0DETAILED 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 .
Preliminary amendment
The preliminary amendment filed on November 28th, 2023 has been acknowledged and entered.
Priority
Receipt is acknowledged of certified copies of papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record on file.
Information Disclosure Statement(s)
The Information disclosure statement (IDS) filed on February 26th, 2024 has been acknowledged and considered by the examiner.
Status of claims
Claims 1-2, 5-6, 8-18, 22-24, 42 and 63 are pending, claims 3-4, 7, 19-21, 25-41 and 43-62 are canceled.
Drawing Objection(s)
Figures 1, 4-5 and 7-14 are objected to as depicting a block diagram without “readily identifiable” descriptors of each block, as required by 37 CFR 1.84(n). Rule 84(n) requires “labeled representations” of graphical symbols, such as blocks; and any that are “not universally recognized may be used, subject to approval by the Office, if they are not likely to be confused with existing conventional symbols, and if they are readily identifiable.” In the case of figures 1, 4-5 and 7-14, the blocks are not readily identifiable per se and therefore require the insertion of text that identifies the function of that block. That is, each vacant block should be provided with a corresponding label identifying its function or purpose.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
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:
1) “using an image acquisition device” as recited in claim 1 and mentioned in the dependent claims 11-13,
The specification discloses sufficient structure, material and/or act for the recited image acquisition device to perform the recited function such as disclosed in the instant specification’s [0038] wherein the image acquisition device is any type of camera, including a still camera, a video camera, a high-speed camera, a 3D depth camera, an infrared camera, etc.
2) “an image input layer configured to….” as recited in claim 23,
The specification does not provide sufficient structure, material and/or act for the recited “image input layer” to perform the recited function, the closest disclosure can be found in the instant specification’s [0056] to have the image input layer as a model input for the entire model, used to input the full volume image into the image recognition model, however, lack of material, structure and/or act sufficiently disclosed to perform the recited function.
furthermore, additional claim limitations evoke 112(f) are:
3) “a feature extraction layer configured to extract….” as recited in claim 23;
The specification discloses sufficient structure, material and act for the recited features as mentioned above to perform the recited functions as disclosed in [0057] wherein the feature extraction layer include a convolutional neural network such as, ResNet, ResNeXt, SE-Net, DenseNet, MobileNet, ShuffleNet, RegNet, EfficientNet, Inception, etc., a recurrent neural network model, or the like, or a combination thereof.
4) “an analysis layer configured to output….” as recited in claim 23;
The specification does not provide sufficient support for a structure, material and/or act for the recited analysis layer to perform the recited function. the closest support can be found in the instant specification’s [0059] to have the analysis layer to may be configured as a classifier model which still does not provide sufficient structure, material and/or act for the recited analysis layer to perform the recited function.
Because some of these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are 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 these limitations 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 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 limitations recite 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 § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 23 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Such as in claim 23, as discussed above in the 112f claim interpretation section above, to recite the features of “image input layer” as recited in claim 23; “analysis layer” as recited in claim 23, which are lack of written support from the specification to provide sufficient structure, material and/or act for these features to perform the recited functions.
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 23 is rejected under 112(b). The claim limitations of “image input layer” as recited in claim 23; “analysis layer” as recited in claim 23 invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. Such as in claim 23, as discussed above in the 112f claim interpretation section above, to recite the features of “image input layer” as recited in claim 23; “analysis layer” as recited in claim 23, which are lack of written support from the specification to provide sufficient structure, material and/or act for these features to perform the recited functions. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
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 1-2, 5-6, 8-18, 22, 24, 42 and 63 are rejected under 35 U.S.C. 101
Regarding Independent Claim 1 and its dependent claims 2, 5-6, 8-18 and 22, 24,
Step 1 Analysis: Claim 1 is directed to a method/process, which falls within one of the four statutory categories.
Step 2A Prong 1 Analysis: Claim 1 recites, in part:
“determining an analysis parameter of the particles in the test sample based on the full volume image”
The limitations as drafted, are processes that, under broadest reasonable interpretation, covers the performance of the limitation in the mind which falls within the “Mental Processes” grouping of abstract ideas. The limitations of:
“determining….the full volume image” is a step, under BRI, a human mind can perform with using pen and paper through a process of observation and evaluation such as, the human mind can observe some full volume image and the information of the particles in the test sample and make an evaluation to determine analysis parameter.
Accordingly, the claim recites an abstract idea.
Step 2A Prong 2 Analysis: This judicial exception is not integrated into a practical application. particular, the claim recites the following additional element(s) –
“for analyzing particles in a test sample;
obtaining a full volume image of the test sample using an image acquisition device”
The additional elements “for analyzing particles in a test sample” is an general intended use recitation insignificant, “obtaining a full volume image” is an insignificant extra-solution activity of data gathering recited to be a generic function of an image acquisition device (generic imaging device) recited at high level of generality.
Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claim as a whole is directed to an abstract idea.. Please see MPEP §2106.04.(d).III.C.
Step 2B Analysis: there are no additional elements, such as for these additional elements as indicated above, that amount to significantly more than the judicial exception. Please see MPEP §2106.05. The claim is directed to an abstract idea.
For all of the foregoing reasons, claim 1 does not comply with the requirements of 35 USC 101.
Accordingly, the dependent claims 2, 5-6, 8-18 and 22, 24 do not provide elements that overcome the deficiencies of the independent claim 1. Moreover, claim 2 recites, in part, “performing an enrichment process on the test sample to obtain a processed test sample, the particles in the processed test sample aggregating at a bottom of a sample container” are processes/steps performed by a human, using of human mental processes to follow instructions of organizing human activities, through process of observation and evaluation mental process abstract ideas. Claim 5 recites, in part, “when the particles include at least two types” is a recitation of giving further specification of what the particles include, abstract idea, “before the obtaining the full volume image of the test sample, the method further comprises: removing other types of particles in the test sample except for one target type of particles” is a step which includes human activities involve following certain instructions to remove some types of particles in a test samples according to a certain condition hence, a certain method of organizing human activities abstract idea. Claim 6 recites, in part, “wherein the at least two types of particles include a transparent particle and a non-transparent particle, and the target type of particles is the non-transparent particle” is a recitation of giving further specification of what the at least two types of particles include, abstract idea; “adding a lysis solution to the test sample to lyse the transparent particle” is a step which includes human activities involve following certain instructions to add a lysis solution to a test sample to lyse according to a certain condition hence, a certain method of organizing human activities abstract idea. Claim 8 recites, in part, “obtaining the full volume image of the test sample based on a single imaging field on an imaging surface of a sample container, or obtaining the full volume image…surface of the sample container” recites “or” indicating a selection therefore, only one of the options is the instant scope of the claim, both of which are steps of obtaining data/information of a certain condition, certain type hence merely recitation of an insignificant extra-solution activity additional element of data gathering. Claim 9 recites, in part, “wherein the sample container is provided with a plurality of markers, and an overlap region between two adjacent detection image includes at least one sample marker” is recitation of limitations providing further specification to what the sample container is provided with and the overlap region includes of, hence, mere abstract ideas. Claim 10 recites, in part, “wherein the plurality of markers are provided at equal intervals on an edge or a bottom of the sample container” recite a wherein clause which is a recitation of limitation of further specification of what the plurality of markers are provided by. Claim 11 recites, in part, “controlling a maximum width of the sample container to be less than a long side width of the single imaging field of the image acquisition device, such that the single imaging field completely covers the width of the sample container” is a instruction to be followed by a human hence, involves following certain instructions/rules hence, a certain method of organizing human activities abstract idea. Claim 12 recites, in part, “determining the plurality of imaging fields of the image acquisition device on the imaging surface of the sample container” is a step of which a human mind can perform through a process of observation and evaluation such as the human mind can observe and control the image acquisition device to make an evaluation to determine the plurality of imaging fields according to a certain criteria give; “obtaining at least one….overlapping region” is a step of insignificant extra-solution activity of data gathering of obtaining data/information of a certain specification; “directly stitching the detection images to obtain the full volume image of the test sample” recites a step which, under BRI, falls under the scope of mental process abstract idea which a human mind can perform through observation and evaluation by observing some images and stitch them together to obtain a full volume image. Claim 13 recites, in part, “determining the plurality of imaging fields of the image acquisition device on the imaging surface of the sample container” is a step of determining imaging fields which a human mind can also perform based on observing the image acquisition device on its imaging surface of the sample container; “obtaining at least one detection image of the test sample within each of the plurality of imaging fields” is a step of insignificant extra-solution activity additional element of obtaining data/information of data gathering, “wherein the detection images collected in the adjacent two imaging fields have no overlapping region” is a further specification wherein clause limitation to further specify what the detection images are collected based on a condition hence, still data specification of the data gathering; “directly stitching….of the test sample” recites a step which, under BRI, falls under the scope of mental process abstract idea which a human mind can perform through observation and evaluation by observing some images and stitch them together to obtain a full volume image. claim 14 recites, in part, “wherein the sample container is provided….one same marker” is a further specification wherein clause limitation to further specify what the sample container is provided by a certain condition hence, still further specifying the abstract idea; “sequentially stitching the detection images….of the test sample” recites a step which, under BRI, falls under the scope of mental process abstract idea which a human mind can perform through observation and evaluation by observing some images and stitch them together to obtain a full volume image. Claim 15 recites, in part, “determining a stitching range for a first alignment operation on the two detection images” is step which the human mind can determine a stitching range for a certain alignment operation by observing the images make an evaluation; “performing the first alignment operation on the two detection images based on the stitching range” is a step which the human mind can perform, based on BRI, to align some images based on a range according to a certain condition by observing and evaluating the images; “performing a second alignment operation on the two detection images based on the at least one same marker to obtain the full volume image” is a step which the human mind can perform, based on BRI, to align some images based on a range according to a certain condition by observing and evaluating the images to obtain a full volume image. Claim 16 recites, in part, “determining the stitching range for the first alignment operation based on…..distance between centers of the two imaging fields” is a step which, the human mind, can perform, based on BRI, such as the human mind can determine the stitching range for an alignment operation wherein the human mind can determine such based on a certain condition/criteria. Claim 17 recites, in part, “wherein the full volume image is obtained through….or scatter light imaging” is a further specification wherein clause limitation to further specify what the volume image is obtained by. Claim 18 recites, in part, “wherein the analysis parameter….a concentration of the each type of the particles or characterizing….locations of the test sample” recites “or” therefore, only of the options is the instant scope of the claim therefore, moreover, both of these options are steps of providing further specification to what the analysis parameter includes, hence, mere further specification of the data gathering, abstract idea. Claim 22 recites, in part, “determining the analysis parameter of the….recognition model” is a step, based on BRI, which a human mind can also perform through process of observation and evaluation such as, the human mind can observe a processing process of the volume image and make an evaluation to determine the analysis parameter. Claim 24 recites, in part, “extracting at least one of a color…in the full volume image” is a step of insignificant extra-solution activity additional element of data gathering of extracting data/information from a volume image; “outputting the analysis parameter of the…full volume image” is a step of insignificant extra-solution activity additional element of data gathering of outputting the analysis parameter from a volume image.
Accordingly, the dependent claims 2, 5-6, 8-18 and 22, 24 are not patent eligible under 101.
Regarding Independent Claim 42,
Step 1 Analysis: Claim 42 is directed to a chamber/device, which falls within one of the four statutory categories.
Step 2A Prong 2 Analysis: This judicial exception is not integrated into a practical application. particular, the claim recites the following additional element(s) –
“a counting chamber, comprising:
A carrier, wherein
The carrier is provided with a concave sample well; and
At least one marker for image stitching is provided in the sample well”
The additional elements “a counting chamber,” “a carrier,” “the carrier is provided with a concave sample well,” “at least one marker for image stitching is provided in the sample well” - recited at a high level of generality to be generic objects, mere recitation of the specification of the device, object. The element of “for image stitching” is an intended use recitation.
Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claim as a whole is directed to an abstract idea.. Please see MPEP §2106.04.(d).III.C.
Step 2B Analysis: there are no additional elements, such as for these additional elements as indicated above, that amount to significantly more than the judicial exception. Please see MPEP §2106.05. The claim is directed to an abstract idea.
For all of the foregoing reasons, claim 42 does not comply with the requirements of 35 USC 101.
Regarding Independent Claim 63,
The independent claim 63 recites analogous limitations to the independent claim 42 therefore, these limitations are considered 101 ineligible under the same reasons as for claim 42. Moreover, claim 63 recites further additional elements of “a system used for analyzing particles in a test sample” is an intended use limitation and a generic system recited at high level of generality.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 42 and 63 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yi-Hsuan Weng et. al. (“US 2018/0144522 A1” hereinafter as “Weng”).
Regarding claim 42, Weng discloses a counting chamber ([0051] discloses a counting plate), comprising: a carrier, wherein the carrier is provided with a concave sample well ([0035] discloses the chip [carrier] is provided with concave lens; moreover, [0029-0031] discloses the chip including a well as shown in figure 1B with a lateral pulling [concave down]); and at least one marker for image stitching is provided in the sample well ([[0032] discloses the detection chip including the well is provided with mark] for image stitching [0016]).
Regarding claim 63, Weng discloses a system used for analyzing particles in a test sample (abstract discloses a system for analyzing cell images[0051] discloses a counting plate), comprising: a carrier, wherein the carrier is provided with a concave sample well ([0035] discloses the chip [carrier] is provided with concave lens; moreover, [0029-0031] discloses the chip including a well as shown in figure 1B with a lateral pulling [concave down]); and at least one marker for image stitching is provided in the sample well ([[0032] discloses the detection chip including the well is provided with mark] for image stitching [0016]).
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.
Claims 1-2, 5, 8-10, 12, 14, 17-18, 22 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Yi-Hsuan Weng et. al. (“US 2018/0144522 A1” hereinafter as “Weng”) in view of Jing Zhou et. al. (“High-Content Single-Cell Analysis On-Chip Using a Laser Microarray Scanner, August 2012, Lab on Chip Journal” hereinafter as “Zhou”).
(best understood based on the 112f interpretation section above) Regarding claim 1, Weng discloses a method for analyzing particles in a test sample, comprising (abstract discloses of image processing for cell detection which is analogous to analyzing particles [cells]): obtaining a full volume image of the test sample using an image acquisition device ([0012] discloses an image capturing device [image acquisition device] to capture a plurality of images to be stitched into a total chip image [analogous to full volume image]).
However, Weng does not explicitly disclose and determining an analysis parameter of the particles in the test sample based on the full volume image.
In the same field of Cell Chip Image Processing (title and abstract, Zhou) Zhou discloses and determining an analysis parameter of the particles in the test sample based on the full volume image (page 5026, 2nd column, discloses the images are stitched together [analogous to the total chip image of Weng and the full volume image as claimed] for quantitative analysis of single cell morphometric and proteomic signatures based on quantification of celomic parameters [2nd par.] to identify cell periphery a number identity for cell is given for analysis, all of these information together are analogous to analysis parameter being determined).
Thus, it would have been obvious for a person of ordinary skill in the art before the effective filing date to modify Weng to have a method for analyzing particles in a test sample, comprising: obtaining a full volume image of the test sample using an image acquisition device and determining an analysis parameter of the particles in the test sample based on the full volume image as taught by Zhou to arrive at the claimed invention discussed above. Such a modification is the result of combing prior art elements according to known methods to yield predictable results. The motivation for the proposed modification would have been to perform cell detection successfully and effectively (abstract and “Results” section, last paragraph, Zhou).
Regarding claim 2, Weng in view of Zhou discloses the method of claim 1, wherein before the obtaining a full volume image of the test sample, the method further comprises: performing an enrichment process on the test sample to obtain a processed test sample (Weng, [0031], discloses the process including filling PBS solution in the chip into the injected cells [adding PBS solution is analogous to an enrichment process]), the particles in the processed test sample aggregating at a bottom of a sample container (Weng, [0031], discloses the cells settle downward due to gravity to the lateral runner at the bottom [analogous to a bottom of a sample container, the particles aggregating at]).
Regarding claim 5, Weng in view of Zhou discloses the method of claim 1, wherein, when the particles include at least two types (Weng, [0004], discloses a cell sorting process [indicating a more than one size of cells, a plurality of types of cells in terms of size]), before the obtaining the full volume image of the test sample, the method further comprises: removing other types of particles in the test sample except for one target type of particles (Weng, [0004], discloses the cell sorting, indicating a type of cells of a certain desired size is kept while others are being sorted out [removed]).
Regarding claim 8, Weng in view of Zhou discloses the method of claim 1, wherein the obtaining a full volume image of the test sample further (as discussed above in claim 1) includes: obtaining the full volume image of the test sample based on a single imaging field on an imaging surface of a sample container, or obtaining the full volume image of the test sample by stitching detection images corresponding to a plurality of imaging fields on the imaging surface of the sample container (“or” indicates a selection, therefore, only one of the option is the instant scope of the claim, the examiner selects “obtaining the full…..by stitching detection images……the sample container” which is disclosed in Weng’s [0016] wherein the images of the cell on the detection chip within the imaging fields of the camera are being stitched to form the total chip image).
Regarding claim 9, Weng in view of Zhou discloses the method of claim 8, wherein the sample container is provided with a plurality of markers, and an overlap region between two adjacent detection images includes at least one same marker (Weng, [0016], discloses the chip includes markers [0014] for the stitching of images adjacent overlapped with same marker to be stitched).
Regarding claim 10, Weng in view of Zhou discloses the method of claim 9, wherein the plurality of markers are provided at equal intervals on an edge or a bottom of the sample container (“or” indicates a selection, therefore, only one of the options is the instant scope of the claim, the examiner selects “provided at a bottom of the sample container” which is disclosed in Weng’s [0042] wherein the markers are increased at the bottom of the chip [provided at the bottom of the container as claimed]).
Regarding claim 12, Weng in view of Zhou discloses the method of claim 8, wherein the obtaining the full volume image of the test sample by stitching detection images corresponding to a plurality of imaging fields on the imaging surface of the sample container (as disclosed above in claim 8) further includes: determining the plurality of imaging fields of the image acquisition device on the imaging surface of the sample container (Weng, [0016], discloses images of each of the regions in a detection region [plurality of imaging fields on the imaging surface of the sample container as claimed]); obtaining at least one detection image of the test sample within each of the plurality of imaging fields (Weng, [0016] discloses the each of the regions is being obtained an image), wherein detection images collected in two adjacent imaging fields have an overlapping region (Weng, [0016] discloses images sharing same markers [analogous to adjacent images] are stitched to be overlapped); and stitching the detection images based on the overlapping region in the detection images to obtain the full volume image of the test sample (Weng, [0016] discloses the images after being stitched sharing overlapped region to obtain the total chip image).
Regarding claim 14, Weng in view of Zhou discloses the method of claim 12, wherein the sample container is provided with a plurality of markers (Weng, [0016] discloses the cell chip is marked with a plurality of markers), and the overlapping region between the two adjacent detection images includes at least one same marker (Weng, [0016] discloses the overlapped potions includes same marker); and the stitching the detection images based on the overlapping region in the detection images to obtain the full volume image of the test sample further includes (as discussed above in claim 12): sequentially stitching the detection images based on the at least one same marker in the two adjacent detection images to obtain the full volume image of the test sample (Weng, [0016] discloses the images after being stitched sharing overlapped region to obtain the total chip image).
Regarding claim 17, Weng in view of Zhou discloses the method of claim 1, wherein the full volume image is obtained through one of bright imaging field imaging, fluorescence imaging, or scattered light imaging (“one of….or…” indicates a selection, therefore, only one of the options is the instant scope of the claim, which the examiner finds Weng’s [0004] to cover wherein the imaging is of fluorescence imaging).
Regarding claim 18, Weng in view of Zhou discloses the method of claim 1, wherein the analysis parameter of the particles includes at least one or a count of the particles, a percentage of each type of the particles, a concentration of the each type of the particles; or (“or” here indicates a selection between the limitations, therefore, only one of the limitations between the “;” is the instant scope of the claim) characterizing a state of the particles, wherein the state of the particles includes one or more of a type of the particles, a morphological parameter of the particles, a concentration of the particles, or a distribution of the particles in different locations of the test sample (as discussed in the previous statement, “or” indicates a selection, therefore, the examiner selects “characterizing a state of the particles….of the test sample” to be the instant scope of the claim, the examiner finds Zhou to discloses, in page 5026, 2nd column, wherein the method includes generate quantitative measurements of either morphometric or molecular signatures of all single cells [characterizing a state of the particles as claimed]; moreover, the state of the particles includes morphometric signatures [analogous to a morphological parameter of the particles]). The motivation for combination of arts is the same as for claim 1 above.
Regarding claim 22, Weng in view of Zhou discloses the method of claim 1, wherein the determining an analysis parameter of the particles in the test sample based on the full volume image (as discussed above in claim 1) includes: determining the analysis parameter of the particles by processing the full volume image based on an image recognition model (Zhou, 5026, 2nd column, discloses the stitched image is used for determining the cell analysis and its parameters such as discussed above in claim 1, through a analysis algorithms implemented in CellProfiler [analogous to the recited image recognition model]). The motivation for combination of arts is the same as for claim 1 above.
Regarding claim 24, Weng in view of Zhou discloses the method of claim 22, wherein the processing the full volume image based on an image recognition model (as discussed above in claim 22) further includes: extracting at least one of a color or a shape feature of the particles in the full volume image (“or” indicates a selection therefore, only one of the options is the instant scope of the limitation, the examiner selects “color feature” which is disclosed in Zhou’s page 5026, 2nd column, wherein the image analysis analyzes the raw scanned image of the gray scale image and the intensity correspond to the original photo count in a specific range to identify the cell [the intensity value of the photon of the image correspond to the color feature of the image including the cells/particles]); and outputting the analysis parameter of the particles based on at least one of the color or the shape feature of the full volume image (Zhou’s page 5026, 2nd column, discloses the image analysis output cell periphery and cell number identify [analogous to analysis parameter of the cells/particles]). The motivation for combination of the arts is the same as for claim 1 above.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Yi-Hsuan Weng et. al. (“US 2018/0144522 A1” hereinafter as “Weng”) in view of Jing Zhou et. al. (“High-Content Single-Cell Analysis On-Chip Using a Laser Microarray Scanner, August 2012, Lab on Chip Journal” hereinafter as “Zhou”) and Sze Ying Lee et. al. (“Cell Separation and Disruption, Product Recovery, and Purification, July 2019, Part of the book series: Learning Materials in Biosciences, pp 237-271” hereinafter as “Lee”).
Regarding claim 6, Weng in view of Zhou discloses the method of claim 5 (as discussed above in claim 5).
However, Weng in view of Zhou does not explicitly disclose wherein the at least two types of particles include a transparent particle and a non-transparent particle, and the target type of particles is the non-transparent particle, the removing other types of particles in the test sample except for the target type of particles further includes: adding a lysis solution to the test sample to lyse the transparent particle.
In the same field of cell sorting based on cell image processing (title and abstract, Lee) Lee discloses wherein the at least two types of particles include a transparent particle and a non-transparent particle (page 241, section 8.2, 2nd par., discloses the removal of the cell debris particles for purification, therefore, it can be understood there are cell particles [transparent particles] and cell debris particles [non-transparent particles, since these needs to be purified] which aligns with the examples in the instant specification’s [0047]), and the target type of particles is the non-transparent particle (since the process is to remove the cell debris particles, therefore, it can be understood as the cell particles are being kept as target type of particles), the removing other types of particles in the test sample except for the target type of particles (as discussed previously, in page 241, section 8.2, 2nd par., wherein the cell debris particles are being removed) further includes: adding a lysis solution to the test sample to lyse the transparent particle (section 8.2, last par., of page 244, wherein the removal of debris include lysing the cells [transparent particles]).
Thus, it would have been obvious for a person of ordinary skill in the art before the effective filing date to modify Weng in view of Zhou to have a system to have two types of particles including transparent particle and non-transparent particle and remove the other types of particles rather than the target type of particles being the non-transparent particles, which includes adding a lysis solution to the test sample to lyse the transparent particles as taught by Lee to arrive at the claimed invention discussed above. Such a modification is the result of combing prior art elements according to known methods to yield predictable results. The motivation for the proposed modification would have been to harvest cells effectively (page 238, 1st par., Lee).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Yi-Hsuan Weng et. al. (“US 2018/0144522 A1” hereinafter as “Weng”) in view of Jing Zhou et. al. (“High-Content Single-Cell Analysis On-Chip Using a Laser Microarray Scanner, August 2012, Lab on Chip Journal” hereinafter as “Zhou”) and Laurens Nunnink et. al. (“US 2014/0340758 A1” hereinafter as “Nunnink”).
Regarding claim 11, Weng in view of Zhou discloses the method of claim 8, wherein the obtaining the full volume image of the test sample based on a single imaging field on an imaging surface of a sample container further includes (as discussed above in claim 8).
However, Weng in view of Zhou does not explicitly disclose controlling a maximum width of the sample container to be less than a long side width of the single imaging field of the image acquisition device, such that the single imaging field completely covers the width of the sample container.
In the same field of camera system processing (abstract, Nunnink) Nunnink discloses controlling a maximum width of the sample container to be less than a long side width of the single imaging field of the image acquisition device ([0027-0029] disclose the width of the object with a sufficient height to fully image an ID within a given acquire image frame, indicating that the max. width of the object is covered/controlled to be within the field of view of the camera, hence, is smaller than the field of the view of the camera), such that the single imaging field completely covers the width of the sample container ([0039] so that the camera can image the whole field of use with the width of the object being covered [analogous to the sample container or any object for imaging]).
Thus, it would have been obvious for a person of ordinary skill in the art before the effective filing date to modify Weng in view of Zhou to perform obtaining the full volume image of the test sample based on a single imaging field on an imaging surface of a sample container further includes: controlling a maximum width of the sample container to be less than a long side width of the single imaging field of the image acquisition device, such that the single imaging field completely covers the width of the sample container as taught by Nunnink to arrive at the claimed invention discussed above. Such a modification is the result of combing prior art elements according to known methods to yield predictable results. The motivation for the proposed modification would have been to capture an image of a target object successfully and fully (abstract, Nunnink).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Yi-Hsuan Weng et. al. (“US 2018/0144522 A1” hereinafter as “Weng”) in view of Jing Zhou et. al. (“High-Content Single-Cell Analysis On-Chip Using a Laser Microarray Scanner, August 2012, Lab on Chip Journal” hereinafter as “Zhou”) and Frank Fuchs (foreign patent document “AU 2014253889 A1”/”WO 2014/172530 A1” hereinafter as “Fuchs”).
Regarding claim 13, Weng in view of Zhou discloses the method of claim 8, wherein the obtaining the full volume image of the test sample by stitching detection images corresponding to a plurality of imaging fields on the imaging surface of the sample container (as disclosed above in claim 8) further includes: determining the plurality of imaging fields of the image acquisition device on the imaging surface of the sample container (Weng, [0016], discloses images of each of the regions in a detection region [plurality of imaging fields on the imaging surface of the sample container as claimed]), obtaining at least one detection image of the test sample within each of the plurality of imaging fields (Weng, [0016] discloses the each of the regions is being obtained an image); and directly stitching the detection images to obtain the full volume image of the test sample (Weng, [0016] discloses the images after being stitched sharing regions to obtain the total chip image).
However, Weng in view of Zhou does not explicitly disclose wherein the detection images collected in the adjacent two imaging fields have no overlapping region.
In the same field of image stitching (title, Fuchs) Fuchs discloses wherein the detection images collected in the adjacent two imaging fields have no overlapping region (page 2, 2nd par., discloses the adjacent sub-images [analogous to the recited two imaging fields] that are adjacent and non-overlapping; page 2, 2nd par., discloses stitching these two sub-images together).
Thus, it would have been obvious for a person of ordinary skill in the art before the effective filing date to modify Weng in view of Zhou to perform stitching detection images corresponding to a plurality of imaging fields on the imaging surface of the sample container further includes: determining the plurality of imaging fields of the image acquisition device on the imaging surface of the sample container; obtaining at least one detection image of the test sample within each of the plurality of imaging fields, wherein the detection images collected in the adjacent two imaging fields have no overlapping region as taught by Fuchs to arrive at the claimed invention discussed above. Such a modification is the result of combing prior art elements according to known methods to yield predictable results. The motivation for the proposed modification would have been to perform stitching of images sharing non-overlapping so that stitching can be performed more efficiently and accurately (Fuchs, page 2, 2nd par.).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Yi-Hsuan Weng et. al. (“US 2018/0144522 A1” hereinafter as “Weng”) in view of Jing Zhou et. al. (“High-Content Single-Cell Analysis On-Chip Using a Laser Microarray Scanner, August 2012, Lab on Chip Journal” hereinafter as “Zhou”) and Fang-Yu Hwu et. al. (“Maintenance and Quantitative Phenotyping of the Oomycete-plant Model Pathosystem Hyaloperonospora Arabidopsidis-Aradidopsis, 2020, Bio-Protocol 10, e3661” hereinafter as “Hwu”).
Regarding claim 15, Weng in view of Zhou discloses the method of claim 14, wherein the sequentially stitching the detection images based on the at least one same marker in the two adjacent detection images includes stitching two detection images in any adjacent imaging fields according to operations (as discussed above in claim 14), operation on the two detection images based on the at least one same marker to obtain the full volume image (Weng, [0032] discloses the detection chip including the well is provided with mark] for image stitching [0016]).
However, Weng in view of Zhou does not explicitly disclose include: determining a stitching range for a first alignment operation on the two detection images; performing the first alignment operation on the two detection images based on the stitching range; and operation on the two detection images based on the at least one same marker to obtain the full volume image.
In the same field of image stitching (abstract, Hwu) Hwu discloses include: determining a stitching range for a first alignment operation on the two detection images (page 8, 1st par., bullet “b”, discloses the image stitching operation includes determining a “Stitching” window for the area to be included in the stitched image [first alignment operation using the stitching function], stitching function here to align images together without overlap hence is analogous aligning the images together); performing the first alignment operation on the two detection images based on the stitching range (age 8, 1st par., bullet “b”, discloses the image stitching operation includes determining a “Stitching” window for the area to be included in the stitched image [first alignment operation using the stitching function], stitching function here to align images together without overlap hence is analogous aligning the images together); and performing a second alignment operation on the two detection images based on the at least one same marker to obtain the full volume image (page 9 discloses in figure 5, the stitching can be perform additionally therefore, additional stitching function is analogous to second alignment operation as claimed).
Thus, it would have been obvious for a person of ordinary skill in the art before the effective filing date to modify Weng in view of Zhou to perform sequentially stitching the detection images based on the at least one same marker in the two adjacent detection images includes stitching two detection images in any adjacent imaging fields according to operations including: determining a stitching range for a first alignment operation on the two detection images; performing the first alignment operation on the two detection images based on the stitching range; and performing a second alignment operation on the two detection images based on the at least one same marker to obtain the full volume image as taught by Hwu to arrive at the claimed invention discussed above. Such a modification is the result of combing prior art elements according to known methods to yield predictable results. The motivation for the proposed modification would have been to use stitching window to stitch images more efficiently (page 2, Hwu) and perform additional stitching to make sure stitching is more accurate (page 9, Hwu).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Yi-Hsuan Weng et. al. (“US 2018/0144522 A1” hereinafter as “Weng”) in view of Jing Zhou et. al. (“High-Content Single-Cell Analysis On-Chip Using a Laser Microarray Scanner, August 2012, Lab on Chip Journal” hereinafter as “Zhou”) further in view of Fang-Yu Hwu et. al. (“Maintenance and Quantitative Phenotyping of the Oomycete-plant Model Pathosystem Hyaloperonospora Arabidopsidis-Aradidopsis, 2020, Bio-Protocol 10, e3661” hereinafter as “Hwu”) and Yu Wang et. al. (“Research on Stitching Technique of Medical Infrared Images, 2010, 2010 International Conference on Computer Application and System Modeling, ICCASM 2010” hereinafter as “Wang”).
Regarding claim 16, Weng in view of Zho and Hwu discloses the method of claim 15, wherein the determining a stitching range for the first alignment operation on the two detection images further includes (as discussed above in claim 15).
However, Weng in view of Zho and Hwu does not explicitly disclose determining the stitching range for the first alignment operation based on an imaging field distance of two imaging fields corresponding to the two detection images, wherein the imaging field distance represents a distance between centers of the two imaging fields.
In the same field of image stitching (abstract, Wang) Wang discloses determining the stitching range for the first alignment operation based on an imaging field distance of two imaging fields corresponding to the two detection images (section II.A, 1st 2 paragraphs, discloses the registration algorithm is based grid temple [including imaging field distance] such as shown in figure 1), wherein the imaging field distance represents a distance between centers of the two imaging fields (section II.A, 2nd par., discloses the distance is of the distance between the grids narrowed with point A as the center to renew the registration template, hence, is based on a distance between the centers of the grids [imaging fields]).
Thus, it would have been obvious for a person of ordinary skill in the art before the effective filing date to modify Weng in view of Zho and Hwu to perform determining a stitching range for the first alignment operation on the two detection images further includes: determining the stitching range for the first alignment operation based on an imaging field distance of two imaging fields corresponding to the two detection images, wherein the imaging field distance represents a distance between centers of the two imaging fields s as taught by Wang to arrive at the claimed invention discussed above. Such a modification is the result of combing prior art elements according to known methods to yield predictable results. The motivation for the proposed modification would have been to perform image stitching more efficiently and accurately (abstract and section II.A, Wang).
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Yi-Hsuan Weng et. al. (“US 2018/0144522 A1” hereinafter as “Weng”) in view of Jing Zhou et. al. (“High-Content Single-Cell Analysis On-Chip Using a Laser Microarray Scanner, August 2012, Lab on Chip Journal” hereinafter as “Zhou”) in David J. Williamson et. al. (“Machine Learning for Cluster Analysis of Localization Microscopy Data, March 2020, Nature Communications 11, article number 1493” hereinafter as “Williamson”).
(best understood based on the 112f interpretation section above) Regarding claim 23, Weng in view of Zhou discloses the method of claim 22, wherein the image recognition model (as discussed above in claim 22.
However, Weng in view of Zhou does not explicitly disclose the image recognition model is a machine learning model generated through a training process including: iteratively training an initial image recognition model based on a plurality of labeled training samples, wherein the image recognition model includes: an image input layer configured to obtain the full volume image; a feature extraction layer configured to extract at least one of a color or a shape feature of the particles in the full volume image; and an analysis layer configured to output the analysis parameter of the particle to be analyzed based on at least one of the color or the shape feature the full volume image.
In the same field of cell detection (abstract, Williamson) Williamson discloses the image recognition model is a machine learning model generated through a training process including (abstract cell localization neural network to classify single molecule): iteratively training an initial image recognition model based on a plurality of labeled training samples (page 2, 1st 3 paragraphs, discloses the neural network uses training data including labeled training samples; moreover, additional training take place according to page 8, 2nd col., last 2 pars., indicating iteratively training), wherein the image recognition model includes: an image input layer configured to obtain the full volume image (figure 1, shows the neural network includes a layer to input data [the image input layer as claimed]; the input image can be understood as the full volume image, since the full volume image is already mapped to Weng, wherein the Weng’s complete chip image is used for subsequential processing here, Williamson discloses the subsequent processing); a feature extraction layer configured to extract at least one of a color or a shape feature of the particles in the full volume image (“or” indicates a selection, therefore, only one of the options is the instant scope of the claim, the examiner selects “shape” which is disclosed in Williamson’s page 3, 1st col., last par., including convolutional neural networks [according to page 2, 1st col., last par.]); and an analysis layer configured to output the analysis parameter of the particle to be analyzed based on at least one of the color or the shape feature the full volume image (disclosed in figure 4 the output of the neural network include peripheral region of the cells and the shape of the cell morphometric identity of the cell which is analogous to the analysis parameter as claimed, and analogous to the mapped morphometric and peripheral identity of the ell of Zhou teaches, as discussed above in claim 1).
Thus, it would have been obvious for a person of ordinary skill in the art before the effective filing date to modify Weng in view of Zhou to perform image recognition by an image recognition model is a machine learning model generated through a training process including: iteratively training an initial image recognition model based on a plurality of labeled training samples, wherein the image recognition model includes: an image input layer configured to obtain the full volume image; a feature extraction layer configured to extract at least one of a color or a shape feature of the particles in the full volume image; and an analysis layer configured to output the analysis parameter of the particle to be analyzed based on at least one of the color or the shape feature the full volume image as taught by Williamson to arrive at the claimed invention discussed above. Such a modification is the result of combing prior art elements according to known methods to yield predictable results. The motivation for the proposed modification would have been to detect and count cells more accurately using images (abstract, Williamson).
Pertinent Prior Art(s)
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Gou Bingxue et. al. (foreign patent document “WO 2021027135 A1” hereinafter as “Bingxue”) discloses cell detection neural network model based on image stitching (page 1) based on overlapped region of the images (page 3, 4th par.) using feature map and bounding and category of the region (page 4).
Wolfgang Schuh (foreign patent document “WO 0118555 A1/WO 2001018555 A1” hereinafter as “Schuh”) discloses camera capturing technique (page 1) considering width and height of the field of view and the object of target to be captured (page 3).
Conclusion
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/PHUONG HAU CAI/Examiner, Art Unit 2673
/CHINEYERE WILLS-BURNS/Supervisory Patent Examiner, Art Unit 2673