DETAILED ACTION
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument in light of the amendment to the claims.
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 1-4, 6-12, 19, 22-24, 28-29, 32, 35, and 39 are rejected under 35 U.S.C. 103 as being unpatentable over Hanna (US Pat. 4,996,423, hereinafter Hanna) in view of Datwani et al. (US PGPub 2019/0157060, hereinafter Datwani).
Regarding claim 1, Hanna discloses a method for mass spectrometry (operation of the mass spectrometer, see abstract), the method comprising:
ionizing each of the samples for introduction into the mass spectrometer (mass spectrometer 10 includes an analyzer 12 including an ion source, see col. 3, lines 19-30);
detecting the received sample ion pulses in the mass spectrometer to generate a signal (mass spectrometer 10 includes an analyzer 12 that includes at least one detector, see col. 3, lines 19-30);
isolating an analyte signal by signal conditioning (signal filtering, see col. 3, lines 35-63) the generated signal based on the predetermined time pattern (see col. 4, line 64 – col. 5, line 6); and
identifying a presence of an analyte based on the isolated analyte signal (see col. 4, lines 14-25).
Hanna fails to disclose receiving a plurality of samples in a pre-determined time pattern from a sampling interface, wherein the sampling interface comprises an ADE-OPI, an ESI, ACPI, APPI, or a MALDI. Hanna further does not explicitly disclose when ionizing the samples to produce a plurality of sample ion pulses.
Datwani discloses receiving a plurality of samples in a pre-determined time pattern from a sampling interface (mass analyzing analytes received within an open end of a sampling probe 51, see paragraph [0096]), ionizing each of the plurality of samples to produce a plurality of sample ion pulses (sampling probe 51 in fluid communication with a nebulizer assisted ion source 160 (e.g. with an electrospray electrode 164), see paragraph [0096]; samples arrive in discrete pulses at about 250 Hz, see paragraph [0080]), wherein the sampling interface comprises an ADE-OPI and an ESI (acoustic droplet injection device 11 (e.g. ADE forming droplets, see paragraph [0072]) provides droplets, see paragraph [0096], to the sampling probe 50 (e.g. open sampling end for the sampling probe, see paragraph [0065]), for ionization at electrospray (e.g. ESI), see paragraph [0096]). Datwani teaches the ADE-OPI is advantageous for substantially reducing the time between successive samples for increased throughput (see paragraph [0072]).
Datwani modifies Hanna by suggesting a specific application of the ionization method to be an ADE-OPI interface connected to an ESI.
Since both inventions are drawn to mass spectrometers, it would have been obvious to the ordinary artisan before the effective filing date to modify Hanna by providing ADE-OPI interface connected to an ESI for the purpose of substantially reducing the time between successive samples for increased throughput as taught by Datwani.
Regarding claim 2, Fig. 1 of Hanna discloses the signal conditioning comprises pulse based averaging based on the predetermined time pattern (see col. 5, line 64 – col. 6, line 16).
Regarding claim 3, Fig. 1 of Hanna discloses the predetermined time pattern results in sample ion pulses occurring at a specific carrier frequency (see col. 4, lines 14-25).
Regarding claim 4, Fig. 1 of Hanna discloses the signal conditioning comprises converting the generated signal to a frequency domain signal and calculating a modulus of only the carrier frequency to isolate the analyte signal (see col. 4, line 64 – col. 5, line 20).
Regarding claim 6, Hanna discloses the identifying the presence of the analyte comprises quantitating an amount of analyte present in the sample ion pulses (see col. 4, lines 19-25).
Regarding claim 7, Hanna discloses the predetermined time pattern is periodic (see col. 4, lines 14-25) and the signal conditioning comprises performing a Fourier Transform (FFT) on the signal to convert it to a frequency domain signal (see col. 5, lines 2-9).
Regarding claim 8, Hanna discloses filtering the frequency domain signal of any frequencies outside of a configured bandwidth centered at a frequency corresponding to the periodic predetermined time pattern (see col.4, line 64 – col. 5, line 6).
Regarding claim 9, Hanna discloses the signal conditioning comprises a deconvolution of frequency components of the generated signal and wherein the isolating the analyte signal comprises evaluating a pulse frequency component corresponding to the predetermined time pattern (see col. 4, line 64 – col. 5, line 6).
Regarding claim 10, Fig. 1 of Hanna discloses identifying the presence of the analyte comprises quantitating an amount of analyte present in the sample ion pulses (see col. 3, lines 31-34).
Regarding claim 11, Fig. 1 of Hanna discloses a magnitude of the pulse frequency component is used to identify the presence of the analyte (see col. 4, line 64 – col. 5, line 41).
Regarding claim 12, Fig. 1 of Hanna discloses the signal conditioning comprises de-noising, and wherein the de-noising comprises selectively rejecting any signal not following the predetermined time pattern (see col. 4, line 64 – col. 5, line 41).
Regarding claim 15, Fig. 1 of Hanna discloses identifying an initial ion pulse (digital signal corresponds to the inlet valve 14); identifying a background signal based on the initial ion pulse and the predetermined time pattern (see col. 4, line 64 – col. 5, line 41); and subtracting the background signal from the generated signal (see col. 1, line 62 – col. 2, line 2).
Regarding claim 19, Hannah discloses a system for mass spectrometry (operation of the mass spectrometer, see abstract), the system comprising:
an ionization source being operable to ionize the sample and transfer the ionized sample to the mass spectrometer (mass spectrometer 10 includes an analyzer 12 including an ion source, see col. 3, lines 19-30), the mass spectrometer being operable to:
detect the received sample ion to generate a signal (mass spectrometer 10 includes an analyzer 12 that includes at least one detector, see col. 3, lines 19-30);
isolate an analyte signal by signal conditioning (signal filtering, see col. 3, lines 35-63) the generated signal based on the pre-determined time pattern (see col. 4, line 64 – col. 5, line 6); and
identify a presence of an analyte based on the isolated analyte signal (see col. 4, lines 14-25).
Hanna fails to disclose receiving a plurality of samples in a pre-determined time pattern from a sampling interface, wherein the sampling interface comprises an ADE-OPI, an ESI, ACPI, APPI, or a MALDI. Hanna further does not explicitly disclose when ionizing the samples to produce a plurality of sample ion pulses.
Datwani discloses receiving a plurality of samples in a pre-determined time pattern from a sampling interface (mass analyzing analytes received within an open end of a sampling probe 51, see paragraph [0096]), ionizing each of the plurality of samples to produce a plurality of sample ion pulses (sampling probe 51 in fluid communication with a nebulizer assisted ion source 160 (e.g. with an electrospray electrode 164), see paragraph [0096]; samples arrive in discrete pulses at about 250 Hz, see paragraph [0080]), wherein the sampling interface comprises an ADE-OPI and an ESI (acoustic droplet injection device 11 (e.g. ADE forming droplets, see paragraph [0072]) provides droplets, see paragraph [0096], to the sampling probe 50 (e.g. open sampling end for the sampling probe, see paragraph [0065]), for ionization at electrospray (e.g. ESI), see paragraph [0096]). Datwani teaches the ADE-OPI is advantageous for substantially reducing the time between successive samples for increased throughput (see paragraph [0072]).
Datwani modifies Hanna by suggesting a specific application of the ionization method to be an ADE-OPI interface connected to an ESI.
Since both inventions are drawn to mass spectrometers, it would have been obvious to the ordinary artisan before the effective filing date to modify Hanna by providing ADE-OPI interface connected to an ESI for the purpose of substantially reducing the time between successive samples for increased throughput as taught by Datwani.
Regarding claim 22, Fig. 1 of Hanna discloses the signal conditioning comprises pulse based averaging based on the predetermined time pattern (see col. 5, line 64 – col. 6, line 16).
Regarding claim 23, Fig. 1 of Hanna discloses the predetermined time pattern results in sample ion pulses occurring at a specific carrier frequency (see col. 4, lines 14-25).
Regarding claim 24, Fig. 1 of Hanna discloses the signal conditioning comprises converting the generated signal to a frequency domain signal and calculating a modulus of only the carrier frequency to isolate the analyte signal (see col. 4, line 64 – col. 5, line 20).
Regarding claim 28, Hanna discloses filtering the frequency domain signal of any frequencies outside of a configured bandwidth centered at a frequency corresponding to the periodic predetermined time pattern (see col.4, line 64 – col. 5, line 6).
Regarding claim 29, Hanna discloses the signal conditioning comprises a deconvolution of frequency components of the generated signal and wherein the isolating the analyte signal comprises evaluating a pulse frequency component corresponding to the predetermined time pattern (see col. 4, line 64 – col. 5, line 6).
Regarding claim 32, Fig. 1 of Hanna discloses the signal conditioning comprises de-noising, and wherein the de-noising comprises selectively rejecting any signal not following the predetermined time pattern (see col. 4, line 64 – col. 5, line 41).
Regarding claim 35, Fig. 1 of Hanna discloses identifying an initial ion pulse (digital signal corresponds to the inlet valve 14); identifying a background signal based on the initial ion pulse and the predetermined time pattern (see col. 4, line 64 – col. 5, line 41); and subtracting the background signal from the generated signal (see col. 1, line 62 – col. 2, line 2).
Regarding claim 39, Hanna fails to disclose the sampling interface comprises an ADE and wherein each sample comprises one or more sample droplets ejected by the ADE into a continuous flow of solvent for discharge into the ionization source.
Datwani discloses receiving a plurality of samples in a pre-determined time pattern from a sampling interface (mass analyzing analytes received within an open end of a sampling probe 51, see paragraph [0096]), ionizing each of the plurality of samples to produce a plurality of sample ion pulses (sampling probe 51 in fluid communication with a nebulizer assisted ion source 160 (e.g. with an electrospray electrode 164), see paragraph [0096]; samples arrive in discrete pulses at about 250 Hz, see paragraph [0080]), wherein the sampling interface comprises an ADE-OPI and an ESI (acoustic droplet injection device 11 (e.g. ADE forming droplets, see paragraph [0072]) provides droplets, see paragraph [0096], to the sampling probe 50 (e.g. open sampling end for the sampling probe, see paragraph [0065]), for ionization at electrospray (e.g. ESI), see paragraph [0096]). Datwani teaches the ADE-OPI is advantageous for substantially reducing the time between successive samples for increased throughput (see paragraph [0072]).
Datwani modifies Hanna by suggesting a specific application of the ionization method to be an ADE-OPI interface connected to an ESI.
Since both inventions are drawn to mass spectrometers, it would have been obvious to the ordinary artisan before the effective filing date to modify Hanna by providing ADE-OPI interface connected to an ESI for the purpose of substantially reducing the time between successive samples for increased throughput as taught by Datwani.
Claims 5 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Hanna in view Datwani and in further view of Grothe, Jr et al. (US PGPub 2014/0138537, hereinafter Grothe).
Regarding claim 5, the combination of Hanna and Datwani fails to disclose identifying the presence of the analyte comprises determining whether the modulus exceeds a threshold value.
Grothe discloses identifying ions of interest comprises determining whether the signal exceeds a threshold above the noise (see paragraph [0064]). Grothe teaches the threshold is advantageous to minimize the amount of false positives for the analysis (see paragraph [0064]).
Grothe modifies the combination of Hanna and Datwani by suggesting setting a threshold value.
Since all inventions are drawn to mass spectrometers, it would have been obvious to the ordinary artisan before the effective filing date to modify the combination of Hanna and Datwani by setting a threshold to reduce the number of false positives from the signal as taught by Grothe.
Regarding claim 14, Fig. 1 of Hanna discloses identifying an initial ion pulse (digital signal corresponds to the inlet valve 14); windowing the generated signal based on the initial ion pulse and the predetermined time pattern (see col. 4, line 64 – col. 5, line 6); summing the windows to generate a sum of detected ion pulses (see col. 4, line 64 – col. 5, line 6).
The combination of Hanna and Datwani fails to disclose identifying the presence of the analyte comprises determining whether the modulus exceeds a threshold value.
Grothe discloses identifying ions of interest comprises determining whether the signal exceeds a threshold above the noise (see paragraph [0064]). Grothe teaches the threshold is advantageous to minimize the amount of false positives for the analysis (see paragraph [0064]).
Grothe modifies the combination of Hanna and Datwani by suggesting setting a threshold value.
Since all inventions are drawn to mass spectrometers, it would have been obvious to the ordinary artisan before the effective filing date to modify the combination of Hanna and Datwani by setting a threshold to reduce the number of false positives from the signal as taught by Grothe.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 HANWAY CHANG whose telephone number is (571)270-5766. The examiner can normally be reached Monday - Friday 7:30 AM - 4:00 PM EST.
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, Georgia Epps can be reached at (571) 272-2328. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
Hanway Chang
/HC/ Examiner, Art Unit 2878
/GEORGIA Y EPPS/ Supervisory Patent Examiner, Art Unit 2878