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 .
Response to Arguments
102 Rejection
Applicant’s arguments have been considered by are not persuasive. The examiner respectfully disagrees that Zhang fails to disclose the claimed controller. Under the broadest reasonable interpretation in light of applicant’s filed specification, the claimed controller configured to coordinate operations does not require a signal, dedicated hardware controller independently controlling each component or issuing individual control signals to each device; see [0058] of applicant specification. Further, [0057] describes commercially available computer systems utilizing associated control software, essentially the same coordination of operations taught in Zhang.
As discussed below, Zhang discloses an automated acoustic ejection mass spectrometry system utilizing Cherry Pick client/server software to operate the ejection apparatus and Analyst software to operate the mass spectrometer; see THE ADE-OPI-MS System section. Zhang further describes an integrated analytical process involving acoustic sample ejection, sample capture, ionization and mass spectrometric analysis.
Therefore, the examiner maintains that the claimed coordination does not require a single physical controller or direct, independent control of each component. Zhang teaches computer-based control arrangements configured to coordinate the operation of the recited elements. The lack of the term “controller” does not, by itself, establish that the claimed controller is not taught. Hence, Zhang teaches software-controlled instrumentation reads as “a controller” arrangement under the BRI of the claimed invention.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 3-8, 16, 18 and 19 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Zang et al. (Acoustic Ejection Mass Spectrometry for High-Throughput Analysis).
With respect to claim 1, Zang et al. teaches in Fig. 1A-B a system for analyzing a collection of substance samples (Abstract; diluted samples), the system comprising: a sample ejector (i.e. an acoustic transducer depicted in Fig. 1A) configured to eject, independently, a plurality of samples (Abstract) from a plurality of wells of a well plate (i.e. depicted wells on a well microplate seen in Fig. 1), each of the plurality of samples (within the wells of the microplate) corresponding to each of the plurality of wells (as seen in Fig. 1A); a capture probe (i.e. the structure labeled as capture region of Fig. 1A) configured to capture the ejected samples (as the capture region captures ejected samples from the acoustic transducer) and dilute (via the carrier solvent) and transport the captured samples (via the transfer capillary); a nebulizer nozzle (i.e. the structure labeled nebulizer capillary in Fig. 1A) configured to receive and ionize the transported diluted samples to produce sample ions (page 10852, left column; section Sample Analysis with ADE-OPI-MS); a mass analysis instrument (i.e. MS system taught on page 10852, right column) configured to filter and detect ions of interest from the sample ions (as the MS taught by Zang filters and detects specific ions and not the whole sample); a controller configured to coordinate operations of the sample ejector (ATS-100 software and the indirectly taught controller operating those instructions; page 10852, left column, first paragraph), the capture probe, the nebulizer nozzle, and the mass analysis instrument (page 10852, left column, first paragraph, which teaches the system for controlling the probe, nozzle, and mass analysis instruments, MS); and a data processing system (i.e. a post-processing system PC storing and operating software) connected with the mass analysis instrument and the controller (page 10852, right column, paragraphs 1-3), wherein the data processing system (i.e. software and the indirectly taught controller operating the software) is configured to acquire data from the mass analysis instrument and conduct an automatic data processing process (as read on page 10852, right column, paragraphs 1-3), wherein the automatic data processing process is triggered by completion of the acquiring the data from the mass analysis instrument (as after the data is acquired from the mass analysis instrument, the data is automatically processed offline by a PC).
The method steps of claim 18 are performed during the operation of the rejected structure of claim 1.
With respect to claim 19, Zang et al. a non-transitory computer-readable medium containing program instructions (i.e. as Zang et al. teaches various software instructions used to perform the recited steps during the operation of the rejected structure of claim 1), wherein execution of the program instructions (i.e. software) by one or more processors (i.e. as the instructions operated in a computer environment having inherent processors that) cause[s] a system for analyzing collection of substance samples.
With respect to claim 3, Zang et al. teaches in Fig. 1A-B the system wherein the automatic data processing process (as performed by the indirectly taught controller) comprises: correlating intensity peaks in an intensity-versus-time signal with the plurality of samples from the plurality of wells (as Zang et al. teaches on page 10851, fourth paragraph int his work, we describe a novel sample delivery approach combining technologies that are synergistic for MS performance: acoustic droplet ejection (ADE) and an open-port interface (OPI).22 ADE technology can sample nanoliter volumes accurately and precisely on a hertz timescale and, notably, the ADE transducer renders samples directly such that no workup is required and in Fig. 1B and 2A).
With respect to claim 4, Zang et al. teaches in Fig. 1A-B the system wherein the automatic data processing process (as performed by the indirectly taught controller) further comprises: splitting the data to generate a plurality of data subsets (i.e. Groups 1-4; Fig. 2A), each of the plurality of data subsets (Groups 1-4) corresponding to each of the plurality of samples from the plurality of wells (i.e. the four sets prepared samples, as read in the caption of Fig. 2).
With respect to claim 5, Zang et al. teaches in Fig. 1A-B the system wherein the intensity peaks in the intensity-versus-time signal (seen in Fig. 1B and 2A) is correlated with the plurality of samples from the plurality of wells (as depicted by the key of Fig. 2A), based on acoustic ejection timing information of the sample ejector (i.e. x axis shows the timing in which those sample were ejected).
With respect to claim 6, Zang et al. teaches in Fig. 1A-B the system wherein the automatic data processing process (as performed by the indirectly taught controller) further comprises: introducing a compound file comprising information of one or more target compounds for each of the plurality of samples (as Zang et al. teaches using a MS raw data file and acoustic ejection log to correlate the sample well information to ejection events; page 10852, right column, second paragraph).
With respect to claim 7, Zang et al. teaches in Fig. 1A-B the system wherein the automatic data processing process further comprises: generating one or more mass spectra corresponding to the one or more target compounds for each of the plurality of samples (see Fig. 4, as Zang et al. teaches generating mass spectra for the groups with corresponding target compounds for each sample group).
With respect to claim 8, Zang et al. teaches in Fig. 1A-B the system wherein the automatic data processing process further comprises: generating a background spectrum (page 10852, right column, paragraph 4); and subtracting the background spectrum from the one or more mass spectra (Zang et at. teaches subtracting background spectrum to normalize the data).
With respect to claim 16, Zang et al. as modified by Jones et al. teaches the system wherein the automatic data processing process further comprises: visualizing the one or more mass spectra corresponding to the one or more target compounds for each of the plurality of samples in a heat map (as Fig. 2 is considered to be an outputted visualization of the mass spectra of the groups in the form of an intensity map, i.e. “heat map”).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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) 9-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zang et al. (Acoustic Ejection Mass Spectrometry for High-Throughput Analysis) in view of Jones et al. (2021/0109069).
With respect to claim 9, Zang et al. teaches all that is claimed in the above rejection of claim 6 but remains silent regarding wherein the automatic data processing process further comprises: identifying abnormal samples, among the plurality of samples, based on one or more validation rules.
Jones et al. teaches a similar processing process that includes identifying abnormal samples, among the plurality of samples, based on one or more validation rules (as Jones et al. teaches rapid mass spectrometry sampling and a determination to whether or not threshold rules have been met or not; Abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing of the instant invention to modify the process of Zang et al. to include identification of abnormal samples using threshold rules, as taught in Jones et al. because Jones teaches such a modification provides an improvement in analyzing samples by removing wasted time acquiring unnecessary data; [0009-0010].
With respect to claim 10, Zang et al. as modified by Jones et al. teaches the system wherein the one or more validation rules comprise a first validation rule, under which each of the abnormal samples has a mass shift larger than a threshold mass shift (as Jones et al. teaches in [0029-0030] teaches a “mass shift” specifically as a "mass loss" used as a filtering threshold criterion in mass spectrometry).
With respect to claim 11, Zang et al. as modified by Jones et al. teaches the system wherein the one or more validation rules (i.e. threshold) comprise a second validation rule (i.e. a second threshold), under which each of the abnormal samples has an isotope pattern distribution similarity larger than a threshold isotope pattern distribution similarity (as Jones teaches selective isotopic peak monitoring for quality control where if the peaks are in excess of a threshold, an abnormality is determined; [0054-0056].
Claim(s) 12-15 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zang et al. (Acoustic Ejection Mass Spectrometry for High-Throughput Analysis) in view of Jones et al. (2021/0109069), as applied to claim 9, further in view of Greving et al. (10,068,200)
With respect to claim 12, Zang et al. as modified teaches all that that is claimed in the above rejection of claim 9 but remains silent regarding the automatic data processing process further comprises: prompting, to a user of the system, a notification of the abnormal samples.
Greving et al. teaches a similar system that includes prompting, to a user of the system, a notification of an abnormal samples (as Greving et al. teaches reporting to a user a report 250 regarding the results of the analysis; Col. 3 lines 1-10).
It would have been obvious to one of ordinary skill in the art before the effective filing of the instant invention to modify the system of Zang et al. to include the user prompting capabilities of Greving et al. via the taught report in Greving et. al. because such a modification provides convenient and cost-effective customer access to offsite MS analysis data, Col. 3 line 66 to Col. 4 line 3.
With respect to claim 13, Zang et al. as modified teaches all that that is claimed in the above rejection of claim 9 but remains silent regarding the automatic data processing process further comprises: sending a feedback message comprising information of the abnormal samples to the controller.
Greving et al. teaches a similar system that sends a feedback message (i.e. report) comprising information to a controller (as Greving et al. teaches reporting message data to a user and a controller regarding the results of the MS analysis; Col. 3 lines 1-10).
It would have been obvious to one of ordinary skill in the art before the effective filing of the instant invention to modify the system of Zang et al. such that any abnormality determined by Zang et al. is entered into the report and sent to the user; as such a modification provides convenient and cost-effective customer access to offsite MS analysis data, Col. 3 line 66 to Col. 4 line 3.
With respect to claim 14, Zang et al. as modified by Jones et al. teaches the modified system wherein the automatic data processing process further comprises: adjusting the operations of the sample ejector, the capture probe, the nebulizer nozzle, and the mass analysis instrument (as Zang et al. teaches software and the modified control to control these elements), based on the feedback message (as based on the generated report and abnormalities, the modified software can adjust their respective operations based on the generated data used for the report).
With respect to claim 15, Zang et al. as modified by Jones et al. teaches the modified system wherein the automatic data processing process further comprises: ejecting, independently, the abnormal samples, based on the feedback message (as the combination as a whole teaches ejecting abnormal samples using the acoustic ejection parameters taught in Zang et al, page 10852, left column, last paragraph, based on the feedback message when the modified system determined that an abnormality exists).
With respect to claim 17, Zang et al. as modified teaches all that that is claimed in the above rejection of claim 9 but remains silent regarding the automatic data processing process further comprises: generating a report file comprising information of the one or more mass spectra corresponding to the one or more target compounds for each of the plurality of samples.
Greving et al. teaches a similar system that includes generating a report file comprising information of the one or more mass spectra corresponding to the one or more target compounds for each of the plurality of samples (as Greving et al. teaches reporting to a user a report 250 regarding the results of the MS analysis; Col. 3 lines 1-10).
It would have been obvious to one of ordinary skill in the art before the effective filing of the instant invention to modify the system of Zang et al. to include the user prompting capabilities of Greving et al. via the taught report in Greving et. al. because such a modification provides convenient and cost-effective customer access to offsite MS analysis data, Col. 3 line 66 to Col. 4 line 3.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Greving et al. (9,460,904) which teaches an apparatus for perform mass spectrometry and sending the results to remote users.
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 MATTHEW G MARINI whose telephone number is (571)272-2676. The examiner can normally be reached Monday-Friday 8am-5pm.
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/MATTHEW G MARINI/ Primary Examiner, Art Unit 2853
