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 .
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) 1, 5, 10, 14, and 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yamada (US 8977030) in view of Kobe-shi (EP 2339354).
Yamada discloses a sample analysis system, comprising at least one hematology analyzer (FIG. 1, element 5), a controller (FIG. 1, element 9), a first transport apparatus (FIG. 1, element 3), a sample slide preparation apparatus (FIG. 1, element 6), and a sample image capturing apparatus (FIG. 1, element 7), wherein:
one of the at least one hematology analyzer is configured to analyze a first test blood sample of a subject, so as to obtain a sample analysis result (column 6, 13-26: The blood cell analyzing apparatus classifies blood cells included in the specimen and counts the number of blood cells for each type to create a scattergram);
the controller (FIG. 1, element 9) is configured to control the first transport apparatus to transport the first test blood sample to the sample slide preparation apparatus, when the sample analysis result satisfies a preset condition (FIG. 1: The transport 3 conveys the blood sample between the apparatuses of the analyzing system), wherein the preset condition comprises that the sample analysis result from the hematology analyzer is abnormal (column 26, lines 50-65: When an abnormality is detected as a result of the analysis, an re-examination by imaging a blood smear preparation is conducted);
the sample slide preparation apparatus is configured to prepare a sample slide of a second test blood sample (column 8, lines 14-20: The smear preparing apparatus aspirates a blood specimen so as to deliver it onto a slide glass);
the sample image capturing apparatus is configured to capture a sample image of a sample region on the sample slide (column 8, lines 60-65: The blood cell image display apparatus comprises a microscope unit for imaging a magnified image of blood smear);
the controller is further configured to analyze the sample image, to determine whether the sample image contains information indicating that the second test blood sample is an abnormal sample (column 28, lines 35-40: The abnormality of the blood cell image is determined); and
the controller is further configured to generate a retest instruction to retest a test blood sample of the subject, when the sample image contains information indicating that the first test blood sample is an abnormal sample (column 27, lines 20-25: A specimen, in which an abnormality has been detected by the analysis of the blood cell analyzing apparatus, requires re-examination (retest)).
Yamada however does not teach sending the retest instruction to one of the at least one hematology analyzer, so that said hematology analyzer retests a third test blood sample of the subject, in response to determining that the sample image contains the information indicating that the second test blood sample is the abnormal sample.
Kobe-shi discloses an apparatus for processing a blood sample in a plurality of sample portions (FIGs. 2-3). The apparatus comprises a controller (FIG. 1, element 9) for controlling a transport apparatus (FIG. 1, element 3) for transporting the blood sample portions to a hematology analyzer (FIG. 1, element 5) and a sample slide preparation unit (FIG. 1, element 6) for retesting purpose when necessary (paragraph [0076]: Since the first test and the retest are performed by different measurement units (hematology analyzers), the sample rack transports the sample to a measurement unit for the first test and to another measurement unit for the retest), wherein the controller sends a blood sample portion to the analyzer for retesting after the smear slide preparation test indicates an abnormality (paragraph [0094]: The retest is done, after the first retesting by the smear sample preparing apparatus, by the measurement unit).
Therefore, it would have been obvious for one having ordinary skill in the art at the time before the effective filing date to modify Yamada’s apparatus to perform the re-examination, instead of visual, by the measurement unit/hematology analyzer as disclosed by Kobe-shi so the retest result can be automatically updated and stored in the database.
Regarding to claims 5, 14, 18: wherein the controller is further configured to: determine an abnormality type of the second test blood sample based on the sample image, and generate the retest instruction based on the abnormality type, wherein the retest instruction comprises an instruction that causes said hematology analyzer to perform the retest under a test condition corresponding to the abnormality type (Yamada: Depending on the detected abnormality, a blood cell type attracting attention in the re-examination is specified (column 27, lines 20-27)).
Allowable Subject Matter
Claims 6-7, 15-16, 19-20 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.
Regarding to claims 6, 15, 19: The primary reasons for the indication of the allowability of the claims is the inclusions therein, in combination as currently claimed, of the limitation that wherein the controller is further configured to: generate the retest instruction that causes said hematology analyzer to analyze the third test blood sample by using an optical method, when it is determined, based on the sample image, that the second test blood sample is at least one of a sample having a low platelet value, a sample having platelet aggregation, a sample having erythrocyte fragments, a sample having leukocyte fragments, a sample having microcytes, and a sample having large platelets; and/or generate the retest instruction that causes said hematology analyzer to treat the third test blood sample with a platelet disaggregation reagent, when it is determined, based on the sample image, that the second test blood sample is a sample having a low platelet value or a sample having platelet aggregation is neither disclosed nor taught by the cited prior art of record, alone or in combination.
Regarding to claims 7, 16, 20: The primary reasons for the indication of the allowability of the claims is the inclusions therein, in combination as currently claimed, of the limitation that wherein the controller is further configured to perform at least one of the following: generating the retest instruction that causes said hematology analyzer to analyze erythrocytes in the second test blood sample by using an optical method, when it is determined, based on the sample image, that the second test blood sample is a sample having erythrocyte aggregation; generating the retest instruction that causes said hematology analyzer to analyze hemoglobin in the third test blood sample by using an optical method, when it is determined, based on the sample image, that the second test blood sample is a sample having falsely elevated hemoglobin; and generating the retest instruction that causes said hematology analyzer to count leukocytes in the third test blood sample by using a leukocyte differential channel, when it is determined, based on the sample image, that the second test blood sample is a sample having leukocyte aggregation is neither disclosed nor taught by the cited prior art of record, alone or in combination.
Response to Arguments
Applicant's arguments filed 8/4/2026 have been fully considered but they are not persuasive. Please see the rejection above for newly citations and explanations.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAM S NGUYEN whose telephone number is (571)272-2151.
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/LAM S NGUYEN/ Primary Examiner, Art Unit 2853
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