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 .
Priority
Acknowledgement is made of Applicant’s claim of priority from Foreign Application No. JP2020-129097, filed July 30, 2020 and from PCT Application No. PCT/JP2021/022375, filed June 11, 2021.
Status of Claims
Claims 1-4, 6-7 and 9-11 are pending. Claims 5 and 8 have been cancelled. Claims 9-11 are newly added.
Response to Arguments
Applicant's arguments filed August 29, 2025 have been fully considered but they are not persuasive. Applicant argues that the El-Zehiry reference does not teach the limitation to “select a blood cell to be used for discrimination”. Examiner respectfully disagrees. As described in the 35 USC 103 rejections below, Paragraph [0053] of the Basiji reference teaches using a gold standard truth (i.e., selected blood cell) for identifying if a blood cell is one of the five types of white blood cells. Basiji does not teach that the gold standard truth is selected based on variations in the features of each cluster after the clustering. However, the El-Zehiry reference teaches clustering using a hierarchical k-means clustering (see Paragraph [0051]) and teaches the SIFT descriptors (i.e., feature vector) from the clustering are used to construct a binary search tree (see Paragraph [0008]). It would have been obvious to one having ordinary skill in the art to combine these references in order to teach clustering the plurality of blood cells and selecting a blood cell to be used for discrimination (i.e., comparison) based on the variations in the features of the clusters (i.e., SIFT descriptors).
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, as described in the 35 USC 103 rejections below, combining the references would allow for performing the identification of one or more white blood cell types in images using the k-means clustering as taught by El-Zehiry. One having ordinary skill in the art would find it obvious to combine these references because they are in analogous fields of endeavor and because it would allow for discriminating a blood cell type as taught by Basiji by using a clustering process as taught by El-Zehiry. Thus, the 35 USC 103 rejections are upheld.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 11 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 11 recites the limitation "the calculated score of the LOF". There is insufficient antecedent basis for this limitation in the claim.
The rejection would be overcome by amending the limitation to recite “a calculated score of the LOF” or by amending claim 11 to depend from claim 10, which does provide antecedent basis for a score of the LOF.
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 1-2, 4 and 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Basiji et al. (US 2014/0030729 A1) in view of El-Zehiry et al. (US 2017/0132450 A1).
Regarding claim 1, Basiji teaches a discrimination device for discriminating whether or not a discrimination target object is a blood cell based on an image of the discrimination target object, the discrimination device comprising circuitry (Para. [0102], the image processing and identification may be implemented by many different types of computing devices) configured to:
acquire an image of a plurality of blood cells and extract features of the plurality of blood cells from the acquired image (Para. [0082], collecting images for each type of white blood cells in the DAPI, side scatter, and immunofluorescence imaging channels of the imaging system. The immunofluorescence channels provide the “truth” of the type of each white blood cell being imaged. The classifiers for each type of white blood cell can be “trained” using features derived from the bright field, side scatter, and nuclear fluorescence (DAPI) channel images for a white blood cell type identified based on the immunofluorescence channel images);
acquire the image of the discrimination target object and extract a feature of the discrimination target object from the acquired image (Para. [0094], the sample, which now comprises a concentration of mostly white blood cells is run through the imaging region of the flow cytometer imaging system. The imaging system simultaneously produces bright field, side scatter, and nuclear fluorescence images of each of the cells passing through the imaging region of the flow cytometer. The images are processed using software instructions that employ the classifiers previously determined (i.e., a feature is extracted)); and
discriminate whether or not the discrimination target object is a blood cell through anomaly detection based on the feature of the selected blood cell and the feature of the discrimination target object (Para. [0094], the images are processed using software instructions that employ the classifiers previously determined, to identify cells from the sample being imaged as one of the five types of white blood cells, i.e., to identify a first subset of images for normal cells, or if not so identified, to include the images for any cells not identified as any type of white blood cell in a second subset designated as potentially cancerous or otherwise abnormal cells).
Although Basiji teaches determining classifier features using a gold standard for truth, the object in each image can be identified if it is one of the five types of white blood cells (Basiji, Para. [0053]), Basiji does not explicitly teach to “cluster, using vector quantization, the plurality of blood cells based on the extracted features of the plurality of blood cells” and “select a blood cell to be used for discrimination of whether or not the discrimination target object is the blood cell based on variations in the features of each cluster after the clustering”. However, in an analogous field of endeavor El-Zehiry teaches defining a hierarchical quantization using a hierarchical k-means clustering. The initial k-means algorithm is applied on to the training data (a collection of SIFT descriptors derived from training data set) and then partitioned into 2 groups, where each group comprises SIFT descriptors closest to the cluster center. A SIFT descriptor (a vector) is passed down the tree by each level via comparing this feature vector to the 2 cluster centers and choosing the closest one. (El-Zehiry, Para. [0051]). El-Zehiry further teaches the SIFT descriptors are used to construct a binary search tree representative of a vocabulary dictionary structure. A one against one n-label supporting vector machine (SVM) may be used for identifying one or more of the plurality of white blood cell types in the images (El-Zehiry, Para. [0008]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Basiji with the teachings of El-Zehiry by including clustering blood cells using a k-means algorithm and selecting a blood cell to use based on variations in the features (i.e., SIFT descriptors). One having ordinary skill in the art would have been motivated to combine these references, because doing so would allow for identifying one or more of the plurality of white blood cell types in images, as recognized by El-Zehiry. Thus, the claimed invention would have been obvious to one having ordinary skill in the art before the effective filing date.
Regarding claim 2, Basiji in view of El-Zehiry teaches the discrimination device according to claim 1, and further teaches wherein the circuitry discriminates whether or not the discrimination target object is the blood cell through LOF or One class SVM as the anomaly detection (El-Zehiry, Para. [0049], ne against one n-label supporting vector machine (SVM) may be utilized for classification).
The proposed combination as well as the motivation for combining the Basiji and El-Zehiry references presented in the rejection of Claim 1, apply to Claim 2 and are incorporated herein by reference. Thus, the device recited in Claim 2 is met by Basiji in view of El-Zehiry.
Regarding claim 4, Basiji in view of El-Zehiry teaches the discrimination device according to claim 1, and further teaches wherein the blood cell includes a white blood cell (Basiji, Para. [0053], the object in each image can be identified if it is one of the five types of white blood cells and if not identified in this manner, is placed in the subset of images of possible cancerous or abnormal objects).
Claim 6 recites a method with steps corresponding to the elements of the device recited in Claim 1. Therefore, the recited steps of this claim are mapped to the proposed combination in the same manner as the corresponding elements in its corresponding device claim. Additionally, the rationale and motivation to combine the Basiji in view of El-Zehiry references, presented in rejection of Claim 1, apply to this claim.
Claim 7 recites a computer-readable storage medium storing a program with instructions corresponding to the steps recited in Claim 6. Therefore, the recited programming instructions of this claim are mapped to the proposed reference in the same manner as the corresponding steps in its corresponding method claim. Additionally, the rationale and motivation to combine the Basiji in view of El-Zehiry references, presented in rejection of Claim 1, apply to this claim. Finally, the Basiji in view of El-Zehiry references disclose a computer readable storage medium (Para. [0104], included in processing unit 1504 are a random access memory 1506 (RAM) and non-volatile memory 1510, which typically includes read only memory (ROM) and some form of memory storage, such as a hard drive, optical drive, etc. These memory devices are bi-directionally coupled to CPU 1508. Such storage devices are well known in the art. Machine instructions and data are temporarily loaded into RAM 1506 from non-volatile memory 1510).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Basiji et al. (US 2014/0030729 A1) in view of El-Zehiry et al. (US 2017/0132450 A1), as applied to claims 1-2 , 4 and 6-7 above, and further in view of Ozaki et al. (US 2017/0212033 A1).
Regarding claim 3, Basiji in view of El-Zehiry teaches the discrimination device according to claim 1, as described above.
Although Basiji in view of El-Zehiry teaches identifying cells (i.e., discrimination target object) in an image as one of the five types of white blood cells (Basiji, Para. [0094]), they do not explicitly teach “wherein the circuitry acquires an image of an optical thickness distribution of the blood cell, and acquires an image of an optical thickness distribution of the discrimination target object”. However, in an analogous field of endeavor, Ozaki teaches acquiring a quantitative phase image of an object (cell), wherein the quantitative phase image is an image of an optical thickness distribution of the cell (Ozaki, Para. [0027]). Ozaki further teaches identifying a white blood cell and a cancer cell by extracting inclination information of an optical thickness as a feature quantity (Ozaki, Para. [0039]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Basiji in view of El-Zehiry with the teachings of Ozaki by acquiring a quantitative phase image of an optical thickness distribution of the blood cell and of the discrimination target object. One having ordinary skill in the art would have been motivated to combine these references because doing so would allow for discrimination between white blood cells and cancer cells, as recognized by Ozaki. Thus, the claimed invention would have been obvious to one having ordinary skill in the art before the effective filing date.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Basiji et al. (US 2014/0030729 A1) in view of El-Zehiry et al. (US 2017/0132450 A1), as applied to claims 1-2 , 4 and 6-7 above, and further in view of Nakakoji et al. (US 2010/0050260 A1).
Regarding claim 9, Basiji in view of El-Zehiry teaches the discrimination device according to claim 1, as described above.
Although Basiji in view of El-Zehiry teaches clustering blood cells using k-means and selecting a blood cell based on variations in the features (El-Zehiry, Para. [0051]), they do not explicitly teach “wherein the variations in the features of each cluster are at least one of a variance and an average distance for each cluster”. However, in an analogous field of endeavor, Nakakoji teaches the analysis program performs clustering and determines a collective behavior cluster. The collective behavior cluster means a cluster which has events strongly related to each other (that is, a cluster having a high evaluation value) among all clusters (Nakakoji, Para. [0065]). An evaluation value is obtained which is a quantified combination of a ratio of the number included in the cluster with respect to the total number of events, the number of events, a variance value and an average of a distance between a centroid of the cluster and an event included in the cluster (Nakakoji, Para. [0095]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Basiji in view of El-Zehiry with the teachings of Nakakoji by including determining a cluster based on an evaluation value (i.e., variations) that includes at least a variance and an average distance for the cluster. One having ordinary skill in the art would have been motivated to combine these references because doing so would allow for selecting a cluster for further evaluation based on the variance and average distance of the clusters, as recognized by Nakakoji. Thus, the claimed invention would have been obvious to one having ordinary skill in the art before the effective filing date.
Claims 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Basiji et al. (US 2014/0030729 A1) in view of El-Zehiry et al. (US 2017/0132450 A1), as applied to claims 1-2 , 4 and 6-7 above, and further in view of Harutyunyan (US 2019/0026459 A1).
Regarding claim 10, Basiji in view of El-Zehiry teaches the discrimination device according to claim 2, as described above.
Although Basiji in view of El-Zehiry teaches using One class SVM for anomaly detection (El-Zehiry, Para. [0049]), they do not explicitly teach “wherein the circuitry discriminates whether or not the discrimination target object is the blood cell through LOF” and “wherein the circuitry discriminates whether or not the discrimination target object is the blood cell by calculating a score of the LOF for the discrimination target object by using positions in a feature space of the extract features of the plurality of blood cells and the feature of the discrimination target object”. However, in an analogous field of endeavor, Harutyunyan teaches determining a local outlier factor (“LOF”) for each coordinate data point (i.e., discrimination target object) and the magnitude of the LOF is used to determine if the corresponding coordinate data point is an outlier (i.e., the blood cell) (Harutyunyan, Para. [0140]). Harutyunyan further teaches that an LOF of about 1 indicates that the coordinate data point is comparable to the neighboring coordinate data points and is not an outlier. An LOF value less than 1 indicates that the coordinate point is part of a dense region of coordinate data points. An LOF value that is significantly larger than 1 indicates that the coordinate data point is an outlier (i.e., LOF is calculated using positions in a feature space of the extracted features of the plurality of blood cells and the features of the discrimination target object) and is not an outlier (Harutyunyan, Para. [0147]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Basiji in view of El-Zehiry with the teachings of Harutyunyan by including discriminating whether the discrimination target object is the blood cell using LOF by calculating a score of the LOF using the positions of the neighboring features and the discrimination target object. One having ordinary skill in the art would have been motivated to combine these references because doing so would allow for determining anomalous behavior using LOF, as recognized by Harutyunyan. Thus, the claimed invention would have been obvious to one having ordinary skill in the art before the effective filing date.
Regarding claim 11, Basiji in view of El-Zehiry teaches the discrimination device according to claim 2, as described above.
Although Basiji in view of El-Zehiry teaches X, they do not explicitly teach “wherein the circuitry discriminates whether or not the discrimination target object is the blood cell by further comparing the calculated score of the LOF with a preset threshold value”. However, in an analogous field of endeavor, Harutyunyan teaches an LOF threshold may be set. An LOF of about 1 indicates the coordinate data point is not an outlier. An LOF that is significantly greater than 1 indicates that the coordinate data point is an outlier (Harutyunyan, Para. [0146]-[0147]).
The proposed combination as well as the motivation for combining the Basiji, El-Zehiry and Harutyunyan references presented in the rejection of Claim 10, apply to Claim 11 and are incorporated herein by reference. Thus, the system recited in Claim 11 is met by Basiji in view of El-Zehiry further in view of Harutyunyan.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Emma Rose Goebel whose telephone number is (703)756-5582. The examiner can normally be reached Monday - Friday 7:30-5.
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/Emma Rose Goebel/Examiner, Art Unit 2662
/AMANDEEP SAINI/Supervisory Patent Examiner, Art Unit 2662