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
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) 1-3, 11, 14-16, 22-23, and 25 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2005/0072915 (Stults et al.).
Regarding claim 1, Stults et al. discloses as prior art a system comprising:
one or more processors; and memory storing executable instructions that, when executed by the one or more processors, cause a computing device to perform a process (“The central processing unit includes or can be coupled to a memory having an optimization algorithm for optimizing electrospray conditions of the calibration solution.” P 6) comprising:
acquiring a set of mass spectra, the acquiring the set of mass spectra comprising: directing an automated positioning system to sequentially position an ionization emitter at a plurality of positions relative to an inlet of a mass spectrometer; and directing the mass spectrometer to acquire, while the ionization emitter is positioned at each position of the plurality of positions, a mass spectrum of ions introduced into the inlet, wherein the ions introduced into the inlet include ions emitted from the ionization emitter (“The electrospray voltage, position of the microfluidic chip and/or flow rate can be adjusted as with other spray variables as needed until the expected ESI signal or ion current is achieved.” P 7);
generating, based on the set of mass spectra, an ion intensity map representing detected intensity of ions introduced into the inlet of the mass spectrometer as a function of position of the ionization emitter; and identifying, based on the ion intensity map, an optimum position for the ionization emitter (“Based on the resulting ESI signals or ion currents, selected electrospray conditions can be adjusted in order to obtain the expected ESI signal for the calibration standard.” P 7).
Regarding claim 2, Stults et al. discloses the system of claim 1, wherein the ion intensity map comprises a total ion map that indicates, for each position of the plurality of positions, a summed intensity of the ions while the ionization emitter is positioned at each respective position (“produce expected ESI signals or ion currents in the mass spectrometer for selected solutions.” Abstract, where ion current is a measure of the intensity summed over all ions).
Regarding claim 3, Stults et al. discloses the system of claim 1, wherein the ion intensity map comprises an extracted ion map that indicates, for each position of the plurality of positions, a summed intensity of a subset of the ions while the ionization emitter is positioned at each respective position (“One or more defined analytes with known m/z ratios can be therefore selected to provide expected signals for verification of a prior calibration standard or for generation of a new mass axis calibration.” P 21).
Regarding claim 11, Stults et al. discloses the system of claim 1, wherein the process further comprises directing the automated positioning system to position the ionization emitter at the optimum position (“The XYZ positioner 15 can be manually positioned to a desired location or coordinate, or it may be motorized and automatically controlled by the I/O controller.” P 20).
Regarding claim 14, Stults et al. discloses as prior art a non-transitory computer-readable medium storing instructions that, when executed, direct at least one processor a computing device for mass spectrometry to perform a process (“The central processing unit includes or can be coupled to a memory having an optimization algorithm for optimizing electrospray conditions of the calibration solution.” P 6) comprising:
acquiring a set of mass spectra, the acquiring the set of mass spectra comprising: directing an automated positioning system to sequentially position an ionization emitter at a plurality of positions relative to an inlet of a mass spectrometer; and directing the mass spectrometer to acquire, while the ionization emitter is positioned at each position of the plurality of positions, a mass spectrum of ions introduced into the inlet, wherein the ions introduced into the inlet include ions emitted from the ionization emitter (“The electrospray voltage, position of the microfluidic chip and/or flow rate can be adjusted as with other spray variables as needed until the expected ESI signal or ion current is achieved.” P 7);
generating, based on the set of mass spectra, an ion intensity map representing detected intensity of ions introduced into the inlet of the mass spectrometer as a function of position of the ionization emitter; and identifying, based on the ion intensity map, an optimum position for the ionization emitter (“Based on the resulting ESI signals or ion currents, selected electrospray conditions can be adjusted in order to obtain the expected ESI signal for the calibration standard.” P 7).
Regarding claim 15, Stults et al. discloses the computer-readable medium of claim 14, wherein the ion intensity map comprises a total ion map that indicates, for each position of the plurality of positions, a summed intensity of the ions while the ionization emitter is positioned at each respective position (“produce expected ESI signals or ion currents in the mass spectrometer for selected solutions.” Abstract, where ion current is a measure of the intensity summed over all ions).
Regarding claim 16, Stults et al. discloses the computer-readable medium of claim 14, wherein the ion intensity map comprises an extracted ion map that indicates, for each position of the plurality of positions, a summed intensity of a subset of the ions while the ionization emitter is positioned at each respective position (“One or more defined analytes with known m/z ratios can be therefore selected to provide expected signals for verification of a prior calibration standard or for generation of a new mass axis calibration.” P 21).
Regarding claim 22, Stults et al. discloses as prior art a system comprising:
one or more processors; and memory storing executable instructions that, when executed by the one or more processors, cause a computing device to perform a process (“The central processing unit includes or can be coupled to a memory having an optimization algorithm for optimizing electrospray conditions of the calibration solution.” P 6) comprising:
acquiring a set of mass spectra, the acquiring the set of mass spectra comprising: directing an automated positioning system to sequentially position an ionization emitter at a plurality of positions relative to an inlet of a mass spectrometer; and directing the mass spectrometer to acquire, while the ionization emitter is positioned at each position of the plurality of positions, a mass spectrum of ions introduced into the inlet, wherein the ions introduced into the inlet include ions emitted from the ionization emitter (“The electrospray voltage, position of the microfluidic chip and/or flow rate can be adjusted as with other spray variables as needed until the expected ESI signal or ion current is achieved.” P 7);
generating, based on the set of mass spectra, an ion signal quality map representing detected a figure of merit of signals corresponding to ions introduced into the inlet of the mass spectrometer as a function of position of the ionization emitter; identifying, based on the ion intensity map, an optimum position for the ionization emitter; and directing the automated positioning system to position the ionization emitter at the optimum position (“Based on the resulting ESI signals or ion currents, selected electrospray conditions can be adjusted in order to obtain the expected ESI signal for the calibration standard.” P 7).
Regarding claim 23, Stults et al. discloses the system of claim 22, wherein the figure of merit comprises signal-to-noise ratio (SNR) and the ion signal quality map comprises an SNR map (“Optimal spray conditions can be also characterized with the formation of a stable Taylor cone and minimal or reduced background signal from a selected solvent that is used with the analyte.” P 18).
Regarding claim 25, Stults et al. discloses the system of claim 22, wherein the figure of merit comprises a measure of signal stability and the ion signal quality map quality comprises a signal stability map (“This process may be monitored by observing one or more optimal electrospray characteristics such as a constant electrospray current,” P 27).
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) 4-8, 10, 12, 17-21, and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2005/0072915 (Stults et al.).
Regarding claims 4 & 17, Stults et al. discloses the claimed invention except for the subset of ions comprising a set of the ions corresponding to the most intense signals. It would have been obvious to a person having ordinary skill in the art at the time the application was filed to choose the expected ions with the most intense signals because this would produce the strongest signal and therefore require less calibration time to acquire the necessary data.
Regarding claims 5 & 18, Stults et al. discloses the claimed invention except for the subset of ions comprising only ions having an m/z value less than a threshold m/z value. It would have been obvious to a person having ordinary skill in the art at the time the application was filed to choose ions having an m/z value less than a threshold m/z value so that larger interference ions could be eliminated.
Regarding claims 6 & 19, Stults et al. discloses the claimed invention except for the subset of ions comprising only solvent ions. It would have been obvious to a person having ordinary skill in the art at the time the application was filed to substitute a subset of expected solvent ions for the subset of expected analyte ions because this would allow for calibration to be done during analysis using only an unknown solution and known solvents without need for a calibrant solution without known analyte ions.
Regarding claims 7 & 20, Stults et al. discloses the claimed invention except for classifying a selected ion introduced into the inlet as a contaminant ion; and the subset of ions excludes the ion classified as a contaminant ion. Classifying ions as contaminants based on m/z is common in the art, and it would have been obvious to a person having ordinary skill in the art at the time the application was filed to modify the system of Stults to classify ions as contaminant and exclude those ions because this accomplishes two of the goals of calibration as stated by Stults – increasing analyte ions (not contaminant) and reducing background (contaminant) ions.
Regarding claim 8, Stults et al. discloses the system of claim 7, wherein the classifying the selected ion as a contaminant ion comprises: generating, based on the set of mass spectra, an extracted ion map for the selected ion; and classifying the selected ion based on the extracted ion map and a reference ion map (standard method of classifying ions as contaminant or analyte/solvent).
Regarding claims 10 & 21, Stults et al. discloses the claimed invention except for classifying one or more of the ions introduced into the inlet as proxy ions; and the subset of ions comprises only the one or more ions classified as proxy ions. It would have been obvious to a person having ordinary skill in the art at the time the application was filed to substitute a subset of proxy ions for the subset of analyte ions because the proxy ions may provide a stronger signal.
Regarding claim 12, Stults et al. discloses the system of claim 1, wherein: the plurality of positions relative to the inlet are located along a linear search path (“For example, the position of the emitter can be changed and moved closer or further away from a mass spectrometer.” (P 8). Stults does not disclose whether a sheath gas flows coaxially around the ions emitted from the ionization emitter. Electrospray ionization devices with a sheath gas flow coaxially around the ions is known in the art, and it would have been obvious to a person having ordinary skill in the art at the time the application was filed to include flowing of such a sheath gas to entrain the ions and reduce the spread of the ions that can cause loss of signal.
Regarding claim 24, Stults et al. discloses the claimed invention except for the figure of merit comprising relative standard deviation (RSD) and the ion signal quality map comprises an RSD map. Stults et al. does disclose using the consistency of the signal as a figure of merit (“This process may be monitored by observing one or more optimal electrospray characteristics such as a constant electrospray current,” P 27). It would have been obvious to a person having ordinary skill in the art at the time the application was filed to use standard deviation as the unspecified measure of consistency because it is a well-known figure of merit for measuring consistency.
Allowable Subject Matter
Claims 9 & 13 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter regarding claim 9: the prior art of record does not disclose the system of claim 7, wherein the classifying the selected ion as a contaminant ion comprises determining that a sheath gas flows coaxially around the ions emitted from the ionization emitter and that an extracted ion map for the selected ion does not have a linear cloud distribution.
The following is a statement of reasons for the indication of allowable subject matter regarding claim 13: the prior art of record does not disclose the system of claim 12, wherein the process further comprises identifying the search path, wherein identifying the search path comprises: acquiring an additional set of mass spectra data by sequentially positioning the emitter at a plurality of positions along each of a plurality of scan lines and acquiring a mass spectrum while the emitter is positioned at each of the plurality of positions; identifying, based on the additional set of mass spectra, an optimum position along each scan line; and determining the search path based on the optimum position of each scan line.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELIZA W OSENBAUGH-STEWART whose telephone number is (571)270-5782. The examiner can normally be reached 10am - 6pm Pacific Time M-F.
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/ELIZA W OSENBAUGH-STEWART/Primary Examiner, Art Unit 2881