DETAILED CORRESPONDENCE
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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 3/6/23, 8/24/23, 8/29/25 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Remarks
The preliminary amendment filed on 3/11/25 has been entered.
Claim Status
Claims 1-19 are pending.
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 1-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim 1 is rejected based on the following analysis
Step 2A, Prong One: Identify the law of nature/natural phenomenon/abstract ideas.
Claim 1 recites the abstract ideas of “setting” an index, “obtaining” a value, and “outputting” information, which are all mental processes. The examiner notes that the outputting, as drafted in the claim under BRI, may just be the creation of a graph/chart that can be done with pencil and paper and is therefore an abstract idea. Although the abstract ideas are performed by a computer/controller, MPEP 2106.04(a)(2)III is clear that using a computer/controller to perform the abstract idea does not preclude the steps from being considered an abstract idea.
Step 2A Prong Two: Has the abstract idea been integrated into a particular practical application?
No. Once the “setting”, “obtaining” and “outputting” is done then there is no application.
If the “outputting” is determined to not be an abstract idea, then it does not integrate the exception into a practical application because simply outputting information is insignificant post-solution activity and not a particular practical application, similar to the alarm in Parker v. Flook. See MPEP 2106.04(d) and 2106.05(g).
The abstract ideas are performed by a controller/computer. However, a general-purpose computer is not a particular machine, and performing the abstract idea on a general-purpose computer is not enough to integrate the exception into a practical application (MPEP 2106.05(b)I.).
The claim also recites a specimen preparing apparatus, an image capturing apparatus, and a specimen transporting apparatus. The claim also recites storing information. However, these apparatuses are just being used to gather data to be used in the abstract idea. However, data gathering to be used in the abstract idea does not integrate the judicial exception into a practical application because data gathering is insignificant extra-solution activity, and not a particular practical application. See MPEP 2106.05(g). Additionally, this is recited at such a high level of generality that it amounts to just generally linking the abstract idea to a field of use per MPEP 2106.05(h), which are not particular practical applications.
Step 2B: Does the claim recite any elements which are significantly more than the abstract idea?
The claim recites the additional elements of a specimen preparing apparatus, an image capturing apparatus, and a specimen transporting apparatus. These additional elements do not amount to significantly more as they are well-understood, routine, and conventional (WURC) in the art as evidenced by Yamada, K (US 20100183216; hereinafter “Yamada”; already of record). Yamada teaches a specimen preparing apparatus configured to prepare a specimen from a sample (Yamada; #2, [63, 64, 66], Fig. 1B); an image capturing apparatus configured to capture an image of the specimen (Yamada; #3, [63, 64, 66, 71], Fig. 1B); a specimen transporting apparatus configured to transport the specimen to the image capturing apparatus (Yamada; #5/6 [63, 64, 66, 68], Fig. 1B).
The dependent claims 2-14 and 16-19 undergo a similar analysis and do not appear to resolve any of the above issues. Claims 2 and 16 further recite the details of the chart which is considered an abstract idea under step 2A prong one, or alternatively is just displaying and therefore insignificant extra solution activity under step 2A prong two. Claims 3-13 and 17-19 further recite the details of the index which is considered an abstract idea under step 2A prong one, or alternatively is just generally linking the abstract idea to the field of endeavor or data gathering and therefore insignificant extra solution activity under step 2A prong two. Claim 14 recites the details of the specimen, which is intended use under BRI and does not further define the device/apparatus structure, but nonetheless is considered WURC (see prior art rejection and corresponding citations below).
Claim Rejections - 35 USC § 112
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.
Claims 1-14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
As to claim 1, it is unclear what the difference between a specimen and a sample is in line 3-4. Typically, these terms are synonyms and the use of different terms creates ambiguity as to what function is being recited. It is also unclear how a sample and specimen are different. Further, how is the specimen prepared such that it is different from the sample? It is unclear what structure would be defined by the preparing apparatus because it is not yet clear how the specimen and sample are different such that one could be prepared from the other.
Claims 2-14 are rejected based on further claim dependency.
Regarding claim 6, it is unclear what a “region” is describing in reference to where the specimen is prepared. Is this the location of the specimen? Is this the location of the preparing apparatus? How is the specimen prepared in different regions?
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.
(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 1-19 are rejected under 35 U.S.C. 102a1/a2 as being anticipated by Yamada, K (US 20100183216; hereinafter “Yamada”; already of record).
As to claim 1, Yamada teaches a system (Yamada; Title) comprising: a specimen preparing apparatus configured to prepare a specimen from a sample (Yamada; #2, [63, 64, 66], Fig. 1B); an image capturing apparatus configured to capture an image of the specimen (Yamada; #3, [63, 64, 66, 71], Fig. 1B); a specimen transporting apparatus configured to transport the specimen to the image capturing apparatus (Yamada; #5/6 [63, 64, 66, 68], Fig. 1B); and a computer communicably connected to the image capturing apparatus, the computer comprising a storage and a controller (Yamada; #320-323, [80-84], Fig. 1B, 4, 6), wherein the storage stores control index information in which a plurality of indexes for the specimen are respectively associated with control values corresponding to the plurality of indexes, and the controller is configured to perform operations comprising: setting, from the control index information, at least one index to be used for quality control for the specimen; obtaining, from image data of the specimen obtained by the image capturing apparatus, a feature value of the specimen relating to the at least one index; and outputting, based on the feature value and the control value that is associated with the at least one index, quality control information for the specimen preparing apparatus (Yamada teaches calibrating the device by correcting images s228 and then storing the corrections s229 where the stored corrected data is a plurality of indexes, the indexes being differences in nucleus/cytoplasm or types of cells, or in the color values; Fig. 13, [134-135]. Yamada teaches then setting/specifying the area for the nucleus and cytoplasm as the control index in s230; [135]. Then, based on the corrected/calibrated info, Yamada teaches obtaining data on the specimen as feature values, which is the process of calculating the characteristic parameter of the WBC to determine and classify the type of cell; [136-137]. Yamada then teaches outputting the generated information; [139-140], Figs. 16-17. Yamada teaches various databases storing the index information; [86-89]. Yamada also teaches the process of storing the index information and then obtaining data and making comparisons based on the data and outputting the quality control information as a potential abnormality; [141-146]. Further, and alternatively, Yamada teaches control index as thresholds for multiple characteristics, where Yamada determines the specimen values as feature values for each characteristic and compares them to thresholds as the index for quality control and then outputs that information; Figs. 24, [179-181]. Yamada teaches that the initial values used for thresholds and comparison prior to correction and/or notification of abnormality are obtained by standards, which are used for calibration to create an index for quality control for what is normal and abnormal; [192]. Yamada teaches that this process can also occur for various color values; [188-189]).
Note: The instant Claims contain a large amount of functional language (ex: “configured to…”). However, functional language does not add any further structure to an apparatus beyond a capability. Apparatus claims must distinguish over the prior art in terms of structure rather than function (see MPEP 2114 and 2173.05(g)). Therefore, if the prior art structure is capable of performing the function, then the prior art meets the limitation in the claims.
As to claim 2, Yamada teaches the system according to claim 1, wherein the quality control information is a chart displaying the feature value and the control value in a comparable manner or notification information displaying the feature value and the control value in a comparable manner (Yamada teaches a warning notification; [141-146]. Yamada also teaches a chart; Figs. 24, [179-181]).
As to claim 3, Yamada teaches the system according to claim 1, wherein the index is set according to a selection from the control index information (Yamada teaches the index being differences in nucleus/cytoplasm or types of cells, or in the color values; Fig. 13, [134-135]. Yamada teaches various databases storing the index information; [86-89]).
As to claim 4, Yamada teaches the system according to claim 1, wherein the index is set based on a predetermined standard for the specimen quality control (The examiner notes that any difference is a comparison, where the data used in the comparison is set via calibration by a standard. Yamada teaches that the initial values used for thresholds and comparison prior to correction and/or notification of abnormality are obtained by standards, which are used for calibration to create an index for quality control for what is normal and abnormal; [192]. Yamada teaches various databases storing the index information; [86-89]).
As to claim 5, Yamada teaches the system according to claim 1, wherein the index is set based on a guideline for the specimen quality control (The examiner notes that any difference is a comparison, where the data used in the comparison is set via calibration by a standard. Yamada teaches that the initial values used for thresholds and comparison prior to correction and/or notification of abnormality are obtained by standards, which are used for calibration to create an index for quality control for what is normal and abnormal; [192]. Yamada teaches various databases storing the index information; [86-89]).
As to claim 6, Yamada teaches the system according to claim 5, wherein the index is set based on the guideline that is determined according to a region in which the specimen is prepared (The examiner notes that how the guideline is determined is a matter of intended use and function. The examiner notes that any difference is a comparison, where the data used in the comparison is set via calibration by a standard. Yamada teaches that the initial values used for thresholds and comparison prior to correction and/or notification of abnormality are obtained by standards, which are used for calibration to create an index for quality control for what is normal and abnormal; [192]. Yamada teaches various databases storing the index information; [86-89]. As best understood, the examiner notes that the guideline/index of Yamada is set based on initial analysis/calibration, and that the region could be the device the index is created on whereby the index is based on the device since it is created on the device).
As to claim 7, Yamada teaches the system according to claim 1, wherein the index is set based on a predetermined standard regarding a specimen preparing condition (The examiner notes that any difference is a comparison, where the data used in the comparison is set via calibration by a standard. Yamada teaches that the initial values used for thresholds and comparison prior to correction and/or notification of abnormality are obtained by standards, which are used for calibration to create an index for quality control for what is normal and abnormal; [192]. Yamada teaches various databases storing the index information; [86-89]).
As to claim 8, Yamada teaches the system according to claim 7, wherein the index is set based on the predetermined standard that is determined according to a type of a reagent used for preparing the specimen and/or a type of the specimen preparing apparatus (The examiner notes that how the standard is determined is a matter of intended use and function. The examiner notes that any difference is a comparison, where the data used in the comparison is set via calibration by a standard. Yamada teaches that the initial values used for thresholds and comparison prior to correction and/or notification of abnormality are obtained by standards, which are used for calibration to create an index for quality control for what is normal and abnormal; [192]. Yamada teaches various databases storing the index information; [86-89]. Yamada teaches that the standard has predetermined values, where this standard could be considered a standardized reagent; [192]. Further, all calibrations are based off of standardized reagents that have set values. Further still, the examiner notes that the guideline/index of Yamada is set based on initial analysis/calibration, whereby the index is based on the device since it is created on the device).
As to claim 9, Yamada teaches the system according to claim 1, wherein the index is set based on information transmitted from a server that controls the control index information (Yamada teaches multiple computers forming a server, where the computers can access different files via a server; Fig. 4, [86]. Yamada teaches various databases storing the index information; [86-89]. Yamada teaches the index being differences in nucleus/cytoplasm or types of cells, or in the color values; Fig. 13, [134-135]. The examiner notes that any difference is a comparison, where the data used in the comparison is set via calibration by a standard. Yamada teaches that the initial values used for thresholds and comparison prior to correction and/or notification of abnormality are obtained by standards, which are used for calibration to create an index for quality control for what is normal and abnormal; [192]).
As to claim 10, Yamada teaches the system according to claim 9, wherein the information includes a predetermined standard regarding a specimen preparing condition (Yamada teaches multiple computers forming a server, where the computers can access different files via a server; Fig. 4, [86]. Yamada teaches various databases storing the index information; [86-89]. Yamada teaches the index being differences in nucleus/cytoplasm or types of cells, or in the color values; Fig. 13, [134-135]. The examiner notes that any difference is a comparison, where the data used in the comparison is set via calibration by a standard. Yamada teaches that the initial values used for thresholds and comparison prior to correction and/or notification of abnormality are obtained by standards, which are used for calibration to create an index for quality control for what is normal and abnormal; [192]. Yamada teaches various databases storing the index information; [86-89]).
As to claim 11, Yamada teaches the system according to claim 1, wherein the specimen is prepared from the sample that includes cells collected from a subject (How the specimen is prepared is a matter of intended use as the sample has not been positively recited. Yamada teaches preparing the specimen; #2, [63, 64, 66], Fig. 1B. Yamada teaches cells; [127, 134-136, 139, 140-141, 192]).
As to claim 12, Yamada teaches the system according to claim 11, wherein the specimen is a blood smear that is prepared from a blood sample collected from a subject (How the specimen is prepared is a matter of intended use as the sample has not been positively recited. Yamada teaches preparing the specimen; #2, [63, 64, 66], Fig. 1B. Yamada teaches cells and a smear; [127, 134-136, 139, 140-141, 192]).
As to claim 13, Yamada teaches the system according to claim 1, wherein the index includes at least color information of cells in the image data of the specimen (Yamada teaches cells and a smear; [127, 134-136, 139, 140-141, 192]. Yamada teaches the index being differences in nucleus/cytoplasm or types of cells, or in the color values; Fig. 13, [134-135]).
As to claim 14, Yamada teaches the system according to claim 13, wherein the cells are blood cells (Yamada; [127, 134-136, 139, 140-141]).
As to claim 15, Yamada teaches a quality control apparatus (Yamada; Title, Fig. 1B) to perform quality control of a specimen that is prepared from a sample by a specimen preparing apparatus, comprising a storage and a controller (Yamada; #320-323, [80-84], Fig. 1B, 4, 6), wherein the storage that stores control index information in which a plurality of indexes for the specimen are respectively associated with control values corresponding to the plurality of indexes, and the controller is configured to perform operations comprising: setting, from the control index information, at least one index to be used for the quality control of the specimen; obtaining, from image data of the specimen, a feature value of the specimen relating to the at least one index; and outputting, based on the feature value and the control value that is associated with the at least one index, quality control information for the specimen preparing apparatus (Yamada teaches calibrating the device by correcting images s228 and then storing the corrections s229 where the stored corrected data is a plurality of indexes, the indexes being differences in nucleus/cytoplasm or types of cells, or in the color values; Fig. 13, [134-135]. Yamada teaches then setting/specifying the area for the nucleus and cytoplasm as the control index in s230; [135]. Then, based on the corrected/calibrated info, Yamada teaches obtaining data on the specimen as feature values, which is the process of calculating the characteristic parameter of the WBC to determine and classify the type of cell; [136-137]. Yamada then teaches outputting the generated information; [139-140], Figs. 16-17. Yamada teaches various databases storing the index information; [86-89]. Yamada also teaches the process of storing the index information and then obtaining data and making comparisons based on the data and outputting the quality control information as a potential abnormality; [141-146]. Further, and alternatively, Yamada teaches control index as thresholds for multiple characteristics, where Yamada determines the specimen values as feature values for each characteristic and compares them to thresholds as the index for quality control and then outputs that information; Figs. 24, [179-181]. Yamada teaches that the initial values used for thresholds and comparison prior to correction and/or notification of abnormality are obtained by standards, which are used for calibration to create an index for quality control for what is normal and abnormal; [192]. Yamada teaches that this process can also occur for various color values; [188-189]).
As to claim 16, Yamada teaches the quality control apparatus according to claim 15, wherein the quality control information is a chart displaying the feature value and the control value in a comparable manner or notification information displaying the feature value and the control value in a comparable manner (Yamada teaches a warning notification; [141-146]. Yamada also teaches a chart; Figs. 24, [179-181]).
As to claim 17, Yamada teaches the quality control apparatus according to claim 15, wherein the index is set according to a selection from the control index information (Yamada teaches the index being differences in nucleus/cytoplasm or types of cells, or in the color values; Fig. 13, [134-135]. Yamada teaches various databases storing the index information; [86-89]).
As to claim 18, Yamada teaches the quality control apparatus according to claim 15, wherein the index is set based on a predetermined standard for the specimen quality control (The examiner notes that any difference is a comparison, where the data used in the comparison is set via calibration by a standard. Yamada teaches that the initial values used for thresholds and comparison prior to correction and/or notification of abnormality are obtained by standards, which are used for calibration to create an index for quality control for what is normal and abnormal; [192]. Yamada teaches various databases storing the index information; [86-89]).
As to claim 19, Yamada teaches the quality control apparatus according to claim 15, wherein the index is set based on a guideline for the specimen quality control (The examiner notes that any difference is a comparison, where the data used in the comparison is set via calibration by a standard. Yamada teaches that the initial values used for thresholds and comparison prior to correction and/or notification of abnormality are obtained by standards, which are used for calibration to create an index for quality control for what is normal and abnormal; [192]. Yamada teaches various databases storing the index information; [86-89]).
Other References Cited
The prior art of made of record and not relied upon is considered pertinent to applicant's disclosure include;
Fong Amaris et al (Fong et al. “Image features for quality of analysis of thick blood smears employed in malaria diagnosis”, 3/5/22, vol. 21, no. 1, Malaria Journal; hereinafter “Fong”; already of record) teaches various indexes for colors in table 2 that are set. Fong teaches quality control information is generated from each feature vector; abstract. Fong teaches that various standards are generated based on guidelines from various organizations such as WHO and also from various locations/regions; p. 5.
Yamaguchi et al (US 20080114559; hereinafter “Yamaguchi”) teaches a server which stores and sends quality control information; Fig. 1-11.
Schwartz et al (US 5380663; hereinafter “Schwartz”) teaches a software program which compares calibration data to correct the calibration plot; col. 11 lines 36-48.
Hart et al (US 20210011018; hereinafter “Hart”) teaches that it is important to normalize data across systems; [50].
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the claims at issue are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of copending Application No. 18178569. Although the claims at issue are not identical, they are not patentably distinct from each other because they are directed to a system comprising: a specimen preparing apparatus; an image capturing apparatus; a specimen transporting apparatus; and a computer communicably connected to the image capturing apparatus, the computer comprising a controller configured to perform operations comprising: setting, from the control index information, at least one index to be used for quality control for the specimen; obtaining, from image data of the specimen obtained by the image capturing apparatus, a feature value of the specimen relating to the at least one index; and outputting, based on the feature value and the control value that is associated with the at least one index, quality control information for the specimen preparing apparatus (see claims 1 and 2 of the copending application). Although the claims of the copending application do not explicaitly recite the storage of index information, this index information is implied to be stored since the copending application claims compare feature values to a staining state, where the staining state would be indexed in some fashion to identify different states. Thus, all of the elements of the invention recited in instant claim 1 are encompassed by claims 1-2 of copending Application No. 18178569.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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/Benjamin R Whatley/Primary Examiner, Art Unit 1798