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) 1-18 are rejected under 35 U.S.C. 103 as being unpatentable over Zheng U.S. Publication 2022/0334046 in view of Ohsaka U.S. Publication 2023/0028011.
With respect to claim 1, Zheng discloses a blood analyzer comprising:
A specimen aspiration device configured to aspirate a blood specimen to be tested (P.0006, P.0052)
A sample preparation device, comprising a reagent supply part and a reaction cell, wherein the reagent supply part is configured to provide a reagent to the reaction cell, the reaction cell is configured to allow the reagent to react with the blood specimen to be tested to prepare a sample (P.0007)
wherein the reagent comprises a hemolytic agent and a fluorescent dye, the hemolytic agent is capable of lysing red blood cells in the sample and differentiating light scattered characteristics of mature white blood cells from light scattered characteristics of immature white blood cells (P.0007, P.0084, immature white blood cells = immature granulocytes and blast cells)
An optical detection device comprising a light source, a flow chamber, a scattered light detector and a fluorescence detector, wherein the light source is configured to emit a light beam to irradiate a detection area of the flow chamber, the flow chamber is connected with the reaction cell, and particles in the sample in the reaction cell are capable of passing through the detection area of the flow chamber one by one (P.0008)
the scattered light detector is configured to detect scattered light information generated by each of the particles passing through the detection area and irradiated by the light beam, and the FL detector is configured to detect FL information generated by each of the particles passing through the detection area and irradiated by the light beam (P.0033, P.0017)
A processor configured to obtain information characterizing immature granulocytes and blast cells information based on the scattered light information and or the FL information ( P.0068, P.0019, P.0025)
However, Zheng fails to disclose the processor obtains information characterizing "acute promyelocytic leukemia (APL) or abnormal promyelocyte information".
Ohsaka discloses cell analysis method comprising:
A processor configured to obtain information characterizing immature granulocytes and blast cells in order to characterize acute promyelocytic leukemia and abnormal promyelocyte information (P.0059 determines different types of immature granulocytes, with the goal of P.0061 detecting chromosomal abnormality including promyelocytic leukemia)
It would have been obvious to one of ordinary skill in the art at the time of the invention to use the information regarding the immature granulocyte to characterize APL or abnormal promyelocyte information in order to flag the clinically significant abnormal promyelocyte population that Zheng already detects as Ohsaka teaches.
With respect to claim 2, Zheng in view of Ohsaka discloses all of the limitations as applied to claim 1 above. In addition, Zheng discloses:
The scattered light information comprises a forward scattered light intensity and a side scattered light intensity, the FL information comprises a FL intensity (P.0017)
Generating a first scatter plot based on the FS light intensity and the SS light intensity, generating a second scatter plot based on the FS light intensity and the FL intensity or generating a third scatter plot based on the SS light intensity and the FL intensity (P.0084, first scatter plot = scatter diagram based on at least the side scattered light and fluorescence signals Figure 2-5, P.0068 and P.0024, second scatter plot = based on forward scattered and fluorescence signals Figure 6, third plot = Figure 7)
Identifying a first characteristic region containing promyelocyte information from one of the first, second or third scatter plots and acquiring first characteristic parameters from the first characteristic region (P.0019, identifying characteristic region containing promyelocyte, Figure 2, Figure 6, regions labeled)
Obtaining information characterizing the immature granulocytes based on the first characteristics parameters (P.0057, P.0019, Figure 11, step S1140)
It would have been obvious to one of ordinary skill in the art at the time of the invention as described above to go the further step of linking the immature granulocytes or blast cells to APL or abnormal promyelocyte information.
With respect to claim 3, Zheng in view of Ohsaka discloses all of the limitations as applied to claim 1 and 2 above. In addition, Zheng discloses:
When identifying the first characteristic region containing promyelocyte information from the first scatter plot, the first characteristic parameters comprise a number of particles in the first region, a distribution of the number of particles (Figure 2-4)
When identifying the first characteristic region containing promyelocyte information from the second scatter pot, the first characteristic region comprises a number of particles in the first characteristic region, a ratio of the number of particles in the first characteristics region relative to white blood cells, a distribution of particles (Figure 6)
When identifying the first characteristic region containing promyelocyte information from the third scatter plot the characteristic parameter comprises a number of particles in the first characteristic region, a ratio of a number of particles in the first characteristic region relative to a number of white blood cells, a distribution of particles (Figure 7)
It should be noted that the limitations as presented in the alternative but that that the other potential parameters are all well-known variations on conventional statistical descriptions from scatter plots.
With respect to claim 4, Zheng in view of Ohsaka discloses all of the limitations as applied to claims 1 and 2 above. In addition, Zheng discloses:
Obtaining classification information according to the first scatter plot and identifying a region containing a neutrophil cluster as the first characteristic region according to the classification information (P.0009, P.0061)
With respect to claim 5, Zheng in view of Ohsaka discloses all of the limitations as applied to claims 1 and 2 above. In addition, Zheng discloses:
Comparing the at least one of the first characteristic parameters to a preset range and obtaining the information characterizing blast cells or immature granulocytes according to a comparison result (P.0025, P.0031, wherein threshold = preset range, generating alarm = characterizing a certain type of cells)
It would have been obvious to one of ordinary skill in the art at the time of the invention as described above to take the immature granulocytes or blast cells as an proxy for APL or abnormal promyelocyte information.
With respect to claim 6 and 7, Zheng in view of Ohsaka disclose all of the limitations as applied to claims 1 and 2 above. In addition, Zheng discloses:
Obtaining a first classification information of particles in the first characteristic region according to the FL intensities of the particles in the first characteristic region (P.0084, Figure 6 and 7)
It should be noted that the limitation of claim 7 is an alternative limitation only and not required by the claim.
With respect to claim 8, Zheng in view of Ohsaka discloses all of the limitations as applied to claim 1 and 2 above. In addition, Zheng discloses:
Identifying a second characteristic region containing lymphocyte information from of the scatter plots, acquire second characteristic parameters from the second characteristic region and obtain the lymphocyte information based on at least one of the second characteristic parameters (Figure 5, lymphocyte population, P.0068)
However, Zheng fails to disclose identifying abnormal lymphocyte information.
It would have been obvious to one of ordinary skill in the art at the time of the invention to determine abnormal lymphocyte information contrasted with the normal lymphocyte population as Zheng discloses abnormal blood analysis (P.0066) and identifying the abnormal lymphocyte would not predictably add to the information regarding the abnormal blood cells.
With respect to claim 9, Zheng in view of Ohsaka discloses all of the limitations as applied to claims 1, 3, and 8 above. In addition, Zheng discloses:
When identifying the second characteristic region containing lymphocyte information from the first scatter plot, the second characteristic parameters of the second characteristic region comprise a ratio of number of particles in the second characteristic region relative to a number of particles of white blood cells (Figure 2 and 5, wherein lymphocyte ratio comparison to neutrophil granulocyte, a type of white blood cells)
Per claim 8 above, identifying abnormal lymphocyte information rather than normal would have been obvious and in line with the purposes of Zheng.
With respect to claim 10 and 12, Zheng in view of Ohsaka discloses all of the limitations as applied to claims 1, 2, and 8 above. In addition, Zheng discloses:
Identify a third characteristic region containing blast cell information from one of the first, second or third scatter plots, acquire third characteristic parameters from the third characteristic region, and obtain the blast cell information based on at least one of the third characteristic parameters (Figure 2-5, third characteristic region = first predetermined feature region, P.0009, P.0024-26, P.0050)
With respect to claim 11 and 13, Zheng in view of Ohsaka discloses all of the limitations as applied to claim 1, 2, and 10 above. In addition, Zheng discloses:
When identifying the third characteristic region containing blast cell information from the first, second, and third scatter plot, the third characteristic parameter of the third characteristic region comprise: a number of particles in the third characteristic region (P.0059)
With respect to claim 14, Zheng in view of Ohsaka discloses all of the limitations as applied to claim 1 above. In addition, Zheng discloses:
A user interaction interface, configured to output the relevant information characterizing a hematological malignancy (P.0051, P.0058)
With respect to claims 15, 16, 17, and 18, Zheng in view of Ohsaka disclose all of the limitations as applied to claim 1 above. However, Zheng and Ohsaka fail to disclose the specific hemolytic agent used.
The examiner takes Official Notice of the fact that dehydrated sorbitan fatty acid ester-based nonionic surfactants are one of a select group of well-known hemolytic agents and are well known in the are specifically for use for blood testing (See CN102226804 or CN116429668 as evidence). This type of hemolytic agent is known for selectively hemolyzing red blood cells for differentiation from white blood cells and would have been one of a select few available and known to be used by those of ordinary skill in the art. This extends to the further limitations of claims 16-18 further defining the exact type of dehydrated sorbitan fatty acid surfactant. It is within ordinary skill to select the optimum element in predictable use.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA CAROLE BRYANT whose telephone number is (571)272-9787. The examiner can normally be reached M-F, 12-4 pm.
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/REBECCA C BRYANT/Primary Examiner, Art Unit 2877
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