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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “high-throughput” in claims 1 and 20 is a relative term which renders the claim indefinite. The term “high-throughput” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is not clear what level of sample throughput is required to achieve the required result.
Claims 2-19 are rejected for their dependence on claim 1.
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 1-14 and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Maeda (US 20190011406 A1) in view of Satake (US 20160025692 A1).
Regarding claim 1, Maeda teaches a method of operating a high-throughput mass analysis device (Mass spectrometric analysis, [0035]; “high-throughput” is a relative term as argued above), comprising:
Sampling an unseparated sample from at least one sample holding element (sample wells 70a-70e) during a sampling interval for introduction of the sample into an ion source (ionization probe 30) for ionizing at least one target analyte, if any, in the sample to generate a plurality of ions for delivery to an ion mobility separation device ([0035]), and
Activating at least one control parameter of a mass analysis device for detection of said sample based on the timing of the sampling of the sample and at least one sample identifier associated with the sample (retention time and name of component in sample are input by user to create analysis condition file; controller operates system based on analysis execution file, including activating a control parameter, e.g. target mass range, for operating the TOF-MS, [0036]).
Maeda does not teach that the control parameter is a control parameter of an ion mobility separation device.
Satake teaches an ion mobility spectrometer which stores a file (database 19) associating a sample peak with a control parameter of an ion mobility separation device ([0047], figs. 8A-8B).
It would have been obvious to one of ordinary skill in the art on or before the effective filing date of the invention to store parameters such as an optimum compensation voltage for an ion mobility device in the file of Maeda, in the embodiment of Maeda which includes an ion mobility device, as Satake teaches that pre-storing this value for a given compound can optimize the ion mobility analysis by maximizing the ion transmission parameter of the compound.
Regarding claim 2, Maeda (as modified by Satake, above) teaches that the step of activating the at least one control parameter comprises utilizing a controller (90) to set a value of said control parameter based on reference data indicative of said value of the control parameter suitable for identification of said at least one target analyte (setting analysis conditions based on analysis execution file, [0035], including mass range for given a compound (fig. 3); it would be obvious to one of ordinary skill in the art to include ion mobility parameters in the table based on the teaching of Satake as argued above).
Regarding claim 3, Maeda teaches that said step of activating the at least one control parameter is further based on a time delay between the sampling of the sample and the delivery of the plurality of ions to the ion mobility separation device (retention time in chromatography system, fig. 3).
Regarding claim 4, Maeda teaches that said at least one sample identifier identifies at least one target analyte associated with the sample (component name, fig. 3).
Regarding claim 5, Maeda teaches that the sample identifier identifies a duration of said sampling interval (measuring interval, fig. 3).
Regarding claim 6, Maeda teaches that the sample identifier identifies a start time and an end time associated with each sampling interval (measurement time includes start and end time, fig. 3).
Regarding claim 7, Maeda teaches that said at least one sample identifier identifies said at least one sample holding element (liquid sample container, fig. 3).
Regarding claim 8, Maeda teaches that said at least one sample identifier identifies said at least one target analyte associated with the sample contained in said at least one sample holding element (component name, fig. 3).
Regarding claim 9, Maeda teaches retrieving reference data indicative of said at least one target analyte and a value of the at least one control parameter from a single datafile (fig. 3, table includes compound name and control parameter, i.e. target mass range).
Regarding claim 10, Maeda teaches that said at least one target analyte comprises a plurality of analytes and the step of activating the at least one control parameter comprises activating different values of said control parameter during the sampling interval, wherein each of the different values of the control parameter is suitable for detection of one of said plurality of analytes (different compounds have different mass ranges, fig. 3).
Regarding claim 11, Maeda teaches that said at least one sample holding element comprises a plurality of sample holding elements (wells 70a-70e).
Regarding claim 12, Maeda teaches that at least one sample identifier identifies one of said plurality of sample holding elements and said at least one target analyte associated with the sample contained in said identified sample holding element (table identifies sample holder and compound, fig. 3).
Regarding claim 13, Maeda teaches that said sampling step is performed via a plurality of discrete sampling events during said sampling interval (sample supply passage may be closed if no analysis is performed, [0020]).
Regarding claim 14, Maeda teaches that said sampling step is performed continuously during said sampling interval (e.g. continuously during each retention time period, fig. 3).
Regarding claim 17, Maeda teaches that said sampling step comprises utilizing an energy source for removing the sample from said sampling holding element.
Regarding claim 18, Maeda teaches that said energy source comprises a source for generating pneumatic pressure (pressure due to nitrogen gas, [0051-0052]).
Regarding claim 19, Maeda teaches that said ion mobility separation device comprises an ion mobility spectrometer.
Regarding claim 20, Maeda teaches a high-throughput mass analysis device (Mass spectrometric analysis, [0035]; “high-throughput” is a relative term as argued above), comprising:
At least one sample holding element (70a-70e) for storing a sample,
An ion source (ionization probe 30),
An ion mobility separation device ([0035]),
A sample introduction device (fig. 2) for directing the sample from the at least one sample holding element to the ion source,
A controller (90) in communication with the sample introduction device for controlling sampling of the sample from said at least one sample holding element for delivery to said ion source to cause ionization of at least one target analyte, if any, in the sample, thereby generating a plurality of ions associated with said at least one target analyte,
Said controller further being in communication with said mass analysis device for controlling at least one control parameter thereof (e.g. mass range, [0036], fig. 3),
Wherein said controller is configured to activate the at least one control parameter for detecting the target analyte in the sample based on timing the sampling of the sample from the sample holding element and an identifier associated with the sample (retention time and name of component in sample are input by user to create analysis condition file; controller operates system based on analysis execution file, including activating a control parameter, e.g. target mass range, for operating the TOF-MS, [0036]).
Maeda does not teach that the control parameter is a control parameter of an ion mobility separation device.
Satake teaches an ion mobility spectrometer which stores a file (database 19) associating a sample peak with a control parameter of an ion mobility separation device ([0047], figs. 8A-8B).
It would have been obvious to one of ordinary skill in the art on or before the effective filing date of the invention to store parameters such as an optimum compensation voltage for an ion mobility device in the file of Maeda, in the embodiment of Maeda which includes an ion mobility device, as Satake teaches that pre-storing this value for a given compound can optimize the ion mobility analysis by maximizing the ion transmission parameter of the compound.
Claims 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Maeda in view of Satake and in further view of Jones (US 20210109069 A1).
Regarding claims 15 and 16, Maeda and Satake teach all the limitations of claims 1 and 14 as described above. Maeda and Satake do not teach that the sampling interval is equal to or less than about 10 seconds, or 0.5-10 seconds.
Jones teaches an ion mobility system ([0149]) having a sampling interval equal to or less than about 10 seconds (up to three samples per second, [0003]).
It would have been obvious to one of ordinary skill in the art on or before the effective filing date to apply the control method of Maeda and Satake to an ion mobility spectrometer having a fast sampling interval based on an acoustic mist ionization technique as taught by Jones, in order to allow effective control of the system by setting optimum parameters for each sample in a known manner with no unexpected result.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID E SMITH whose telephone number is (571)270-7096. The examiner can normally be reached M to F 8:30 AM-5:00 PM.
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/DAVID E SMITH/Examiner, Art Unit 2881
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