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.
Claims 1 and 5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Franz et al (US PGPub 2018/0292368).
Regarding Claim 1, Franz et al teaches a control method of a sample pretreatment apparatus (referred to as a sample preparation apparatus 50 for automated pre-treatment of samples) (see [0110] and Figure 1 of a sample inspection automation system (referred to as clinical diagnostic system 100, see [0110])0 to which a sample pretreatment apparatus applying pretreatment to a sample used in mass spectrometry, a mass spectrometer (90), and another automatic analyzer (such as liquid chromatography (LC) separation station 60) are connected (see [0120] and Figure 1), comprising:
determining serum information (wherein the sample may be a serum, see [0045]) by referring to a measurement result of the sample by the other automatic analyzer (i.e. station 60) or previous value information (wherein information is obtained through LC channels and sent to LC/MS interface 91) (see [0030], [0048], [0120] and [0147]) , determining conditions of a washing process (i.e. washing steps W1, W2) of eliminating impurities (i.e. washing away bound-free matrix components, see [0107]) contained in the sample during the sample pretreatment based on the serum information (see [0043], [0142] and [0149]); and dispensing a cleaning fluid (i.e. a washing liquid or washing buffer) into a reaction container for mixing the sample and a reagent based on the conditions (see [0142] and [0149]).
Regarding Claim 5, Franz et al teaches that a reagent containing magnetic particles (i.e. magnetic beads) is dispensed into the reaction container (see [0107], and magnetic components and nonmagnetic components in the reaction container are separated to conduct the washing process (see [0107], [0110] and [0142]-[0144]).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Franz et al as applied to claim 1 above, and further in view of Everson et al (US PGPub 2021/0318274).
Regarding Claim 2, Franz et al teaches that the measurement result of the sample in the other automatic analyzer or the previous value information is referred to (see [0056]).
However, Franz et al does not disclose that the determined information shows whether the sample is a sample having a possibility of occurrence of ionization suppression in the mass spectrometry.
However, in the analogous art of liquid chromatography-mass spectrometry (LC-MS) assays, Everson et al teaches a test for ion suppression/ion enhancement, 20 μL of the blank extracted matrix samples (from different individuals, no internal standard added during extraction) were injected. A dip of the MS/MS signal at the retention time of the analytes indicates ion suppression, a peak ion enhancement. There was a dip in the MS/MS signal at the analytes's retention times, which is consistent with the ion suppression also detected in the matrix effect experiments following the protocol described by Matuszewski et al. (2003) described above. In summary: Absolute matrix effects resulted in negative matrix bias (ion suppression) of −19.7 to −34.9%. Ion suppression was compensated by the internal standard cholic acid-D.sub.4, albeit was overcompensated in the case of cholic acid (+40.4% relative matrix bias) (see [0544]). Accordingly, it would have been obvious to one of ordinary skill in the art to utilize a test for ion suppression in the mass spectrometer (as taught by Everson et al) for the benefit of enabling the user to measure dips of the MS/MS signal and detect ion suppression of the mass spectrometer that would negatively impact the sensitivity of the mass spectrometer.
Claims 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Franz et al and Everson et al as applied to claim 2 above, and further in view Kubo (US PGPub 2018/0180607), as cited on the IDS..
Regarding Claims 3-4, the combination of Franz et al and Everson et al teaches the method of claim 2.
However, the combination of Franz et al and Everson et al does not disclose that either a kind of the cleaning fluid or a mixed ratio of the cleaning fluid is changed based on the serum information or the number of times of washing or a washing temperature in the washing process is changed based on the serum information.
However, in the analogous art of analysis methods and analyzers, Kubo teaches systems and methods for sample processing, wherein a controller 12 is utilized to change either the kid of cleaning (i.e. washing fluid) used or the number of times of washing (see [0054]-[0057]). It would have been obvious to one of ordinary skill in the art to replace the controller of Franz et al with the controller of Kubo et al for the benefit of enabling one to change/vary the kind/type of cleaning fluid as well as the times of washing such that various different samples (having different target components) may be effectively cleaned.
Claims 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Franz et al and Everson et al as applied to claim 2 above, and further in view Suzuki et al (US PGPub 2014/0363896), as cited on the IDS.
Regarding Claims 3-4, the combination of Franz et al and Everson et al teaches the method of claim 2.
However, the combination of Franz et al and Everson et al does not disclose that either a kind of the cleaning fluid or a mixed ratio of the cleaning fluid is changed based on the serum information or the number of times of washing or a washing temperature in the washing process is changed based on the serum information.
However, in the analogous art of automatic analyzer systems, Suzuki et al teaches an automatic analyzer hat performs quantitative and qualitative analyses on biological samples of a plurality of types such as blood, urine, and CSF (cerebrospinal fluid) (see [0001]). Furthermore, Suzuki et al teaches the use of a controller (such as simple-pipetting mechanism controller 1125) which is utilized to change either the kid of cleaning (i.e. washing fluid) used or the number of times of washing (see [0056] and [0064]). It would have been obvious to one of ordinary skill in the art to further incorporate the controller 1125 of Suzuki et al in the control system of Franz et al for the benefit of enabling one to change/vary the kind/type of cleaning fluid as well as the times of washing such that various different sample types may be effectively cleaned the correct amount of time.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Chen et al (CN 116130332) discloses that sample pre-treatment is a necessary step of analyzing most complex samples (such as food, medicine, biological or environment), because of the fussy and time-consuming operation, it is often more than half of the total analysis time. At present, the target analyte of complex sample is mostly trace level, before qualitative or quantitative analysis, the sample often needs to be purified or enriched by solid phase extraction (SPE) column or solid phase micro-extraction (SPME) probe and then test, so as to ensure satisfactory method detection limit. for micro-sample of ultra-trace object analysis, patent CN112630289A shows, using nano-current spray ionization technology, using the direct sampling mode, which can effectively solve the problem of detecting ion signal suppression and loss, so as to improve the detection sensitivity.
Cherubini et al (US PGPub 20180010990) discloses an automated analysis system (see title), which comprises a control unit which can control the automated system in a way that the necessary steps for the processing protocols can be conducted by the automated system. That can mean the control unit may, for example, instruct the automated system to conduct certain pipetting steps with a pipettor to mix the liquid biological sample with reagents, or the control unit can control the automated system to incubate the biological sample or reagents or mixtures of both for a certain time at a certain temperature, or the control unit controls the acceleration, speed of rotation, time of rotation and deceleration of the rotatable vessel described herein, or other related parameters. The control unit may receive information from a data management unit (DMU) regarding which steps need to be performed with a certain sample. In some embodiments, the control unit may be integral with the data management unit or may be embodied by a common hardware. The control unit may, for instance, be embodied as a programmable logic controller running a computer-readable program provided with instructions to perform operations in accordance with a process operation plan. The control unit may be set up to control, for example, any one or more of the following operations: loading, wasting or washing of the rotatable vessel described herein or pipette tips, moving or opening of sample tubes and reagent cassettes, pipetting of samples or reagents, mixing of samples or reagents, washing pipetting needles or tips, controlling of a detection unit such as light source, for example, by selection of the wavelength, or the like. In particular, the control unit may include a scheduler, for executing a sequence of steps within a predefined cycle time. The control unit may further determine the order of samples to be processed according to the assay type, urgency, and the like. The control unit may also receive data from a detection unit related to a measurement of parameter of the sample (see [0035]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER WECKER whose telephone number is (571)270-1109. The examiner can normally be reached 9:30AM - 6 PM EST M-F.
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, Lyle Alexander can be reached at 571-272-1254. 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.
/JENNIFER WECKER/ Primary Examiner, Art Unit 1797