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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/16/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
The information disclosure statement (IDS) submitted on 12/19/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Preliminary Amendment
The preliminary amendment filed 12/19/2024 has been entered.
Claims 4, 9 and 11 have been amended.
Claims 12-17 have been added.
Claims 1-17 are pending.
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 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)(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.
Claims 1-17 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Chang et al (“Chang” hereinafter, U.S. Publication No. 2022/0390478 A1).
As per claim 1, Chang discloses a specimen condition assessing device (abstract) comprising: a processor that executes a program for performing image processing on an image of a target specimen container; and a memory for storing a result of the image processing (paragraph [0055]: computer 143 in figure 1 inherently includes a processor and memory for storage), wherein the processor performs: processing of inputting an image (paragraph [0040]: image devices 106A-C are used to captured images of the sample tube 102); processing of detecting a boundary position from the image (paragraph [0043]: “the characterization methods and apparatus may be used to determine a location of the interface boundaries of the serum or plasma portion 212SP and/or the settled blood portion 212SB, and/or gel separator 313”); processing of determining a type of upper and lower regions of each of the detected boundary position and determining a boundary position of each inclusion (as shown in figures 2-3, see lines of demarcation between air 216, 212SP, 212SB and gel separator 313 in figure 3, for example, for the line of demarcation between air 216 and plasma 212SP, the upper region type is air, and the lower region type is plasma, as same for other lines of demarcation, the upper region type may be plasma and the lower region type may be settled blood); and processing of assessing whether or not the target specimen container is testable on the basis of the determined boundary position of each inclusion (paragraph [0056]-[0057]: the lines of demarcation is used to determine the height of plasma, serum and blood to determine if the sufficient amount of serum or plasma is available to carry out the ordered tests).
As per claim 2, Chang discloses processing of correcting each of the detected boundary position on the basis of the determined type of the upper and lower regions of each of the detected boundary position (as shown between figures 2 and 3, the boundary position or line of demarcation changes when the types of portions changed, for example, in figure 2, line of demarcation between 212SP and 212SB, and figure 3, the line of demarcation between 212 SP and 212SB is changed to include separator gel 313).
As per claim 3, Chang discloses processing of identifying a container from the image to calculate container information; processing of selecting a detector according to the container information; and processing of determining the type of the upper and lower regions of each of the boundary position detected by using the selected detector and determining the boundary position of each inclusion and the processor assesses whether or not the target specimen container is testable on the basis of the determined boundary position of each inclusion (see explanation in claim 1 above).
As per claim 4, Chang discloses processing of calculating a content on the basis of the determined boundary position of each inclusion and the processor assesses whether or not the target specimen container is testable on the basis of the calculated content (as explained above, whether a sufficient amount of plasma or serum is determined to carry out the ordered tests).
As per claim 5, see explanation in claim 4 above.
As per claim 6, see explanation in claim 1.
As per claim 7, see explanation in claim 2.
As per claim 8, see explanation in claim 3.
As per claim 9, see explanation in claim 4.
As per claim 10, see explanation in claim 5.
As per claim 11, Chang discloses A specimen testing device (paragraph [0003]: automated testing system) comprising: the specimen condition assessing device according to claim 1; a specimen sucking device that controls whether or not to suck a specimen to analyze a testing item of the specimen; and a display device that displays a result of the analysis, wherein the specimen sucking device uses information on the testability assessed by the specimen condition assessing device to control whether or not to suck the specimen in the specimen container and uses the sucked specimen and a reagent to analyze the testing item related to the specimen and the display device displays a result of the analysis of the testing item (as shown in figure 1, the computer 143 and LIS 147 inherently includes a display for determining whether the ordered test can be carried out based on the image measurement of serum, plasma as disclosed in paragraphs [0056]-[0057], and if test is determined not to be carried out, the sucking device for automated testing systems will not be used to suck the specimen using reagents for testing).
As per claim 12, see explanation in claim 4.
As per claim 13, see explanation in claim 4.
As per claim 14, see explanation in claim 4.
As per claim 15, see explanation in claim 4.
As per claim 16, see explanation in claim 11.
As per claim 17, see explanation in claim 11.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TOM Y LU whose telephone number is (571)272-7393. The examiner can normally be reached Monday - Friday, 9AM - 5PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Matthew Bella can be reached at (571) 272 - 7778. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TOM Y LU/Primary Examiner, Art Unit 2667
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