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 .
Election/Restrictions
Claims 64 and 67 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12 November 2025.
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 1-3, 8, 10 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Roder (US 8,467,988 B1) in view of Quimby (US 8,378,293 B1).
Regarding claim 1, Roder teaches a system for mass analysis operation by proactively identifying contamination or degradation (performance valuation of mass spectrometer, Abstract), the system comprising:
A mass analysis instrument (mass spectrometer 110) comprising mass analysis hardware components; a processor (CPU 202), and
Memory (204) storing instructions (program code, col. 10 line 13) that, when executed by the processor, cause the system to perform a set of operations, the set of operations comprising:
Performing, by the mass analysis instrument at a first time, a predefined series of operational tests to produce first mass analysis results for a calibrant (standard run of mass spectrometer using machine qualification sample set, conducted at an earlier time, col..7 lines 35-45);
Performing, by the mass analysis instrument at a second time, the predefined series of operational tests to produce second mass analysis results for the calibrant (test machine run 100, col. 6 lines 11-45);
Determining an analysis difference between the first mass analysis results and the second mass analysis results (comparison, col. 7 lines 52-65), and
Based on a magnitude of the analysis difference, generating at least one of a contamination indicator or a degradation indicator (FAIL flag, col. 11 lines 1-15).
Roder does not teach that generating at least one of the contamination indicator or degradation indicator comprises determining when proactive maintenance should be performed to prevent contamination or degradation from impacting instrument performance.
Quimby teaches a mass spectrometry system which can generate a contamination indicator (user-readable indication, col. 20 line 5) comprising determining when proactive maintenance should be performed to prevent contamination or degradation from impacting instrument performance (scheduling a conditioning mode or modifying a pre-determined schedule for a conditioning mode, col. 19 line 63-col. 20 line 3).
It would have been obvious to one of ordinary skill in the art on or before the effective filing date of the claimed invention to modify the system of Roder to include scheduling a conditioning (i.e. decontamination) based on the contamination indicator as taught by Quimby, in order to automatically assist the user in maintaining the operating quality of the mass spectrometer.
Regarding claims 2 and 3, Quimby teaches that the processor and memory are either incorporated into the mass analysis instrument (included system controller, col. 11 lines 52-53) or incorporated into a server remotely located from the mass analysis instrument (remotely located controller, col. 12 lines 23-30).
It would have been obvious to one of ordinary skill in the art at or before the effective filing date of the invention to modify the system of Roder to have the controller incorporated into the instrument or remotely located as taught by Quimby, as Quimby teaches that these are known equivalent means of arranging the controlling elements with respect to the mass analysis instrument used in the art, which both allow effective control of the system with no unexpected result.
Regarding claim 8, Roder teaches that the mass analysis instrument further comprises a display (206), and the operations further include displaying the contamination indicator on the display (col. 8 lines 65-67).
Regarding claim 10, Quimby teaches transmitting the degradation indicator in an electronic communication (col. 20 line 10).
It would have been obvious to one of ordinary skill in the art on or before the effective filing date of the claimed invention to modify the system of Roder to include the electronic communication of Quimby, as a known equivalent means of alerting a user to a degradation status of a mass spectrometer.
Regarding claim 15, Quimby teaches scheduling a cleaning of the mass analysis hardware to remove the contamination (col. 20 lines 1-3).
Claims 4-5 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Roder in view of Quimby and in further view of Quarmby (US 20210111013 A1).
Regarding claim 4, Roder and Quimby teaches all the limitations of claim 1 as described above. Roder and Quimby do not teach that the operational tests include at least one of a polarity test or a ramping test.
Quarmby teaches a mass spectrometer calibration method including a ramping test (tuning data includes RF/DC ramp data, [0060]).
It would have been obvious to one of ordinary skill in the art on or before the effective filing date of the claimed invention to modify the system of Roder to ramp the voltage applied to the mass spectrometer during a calibration (tuning) process as described by Quarmby, as this is a typical way of scanning a mass filter to produce a mass spectrum (as described by Quarmby) and would therefore be a known simple way to obtain the calibration data mass peaks of Roder.
Regarding claim 5, Roder and Quimby teach all the limitations of claim 1 as described above. Roder does not teach that generating the contamination indicator is based on whether the analysis difference is positive or negative.
Quarmby teaches a contamination indicator based on a difference in mass resolution ([0002]).
It would have been obvious to one of ordinary skill in the art on or before the effective filing date of the current invention to use a mass resolution as a contamination indicator as taught by Quarmby, as a known parameter that is typically optimized as part of a mass spectrometer calibration system. It would further be obvious to determine whether contamination is present based on whether the resolution difference is positive (improved) or negative (degraded), in order to ensure that the mass spectrometer has adequate resolution for a desired investigation.
Regarding claim 20, Roder and Quimby teach all the limitations of claim 1 as described above. Roder does not teach that the at least one of the contamination indicator or the degradation indicator are generated by a trained machine learning model, wherein the trained machine learning model has been trained on prior mass analysis results from a plurality of mass analysis instruments.
Quarmby teaches a mass spectrometer having calibration indicator using a machine learning model that has been trained on mass analysis results from the mass analysis instrument (machine learning based on passively acquired tune data, [0112]).
It would have been obvious to one of ordinary skill in the art on or before the effective filing date of the claimed invention to modify the system of Roder to have the machine learning based indicator of Quarmby, in order to ensure an accurate indication of a need for calibration with no unexpected result. It would further have been obvious to train the machine learning model using data from multiple instruments, as a simple matter of loading additional data into the model to improve the performance of the model with no unexpected result.
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Roder in view of Quimby and in further view of Smith (US 20210305035 A1).
Regarding claim 6, Roder and Perelman teach all the limitations of claim 1 as described above. Roder does not teach storing, at the first time, first machine-level characteristics for the mass analysis instrument, storing at the second time, second machine-level characteristics for the mass analysis instrument; determining a machine-level difference between the first machine-level characteristics for the mass analysis instrument; and wherein generating the at least one of the contamination indicator or the degradation indicator is further based on the machine level difference.
Smith teaches a method of tuning a mass spectrometer including measuring machine-level characteristics (determining RF amplitude, 210, fig. 2) comparing it to tune data obtained during a calibration run (compare amplitude with expected amplitude, i.e. historical data ([0010]) obtained during a different run that can be designated a “calibration run”, 215 fig. 2) determining a difference and generating a degradation indicator based on the difference (determining current performance based on comparison, 215-220, fig. 2; alert indicating that maintenance is needed can be generated, [0063]).
It would have been obvious to one of ordinary skill in the art on or before the effective filing date of the claimed invention to modify the system of Roder to include generating a contamination indicator based on machine-level characteristics as taught by Smith, in order to detect and correct degradation of the quadrupole components of a mass spectrometer with no unexpected result.
Regarding claim 7, Smith teaches that the machine level characteristics include a voltage level (RF amplitude).
Claims 11 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Roder in view of Quimby and in further view of Hohndorf (US 20120228489 A1).
Regarding claims 11 and 13, Roder and Quimby teach all the limitations of claim 1 as described above. Roder does not teach that the contamination/degradation indicator indicates a current level of contamination/degradation of a hardware component of the mass analysis instrument.
Hohndorf teaches a contamination/degradation indicator which can indicate a current level of contamination/degradation of a hardware component of a mass analysis instrument (indicator having several levels that indicate cleaning urgency of ion source, [0016-0017]).
It would have been obvious to one of ordinary skill in the art on or before the effective filing date of the claimed invention to modify the system of Roder to have an indicator of the current level of contamination and/or degradation of at least a part of the mass analyzer as described by Hohndorf, in order to allow a user to judge the level of contamination and decide whether to clean the instrument as described by Hohndorf.
Claims 12 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Roder in view of Quimby and in further view of Knecht (US 6,982,413 B2).
Regarding claims 12 and 14, Roder and Quimby teach all the limitations of claim 1 as described above. Roder and Quimby do not teach that the contamination/degradation indicator indicates a predicted future level of contamination/degradation of a hardware component of the mass analysis instrument.
Knecht teaches a contamination/degradation indicator which can indicate a predicted future level of contamination/degradation of a hardware component of a mass analysis instrument (predicting future performance including impending component degradation or failure, Abstract).
It would have been obvious to one of ordinary skill in the art on or before the effective filing date of the claimed invention to modify the system of Roder to have an indicator of the future level of contamination and/or degradation of at least a part of the mass analyzer as described by Knecht, in order to allow a user to judge the future performance and decide whether and when to clean the instrument in order to ensure accurate measurement of a desired compound.
Claims 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Roder and Quimby and in further view of Wiederin (US 20190383840 A1).
Regarding claims 17 and 18, Roder and Quimby teach all the limitations of claim 1 as described above. Roder does not teach that the mass spectrometer is configured to automatically perform the predefined series of operational tests upon receipt of the calibrant (or detecting, by the mass analysis, receipt of the calibrant, and based on detecting receipt of the calibrant, automatically performing the predefined series of operational tests).
Wiederin teaches a mass spectrometer ([0029]) which automatically performs a test upon receipt of a calibrant (identifying sample as calibration sample, [0066]; automatically scheduling and performing analysis, [0066-0069]).
It would have been obvious to one of ordinary skill in the art on or before the effective filing date of the claimed invention to modify the system of Roder to have the automatic testing method of Wiederin, in order to easily calibrate the system and ensure continuous activation with no unexpected result.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Roder in view of Quimby and in further view of Schmidt (US 20180182603 A1).
Regarding claim 19, Roder and Quimby teach all the limitations of claim 1 as described above. Roder does not teach that the mass analysis instrument is configured to automatically perform the predefined series of operational tests upon receiving an input at the mass analysis instrument to enter a diagnostic mode.
Schmidt teaches a mass analysis instrument that automatically performs calibration upon user input (calibration on demand, [0035]).
It would have been obvious to one of ordinary skill in the art on or before the effective filing date of the claimed invention to modify the system of Roder to have the user-based control of the calibration taught by Schmidt, in order to allow a user to calibrate the instrument at will with no unexpected result.
Response to Arguments
Applicant's arguments filed 6 July 2026 have been fully considered but they are not persuasive.
Regarding the argument that Roder’s output is a validation state and so Roder does not identify a contamination state nor a degradation state, Examiner disagrees. Roder performs validation of a mass spectrometry system including at times during the operation of the system () to whether it is “subject to performance drift over time” (col. 2 line 10), which is a form of “degradation” in that the performance of the system has been degraded from the ideal.
Regarding the combination of Roder and Quimby, it is true that “Quimby does not teach generating a contamination or degradation indicator based on a magnitude of an analysis difference between first and second mass analysis results for a calibrant”, but Quimby is not relied upon for this teaching in the rejection. Quimby is relied upon only for the teaching that it is known in the mass spectrometry art for a user interface to provide suggestions of proactive maintenance based on test results including measurement of mass spectra. It would be obvious to one of ordinary skill in the art to modify the system of Roder to provide such a suggestion, as a matter of slightly adjusting the user interface of Roder in order to assist the user in maintaining the mass spectrometer. The suggestion of Quimby can be considered a “contamination or degradation indicator” (as the need for maintenance implicitly suggests that performance degradation has occurred) and so the combination of Quimby and Roder would meet the limitations of claim 1.
Regarding the argument that “Roder is concerned with determining whether an instrument remains qualified, while Quimby is concerned with performing conditioning and cleaning operations”, it would be obvious to one of ordinary skill in the art that the purpose of Quimby’s conditioning operations is to maintain the function of the mass spectrometer, i.e. to ensure that it is qualified.
Regarding the argument that the modification would require redesigning Roder’s validation methodology, in the Examiner’s judgment it would be within the skill of one of ordinary skill in the art to modify the user interface of Roder to incorporate the warning of Quimby as a simple software modification with a benefit of allowing the user to perform proactive maintenance and with no unexpected result.
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 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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Kim can be reached at 22293. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID E SMITH/ Examiner, Art Unit 2881
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