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 .
Status of Claims
Claims 1-20 remain pending in the application.
Claim Objections
Claims 1-4, 9-11, 20 are objected to because of the following informalities:
Claim 1 lines 4-5 recites “for each assay type” and “said assay type”, and lines 8-9 recites “at least one assay type” and line 10 recites “the at least one assay type”
As the assay types are understood to be the same, it is suggested that the phrasing remain consistent.
For example, lines 4-5 could be amended to recite “for at least one assay type” and “said at least one assay type” and then lines 8-9 could be amended to recite “the at least one assay type” and line 10 may remain as it is.
Line 9 recites “the system or device” where because applicant has amended the preamble to just be a system, “or device” should be deleted.
Claim 3 recites “the system or device” on both lines 7 and 8, where “or device” should be deleted from both lines for reasons described supra in claim 1.
Claim 4 recites “the system or device” on both lines 4 and 5, where “or device” should be deleted from both lines for reasons described supra in claim 1.
Claim 9 similarly recites “each assay type” on lines 3-4, “said assay type” on line 4, “at least one assay type” on line 7, and “the at least one assay type” on line 9. For similar reasons described in claim 1 supra, it is suggested that these phrasings be amended to be consistent such that it is clear they are all referring to the same at least one assay type.
Claim 10 appears to be an improper Markush group, please see claim 2 supra for further explanation.
Claim 11 recites “the system or device” on both lines 7 and 8, where because claim 9 has been amended to just be a system, lines 7 and 8 should both remove “or device”.
Claim 20 recites “for each assay type” on line 2 and “said assay type” on line 3.
Similar to claims 1 and 9 supra, it is suggested that the phrasing for the assay type be consistent to make it clear they are all referring to the same assay type. Note that claim 17 recites “at least one assay type”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 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.
Claim 1 recites “the control type” on line 5, where there is insufficient antecedent basis for this limitation, as no control type has been recited prior. It is therefore unclear what control type is being referred to.
Additionally, lines 13-14 recites “the control unit scheduling an assay run comprising instructions to include the determined control type based on the determined allocation rule” where this is unclear because lines 10-12 recites “the control unit determining for the at least one assay type comprised in the at least one assay order, the control type to be used, and the corresponding allocation rule for said control type”
Lines 10-12 makes it appear that the control type and allocation rule are determined, where the allocation rule corresponds to the control type. However then lines 13-14 makes it sound like the determined control type is based on the determined allocation rule, which appears to be the opposite of the relationship described in lines 10-12.
Further clarification is requested.
Claims 2-8 are rejected by virtue of being dependent on a rejected claim.
Claim 8 recites “an allocation rule” on line 3, where it is unclear if this allocation rule is the same or different from the one described in claim 1.
For examination, it will be interpreted that they are the same allocation rule.
Claim 9 recites “the control type” on line 4, where there is insufficient antecedent basis for this limitation, as no control type has been recited prior. It is therefore unclear what control type is being referred to.
Lines 11-12 recites “schedule an assay run comprising instructions to include the determined control type based on the determined allocation rule”, where this is unclear because lines 9-10 recites “determine for the at least one assay type comprised in the at least one assay order, the control type to be used, and the corresponding allocation rule for said control type”
Lines 9-10 makes it appear that the control type and corresponding allocation rule for the control type are determined. However, then lines 11-12 makes it sound like the determined control type is based on the determined allocation rule, which appears to be opposite of the relationship described in lines 9-10.
Further clarification is requested.
Claims 10-16 are rejected by virtue of being dependent on a rejected claim.
Claim 16 recites “an allocation rule” on line 2 where it is unclear if this allocation rule is the same or different from the one described in claim 9.
For examination, it will be interpreted that they are the same allocation rule.
Claim 17 recites “the control type” on line 8, where there is insufficient antecedent basis for this limitation, as no control type has been recited prior. It is therefore unclear what control type is being referred to.
Line 8 recites “the corresponding allocation rule” where there is insufficient antecedent basis for this limitation, as no allocation rule has been described prior. It is therefore unclear what allocation rule is being referred to.
Additionally, similar for reasons described in both claims 1 and 9, recitation of “determining… the control type to be used, and the corresponding allocation rule… the determined control type based on the determined allocation rule” is unclear and further clarification is requested.
Claims 18-20 are rejected by virtue of being dependent on a rejected claim.
Claim 20 recites “an allocation rule” on line 3, where it is unclear if this allocation rule is the same or different from the one described in claim 17.
For examination it will be interpreted that they are the same allocation rule.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim(s) recite(s):
Claim 1 “the control unit determining for the at least one assay type comprised in the at leas tone assay order, the control type to be used, and the corresponding allocation rule for said control type”
Claim 9 “the control unit is configured to: … determine for at least one assay type comprised in the at least one assay order, the control type to be used, and the corresponding allocation rule for said control type,”
Claim 17 “determining, by the control unit, for the at least one assay type comprised in the at least one assay order, the control type to be used, and the corresponding allocation rule for said control type”
This judicial exception is not integrated into a practical application because after the control unit schedules the assay run, the control unit controls the system to perform the scheduled assay run. This is recited at such a high level of generality that it amounts to just generally applying the abstract idea, and is generally linking the abstract idea to a field of use per MPEP 2106.05(h) which are not particular practical applications. Additionally the claim recites a storage unit containing instructions and that the control unit receives at least one assay order, however, these are insignificant extra-solution activities and not a practical application, and is also generally linking the abstract idea to a field of use, which are not practical applications.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception. The additional elements are a controller and a storage, which are a general purpose computer. A general purpose computer is not a particular machine, see MPEP 2106.05(b). Further, a controller and storage are well understood and conventional within the prior art, please see 103 rejection section below where Kurono teaches a control unit and storage.
Claims 2-8, 10-16, 18-20 do not resolve the deficiency described for respective claims 1, 9, and 17 and are therefore rejected under 101.
Claims 2-4 describe constraints on the control type and allocation rule, claim 5 describes other determining steps by the control unit and does not integrate the determining control type and allocation rule into a practical application, claims 6-7 add constraints to the allocation rule, and claim 8 describes receiving an allocation rule which is not integrating the determining control type and allocation rule into a practical application.
Dependent claims 10-16 are similar to those described above.
Claim 18 is directed to a non-transitory computer-readable storage medium having stored thereon the computer program product of claim 17 and does not integrate the determining control type and allocation rule into practical application.
Claims 19-20 describe constraints on the control type and allocation rule.
Claim Interpretation
Claim 3 recites “wherein the allocation rule comprises a time rule or a run rule”, where when describing the limitations of the time rule and run rule, they are separated by “and” on line 4.
Currently, based on the phrasing “wherein the allocation rule comprises a time rule or a run rule” it appears that either the allocation rule is a time rule or a run rule.
Based on the instant specification page 6 lines 32-33 and page 7 lines 1-15 and Figure 1, it describes where in a first step 100 it can be selected if the allocation rule should comprise a time rule or a run rule, where if it is decided that a time rule will be the allocation rule, the next step 110 is performed, but if a run rule is the allocation rule, the next step 120 is performed.
Therefore, it will be interpreted that both the time rule and run rule are present, but only one is selected to be the allocation rule that is followed.
Claim 11 and 20 both have similar phrasing as described for claim 3 above, and will therefore be interpreted in the same way.
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.
Claim(s) 1-4, 6-12, 14-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kurono (US-2020/0174028-A1).
Regarding claim 1, Kurono teaches a method for increasing and optimizing controls handling in a laboratory system (specimen analyzer 30), the system (30) comprising ([0006], [0038] see specimen analysis method, Figure 1):
- a control unit (controller 331) for controlling operation of the system (30) ([0123], [0125], Figure 4, [0130] see the measurement section 32 and analysis section 33 are provided as separate sections or may be configured by a single apparatus, where the single apparatus may include controller 321 and controller 331 separately or alternatively the controller 331 may perform all the processes that are otherwise performed by controller 321 and controller 321 may be omitted. Therefore, when Kurono refers to operations of controller 321 or 331 it will be understood that it may be conducted by the same controller, and for mapping 331 will be used),
- a storage unit (storage unit 322 and storage unit 332) connected to the control unit (331) and containing instructions, for each assay type (measurement items), of the control type to be used when running said assay type (measurement items), and, for each control type, an allocation rule (quality control group) for the control type ([0006] see specimen analyzer configured to perform analysis on a specimen for a plurality of measurement items, where the analyzer is configured to perform a quality control measurement corresponding to the measurement item and the controller 331 programmed to set a quality control for each measurement item from a quality control group that includes at least two types of quality controls, [0123] see controller 321 controls various components of the measurement section 32 and transport section 31 in accordance with programs and data stored in the storage unit 322, [0125] see storage unit 332 has stored a program 332a for causing the analysis section to perform a predetermined process, Figure 4),
[0129] see controller 321 of measurement section 32 causes a quality control substance to be mixed with a reagent corresponding to a measurement item. Further see [0093] which describes the quality control substance (also referred to as a control sample) is a sample of which compositions are known. Therefore, the quality control substance is the control type for the measurement items. Additionally, as controller 331 performs the processes of controller 321 and [0123] and [0125] describe where controller 321 is associated with storage unit 322 and controller 331 is associated with storage unit 332, therefore both storage units 322 and 332 will be associated with controller 331.
the method comprising the following steps:
- the control unit (331) receiving at least one assay order comprising instructions to run at least one assay type (measurement types) on the system (30) or device ([0008] see the controller may be programmed to receive a measurement item and set a quality control for the received measurement item),
- the control unit (331) determining for the at least one assay type (measurement types) comprised in the at least one assay order, the control type to be used, and the corresponding allocation rule (quality control group) for said control type ([0008], [0020] see controller may be programmed to cause the display unit to display for each measurement item recommendation information that suggests which of the quality controls in the quality control group is preferable),
[0034] describes where the analyzer performs a specimen measurement for measuring a sample prepared from the specimen and reagent corresponding to a measurement item, and is configured to perform a quality control measurement for measuring a measurement sample prepared from a quality control substance and a reagent corresponding to a measurement item. One skilled in the art would therefore find it obvious that when conducting the quality control measurement, the quality control group (allocation rule) and quality control substance (control type) will be determined.
- the control unit (331) scheduling an assay run comprising instructions to include the determined control type based on the determined allocation rule (quality control group) ([0034], [0048], [0129]), and
- the control unit (331) controlling the system (30) to perform the scheduled assay run ([0034], [0048], [0129]).
Regarding claim 2, Kurono teaches the method of claim 1. Kurono further teaches wherein the control type comprises at least one selected from a positive control type ([0093] which describes the quality control substance (also referred to as a control sample) is a sample of which compositions are known and encompasses substances prepared by extracting a predetermined component from a specimen collected from an animal, and artificially produced substances so as to be analogous to particles contained in a specimen, and is therefore a positive control type).
Please see page 1 lines 8-11 of the instant specification which describes that positive controls are controls that contain an analyte of interest and are used to check if the assay or reagents used are working as expected, where the results of a positive control is expected to be a positive result.
Regarding claim 3, Kurono teaches the method of claim 1. Kurono further teaches wherein the allocation rule (quality control group) comprises a time rule or a run rule, wherein
- the time rule comprises at least instructions to run the control type once in a time frame ([0139] and Figure 6C describing the test number QC (quality control) where the controller 331 counts the number of times of specimen measurement for a target measurement item, i.e., test number, and every time the test number reaches a predetermined number of times Nt the controller 331 causes a quality control measurement to be performed), and
Based on Figure 6C, the first Nt interval labeled will define a time frame, where one quality control measurement is conducted during this time interval. The quality control measurement will be a measurement with the quality control substance.
- the run rule comprises instructions to run the control type:
o once for every reagent cartridge firstly used in the system or device ([0141], [0142], [0143] and Figure 7A describing the controller 331 estimates the number of times of specimen measurement executable in a time period Tc required for a quality control measurement, where an estimated number of times Nc is estimated on the basis of history information, and the controller 331 determines whether or not the remaining amount of current reagent has become smaller than a reagent amount that is necessary for specimen measurements to be performed the estimated number of times Nc and when the remaining amount of the current reagent has become smaller than the reagent amount necessary the controller 331 causes a quality control measurement to be performed on the basis of the reagent of a reagent container that contains a new reagent), and/or
Please note that the limitations “o once for every assay run, and/or
o once for every reagent cartridge lot firstly used in the system or device.” are not required due to recitation of “and/or”.
Regarding claim 4, Kurono teaches the method of claim 3. Kurono further teaches wherein the time rule further comprises instructions to run the control type:
- once for every assay run, and/or
As described in [0139] the controller 331 starts counting the number of times of specimen measurement for a target measurement item and every time the test number reaches a predetermined number of times Nt the controller 331 causes a quality control measurement to be performed. While Figure 6C shows that there are three specimen measurements conducted before a quality control measurement is then conducted, one skilled in the art would find it obvious that Nt may be set to one. As such, a quality control measurement will occur once for every assay run.
Please note the limitations “- once for every reagent cartridge firstly used in the system or device, and/or
- once for every reagent cartridge lot firstly used in the system or device.” are not required due to recitation of “and/or”.
Regarding claim 6, Kurono teaches the method of claim 3. Kurono further teaches wherein the time frame comprises a minimum time frame duration and a maximum time frame duration ([0139] and Figure 6C where because the quality control measurement is conducted for a predetermined number of specimen measurements, one skilled in the art would find it obvious that there will therefore be a minimum time frame duration and a maximum time frame duration based on when the specimen measurements are conducted. Additionally, as seen in Figure 6C it can be seen that the first Nt interval is shorter than the last Nt interval, and therefore they have different time frames).
Regarding claim 7, Kurono teaches the method according to claim 6. Kurono further teaches wherein the maximum time frame duration and/or the minimum time frame duration is predetermined ([0139] and Figure 6C where the number of specimen measurements to be conducted and the type will dictate how long the measurements will be and therefore determine the time frames).
Regarding claim 8, Kurono teaches the method according to claim 1. Kurono further teaches further comprising receiving, by the control unit (331), an allocation rule (quality control group) over a user interface of the control unit (331) ([0161] describes Figure 10 showing a control measurement item selection screen 401).
Regarding claim 9, Kurono teaches a laboratory system (specimen analyzer 30), comprising ([0006], Figure 1):
- a control unit (controller 331) for controlling operation of the system (30) ([0123], [0125], Figure 4, [0130] see the measurement section 32 and analysis section 33 are provided as separate sections or may be configured by a single apparatus, where the single apparatus may include controller 321 and controller 331 separately or alternatively the controller 331 may perform all the processes that are otherwise performed by controller 321 and controller 321 may be omitted. Therefore, when Kurono refers to operations of controller 321 or 331 it will be understood that it may be conducted by the same controller, and for mapping 331 will be used),
- a storage unit (storage unit 322 and storage unit 332) connected to the control unit (331) and containing instructions, for each assay type (measurement items), of the control type to be used when running said assay type (measurement items), and, for each control type, an allocation rule (quality control group) for the control type ([0006] see specimen analyzer configured to perform analysis on a specimen for a plurality of measurement items, where the analyzer is configured to perform a quality control measurement corresponding to the measurement item and the controller 331 programmed to set a quality control for each measurement item from a quality control group that includes at least two types of quality controls, [0123] see controller 321 controls various components of the measurement section 32 and transport section 31 in accordance with programs and data stored in the storage unit 322, [0125] see storage unit 332 has stored a program 332a for causing the analysis section to perform a predetermined process, Figure 4),
[0129] see controller 321 of measurement section 32 causes a quality control substance to be mixed with a reagent corresponding to a measurement item. Further see [0093] which describes the quality control substance (also referred to as a control sample) is a sample of which compositions are known. Therefore, the quality control substance is the control type for the measurement items. Additionally, as controller 331 performs the processes of controller 321 and [0123] and [0125] describe where controller 321 is associated with storage unit 322 and controller 331 is associated with storage unit 332, therefore both storage units 322 and 332 will be associated with controller 331.
wherein the control unit (331) is configured to:
- receive at least one assay order comprising instructions to run at least one assay type (measurement types) on the system (30) ([0008] see the controller may be programmed to receive a measurement item and set a quality control for the received measurement item),
- determine for the at least one assay type (measurement types) comprised in the at least one assay order, the control type to be used, and the corresponding allocation rule (quality control group) for said control type ([0008], [0020] see controller may be programmed to cause the display unit to display for each measurement item recommendation information that suggests which of the quality controls in the quality control group is preferable),
[0034] describes where the analyzer performs a specimen measurement for measuring a sample prepared from the specimen and reagent corresponding to a measurement item, and is configured to perform a quality control measurement for measuring a measurement sample prepared from a quality control substance and a reagent corresponding to a measurement item. One skilled in the art would therefore find it obvious that when conducting the quality control measurement, the quality control group (allocation rule) and quality control substance (control type) will be determined.
- schedule an assay run comprising instructions to include the determined control type based on the determined allocation rule (quality control group) ([0034], [0048], [0129]), and
- control the system (30) to perform the scheduled assay run ([0034], [0048], [0129]).
Regarding claim 10, Kurono teaches the system of claim 9. Kurono further teaches wherein the control type comprises at least one selected from a positive control type ([0093] which describes the quality control substance (also referred to as a control sample) is a sample of which compositions are known and encompasses substances prepared by extracting a predetermined component from a specimen collected from an animal, and artificially produced substances so as to be analogous to particles contained in a specimen, and is therefore a positive control type).
Please see page 1 lines 8-11 of the instant specification which describes that positive controls are controls that contain an analyte of interest and are used to check if the assay or reagents used are working as expected, where the results of a positive control is expected to be a positive result.
Regarding claim 11, Kurono teaches the system of claim 9. Kurono further teaches wherein the allocation rule (quality control group) comprises a time rule or a run rule, wherein
- the time rule comprises at least instructions to run the control type once in a time frame ([0139] and Figure 6C describing the test number QC (quality control) where the controller 331 counts the number of times of specimen measurement for a target measurement item, i.e., test number, and every time the test number reaches a predetermined number of times Nt the controller 331 causes a quality control measurement to be performed), and
Based on Figure 6C, the first Nt interval labeled will define a time frame, where one quality control measurement is conducted during this time interval. The quality control measurement will be a measurement with the quality control substance.
- the run rule comprises instructions to run the control type:
o once for every reagent cartridge firstly used in the system or device ([0141], [0142], [0143] and Figure 7A describing the controller 331 estimates the number of times of specimen measurement executable in a time period Tc required for a quality control measurement, where an estimated number of times Nc is estimated on the basis of history information, and the controller 331 determines whether or not the remaining amount of current reagent has become smaller than a reagent amount that is necessary for specimen measurements to be performed the estimated number of times Nc and when the remaining amount of the current reagent has become smaller than the reagent amount necessary the controller 331 causes a quality control measurement to be performed on the basis of the reagent of a reagent container that contains a new reagent), and/or
Please note the limitations “o once for every assay run, and/or
o once for every reagent cartridge lot firstly used in the system or device.” are not required due to recitation of “and/or”.
Regarding claim 12, Kurono teaches the system of claim 11. Kurono further teaches wherein the time rule further comprises instructions to run the control type:
- once for every assay run, and/or
As described in [0139] the controller 331 starts counting the number of times of specimen measurement for a target measurement item and every time the test number reaches a predetermined number of times Nt the controller 331 causes a quality control measurement to be performed. While Figure 6C shows that there are three specimen measurements conducted before a quality control measurement is then conducted, one skilled in the art would find it obvious that Nt may be set to one. As such, a quality control measurement will occur once for every assay run.
Please note the limitations “- once for every reagent cartridge firstly used in the system or device, and/or
- once for every reagent cartridge lot firstly used in the system or device.” are not required due to recitation of “and/or”.
Regarding claim 14, Kurono teaches the system of claim 11. Kurono further teaches wherein the time frame comprises a minimum time frame duration and a maximum time frame duration ([0139] and Figure 6C where because the quality control measurement is conducted for a predetermined number of specimen measurements, one skilled in the art would find it obvious that there will therefore be a minimum time frame duration and a maximum time frame duration based on when the specimen measurements are conducted. Additionally, as seen in Figure 6C it can be seen that the first Nt interval is shorter than the last Nt interval, and therefore they have different time frames).
Regarding claim 15, Kurono teaches the system according to claim 14. Kurono further teaches wherein the maximum time frame duration and/or the minimum time frame duration is predetermined ([0139] and Figure 6C where the number of specimen measurements to be conducted and the type will dictate how long the measurements will be and therefore determine the time frames).
Regarding claim 16, Kurono teaches the system according to claim 9. Kurono further teaches wherein control unit (331) is further configured to receive an allocation rule (quality control group) over a user interface of the control unit (331) ([0161] describes Figure 10 showing a control measurement item selection screen 401).
Regarding claim 17, Kurono teaches a computer program product comprising instructions to cause a laboratory system (specimen analyzer 30) to execute a method comprising the steps of ([0006], Figure 1):
- receiving, at a control unit (controller 331) for controlling operation of the system (30), at least one assay order comprising instructions to run at least one assay type (measurement types) on the system (30) ([0006] see specimen analyzer configured to perform analysis on a specimen for a plurality of measurement items, where the analyzer is configured to perform a quality control measurement corresponding to the measurement item, [0008] see the controller may be programmed to receive a measurement item and set a quality control for the received measurement item, [0123] see controller 321 controls various components of measurement section 32 and transport section 31 in accordance with programs and data stored in storage unit 322, [0125] see storage unit 332 has stored a program 332a for causing the analysis section 33 to perform a predetermined process, [0130] see the measurement section 32 and analysis section 33 are provided as separate sections or may be configured by a single apparatus, where the single apparatus may include controller 321 and controller 331 separately or alternatively the controller 331 may perform all the processes that are otherwise performed by controller 321 and controller 321 may be omitted. Therefore, when Kurono refers to operations of controller 321 or 331 it will be understood that it may be conducted by the same controller, and for mapping 331 will be used);
- determining, by the control unit (331), for the at least one assay type (measurement types) comprised in the at least one assay order, the control type to be used, and the corresponding allocation rule (quality control group) for said control type ([0006] see analyzer is configured to perform a quality control measurement corresponding to the measurement item and controller 331 programmed to set a quality control for each measurement item from a quality control group that includes at least two types of quality controls, [0008], [0020] see controller may be programmed to cause the display unit to display for each measurement item recommendation information that suggests which of the quality controls in the quality control group is preferable);
[0129] see controller 321 of measurement section 32 causes a quality control substance to be mixed with a reagent corresponding to a measurement item. Further see [0093] which describes the quality control substance (also referred to as a control sample) is a sample of which compositions are known. Therefore, the quality control substance is the control type for the measurement items.
- scheduling, by the control unit (331), an assay run comprising instructions to include the determined control type based on the determined allocation rule (quality control group) ([0034], [0048], [0129]); and
- controlling, by the control unit (331), the system (31) to perform the scheduled assay run ([0034], [0048], [0129]).
Regarding claim 18, Kurono teaches a non-transitory computer-readable storage medium having stored thereon the computer program product of claim 17 ([0123] see storage unit 322 is a ROM, RAM or hard disk, [0125] see storage unit 332 is a ROM, RAM, or hard disk).
Regarding claim 19, Kurono teaches the computer program product of claim 17. Kurono further teaches wherein the control type comprises at least one selected from a positive control type ([0093] which describes the quality control substance (also referred to as a control sample) is a sample of which compositions are known and encompasses substances prepared by extracting a predetermined component from a specimen collected from an animal, and artificially produced substances so as to be analogous to particles contained in a specimen, and is therefore a positive control type).
Please see page 1 lines 8-11 of the instant specification which describes that positive controls are controls that contain an analyte of interest and are used to check if the assay or reagents used are working as expected, where the results of a positive control is expected to be a positive result.
Regarding claim 20, Kurono teaches the computer program product of claim 17. Kurono further teaches wherein the method further comprises storing, in a memory (storage unit 322 and storage unit 332), instructions, for each assay type (measurement types), of the control type to be used when running said assay type (measurement types), and, for each control type, an allocation rule (quality control group) for the control type, wherein the allocation rule (quality control group) comprises a time rule or a run rule, and wherein ([0123] see storage unit 322 is a ROM, RAM or hard disk that has programs and data stored on it, and [0125] see storage unit 332 has program 332a for causing analysis section to perform a predetermined process):
the time rule comprises at least instructions to run the control type once in a time frame ([0139] and Figure 6C describing the test number QC (quality control) where the controller 331 counts the number of times of specimen measurement for a target measurement item, i.e., test number, and every time the test number reaches a predetermined number of times Nt the controller 331 causes a quality control measurement to be performed), and
Based on Figure 6C, the first Nt interval labeled will define a time frame, where one quality control measurement is conducted during this time interval. The quality control measurement will be a measurement with the quality control substance.
the run rule comprises instructions to run the control type:
o once for every reagent cartridge firstly used in the system ([0141], [0142], [0143] and Figure 7A describing the controller 331 estimates the number of times of specimen measurement executable in a time period Tc required for a quality control measurement, where an estimated number of times Nc is estimated on the basis of history information, and the controller 331 determines whether or not the remaining amount of current reagent has become smaller than a reagent amount that is necessary for specimen measurements to be performed the estimated number of times Nc and when the remaining amount of the current reagent has become smaller than the reagent amount necessary the controller 331 causes a quality control measurement to be performed on the basis of the reagent of a reagent container that contains a new reagent), and/or
The limitations “o once for every assay run, and/or
o once for every reagent cartridge lot firstly used in the system.” are not required due to recitation of “and/or”.
Claim(s) 5, 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kurono (US-2020/0174028-A1) in view of Bowers (US-2020/0303066-A1).
Regarding claim 5, Kurono teaches the method of claim 3. Kurono does not teach further comprising:
- determining, by the control unit, an estimated end time of the scheduled run,
- determining, by the control unit, in a lifetime determination if the estimated end time of the scheduled run lies outside of the time frame of the time rule, and
- if said lifetime determination is successful, rescheduling, by the control unit, the assay run comprising updated instructions to include the determined control type for which lifetime determination has been determined as successful.
In the analogous art of automated orchestration of biological assays, Bowers teaches an orchestration core application (Bowers; [0002], [0037]).
Specifically, Bowers teaches an orchestration core application 220 executed on an orchestration core computing device 224 that communicates with analyzer instruments 108 and pre-analytical instrument 104 (Bowers; [0040]). It is described by [0041] that the orchestration core application 220 coordinates processes and manages resources among the one or more analyzer instruments 108 and pre-analytical instrument 104 in order to achieve efficient uses of the available resources and keep the activity of those resources at or above a predetermined threshold level. [0052] describes that the orchestration application tracks the biological/chemical/mechanical lifetime of consumable inventory and samples, such as assay controls and reagents, where exceeding limits of useful lifetime of samples and consumables may adversely affect the integrity of the assay results, and that the orchestration core application 220 may prioritize samples in such a way that completion of assay protocol steps prior to a reagent or sample exceeding its lifetime is ensured.
Figure 10 shows a block diagram of exemplary method 1000 of determining an order of performance of assays or assay steps for samples to maximize performance, where [0110] describes that in block 1044 determines an order of performance to maximize a performance metric, where the performance metric may be based on one or more factors such as the time duration for performing all the assays, the energy used for performing all the assays, and quality or accuracy of assay results.
[0114] and [0117] describes Figure 12 for an exemplary method 1200 of determining an updated order of performance of assays or assay steps after receiving a new assay instruction.
[0123] further describes that the orchestration core application 220 can plan to ensure completion of all assays or assay steps once started and before patient samples expire.
It would have been obvious to one skilled in the art to modify the process of the system of Kurono such that it includes the steps to ensure that sample and reagents stable and do not expire as taught by Bowers because Bowers teaches that if the lifetime of consumables and samples is exceeded it may adversely affect the integrity of assay results (Bowers; [0052]).
One skilled in the art would find it obvious that maximizing a performance metric (which may be the time duration for performing all the assays) described in [0110] of Bowers would require the process of the system to determine an estimated end time for an assay run. Further, description of tracking the biological/chemical/mechanical lifetime of consumable inventory and samples described in [0052] of Bowers requires the process of the system to conduct a lifetime determination. Description of determining an updated order of performance assays or assay steps after receiving a new assay instruction and planning to ensure completion of all assays or assay steps once started and before patient samples expire described by [0114], [0117], and [0123] of Bowers would require the process of the system to determine if the run time of the scheduled run is within the lifetime of the consumable inventory and samples, and reschedule the assay if necessary.
Regarding claim 13, Kurono teaches the system of claim 11. Kurono does not teach wherein the control unit is further configured to:
- determine an estimated end time of the scheduled run,
- determine in a lifetime determination if the estimated end time of the scheduled run lies outside of the time frame of the time rule, and
- if said lifetime determination is successful, to reschedule the assay run comprising updated instructions to include the determined control type for which lifetime determination has been determined as successful.
In the analogous art of automated orchestration of biological assays, Bowers teaches an orchestration core application (Bowers; [0002], [0037]).
Specifically, Bowers teaches an orchestration core application 220 executed on an orchestration core computing device 224 that communicates with analyzer instruments 108 and pre-analytical instrument 104 (Bowers; [0040]). It is described by [0041] that the orchestration core application 220 coordinates processes and manages resources among the one or more analyzer instruments 108 and pre-analytical instrument 104 in order to achieve efficient uses of the available resources and keep the activity of those resources at or above a predetermined threshold level. [0052] describes that the orchestration application tracks the biological/chemical/mechanical lifetime of consumable inventory and samples, such as assay controls and reagents, where exceeding limits of useful lifetime of samples and consumables may adversely affect the integrity of the assay results, and that the orchestration core application 220 may prioritize samples in such a way that completion of assay protocol steps prior to a reagent or sample exceeding its lifetime is ensured.
Figure 10 shows a block diagram of exemplary method 1000 of determining an order of performance of assays or assay steps for samples to maximize performance, where [0110] describes that in block 1044 determines an order of performance to maximize a performance metric, where the performance metric may be based on one or more factors such as the time duration for performing all the assays, the energy used for performing all the assays, and quality or accuracy of assay results.
[0114] and [0117] describes Figure 12 for an exemplary method 1200 of determining an updated order of performance of assays or assay steps after receiving a new assay instruction.
[0123] further describes that the orchestration core application 220 can plan to ensure completion of all assays or assay steps once started and before patient samples expire.
It would have been obvious to one skilled in the art to modify the controller of Kurono such that process of the system includes the steps to ensure that sample and reagents stable and do not expire as taught by Bowers because Bowers teaches that if the lifetime of consumables and samples is exceeded it may adversely affect the integrity of assay results (Bowers; [0052]).
One skilled in the art would find it obvious that maximizing a performance metric (which may be the time duration for performing all the assays) described in [0110] of Bowers would require the process of the system to determine an estimated end time for an assay run. Further, description of tracking the biological/chemical/mechanical lifetime of consumable inventory and samples described in [0052] of Bowers requires the process of the system to conduct a lifetime determination. Description of determining an updated order of performance assays or assay steps after receiving a new assay instruction and planning to ensure completion of all assays or assay steps once started and before patient samples expire described by [0114], [0117], and [0123] of Bowers would require the process of the system to determine if the run time of the scheduled run is within the lifetime of the consumable inventory and samples, and reschedule the assay if necessary.
Other References Cited
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Tanoshima (US-2007/0183926-A1) teaches a sample measuring apparatus comprising a sample setting unit for setting a sample specimen and a quality control sample, where the quality control sample includes both a positive control and negative control (Tanoshima; abstract, [0055], [0058]).
Conclusion
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/S.Y.L./Examiner, Art Unit 1796
/MELVIN C. MAYES/Supervisory Patent Examiner, Art Unit 1759
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