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.
Claim(s) 1-4 and 10-14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent Application Publication 2005/0192770 to Parvin et al. (Parvin).
Claims 1
With regard to a processor; Parvin teaches a central processing unit (Fig. 1, central processing unit 50; par. 71).
With regard to measurement hardware in communication with the processor and configured to measure properties of a specimen; Parvin teaches measurement hardware that is connected to the CPU (Fig. 1, biometric QC module measurement hardware 40, CPU 50; pars. 12, 71).
With regard to a memory device having stored thereon executable instructions that, when executed by the processor, cause the clinical diagnostic analyzer to perform operations; Parvin teaches a hard drive that stores instructions (Fig. 1, hard drive 52; par. 72).
With regard to loading a specimen from a new lot of quality control material into the measurement hardware; Parvin teaches reagent lot changes and regular calibration with reagent lot numbers (pars. 40, 50, 318-320).
With regard to analyzing the specimen at periodic intervals to obtain a data value corresponding to an attribute of the specimen; Parvin teaches regular quality control (pars. 23, 338, 339).
With regard to obtaining and storing at least ten consecutively obtained data values corresponding to analyses performed at consecutive periodic intervals as part of a defined crossover study for transitioning from an old lot of quality control material to the new lot of quality control material; Parvin teaches collecting a minimum of 91 days worth of data and maintaining individual QC data points and patient test results for a period of two years (pars. 82-84, 338-341). The QC data points are maintained for a change in reagent information including lot changes (pars. 39, 40, 478-480).
With regard to calculating a mean for the new lot of quality control material based on the stored data values; Parvin teaches calculating the mean (pars. 154, 155, 356).
With regard to calculating a standard deviation based on the calculated mean and a coefficient of variation of an old lot of quality control material; Parvin teaches calculating the standard deviation using the mean and a coefficient of variation (pars. 762-765).
With regard to storing the calculated mean and the calculated standard deviation in the memory device as crossover parameters establishing statistical control for the new lot of quality control material for use in subsequent analyses; Parvin teaches that data is not discarded (pars. 363, 369; pars. 39, 40, 478-480).
With regard to automatically transitioning the clinical diagnostic analyzer from the crossover study to patient specimen testing based on completion of the crossover study; Parvin teaches that patient testing is halted when limits are exceeded, suggesting that quality control data has to be updated before continuing patient testing (pars. 81-86).
With regard to loading and testing an analyte from a patient specimen using the stored mean and standard deviation; Parvin teaches testing patient data using the established limits (pars. 50, 352-362).
Claim 10
With regard to loading a specimen from a new lot of quality control material into the measurement hardware; Parvin teaches reagent lot changes and regular calibration with reagent lot numbers (pars. 40, 50, 318-320).
With regard to analyzing the specimen at periodic intervals to obtain a data value corresponding to an attribute of the specimen; Parvin teaches regular quality control (pars. 23, 338, 339).
With regard to obtaining and storing at least ten consecutively obtained data values corresponding to analyses performed at consecutive periodic intervals; Parvin teaches collecting a minimum of 91 days worth of data and maintaining individual QC data points and patient test results for a period of two years (pars. 82-84, 338-341).
With regard to calculating a mean for the new lot of quality control material based on the stored data values; Parvin teaches calculating the mean (pars. 154, 155, 356).
With regard to calculating a standard deviation based on the calculated mean and a coefficient of variation of an old lot of quality control material; Parvin teaches calculating the standard deviation using the mean and a coefficient of variation (pars. 762-765).
With regard to storing the calculated mean and the calculated standard deviation in the memory device as crossover parameters establishing statistical control for the new lot of quality control material for use in subsequent analyses; Parvin teaches that data is not discarded (pars. 363, 369).
With regard to loading and testing an analyte from a patient specimen using the stored mean and standard deviation; Parvin teaches testing patient data using the established limits (pars. 50, 352-362).
Claims 2 and 11
Parvin teaches calculating a thirty-day rolling average of the calculated mean; and storing the thirty-day rolling average of the calculated mean in the memory device for use in subsequent analyses (par. 765).
Claims 3 and 12
Parvin teaches comparing the calculated thirty-day rolling average to a predetermined confidence interval (pars. 762-768); and
alerting a user if the calculated thirty-day exceeds an allowable variation based on the confidence interval (pars. 779 provides normalized plot, 583).
Claim 4
Parvin teaches an input panel and display operable to present information and data from the processor to a user and to accept input and selections from a user (pars. 68, 71, 72).
Claim 13
Parvin teaches a plurality of clinical diagnostic analyzers in communication over a network (par. 70).
Claim 14
Parvin teaches that obtaining and storing at least ten consecutively obtained data values corresponding to analyses performed at consecutive periodic intervals comprises obtaining and storing obtained data values from each of the plurality of clinical diagnostic analyzers (pars. 12, 82, 338).
Claim Rejections - 35 USC § 103
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.
Claim(s) 5-9 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Parvin in view of US Patent Application Publication 2005/0037502 to Miller (Miller).
Claims 5 and 15
Parvin teaches all the limitations of claim 4 upon which claim 5 depends and claim 10 upon which claim 15 depends. Parvin does not teach presenting a prompt on the input panel and display to a user to load an analyte into the measurement hardware; and accept an input from the user indicating that the analyte has been loaded. Miller teaches prompting an operator to load QC, and displaying a popup to confirm an action (pars. 90, 160). It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the quality control process, as taught by Parvin, to include prompting an user to load QC and displaying a popup, as taught by Miller, because then proper quality control procedures would have been ensured (Miller, par. 9).
Claim 6
With regard to a server comprising a processor, a memory and a database; Parvin teaches a server with a database (Fig. 1, server 60; par. 70).
With regard to a plurality of clinical diagnostic analyzers in communication with the server; Parvin teaches multiple client systems that connect to the server (Fig. 1, biometric QC module measurement hardware 40, connected to CPU 50; pars. 12, 70, 71).
With regard to a processor; Parvin teaches a central processing unit (Fig. 1, central processing unit 50; par. 71).
With regard to measurement hardware in communication with the processor and configured to measure properties of a specimen; Parvin teaches measurement hardware that is connected to the CPU (Fig. 1, biometric QC module measurement hardware 40, CPU 50; pars. 12, 71).
With regard to a memory device having stored thereon executable instructions that, when executed by the processor, cause the clinical diagnostic analyzer to perform operations; Parvin teaches a hard drive that stores instructions (Fig. 1, hard drive 52; par. 72).
With regard to loading a specimen from a new lot of quality control material into the measurement hardware; Parvin teaches reagent lot changes and regular calibration with reagent lot numbers (pars. 40, 50, 318-320).
With regard to wherein the memory of the server has stored thereon executable instructions that, when executed by the server processor, cause the server to perform operations; Parvin teaches a hard drive that stores instructions (Fig. 1, hard drive 52; par. 72).
With regard to receiving, from the plurality of clinical diagnostic analyzers, stored data values corresponding to analyses performed by the plurality of clinical diagnostic analyzers on the specimen from the new lot of quality control material; Parvin teaches that the server executes QC module code and provides results (par. 70; 23, 338, 339).
With regard to calculating a mean for the new lot of quality control material based on the received values; Parvin teaches calculating the mean (pars. 154, 155, 356).
With regard to calculating a standard deviation based on the calculated mean and a coefficient of variation of an old lot of quality control material; Parvin teaches calculating the standard deviation using the mean and a coefficient of variation (pars. 762-765).
With regard to storing the calculated mean and the calculated standard deviation in the memory as crossover control parameters applicable across the plurality of clinical diagnostic analyzers for use in subsequent analyses; Parvin teaches that data is not discarded (pars. 363, 369).
With regard to determining, by the server, completion of the crossover study based on receipt of the stored data values; Parvin teaches that patient testing is halted when limits are exceeded, suggesting that quality control data has to be updated before continuing patient testing (pars. 81-86).
Parvin does not teach prompting a user of one or more of the plurality of clinical diagnostic analyzers to load and test an analyte from a patient specimen using the stored mean and standard deviation after determining completion of the crossover study. Miller teaches prompting an operator to load QC, and displaying a popup to confirm an action (pars. 90, 160). It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the quality control process, as taught by Parvin, to include prompting an user to load QC and displaying a popup, as taught by Miller, because then proper quality control procedures would have been ensured (Miller, par. 9).
Claim 7
Parvin teaches calculating a thirty-day rolling average of the calculated mean; and storing the thirty-day rolling average of the calculated mean in the memory, the database, or combinations thereof, for use in subsequent analyses (par. 765).
Claim 8
Parvin teaches comparing the calculated thirty-day rolling average to a predetermined confidence interval (pars. 762-768); and
alerting a user if the calculated thirty-day exceeds an allowable variation based on the confidence interval (pars. 779 provides normalized plot, 583).
Claim 9
Parvin teaches an input panel and display (pars. 68, 71, 72).
Parvin does not teach transmitting an instruction to at least one of the plurality of clinical diagnostic analyzers to present a prompt on the input panel and display to a user to load an analyte into the measurement hardware; and accept an input from the user of the at least one of the plurality of clinical diagnostic analyzers indicating that the analyte has been loaded. Miller teaches prompting an operator to load QC, and displaying a popup to confirm an action (pars. 90, 160). It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the quality control process, as taught by Parvin, to include prompting an user to load QC and displaying a popup, as taught by Miller, because then proper quality control procedures would have been ensured (Miller, par. 9).
Response to Arguments
Applicant's arguments filed 23 December 2025 have been fully considered but they are not persuasive.
Applicant states that Parvin does not disclose a defined crossover study as a discrete operational mode of a clinical diagnostic analyzer for transitioning between quality control material lots as called for in the claims (as amended) of the present application. However, Parvin teaches in paragraphs 82-84 and 338 clearly defined test parameters for data to be collected and for retaining data. Further, Parvin in paragraphs 39, 40, 478-480, demonstrates documenting reagent lot changes during quality control.
Applicant states that Parvin does not teach, suggest, or disclose any determination of any “completion” of a crossover study, nor does it teach, suggest or disclose any automatic transition of analyzer operation contingent upon any such completion. However, while QC may be continuous, patient data is tested, and QC may be performed again as needed and as reagent information changes including lot changes (par. 39, 40, 81-84).
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MANUEL L BARBEE whose telephone number is (571)272-2212. The examiner can normally be reached M-F: 9-5:30..
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/MANUEL L BARBEE/Primary Examiner, Art Unit 2857