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 .
DETAILED ACTION
Information Disclosure Statement
1. The information disclosure statements (IDS) submitted on 07/10/25, 10/02/25, have been entered. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
2. The drawings filed on 04/02/25. These drawings are acceptable.
Claim Rejections - 35 USC § 101
3. 35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
4. Claims 1-20, rejected under 35 U.S.C. §101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
5. Claim 1 will be addressed below according to the 2019 Patent Eligibility Guidelines.
Step 1: Is the Claim to a Process, Machine, Manufacture or Composition of Matter?
The claims recite a method of labeling flow cytometry data. Thus, the claims recite a method.
Step 2A Prong One: Does the Claim Recite an Abstract Idea?
Claim 1 recites: method comprising:
identifying a plurality of parameters, each parameter associated with a dimension of a data space of the portion of the cytometry data;
calculating a metric for each parameter of at least a portion of the plurality of parameters based on a magnitude of the cytometry data associated with the respective parameter's dimension;
generating a label for the flow cytometry gate input based on at least one metric and a predetermined magnitude threshold associated with the metric.
The examiner finds that the foregoing underlined elements recite a mental process because they can be performed in the human mind.
Step 2A Prong Two: Does the Claim Recite Additional Elements That Integrate the Abstract Idea into a Practical Application?
The elements in the claim that are not underlined above are the additional elements.
The examiner finds that each of the following additional elements merely adds insignificant extra-solution activity to the abstract idea: associated with a dimension of a data space of the portion of the cytometry data; a magnitude of the cytometry data associated with the respective parameter's dimension; at least one metric and a predetermined magnitude threshold associated with the metric.
The examiner finds that each of the following additional elements does no more than generally link the use of the abstract idea to a particular technological environment or field of use because they are merely an incidental or token addition to the claim that does not alter or affect how the process steps of identifying, calculating, generating, are perform: a flow cytometry gate input.
Thus, taken alone, the additional elements do not integrate the abstract idea into a practical application. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. For example, there is no indication that the combination of elements improves the functioning of a computer or improves any other technology.
Step 2B: Does the Claim Recite Additional Elements That Amount to Significantly More Than the Abstract Idea?
The examiner finds that the additional elements do not amount to significantly more than the abstract idea for the same reasons discussed above with respect to the conclusion that the additional elements do not integrate the abstract idea into a practical application.
Therefore, the claimed subject matter does not recite patent eligible subject matter under 35 USC §101.
Claim Rejections - 35 USC § 103
6. 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 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.
7. 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 of this title, 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.
8. Claim(s) 1-2, 12-20, is/are rejected under 35 U.S.C. 103 as being unpatentable over Sukigara et al. (Pub. No. 2023/0383234) in view of Roberts et al. (U.S. Pub. No. 2022/0390349). Hereafter “Sukigara” and “Roberts”.
Regarding Claim(s) 1, 2, Sukigara discloses a method of labeling flow cytometry data, ([0113, 0232-0233]; Figures 13-21. Sorting biological flow particles and display gate tree are not different from labeling flow cytometry data), the method comprising:
(a) receiving a flow cytometry gate input comprising a portion of the cytometry data ([0209-0210, 0232-0233], setting information display area, setting gate for sorting target is not different from receiving a flow cytometry gate input, the cytometry data);
(b) identifying a plurality of parameters, each parameter associated with a dimension of a data space of the portion of the cytometry data ([0132], the displaying measurement data for biological particle is not different from identifying parameters, dimension of a data space of the cytometry data);
(d) generating a label for the flow cytometry gate input based on at least one metric, ([0232-0233]. Name of gate is not different from label).
However, Sukigara does not teach calculating a metric for each parameter of at least a portion of the plurality of parameters based on a magnitude of the cytometry data associated with the respective parameter's dimension, and a predetermined magnitude threshold associated with the metric. Roberts teaches calculating a metric for each parameter of at least a portion of the plurality of parameters based on a magnitude of the cytometry data associated with the respective parameter's dimension, ([0033, 0047, 0052]; Figure 4. Define each group particle or each gate, or determine location of each data point, is not different from calculating a metric for each parameter. Number of analytes or different color-coded populations or stratum, strata, are not different from magnitude threshold associated with the metric), and a predetermined magnitude threshold associated with the metric ([0037], lines 11-18; [0040], lines 2-10; [0085], lines 14-18; [0125], lines 14-18). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention was made to modify Sukigara by calculating a metric for each parameter, and having a predetermined magnitude threshold associated with the metric in order to classify flow cytometer efficiently (Roberts, abstract).
Regarding Claim(s) 12-14, Sukigara in view of Roberts disclose the claimed invention according to claim 1 as stated above except for the input being received by a selection on a graphical representation of the data space, the data space is dimensionally reduced, wherein the dimensionality reduction comprising a Principal Component Analysis (PCA) reduction, a t-distributed Stochastic Neighbor Embedding (t-SNE) reduction, a Uniform Manifold Approximation and Projection (UMAP) reduction, a machine learning model reduction, or any combination thereof. Sukigara further discloses the input being received by a selection on a graphical representation of the data space, the data space is dimensionally reduced, ([0209, 0219, 0232-0233]; Figures 13-21). Roberts discloses a Principal Component Analysis (PCA) reduction, a t-distributed Stochastic Neighbor Embedding (t-SNE) reduction, a Uniform Manifold Approximation and Projection (UMAP) reduction, a machine learning model reduction, or any combination thereof ([0051]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention was made to modify Sukigara by comprising a Principal Component Analysis (PCA) reduction, a t-distributed Stochastic Neighbor Embedding (t-SNE) reduction, a Uniform Manifold Approximation and Projection (UMAP) reduction, a machine learning model reduction, or any combination thereof in order to classify flow cytometer data with a dimensionality reduction algorithm (Roberts, [0051]).
Regarding Claim(s) 15, Sukigara in view of Roberts disclose the claimed invention according to claim 1 as stated above except for a plurality of data points wherein each data point corresponds to a measurement of a single sample cell. Sukigara further discloses a plurality of data points wherein each data point corresponds to a measurement of a single sample cell ([0005]. Light scatter characteristics and fluorescence emissions resulting from labeling each various cell is not different from data point corresponds to a measurement of a single sample cell).
Regarding Claim(s) 16, Sukigara in view of Roberts disclose the claimed invention according to claim 1 as stated above except for the plurality of parameters corresponds to the presence or expression of a marker. Sukigara further discloses the plurality of parameters corresponds to the presence or expression of a marker ([0358, 0386, 0387]. Mark displayed in the gate is not different from a marker).
Regarding Claim(s) 17-18, Sukigara in view of Roberts disclose the claimed invention according to claim 1 as stated above except for determining the number of dimensions of the data space, determining the number of parameters associated with each dimension of the data space. Sukigara further discloses determining the number of dimensions of the data space, determining the number of parameters associated with each dimension of the data space ([0106, 0110]. Feature quantities such as area, height, and width are not different from dimensions of the data space).
Regarding Claim(s) 19, 20, Sukigara in view of Roberts disclose the claimed invention according to claim 1 as stated above except for displaying a confirmation prompt based on the generated label, and to edit the name of the generated label. Roberts discloses displaying a confirmation prompt based on the generated label, and to edit the name of the generated label ([0005, 0033, 0060]; Figures 4, 6, 8). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention was made to modify Sukigara by displaying a confirmation prompt based on or to edit the name of the generated label in order to determine by the location of each data point, (Roberts, [0005, 0033, 0060]).
9. Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sukigara et al. (Pub. No. 2023/0383234) in view of Roberts et al. (U.S. Pub. No. 2022/0390349), further in view of Irvine et al. (U.S. Pub. No. 2021/0278333). Hereafter “Sukigara”, “Roberts”, “Irvine”.
Regarding Claim(s) 3, Sukigara in view of Roberts disclose the claimed invention according to claim 1 as stated above except for the metric being normalized by the average magnitude of the plurality of parameters. Irvine discloses the metric being normalized by the average magnitude of the plurality of parameters ([0007], lines 20-38). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention was made to modify Sukigara and Roberts by having the average magnitude of the plurality of parameters in order to determine a generation value of the plurality of parameters, (Irvine, [0007], lines 20-38).
10. Claim(s) 4, 8-11, is/are rejected under 35 U.S.C. 103 as being unpatentable over Sukigara et al. (Pub. No. 2023/0383234) in view of Roberts et al. (U.S. Pub. No. 2022/0390349), further in view of Wang et al. (U.S. Pub. No. 2023/0215571). Hereafter “Sukigara”, “Roberts”, “Wang”.
Regarding Claim(s) 4, Sukigara in view of Roberts disclose the claimed invention according to claim 1 as stated above except for the metric is normalized by the sum of the magnitudes of the plurality of parameters. Wang discloses the metric being normalized by the sum of the magnitudes of the plurality of parameters ([0098]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention was made to modify Sukigara and Roberts by having sum of the magnitudes of the plurality of parameters in order to classify a given sample efficiently, (Wang, [0098]).
Regarding Claim(s) 8, 9, Sukigara in view of Roberts disclose the claimed invention according to claim 1 as stated above except for determining that the metric meets or exceeds the predetermined magnitude threshold, and a positive indicator of the parameter. Wang teaches determining that the metric meets or exceeds the predetermined magnitude threshold, and a positive indicator of the parameter ([0074]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention was made to modify Sukigara and Roberts by meeting or exceeding the predetermined magnitude threshold in order to calculate the coefficient of determination, (Wang, [0074]).
Regarding Claim(s) 10, 11, Sukigara in view of Roberts disclose the claimed invention according to claim 1 as stated above except for determining that the metric meets or falls below the predetermined magnitude threshold, and a negative indicator of the parameter. Wang teaches determining that the metric meets or falls below the predetermined magnitude threshold, and a positive indicator of the parameter ([0074]. Note: the limitation “the value does not exceed the upper threshold” is not different from falls below the predetermined magnitude threshold). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention was made to modify Sukigara and Roberts by meeting or falling below the predetermined magnitude threshold in order to calculate the coefficient of determination, (Wang, [0074]).
Allowable Subject Matter
11. Claims 5-7, 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, and if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 101, set forth in this Office action.
12. The following is a statement of reasons for the indication of allowable subject matter: there was no prior art found by the examiner that suggested modification or combination with the cited art so as to satisfy the combination of all the limitations in claims 5, 6.
13. As claim 5, the prior art of record taken alone or in combination, fails to disclose or render obvious a method of labeling flow cytometry data comprising all the steps from (a) to (d);
wherein calculating the metric comprises determining a ratio between a maximum magnitude of the associated dimension within the portion of the cytometry data and a magnitude of the associated dimension within the entire cytometry data; in combination with the rest of the limitations of claims 1 and 5.
14. As claim 6, the prior art of record taken alone or in combination, fails to disclose or render obvious a method of labeling flow cytometry data comprising all the steps from (a) to (d);
wherein calculating the metric comprises determining a ratio between a minimum magnitude of the associated dimension within the portion of the cytometry data and a magnitude of the associated dimension within the entire cytometry data; in combination with the rest of the limitations of claims 1 and 6.
15. As claim 7, the prior art of record taken alone or in combination, fails to disclose or render obvious a method of labeling flow cytometry data comprising all the steps from (a) to (d);
wherein calculating the metric comprises determining a difference between an average magnitude of the associated dimension within the portion of the cytometry data and a magnitude of the associated dimension within the entire cytometry data; in combination with the rest of the limitations of claims 1 and 7.
Fax/Telephone Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TRI T TON whose telephone number is (571)272-9064. The examiner can normally be reached on 8am-4pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michelle Iacoletti can be reached on (571)270-5789. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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August 13, 2026
/Tri T Ton/
Primary Examiner Art Unit 2877
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