DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Status of Claims
The claim set received 27 March 2026 has been entered into the application.
Claims 1-31 are cancelled.
Claims 32-60 are pending.
Priority
This Application is a continuation of Patent Application 15/955,401 filed 17 April 2018 which is a continuation of Patent Application 14/211,565 (Now U.S Patent 9,976,175) filed 14 March 2014 which claim benefit to U.S Provisional Application 61/792,409 filed 15 March 2013.
Information Disclosure Statement
The Foreign Patent literature and NPL have been located in parent application(s) 15/955,401 and 14/211,565.
Claim Objections
The objection of claim 35-45 and 51-60 in the Office Action mailed 30 December 2025 is withdrawn in view of the arguments received 27 March 2026.
Claim Rejections - 35 USC § 112
35 USC § 112(b)
The rejection of claim 35-45, 47-49, and 51-60 under 35 U.S.C § 112(b) in the Office Action mailed 30 December 2025 is withdrawn in view of the arguments received 27 March 2026.
Claim Rejections - 35 USC § 103
The instant rejection is maintained for reason for record in the Office Action mailed 30 December 2025 and modified in view of the amendments filed 27 March 2026.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claim 32-60 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Carrick et al. (Cited in the IDS received 22 August 2023; U.S Patents No. 7,930,106; U.S Patent U.S. Patent Date: 19 April 2011).
Claim 32 recites (a) a local instrument that carries out real-time nucleic acid amplification, the local instrument comprising a temperature-controlled incubator and a detection system.
Claim 32 step (a) recites wherein the detection system is configured to measure signals indicating respective quantities of a known amount of an analyte polynucleotide and an internal calibrator polynucleotide that coamplify in a real-time nucleic acid amplification reaction carried out using the temperature-controlled incubator.
Claim 32 step (a) recites wherein the analyte polynucleotide and the internal calibrator polynucleotide are both components of an adjustment calibrator.
Claim 32 step (b) recites a processor in communication with the detection system of the local instrument.
Claim 32 step (b) recites wherein the processor is programmed with a pair of coordinates for a fixed point specifying an amount of the analyte polynucleotide and a first normalized indicia of amplification value. Claim 32 recites wherein the fixed-point was determined from a linear calibration curve fitted to pooled data that was not determined using the local instrument.
Claim 32 step (b) wherein the processor is programmed with software causing the processor to determine indicia of amplification for each of the analyte polynucleotide and the internal calibrator polynucleotide that coamplify in the real-time nucleic acid amplification reaction, and then divide one by the other to calculate a second normalized indicia of amplification value.
Claim 32 step (b) recites wherein the processor is further programmed with software causing the processor to fit a linear calibration curve to the fixed-point and a pair of coordinates specifying the known amount of the analyte polynucleotide of the adjustment calibrator and the second normalized indicia of amplification value.
Claim 32 step (b) recites wherein the processor is further programmed with software causing the processor to compare a third normalized indicia of amplification value with the linear calibration curve to determine the starting quantity of the target nucleic acid sequence in the test sample.
Carrick et al. (Carrick) disclose “the temperature-controlled incubator used to perform and analyze real-time nucleic acid amplification may be of a conventional design which can hold a plurality of reaction tubes, or reaction samples in a temperature- controlled block in standard amplification reaction tubes or in wells of a multi-well plate [disclosure, col 32 lines 8-15]. Carrick discloses “this adjustment can be accomplished by an end-user performing one, or more preferably two amplification reactions using adjustment calibrators containing known amounts of analyte polynucleotide standard and the same constant amount of internal calibrator as in the reactions used for creating the master calibration curve, determining indicia of amplification for both the analyte polynucleotide standard and internal calibrator, and then adjusting the stored master calibration curve based on these results.” [disclosure col 21 lines 35-46]. Here, the end-user is referring to the local instrument as described in the specification [0047]. Carrick discloses “the detection system is suitable for detecting optical signals from one or more fluorescent labels. The output of the detection system ( e.g., signals corresponding to those generated during the amplification reaction) can be fed to the computer for data storage and manipulation. In one embodiment, the system detects multiple different types of optical signals, such as multiple different types of fluorescent labels and has the capabilities of a microplate fluorescence reader.”[disclosure col 32 lines 10-23]. Carrick discloses “Either or both of a controller system for controlling a real-time amplification device and/or the detection system of the real-time amplification device can be coupled to an appropriately programmed computer which functions to instruct the operation of these instruments in accordance with preprogrammed or user input instructions. The computer preferably also can receive data and information from these instruments, and interpret, manipulate and report this information to the user.” [disclosure col 31 left col lines 30-41]. Carrick discloses “the temperature-controlled incubator used to perform and analyze real-time nucleic acid amplification may be of a conventional design which can hold a plurality of reaction tubes, or reaction samples in a temperature- controlled block in standard amplification reaction tubes or in wells of a multi-well plate [disclosure, col 32 lines 8-15], as in instant claim 32 (a) a local instrument that carries out real-time nucleic acid amplification, the local instrument comprising a temperature-controlled incubator and a detection system and wherein the detection system is configured to measure signals indicating respective quantities of a known amount of an analyte polynucleotide and an internal calibrator polynucleotide that coamplify in a real-time nucleic acid amplification reaction carried out using the temperature-controlled incubator.
Carrick discloses “there is a step for obtaining an adjustment calibrator that includes a predetermined quantity of the analyte polynucleotide standard and the constant starting quantity of the internal calibrator. Next, there is a step for coamplifying the internal calibrator and the analyte polynucleotide standard of the adjustment calibrator. This is followed by a step for determining for the adjustment calibrator indicia of amplification for the internal calibrator and the analyte polynucleotide standard that coamplified.” [disclosure col 2 summary of invention lines 44-53], as in instant claim 32 wherein the analyte polynucleotide and the internal calibrator polynucleotide are both components of an adjustment calibrator.
Carrick discloses “Optical signals received by the detection system are generally converted into signals which can be operated on by the processor to provide data which can be viewed by a user on a display of a user device in communication with the processor.” [disclosure col 32 lines 30-40], as in instant claim 32 (b) a processor in communication with the detection system of the local instrument.
Carrick discloses “FIG. 1 is a graphic plot showing results from a series of isothermal transcription-associated nucleic acid amplification reactions conducted and monitored on four different 50 FIG. 7 is a graph illustrating a master calibration curve for analyte polynucleotide standard as a function of the starting quantity of analyte polynucleotide standard input into nucleic acid amplification reactions. Filled diamonds (♦) indicate individual results obtained using amplification/detection instruments 2-4. The solid heavy curve fitted to the collection of data points indicates the master calibration curve. The open square (□) indicates a result obtained using a model end-user amplification/detection instrument. Data points shown on the plot indicate the indicia of amplification (i.e., TTime values measured in minutes) for the internal calibrator on the y-axis at different levels of input analyte polynucleotide standard (i.e., x-axis) for instrument 1 ( ◊ ), instrument 2 (□), instrument 3 (Δ) and instrument 4 (X).” [disclosure col 9 lines 45-56 figures 1]. Carrick discloses a collection of calibrated standards [disclosure col 9-10 lines 55-67 and lines 1-5 page 10; Figure 2A-2B]. Here, it is obvious that Carrick teaches pooled data not determined using the local instruments. Carrick discloses a curve fit procedure is applied to normalize and background-adjusted data. Carrick discloses in a preferred embodiment the linear least squared (LLS) curve fit is employed [col 29 lines 20-30]. Carrick discloses “When results of the data point(s) from the user-performed reactions are plotted on a graph illustrating the stored master calibration curve, there is expected to be some amount of difference between the user-determined time-dependent indicia of amplification and the time-dependent indicia of amplification predicted from a calculation using the equation defining the stored master calibration curve.” [disclosure col 21 lines 45-50]. Carrick discloses a collection of calibrated standards [disclosure col 9-10 lines 55-67 and lines 1-5 page 10]. Carrick discloses “This adjustment can be accomplished by an end-user performing one, or more preferably two amplification reactions using adjustment calibrators containing known amounts of analyte polynucleotide standard and the same constant amount of internal calibrator as in the reactions used for creating the master calibration curve, determining indicia of amplification for both the analyte polynucleotide standard and internal calibrator, and then adjusting the stored master calibration curve based on these results. When results of the data point(s) from the user-performed reactions are plotted on a graph illustrating the stored master calibration curve, there is expected to be some amount of difference between the user-determined time-dependent indicia of amplification and the time-dependent indicia of amplification predicted from a calculation using the equation defining the stored master calibration curve.” [col 21 lines 45-53]. Here, it is obvious the stored master calibration curve will encompass data to which the master calibration curve is calibrated because Carrick discloses “If the end-user employs a single data point obtained from a single adjustment calibrator to adjust the stored master calibration curve, then simply adjusting the stored master calibration curve in the dimension corresponding to indicia of amplification (i.e., the y-axis) will be adequate for making the adjustment which suggests using stored data points to calibrate or adjust a master calibration curve [col 21 lines 53-58]. Moreover, it is further obvious because it is known in the art that a stored "master calibration curve" in an analytical instrument or system contains the data and mathematical model derived from an initial, comprehensive calibration run using multiple standards of known concentrations. This information is then used to quantify unknown samples in subsequent runs without needing to run a full set of calibrators each time. It is further obvious that Carrick discloses a fixed point because the specification discloses “Disclosed herein is an internal calibration approach that employs results determined on an end-user's instrument in combination with a stored point (e.g., a "fixed-point") on a calibration plot. Optionally, the fixed-point can be determined on the end-user's instrument and then stored for later use on that same instrument.” [page 8 para 0011 detailed description].
As such, the stored values of master stored master calibration curve of Carrick disclose fixed-points as described by the specification, as in instant claim 32 step (b) a processor in communication with the detection system of the local instrument, wherein the processor is programmed with a pair of coordinates for a fixed-point specifying an amount of the analyte polynucleotide and a first normalized indicia of amplification value, wherein the fixed-point was determined from a linear calibration curve fitted to pooled data that was not determined using the local instrument.
Therefore, it would be obvious to one of ordinary skill in the art to utilize instruments 1-4, applied fitted curves to normalized data, results of the data points from user-performed reaction graph plotting, stored data points of the master calibration curve, and pooled data of fig. 2A-2B of Carrick with the temperature-controlled incubator and a detection system of Carrick to determine an amount of analyte in a sample. Consequently, combining the limitations of Carrick would yield a predictable method step using a pair of coordinates of a fixed-point specifying an amount of the analyte polynucleotide and normalized indicia values that can be incorporated into a calibrated system for determining the starting quantity of a target nucleic acid sequence in a sample.
Carrick discloses “In a highly preferred embodiment, equations for the independently adjusted calibration curve for internal calibrator and analyte polynucleotide standard, or numerical values calculated therefrom, are related to each other by a mathematical operation (e.g., addition, subtraction, multiplication or division).” [disclosure col 22 lines 24-29]. Carrick discloses “Preferably, when using the single-point or other adjustment method there is an additional step for relating fitted equations separately expressing indicia of amplification for analyte polynucleotide standard and internal calibrator, each as a function of the input amount of analyte polynucleotide standard. This may be accomplished, for example, by relating numerical values for (a) indicia of amplification for analyte polynucleotide standard, and (b) indicia of amplification for internal calibrator, each being determined from the adjusted master calibration curves. This may involve a mathematical operation such as multiplication, division, addition or subtraction. For example, there can be calculated the IOA(analyte)/ IOA(IC) ratio using the adjusted master calibration curve equations for analyte polynucleotide and internal calibrator at different values of input analyte polynucleotide standard. This preferably involves first calculating the values of the indicia of amplification for analyte polynucleotide standard and the indicia of amplification for internal calibrator at input analyte polynucleotide levels corresponding to the calibration standards used to create the master calibration curve, or by performing the calculation using arbitrary values of input analyte polynucleotide. The product of this operation is a collection of data points representing processed indicia of amplification that are dependent on the amount of analyte polynucleotide input into the amplification reaction. In the particular example discussed herein, the product is a collection of data points representing ratio values that are dependent on the amount of analyte polynucleotide input into the amplification reaction.” [col 22 lines 30-59], as in instant claim 32 step (b) wherein the processor is programmed with software causing the processor to determine indicia of amplification for each of the analyte polynucleotide and the internal calibrator polynucleotide that coamplify in the real-time nucleic acid amplification reaction, and then divide one by the other to calculate a second normalized indicia of amplification value. Here, although Carrick does not explicitly teach a second normalized indicia of amplification value one of ordinary skill would recognize that the calculated IOA(analyte)/ IOA(IC) ratio of Carrick can be used to calculate a second normalized indicia of amplification value by using the indicia’s of amplification and the indicia’s of internal control and subsequently dividing the indicia’s by each other. Therefore, creating a second normalized indicia of amplification value.
Carrick discloses “In accordance with the method of creating the calibration curve, the relating procedure or step preferably involves optimizing equations to fit: (1) the indicia of amplification for the amplified analyte polynucleotide standard as a function of the amount of analyte polynucleotide standard input into the reaction, and (2) the indicia of amplification for the amplified internal calibrator as a function of the amount of analyte polynucleotide standard input into the reaction. This can be accomplished by applying standard mathematical curve fitting techniques to each of the data sets to result in equations (i.e., "fitted equations") that define curves associated therewith. Thus, fitted equations for each of two different two-dimensional curves can be obtained by this procedure. In one embodiment, a single type of equation is used for describing each of the curves, with each of the two-dimensional curves being associated with a different set of numerical values for the equation coefficients.”[col 20 lines 4-20]. Carrick discloses “The result of these procedures is a collection of indicia of amplification for each of the nucleic acid calibrator and analyte polynucleotide as a function of the known starting quantity of analyte polynucleotide standard that was present in the reaction mixture before the amplification reaction was initiated.” [disclosure col 19 lines 45-52]. Carrick discloses “The result of this procedure is a collection of data points representing calculated ratios as a function of the known starting quantity of analyte polynucleotide standard that was present in the reaction mixture before the amplification reaction was initiated.” [col 26 lines 50-56]. Carrick discloses “The curves drawn in FIGS. 2A-2B represent the graphic products of fitted equations solved over a range of values for the known starting amounts of input analyte polynucleotide standard (S), referred to herein as "fitted indicia of amplification." [disclosure col 20 lines 45-52]. Carrick discloses “FIG. 5 is a graphic plot showing data points representing ratios for IOA(analyte)/IOA(IC) calculated from raw data. Also shown is a curve fitted to the collection of data points.“ [col 15 lines 33-37]. Carrick discloses “Next, there is a step for obtaining an adjustment calibrator that includes a predetermined quantity of the analyte polynucleotide standard and the constant starting quantity of the internal calibrator.” [disclosure col 2 lines 44-47], as in instant claim 32 step (b) reciting wherein the processor is further programmed with software causing the processor to fit a linear calibration curve to the fixed-point and a pair of coordinates specifying the known amount of the analyte polynucleotide of the adjustment calibrator and the second normalized indicia of amplification value. Here, one of ordinary skill in the art would recognize that the disclosed fitted graphs reflecting known starting amounts and fitted ratios and the step of obtaining an adjustment calibrator of Carrick would yield a predictable method step for fitting a linear calibration curve using fixed-points and a pair of coordinates specifying a known amount of an adjustment calibrator and fitting normalized indicia of amplification values that can be incorporated into a calibration system to determine a starting quantity of polynucleotide analyte.
With respect to claim 32 step (b) wherein the processor is further programmed with software causing the processor to compare a third normalized indicia of amplification value with the linear calibration curve to determine the starting quantity of the target nucleic acid sequence in the test sample, the claimed step is rendered obvious because Carrick discloses ratios being compared with multiple analyte of polynucleotides samples [figs 5-6 and 9-12]. Here, because Carrick teaches analyzing multiple samples and displaying the ratios (i.e., normalized indica) it would be obvious to compare three or more normalized indicia of amplification value with the linear calibration curve to determine the starting quantity of the target nucleic acid sequence in the test sample. As such, the combination of the temperature-controlled incubator and a detection system of Carrick with the displayed three or more indicia ratios of Carrick figures 5-6 and 9-12 would yield a predictable calibration system that can compare one or more indicia of amplification values with linear calibration curves to determine the starting quantities of the target nucleic acid sequence.
Dependent claims 33-60.
Carrick discloses using isothermal nucleic acid amplification reactions [Carrick, claims 11-12]. Carrick discloses “The temperature-controlled incubator used to perform and analyze real-time nucleic acid amplification may be of a conventional design which can hold a plurality of reaction tubes, or reaction samples in a temperature- controlled block in standard amplification reaction tubes or in wells of a multi-well plate.” [disclosure col 32 lines 5-14], as in claims 33 and 50. Here, is it obvious that the temperature can be held constant using a temperature controlled incubator.
With respect to claim 34, Carrick discloses real-time amplification for monitoring a product as a function of time [col. 31 lines 25-35] which reads on claim 34.
With respect to claim 35 and 60, Carrick discloses growth curve that refers to the characteristic pattern appearance of a synthetic product such as an amplicon [disclosure col 15 lines 5-10]. Additionally, using synthetic standard analyte and internal calibrators is a standard practice in industry and the art. Therefore, the teaching of Carrick reads on “synthetic transcripts” for polynucleotides and internal calibrator polynucleotide of the adjustment calibrator.
Carrick discloses “In one embodiment, the system detects multiple different types of optical signals, such as multiple different types of fluorescent labels” [col 32 lines 18-19], as in claims 36 and 52.
Carrick discloses “The detection system is preferably a multiplexed fluorimeter” [col 32 lines 21-23], as in claim 37 and 53.
Carrick discloses “The detection system is preferably a multiplexed fluorimeter containing an excitation light source [Carrick, disclosure col 32 lines 20-25], as in claim 38 and 54.
Carrick discloses “Optical signals received by the detection system are generally converted into signals which can be operated on by the processor to provide data which can be viewed by a user on a display of a user device in communication with the processor.” [disclosure col 32 lines 32-35], as in claim 39 and 55.
With respect to claims 40 and 59, the claim is render obvious because Carrick discloses “As used herein, the phrase "threshold-based indicia of amplification" refers to indicia of amplification that measure the time or cycle number when a growth curve signal crosses” [disclosure col 15 lines 43-47].
Carrick discloses algorithm can be loaded or otherwise held in a memory component of a freestanding computer [Col 31 lines 23-24]. Carrick, therefore, teaches that that the computer can be separate from the instrument and not physical linked, as in claims 41 and 56.
Carrick discloses a conventional commercially available computer system [col 32 lines 35-40] which suggests wired or wireless connection capabilities, as in claims 42 and 57.
Carrick discloses an analyzing device connected to a computer [col 31 lines 66-67; col 32 lines 1-3]. Carrick discloses a computer memory linked to the instruments and integrated with the device [col 31 lines 29-32], which reads on an integrated assembly on a single chassis, as in claim 43 and 58.
Carrick discloses stored master calibration curves [disclosure col 5 lines 15-20]. Carrick discloses using a first and second stored master calibration equation [Carrick, claim 50], as instant claims 44 and 49.
Carrick discloses “The user device may comprise a user interface or may be a conventional commercially available computer system with a keyboard and video monitor” [disclosure col 32 lines 35-40], as in instant claims 45 and 48.
Carrick discloses “The temperature-controlled incubator used to perform and analyze real-time nucleic acid amplification may be of a conventional design which can hold a plurality of reaction tubes, or reaction samples in a temperature- controlled block in standard amplification reaction tubes or in wells of a multi-well plate.” [disclosure col 32 lines 5-14]. Carrick disclose “software for executing the calibration algorithm is held in a memory component of a computer that is linked to, or that is an integral part of a device capable of monitoring the amount of an amplicon present in a reaction mixture as a function of time.” [disclosure col 31 lines 25-32], as in claims 46-47 and 51. Here is obvious that the signals of the detection system are measured as a function of time because amplification is executed as a function of time for analyzing and detecting analyte polynucleotide signals.
Response to Arguments
Applicant's arguments filed, 27 March 2026, have been fully considered but they are not persuasive. Therefore, the rejection is maintained.
The Applicant states Carrick does not disclose every element of claim 32 such as not disclosing a fixed-point system as define by the disclosure [0050]. The Applicant points to the MPEP 2111.01 IV.A for guidance [remarks, pages 9-10]. The Applicant points to Carrick [col 21 lines 2-27] and Figure 9 of the instant disclosure for further guidance. The Applicant states the fixed-point does not change with time. The Applicant points to the specification [0009 and 0066]. The Applicant states the disclosure of Carrick does not teach a system configured with a fixed-point and Carrick never teaches or suggests a processor programmed to utilize a point from a master curve without changing it [remarks, page 11]. The Applicant states Carrick does not disclose a system to utilize a fixed point as presently claimed. The Applicant point to Carrick for guidance. The Applicant states Carrick does not teach fixed-point and does not disclose or suggest a processor programmed to fit a linear calibration curve to the fixed-point and a pair of coordinates specifying the known amount of the analyte polynucleotide of the adjustment calibrator and the second normalized indicia of amplification value [remarks, pages 11-12].
In response, the argument is not persuasive because Carrick discloses the terms “optimized equations” and “fitted equation” are alternatives references containing “fixed” numerical values for coefficients as the result of an optimizing procedure [Carrick, col 16 lines 22-31]. Carrick discloses using four different instruments (i.e., system) designated using different symbols which can performed calibrating functions. Carrick discloses the produced calibration curves are used to produce a plot (i.e., plots x- and y- axis). Carrick discloses the shape of the stored master calibration curves(s) is not changed (i.e., fixed-point system) by the present adjustment procedure which is intended to be performed on a device operated by an end-user [Carrick, left col 17 lines 23-60].
Carrick discloses “This adjustment can be accomplished by an end-user performing one, or more preferably two amplification reactions using adjustment calibrators containing known amounts of analyte polynucleotide standard and the same constant amount of internal calibrator as in the reactions used for creating the master calibration curve, determining indicia of amplification for both the analyte polynucleotide standard and internal calibrator, and then adjusting the stored master calibration curve based on these results. When results of the data point(s) from the user-performed reactions are plotted on a graph illustrating the stored master calibration curve, there is expected to be some amount of difference between the user-determined time-dependent indicia of amplification and the time-dependent indicia of amplification predicted from a calculation using the equation defining the stored master calibration curve (i.e., coordinates of fixed-points for pooled data).” [col 21 lines 45-53].
Carrick discloses in a preferred embodiment the linear least squared (LLS) curve fit is employed [Carrick col 29 lines 20-30] (i.e., linear calibrating curve). Carrick discloses figure 2A the results of master calibration curves (i.e., curves representing the indicia of amplification (y-axis) against a copy level of the polynucleotide analyte contained in the collection of calibration standards (x-axis) of different standards from different sources (i.e., instrument 1, instrument 2, instrument 3, instrument 4 (i.e., curve fitted to pooled data) [col 29 lines 20-30, figure 2A].
Carrick discloses “Any equation that would be appropriate for use in curve fitting the individual indicia of amplification also would be useful for establishing an equation that defines a curve for the processed indicia of amplification.” [Carrick col 27 lines 5-11].
Here, and as outlined above, the system Carrick discloses using four different instruments (i.e., anyone can be a local or other than local instrument for performing calibrations). Here, the instruments inherently encompass processors/computer systems that can be operated by a user for producing calibration master calibrations curves using fixed-point data (i.e., using x- and y- axis points) for specifying an amount of the analyte polynucleotide and a first normalized indicia of amplification values of pooled data not using the local instrument (i.e., anyone of the four instruments) which makes obvious and reads on the limitations of claim 32 step (b) with respect to utilizing systems performing of master calibration curves for plotting fixed-point coordinates analyzed analytes that do not change.
Therefore, rejection under 35 U.S.C § 103 is maintained.
Conclusion
Claims 32-60 are rejected.
No claims are allowed.
Finality
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.
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/J.C.P./ Examiner, Art Unit 1687
/Anna Skibinsky/
Primary Examiner, AU 1635
Prosecution Insights