Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
Acknowledgment is made of applicant's claim for foreign priority based on applications filed in Japan on 05/11/2023 and 04/17/2024. It is noted, however, that applicant has not filed a certified copy of the JP2024-067026 and JP2023-078865 application as required by 37 CFR 1.55. The PTO was unable to retrieve the priority applications using the Access Codes applicant provided.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
1. Claims 1-3 are rejected under 35 USC 103 as being unpatentable over U.S. Patent Application Publication No. 2023/0095831 to Ehrenkranz. (cited by applicant)
Ehrenkranz discloses devices and methods for performing point of care diagnostic tests for detecting and quantifying at least one of the activity level or the concentration of an enzyme or a biochemical analyte in a biological sample. [0006]
Referring to Fig. 7A, Ehrenkranz teaches a target device 500 is illustrated. The target device 500 can be used to normalize/calibrate the response of at least one of the camera or the light source of the testing device. In one embodiment, the target device may located on an interior surface 325 of the assay housing 320 in close proximity to the cassette port 270 in an area that can be illuminated by a light source that will be employed for illumination of an assay cassette and viewable by a camera of a testing device that is going to be used to capture data from the cassette. For example, the target device may have a known color and/or color intensity that can give a known response for calibrating the light source and the camera. In addition, the target device 500 can be used to ensure that the light source and the camera are directed at the proper point when the testing device in inserted into the housing. [0083]
Using a target device having a known color and/or light intensity to give a known response for calibrating the light source and camera is interpreted as involving taking a pre-measurement image for calibration purposes or otherwise rendering it obvious to take a pre-measurement image for calibration purposes.
In paragraph [0043] Ehrenkranz teaches that analyte(s) of interest (e.g., enzyme(s) or enzyme substrate(s)) and the first and second calibration standards can be detected on their various target lines, 140, 150a, and 150b, respectively, with various reporters. The reporters 160 for each of the various target lines, 140, 150a, and 150b, may be the same or different. Examples of suitable reporters include, but are not limited to, visible and fluorescent dyes, gold nanoparticles, silver nanoparticles, titanium nanoparticles, europium fluorophores, quantum dots, latex beads, enzymes, and the like.
The target lines of Ehrenkranz read on a plurality of measurement sites.
In paragraph [0010] Ehrenkranz teaches that the algorithm then can….perform background subtraction to determine a calibration for the image, and in paragraph [0009] teaches where the image was acquired with uneven illumination, a background correction can be applied to equalize the pixel values from the different sides of both the membrane and calibration region.
Thus, Ehrenkranz teaches equalizing fluorescence intensity of the measurement sites that is used to correct the luminescence intensity for each measurement site in the measurement images (see below) in the arithmetic value of the measurement sites.
In paragraph [0044] Ehrenkranz teaches illumination by the light source 180 may produce a detectable signal that includes at least one of emission (e.g., fluorescence), color, reflectance, diffuse scattering (i.e., scattering and absorbance), elastic light scattering, chemiluminescence, chemifluorescence, transmission, or absorbance from the reporters. A lens 190 (e.g., a collimating lens) and a detector (e.g., a CCD or CMOS camera) are used to collect data from the reporters and the first and second calibration standards, thus teaching photographing measurement images of the test device before a sample is introduced for calibration purposes and after a sample is introduced for analysis purposes.
In paragraph [0094] Ehrenkranz teaches that in one embodiment, a light source may be positioned at a certain angle to the lateral flow assay cassette and the detector (e.g., a detection fiber or a cell phone camera) or fiber (eventually the cellphone camera CCD). In one embodiment, the reporter(s) may be queried by taking a reading from each reporter (of the target lines) and calculating the intensity of the scattered light. Signal intensity (i.e., the amount of scattered light that is detected) decreases as the concentration of the analyte of interest increases, thus teaching measuring luminescence intensity for each measurement site corresponding to each measurement site of the pre-measurement image in the photographed measurement image.
I.) Regarding applicant’s claim 1, as noted above Ehrenkranz renders all the limitations of claim 1 obvious.
Therefore, Ehrenkranz renders claim 1 obvious.
II.) Regarding applicant’s claim 2, as noted above Ehrenkranz renders claim 1 obvious from which claim 2 depends.
Claim 2 recites that the plurality of measurement sites are set along a direction in which the sample introduced in the test piece moves.
As shown in Fig. 1A of Ehrenkranz, the measurement sites are set along a direction in which the sample introduced in the test piece moves.
Therefore, Ehrenkranz renders claim 2 obvious.
III.) Regarding applicant’s claim 3, as noted above Ehrenkranz renders claim 2 obvious from which claim 3 depends.
Claim 3 recites that the arithmetic value is specified based on an average value of luminescence intensities obtained along a direction orthogonal to the direction in which the sample moves in each of the measurement sites.
As noted above, Ehrenkranz teaches where the image was acquired with uneven illumination, a background correction can be applied to equalize the pixel values from the different sides of both the membrane and calibration region.
Pixel values that are equalized (having arithmetic values equalized) would be along a direction orthogonal to the direction in which the sample moves in each of the measurement sites, absent Ehrenkranz teaching excluding some pixels.
Therefore, Ehrenkranz renders claim 3 obvious.
2. Claims 4-6 are rejected under 35 USC 103 as being unpatentable over Ehrenkranz.
As noted above, Ehrenkranz discloses devices and methods for performing point of care diagnostic tests for detecting and quantifying at least one of the activity level or the concentration of an enzyme or a biochemical analyte in a biological sample. [0006]
Referring to Fig. 7A, Ehrenkranz teaches a target device 500 is illustrated. The target device 500 can be used to normalize/calibrate the response of at least one of the camera or the light source of the testing device. In one embodiment, the target device may located on an interior surface 325 of the assay housing 320 in close proximity to the cassette port 270 in an area that can be illuminated by a light source that will be employed for illumination of an assay cassette and viewable by a camera of a testing device that is going to be used to capture data from the cassette. For example, the target device may have a known color and/or color intensity that can give a known response for calibrating the light source and the camera. In addition, the target device 500 can be used to ensure that the light source and the camera are directed at the proper point when the testing device in inserted into the housing. [0083]
Using a target device having a known color and/or light intensity to give a known response for calibrating the light source and camera is interpreted as involving taking a pre-measurement image for calibration purposes or otherwise rendering it obvious to take a pre-measurement image for calibration purposes.
In paragraph [0043] Ehrenkranz teaches that analyte(s) of interest (e.g., enzyme(s) or enzyme substrate(s)) and the first and second calibration standards can be detected on their various target lines, 140, 150a, and 150b, respectively, with various reporters. The reporters 160 for each of the various target lines, 140, 150a, and 150b, may be the same or different. Examples of suitable reporters include, but are not limited to, visible and fluorescent dyes, gold nanoparticles, silver nanoparticles, titanium nanoparticles, europium fluorophores, quantum dots, latex beads, enzymes, and the like.
The target lines of Ehrenkranz read on a plurality of measurement sites.
In paragraph [0010] Ehrenkranz teaches that the algorithm then can….perform background subtraction to determine a calibration for the image, and in paragraph [0009] teaches where the image was acquired with uneven illumination, a background correction can be applied to equalize the pixel values from the different sides of both the membrane and calibration region.
Thus, Ehrenkranz teaches equalizing fluorescence intensity of the measurement sites that is used to correct the luminescence intensity for each measurement site in the measurement images (see below) in the arithmetic value of the measurement sites.
In paragraph [0044] Ehrenkranz teaches illumination by the light source 180 may produce a detectable signal that includes at least one of emission (e.g., fluorescence), color, reflectance, diffuse scattering (i.e., scattering and absorbance), elastic light scattering, chemiluminescence, chemifluorescence, transmission, or absorbance from the reporters. A lens 190 (e.g., a collimating lens) and a detector (e.g., a CCD or CMOS camera) are used to collect data from the reporters and the first and second calibration standards, thus teaching photographing measurement images of the test device before a sample is introduced for calibration purposes and after a sample is introduced for analysis purposes.
In paragraph [0094] Ehrenkranz teaches that in one embodiment, a light source may be positioned at a certain angle to the lateral flow assay cassette and the detector (e.g., a detection fiber or a cell phone camera) or fiber (eventually the cellphone camera CCD). In one embodiment, the reporter(s) may be queried by taking a reading from each reporter (of the target lines) and calculating the intensity of the scattered light. Signal intensity (i.e., the amount of scattered light that is detected) decreases as the concentration of the analyte of interest increases, thus teaching measuring luminescence intensity for each measurement site corresponding to each measurement site of the pre-measurement image in the photographed measurement image.
In paragraph [0075] Ehrenkranz discloses that while the hand held device’s 250 light source (not shown) can be used to illuminate the lateral flow enzymatic assay cassette 105, the enzyme-based diagnostic testing system 240 may also include one or more additional light sources that can be housed in either the assay housing 320 or the main body housing 310.
In paragraph [0069] Ehrenkranz discloses that the testing 250 device can be essentially any cell phone device, digital camera device, or a similar device that has an onboard camera/image capture function, data collection and analysis capabilities, data and results display capabilities.
Thus, Ehrenkranz teaches the light source and photographing unit recited in claim 4.
I.) Regarding applicant’s claim 4, as noted above Ehrenkranz renders all the elements of claim 4 obvious.
Therefore, Ehrenkranz renders claim 4 obvious.
II.) Regarding applicant’s claim 5, as noted above Ehrenkranz renders claim 4 obvious from which claim 5 depends.
Claim 5 recites that the plurality of measurement sites are set along a direction in which the sample introduced in the test piece moves.
As shown in Fig. 1A of Ehrenkranz, the measurement sites are set along a direction in which the sample introduced in the test piece moves.
Therefore, Ehrenkranz renders claim 5 obvious.
III.) Regarding applicant’s claim 6, as noted above Ehrenkranz renders claim 5 obvious from which claim 6 depends.
Claim 6 recites that the arithmetic value is specified based on an average value of luminescence intensities obtained along a direction orthogonal to the direction in which the sample moves in each of the measurement sites.
As noted above, Ehrenkranz teaches where the image was acquired with uneven illumination, a background correction can be applied to equalize the pixel values from the different sides of both the membrane and calibration region.
Pixel values that are equalized (having arithmetic values equalized) would be along a direction orthogonal to the direction in which the sample moves in each of the measurement sites, absent Ehrenkranz teaching excluding some pixels.
Therefore, Ehrenkranz renders claim 3 obvious.
VI.) Regarding applicant’s claim 7, as noted above Ehrenkranz renders claim 4 obvious from which claim 7 depends.
Claim 7 recites a mobile device having a camera as the photographing unit; a housing configured to hold the mobile device; and a holding unit into which the test piece is inserted, the holding unit being provided with the light source and attached to the housing, wherein a central processing unit of the mobile device functions as the analysis unit.
As shown in Fig. 5A Ehrenkranz teaches a mobile device having a camera as the photographing unit; a housing 310 configured to hold the mobile device; and a holding unit into which the test piece 105 is inserted, the holding unit being provided with the light source and attached to the housing. [0072]
In paragraph [0069] Ehrenkranz teaches that the testing device can be a cell phone device, digital camera device, or a similar device that has an onboard camera/image capture function, data collection and analysis capabilities, data and results display capabilities, and, preferably, the ability to communicate with one or more remote computer networks through a cellular telephone network for data upload, querying a data analysis algorithm, querying a decision support algorithm, and the like.
Therefore, Ehrenkranz renders claim 7 obvious.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
U.S. Patent Application Publication No. 2018/0149599 to Humphrey teaches normalizing emission intensity. (Figs. 13 and 18)
U.S. Patent Application Publication No. 2008/0278722 to Cunningham et al. teaches averaging intensity from fluorophores. [0024]
U.S. Patent Application Publication No. 2004/0076325 to Wada et al. (cited by applicant) teaches some pixels in the vicinity of the brightest pixel within an image are selected so that by using the average value of these pixel outputs, linearizing correction data is formed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL S. GZYBOWSKI whose telephone number is (571)270-3487. The examiner can normally be reached M-F 8:30-5:00.
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/MICHAEL STANLEY GZYBOWSKI/Examiner, Art Unit 1798
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