DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status
Claims 1-15 are cancelled.
Claims 16-33 are newly added.
Claims 16-33 are currently pending and under exam herein.
Claims 16-33 are rejected.
Priority
The instant application claims benefit to foreign application No. 202110400024.6 filed on April 14, 2021. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. The claim to foreign priority benefit is acknowledged. Thus, the effective filing date of claims 16-33 will be April 14, 2021 going forth.
Information Disclosure Statement
The information disclosure statement (IDS) was filed on 6/12/2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings are objected to under 37 CFR 1.83(a) because they fail to show an optical detection portion (60) as described in the specification (Page 14, Line 10). Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). 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.
Specification
The use of the terms DVD and Blu Ray (Page 37, Line 28), which are trade names or marks used in commerce, has been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever they appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the terms.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
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 limitation(s) are: the term "portion" in claims 16 and 22.
In claims 16 and 22, the instant application recites “a blood sample supply portion configured to provide a blood sample”, which uses the generic placeholder “portion” coupled with the function language “configured to”. In addition, is not preceded or followed by sufficient structure, material, or acts for performing the claimed function. In looking at the specification paragraph [0109], the blood sample supply portion is described to include a sample needle that can perform 2D and 3D movements to aspirate a blood sample and move it to a mixing chamber. Hence, going forth, examiner will interpret the blood sample supply portion to be as such.
In claims 16 and 22, the instant application recites “a reagent supply portion configured to provide a reaction reagent”, which uses the generic placeholder “portion” coupled with the function language “configured to”. In addition, is not preceded or followed by sufficient structure, material, or acts for performing the claimed function. In looking at the specification paragraph [0109], the reagent supply portion is described to include a reagent tray and reagent needle. It further going on to detail how the combined tray and needle are able to hold multiple reagents and operate in 2D and 3D to move reagents to the mixing chamber. Hence, going forth, examiner will interpret the reagent supply portion to be as such.
Because 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 this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 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 16-33 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “normal” in claims 16, 22, and 28 is a relative term which renders the claim indefinite. The term “normal” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The dependent claims 17-21, 23-27, and 29-33 are rejected as well, for they do not resolve the indefiniteness of the independent claims 16, 22 and 28.
The term “abnormal” in claims 16, 18-20, 22, 24-26, 28, 30-32 is a relative term which renders the claim indefinite. The term “abnormal” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The dependent claims 17, 21, 23, 27, 29, and 33 are rejected as well, for they do not resolve the indefiniteness of the independent claims 16, 22 and 28.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 16-33 is rejected under 35 U.S.C 103 as being unpatentable over Kuroda et al. (US5260027 A) in view of Ikeuchi et al. (US7633604 B2). The italicized text corresponds to the instant claim limitations.
With respect to claim 16, Kuroda et al. discloses an apparatus for automatically analyzing particles for blood examinations (col 1, line 7-10, a blood analysis apparatus). Kuroda et al.’s apparatus is composed of a sample suction probe (28) and specimen container (20) that helps to supply the apparatus with blood samples (col 7 line 65, col 8 line 28-29, a blood sample supply portion configured to provide a blood sample). In addition, the apparatus includes a measuring solution preparing means (15) which is comprised of a sampling valve (17) connected to the sample suction probe (28) that gets the blood sample, a liquid dispensing means for the basic analyzing module (S1), and a liquid dispensing means for the additional analyzing module (S2) that helps to prepare the measuring solutions for the blood tests (col 6, line 45-55, a reagent supply portion configured to provide a reaction reagent; at least one mixing chamber configured to receive the blood sample provided by the blood sample supply portion and the reaction reagent provided by the reagent supply portion to prepare a test sample). The measuring solutions refers to the treated and adjusted blood samples that is inputted into the measuring units, the samples may be diluted with a solution, or mixed with hemolyzing agents or dyestuff (col 6 lines 65 – col 7 line 3; a first test sample mixed with a first reaction reagent that contains a hemolytic agent, a second test sample mixed with a second reaction reagent that contains no hemolytic agent). Kuroda et al. specifies that there are a plurality of analyzing modules in the apparatus, primary modules that measures basic items such as the number of white blood cells, number of red blood cells, or number of platelets, and secondary additional analyzing modules that can measure items such as reticulocytes (col 8 line 50-59, col 9 line 6-9; a first measurement mode and a second measurement mode, the first test result of the blood sample comprises a white blood cell count result and/or a white blood cell classification result, the second test result comprises any one or a combination of a reticulocyte parameter, an immature platelet parameter and a large-volume platelet parameter of the second test sample). The apparatus measures the basic items by a basic analyzing module, judges whether an additional item is necessary or not by analyzing the result of the measurement, and measuring only the specimens requiring the additional item in an additional analyzing module, thereby increasing efficiency of the examination (col 1 line 67 – col 2 line 4). More specifically, when normal, measurement of additional items is not necessary, but if an abnormality is detected by the analyzing device (14), it is judged necessary to measure the additional items, and the controlling device (13) runs the additional modules (col 6 line 28-31, col 7 line 20-27; a processor, wherein the processor determines whether the second measurement mode is enabled by determining whether any one or a combination of reticulocytes, immature platelets and large-volume platelets in the blood sample is abnormal from the first test sample). If there are abnormalities detected, an additional measuring solution will be sent to the necessary measuring units, and the additional items are measured (col 7 line 29-30, the processor controls the blood sample supply portion to provide the blood sample to the mixing chamber, and controls the reagent supply portion to provide a second reaction reagent to the mixing chamber to prepare a second test sample in the mixing). However, if no abnormalities are detected, only the basic measurements are run (col 7 line 57-29; if it is determined that the blood sample are all normal, it is determined that the second measurement mode should not be enabled). Please see below for a drawing of the proposed apparatus in Kuroda et al. and how it maps to the invention in the instant application.
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With regards to claim 17, Kuroda et al. teaches all of the above and how the measuring solution is prepared in the measuring solution preparing means (15) by combining the original blood sample with hemolyzing agents and dyestuff (col 6 lines 65 – col 7 line 3, the blood sample supply portion to provide the blood sample to the mixing chamber and controls the reagent supply portion to provide the hemolytic agent and a first fluorescent agent to the mixing chamber to prepare the first test sample).
With regards to claim 21, Kuroda et al. teaches all of the above and how the measuring solution is prepared in the measuring solution preparing means (15) by combining the original blood sample with diluents and dyestuff (col 6 lines 65 – col 7 line 3, the blood sample supply portion to provide the blood sample to the mixing chamber and controls the reagent supply portion to provide a diluent and a second fluorescent agent to the mixing chamber to prepare the second test sample).
With respect to claim 22, Kuroda et al. discloses an apparatus for automatically analyzing particles for blood examinations (col 1, line 7-10, a blood analysis apparatus). Kuroda et al.’s apparatus is composed of a sample suction probe (28) and specimen container (20) that helps to supply the apparatus with blood samples (col 7 line 65, col 8 line 28-29, a blood sample supply portion configured to provide a blood sample). In addition, the apparatus includes a measuring solution preparing means (15) which is comprised of a sampling valve (17) connected to the sample suction probe (28) that gets the blood sample, a liquid dispensing means for the basic analyzing module (S1), and a liquid dispensing means for the additional analyzing module (S2) that helps to prepare the measuring solutions for the blood tests (col 6, line 45-55, a reagent supply portion configured to provide a reaction reagent; at least one mixing chamber configured to receive the blood sample provided by the blood sample supply portion and the reaction reagent provided by the reagent supply portion to prepare a test sample). The measuring solutions refers to the treated and adjusted blood samples that is inputted into the measuring units, the samples may be diluted with a solution, or mixed with hemolyzing agents or dyestuff (col 6 lines 65 – col 7 line 3; a first test sample mixed with a first reaction reagent that contains a hemolytic agent, a second test sample mixed with a second reaction reagent that contains no hemolytic agent). Kuroda et al. specifies that there are a plurality of analyzing modules in the apparatus, primary modules that measures basic items such as the number of white blood cells, number of red blood cells, or number of platelets, and secondary additional analyzing modules that can measure items such as reticulocytes (col 8 line 50-59, col 9 line 6-9; the first test result of the blood sample comprises a white blood cell count result and/or a white blood cell classification result, the second test result comprises any one or a combination of a reticulocyte parameter, an immature platelet parameter and a large-volume platelet parameter of the second test sample). The apparatus measures the basic items by a basic analyzing module, judges whether an additional item is necessary or not by analyzing the result of the measurement, and measuring only the specimens requiring the additional item in an additional analyzing module, thereby increasing efficiency of the examination (col 1 line 67 – col 2 line 4; the processor further determines whether any one or a combination of reticulocytes, immature platelets and large-volume platelets in the blood sample is abnormal). More specifically, when normal, measurement of additional items is not necessary, but if an abnormality is detected by the analyzing device (14), it is judged necessary to measure the additional items, and the controlling device (13) runs the additional modules (col 6 line 28-31, col 7 line 20-27). If there are abnormalities detected, an additional measuring solution will be sent to the necessary measuring units, and the additional items are measured (col 7 line 29-30, the processor controls the blood sample supply portion to provide the blood sample to the mixing chamber, and controls the reagent supply portion to provide a second reaction reagent to the mixing chamber to prepare a second test sample in the mixing). However, if no abnormalities are detected, only the basic measurements are run and outputted (col 7 line 57-29; processor further outputs the first test result if it is determined that the reticulocytes, the immature platelets and the large-volume platelets in the blood sample are all normal).
With regards to claim 23, Kuroda et al. teaches all of the above and how the measuring solution is prepared in the measuring solution preparing means (15) by combining the original blood sample with hemolyzing agents and dyestuff (col 6 lines 65 – col 7 line 3, the blood sample supply portion to provide the blood sample to the mixing chamber and controls the reagent supply portion to provide the hemolytic agent and a first fluorescent agent to the mixing chamber to prepare the first test sample).
With regards to claim 27, Kuroda et al. teaches all of the above and how the measuring solution is prepared in the measuring solution preparing means (15) by combining the original blood sample with diluents and dyestuff (col 6 lines 65 – col 7 line 3, the blood sample supply portion to provide the blood sample to the mixing chamber and controls the reagent supply portion to provide a diluent and a second fluorescent agent to the mixing chamber to prepare the second test sample).
With respect to claim 28, Kuroda et al. discloses a method and apparatus for automatically analyzing particles for blood examinations (col 1, line 7-10, a blood analysis method). The apparatus uses measuring solutions, which are the treated and adjusted blood samples that is inputted into the measuring units, the samples may be diluted with a solution, or mixed with hemolyzing agents or dyestuff (col 6 lines 65 – col 7 line 3; the second test sample is obtained by treating the blood sample with at least a second reaction reagent, and the second reaction reagent contains no hemolytic agent, the first test sample is obtained by treating the blood sample with at least a first reaction reagent, and the first reaction reagent contains a hemolytic agent). Kuroda et al. specifies that there are a plurality of analyzing modules in the apparatus, primary modules that measures basic items such as the number of white blood cells, number of red blood cells, or number of platelets, and secondary additional analyzing modules that can measure items such as reticulocytes (col 8 line 50-59, col 9 line 6-9; a blood analysis apparatus comprises a first measurement mode and the second measurement mode, the first test result of the blood sample comprises a white blood cell count result and/or a white blood cell classification result, the second test result comprises any one or a combination of a reticulocyte parameter, an immature platelet parameter and a large-volume platelet parameter of the second test sample). The apparatus first measures the basic items by a basic analyzing module, judges whether to enable additional items or not by analyzing the result of the measurement, and measuring only the specimens requiring the additional item in an additional analyzing module, thereby increasing efficiency of the examination (col 1 line 67 – col 2 line 4; determining whether to enable the second measurement mode by determining whether any one or a combination of reticulocytes, immature platelets and large-volume platelets in the blood sample is abnormal). More specifically, when normal, measurement of additional items is not necessary, but if an abnormality is detected by the analyzing device (14), it is judged necessary to measure the additional items, and the controlling device (13) runs the additional modules (col 6 line 28-31, col 7 line 20-27). If there are abnormalities detected, an additional measuring solution will be sent to the necessary measuring units, and the additional items are measured (col 7 line 29-30, if it is determined that any one or a combination of the reticulocytes, the immature platelets and the large-volume platelets in the blood sample is abnormal, it is determined that the second measurement mode should be enabled and the first test result is output). However, if no abnormalities are detected, only the basic measurements are run (col 7 line 57-29; if it is determined that the reticulocytes, the immature platelets and the large-volume platelets in the blood sample are all normal, it is determined that the second measurement mode should not be enabled and the first test result is output).
With regards to claim 29, Kuroda et al. teaches all of the above and how the measuring solution is prepared in the measuring solution preparing means (15) by combining the original blood sample with hemolyzing agents and dyestuff (col 6 lines 65 – col 7 line 3, wherein the first test sample is obtained by treating the blood sample with the hemolytic agent and a first fluorescent agent).
With regards to claim 33, Kuroda et al. teaches all of the above and how the measuring solution is prepared in the measuring solution preparing means (15) by combining the original blood sample with diluents and dyestuff (col 6 lines 65 – col 7 line 3; wherein the second test sample is obtained by treating the blood sample with a diluent and a second fluorescent agent).
However, Kuroda et al. fails to elaborate on the measuring units, and does not specifically mention a measuring portion comprising an optical detection portion, wherein the optical detection portion comprises a flow chamber, a light source, and an optical detector. Due to this Kuroda et al. does not teach the use of optical signals (forward-scattered light signals and fluorescence signals) and scatter diagrams to determine the sample results and display them. However, the use of optical sensors and flow cytometry for blood analysis were known in the art at the time of the effective filing date of the invention as taught by Ikeuchi et al.
With respect to claim 16, Ikeuchi et al. teaches a sample analyzer that utilizes an optical detection unit (20) which includes a laser diode (40), sheath flow cell (43) and photodiode (46) to measure cellular characteristics (col 1 line 55-67, col 4 line 28-30; a measuring portion comprising an optical detection portion, wherein the optical detection portion comprises a flow chamber, a light source, and an optical detector). In the optical detection unit (20), light from the laser diode (40) irradiates the assay sample flowing through the orifice of the sheath flow cell (43), and the light scattered (forward, lateral, and fluorescence) is fed into the photodiode (46) which is an optical/light detector (col 4 line 37-42, 44, 47; wherein the flow chamber communicates with the mixing chamber to allow cells of the test sample to pass therethrough one by one, the light source is configured to irradiate the cells passing through the flow chamber, and the optical detector is configured to obtain optical signals of the cells passing through the flow chamber). Ikeuchi et al. also discloses that based on these light signals, the analyzer can measure variables including number of white blood cells (WBC), classification of WBC, and number of reticulocytes (RET) (col 9 line 48-53; optical detection portion to obtain optical signals of the second test sample and obtains a second test result of the blood sample from the optical signals of the second test sample, wherein the second test result comprises any one or a combination of a reticulocyte parameter, optical detection portion to obtain optical signals of the first test sample, and determines a first test result of the blood sample from the optical signals of the first test sample, wherein the first test result of the blood sample comprises a white blood cell count result and/or a white blood cell classification result).
With regards to claim 17, Ikeuchi et al. teaches the use of forward scattered light, lateral scattered light, and fluorescent light for analysis of samples (col 4 line 37-51; wherein the optical signals of the first sample comprise forward-scattered light signals and fluorescence signals).
Concerning claim 18, Ikeuchi et al. teaches the method of analyzing reticulocytes through the body side controller (26) generating a scattergram based on forward scatter and fluorescence light signals (col 5 line 60-65; the processor generating a scatter diagram corresponding to the first test sample from the optical signals of the first test sample). With the scattergram, the body side controller (26) classifies and stores the individual cells into cell groups, including a reticulocyte group, based on the criteria known to those cells (col 6 line 10-12, col 6 line 22-25; on the scatter diagram of the first test sample, feature regions corresponding to the reticulocytes). Based on the scattergram, the body side controller (26) calculates and transmits the number of reticulocytes to the terminal side controller (34) (col 7 line 8-11, col 7 line 46-48). The terminal side controller (34) can then compare and display the correlation of the results to normal ranges (col 9 line 38-40; determining whether any one or a combination of the reticulocytes, in the blood sample is abnormal based on scatter point information in the obtained feature regions).
With respect to claim 19, Ikeuchi et al. discloses all of the above and the method of counting the number of reticulocytes based on the scattergram (col 7 line 8-10; counting first scatter points in the feature region corresponding to the reticulocytes in the blood sample). And based on this count, the controller then compares it to the expected normal ranges to see if it within the range, if it is not it will display a RET flag, a message indicating the analysis result is abnormal (col 9 line 38-47, col 9 line 60-64; determining that the reticulocytes in the blood sample are normal if the count of the first scatter points is within a first threshold range; the processor determining that the reticulocytes in the blood sample are abnormal if the count of the first scatter points is outside the first threshold range).
Regarding claim 20, Ikeuchi et al. displays corresponding flag prompt, a message indicating the analysis results are abnormal, if results are outside of expected normal ranges (col 9 line 60-64; generates a corresponding alarm prompt if it is determined that any one or a combination of the reticulocytes, the immature platelets and the large-volume platelets in the blood sample is abnormal).
With regards to claim 21, Ikeuchi et al. teaches the use of forward scattered light, lateral scattered light, and fluorescent light for analysis of samples (col 4 line 37-51; wherein the optical signals of the second sample comprise forward-scattered light signals and fluorescence signals).
With respect to claim 22, Ikeuchi et al. teaches a sample analyzer that utilizes an optical detection unit (20) which includes a laser diode (40), sheath flow cell (43) and photodiode (46) to measure cellular characteristics (col 1 line 55-67, col 4 line 28-30; a measuring portion comprising an optical detection portion, wherein the optical detection portion comprises a flow chamber, a light source, and an optical detector). In the optical detection unit (20), light from the laser diode (40) irradiates the assay sample flowing through the orifice of the sheath flow cell (43), and the light scattered (forward, lateral, and fluorescence) is fed into the photodiode (46) which is an optical/light detector (col 4 line 37-42, 44, 47; wherein the flow chamber communicates with the mixing chamber to allow cells of the test sample to pass therethrough one by one, the light source is configured to irradiate the cells passing through the flow chamber, and the optical detector is configured to obtain optical signals of the cells passing through the flow chamber). Ikeuchi et al. also discloses that based on these light signals, the analyzer can measure variables including number of white blood cells (WBC), classification of WBC, and number of reticulocytes (RET) (col 9 line 48-53; processor further controls the optical detection portion to obtain optical signals of the first test sample, and determines a first test result of the blood sample from the optical signals of the first test sample, wherein the first test result of the blood sample comprises a white blood cell count result and/or a white blood cell classification result; the processor further determines whether any one or a combination of reticulocytes, immature platelets and large-volume platelets in the blood sample is abnormal from the optical signals of the first test sample, and the processor further controls the optical detection portion to obtain optical signals of the second test sample, obtains a second test result of the blood sample from the optical signals of the second test sample, and outputs the first test result, wherein the second test result comprises any one or a combination of a reticulocyte parameter, an immature platelet parameter and a large-volume platelet parameter of the second test sample).
With regards to claim 23, Ikeuchi et al. teaches the use of forward scattered light, lateral scattered light, and fluorescent light for analysis of samples (col 4 line 37-51; wherein the optical signals of the first sample comprise forward-scattered light signals and fluorescence signals).
Concerning claim 24, Ikeuchi et al. teaches the method of analyzing reticulocytes through the body side controller (26) generating a scattergram based on forward scatter and fluorescence light signals (col 5 line 60-65; the processor generating a scatter diagram corresponding to the first test sample from the optical signals of the first test sample). With the scattergram, the body side controller (26) classifies and stores the individual cells into cell groups, including a reticulocyte group, based on the criteria known to those cells (col 6 line 10-12, col 6 line 22-25; on the scatter diagram of the first test sample, feature regions corresponding to the reticulocytes). Based on the scattergram, the body side controller (26) calculates and transmits the number of reticulocytes to the terminal side controller (34) (col 7 line 8-11, col 7 line 46-48). The terminal side controller (34) can then compare and display the correlation of the results to normal ranges (col 9 line 38-40; determining whether any one or a combination of the reticulocytes, in the blood sample is abnormal based on scatter point information in the obtained feature regions).
With respect to claim 25, Ikeuchi et al. discloses all of the above and the method of counting the number of reticulocytes based on the scattergram (col 7 line 8-10; counting first scatter points in the feature region corresponding to the reticulocytes in the blood sample). And based on this count, the controller then compares it to the expected normal ranges to see if it within the range, if it is not it will display a RET flag, a message indicating the analysis result is abnormal (col 9 line 38-47, col 9 line 60-64; determining that the reticulocytes in the blood sample are normal if the count of the first scatter points is within a first threshold range; the processor determining that the reticulocytes in the blood sample are abnormal if the count of the first scatter points is outside the first threshold range).
Regarding claim 26, Ikeuchi et al. displays corresponding flag prompt, a message indicating the analysis results are abnormal, if results are outside of expected normal ranges (col 9 line 60-64; generates a corresponding alarm prompt if it is determined that any one or a combination of the reticulocytes, the immature platelets and the large-volume platelets in the blood sample is abnormal).
With regards to claim 27, Ikeuchi et al. teaches the use of forward scattered light, lateral scattered light, and fluorescent light for analysis of samples (col 4 line 37-51; wherein the optical signals of the second sample comprise forward-scattered light signals and fluorescence signals).
With respect to claim 28, Ikeuchi et al. teaches the use of light/optical signals in cellular analysis, the light/optical signals can be used to measure variables including number of white blood cells (WBC), classification of WBC, and number of reticulocytes (RET) (col 9 line 48-53; obtaining optical signals of the second test sample, and obtaining a second test result of a blood sample from the optical signals of the second test sample, wherein the second test result comprises any one or a combination of a reticulocyte parameter, an immature platelet parameter and a large-volume platelet parameter of the second test sample, obtaining optical signals of the first test sample in the first measurement mode, wherein the optical signals of the first test sample are used to determine a first test result of the blood sample, the first test result comprises a white blood cell count result and/or a white blood cell classification result).
With regards to claim 29, Ikeuchi et al. teaches the use of forward scattered light, lateral scattered light, and fluorescent light for analysis of samples (col 4 line 37-51; the optical signals of the first test sample comprise forward-scattered light signals and fluorescence signals).
Concerning claim 30, Ikeuchi et al. teaches the method of analyzing reticulocytes through the body side controller (26) generating a scattergram based on forward scatter and fluorescence light signals (col 5 line 60-65; generating a scatter diagram corresponding to the first test sample from the optical signals of the first test sample). With the scattergram, the body side controller (26) classifies and stores the individual cells into cell groups, including a reticulocyte group, based on the criteria known to those cells (col 6 line 10-12, col 6 line 22-25; obtaining, on the scatter diagram of the first test sample, feature regions corresponding to the reticulocytes). Based on the scattergram, the body side controller (26) calculates and transmits the number of reticulocytes to the terminal side controller (34) (col 7 line 8-11, col 7 line 46-48). The terminal side controller (34) can then compare and display the correlation of the results to normal ranges (col 9 line 38-40; determining whether any one or a combination of the reticulocytes, the immature platelets and the large-volume platelets in the blood sample is abnormal based on scatter point information in the obtained feature regions).
With respect to claim 31, Ikeuchi et al. discloses all of the above and the method of counting the number of reticulocytes based on the scattergram (col 7 line 8-10; counting first scatter points in the feature region corresponding to the reticulocytes in the blood sample). And based on this count, the controller then compares it to the expected normal ranges to see if it within the range, if it is not it will display a RET flag, a message indicating the analysis result is abnormal (col 9 line 38-47, col 9 line 60-64; determining that the reticulocytes in the blood sample are normal if the count of the first scatter points is within a first threshold range; the processor determining that the reticulocytes in the blood sample are abnormal if the count of the first scatter points is outside the first threshold range).
Regarding claim 32, Ikeuchi et al. displays corresponding flag prompt, a message indicating the analysis results are abnormal, if results are outside of expected normal ranges (col 9 line 60-64; generates a corresponding alarm prompt if it is determined that any one or a combination of the reticulocytes, the immature platelets and the large-volume platelets in the blood sample is abnormal).
With regards to claim 33, Ikeuchi et al. teaches the use of forward scattered light, lateral scattered light, and fluorescent light for analysis of samples (col 4 line 37-51; the optical signals of the second test sample comprise forward-scattered light signals and fluorescence signals).
An invention would have been prima facie obvious to one of ordinary skill in the art at the effective filing date of the invention to modify the analyzing modules of Kuroda et al.’s apparatus with the optical detection unit of Ikeuchi et al. for a more efficient and accurate blood analyzer that would be adept at measuring multiple variables with optical signals. One of ordinary skill in the art would have been motivated to utilize the optical detection unit as a measuring units due to its ability to rapidly count and differentiate various cell populations just based on one sample and its scatter diagram. In fact, Ikeuchi et al. states that many blood analyzers which analyze blood using a flow cytometer have been developed for automatic high-speed analysis of many biological samples and gives example patents which have done so before the effective filing date of the instant application (col 1 line 20-23). In addition, one of skill in the arts before the effective filing date of the claimed invention would have had a reasonable expectation of success at incorporating Ikeuchi et al.’s optical detection unit into Kuroda et al.’s blood analysis apparatus, as the use of flow cytometry in blood analysis was a well-established field by this time.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure.
Padmanabhan et al., US8540946 B2
Rodriguez et al., US5616201
Lee et al. US4883867
Takkai et al. JP5732576 B2
Claims 16-33 are patent eligible because although the claims contain judicial exceptions in the form of abstract ideas (mental process and mathematical concepts) (Step 2A, Prong 1: Yes), the additional elements of the particular machine integrate the judicial exceptions into a practical application (Step 2A, Prong 2: Yes). Specifically, the judicial exceptions are implemented with the blood analysis apparatus, that is integral to the claim. According to MPEP § 2106.05(b) judicial exceptions applied with the use of a particular machine may be patent eligible if the elements of the machine can be specifically identified, play a significant part in permitting the claimed method to be performed rather than function solely as an obvious mechanism, and the machine or apparatus imposes meaningful limits on the claim. In the instant application, the examiner believes that the additional elements describing the blood analysis apparatus does indeed constitute as a particular machine to the judicial exceptions of abstract ideas. Therefore, claims 16-33 are patent eligible under U.S.C. 101.
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/W.Y./Examiner, Art Unit 1685
/OLIVIA M. WISE/Supervisory Patent Examiner, Art Unit 1685