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 .
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.
Claim Objections
Claims 5, 7, 12, 14, 19, 21 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.
None of the cited prior art teaches nor fairly suggests “determine/determining direction and magnitude of a vector from the configurable location to the centroid of the group of dots; and determine/determining presence of left shift based on:(1) the direction of the vector being directed towards one or both of: a lesser-value side of the complexity-axis value, and a greater-value side of the size-axis value; and (2) the magnitude of the vector being greater than a configurable magnitude threshold” as recited in instant claims, 5, 12, and 19 or “determine/determining presence of left shift based on a designated low-density band among the spatial density bands defining at least one of: a height evaluated along the size axis greater than a configurable height threshold or a width evaluated along the complexity axis less than a configurable width threshold” as recited in instant claims 7, 14, and 21. The combination of Fang and Cezar renders obvious the use a centroid model utilizing a central vector (i.e., mid value for each axis), however fails to disclose using a lesser value for the x-axis and/or greater value of the y-axis to determine the direction of the vector of the scatter plot. The combination of Fang and Gibbons renders obvious the use of spatial density band analysis of a scatter plot, however, fails to disclose designating a low-density band defined by a height threshold of the y-axis or width threshold of the x-axis to determine left shift.
Claim Rejections - 35 USC § 102
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2, 6, 8-9, 13, 15-16, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chinese Publication CN 114419620 to Fang Jianwei (herein Fang) as cited on the 21 May 2024 IDS (see machine translation provided).
Regarding claims 1, 8, and 15 Fang discloses an abnormal sample identification device 400 (i.e., system for identifying conditions in hematology samples) (see [n0058]), the system comprising: at least one processor (see [n0070-n0071]); and computer storage medium (i.e., at least one memory) providing storage space containing one or more instructions executed by the processor (see [n0070]), causing the system to, without human intervention: obtain a scatter plot of white blood cells (i.e., process and identify constituents in a hematology sample) (see step 101); determine a leukocyte (or white blood cell) 2D scatter plot corresponding to cell size and material (i.e., complexity of constituents) based on direction of light scatter to classify cell type, such as neutrophils (see [n0027-n0029]); analyze the 2D scatter plot to determine spatial distribution of a group of dots corresponding to a portion of white blood cells such as immature granulocytes (see [n0032-n0033]); and comparing morphological parameters of neutrophils to preset neutrophil parameter thresholds to determine whether there are immature granulocytes present and outputting the information (see [0079, n0041, n0043-n0044]), wherein the presence of abnormal neutrophils indicate a left shift (see [n0052-n0053]). The process performed by the system reads on the method of independent claim 8 and the computer storage medium reads on the non-transitory process-readable medium of independent claim 15.
Regarding claims 2, 9, and 16 Fang discloses the system, method, and non-transitory process-readable medium of claims 1, 8 and 15 and discloses cells can be classified according to different dimensions (see [n0030]) and wherein morphological parameters can be calculated based on mean and variance of cells at different angles or the corresponding number of pixels (see n0039]).
Regarding claims 6, 13, and 20, Fang discloses the system, method, and non-transitory process-readable medium of claims 2, 9 and 16 and Fang discloses utilizing mean and variance of a neutrophil parameter threshold to determine the presence of an immature neutrophil (i.e., left shit) (see [0019]).
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.
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 3, 10, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Chinese Publication CN 114419620 to Fang Jianwei (herein Fang) as cited on the 21 May 2024 IDS (see machine translation provided) in view of Chinese Publication CN 104212872 to Tanaka Masamichi et al. (herein Tanaka) (see machine translation provided); United States Patent Application Publication US 2015/0363551 to Cezar et al. (herein Cezar); and United States Patent Application Publication US 2022/0252503 to Gibbons et al. (herein Gibbons).
Regarding claims 3, 10, and 17 Fang discloses the system, method, and non-transitory process-readable medium of claims 2, 9 and 16, however fails to disclose “perform each analysis in the plurality of analyses” as recited in instant claim 3, wherein the plurality of analysis would further include “determining orientation and dimensions of a geometric shape that surrounds the group of dots in the 2D plot, determining a centroid of the group of dots relative to a configurable location in the 2D dot plot where a centroid of dots corresponding to healthy populations of corresponding white blood cells would be located in the 2D dot plot” as recited in instant claim 2 from which claim 3 depends.
Tanaka discloses a method for detecting bacteria contained in a test sample by irradiating it with light to obtain optical information and analyzing the bacteria contained in the test sample based on the optical information, as well as a test sample device equipped with the function of analyzing the bacteria (see [0002]). In this method, a scatter plot is created using the scattered light and fluorescence information of the bacteria contained in the detection body as parameters (see [0005]). Tanaka discloses how the orientations and dimensions of a shape formed by a group of dots can be used to identify bacteria morphology (see [0156-0157]; Figs. 16(a)/16(b).
Cezar discloses a method for identifying a subpopulation of specific cells among a large population of cells (see abstract). Cezar discloses the method utilizes a centroid model for analysis and classifying cells (see [0050]) and wherein healthy cells can be identified (see [0177]).
Gibbons discloses using statistical methods for clustering cells into separate populations for identification in the field of hematology (see [0731]), wherein analysis of leukocytes can be performed using a scatter plot (see 0733-0734]), and wherein an energy band assessment, energy density distribution, and spatial distribution can all be performed (see [0747]).
Fang, Tanaka, Cezar, and Gibbons are all analogous in the field of utilizing scatter plots/dot plots for analysis of cells. The MPEP states that when the only difference between the instant invention is the absence of components in a single reference together and one of ordinary skill in the art would recognize that methods of Tanaka, Cezar, and Gibbons are known methods that can be used to perform analysis of cells based on a scatter plot/dot plot, thus performing the same function separately as it would in combination with Fang, the combination would yield predictable results (see MPEP 2143 A. Combining Prior Art Elements According to Known Methods to Yield Predictable Results). Therefore, it would have been obvious, before the effective filing date to combine the analysis methods of Tanaka, Cezar, Gibbons, or all three with the method of Fang.
Claims 4, 11, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Chinese Publication CN 114419620 to Fang Jianwei (herein Fang) as cited on the 21 May 2024 IDS (see machine translation provided) in view of Chinese Publication CN 104212872 to Tanaka Masamichi et al. (herein Tanaka) (see machine translation provided).
Regarding claims 4, 11, and 18, Fang discloses the system, method, and non-transitory process-readable medium of claims 2, 9 and 16, however, Fang fails to disclose “compare an angle, formed by a major axis of the geometric shape and the complexity axis of the 2D plot, to a configurable angle threshold; and determine left shift based on the angle being greater than the configurable angle threshold” as recited in the instant claim.
Tanaka discloses a method for detecting bacteria contained in a test sample by irradiating it with light to obtain optical information and analyzing the bacteria contained in the test sample based on the optical information, as well as a test sample device equipped with the function of analyzing the bacteria (see [0002]). In this method, a scatter plot is created using the scattered light and fluorescence information of the bacteria contained in the detection body as parameters (see [0005]). Tanaka discloses how the orientations and dimensions of a shape formed by a group of dots can be used to identify bacteria morphology (see [0156-0157]; Figs. 16(a)/16(b). Tanaka discloses calculating a skew angle using the two-dimensional scatter plot with the horizontal axis and comparing the calculated skew angle with a specified threshold to determine bacterial morphology (see [0081]).
Fang and Tanaka are analogous in the field of utilizing scatter plots/dot plots for analysis of cells. The MPEP states that when the only difference between the instant invention is the absence of components in a single reference together and one of ordinary skill in the art would recognize that methods of Tanaka as a known method that can be used to perform analysis of cells based on a scatter plot/dot plot, thus performing the same function separately as it would in combination with Fang, the combination would yield predictable results (see MPEP 2143 A. Combining Prior Art Elements According to Known Methods to Yield Predictable Results). Therefore, it would have been obvious, before the effective filing date to combine the analysis method of Tanaka the method of Fang.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHRYN E LIMBAUGH whose telephone number is (571)272-0787. The examiner can normally be reached Monday-Thursday 7:00-5:00.
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/KATHRYN ELIZABETH LIMBAUGH/Primary Examiner, Art Unit 1797
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