DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 101
2. 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.
3. Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims recite a mental process. This judicial exception is not integrated into a practical application. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. The following reasons are provided to evaluate subject matter eligibility.
(1) Are the claims directed to a process, machine, manufacture or composition of matter;
(2A) Prong One: Are the claims directed to a judicially recognized exception, i.e., a law of nature, a natural phenomenon, or an abstract idea;
Prong Two: If the claims are directed to a judicial exception under Prong One, then is the judicial exception integrated into a practical application;
(2B) If the claims are directed to a judicial exception and do not integrate the judicial exception, do the claims provide an inventive concept.
With regard to (1), the analysis is a ‘yes’, claim 1 recites a process.
With regard to (2A) Prong One, the analysis is a “yes”. Claim 1 recites “processing microscope image data…”. When viewed under the broadest most reasonable interpretation the claim recites an abstract idea of mental processes. The step of “processing” is generically recited because there is no description of how this is accomplished. It can be interpreted as merely looking at the data, and evaluating the data in the mind. The concepts, as claimed, are observations and/or evaluations (“comparing…,” “either flagging or not flagging…” ), judgements (“determining…..” ), and opinions (“reporting….”). There is nothing in the claim that requires more than an operation that a human, armed with the appropriate apparatus, pen/paper, can perform. One can perform the process using pen and paper, and the recitation of modules (such as judgers, gathering unit, an inference model) in the system/device claim is a mere use of generic computer components. See MPEP 2106.04 and the 2019 PEG.
With regard to (2A) Prong Two: the analysis is a “No”. Claim 1 recites the additional elements of “comparing the number of cells of said each of the first plurality of cell types with a corresponding user adjustable rule, the corresponding user adjustable rule comprising one or more values for flagging or not flagging the sample for further review; either flagging or not flagging the sample for further review in response to the comparing of the number of cells of said each of the first plurality of cell types with the corresponding user adjustable rule” these additional elements represents mere data gathering and indexing the data all together that is necessary for use of the recited abstract idea. Therefore, the limitation(s) is/are insignificant extra-solution activity, as transforming data into vector(s) is a generic operation. See MPEP 2106.05(1). The claim as a whole, looking at the additional elements individually and in combination, does not integrate the abstract idea into a practical application.
With regard to (2B): the pending claims do not show what is more than a routine in the art presented in the claims, i.e., the additional elements are nothing more than routine and well-known steps. The additional elements do not reflect an improvement to a technology or technical field, including the use of a particular machine or particular transformation. It has not been shown that the mental process allows the “technology” to do something that it previously was not able to do.
Dependent claims 2-20 do not include additional elements that are sufficient to amount to significantly more than the judicial exception. The claims are rejected for the same reasons and not repeated herewith.
Claim Rejections - 35 USC § 103
4. 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 (i.e., changing from AIA to pre-AIA ) 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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Jimenez et al. (U.S. patent pub. 2022/0036979 A1 will be further referred to as Jim) and further in view of Farrell et al. (U.S. patent pub. 2016/0187246 A1 will be further referred to as Farr).
Regarding claim 1: Jim discloses a computer implemented method of processing microscope image data (Jim; abstract, and paragraphs 0002-0006 and 0041), the method comprising:
receiving microscope image data from a slide from a sample of the patient, the microscope image data comprising a plurality of cells (Jim; paragraph 0041),
processing the microscope image data with one or more classifiers to identify a plurality of cell types, the plurality of cell types comprising a first plurality of cell types and a second plurality of cell types (Jim; paragraphs 0037-0041);
determining a number of cells for each of the first plurality of cell types and a number of cells for each the second plurality of cell types (Jim. Paragraphs 0037-0041, the analyzers count the cells (i.e. RBCs, WBCs, platelets, etc,);
comparing the number of cells of said each of the first plurality of cell types with a corresponding user adjustable rule, the corresponding user adjustable rule comprising one or more values for flagging or not flagging the sample for further review (Jim; figs. 5-7 and paragraphs 0037-0041, 0093-0100, and 0111-0113);
either flagging or not flagging the sample for further review in response to the comparing of the number of cells of said each of the first plurality of cell types with the corresponding user adjustable rule (Jim; paragraphs 0111-0113 and 0121-0126); and
reporting the number of cells of said each of the first plurality of cell types and the number of cells of said each of the second plurality of cell types to a patient record (paragraphs 0037-0041). Jim does not teach the feature of “the plurality of cells comprising at least 100 white blood cells, at least 1000 red bloods cells, and platelet image data from an area of at least 50,000 µm2.” Farr discloses the feature of “the plurality of cells comprising at least 100 white blood cells, at least 1000 red bloods cells, and platelet image data from an area of at least 50,000 µm2” (Farr; paragraphs 0010-0021, 00398-0040, 0099, and 0195). It would have been obvious to one ordinary skilled in the art to combine the teaching of Farr into the disclosure of Jim because they are analogous in the field of microscopic fluid sample analysis. One ordinary skilled in the art would have been motivated to incorporate the teaching of Farr into the disclosure of Jim in order “for detecting, counting and characterizing particles in biological fluids such as red blood cells, reticulocytes, nucleated red blood cells, platelets, and for image and morphologically-based white blood cell differential counting, categorization, subcategorization, characterization and/or analysis” (Farr; paragraphs 0002).
Regarding claim 2: The computer implemented method of claim 1, wherein the sample is not flagged for further review of the microscope image data in response to the number of cells of said each of the second plurality of cell types (Jim; paragraphs 0037-0041, 0093-0100, and 0111-0113).
Regarding claim 3: The computer implemented method of claim 1, further comprising receiving a user input to adjust at least one user adjustable rule and wherein the sample is flagged or not flagged in response to the user input (Jim; paragraphs 0037-0041, 0093-0100, and 0111-0113)..
Regarding claim 4: The computer implemented method of claim 3, wherein a user input is received to adjust the corresponding user adjustable rule for said each of the first plurality of cell types(Jim; paragraphs 0037-0041 and 0093-0100).
Regarding claim 5: The computer implemented method of claim 4, wherein the sample is flagged or not flagged in response to a user adjusted rule for said each of the first plurality of cell types (Jim; paragraphs 0037-0041, 0093-0100, and 0111-0113).
Regarding claim 6: The computer implemented method of claim 1, wherein the number of said each of the second plurality of cell types is not compared to a user adjustable rule to flag or not flag the sample for morphological review and wherein the number is compared to a rule to flag or not flag for said each of the second plurality of cell types for review by a clinician (Jim; paragraphs 0037-0041).
Regarding claim 7: The computer implemented method of claim 1, further comprising imaging the slide to generate the microscope image data (Jim; paragraphs 0037-0041).
Regarding claim 8: The computer implemented method of claim 1, wherein the steps of receiving the microscope image data, processing the microscope image data, determining the number of cells, comparing the number of cells, and flagging or not flagging the sample are automated (Jim; paragraphs 0037-0041).
Regarding claim 9: The computer implemented method of claim 1, wherein the steps of receiving the microscope image data, processing the microscope image data, determining the number of cells, comparing the number of cells, and flagging or not flagging the sample are performed in sequence (Jim; paragraphs 0002-0006, 0037-0041, 0093-0100, 0111-0113, and 0121-0126).
Regarding claim 10: The computer implemented method of claim 1, further comprising loading and unloading a plurality of slides from a microscope with a slide loader and wherein each of a plurality of slides is imaged with a microscope (Jim; paragraphs 0037-0041).
Regarding claim 11: The computer implemented method of claim 10, wherein the method is fully automated from the step of loading and unloading the plurality of slides to the step of flagging or not flagging the sample (Jim; paragraphs 0037-0041).
Regarding claim 12: The computer implemented method of claim 11, wherein if the sample is not flagged for further review by a person, the first plurality of cell types and the second plurality of cell types are reported to the patient record, and if the sample is flagged for further review by a person, the number of the first plurality of cell types is not reported to the patient record until a user input has been received indicating that the person has reviewed the sample (Jim; paragraphs 0037-0041, 0093-0100, and 0111-0113).
Regarding claim 13: The computer implemented method of claim 1, wherein the user adjustable rules are configured for the user to classify a cell type as being in either the first plurality of cells or the second plurality of cells and optionally wherein a user interface is configured for a user to switch a cell type between the first plurality of cell types and the second plurality of cell types (Jim; paragraphs 0037-0041, 0076-0086, and 0093-0100).
Regarding claim 14: The computer implemented method of claim 1, wherein a user interface is configured for a user to adjust one or more of a threshold value or a range of the user adjustable rule of said each of the first plurality of cell types (Jim; paragraphs 0037-0041, 0093-0100, and 0111-0113).
Regarding claim 15: The computer implemented method of claim 1, wherein the first plurality of cell types comprises one or more of blasts, aberrant lymphocytes, intracellular micro-organisms, nucleated red blood cells (nRBCs), immature myeloids, smudge cells or schistocytes, and the second plurality of cell types comprises one or more of monocytes, toxic neutrophils, Large Granular Lymphocytes (LGLs), anisocytosis or platelet clumps (Jim; paragraphs 0037-0041).
Regarding claim 16: The computer implemented method of claim 15, further comprising receiving data for a patient, wherein the sample has been taken from the patient and wherein the patient data comprises one or more of an age or a sex of the patient (Jim; paragraphs 0076-0081).
Regarding claim 17: The computer implemented method of claim 16, wherein the comparing is performed in response to the one or more of the age or the sex of the patient (Jim; paragraphs 0076-0081).
Regarding claim 18: The computer implemented method of claim 17, wherein the age is greater than one month, and the first plurality of cell types comprises nRBCs (Farr; paragraphs 0039-0040).
Regarding claim 19: The computer implemented method of claim 15, wherein the intracellular micro- organism comprises a pathogen and optionally wherein the pathogen comprises malaria (Farr; paragraphs 0197-0204).
Regarding claim 20: The computer implemented method of claim 15, wherein the immature myeloids comprise one or more of metamyelocytes, myelocytes, or promyelocytes (Farr; paragraphs 0039-0040).
Contact Information
5. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANAND BHATNAGAR whose telephone number is (571)272-7416. The examiner can normally be reached on M-F 7:30am-4:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Vu Le can be reached on 571-272-4650. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANAND P BHATNAGAR/
Primary Examiner, Art Unit 2668
July 22, 2026
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