Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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.
1. Claims 1-4 are rejected under 35 USC 103 to U.S. Patent Application Publication No. 2016/0178651 to Shima et al. (cited by applicant) in view of U.S Patent Application Publication No. 2009/0069639 to Linssen et al.
Shima et al. discloses a blood sample determination method and a blood sample analyzer.
The blood sample analyzer 10 includes: a measuring unit 20 (equivalent to an analysis unit that analyzes the sample) that obtains optical information about the amount of light from the measurement sample; a sample transfer unit 30 provided in front of the measurement unit 20; and a control device 40 which analyzes the measurement data obtained by the measuring unit 20 and gives instructions to the measuring unit 20. The measurement unit 20 and the sample transfer unit 30 form an optical information obtaining unit 50. [0064]
As shown in FIG. 2, the control device 40 is composed of a display unit 41 (equivalent to a display unit that displays measured data calculated by the control unit), an input unit 42 (equivalent to an operation unit that accepts operations from an operator), and a computer body 43. The control device 40 receives optical information from the measurement unit 20. The processor of the control device 40 (equivalent to a control unit that controls the analysis unit based on the input of the operating unit and calculates the assay data using the assay value taken from the analysis unit) executes a computer program for blood sample determination based on the optical information. [0076], [0082], [0084], [0091]
In Shima et al. the blood sample assay method includes emitting light to a measurement sample prepared by mixing a clotting time measurement reagent and a blood sample suspected of being derived from a subject having lupus anticoagulants or clotting factor inhibitors to obtain optical information regarding the amount of light from the measurement sample. (Abstract)
Based on the obtained optical information, at least one parameter regarding a derivative of the clot waveform is obtained and whether the blood sample is suspected of being a sample derived from a subject with lupus anticoagulant or suspected of being a sample derived from a subject with a coagulation factor inhibitor is determined based on the obtained value of the parameter. (Abstract)
Preferably, the determination is made based on a comparison result of the obtained value of the parameter with a predetermined threshold value corresponding to the parameter. [0010]
For example, in case maximum coagulation velocity (|min 1|) |min 1| is obtained, the value of (|min 1 is compared with a first threshold, and in case min2 has been obtained, the value of min2 is compared with a second threshold, and in case maximum coagulation acceleration (|min 2|) |min 2| is obtained, the value of |min 2| is compared with a third threshold. Then, based on the result of the comparison, a determination may be made. For example, when at least one of the values that have been obtained in |min 1|, |min 2| and |min 2| is greater than or equal to a predetermined threshold corresponding to that value, it may be determined that the blood sample is suspected of being a sample derived from a subject with lupus anticoagulant. On the other hand, when all of the values obtained in |min 1|, |min 2| and |min 2|are less than a predetermined threshold corresponding to those values, the blood sample may be determined to be suspected of being a sample derived from a subject with a coagulation factor inhibitor. [0044]-[0053]
In Shima et al. the predetermined threshold is not limited to a specific threshold. For example, by accumulating data regarding various parameters of the clot waveform derivatives of lupus anticoagulant positive samples and clotting factor inhibitor positive samples, predetermined thresholds corresponding to the respective parameters can be empirically set. Alternatively, values for various parameters regarding the derivatives of the clot waveform are obtained for each of the Lupus anticoagulant positive sample group and the clotting factor inhibitor positive sample group, and each value that can clearly separate the groups from each other can be set as a predetermined threshold. [0054]
In Shima et al. The output section 405 outputs the determination result to be displayed on the display unit 41 or printed by the printer. [0100]
As one example of a screen on which results of an analysis are displayed, a screen on which results of an analysis performed on a coagulation process of a blood sample by using a prothrombin time measurement reagent are displayed is described with reference to Figure 9. The screen D1 comprises an area D11 for displaying a sample number, an area D12 for displaying a measurement item name, a button D13 for displaying a detailed screen, an area D14 for displaying a measurement date and time, an area D15 for displaying measurements, an area D16 for displaying analysis information, and an area D17 for displaying a clot waveform and a graph obtained by calculating a derivative of the clot waveform (equivalent to the control unit causing the display unit to display assay reaction process information based on assay data of a sample of an analysis subject). [0117]
Shima et al. does not teach that control unit is configured to cause the display unit to display not only measurement reaction course information based on the measurement data of the sample to be analyzed, but also reference reaction course information designated by the operation unit from among reference reaction course information classified in advance on an illness basis.
Linssen et al. discloses an application program 304a determines whether or not an obtained analysis result satisfies the conditions of each disease included beforehand in the application program 304a. When it has been determined that conditions of a disease are satisfied, a notification screen 150 is displayed, as shown in FIG. 15. The conditions concerning "MAHA" include that the PLT, WBC, HGB, IPF, RET, IRF, and FRC values are outside predetermined ranges in addition to the measurement items including CBC, DIFF, and RET, and that there is no platelet aggregation in the sample. Conditions concerning "HELLP-Syndrom" include that the patient is hospitalized for childbirth, the values of PLT, WBC, HGB, IPF, RET, IRF, and MCH are outside predetermined ranges in addition to the measurement items including CBC, DIFF, and RET, and that there is no platelet aggregation in the sample. Other diseases have respectively different conditions. [0080]
When it is determined that the corresponding conditions of a certain disease are satisfied, as illustrated in FIG. 15, a notification screen 150 is displayed. FIGS. 16 and 17 are an auxiliary diagnosis information display screen 200 of the auxiliary diagnosis system including a specimen attribute information display area 210, an analysis result display area 220, and a disease information display area 230. The specimen attribute information display area 210 is displayed with information of a specific subject and a specimen (specimen) collected from a subject. The analysis result display area 220 is displayed with partial numerical values of the analysis results shown in Fig. 15 and thumbnails 221 of graphs such as scatter plots and histograms of the analysis results. A double click on this thumbnail 221 may be used to enlarge the scatter plot. histogram, and the like as shown in FIG. 17.
The enlarged displayed scatter plot and graph 222 may be dragged with a mouse. Thereby, the user may compare the contents of the disease information display area 230 and the enlarged displayed graphic 222. The disease information display area 230 displays information about a disease that the application 304a judges that the subject may have. As shown in Figure 20, typical graphs (scatterplots and histograms) and blood smear images representing "MAHA (Microangiopathlc hemolytic anemia)" features are shown in the "Test Results” term. A comparison illustration with a normal human (Fig. 3c)s also shown. [0085]
As seen in Figure 20 are histograms representing abnormal platelet numbers, scatter plots representing IPF (immature platelet splitting), scatter plots representing red blood cell numbers and smear images of immature platelets and fragmented red blood cells. The user can simultaneously compare viewing these graphics and the enlarged graphic 222 (FIG. 17) of the analysis results. The disease information display area 230 displays typical graphs (scatterplots, histograms, etc.) and images (smear images) representing characteristics of the disease to which the user can make a diagnosis (corresponding to reference reaction process information which the control unit also displays with reaction process information of a particular disease).
Linssen et al. thus teaches providing for visually comparing historical waveforms of known diseases to determine which disease type a current sample is more similar to.
It would have been obvious to one of ordinary skill in the art to before applicant’s effective filing date to modify Shima et al. to cause the display unit to display not only measurement reaction course information based on the measurement data of a sample analyzed, but also reference reaction course information designated by the operation unit from among reference reaction course information classified in advance on an illness basis as taught by Linssen et al, for purposes of allowing an operator to determine a similar illness based on a coagulation reaction of a subject’s blood sample.
I.) Regarding applicant’s claim 1, as noted above Shima et al. in view of Linssen et al. renders all of the limitations of claim 1 obvious.
Therefore, Shima et al. in view of Linssen et al. renders claim 1 obvious.
II.) Regarding applicant’s claim 2, as noted above Shima et al. in view of Linssen et al. renders claim 1 obvious from which claim 2 depends.
Claim 2 recites that the control unit is configured to display the measurement reaction course information and the reference reaction course information side by side or in an overlapping manner on the display unit.
In Shima et al. in view of Linssen et al it would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to display the measurement reaction course information (sample measured information) and the reference reaction course information in any convenient manner, including side by side or in an overlapping manner on the display unit.
Therefore, Shima et al. in view of Linssen et al. renders claim 2 obvious.
III.) Regarding applicant’s claim 3, as noted above Shima et al. in view of Linssen et al. renders claim 1 obvious from which claim 3 depends.
Claim 3 recites that when a classification of an illness is selected by the operation unit with respect to the measurement reaction course information, the measurement reaction course information is stored as the reference reaction course information in association with the selected illness.
Shima et al. in view of Linssen et al. does not teach that when a classification of an illness is selected by the operation unit with respect to the measurement reaction course information, the measurement reaction course information is stored as the reference reaction course information in association with the selected illness.
However, in Shima et al. in view of Linssen et al. it would have been obvious to store the measurement reaction course information as the reference reaction course information in association with the selected illness, when a classification of an illness is selected by the operation unit with respect to the measurement reaction course information, for purposes of tracking and associating the measurement course information for future use in determining illnesses.
Therefore, Shima et al. in view of Linssen et al. renders claim 3 obvious.
IV.) Regarding applicant’s claim 4, as noted above Shima et al. in view of Linssen et al. renders claim 1 obvious from which claim 4 depends.
Claim 4 recites that the control unit is connected to a server that stores the reference reaction course information.
Shima et al. in view of Linssen et al. does not teach that the control unit is connected to a server that stores the reference reaction course information.
In Shima et al. in view of Linssen et al. it would have been obvious to one of ordinary skill in the art to provide a control unit is connected to a server that stores the reference reaction course information for purposes of accessing the reference course information for comparison with measurement course information.
Therefore, Shima et al. in view of Linssen et al. renders claim 4 obvious.
2. Claim 5 is rejected under 35 USC 103 as being unpatentable over Shima et al. in view of Linssen et al.
As noted above, Shima et al. discloses a blood sample determination method and a blood sample analyzer.
The blood sample analyzer 10 includes: a measuring unit 20 (equivalent to an analysis unit that analyzes the sample) that obtains optical information about the amount of light from the measurement sample (equivalent to a data processing device); a sample transfer unit 30 provided in front of the measurement unit 20; and a control device 40 which analyzes the measurement data obtained by the measuring unit 20 and gives instructions to the measuring unit 20. The measurement unit 20 and the sample transfer unit 30 form an optical information obtaining unit 50. [0064]
As shown in FIG. 2, the control device 40 is composed of a display unit 41 (equivalent to a display unit that displays measured data calculated by the control unit), an input unit 42 (equivalent to an operation unit that accepts operations from an operator), and a computer body 43. The control device 40 receives optical information from the measurement unit 20. The processor of the control device 40 (equivalent to a control unit that controls the analysis unit based on the input of the operating unit and calculates the assay data using the assay value taken from the analysis unit) executes a computer program for blood sample determination based on the optical information. [0076], [0082], [0084], [0091]
In Shima et al. the blood sample assay method includes emitting light to a measurement sample prepared by mixing a clotting time measurement reagent and a blood sample suspected of being derived from a subject having lupus anticoagulants or clotting factor inhibitors to obtain optical information regarding the amount of light from the measurement sample. (Abstract)
Based on the obtained optical information, at least one parameter regarding a derivative of the clot waveform is obtained and whether the blood sample is suspected of being a sample derived from a subject with lupus anticoagulant or suspected of being a sample derived from a subject with a coagulation factor inhibitor is determined based on the obtained value of the parameter. (Abstract)
Preferably, the determination is made based on a comparison result of the obtained value of the parameter with a predetermined threshold value corresponding to the parameter. [0010]
For example, in case maximum coagulation velocity (|min 1|) |min 1| is obtained, the value of (|min 1 is compared with a first threshold, and in case min2 has been obtained, the value of min2 is compared with a second threshold, and in case maximum coagulation acceleration (|min 2|) |min 2| is obtained, the value of |min 2| is compared with a third threshold. Then, based on the result of the comparison, a determination may be made. For example, when at least one of the values that have been obtained in |min 1|, |min 2| and |min 2| is greater than or equal to a predetermined threshold corresponding to that value, it may be determined that the blood sample is suspected of being a sample derived from a subject with lupus anticoagulant. On the other hand, when all of the values obtained in |min 1|, |min 2| and |min 2|are less than a predetermined threshold corresponding to those values, the blood sample may be determined to be suspected of being a sample derived from a subject with a coagulation factor inhibitor. [0044]-[0053]
In Shima et al. the predetermined threshold is not limited to a specific threshold. For example, by accumulating data regarding various parameters of the clot waveform derivatives of lupus anticoagulant positive samples and clotting factor inhibitor positive samples, predetermined thresholds corresponding to the respective parameters can be empirically set. Alternatively, values for various parameters regarding the derivatives of the clot waveform are obtained for each of the Lupus anticoagulant positive sample group and the clotting factor inhibitor positive sample group, and each value that can clearly separate the groups from each other can be set as a predetermined threshold. [0054]
In Shima et al. the output section 405 outputs the determination result to be displayed on the display unit 41 or printed by the printer (from data acquired by a data acquisition unit). [0100]
As one example of a screen on which results of an analysis are displayed, a screen on which results of an analysis performed on a coagulation process of a blood sample by using a prothrombin time measurement reagent are displayed is described with reference to Figure 9. The screen D1 comprises an area D11 for displaying a sample number, an area D12 for displaying a measurement item name, a button D13 for displaying a detailed screen, an area D14 for displaying a measurement date and time, an area D15 for displaying measurements, an area D16 for displaying analysis information, and an area D17 for displaying a clot waveform and a graph obtained by calculating a derivative of the clot waveform (equivalent to the control unit causing the display unit to display assay reaction process information based on assay data of a sample of an analysis subject). [0117]
Shima et al. does not teach that control unit is configured to cause the display unit to display not only measurement reaction course information based on the measurement data of the sample to be analyzed, but also reference reaction course information designated by the operation unit from among reference reaction course information classified in advance on an illness basis.
Linssen et al. discloses an application program 304a determines whether or not an obtained analysis result satisfies the conditions of each disease included beforehand in the application program 304a. When it has been determined that conditions of a disease are satisfied, a notification screen 150 is displayed, as shown in FIG. 15. The conditions concerning "MAHA" include that the PLT, WBC, HGB, IPF, RET, IRF, and FRC values are outside predetermined ranges in addition to the measurement items including CBC, DIFF, and RET, and that there is no platelet aggregation in the sample. Conditions concerning "HELLP-Syndrom" include that the patient is hospitalized for childbirth, the values of PLT, WBC, HGB, IPF, RET, IRF, and MCH are outside predetermined ranges in addition to the measurement items including CBC, DIFF, and RET, and that there is no platelet aggregation in the sample. Other diseases have respectively different conditions. [0080]
When it is determined that the corresponding conditions of a certain disease are satisfied, as illustrated in FIG. 15, a notification screen 150 is displayed. FIGS. 16 and 17 are an auxiliary diagnosis information display screen 200 of the auxiliary diagnosis system including a specimen attribute information display area 210, an analysis result display area 220, and a disease information display area 230. The specimen attribute information display area 210 is displayed with information of a specific subject and a specimen (specimen) collected from a subject. The analysis result display area 220 is displayed with partial numerical values of the analysis results shown in Fig. 15 and thumbnails 221 of graphs such as scatter plots and histograms of the analysis results. A double click on this thumbnail 221 may be used to enlarge the scatter plot. histogram, and the like as shown in FIG. 17.
The enlarged displayed scatter plot and graph 222 may be dragged with a mouse. Thereby, the user may compare the contents of the disease information display area 230 and the enlarged displayed graphic 222. The disease information display area 230 displays information about a disease that the application 304a judges that the subject may have. As shown in Figure 20, typical graphs (scatterplots and histograms) and blood smear images representing "MAHA (Microangiopathlc hemolytic anemia)" features are shown in the "Test Results” term. A comparison illustration with a normal human (Fig. 3c)s also shown. [0085]
As seen in Figure 20 are histograms representing abnormal platelet numbers, scatter plots representing IPF (immature platelet splitting), scatter plots representing red blood cell numbers and smear images of immature platelets and fragmented red blood cells. The user can simultaneously compare viewing these graphics and the enlarged graphic 222 (FIG. 17) of the analysis results. The disease information display area 230 displays typical graphs (scatterplots, histograms, etc.) and images (smear images) representing characteristics of the disease to which the user can make a diagnosis (corresponding to reference reaction process information which the control unit also displays with reaction process information of a particular disease).
Linssen et al. thus teaches providing for visually comparing historical waveforms of known diseases to determine which disease type a current sample is more similar to.
It would have been obvious to one of ordinary skill in the art to before applicant’s effective filing date to modify Shima et al. to cause the display unit to display not only measurement reaction course information based on the measurement data of a sample analyzed, but also reference reaction course information designated by the operation unit from among reference reaction course information classified in advance on an illness basis as taught by Linssen et al, for purposes of allowing an operator to determine a similar illness based on a coagulation reaction of a subject’s blood sample.
It would have further been obvious to one of ordinary skill in the art to modify Shima et al. in view of Linssen et al. to include a storage unit to store the reference course information for purposes of retrieving such information for display purposes.
I.) Regarding applicant’s claim 5, as noted above Shima et al. in view of Linssen et al. renders all the limitations of claim 5 obvious.
Therefore, Shima et al. in view of Linssen et al. renders claim 5 obvious.
3. Claim 6 is rejected under 35 USC 103 as being unpatentable over Shima et al. in view of Linssen et al.
As noted above, Shima et al. discloses a blood sample determination method and a blood sample analyzer.
The blood sample analyzer 10 includes: a measuring unit 20 (equivalent to an analysis unit that analyzes the sample) that obtains optical information about the amount of light from the measurement sample; a sample transfer unit 30 provided in front of the measurement unit 20; and a control device 40 which analyzes the measurement data obtained by the measuring unit 20 and gives instructions to the measuring unit 20. The measurement unit 20 and the sample transfer unit 30 form an optical information obtaining unit 50. [0064]
As shown in FIG. 2, the control device 40 is composed of a display unit 41 (equivalent to a display unit that displays measured data calculated by the control unit), an input unit 42 (equivalent to an operation unit that accepts operations from an operator), and a computer body 43. The control device 40 receives optical information from the measurement unit 20. The processor of the control device 40 (equivalent to a control unit that controls the analysis unit based on the input of the operating unit and calculates the assay data using the assay value taken from the analysis unit) executes a computer program for blood sample determination based on the optical information. [0076], [0082], [0084], [0091]
In Shima et al. the blood sample assay method includes emitting light to a measurement sample prepared by mixing a clotting time measurement reagent and a blood sample suspected of being derived from a subject having lupus anticoagulants or clotting factor inhibitors to obtain optical information regarding the amount of light from the measurement sample. (Abstract)
Based on the obtained optical information, at least one parameter regarding a derivative of the clot waveform is obtained and whether the blood sample is suspected of being a sample derived from a subject with lupus anticoagulant or suspected of being a sample derived from a subject with a coagulation factor inhibitor is determined based on the obtained value of the parameter. (Abstract)
Preferably, the determination is made based on a comparison result of the obtained value of the parameter with a predetermined threshold value corresponding to the parameter. [0010]
For example, in case maximum coagulation velocity (|min 1|) |min 1| is obtained, the value of (|min 1 is compared with a first threshold, and in case min2 has been obtained, the value of min2 is compared with a second threshold, and in case maximum coagulation acceleration (|min 2|) |min 2| is obtained, the value of |min 2| is compared with a third threshold. Then, based on the result of the comparison, a determination may be made. For example, when at least one of the values that have been obtained in |min 1|, |min 2| and |min 2| is greater than or equal to a predetermined threshold corresponding to that value, it may be determined that the blood sample is suspected of being a sample derived from a subject with lupus anticoagulant. On the other hand, when all of the values obtained in |min 1|, |min 2| and |min 2|are less than a predetermined threshold corresponding to those values, the blood sample may be determined to be suspected of being a sample derived from a subject with a coagulation factor inhibitor. [0044]-[0053]
In Shima et al. the predetermined threshold is not limited to a specific threshold. For example, by accumulating data regarding various parameters of the clot waveform derivatives of lupus anticoagulant positive samples and clotting factor inhibitor positive samples, predetermined thresholds corresponding to the respective parameters can be empirically set. Alternatively, values for various parameters regarding the derivatives of the clot waveform are obtained for each of the Lupus anticoagulant positive sample group and the clotting factor inhibitor positive sample group, and each value that can clearly separate the groups from each other can be set as a predetermined threshold. [0054]
In Shima et al. The output section 405 outputs the determination result to be displayed on the display unit 41 or printed by the printer. [0100]
As one example of a screen on which results of an analysis are displayed, a screen on which results of an analysis performed on a coagulation process of a blood sample by using a prothrombin time measurement reagent are displayed is described with reference to Figure 9. The screen D1 comprises an area D11 for displaying a sample number, an area D12 for displaying a measurement item name, a button D13 for displaying a detailed screen, an area D14 for displaying a measurement date and time, an area D15 for displaying measurements, an area D16 for displaying analysis information, and an area D17 for displaying a clot waveform and a graph obtained by calculating a derivative of the clot waveform (equivalent to the control unit causing the display unit to display assay reaction process information based on assay data of a sample of an analysis subject). [0117]
Shima et al. does not teach that control unit is configured to cause the display unit to display not only measurement reaction course information based on the measurement data of the sample to be analyzed, but also reference reaction course information designated by the operation unit from among reference reaction course information classified in advance on an illness basis.
Linssen et al. discloses an application program 304a determines whether or not an obtained analysis result satisfies the conditions of each disease included beforehand in the application program 304a. When it has been determined that conditions of a disease are satisfied, a notification screen 150 is displayed, as shown in FIG. 15. The conditions concerning "MAHA" include that the PLT, WBC, HGB, IPF, RET, IRF, and FRC values are outside predetermined ranges in addition to the measurement items including CBC, DIFF, and RET, and that there is no platelet aggregation in the sample. Conditions concerning "HELLP-Syndrom" include that the patient is hospitalized for childbirth, the values of PLT, WBC, HGB, IPF, RET, IRF, and MCH are outside predetermined ranges in addition to the measurement items including CBC, DIFF, and RET, and that there is no platelet aggregation in the sample. Other diseases have respectively different conditions. [0080]
When it is determined that the corresponding conditions of a certain disease are satisfied, as illustrated in FIG. 15, a notification screen 150 is displayed. FIGS. 16 and 17 are an auxiliary diagnosis information display screen 200 of the auxiliary diagnosis system including a specimen attribute information display area 210, an analysis result display area 220, and a disease information display area 230. The specimen attribute information display area 210 is displayed with information of a specific subject and a specimen (specimen) collected from a subject. The analysis result display area 220 is displayed with partial numerical values of the analysis results shown in Fig. 15 and thumbnails 221 of graphs such as scatter plots and histograms of the analysis results. A double click on this thumbnail 221 may be used to enlarge the scatter plot. histogram, and the like as shown in FIG. 17.
The enlarged displayed scatter plot and graph 222 may be dragged with a mouse. Thereby, the user may compare the contents of the disease information display area 230 and the enlarged displayed graphic 222. The disease information display area 230 displays information about a disease that the application 304a judges that the subject may have. As shown in Figure 20, typical graphs (scatterplots and histograms) and blood smear images representing "MAHA (Microangiopathlc hemolytic anemia)" features are shown in the "Test Results” term. A comparison illustration with a normal human (Fig. 3c)s also shown. [0085]
As seen in Figure 20 are histograms representing abnormal platelet numbers, scatter plots representing IPF (immature platelet splitting), scatter plots representing red blood cell numbers and smear images of immature platelets and fragmented red blood cells. The user can simultaneously compare viewing these graphics and the enlarged graphic 222 (FIG. 17) of the analysis results. The disease information display area 230 displays typical graphs (scatterplots, histograms, etc.) and images (smear images) representing characteristics of the disease to which the user can make a diagnosis (corresponding to reference reaction process information which the control unit also displays with reaction process information of a particular disease).
Linssen et al. thus teaches providing for visually comparing historical waveforms of known diseases to determine which disease type a current sample is more similar to.
It would have been obvious to one of ordinary skill in the art to before applicant’s effective filing date to modify Shima et al. to process data and cause the display unit to output and display not only measurement reaction course information based on the measurement data of a sample analyzed, but also reference reaction course information designated by the operation unit from among reference reaction course information classified in advance on an illness basis as taught by Linssen et al, for purposes of allowing an operator to determine a similar illness based on a coagulation reaction of a subject’s blood sample.
I.) Regarding applicant’s claim 6, as noted above Shima et al. in view of Linssen et al. renders all the limitations of claim 6 obvious.
Therefore, Shima et al. in view of Lessen et al. renders claim 6 obvious.
4. Claim 7 is rejected under 35 USC 103 as being unpatentable over Shima et al. in view of Linssen et al.
As noted above, Shima et al. discloses a blood sample determination method and a blood sample analyzer.
The blood sample analyzer 10 includes: a measuring unit 20 (equivalent to an analysis unit that analyzes the sample) that obtains optical information about the amount of light from the measurement sample; a sample transfer unit 30 provided in front of the measurement unit 20; and a control device 40 which analyzes the measurement data obtained by the measuring unit 20 and gives instructions to the measuring unit 20. The measurement unit 20 and the sample transfer unit 30 form an optical information obtaining unit 50. [0064]
As shown in FIG. 2, the control device 40 is composed of a display unit 41 (equivalent to a display unit that displays measured data calculated by the control unit), an input unit 42 (equivalent to an operation unit that accepts operations from an operator), and a computer body 43. The control device 40 receives optical information from the measurement unit 20. The processor of the control device 40 (equivalent to a control unit that controls the analysis unit based on the input of the operating unit and calculates the assay data using the assay value taken from the analysis unit) executes a computer program for blood sample determination based on the optical information. [0076], [0082], [0084], [0091]
In Shima et al. the blood sample assay method includes emitting light to a measurement sample prepared by mixing a clotting time measurement reagent and a blood sample suspected of being derived from a subject having lupus anticoagulants or clotting factor inhibitors to obtain optical information regarding the amount of light from the measurement sample. (Abstract)
Based on the obtained optical information, at least one parameter regarding a derivative of the clot waveform is obtained and whether the blood sample is suspected of being a sample derived from a subject with lupus anticoagulant or suspected of being a sample derived from a subject with a coagulation factor inhibitor is determined based on the obtained value of the parameter. (Abstract)
Preferably, the determination is made based on a comparison result of the obtained value of the parameter with a predetermined threshold value corresponding to the parameter. [0010]
For example, in case maximum coagulation velocity (|min 1|) |min 1| is obtained, the value of (|min 1 is compared with a first threshold, and in case min2 has been obtained, the value of min2 is compared with a second threshold, and in case maximum coagulation acceleration (|min 2|) |min 2| is obtained, the value of |min 2| is compared with a third threshold. Then, based on the result of the comparison, a determination may be made. For example, when at least one of the values that have been obtained in |min 1|, |min 2| and |min 2| is greater than or equal to a predetermined threshold corresponding to that value, it may be determined that the blood sample is suspected of being a sample derived from a subject with lupus anticoagulant. On the other hand, when all of the values obtained in |min 1|, |min 2| and |min 2|are less than a predetermined threshold corresponding to those values, the blood sample may be determined to be suspected of being a sample derived from a subject with a coagulation factor inhibitor. [0044]-[0053]
In Shima et al. the predetermined threshold is not limited to a specific threshold. For example, by accumulating data regarding various parameters of the clot waveform derivatives of lupus anticoagulant positive samples and clotting factor inhibitor positive samples, predetermined thresholds corresponding to the respective parameters can be empirically set. Alternatively, values for various parameters regarding the derivatives of the clot waveform are obtained for each of the Lupus anticoagulant positive sample group and the clotting factor inhibitor positive sample group, and each value that can clearly separate the groups from each other can be set as a predetermined threshold. [0054]
In Shima et al. The output section 405 outputs the determination result to be displayed on the display unit 41 or printed by the printer. [0100]
As one example of a screen on which results of an analysis are displayed, a screen on which results of an analysis performed on a coagulation process of a blood sample by using a prothrombin time measurement reagent are displayed is described with reference to Figure 9. The screen D1 comprises an area D11 for displaying a sample number, an area D12 for displaying a measurement item name, a button D13 for displaying a detailed screen, an area D14 for displaying a measurement date and time, an area D15 for displaying measurements, an area D16 for displaying analysis information, and an area D17 for displaying a clot waveform and a graph obtained by calculating a derivative of the clot waveform (equivalent to the control unit causing the display unit to display assay reaction process information based on assay data of a sample of an analysis subject). [0117]
Shima et al. does not teach that control unit is configured to cause the display unit to display not only measurement reaction course information based on the measurement data of the sample to be analyzed, but also reference reaction course information designated by the operation unit from among reference reaction course information classified in advance on an illness basis.
Linssen et al. discloses an application program 304a determines whether or not an obtained analysis result satisfies the conditions of each disease included beforehand in the application program 304a. When it has been determined that conditions of a disease are satisfied, a notification screen 150 is displayed, as shown in FIG. 15. The conditions concerning "MAHA" include that the PLT, WBC, HGB, IPF, RET, IRF, and FRC values are outside predetermined ranges in addition to the measurement items including CBC, DIFF, and RET, and that there is no platelet aggregation in the sample. Conditions concerning "HELLP-Syndrom" include that the patient is hospitalized for childbirth, the values of PLT, WBC, HGB, IPF, RET, IRF, and MCH are outside predetermined ranges in addition to the measurement items including CBC, DIFF, and RET, and that there is no platelet aggregation in the sample. Other diseases have respectively different conditions. [0080]
When it is determined that the corresponding conditions of a certain disease are satisfied, as illustrated in FIG. 15, a notification screen 150 is displayed. FIGS. 16 and 17 are an auxiliary diagnosis information display screen 200 of the auxiliary diagnosis system including a specimen attribute information display area 210, an analysis result display area 220, and a disease information display area 230. The specimen attribute information display area 210 is displayed with information of a specific subject and a specimen (specimen) collected from a subject. The analysis result display area 220 is displayed with partial numerical values of the analysis results shown in Fig. 15 and thumbnails 221 of graphs such as scatter plots and histograms of the analysis results. A double click on this thumbnail 221 may be used to enlarge the scatter plot. histogram, and the like as shown in FIG. 17.
The enlarged displayed scatter plot and graph 222 may be dragged with a mouse. Thereby, the user may compare the contents of the disease information display area 230 and the enlarged displayed graphic 222. The disease information display area 230 displays information about a disease that the application 304a judges that the subject may have. As shown in Figure 20, typical graphs (scatterplots and histograms) and blood smear images representing "MAHA (Microangiopathlc hemolytic anemia)" features are shown in the "Test Results” term. A comparison illustration with a normal human (Fig. 3c)s also shown. [0085]
As seen in Figure 20 are histograms representing abnormal platelet numbers, scatter plots representing IPF (immature platelet splitting), scatter plots representing red blood cell numbers and smear images of immature platelets and fragmented red blood cells. The user can simultaneously compare viewing these graphics and the enlarged graphic 222 (FIG. 17) of the analysis results. The disease information display area 230 displays typical graphs (scatterplots, histograms, etc.) and images (smear images) representing characteristics of the disease to which the user can make a diagnosis (corresponding to reference reaction process information which the control unit also displays with reaction process information of a particular disease).
Linssen et al. thus teaches providing for visually comparing historical waveforms of known diseases to determine which disease type a current sample is more similar to.
Shima et al. teaches that a computer program is used to run the analysis. [0010]
Linssen et al. also teaches that a computer program is used to run the analysis. (Abstract)
It would have been obvious to one of ordinary skill in the art to before applicant’s effective filing date to modify Shima et al. to use a computer program to cause the display unit to display not only measurement reaction course information based on the measurement data of a sample analyzed, but also reference reaction course information designated by the operation unit from among reference reaction course information classified in advance on an illness basis as taught by Linssen et al, for purposes of allowing an operator to determine a similar illness based on a coagulation reaction of a subject’s blood sample.
Therefore, Shima et al. in view of Linssen et al. renders claim 7 obvious.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
European Patent Application Publication No. 0844581 to Wood et al. teaches displaying reference images from the library can be called up and displayed on the ultrasound system monitor side by side along with the patient's pathology, enabling comparisons to be made which can aid in diagnosis. (page 7, lines 38-53)
U.S. Patent Application Publication No. 2007/0032733 to Burton teaches means to compare ECG or HRV measures to a global database of normal and abnormal values, threshold and ranges enabling detection of incidence of, or onset, or prediction or onset of, elevated risk or physiological stress relating to illness or a deterioration in state of health. [0052]
U.S. Patent application Publication No. 2015/338415 to Hund et al. teaches determining the amount of at least one angiogenesis biomarker selected from the group consisting of sFlt-1, Endoglin and PlGF in a sample of said subject, and b) comparing the amount with a reference, whereby a subject being not at risk for developing preeclampsia within a short period of time is diagnosed if the amount is identical or decreased compared to the reference in the cases of sFlt-1 and Endoglin and identical or increased in the case of PlGF, wherein said reference allows for making the diagnosis with a negative predictive value of at least about 98%. [0002]
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/MICHAEL STANLEY GZYBOWSKI/Examiner, Art Unit 1798
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