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
Priority is acknowledged from Provisional application 63/604,862 with a filing date of 11/30/2023.
Information Disclosure Statement
The information disclosure statements (“IDS”) filed on 12/13/2024, 03/26/2025, 06/12/2026, and 08/13/2026 were reviewed and the listed references were noted.
Drawings
The 14-page drawings have been considered and placed on record in the file.
Claim Rejections - 35 USC § 101
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.
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 1, 7, and 13 of this application are patentably indistinct from claims 1, 7, and 13 of copending U.S. Application No. 18/961,571. Pursuant to 37 CFR 1.78(f) or pre-AIA 37 CFR 1.78(b), when two or more applications filed by the same applicant contain patentably indistinct claims, elimination of such claims from all but one application may be required in the absence of good and sufficient reason for their retention during pendency in more than one application. Applicant is required to either cancel the patentably indistinct claims from all but one application or maintain a clear line of demarcation between the applications. See MPEP § 822.
Accordingly, Claims 1, 7, and 13 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1, 7, and 13 of copending Application No. 18/961,571 (reference application). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
Claims 13-18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter as follows.
Claim 13 recites a processor-readable medium storing instructions. The broadest reasonable interpretation of a computer-readable storage medium also comprises transitory forms of signal transmission, signals per se, such as a propagating electrical or electromagnetic signal or carrier wave which is not one of the statutory categories of invention. MPEP § 2106. The Examiner suggests that Claim 13 should be rephrased as: "A non-transitory processor-readable medium…" in order to overcome this rejection.
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 1-5, 7-11, and 13-17 are rejected under 35 U.S.C. 103 as being unpatentable over Yafin et al. (US 20230003622 A1) in view of Masuya et al. (WO 2016166847 A1).
Regarding Claim 1, Yafin teaches "An apparatus for analyzing a biological sample, the apparatus comprising: at least one processor; and at least one memory storing instructions which, when executed by the at least one processor, cause the apparatus at least to perform: determining that a sample chamber contains a first type of biological sample, the sample chamber comprising at least one bottom wall through which an imaging device is configured to image the sample chamber"; (Yafin, Abstract and FIG. 9 Paras. 95, 99, 110, and 125, teaches an apparatus comprising a processor and memory in which a cell suspension is placed within a sample chamber, allowed to settle to form a monolayer, an image is acquired while the microscope is focused at the monolayer-depth-level, and platelets are identified in the image, i.e., apparatus for analyzing a biological sample comprising determining a sample chamber contains a first type of biological sample being the identification of platelets, wherein the sample carrier includes a bottom glass layer in which the sample is viewed by the optical measurement devices via the glass layer, i.e., chamber comprises a bottom wall for the imaging device to image the chamber);
"providing a plurality of images by controlling the imaging device to, for each depth of a plurality of depths in the sample chamber: focus on the respective depth, and capture one or more images of one or more fields of view containing the respective depth in the sample chamber"; (Yafin, Paras. 95, 114-115, teaches performing optical measurements by the optical measurement device wherein platelets are identified by focusing the microscope at additional depth levels and acquiring images at the additional depth levels in which he microscope may be focused at additional depth levels that are separated from each other by a given height difference over the height of the portion of the sample that is within the sample chamber in which for each of the additional depth levels, microscopic images are acquired from only a subset of the imaging fields, i.e., a plurality of images are provided for each of the depths in the chamber by focusing on the respective depth and capturing an image of the field of view containing the respective depth in the chamber).
However, Yafin does not explicitly teach "counting one or more types of constituents in the plurality of images to determine one or more depth distributions of the one or more types of constituents across the plurality of depths, the one or more types of constituents comprising a constituent of interest; and quantifying the constituent of interest in the biological sample based on the one or more depth distributions and based on one or more depth distribution curves”.
In an analogous field of endeavor, Masuya teaches "counting one or more types of constituents in the plurality of images to determine one or more depth distributions of the one or more types of constituents across the plurality of depths, the one or more types of constituents comprising a constituent of interest"; (Masuya, FIG. 7 and Pg. 4 Para. 8 and Pg. 5 Paras. 11-15, teaches analyzing image information and calculating at least one quantitative value of the number of bacteria and the proportion of the bacteria in the focal plane wherein the group of images are at a plurality of Z positions at a first and second time and wherein the number of E. coli presenting chemotaxis is counted with respect to the height from the bottom surface of the sample container, i.e., counting the one or more types of constituents in the images to determine a depth distribution of the constituents across the plurality of depths comprising a constituent of interest being the E. coli presenting chemotaxis);
"and quantifying the constituent of interest in the biological sample based on the one or more depth distributions and based on one or more depth distribution curves"; (Masuya, FIGs. 8A-8B and Pg. 5 Paras. 13-15 and Pg. 6 Paras. 1-2, teaches graphs of the number of bacteria counted from the two-dimensional plane data with respect to the height from the bottom surface of the sample container and calculating a change in the number of bacteria with respect to the height of the bottom surface of the sample container from a plurality of two-dimensional plane data at a plurality of Z positions in which the total bacterial count is calculated from the integrated values of the graphs in which the vertical axis represents the height from the bottom surface where the two-dimensional plane data was measured, and the horizontal axis represents the number of bacteria, i.e., quantify the constituent of interest in the sample based on the depth distribution and its depth distribution curve being the plotted graph curve of height from bottom surface and the number of bacteria used to calculate total bacterial count).
It would have been obvious to one having ordinary skill in the art before the effective filing date to modify the invention of Yafin by including the counting of constituents in images to determine a depth distribution and quantifying the constituents using a depth distribution curve taught by Masuya. One of ordinary skill in the art would be motivated to combine the references since it expresses the information about the particles in a plurality of planes over time (Masuya, Abstract, teaches the motivation of combination to be to express change over time of information about the particles in a plurality of focal planes).
Thus, the claimed subject matter would have been obvious to a person having ordinary skill in the art before the effective filing date.
Regarding Claim 2, the combination of references of Yafin in view of Masuya teaches "The apparatus of claim 1, wherein the one or more depth distributions cover less than an entire column of the sample chamber"; (Yafin, Paras. 14-18, teaches acquiring at least one image of a portion of the monolayer of cells focused at a monolayer-depth-level, identifying platelets that have settled within the monolayer in the image, determining a first platelet count of platelets that have settled within the monolayer, acquiring at least one additional microscopic image of the portion of the sample focused at a different depth level, and identifying platelets that have not settled within the monolayer to determine a second count, i.e., depth distribution being the counts of cells across the two depths cover less than an entire column of the sample chamber due to it invention only requiring a single image of a portion of the monolayer and a single image of just one other depth of the portion of the column);
"and wherein the one or more depth distribution curves cover the entire column of the sample chamber"; (Masuya, FIGs. 8A-8B and Pg. 5 Paras. 13-15 and Pg. 6 Paras. 1-2, teaches graphs of the number of bacteria counted from the two-dimensional plane data with respect to the height from the bottom surface of the sample container in which the total bacterial count is calculated from the integrated values of the graphs in which the vertical axis represents the height from the bottom surface where the two-dimensional plane data was measured, and the horizontal axis represents the number of bacteria, i.e., depth distribution curve covers the entire column of the sample chamber as it computes a total bacterial count through all the heights from the bottom of the chamber).
The proposed combination as well as the motivation for combining the Yafin and Masuya references presented in the rejection of Claim 1, applies to claim 2. Thus, the apparatus recited in claim 2 is met by Yafin in view of Masuya.
Regarding Claim 3, the combination of references of Yafin in view of Masuya teaches "The apparatus of claim 1, wherein the one or more depth distributions comprise a depth distribution of the constituent of interest"; (Masuya, FIG. 7 and Pg. 4 Para. 8 and Pg. 5 Paras. 11-15, teaches analyzing image information and calculating at least one quantitative value of the number of bacteria and the proportion of the bacteria in the focal plane wherein the group of images are at a plurality of Z positions at a first and second time and wherein the number of E. coli presenting chemotaxis is counted with respect to the height from the bottom surface of the sample container, i.e., depth distribution may comprise a distribution of the constituent of interest such as E. coli presenting chemo taxis);
"and wherein the one or more depth distribution curves comprise a fitted curve fitted to the depth distribution of the constituent of interest"; (Masuya, FIGs. 8A-8B and Pg. 5 Paras. 13-15 and Pg. 6 Paras. 1-2, teaches graphs of the number of bacteria counted from the two-dimensional plane data with respect to the height from the bottom surface of the sample container and calculating a change in the number of bacteria with respect to the height of the bottom surface of the sample container from a plurality of two-dimensional plane data at a plurality of Z positions in which FIG. 8A is a graph plotting the number of E. coli presenting chemotaxis against the height from the bottom of the sample container and output the determination result of the presence or absence of bacterial chemotaxis from the slopesof the graphs, i.e., depth distribution being the pairs of data of number of constituent of interest and its corresponding depth is fit to a plotted curve being the depth distribution curve which has its slope analyzed).
The proposed combination as well as the motivation for combining the Yafin and Masuya references presented in the rejection of Claim 1, applies to claim 3. Thus, the apparatus recited in claim 3 is met by Yafin in view of Masuya.
Regarding Claim 4, the combination of references of Yafin in view of Masuya teaches "The apparatus of claim 3, wherein in the quantifying the constituent of interest in the biological sample, the instructions, when executed by the at least one processor, cause the apparatus at least to perform: estimating, based on the fitted curve, a count of the constituent of interest in the entire column of the sample chamber"; (Masuya, FIGs. 8A-8B and Pg. 5 Paras. 13-15 and Pg. 6 Paras. 1-2, teaches graphs of the number of bacteria counted from the two-dimensional plane data with respect to the height from the bottom surface of the sample container and calculating a change in the number of bacteria with respect to the height of the bottom surface of the sample container from a plurality of two-dimensional plane data at a plurality of Z positions, i.e., estimating a count of the constituent of interest in the entire column of the sample chamber based on the fitted curve being the combination of the number of bacteria at each height from the bottom of the chamber);
"and estimating, based on the count of the constituent of interest in the entire column of the sample chamber, a total count of the constituent of interest in the sample chamber"; (Masuya, FIGs. 8A-8B and Pg. 5 Paras. 13-15 and Pg. 6 Paras. 1-2, teaches graphs of the number of bacteria counted from the two-dimensional plane data with respect to the height from the bottom surface of the sample container and calculating a change in the number of bacteria with respect to the height of the bottom surface of the sample container from a plurality of two-dimensional plane data at a plurality of Z positions and calculate the total bacterial count from the integrated values of the graphs, i.e., estimating a total count of the constituent of interest in the chamber based on the count of interest in the entire column being the calculation of the total bacterial count from the integrated values).
The proposed combination as well as the motivation for combining the Yafin and Masuya references presented in the rejection of Claim 1, applies to claim 4. Thus, the apparatus recited in claim 4 is met by Yafin in view of Masuya.
Regarding Claim 5, the combination of references of Yafin in view of Masuya teaches "The apparatus of claim 1, wherein the one or more depth distributions comprise a plurality of depth distributions of the constituent of interest"; (Masuya, FIGs 7 and 9-10 and Pg. 5 Para. 11 and Pg. 6 Paras. 3-5, teaches displaying a group of images at a plurality of Z positions at a first time and at a second time, i.e., plurality of depth distributions of the constituent of interest);
"each of the plurality of depth distributions corresponding to a different time period"; (Masuya, FIGs 7 and 9-10 and Pg. 5 Para. 11 and Pg. 6 Paras. 3-5, teaches displaying a group of images at a plurality of Z positions at a first time and at a second time, i.e., plurality of depth distributions of the constituent of interest corresponding to different time periods);
"wherein the one or more depth distribution curves comprise a plurality of fitted curves"; (Masuya, FIGs 7 and 9-10 and Pg. 5 Para. 11 and Pg. 6 Paras. 3-6, teaches displaying two graphs and calculating the number of bacteria at a plurality of Z positions at a first time and a plurality of bacteria at a second time for the respective graphs, i.e., the depth distributions curves comprise a plurality of fitted curves);
"each of the plurality of fitted curves being fitted to a corresponding one of the plurality of depth distributions of the constituent of interest"; (Masuya, FIGs 7 and 9-10 and Pg. 5 Para. 11 and Pg. 6 Paras. 3-6, teaches displaying two graphs and calculating the number of bacteria at a plurality of Z positions at a first time and a plurality of bacteria at a second time for the respective graphs, i.e., the depth distributions curves comprise a plurality of fitted curves being the curve graph for each time period for the depth distributions).
The proposed combination as well as the motivation for combining the Yafin and Masuya references presented in the rejection of Claim 1, applies to claim 5. Thus, the apparatus recited in claim 5 is met by Yafin in view of Masuya.
Claim 7 recites a method with steps corresponding to the elements of the system 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 system claim. Additionally, the rationale and motivation to combine the Yafin and Masuya references, presented in rejection of Claim 1, apply to this claim.
Claim 8 recites a method with steps corresponding to the elements of the system recited in Claim 2. Therefore, the recited steps of this claim are mapped to the proposed combination in the same manner as the corresponding elements in its corresponding system claim. Additionally, the rationale and motivation to combine the Yafin and Masuya references, presented in rejection of Claim 1, apply to this claim.
Claim 9 recites a method with steps corresponding to the elements of the system recited in Claim 3. Therefore, the recited steps of this claim are mapped to the proposed combination in the same manner as the corresponding elements in its corresponding system claim. Additionally, the rationale and motivation to combine the Yafin and Masuya references, presented in rejection of Claim 1, apply to this claim.
Claim 10 recites a method with steps corresponding to the elements of the system recited in Claim 4. Therefore, the recited steps of this claim are mapped to the proposed combination in the same manner as the corresponding elements in its corresponding system claim. Additionally, the rationale and motivation to combine the Yafin and Masuya references, presented in rejection of Claim 1, apply to this claim.
Claim 11 recites a method with steps corresponding to the elements of the system recited in Claim 5. Therefore, the recited steps of this claim are mapped to the proposed combination in the same manner as the corresponding elements in its corresponding system claim. Additionally, the rationale and motivation to combine the Yafin and Masuya references, presented in rejection of Claim 1, apply to this claim.
Claim 13 recites a computer-readable storage medium storing a program with instructions corresponding to the steps recited in Claim 1. Therefore, the recited programming instructions of this claim are mapped to the proposed combination in the same manner as the corresponding steps in its corresponding method claim. Additionally, the rationale and motivation to combine the Yafin and Masuya references, presented in rejection of Claim 1, apply to this claim. Finally, the combination of the Yafin and Masuya references discloses a computer readable storage medium (for example, see Yafin, Paragraph 95).
Claim 14 recites a computer-readable storage medium storing a program with instructions corresponding to the steps recited in Claim 2. Therefore, the recited programming instructions of this claim are mapped to the proposed combination in the same manner as the corresponding steps in its corresponding method claim. Additionally, the rationale and motivation to combine the Yafin and Masuya references, presented in rejection of Claim 1, apply to this claim. Finally, the combination of the Yafin and Masuya references discloses a computer readable storage medium (for example, see Yafin, Paragraph 95).
Claim 15 recites a computer-readable storage medium storing a program with instructions corresponding to the steps recited in Claim 3. Therefore, the recited programming instructions of this claim are mapped to the proposed combination in the same manner as the corresponding steps in its corresponding method claim. Additionally, the rationale and motivation to combine the Yafin and Masuya references, presented in rejection of Claim 1, apply to this claim. Finally, the combination of the Yafin and Masuya references discloses a computer readable storage medium (for example, see Yafin, Paragraph 95).
Claim 16 recites a computer-readable storage medium storing a program with instructions corresponding to the steps recited in Claim 4. Therefore, the recited programming instructions of this claim are mapped to the proposed combination in the same manner as the corresponding steps in its corresponding method claim. Additionally, the rationale and motivation to combine the Yafin and Masuya references, presented in rejection of Claim 1, apply to this claim. Finally, the combination of the Yafin and Masuya references discloses a computer readable storage medium (for example, see Yafin, Paragraph 95).
Claim 17 recites a computer-readable storage medium storing a program with instructions corresponding to the steps recited in Claim 5. Therefore, the recited programming instructions of this claim are mapped to the proposed combination in the same manner as the corresponding steps in its corresponding method claim. Additionally, the rationale and motivation to combine the Yafin and Masuya references, presented in rejection of Claim 1, apply to this claim. Finally, the combination of the Yafin and Masuya references discloses a computer readable storage medium (for example, see Yafin, Paragraph 95).
Claims 6, 12, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Yafin in view of Masuya and Araki et al. (US 20150276564 A1).
Regarding Claim 6, the combination of references of Yafin in view of Masuya teaches "The apparatus of claim 5, wherein in the quantifying the constituent of interest in the biological sample, the instructions, when executed by the at least one processor, cause the apparatus at least to perform: for each fitted curve of the plurality of fitted curves, estimating, based on the respective fitted curve, a respective count of the constituent of interest in the entire column of the sample chamber"; (Masuya, FIGs 7 and 9-10 and Pg. 5 Para. 11 and Pg. 6 Paras. 3-6, teaches displaying two graphs and calculating the number of bacteria at a plurality of Z positions at a first time and a plurality of bacteria at a second time for the respective graphs wherein a total of the counted bacteria are displayed as a set, i.e., estimating a respective count of the constituent of interest in the column of the sample chamber based on the respective fitted curve for each curve).
The proposed combination as well as the motivation for combining the Yafin and Masuya references presented in the rejection of Claim 1, applies to claim 6.
However, the combination of references of Yafin in view of Masuya does not explicitly teach "providing an average of the respective counts as an estimated count of the constituent of interest in the entire column of the sample chamber; and estimating, based on the average of the respective counts, a total count of the constituent of interest in the sample chamber”.
In an analogous field of endeavor, Araki teaches "providing an average of the respective counts as an estimated count of the constituent of interest in the entire column of the sample chamber"; (Araki, Para. 140, teaches selecting several microchambers in the flow path and the cells retained therein were counted in which the average number of cells per microchamber was calculated, i.e., providing an average of the respective counts as an estimated count of the constituent of interest in the chamber);
"and estimating, based on the average of the respective counts, a total count of the constituent of interest in the sample chamber"; (Araki, Para. 140, teaches the number of recovered cells was determined by multiplying the thus obtained average number of cells by the total number of chambers, i.e., estimating a total count of the constituent of interest in the chamber based on the average of the counts).
It would have been obvious to one having ordinary skill in the art before the effective filing date to modify the invention of Yafin and Masuya wherein the respective counts are of the constituent of interest in the entire column of a sample chamber by including the averaging of counts and estimating a total count based on the average taught by Araki. One of ordinary skill in the art would be motivated to combine the references since it effectively detects cells (Araki, Paras. 1-2, teaches the motivation of combination to be to effectively detect cells contained in a suspension).
Thus, the claimed subject matter would have been obvious to a person having ordinary skill in the art before the effective filing date.
Claim 12 recites a method with steps corresponding to the elements of the system recited in Claim 6. Therefore, the recited steps of this claim are mapped to the proposed combination in the same manner as the corresponding elements in its corresponding system claim. Additionally, the rationale and motivation to combine the Yafin, Masuya, and Araki references, presented in rejection of Claim 6, apply to this claim.
Claim 18 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 combination in the same manner as the corresponding steps in its corresponding method claim. Additionally, the rationale and motivation to combine the Yafin, Masuya, and Araki references, presented in rejection of Claim 6, apply to this claim. Finally, the combination of the Yafin, Masuya, and Araki references discloses a computer readable storage medium (for example, see Yafin, Paragraph 95).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW STEVEN BUDISALICH whose telephone number is (703)756-5568. The examiner can normally be reached Monday - Friday 8:30am-5:00pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amandeep Saini can be reached on (571) 272-3382. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREW S BUDISALICH/Examiner, Art Unit 2662
/AMANDEEP SAINI/Supervisory Patent Examiner, Art Unit 2662
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