DETAILED ACTION
Information Disclosure Statement
The information disclosure statement submitted on 08/21/2025 has been considered by the Examiner and made of record in the application 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.
Claims 1-24 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The independent claims are directed to the abstract idea of receiving cell images, counting cells, and classifying the images based on cell count and secretion information, which are data collection, analysis, and classification steps, which are mental processes. The additional elements (apparatus, memory, first and second devices, etc) do not integrate the abstract idea into a practical application because they are recited generically and just receive images, count cells and classify images. The independent claims do not recite a specific improvement in the technology and the additional elements amount to no more than using generic computer components and do not add an inventive concept. The dependent claims are rejected for similar reasons.
Claim Rejections - 35 USC § 102
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.
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.
Claim(s) 1-7, 9-15 and 17-23 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Paczkowski (US 2023/0138672 A1).
Regarding claims 1, 9 and 17, Paczkowski discloses a method comprising:
[claim 9: An apparatus comprising: a non-transitory memory for storing an application, the application for: (paragraph 51)]
receiving a plurality of cell images, wherein each cell image of the plurality of cell images contains a carrier; (Paczkowski discloses that the workflow commences in state 1100 with collection of a plurality of images associated with sample retention regions 124 of the sample array 122 and associated analyte signal readouts for cells/particulates disposed in those sample retention regions, see paragraph 88. Paczkowski further discloses that the sample array includes a plurality of discrete chambers, wells, troughs, channels or other features/areas that comprise retention regions 124 which are configured to contain, hold, or sequester cells/particulates, see paragraph 64. The claimed carrier reads on Paczkowski’s microchamber/microwell.)
counting a number of cells in each carrier in each cell image of the plurality of cell images; (Paczkowski discloses using the first image to discern the location, number, and distribution of cells/particulates 106 in the various sample retention regions 124, see paragraph 90. Paczkowski further discloses determining the occupancy and location of cells/particulates within microchamber/sample retention regions, see paragraph 123. Paczkowski also states that output information includes the number of cells/particulates 106 contained in respective regions, see paragraph 130.)
classifying each of the cell images based on the number of cells in each carrier; and (Paczkowski discloses classifying sample region masks or boundaries based on the cells identified, in particular that from the number cells/particulates associated with a selected area 658, the region may be designated or flagged to be excluded from further analysis as containing multiple cells/particulates, while areas containing a desired number of cells/particulates may be included, such as a single cell/particulate in a single cell analysis, see paragraph 130.)
classifying each of the cell images based on detected secretion information. (Paczkowski discloses associating detected analyte patterns with cells/particulates to profile detected released secretions and analytes, see paragraph 89. Paczkowski also discloses that analyte patterns corresponding to detected analytes 108, expressed, secreted, or released by the cell/particulate 106 are rad by associating sample retention regions with analyte detection regions, mapping signal intensities to pixels, averaging thresholded signal intensities, and outputting valid detected analytes, associated intensities and other characteristics, see paragraphs 151-153.)
Regarding claims 2, 10 and 18, Paczkowski discloses the claimed invention wherein the plurality of cell images are brightfield images. (paragraphs 90 and 95)
Regarding claims 3, 11 and 19, Paczkowski discloses the claimed invention wherein further comprising training a neural network to classify cell images based on counting the number of cells in each carrier, and training the neural network to classify the cell images based on secretion information. (paragraphs 123, 130 and 173-174)
Regarding claims 4, 12 and 20, Paczkowski discloses the claimed invention wherein further comprising retaining only the cell images classified as having a single cell in each carrier. (paragraph 130)
Regarding claims 5, 13 and 21, Paczkowski discloses the claimed invention wherein classifying each of the cell images based on the detected secretion information includes a “no secretion” classification, a “low secretion” classification, and a “high secretion” classification. (paragraphs 63, 151-153, 158-165 and 170)
Regarding claims 6, 14 and 22, Paczkowski discloses the claimed invention wherein classifying each of the cell images based on the detected secretion information includes retaining only images with a “high secretion” classification. (paragraph 151-153 and 158-165)
Regarding claims 7, 15 and 23, Paczkowski discloses the claimed invention wherein classifying each of the cell images based on the number of cells in each carrier and classifying each of the cell images based on the detected secretion information occur in parallel. (paragraphs 59, 76-78 and 124)
Claim Rejections - 35 USC § 103
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.
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.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 8, 16 and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Paczkowski in view of Fordyce (US 2021/0261953 A1).
Regarding claims 8, 16 and 24, Paczkowski discloses the claimed invention except for wherein the carrier comprises a double emulsion.
In related art, Fordyce discloses the carrier comprises a double emulsion. (abstract)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to incorporate the teachings of Fordyce into the teachings of Paczkowski to effectively perform multi-parameter analysis of single cells.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BOBBAK SAFAIPOUR whose telephone number is (571)270-1092. The examiner can normally be reached Monday - Friday, 8:00am - 5:00pm.
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/BOBBAK SAFAIPOUR/Primary Examiner, Art Unit 2665
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