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
The instant application claims priority to and benefit of Japanese Application No. 2024-035886, filed on 03/08/2024.
Information Disclosure Statement
The information disclosure statement (“IDS”) filed on 04/14/2025 and 07/18/2025 was reviewed and the listed references were noted.
Drawings
The 11 pages of drawings have been considered and placed on record in the file.
Status of Claims
Claims 1-14 are currently pending.
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
Claim Rejections - 35 USC § 112(f)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitations are: " an acquisition unit…”, “an estimation unit …”, “a determination unit…:, “an output unit…”, “a learning processing unit…”, “a specification unit…”, “a preprocessing unit…”, and “image capturing unit…” in Claims 1-3, 6-10, and 14.
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it is being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this limitation interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 1-14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Independent Claim 1 is directed to acquiring a cell sample image and estimating the number of target cells within the image.
Step 1:
With regard to Step 1, the instant claims are directed to an apparatus among the statutory categories of invention.
Step 2A – Prong 1:
With regard to Step 2A – Prong 1, for example in apparatus Claim 1, the limitations “…acquires an image of a sample containing cells or microorganisms as image-capturing targets”, “…estimates a proportion of detection targets to image-capturing targets in a sample shown in an image acquired by the acquisition unit, based on a group of an image of a reference sample containing image-capturing targets and a proportion of cells or microorganisms as the detection targets to the image-capturing targets in the reference sample”, and “…outputs a proportion estimated by the estimation unit”, as recited, is an apparatus that, under its broadest reasonable interpretation, covers performance of the limitation in the mind/observation of a person inspecting a sample image of cells and estimating the proportion of target cells that are the sample. That is, nothing in the claim’s steps preclude the limitations from practically being performed in the mind or through observation/judgement of inspecting a cell sample image and determining the number of target cells in the image. If a claim limitation, under its broadest reasonably interpretation covers performance of the limitation in the mind then it falls within the "Mental processes" grouping of the abstract idea, which include concepts performed in the human mind, including an observation, evaluation, judgement, opinion. Accordingly, the claim recites an abstract idea
Step 2A – Prong 2:
The 2019 PEG defines the phrase “integration into a practical application” to require an additional element or a combination of additional elements in the claim to apply, rely on, or use the judicial exception. In the instant case, the additional elements in the claims do not apply, rely on, or use the judicial exception.
Step 2B:
Because the claims fail under Step 2A, the claims are further evaluated under Step 2B. The claims herein do not include additional elements that are sufficient to amount to significantly more than the judicial exception. Accordingly, these claims are not patent eligible.
Further, with regard to dependent Claims 2-12 viewed individually, these additional elements are under their broadest reasonable interpretation, cover performance of the limitation in the mind and do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself. Accordingly, Claims 2-12 are rejected under 35 U.S.C. 101.
Further, with regards to independent Claims 13-14. Claim 13 recites a method with steps corresponding to the elements of the apparatus recited in Claim 1. Therefore, the recited steps of this claim are rejected under 35 U.S.C. 101 in the same manner as the corresponding elements in its corresponding apparatus claim. Furthermore, Claim 14 recites a non-transitory computer-readable storage medium storing a program corresponding to the elements of the apparatus recited in Claim 1, and is rejected under 35 U.S.C. 101.
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 1-6 and 8-14 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Loh et al. (“A deep learning approach to the screening of malaria infection: Automated and rapid cell counting, object detection and instance segmentation using Mask R-CNN” published in March 2021).
Consider Claim 1, Loh teaches “An apparatus comprising: an acquisition unit that acquires an image of a sample containing cells or microorganisms as image-capturing targets;” (Loh; Section 2.1; “Human blood for culturing Plasmodium was purchased from Interstate blood bank (USA). Plasmodium falciparum, 3D7 strain was used for all experiments reported in this work. Parasites cultured in human RBCs under standard conditions (Subramanian et al., 2016) were smeared on glass slides, fixed with methanol and stained with 1:10 diluted Giemsa solution (Merck, Singapore) for microscopic examinations and phenotypic determination. Images were captured using a Leica digital camera connected to a Leica ICC50 W microscope, as reported in prior work (Subramanian et al., 2018).” (emphasis added)) “an estimation unit that estimates a proportion of detection targets to image-capturing targets in a sample shown in an image acquired by the acquisition unit,” (Loh; Section 4; “In this work, we have developed and tested a deep learning based model to segment, classify, and count Plasmodium falciparum-infected red blood cells.”) “based on a group of an image of a reference sample containing image-capturing targets and a proportion of cells or microorganisms as the detection targets to the image-capturing targets in the reference sample;” (Loh; Section 2.2; “Our dataset consists of 297 images, of which 173 were used for training, 64 for validation, and 60 for testing in an approximate ratio of 3:1:1.”) “and an output unit that outputs a proportion estimated by the estimation unit.” (Loh; Fig. 5 (See image below), “Sample Report. It shows the overall cell counts in each stage and the parasitemia values for malaria diagnosis.”).
PNG
media_image1.png
277
397
media_image1.png
Greyscale
Consider Claim 2; Loh teaches “The apparatus according to claim 1, further comprising a determination unit that determines an extraction condition for extracting image-capturing targets in an image of the group according to the proportion of the group,” (Loh; Fig.2(B) (See image below)) “among extraction conditions of image-capturing targets, which are settable by a parameter indicating a shape or a texture of an image-capturing target in the image,” (Loh; Section 2.2; “The polygon shape tool was used to trace out the borders, and regions of interest were then labelled accordingly based on the classification of the specific developmental stage of the parasite (Yang et al., 2017).”) “based on the group of an image of the reference sample and the proportion regarding the reference sample,” (Loh; Section 2.2; “Out of the five classes identified, only four classes, which are uninfected reticulocyte, ring, trophozoite, and schizont, were labelled. Reticulocytes were included in the analysis, since anaemia resulting from malaria can lead to higher reticulocyte counts in blood smears and may have distinct staining pattern compared to mature normocytes. The uninfected normocyte class was intentionally excluded to save time on manual annotations due to a large number of healthy normocytes present in each smear.”) “wherein the estimation unit estimates the proportion regarding a sample shown by an input image, by using the extraction condition determined by the determination unit.” (Loh; Fig.2(C-F) (See image below)).
PNG
media_image2.png
483
816
media_image2.png
Greyscale
Consider Claim 3; Loh teaches “The apparatus according to claim 2, wherein the determination unit determines an extraction condition for extracting image-capturing targets in the image according to a proportion of the detection targets to image-capturing targets in each of a plurality of groups, including the group, based on the plurality of groups with proportions, including the proportion, different from each other.” (Loh; Fig.2 (See image above)).
Consider Claim 4, Loh teaches “The apparatus according to claim 2, wherein: the parameter indicating a shape of an image-capturing target in an image includes at least one of an area, diameter, perimeter, circularity, compactness, ratio of major axis and minor axis, skeletal length, number of branches or number of limbs of the image-capturing target; (Loh; Section 2.2; “The polygon shape tool was used to trace out the borders, and regions of interest were then labelled accordingly based on the classification of the specific developmental stage of the parasite (Yang et al., 2017).”) “and a parameter indicating a texture of an image-capturing target in an image includes a number of at least one preset texture.” (Loh; Fig.2(C-F) (See image above); Section 2.2; “Reticulocytes were included in the analysis, since anaemia resulting from malaria can lead to higher reticulocyte counts in blood smears and may have distinct staining pattern compared to mature normocytes.”(emphasis added)).
Consider Claim 5, Loh teaches “The apparatus according to claim 1, wherein the estimation unit performs estimation by using a learning model that outputs the proportion regarding a sample shown by an input image, which is a learning model produced by learning processing using learning data including the group of an image of the reference sample and the proportion regarding the reference sample.” (Loh; Abstract; “In this work, we used a deep learning model called Mask R-CNN that is trained on uninfected and Plasmodium falciparum-infected red blood cells. Our predictive model produced reports at a rate 15 times faster than manual counting without compromising on accuracy.”).
Consider Claim 6, Loh teaches “The apparatus according to claim 1, further comprising a learning processing unit that produces a learning model that outputs the proportion regarding a sample shown by an input image,” (Loh; Section 4; “In this work, we have developed and tested a deep learning based model to segment, classify, and count Plasmodium falciparum-infected red blood cells.”) “by using learning data including the group of an image of the reference sample and the proportion regarding the reference sample,” (Loh; Abstract; “In this work, we used a deep learning model called Mask R-CNN that is trained on uninfected and Plasmodium falciparum-infected red blood cells.”) “wherein the estimation unit performs estimation by using the learning model.” (Loh; Section 4; “In this work, we have developed and tested a deep learning based model to segment, classify, and count Plasmodium falciparum-infected red blood cells.”)
Consider Claim 8, Loh teaches “The apparatus according to claim 1, further comprising a specification unit that specifies the proportion regarding the reference sample by performing at least one of destruction or staining on cells or microorganisms contained in the reference sample.” (Loh; Section 2.1; “Human blood for culturing Plasmodium was purchased from Interstate blood bank (USA). Plasmodium falciparum, 3D7 strain was used for all experiments reported in this work. Parasites cultured in human RBCs under standard conditions (Subramanian et al., 2016) were smeared on glass slides, fixed with methanol and stained with 1:10 diluted Giemsa solution (Merck, Singapore) for microscopic examinations and phenotypic determination” (emphasis added)).
Consider Claim 9, Loh teaches “The apparatus according to claim 1, further comprising a preprocessing unit that produces the reference sample by performing preprocessing on a sample with a cell sorter.” (Loh Section 2.1; “Parasites cultured in human RBCs under standard conditions (Subramanian et al., 2016) were smeared on glass slides, fixed with methanol and stained with 1:10 diluted Giemsa solution (Merck, Singapore) for microscopic examinations and phenotypic determination” (emphasis added); Examiner notes Loh teaches phenotypic determination of the reference samples using manual annotation of the dataset to sort and label cells based on “the specific development stages of the parasite” (Loh; Section 2,2).).
Consider Claim 10, Loh teaches “The apparatus according to claim 1, further comprising an image capturing unit that captures a sample.” (Loh; Section 2.1; “Images were captured using a Leica digital camera connected to a Leica ICC50 W microscope, as reported in prior work (Subramanian et al., 2018).”).
Consider Claim 11, Loh teaches “The apparatus according to claim 1, wherein the detection targets are cells or microorganisms of a predetermined type.” (Loh; Fig.2(C-F) (See image above)).
Consider Claim 12, Loh teaches “The apparatus according to claim 1, wherein the detection targets are cells or microorganisms in a predetermined state.” (Loh; Fig.2(C-F) (See image above); “Selective mask for extracted stages in the following order: Uninfected Reticulocyte, Ring, Trophozoite, and Schizont.”).
Claim 13 recites a method with steps corresponding to the elements recited in Claim 1. Therefore, the recited elements of this claim are mapped to the proposed combination in the same manner as the corresponding steps in its corresponding apparatus claim.
Claim 14 recites a non-transitory computer-readable medium storing a program corresponding to the elements recited in Claim 1. Therefore, the recited elements of this claim are mapped to the proposed combination in the same manner as the corresponding steps in its corresponding apparatus claim.
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:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
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.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Loh et al. (“A deep learning approach to the screening of malaria infection: Automated and rapid cell counting, object detection and instance segmentation using Mask R-CNN” published in March 2021) in view of Yasushi (US 20240112479 filed on 12/11/2023 and published 04/04/2024).
Consider Claim 7, Loh does not explicitly disclose “The apparatus according to claim 1, wherein the acquisition unit acquires the image captured in a nondestructive and non-staining state of the detection targets.”. However, in an analogous field of endeavor, Yasushi teaches “The apparatus according to claim 1, wherein the acquisition unit acquires the image captured in a nondestructive and non-staining state of the detection targets.” (Yasushi; [0078-0079]; “Training data TD is constituted by stained cell images TD1 that are fluorescence images obtained by staining cell nuclei, and not-stained cell images TD2 that are obtained by achromatizing the stained cell images TD1. The stained cell images TD1 are annotation images in which a ground truth label (in the present embodiment, a label indicating one of the classes 1 to 3) is assigned to each pixel. The training unit 60 inputs the not-stained cell image TD2 as the input image to a training model M and causes the training model M to output the output image PO. The training unit 60 inputs the output image PO output from the training model M and the stained cell image TD1 to the adjustment unit 62.”). Accordingly, before the effective filing date of the instant application, it would have been obvious to one of ordinary skill in the art to combine Loh with the teachings of Yasushi to further input non-stained cell sample images into the learning model to determine the proportion of target cells in the sample. One of ordinary skill in the art would be motivated to combine Loh and Yasushi to improve productivity and quality of target cell detection (Yasushi; [0004]). Accordingly, the combination of Loh and Yasushi discloses the invention of Claim 7.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Annie Pham whose telephone number is (571)272-1673. The examiner can be normally be reached Mon-Fri 9:00a – 5:00p.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ANNIE H PHAM/Examiner, Art Unit 2662
/AMANDEEP SAINI/Supervisory Patent Examiner, Art Unit 2662
