to a higher pixel density, as described in [127-128] of applicants instant specification).
Note: The instant Claims contain a large amount of functional language (ex: “configured to…”). However, functional language does not add any further structure to an apparatus beyond a capability. Apparatus claims must distinguish over the prior art in terms of structure rather than function (see MPEP 2114 and 2173.05(g)). Therefore, if the prior art structure is capable of performing the function, then the prior art meets the limitation in the claims.
Ding teaches that using all of the optical data can cause the analysis to include unwanted errors where it is desirable to correct the data (Ding; [5, 91-94]), and that algorithms are used to help determine actual analytes from false positives (Ding; [295]). Although Ding teaches excluding outlier pixels, including low-density pixels, Ding also suggests in another embodiment that high-density pixels can be removed (Ding suggest that smaller heatmap/matrix pixel values, which correlate to higher pixel density, can be removed during analysis; [293]). It would have been obvious to one of ordinary skill in the art to have modified the determination of the presence of the analyte based on an exclusion of pixels of Ding to have excluded high-density pixels as suggested by Ding because Ding teaches that using all of the optical data can cause the analysis to include unwanted errors or false positives (Ding; [5, 295]) and Ding suggests that removing the outliers as the highest and smallest values helps to improve the assay results (Ding; [284-285, 293]). However, if it is deemed that Ding does not specifically teach the main determination excludes one or more high-density pixels, then Georgescu teaches the analogous art of analysis of samples images where pixels that are high density or low density can be excluded (Georgescu teaches that during the analysis, that removal of outlying pixels helps to create a noise free analysis; [21]. Georgescu teaches that pixels that are too bright (higher pixel value which equals lower pixel density) or pixels that are too dark (lower pixel value which equals higher pixel density) can be removed to create a noise-free analysis; [21, 25, 27]). It would have been obvious to one of ordinary skill in the art to have modified the determination of the presence of the analyte based on an exclusion of low-density pixels of Ding to have excluded high-density pixels as taught by Georgescu because Georgescu teaches that excluding low density and high density pixels are obvious variants (Georgescu; [21, 25, 27]) and because Georgescu teaches that excluding the high density pixels creates a noise free analysis (Georgescu; [21, 25, 27]).
As to claim 2, modified Ding teaches the immunochromatographic assay apparatus according to claim 1, wherein the processor is configured to select a plurality of pixels from a highest density pixel to a pixel of preset order in each of the columns as the high-density pixels (The modification of the determination of the presence of the analyte based on exclusion of pixels of Ding to exclude the high density pixels of Ding/Georgescu has been discussed above; see claim 1 citations).
As to claim 3, modified Ding teaches the immunochromatographic assay apparatus according to claim 2, wherein the number of pixels selected as the high-density pixels is the same in each of the columns (In as much as claimed and as best understood (see 112(b) rejection above, the modification of the determination of the presence of the analyte based on exclusion of pixels of Ding to exclude the high density pixels of Ding/Georgescu has been discussed above; see claim 1 citations).
As to claim 4, modified Ding teaches the immunochromatographic assay apparatus according to claim 1, wherein for each of the columns, the processor is configured to derive a representative value of each of the columns using the residual pixels, and perform the main determination using the derived representative values of the respective columns (In as much as claimed and as best understood (see 112(b) rejection above, the modification of the determination of the presence of the analyte based on exclusion of pixels of Ding to exclude the high density pixels of Ding/Georgescu has been discussed above; see claim 1 citations. Ding also teaches the signal average can be used as a representative value; [94, 118]).
As to claim 5, modified Ding teaches the immunochromatographic assay apparatus according to claim 4, wherein the processor is configured to derive, as the representative value of each of the columns, a pixel value of one pixel selected from the residual pixels in each of the columns according to a preset reference or an average pixel value of two or more pixels selected from the residual pixels in each of the columns according to a preset reference (In as much as claimed and as best understood (see 112(b) rejection above, the modification of the determination of the presence of the analyte based on exclusion of pixels of Ding to exclude the high density pixels of Ding/Georgescu has been discussed above; see claim 1 citations. Ding also teaches the signal average can be used as a representative value; [94, 118]).
As to claim 6, modified Ding teaches the immunochromatographic assay apparatus according to claim 4, wherein the imaging unit is an image sensor that images an observation region including the assay region to output an observation image including the observation region, the observation image is an image in which a plurality of pixels are two-dimensionally arranged in a matrix form, and the processor is configured to generate a profile in the row direction based on the representative values of the respective columns in the observation image, and extract an assay region profile corresponding to the assay region from the generated profile or extract the assay region image corresponding to the assay region from the observation image based on the profile (In as much as claimed and as best understood (see 112(b) rejection above, the modification of the determination of the presence of the analyte based on exclusion of pixels of Ding to exclude the high density pixels of Ding/Georgescu has been discussed above; see claim 1 citations. Ding teaches heatmap/matrix of the pixels which create a profile in rows and columns; [6, 275, 282-286, 293]).
As to claim 7, modified Ding teaches the immunochromatographic assay apparatus according to claim 6, wherein the processor is configured to divide the assay region image into a plurality of areas extending in the row direction, derive an average value or a center value of each column in the areas, which is obtained by using at least a part of a plurality of pixels included in each of the columns, and generate an area profile in the row direction for each of the areas by using the derived average value or the derived center value, and in the main determination, execute a condition determination processing using the area profile derived for each of the areas (In as much as claimed and as best understood (see 112(b) rejection above, the modification of the determination of the presence of the analyte based on exclusion of pixels of Ding to exclude the high density pixels of Ding/Georgescu has been discussed above; see claim 1 citations. Ding teaches heatmap/matrix of the pixels which create a profile in rows and columns; [6, 275, 282-286, 293]. Ding teaches determining the center; [282, 284]. Ding also teaches the signal average can be used as a representative value; [94, 118]).
As to claim 8, modified Ding teaches the immunochromatographic assay apparatus according to claim 7, wherein the processor is configured to execute, as the condition determination processing, at least one of the first, second, or third condition determination processing for determining whether or not a value derived based on the area profile satisfies a preset condition, and determine that the sample is negative in a case where even one of the conditions is not satisfied in the executed condition determination processing, or determine that the sample is positive in a case where all the conditions are satisfied in the executed condition determination processing, the first condition determination processing is a condition determination processing, in which a differential area profile obtained by differentiating the area profile for each of the areas is used, a position in the row direction showing a highest maximal value in the differential area profile is derived for each of the areas, a standard deviation at a plurality of the derived positions in the low direction is derived, and whether or not a first condition that the standard deviation is less than a preset first threshold value is satisfied is determined, the second condition determination processing is a condition determination processing, in which the differential area profile for each of the areas is added, a difference between the highest maximal value in the added addition differential area profile and an average value of maximal value other than the highest maximal value is derived, and whether or not a second condition that the difference is larger than a preset second threshold value is satisfied is determined, and the third condition determination processing is a condition determination processing, in which the area profiles for each of the areas are added, and whether or not the third condition that a value at the position in the row direction which is preset in the addition area profile is larger than the third threshold value is satisfied is determined (In as much as claimed and as best understood (see 112(b) rejection above, the modification of the determination of the presence of the analyte based on exclusion of pixels of Ding to exclude the high density pixels of Ding/Georgescu has been discussed above; see claim 1 citations. Ding teaches heatmap/matrix of the pixels which create a profile in rows and columns; [6, 275, 282-286, 293]. Ding also teaches the signal average can be used as a representative value; [94, 118]. Ding teaches various algorithms including using a reference/threshold; [296, 297]. Ding teaches correcting using the standard deviation; [5, 91-94]).
As to claim 9, modified Ding teaches the immunochromatographic assay apparatus according to claim 8, wherein the processor is configured to execute, as the condition determination processing, all of the first condition determination processing, the second condition determination processing, and the third condition determination processing (In as much as claimed and as best understood (see 112(b) rejection above, the modification of the determination of the presence of the analyte based on exclusion of pixels of Ding to exclude the high density pixels of Ding/Georgescu has been discussed above; see claim 1 citations. Ding teaches heatmap/matrix of the pixels which create a profile in rows and columns; [6, 275, 282-286, 293]. Ding also teaches the signal average can be used as a representative value; [94, 118]. Ding teaches various algorithms including using a reference/threshold; [296, 297]. Ding teaches correcting using the standard deviation; [5, 91-94]).
As to claim 10, modified Ding teaches the immunochromatographic assay apparatus according to claim 7, wherein the processor is configured to, in the main determination, determine that the sample is negative in a case where the maximum position, which is a position in the row direction showing a maximum density in the assay region profile, is located in any of both end regions of the assay region profile, in a case where the maximum position is not located in any of both the end regions, derive a center position of the assay region in the row direction and a width of the assay region, which are defined based on the maximum density and the maximum position, execute a pre-condition determination processing for determining whether or not a pre-determination condition that the maximum density is not less than a preset fourth threshold value and the center position and the width are within preset ranges is satisfied, and determine that the sample is negative in a case where the pre-determination condition is not satisfied, and execute the condition determination processing in a case where the pre-determination condition is satisfied (In as much as claimed and as best understood (see 112(b) rejection above, the modification of the determination of the presence of the analyte based on exclusion of pixels of Ding to exclude the high density pixels of Ding/Georgescu has been discussed above; see claim 1 citations. Ding teaches heatmap/matrix of the pixels which create a profile in rows and columns; [6, 275, 282-286, 293]. Ding teaches determining the center; [282, 284]. Ding also teaches the signal average can be used as a representative value; [94, 118]. Ding teaches various algorithms including using a reference/threshold; [296, 297]. Ding teaches correcting using the standard deviation; [5, 91-94]).
As to claim 11, modified Ding teaches the immunochromatographic assay apparatus according to claim 10, wherein the processor is configured to, in the main determination, in a case where it is determined in the pre-condition determination processing that the pre-determination condition is satisfied, determine whether or not the maximum density is not less than a preset fifth threshold value larger than the fourth threshold value before executing the condition determination processing, determine that the sample is positive in a case where the maximum density is not less than the fifth threshold value, and execute the condition determination processing in a case where the maximum density is less than the fifth threshold value (In as much as claimed and as best understood (see 112(b) rejection above, the modification of the determination of the presence of the analyte based on exclusion of pixels of Ding to exclude the high density pixels of Ding/Georgescu has been discussed above; see claim 1 citations. Ding also teaches the signal average can be used as a representative value; [94, 118]. Ding teaches various algorithms including using a reference/threshold; [296, 297]).
As to claim 12, modified Ding teaches the immunochromatographic assay apparatus according to claim 1, wherein the processor is configured to perform an abnormality determination for determining presence or absence of an abnormality in the assay region image, using, as a determination index, at least one of a difference between a relatively large pixel value and a relatively small pixel value in at least one column in the assay region image, a standard deviation of the pixel values of the pixels included in the at least one column, or a variation coefficient of the pixel values of the pixels included in the at least one column, or at least one of a difference between a relatively large representative value and a relatively small representative value among representative values of all rows, which is derived based on a plurality of pixels existing in different columns in the same row in the assay region image, a standard deviation of the representative values of all the rows or a variation coefficient of the representative values of all the rows, and determine a processing content related to the main determination based on the presence or absence of the abnormality (In as much as claimed and as best understood (see 112(b) rejection above, the modification of the determination of the presence of the analyte based on exclusion of pixels of Ding to exclude the high density pixels of Ding/Georgescu has been discussed above; see claim 1 citations. Ding teaches heatmap/matrix of the pixels which create a profile in rows and columns; [6, 275, 282-286, 293]. Ding teaches determining the center; [282, 284]. Ding also teaches the signal average can be used as a representative value; [94, 118]. Ding teaches various algorithms including using a reference/threshold; [296, 297]. Ding teaches correcting using the standard deviation; [5, 91-94]. Ding teaches the determination of errors/abnormalities and non-uniformities; [5, 91-95]).
As to claim 13, modified Ding teaches the immunochromatographic assay apparatus according to claim 12, wherein the processing content includes any one of whether or not to perform the main determination or a method of presenting a determination result of the main determination (In as much as claimed and as best understood (see 112(b) rejection above, the modification of the determination of the presence of the analyte based on exclusion of pixels of Ding to exclude the high density pixels of Ding/Georgescu has been discussed above; see claim 1 citations. Ding teaches making the determination of the presence or absence of the sample/analyte; [91-94, 249, 304, 332, 344, 348, 352]. Ding teaches presenting/displaying results; [99, 229]).
As to claim 14, modified Ding teaches the immunochromatographic assay apparatus according to claim 13, wherein the processor is configured to perform the main determination to present the main determination result in a case where the abnormality is absent, but not to perform the main determination in a case where the abnormality is present (Ding teaches making the determination of the presence or absence of the sample/analyte or determining abnormality/error; [5, 91-95, 249, 304, 332, 344, 348, 352]).
As to claim 15, modified Ding teaches the immunochromatographic assay apparatus according to claim 14, wherein the processor is configured to present, in a case where the main determination is not performed, that the main determination is not performed (In as much as claimed and as best understood (see 112(b) rejection above, the modification of the determination of the presence of the analyte based on exclusion of pixels of Ding to exclude the high density pixels of Ding/Georgescu has been discussed above; see claim 1 citations. Ding teaches making the determination of the presence or absence of the sample/analyte or determining abnormality/error; [5, 91-95, 249, 304, 332, 344, 348, 352]. Ding teaches presenting/displaying results, where if there was an error and the determination was not made then this would be result displayed; [99, 229]).
As to claim 16, modified Ding teaches the immunochromatographic assay apparatus according to claim 13, wherein the processor is configured to present that the assay region may be stained in a case where the abnormality is present (In as much as claimed and as best understood (see 112(b) rejection above, the modification of the determination of the presence of the analyte based on exclusion of pixels of Ding to exclude the high density pixels of Ding/Georgescu has been discussed above; see claim 1 citations. Ding teaches making the determination of the presence or absence of the sample/analyte or determining abnormality/error; [5, 91-95, 249, 304, 332, 344, 348, 352] Ding teaches presenting/displaying results, where if there was an error and the determination was not made then this would be result displayed; [99, 229]).
As to claim 17, modified Ding teaches the immunochromatographic assay apparatus according to claim 13, wherein the processor is configured to present a determination result of the main determination in a case where the abnormality is absent, or present the determination result of the main determination with reservation indicating that the assay region image has an abnormality or not present the determination result of the main determination in a case where the abnormality is present and in a case where the determination result of the main determination is positive (In as much as claimed and as best understood (see 112(b) rejection above, the modification of the determination of the presence of the analyte based on exclusion of pixels of Ding to exclude the high density pixels of Ding/Georgescu has been discussed above; see claim 1 citations. Ding teaches making the determination of the presence or absence of the sample/analyte or determining abnormality/error; [5, 91-95, 249, 304, 332, 344, 348, 352] Ding teaches presenting/displaying results; [99, 229]).
As to claim 18, modified Ding teaches the immunochromatographic assay apparatus according to claim 17, wherein the processor is configured to perform the main determination, and perform the abnormality determination in a case where a determination result is positive (Ding teaches making the determination of the presence or absence of the sample/analyte or determining abnormality/error; [5, 91-95, 249, 304, 332, 344, 348, 352] Ding teaches presenting/displaying results; [99, 229]).
As to claim 19, modified Ding teaches the immunochromatographic assay apparatus according to claim 13, wherein the processor is configured to present a determination result of the main determination in a case where the abnormality is absent, and present the determination result of the main determination with reservation indicating that the assay region image has an abnormality or not present the determination result of the main determination in a case where the abnormality is present (In as much as claimed and as best understood (see 112(b) rejection above, the modification of the determination of the presence of the analyte based on exclusion of pixels of Ding to exclude the high density pixels of Ding/Georgescu has been discussed above; see claim 1 citations. Ding teaches making the determination of the presence or absence of the sample/analyte or determining abnormality/error; [5, 91-95, 249, 304, 332, 344, 348, 352] Ding teaches presenting/displaying results; [99, 229]).
Other References Cited
The prior art of made of record and not relied upon is considered pertinent to applicant's disclosure include;
Tamura, A (US 20140073062; hereinafter “Tamura”) teaches detecting pixel values; [42, 43, 48].
Uchida et al (US 20110244590; hereinafter “Uchida”; already of record) teaches determining pixel density [67-70] in a matrix [63]; Fig. 4A.
Conclusion
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/Benjamin R Whatley/Primary Examiner, Art Unit 1798