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 .
DETAILED ACTION
Claims 1-16 are Rejected under 35 USC § 103 Rejection.
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.
Claims 1-6, and 11-15 are rejected under 35 U.S.C. 103 as being unpatentable over Kil et al., (US Pub.20200234937A1), hereinafter Kil in view of Kitano (CN2015800830149-A), hereinafter Kitano.
Regarding Claim 1, Kil discloses a system for detecting different acquisition methods used during sample analysis (para 9-11), comprising:
a memory device (MA databases 4002 in memory locations, see para [0112] and Fig. 40);
an analytical instrument (mass spectrometer) that produces intensity versus time measurements or intensity versus mass-to-charge ratio (m/z) measurements for each acquisition of n two or more sample acquisitions using m one or more instrument parameter values for each acquisition of n acquisitions and, for each acquisition of the n acquisitions, stores a data file that includes measurements for the acquisition and m one or more instrument parameter values applied to the analytical instrument for the acquisition in the memory device, producing n data files in the memory device (multiple mass spectrometry data sets in para [0080] and “mass spectrometry parameters” in para [0015] and [0079] , where selected, can be configured to display a description of the molecule of interest (the MS data set(s) may include mass-to-charge ratios (m/z) peaks and peak intensities associated with a molecule of interest see para [0112]) and mass spectrometry parameters, such as shown in FIG. 38B);
a display device (para [0011], where user interface including the selection and display of components); and
a processor that, during data analysis (see para [0113], where one or more processors 4006 of the apparatus 4000),
(a) retrieves a first data file of the n data files for a first acquisition from the memory device (para [0080], where FIGS. 38N-38R illustrate an exemplary user interface process for generating one or more pivot reports from multiple projects. The multiple mass spectrometry data sets can be received as a single file or multiple files),
(b) retrieves a next data file of the n data files of a next acquisition from the memory device (para [0080], where FIGS. 38N-38R illustrate an exemplary user interface process for generating one or more pivot reports from multiple projects. The multiple mass spectrometry data sets can be received as a single file or multiple files)
(d) if any corresponding parameter values differ between the first data file and the next data file, a notification of an instrument parameter difference corresponding to a name of the next data file (Fig. 38 m (table tab) and 38 Q, (new fields appear in flat table)). Specifically, see Fig. 38Q shows a "Flat Table Input Tab" displayed to a user, wherein data associated with multiple mass spectrometry data sets, from multiple projects, are shown in a table. Two arrows indicate "New fields appear in the flat table", wherein these new fields indicate which project the data is associated with, e.g. new fields "flavor" and "lot" (see par. [80], states that “multiple mass spectrometry data sets can be received as a single file or multiple files. …The concatenated data can then be used to generate one or more pivot tables with one or more new fields indicating which project the data is associated with, such as shown in FIG. 38Q (e.g., new fields “flavor” and “lot”).”, Par.[ 90] states that "the multiple projects may be associated with different temperatures, days and/or lots". Temperature is a parameter cited in the present description (par. 90). Therefore, when creating the "Flat Table Input Tab" view of Fig. 38Q, the processor necessarily retrieves each data file and, for each data file, displays a notification of the instrument temperature corresponding to a name of each data file. In other words, in the computer-generated listing of Fig. 38Q, the user is notified of the differences of instrument parameter values in the "New fields" column. See para [80], where pivot tables as shown in Fig. 38Q (e.g., new fields “flavor and “lot”)…including data associated with all of the different projects or report including a subset of data associated with a subset of the different projects.
On the other hand, Fig. 38M also shows a "Flat Table Input Tab" displayed to a user in the form of a matrix. It is apparent that each row corresponds to a data file. The screenshot on Fig. 38M does not allow to read the content of the matrix and of the columns. However, the same paragraph [79] referring to the screenshots of Fig. 38B to 38M mention mass spectrometry parameters.
Kil does not disclose: (c) compares the m corresponding parameter values of the first data file and the next data file; and [in (d)] displays a notification of values differ between the first data file and the next data file on the display device.
Kitano discloses (c) compares the m corresponding parameter values of the first data file and the next data file (page 6, lines 31-35, where data files A, B are stored as the data of the measurement result obtained by measurement for the same sample and data as a quantitative result calculated based on the measurement results. FIG. 2, FIG. 3 to explain the two data files A, B are stored in the measurement data storing part 31 under the state based on the measurement result of the two data files or quantitative result of the comparison analysis operation; page 7, lines 6-11, where analysis of interest in the presence of the desired comparison is based on two data files A measurement results or quantitation result of compound B under the condition that the analyst for example on a screen a quantitative table by using a pointing device to click operation to select the compound of interest name (step S5).)
Therefore, it would have been obvious to one of ordinary skill in the art at the time the applicants' invention was made to compare the first and second files, as taught by Kitano, with the files of Kil, in order to improves precision, relevance, and speed of analysis.
Kil discloses displaying a report view component of the user interface (claim 2)
Therefore, in addition to the different temperatures (an instrument parameter difference) as explained above in relation to Fig. 38Q, on different files and names, it would have been obvious to one of ordinary skill in the art at the time the applicants' invention was made to set one or more columns in this view so as to display a notification relating to one or more mass spectrometry parameters in order to more easily identify error detection and quality control.
Regarding Claim 14 is analyzed and rejected as discussed with respect to claim 1. Additionally, Kil discloses in Claim 14 processor (para [14], where a non-transitory computer-readable medium with instructions stored thereon, that when executed by a processor).
Regarding Claim 15 is analyzed and rejected as discussed with respect to claim 1. Additionally, Kil discloses in Claim 15 comprising a computer program product, comprising a non-transitory tangible computer- readable storage medium whose contents include a program with instructions being executed on a processor (para [14], where a non-transitory computer-readable medium with instructions stored thereon, that when executed by a processor); providing a system, wherein the system comprises one or more distinct software modules, and wherein the distinct software modules comprise a control module and an analysis module (Fig. 2A, para [19], where FIG. 2B shows additional detail on the report modules from the overview of FIG. 2A);
control modules, analysis module (para [0114], where executed by the processor causes the processor to control perform any of the steps, including but not limited to: displaying, communicating with the user, analyzing, modifying parameters (including timing, frequency, intensity, etc.), determining, alerting, or the like, e.g., processor comprising control and analyzing units).
Regarding Claim 2, Kil and Kitano disclose the system of claim 1, wherein the notification displayed next to the name of the next data file on the display device, as recited in claim 1, and additionally, Kil discloses notification is an icon or color (FIG. 38Q (e.g., new fields “flavor” and “lot”).
Regarding Claim 3, Kil and Kitano disclose the system of claim 2, wherein Kil further discloses the processor further detects a selection or mouse over of the icon or color and further displays a pop-up window with the differing corresponding parameter values of the next data file (Fig. 38R, see new “factors” are available to report on); (para [11], where controlling the pivot table engine, including the selection and display of components (including the pre- and/or post-pivot metadata) may be manipulated, in real time, by the user, who may adjust the resulting pivot table and other reports (e.g., graphical output). This is illustrated in the figures (FIGS. 2A-38U), e.g., adjust the pivot table and other report is equal to the differing parameters in pivot table and other report). Graphical user interfaces for analytical instruments.
Regarding Claim 4, Kil and Kitano disclose the system of claim 1, wherein Kil further discloses the notification is a list of the differing corresponding parameter values of the next data file displayed on the display device in a table of m rows representing the m one or more instrument parameter values and n columns representing the n data files and wherein the list of the differing corresponding parameter values of the next data file are displayed in a column representing the next data file (Fig. 38 M and 38Q display a table with n rows of data files and m columns of parameters, on Fig. 38 Q, where represents additionally appearing new fields (2 column with new parameters “flavor” and “lot”), para [80], where multiple mass spectrometry data sets can be received as a single file or multiple files. In some cases, the multiple mass spectrometry data sets are concatenated into a single flat file… the concatenated data can then be used to generate one or more pivot tables with one or more new fields indicating which project the data is associated with, such as shown in FIG. 38Q (e.g., new fields “flavor” and “lot”).. e.g., next data file with differing corresponding parameters).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the applicants' invention was made to provide variant to transpose the rows and columns of the matrix table.
Regarding Claim 5, Kil and Kitano disclose the system of claim 4, wherein Kil further discloses the processor further displays in a column of the table representing the first data file each parameter value of the first data file corresponding to each of the differing corresponding parameter values of the next data file (see Fig. 38Q, new fields appear in flat table).
Regarding Claim 6, Kil and Kitano disclose the system of claim 4, wherein Kil further discloses the processor further displays in a column of the table representing the first data file each parameter value of the first data file (para [13], where a table window and a spectrum window, the table window comprising a table of values comprising a plurality of mass-to-charge ratio values associated with the molecule of interest).
Regarding Claim 11, Kil and Kitano disclose the system of claim 1, wherein Kil further discloses the analytical instrument comprises a mass spectrometer(para [66], where the MS data is collected by a tandem mass spectrometer).
Regarding Claim 12, Kil and Kitano disclose the system of claim 1, wherein Kil further discloses the analytical instrument comprises a chromatography device(para [64], where methods suitable for use in conjunction with the methods disclosed herein include, but are not limited to liquid chromatography (LC), gas chromatography, ion mobility, gel electrophoresis and capillary electrophoresis).
Regarding Claim 13, Kil and Kitano disclose the system of claim 1, wherein Kil further discloses the analytical instrument comprises a capillary electrophoresis (CE) device (para [64], where methods suitable for use in conjunction with the methods disclosed herein include, but are not limited to liquid chromatography (LC), gas chromatography, ion mobility, gel electrophoresis and capillary electrophoresis).
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 7 is rejected under 35 U.S.C. 103 as being unpatentable over Kil in view of Kitano, as applied above and further in view of Asai et al., (US Pub. 20200192324A1), hereinafter Asai.
Regarding Claim 7, Kil and Kitano disclose the system of claim 1, wherein the processor further steps (b)-(d) to detect differences among all of the n acquisitions, as recited in claim 1.
Kil and Kitano do not disclose repeats steps n-2 more times.
Asai discloses repeats steps (para [0271], where parameter file 1 (Parameter 1) to parameter file 11 (Parameter 11) of the repeater apparatus 1(2) are compared with the corresponding parameter file of the master apparatus 1(0) and further in para [0273], where ratios (“matching ratio”) may be displayed to be distinguished from each other on the actual screen; para [0276],[0292], where a ratio at which the comparison result is abnormal (a hatching pattern rising to the left in the figure) are displayed with a bar graph in order from the left).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the applicants' invention was made to use the repeater apparatus, as taught by Asai in specific times into Kil and further into Kitano in order to more accurately detect the abnormal data.
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Kil in view of Kitano, as applied above and further in view of Kitaoka (JP2008157671), hereinafter Kitaoka.
Regarding Claim 8, Kil and Kitano disclose the system of claim 1, Kil discloses wherein the processor further, before step (a), retrieves a list of l known one or more [parameters] for the analytical instrument from the memory device; compares any corresponding parameter values that differ between the first data file and the next data file to the list, and in step (d) if any corresponding parameter values differ between the first data file and the next data file, displays a notification of an instrument parameter difference corresponding to a name of the next data file on the display device, as recited in claim 1.
Kil and Kitano do not disclose acceptable instrument parameter value ranges for the analytical instrument between steps (c) and (d); parameter values do not have a corresponding value range on the list or either of the differing values are outside of a corresponding value range on the list.
Kitaoka discloses acceptable instrument parameter value ranges (page 5, lines 49-51, where mass deviation amount of the mass spectrum is estimated as
follows, and when the deviation amount exceeds the allowable range (usually a range determined by the mass accuracy defined in the specification of the device), Notification is performed; page 5, lines 22-25, where abnormality determination unit 23 determines the estimated amount of deviation of the mass axis, and if the amount of deviation exceeds the allowable range, the notification unit (corresponding to the notification unit in the present invention) 25 alerts the user. The alerting | reporting part 25 shall perform alerting by the sound of a display or a buzzer sound, for example); parameter values do not have a corresponding value range on the list or either of the differing values are outside of a corresponding value range on the list (page 5, lines 22-25, abnormality determination unit 23 determines the estimated amount of deviation of the mass axis, and if the amount of deviation exceeds the allowable range, the notification unit (corresponding to the notification unit in the present invention) 25 alerts the user. The alerting | reporting part 25 shall perform alerting by the sound of a display or a buzzer sound, for example).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the applicants' invention was made to provide amount of deviation exceeds the allowable range, as taught by Kitaoka into list of parameters of Kil and further in view of Kitano in order to more accurately detect the abnormal measured data.
Regarding Claim 9, Kil and Kitano disclose the system of claim 8, further Kil discloses wherein the list can include a range for a parameter that indicates that any parameter value is acceptable for the parameter (para [78], where choose a range of data displayed in the inspection view component).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Kil in view of Kitano, as applied above and further in view of Kitaoka and Asai.
Regarding Claim 10, Kil and Kitano and Kitaoka disclose the system of claim 8, wherein step (b), step (c), the step between steps (c) and (d), and step (d) to detect differences among all of the n acquisitions.
Kil and Kitano and Kitaoka do not disclose the processor further repeats step n-2 more times.
Asai discloses repeats steps (para [0271], where parameter file 1 (Parameter 1) to parameter file 11 (Parameter 11) of the repeater apparatus 1(2) are compared with the corresponding parameter file of the master apparatus 1(0) and further in para [0273], where ratios (“matching ratio”) may be displayed to be distinguished from each other on the actual screen; para [0276], [0292], where a ratio at which the comparison result is abnormal (a hatching pattern rising to the left in the figure) are displayed with a bar graph in order from the left).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the applicants' invention was made to use the repeater apparatus, as taught by Asai into specific times and into specific steps b), c) and c) and d) and step d) as disclose by Kil and further in combination of Kitano and Kitaoka in order to more accurately detect the abnormal data.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KALERIA KNOX whose telephone number is (571)270-5971. The examiner can normally be reached M-F 8am-5pm.
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/KALERIA KNOX/
Examiner, Art Unit 2857
/ANDREW SCHECHTER/Supervisory Patent Examiner, Art Unit 2857
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