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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after allowance or after an Office action under Ex Parte Quayle, 25 USPQ 74, 453 O.G. 213 (Comm'r Pat. 1935). Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, prosecution in this application has been reopened pursuant to 37 CFR 1.114.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“first detection unit”
“second detection unit”
in claims 1 and 4-18.
Because these claim limitation(s)are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof:
“first detection unit” – image sensor such as complementary metal oxide semiconductor (CMOS) image sensor and charge couple device (CCD) image sensor, see Specification paragraph [0086]
“second detection unit” – image sensor, see Specification paragraph [0011]
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Allowable Subject Matter
Claims 1, 5-10, and 16-18 are allowed. Reasons for allowance will be provided in the event the application becomes in condition for allowance.
Claims 11, 12, and 15 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 4 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Chou et al. (U.S.P.G. Pub. No. 2023/0408534) in view of Cheng et al. (U.S.P.G. Pub. No. 2019/0056295) in further view of Hirao (JP 2015169512A, English translation provided, see PTO-892)
Regarding claim 4, Chou et al. (U.S.P.G. Pub. No. 2023/0408534) discloses:
An immunochromatographic assay apparatus comprising:
a loading part in which a cartridge that includes a carrier having a spotting region on which a sample is spotted (Figure 1, Abstract, paragraphs [0159], sample area/sample holder) and an assay region in which a color development state changes depending on whether the sample is positive or negative, and in which a reagent is supplied to the carrier, is attachably and detachably loaded (paragraphs [0100], [0161], [1307], [1332], e.g., samples on sample plate undergo color change/pattern formation due to drying);
a first detection unit that detects a color development state in the assay region (paragraphs [0083], [0161], [1307], [1319], [1332], the image of the sample is image analyzed to determine a change in color properties);
a second detection unit that detects a generation state of bubbles generated in the assay region (Figure 8, paragraphs [0037], [0117], [0243], [0529], [0648] the system determines the presence of air bubbles in the sample); and
a processor configured to discriminate presence or absence of a change in the color development state based on the color development state detected by the first detection unit (paragraphs [0083], [0161], [1307], [1319], [1332], the image of the sample is subjected to colorimetric analysis), and discriminate the presence or absence of the change in the color development state in a case where the bubbles are discriminated to be absent based on the generation state of the bubbles detected by the second detection unit (paragraphs [0117], [0243], [0529], [0648]-[0656], the system monitors for the presence/absence of bubbles to ensure the validity of the sample; if the bubbles are present above a particular threshold, the system raises a flag regarding the trustworthiness of the sample)
wherein the second detection unit is an image sensor that images an observation region including the assay region and a peripheral region of the assay region to output an observation image including the observation region (Figure 8, paragraphs [0037], [0117], [0243], [0529], [0648] the system determines the presence of air bubbles in the sample; as shown, the camera has a field of view covering both the assay region and a periphery of the region)
Chou et al. does not explicitly disclose:
wherein the bubbles generated in the assay region are due to the supply of the reagent
wherein the processor is configured to acquire two or more of observation images having a time difference from the second detection unit, derive a difference or a ratio between pixel values, between images of a region of interest within the observation region in the two or more of observation images, and discriminate the bubbles to be absent in a case where the difference or the ratio is not more than a preset threshold value.
Cheng et al. (U.S.P.G. Pub. No. 2019/0056295) discloses:
An immunochromatographic assay apparatus comprising:
a loading part in which a cartridge that includes a carrier having a spotting region on which a sample is spotted and an assay region in which a color development state changes, and in which a reagent is supplied to the carrier, is attachably and detachably loaded (paragraphs [0009]-[0010], [0056]-[0057], [0071], an assay region in which a replenishable fluid is added that is dispensed onto a substrate (“spotting region”) Is disclosed; see paragraphs [0011], [0059], [0064] regarding color development);
a first detection unit that detects a color development state in the assay region (paragraphs [0058], [0064], [0088], the ratio of bright pixels to dark pixels is determined);
a second detection unit that detects a generation state of bubbles generated in the assay region due to the supply of the reagent (paragraph [0060], [0068], the processor detects bubbles in the assay region; paragraphs [0075] explicitly notes that bubbles may form in the reagent when antibody diluent is used in the sample); and
a processor configured to discriminate presence or absence of a change in the color development state based on the color development state detected by the first detection unit, and discriminate the presence or absence of the change in the color development state (paragraphs [0058]-[0060], [0064]-[0066], [0088], images can be checked with color thresholding to determine fluid boundaries to see if fluid needs to be added) in a case where the bubbles are discriminated to be absent based on the generation state of the bubbles detected by the second detection unit (paragraphs [0060], [0068], the bubble volume is estimated; bubble volume equal to 0 would equate to a case where bubbles are absent)
wherein the second detection unit is an image sensor that images an observation region including the assay region and a peripheral region of the assay region to output an observation image including the observation region (Figure 2, FOV of camera includes sample area and periphery)
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to combine the system of Cheng with the system of Chou such that the system detected a generation state of bubbles generated in the assay region due to the supply of the reagent as described in Cheng. The suggestion/motivation would have been in order to implement a system that “can compensate for the presence of…bubbles in the reagent….when antibody diluent is being used in the sample” (paragraph [0075] of the Cheng reference).
The combination of Cheng and Chou does not explicitly disclose:
wherein the processor is configured to derive a difference or a ratio between a pixel value, between a reference image in a state where bubbles are absent and an image of a region of interest within the observation region, and discriminate the bubbles to be absent in a case where the difference or the ratio is not more than a preset threshold value
Hirao (JP 2015169512A) discloses:
wherein the processor is configured to derive a difference or a ratio between a pixel value, between a reference image in a state where bubbles are absent and an image of a region of interest within the observation region (paragraph [0040], the peripheral portion of an image of an air bubble is darker than of a normal portion), and discriminate the bubbles to be absent in a case where the difference or the ratio is not more than a preset threshold value (paragraph [0040], based on presence or absence of that type of darker image, the portion can potentially be excluded as a bubbled region)
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to combine the system of Hirao with the combination of Chou et al. and Cheng such that the system would have been configured to derive a difference or a ratio between a pixel value, between a reference image in a state where bubbles are absent and an image of a region of interest within the observation region and discriminate the bubbles to be absent in a case where the difference or the ratio is not more than a preset threshold value as described in Hirao. The suggestion/motivation would have been in order to implement a system capable of “exclud[ing]…abnormal data such as a bubble image” (paragraph [0040] of the Hirao reference) in order to achieve more accurate judgment.
Regarding claim 13, the combination of Chou, Chang, and Hirao discloses the apparatus of the parent claim (claim 4).
Chou additionally discloses:
wherein the first detection unit is an imaging unit that images an observation region including the assay region and a peripheral region thereof, and the first detection unit and the second detection unit are used in common (Figure 8, paragraphs [0037], [0117], [0243], [0529], [0648] the system determines the presence of air bubbles in the sample; as shown, the camera has a field of view covering both the assay region and a periphery of the region)
Cheng additionally discloses:
wherein the first detection unit is an imaging unit that images an observation region including the assay region and a peripheral region thereof, and the first detection unit and the second detection unit are used in common (Figure 2, FOV of camera includes sample area and periphery)
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to combine the system of Cheng with the combination of Chou and Hirao such that the system included an imaging unit that images an observation region including the assay region and a peripheral region thereof, and the first detection unit and the second detection unit are used in common as described in Cheng. The suggestion/motivation would have been in order to implement a system that can “capture three samples” at one time and therefore promote efficiency/productivity (paragraph [0057] of the Cheng reference).
Claim(s) 14 is rejected under 35 U.S.C. 103 as being unpatentable over Chou in view of Cheng and Hirao, in further view of Ohara (WO 2020/0045625).
Regarding claim 14, the combination of Chou, Chang, and Hirao discloses the apparatus of the parent claim (claim 4).
The combination of Chou and Chang does not explicitly disclose:
wherein the cartridge includes a cover member that covers the carrier, and in the cover member, has a gap of 0.01 to 1 mm in which a reagent is supplied between a surface of the carrier in the assay region and the cover member, and the reagent is developed in the assay region using the gap as a flow channel.
Ohara discloses:
wherein the cartridge includes a cover member that covers the carrier, and in the cover member, has a gap of 0.01 to 1 mm in which a reagent is supplied between a surface of the carrier in the assay region and the cover member, and the reagent is developed in the assay region using the gap as a flow channel (Figures 1-3, paragraphs [0027], [0052], [0066]-[0078], gap between back surface flow path forming portion and insoluble carrier in the range of .01 mm to 1 mm)
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to combine the system of Ohara with the combination of Chou, Cheng, and Hirao such that the system would have been configured with a cover member that covers the carrier, and in the cover member, has a gap of 0.01 to 1 mm in which a reagent is supplied between a surface of the carrier in the assay region and the cover member, and the reagent is developed in the assay region using the gap as a flow channel as described in Ohara. The suggestion/motivation would have been in order to implement a system capable of having “the amplification solution or the like can be sufficiently infiltrated…[while] capillary force is exerted” (paragraph of the [0077] of the Ohara reference).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN R WALLACE whose telephone number is (571)270-1577. The examiner can normally be reached Monday-Friday from 8:30-5 PM.
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, Benny Tieu can be reached at 571-272-7490. 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.
/JOHN R WALLACE/ Primary Examiner, Art Unit 2682
Prosecution Insights