DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1 – 18 is/are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Joseph et al. (US 2019/0285659 A1; hereinafter “Joseph”).
Regarding claim 1, Joseph throughout the publication teaches a system comprising:
at least one in-vitro diagnosis device (an analyzer module 160 comprising a reaction ring 125 which comprise a plurality of cuvettes organized across a plurality of segments. Each cuvette is designed to hold samples for spectroscopic measurements; figures 1A and 1B; paragraphs 35 and 36), which is configured to carry out a diagnostic assay, the at least one in-vitro diagnosis device configured to detect a deviation of an internal calibration/control measurement parameter from a defined standard value, or a calibration curve, and forward it to a control unit (e.g., the main controller (host computer); paragraphs 40 and 41); and
at least one control unit (e.g., the main controller (host computer); paragraphs 40 and 41), which is bidirectionally connected to the at least one in-vitro diagnosis device (e.g., photometer calibration; paragraph 54) and is configured to perform an evaluation of the deviation of an internal calibration/control measurement parameter from a defined standard value of the at least one in-vitro diagnosis device, the at least one control unit additionally accessing data from a database for the evaluation (the reference measurements are compared to measurements from a predetermined standard setup (a defined standard value), and the photometer is adjusted until the reference measurement matches the certified output of the standard setup; paragraph 54);
wherein the at least one control unit (e.g., the main controller (host computer); paragraphs 40 and 41) is configured to modify the standard value, for which a deviating internal calibration/control measurement parameter has been detected, and to transmit the modified standard value to the at least one in-vitro diagnosis device that detected the deviation to provide a consistent result value by the at least one in-vitro diagnosis device (the predetermined standard setup (a defined standard value) can be modified or changed depending on the photometer as specified by the manufacturer; paragraph 54).
Regarding claim 2, Joseph teaches the system as claimed in claim 1, wherein the internal calibration/control measurement parameter is associated with assay reagents used for carrying out the in-vitro diagnosis (e.g., a variety of different reagents can be used to allow a variety of tests to be performed by the analyzer module 160; paragraphs 35 and 53).
Regarding claim 3, Joseph teaches the system as claimed in claim 1, wherein the internal calibration/control measurement parameter is a device system component parameter (e.g., paragraphs 53 and 54).
Regarding claim 4, Joseph teaches the system as claimed in claim 1, wherein the at least one control unit is configured to perform evaluations of deviations from a defined standard value as a function of assay reagent batches used (e.g., a variety of different reagents can be used to allow a variety of tests to be performed by the analyzer module 160; paragraphs 35 and 53), the device system components, or the device type (e.g., reference measurements are compared to measurements from a predetermined standard setup depending on the standard/specified range (per wavelength) of the photometer as specified by the manufacturer; paragraphs 53 and 54).
Regarding claim 5, Joseph teaches the system as claimed in claim 1, wherein the at least one in-vitro diagnosis device is configured additionally to forward measurement data of a patient sample measured with a patient assay to the at least one control unit (e.g., clinical test information is sent to the host computer (main controller) or a remote computer for display and/or recording; paragraphs 40, 43 and 44).
Regarding claim 6, Joseph teaches the system as claimed in claim 6, wherein the at least one control unit is additionally configured to evaluate the measurement data of the patient assay with the aid of previous measurement data of patient assays, controls or calibrations (e.g., the system may be configured to allow recalibration via the process 800 at any time based on a user request; paragraphs 5, 7 – 9 and 55).
Regarding claim 7, Joseph teaches the system as claimed in claim 1, wherein the evaluation comprises a comparison of the deviations of an internal calibration/control measurement parameter and measurement data of patient assays (e.g., the system may be configured to allow recalibration via the process 800 at any time based on a user request; paragraphs 5, 7 – 9 and 55) of a multiplicity of in-vitro diagnosis devices (an analyzer module 160 comprising a reaction ring 125 which comprise a plurality of cuvettes organized across a plurality of segments. Each cuvette is designed to hold samples for spectroscopic measurements; figures 1A and 1B; paragraphs 35 and 36).
Regarding claim 8, Joseph teaches the system as claimed in claim 1, wherein the at least one control unit (e.g., the main controller (host computer); paragraphs 40 and 41) is configured to access a database containing data relating to the measurement or calibration/control measurement parameters associated with assay reagents or containing data relating to the device system component parameters or containing data relating to patient assays (e.g., clinical test information is sent to the host computer (main controller) or a remote computer for display and/or recording; paragraphs 40, 43 and 44).
Regarding claim 9, Joseph teaches the system as claimed in claim 4, wherein the standard value is modified by a correction factor determined by:
(i) an individual deviation of an in-vitro diagnosis device from a standard value (the reference measurements are compared to measurements from a predetermined standard setup (a defined standard value), and the photometer is adjusted until the reference measurement matches the certified output of the standard setup; paragraph 54),
(ii) an assay reagent batch-dependent deviation (e.g., a variety of different reagents can be used to allow a variety of tests to be performed by the analyzer module 160; paragraphs 35 and 53) of a plurality of in-vitro diagnosis devices from a standard value (the reference measurements are compared to measurements from a predetermined standard setup (a defined standard value), and the photometer is adjusted until the reference measurement matches the certified output of the standard setup; paragraph 54),
(iii) a deviation of measurement data of patient assays from previous measurement data of patient assays (the variance data or deviation of each sample measurement is compared to reference measurements and used to evaluate the quality of the analyzer system and increase the accuracy of testing results; paragraph 53),
(iv) a device type-dependent deviation of a plurality of in-vitro diagnosis devices (an analyzer module 160 comprising a reaction ring 125 which comprise a plurality of cuvettes organized across a plurality of segments. Each cuvette is designed to hold samples for spectroscopic measurements; figures 1A and 1B; paragraphs 35 and 36) from a standard value (the reference measurements are compared to measurements from a predetermined standard setup (a defined standard value), and the photometer is adjusted until the reference measurement matches the certified output of the standard setup; paragraph 54),
(v) a device system component-dependent deviation of a plurality of in-vitro diagnosis devices (an analyzer module 160 comprising a reaction ring 125 which comprise a plurality of cuvettes organized across a plurality of segments. Each cuvette is designed to hold samples for spectroscopic measurements; figures 1A and 1B; paragraphs 35 and 36) from a standard value (the reference measurements are compared to measurements from a predetermined standard setup (a defined standard value), and the photometer is adjusted until the reference measurement matches the certified output of the standard setup; paragraph 54),
(vi) a deviation of the measurement or calibration/control measurement parameters from measurement or calibration/control measurement parameters in a multiplicity of in-vitro diagnosis devices (the reference measurements are compared to measurements from a predetermined standard setup (a defined standard value), and the photometer is adjusted until the reference measurement matches the certified output of the standard setup; paragraph 54), or
(vii) a combination of a device system component-dependent deviation, an assay reagent batch-dependent deviation, or a deviation from measurement data of patient assays (e.g., clinical test information is sent to the host computer (main controller) or a remote computer for display and/or recording; paragraphs 40, 43 and 44).
Regarding claim 10, Joseph teaches the system as claimed in claim 1, wherein the at least one in-vitro diagnosis device is configured to detect the deviation of an internal calibration/control measurement parameter from a defined standard value once per hour, per 12 hours, per day (e.g., recalibration can be executed daily, hourly, etc., or repeated at a predetermined time interval set by the user or system manufacturer; paragraph 55), per 2, 3, 4, 5, 6 days, per week, per 2, 3 weeks, per month, per 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 months, per year or over the life cycle of the at least one in-vitro diagnosis device, assay reagents or a system component or a part of the life cycle, and forward it to the at least one control unit.
Regarding claim 11, Joseph teaches a method for modifying a defined standard value of an internal calibration/control measurement parameter of at least one in-vitro diagnosis device (an analyzer module 160 comprising a reaction ring 125 which comprise a plurality of cuvettes organized across a plurality of segments. Each cuvette is designed to hold samples for spectroscopic measurements; figures 1A and 1B; paragraphs 35 and 36), wherein the internal calibration/control measurement parameter measured in the in-vitro diagnosis device has a deviation from the standard value (the reference measurements are compared to measurements from a predetermined standard setup (a defined standard value), and the photometer is adjusted until the reference measurement matches the certified output of the standard setup; paragraph 54) (the variance data or deviation of each sample measurement is compared to reference measurements and used to evaluate the quality of the analyzer system and increase the accuracy of testing results; paragraph 53), comprising:
forwarding the deviation to at least one control unit (e.g., the main controller (host computer); paragraphs 40, 41, 43 and 44), evaluating the deviation in the at least one control unit (the reference measurements are compared to measurements from a predetermined standard setup (a defined standard value), and the photometer is adjusted until the reference measurement matches the certified output of the standard setup; paragraph 54), and
transmitting a standard value modified on the basis of the deviation to the at least one in-vitro diagnosis device that detected the deviation (e.g., clinical test information is sent to the host computer (main controller) or a remote computer for display and/or recording; paragraphs 40, 43 and 44).
Regarding claim 12, Joseph teaches the method as claimed in claim 11, wherein the internal calibration/control measurement parameter is associated with assay reagents used for carrying out the in-vitro diagnosis, or is a device system component parameter (e.g., a variety of different reagents can be used to allow a variety of tests to be performed by the analyzer module 160; paragraphs 35 and 53).
Regarding claim 13, Joseph teaches the method as claimed in claim 11, wherein the evaluating the deviation from a defined standard value is carried out as a function of assay reagent batches used (e.g., a variety of different reagents can be used to allow a variety of tests to be performed by the analyzer module 160; paragraphs 35 and 53), the device system components, or the device type (e.g., reference measurements are compared to measurements from a predetermined standard setup depending on the standard/specified range (per wavelength) of the photometer as specified by the manufacturer; paragraphs 53 and 54).
Regarding claim 14, Joseph teaches the method as claimed in claim 11, wherein the evaluating comprises a comparison of the deviations of an internal calibration/control measurement parameter (e.g., the system may be configured to allow recalibration via the process 800 at any time based on a user request; paragraphs 5, 7 – 9 and 55) of a multiplicity of in-vitro diagnosis devices (an analyzer module 160 comprising a reaction ring 125 which comprise a plurality of cuvettes organized across a plurality of segments. Each cuvette is designed to hold samples for spectroscopic measurements; figures 1A and 1B; paragraphs 35 and 36).
Regarding claim 15, Joseph teaches the method as claimed in claim 11, wherein the standard value is modified by a correction factor that is determined by:
(i) an individual deviation of an in-vitro diagnosis device from a standard value (the reference measurements are compared to measurements from a predetermined standard setup (a defined standard value), and the photometer is adjusted until the reference measurement matches the certified output of the standard setup; paragraph 54),
(ii) an assay reagent batch-dependent deviation (e.g., a variety of different reagents can be used to allow a variety of tests to be performed by the analyzer module 160; paragraphs 35 and 53) of a plurality of in-vitro diagnosis devices from a standard value (the reference measurements are compared to measurements from a predetermined standard setup (a defined standard value), and the photometer is adjusted until the reference measurement matches the certified output of the standard setup; paragraph 54),
(iii) a deviation of measurement data of patient assays from previous measurement data of patient assays (the variance data or deviation of each sample measurement is compared to reference measurements and used to evaluate the quality of the analyzer system and increase the accuracy of testing results; paragraph 53),
(iv) a device type-dependent deviation of a plurality of in-vitro diagnosis devices (an analyzer module 160 comprising a reaction ring 125 which comprise a plurality of cuvettes organized across a plurality of segments. Each cuvette is designed to hold samples for spectroscopic measurements; figures 1A and 1B; paragraphs 35 and 36) from a standard value (the reference measurements are compared to measurements from a predetermined standard setup (a defined standard value), and the photometer is adjusted until the reference measurement matches the certified output of the standard setup; paragraph 54),
(v) a device system component-dependent deviation of a plurality of in-vitro diagnosis devices (an analyzer module 160 comprising a reaction ring 125 which comprise a plurality of cuvettes organized across a plurality of segments. Each cuvette is designed to hold samples for spectroscopic measurements; figures 1A and 1B; paragraphs 35 and 36) from a standard value (the reference measurements are compared to measurements from a predetermined standard setup (a defined standard value), and the photometer is adjusted until the reference measurement matches the certified output of the standard setup; paragraph 54),
(vi) a deviation of the measurement or calibration/control measurement parameters from measurement or calibration/control measurement parameters in a multiplicity of in-vitro diagnosis devices (the reference measurements are compared to measurements from a predetermined standard setup (a defined standard value), and the photometer is adjusted until the reference measurement matches the certified output of the standard setup; paragraph 54), or
(vii) a combination of a device system component-dependent deviation, an assay reagent batch-dependent deviation, or a deviation from measurement data of patient assays (e.g., clinical test information is sent to the host computer (main controller) or a remote computer for display and/or recording; paragraphs 40, 43 and 44).
Regarding claim 16, Joseph teaches the method as claimed in claim 11, further comprising forwarding measurement data of a patient assay to the at least one control unit (e.g., clinical test information is sent to the host computer (main controller) or a remote computer for display and/or recording; paragraphs 40, 43 and 44).
Regarding claim 17, Joseph teaches the method as claimed in claim 11, further comprising detecting and forwarding periodically to the at least one control unit (e.g., clinical test information is sent to the host computer (main controller) or a remote computer for display and/or recording; paragraphs 40, 43 and 44) the deviation from initial measurements of the internal calibration/control measurement parameter or the deviation of the internal calibration/control measurement parameter from a defined standard value (e.g., the system may be configured to allow recalibration via the process 800 at any time based on a user request; paragraphs 5, 7 – 9 and 55).
Regarding claim 18, Joseph teaches the method as claimed in claim 17, wherein the forwarding periodically occurs once per hour; per 12 hours; per day (e.g., recalibration can be executed daily, hourly, etc., or repeated at a predetermined time interval set by the user or system manufacturer; paragraph 55); per 2, 3, 4, 5, 6 days; per week; per 2, 3 weeks; per month; per 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 months; per year; or over the life cycle of the at least one in-vitro diagnosis device, assay reagents, or a system component or a part of the life cycle.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Orihashi et al. (US 8,600,689 B2) teach an automatic analyzer that utilizes quality control sample measurement data for measurement calibration. Liebfritz (US 9,903,932 B2) teaches a measuring system, calibration device and measuring method with uncertainty analysis.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN J. SINES whose telephone number is (571)272-1263. The examiner can normally be reached 9 AM-5 PM EST M-F.
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BRIAN J. SINES
Primary Patent Examiner
Art Unit 1796
/BRIAN J. SINES/Primary Examiner, Art Unit 1796