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 .
Applicant’s filing of claims 1-17 and 19-21 on 4/14/23 is acknowledged. Claims 1-17 and 19-21 are pending and are under examination.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 9/14/23 and 6/11/25 were acknowledged. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Interpretation
The Office asserts that terms and phrases like “configured to” constitute recitations of intended use language for purposes of examination. The Office asserts that in the examined claims reciting such “configured to” language, the claim language that follows such recitations does not necessarily denote structure MPEP 2173.05(g). The functional limitation was evaluated and considered, for what it fairly conveys to a person of ordinary skill in the art. While all words in each claim are considered in judging the patentability of the claim language, including functional claim limitations, not all limitations provide a patentable distinction.
During patent examination, the examined claims must be given their broadest reasonable interpretation consistent with the specification, unless a term has been given a special definition in the specification (“BRI”). See MPEP 2111.
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.
Claims 1-17 and 19-21 are rejected under 35 U.S.C. 103 as being unpatentable over Qi et al. (“Qi,” CN 111542744A) in view of Ye et al. (“Ye,” US Pub. No. 2020/0209218). Page numbers refer to the English translation of the reference.
As to claims 1, 13 and 19, Qi discloses a sample analyzer, comprising:
a sample preparation device (see 120 in fig. 1, page 6 et seq.) configured to prepare a first test sample containing a first part of a test blood sample and a diluent, and to prepare a second test sample containing a second part of the test blood sample, a hemolysis reagent for hemolyzing red blood cells and a first stain reagent;
an impedance testing device (see 132 in fig. 3, page 7 et seq.) comprising a first flow chamber and a detection component, the first flow chamber being configured to allow the first test sample to pass through, and the detection component being configured to obtain electronic information as the first test sample passes through the first flow chamber;
an optical testing device (see 131 in fig. 2, page 7 et seq.) comprising a second flow chamber, a light source and an optical detector, the second flow chamber being configured to allow the second test sample to pass through, the light source being configured to irradiate the second test sample as the second test sample passes through the second flow chamber with a light, and the optical detector being configured to detect optical information generated by the second test sample after the second test sample is irradiated with the light as it passes through the second flow chamber; and
a controller (see control device 150 in figs. 3 and 4, page 6 et seq.) configured to: control the impedance testing device to test the first test sample (page 6 et seq.).
Regarding claims 1, 13 and 19, while Qi discloses platelet parameters can be obtained by the control device on page 6, Qi does not specifically disclose the control device is to obtain a first platelet counting result for the test blood sample based on the electronic information of the first test sample, control the optical testing device to test the second test sample, so as to obtain a second platelet counting result for the test blood sample based only on the optical information of the second test sample, or to obtain a second platelet counting result for the test blood sample based on both the electronic information of the first test sample and the optical information of the second test sample, determine whether the first platelet counting result is unreliable due to a first abnormality of the test blood sample, and output the first platelet counting result and/or the second platelet counting result according to the result of the determination. Ye discloses in [0028] et seq., the alarming method for a platelet aggregation sample further includes the steps of: determining whether the first platelet test data is abnormal or not; and performing the step of preparing the second test sample from the blood sample under the second reaction condition if the first platelet test data is abnormal. Ye further discloses in fig. 7 and [0139] et seq., FIG. 7 shows a flowchart of an alarming method for a platelet aggregation sample provided in a fourth embodiment of the present disclosure, comprising: step S510 of providing a blood sample; step S520 of preparing a first test sample from the blood sample under a first reaction condition; step S530 of testing the first test sample to acquire a test signal of the first test sample; step S540 of obtaining first platelet test data according to the test signal of the first test sample; step S550 of determining whether the first platelet test data is abnormal or not; step S552 of preparing a second test sample from the blood sample under a second reaction condition when the determination result in step S550 is YES, wherein compared with the first reaction condition, the second reaction condition can reduce the platelet aggregation degree in the blood sample; step S554 of testing the second test sample to acquire a test signal of the second test sample; step S556 of obtaining second platelet test data according to the test signal of the second test sample; step S560 of acquiring an evaluation result based on the first platelet test data and the second platelet test data; step S570 of determining whether the evaluation result meets a preset condition; step S580 of activating an alarm when the determination result of step S570 is YES; and step S590 of outputting an alarm signal to a user interface. It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to have the controller perform the platelet counting steps because it would beneficial to screen suspected platelet aggregation samples simply and quickly without increasing the complexity and costs of the blood sample testing process ([0055] of Ye).
As to claims 2 and 20, the combination of Qi and Ye disclose the controller is further configured to: obtain the second platelet counting result for the test blood sample based on the electronic information and the optical information; when the first platelet counting result is determined to be unreliable due to the first abnormality of the test blood sample, determine whether the second platelet counting result is unreliable due to a second abnormality of the test blood sample; output the second platelet counting result when the second platelet counting result is determined to be reliable; and when the second platelet counting result is determined to be unreliable due to the second abnormality of the test blood sample, control the sample preparation device to prepare a third test sample containing a third part of the test blood sample, a diluent and a second stain reagent, and control the optical testing device to test the third test sample so as to obtain and output a third platelet counting result for the test blood sample based on optical information of the third test sample. See page 5 et seq. of Qi and [0028] et seq. of Ye.
As to claims 3 and 21, the combination of Qi and Ye disclose the controller is further configured to: obtain the second platelet counting result for the test blood sample based only on the optical information; and output the second platelet counting result when the first platelet counting result is determined to be unreliable due to the first abnormality of the test blood sample. See page 5 et seq. of Qi and [0028] et seq. of Ye.
As to claim 4, the combination of Qi and Ye disclose the controller is further configured to: output the first platelet counting result and/or the second platelet counting result when the first platelet counting result is determined to be reliable. See page 5 et seq. of Qi and [0028] et seq. of Ye.
As to claim 5, the combination of Qi and Ye disclose the second abnormality that leads to the second platelet counting result being unreliable comprises at least one of: presence of platelet aggregation in the test blood sample; and presence of at least a predetermined quantity of fragments in the test blood sample that have a volume less than a predetermined value. See page 5 et seq. of Qi and [0028] et seq. of Ye.
As to claim 6, the combination of Qi and Ye disclose the controller is further configured to: obtain a first platelet volume distribution histogram based on the electronic information of the first test sample; determine whether particle information distribution in a specific region of the first platelet volume distribution histogram is abnormal; and when the particle information distribution in the specific region is determined to be abnormal, determine that a sample abnormality that leads to the first platelet counting result being unreliable is present in the test blood sample. See page 5 et seq. of Qi and [0063] et seq. of Ye.
As to claim 7, the combination of Qi and Ye disclose the controller is further configured to: obtain a first boundary position in the first platelet volume distribution histogram for distinguishing a red blood cell volume distribution region from a platelet volume distribution region, the specific region of the first platelet volume distribution histogram being located near the boundary position; obtain a peak position in the platelet volume distribution region of the first platelet volume distribution histogram; calculate a ratio of particle quantity corresponding to the first boundary position to particle quantity corresponding to the peak position in the first platelet volume distribution histogram; and determine, based on the ratio, whether the particle information distribution in the specific region of the first platelet volume distribution histogram is abnormal. See page 5 et seq. of Qi and [0028] et seq. of Ye.
As to claim 8, the combination of Qi and Ye disclose the controller is further configured to: obtain a mean corpuscular volume of the test blood sample based on the electronic information of the first test sample; and when the mean corpuscular volume is lower than a preset threshold, determine that a sample abnormality which leads to the first platelet counting result being unreliable is present in the test blood sample. See page 5 et seq. of Qi and [0078] et seq. of Ye.
As to claims 9 and 15, the combination of Qi and Ye disclose the controller is further configured to: obtain a second platelet volume distribution histogram based on the electronic information of the first test sample and the optical information of the second test sample; determine whether particle information distribution in a specific region of the second platelet volume distribution histogram is abnormal; and when the particle information distribution in the specific region is determined to be abnormal, determine that a sample abnormality which leads to the second platelet counting result being unreliable is present in the test blood sample. See page 5 et seq. of Qi and [0028] et seq. of Ye.
As to claims 10 and 16, the combination of Qi and Ye disclose the controller is further configured to: obtain a second boundary, which corresponds to a preset platelet volume, in the second platelet volume distribution histogram, the specific region of the second platelet volume distribution histogram being a platelet volume distribution region on the left of the second boundary; calculate a first area on the left of the second boundary and a second area on the right of the second boundary below a curve of the second platelet volume distribution histogram; and determine, according to the first area and the second area, whether the particle information distribution in the specific region of the second platelet volume distribution histogram is abnormal. See page 5 et seq. of Qi and [0063] et seq. of Ye.
As to claims 11 and 17, the combination of Qi and Ye disclose the controller is further configured to determine, based on the optical information of the second test sample, whether platelet aggregation is present in the test blood sample, so as to determine whether a sample abnormality of the test blood sample that leads to the first platelet counting result or the second platelet counting result being unreliable is present in the test blood sample. See page 5 et seq. of Qi and [0028] et seq. of Ye.
As to claim 12, the combination of Qi and Ye disclose the controller is further configured to: obtain a leukocyte differential result and/or a leukocyte counting result and/or an immature granulocyte test result for the test blood sample based on the optical information of the second test sample. See page 9 et seq. of Qi and [0028] et seq. of Ye.
As to claim 14, the combination of Qi and Ye disclose the sample abnormality that leads to the second platelet counting result being unreliable comprises at least one of: presence of platelet aggregation in the test blood sample; and presence of at least a predetermined quantity of fragments in the test blood sample that have a volume less than a predetermined value. See page 5 et seq. of Qi and [0028] et seq. of Ye.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LORE RAMILLANO JARRETT whose telephone number is (571)272-7420. The examiner can normally be reached Monday to Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander can be reached at 571-272-1254.
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/LORE R JARRETT/Primary Examiner, Art Unit 1797
5/30/2026
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