CTNF 18/556,160 CTNF 83827 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. 12-151 AIA 26-51 12-51 Status of Claims The claim set submitted on 19 OCTOBER 2023 is acknowledged and considered. In the claim set, Claims 1-5 are presented and are considered on the merits below. Priority 02-26 AIA Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Information Disclosure Statement 06-52 The information disclosure statement (IDS) submitted on 19 OCTOBER 2023 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. 06-52 The information disclosure statement (IDS) submitted on 10 MARCH 2025 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. Claim Objections 07-29-01 AIA Claim 3 is objected to because of the following informalities: In Claim 3 where abbreviations are used, it should first be spelled out in the first instance it appears before a short hand or acronym is used. For example, ‘HPLC performance check’ should be ‘high performance liquid chromatography (HPLC) performance check’ . Appropriate correction is required. 07-30-03-h AIA Claim Interpretation 07-30-03 AIA The following is a quotation of 35 U.S.C. 112(f): (f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof. The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph: An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof. 07-30-05 The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked. As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph: (A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function; (B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and (C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function. Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function. Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function. Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: A “separation unit configured to perform separation of a sample to be measured” in Claims 1 and 5. A “unit” does not connote any particular structure. The specification describes the “separation unit” to be high performance liquid chromatography (HPLC), [0018]. A “detection unit configured to detect a substance to be measured…” in Claims 1 and 5. A “unit” does not connote any particular structure. The specification describes the “detection unit” to be a mass spectrometer (MS), [0018]. A “control device configured to control an operation of the analyzer” and “control device is configured to execute a predictive diagnosis…” in Claims 1 and 5. A “device” does not connote any particular structure. The specification describes the “control unit” to be a data alarm database, a normal data alarm database, a data alarm determination unit a system alarm database, a normal system alarm database, a system alarm database unit, in Claim 1. A “data alarm determination unit configured to compare data …” in Claim 1. A “unit” does not connote any particular structure. The specification does not described what the “data alarm determination unit” is. A “system alarm determination unit configured to compare…” in Claim 1. A “unit” does not connote any particular structure. The specification does not describe what the “system alarm determination unit” is. Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. Claim Rejections - 35 USC § 112 07-30-02 AIA 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. 07-34-01 Claim 1 is 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. Claim limitation “data alarm determination unit” ; “system alarm determination unit configured to compare…” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The specification is devoid of adequate structure to perform the claimed function. In particular, the specification merely states the claimed function of “to compare the data output information…”; “to compare the system output …” is performed by “comparing.” There is no disclosure of any particular structure, either explicitly or inherently, to compare the system output. The use of the term “comparing” is not adequate structure for performing the maintaining function because it does not describe a particular structure for the function and does not provide enough description for one of ordinary skill in the art to understand which comparing structure or structures perform(s) the claimed function. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. 07-34-23 Applicant may: (a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph; (b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or (c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)). If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either: (a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or (b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181. 07-34-01 Claim 2 is 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. 07-34-05 AIA Claim 2 recites the limitation " the peak intensity " in the instant claim, two instances . There is insufficient antecedent basis for this limitation in the claim. 07-34-01 Claim 3 is 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. In the instant claim there are part of the claim which are offset by parenthesis. It is unclear to the Examiner if the parts within the parenthesis are to be considered to be a claim limitation. The parts of the claims offset by the parenthesis are considered to be a ‘for example’ or ‘such as’ recitation. Claim 3 recites the limitation "the peak width" , “the peak intensity” , two instances of each. There is insufficient antecedent basis for this limitation in the claim. 07-30-01 AIA The following is a quotation of the first paragraph of 35 U.S.C. 112(a): (a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention. The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112: The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention. Claim 1 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. As described above, the disclosure does not provide adequate structure to perform the claimed function of to compare. The specification does not demonstrate that applicant has made an invention that achieves the claimed function because the invention is not described with sufficient detail that one of ordinary skill in the art can reasonably conclude that the inventor had possession of the claimed invention. Claim Rejections - 35 USC § 103 07-06 AIA 15-10-15 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. 07-20-aia AIA 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. 07-23-aia AIA 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. 07-20-02-aia AIA This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. 07-21-aia AIA Claim s 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over WAKO, US Publication No. 2014/0288854 A1, submitted on the Information Disclosure Statement on 19 OCTOBER 2023, US Patent Application Publications Cite No. 2, and further in view of HITACHI, WO 2020/084886 A1, submitted on the Information Disclosure Statement on 19 OCTOBER 2023, Foreign Patent Document Cite No. 6 . Applicant’s invention is directed towards a device. Regarding Claim 1 , the reference WAKO discloses an automatic analyzer, abstract, analysis system, Figure 1-12, comprising: an analyzer including a separation unit configured to perform separation of a sample to be measured subjected to a pretreatment, Figure 2, 3, 4-1, 4-2 analysis apparatus 3a, 3b, [0049], and a detection unit configured to detect a substance to be measured of the sample separated by the separation unit, Figure 3, 4-1, 4-2, [0049, 0062] ; and a control device configured to control an operation of the analyzer, wherein the control device, Figure 2, manager 35, [0052], includes: a data alarm database that stores data output information including at least one item generated based on a detection result of the sample of the analyzer, Figure 3, item 61, [0052-0058], Figure 8, S93, S95, [0091]; a normal data alarm database that stores predetermined reference data output information to determine whether the data output information is in a normal state or in an abnormal state, Figure 3, item 57, [0052-0058], Figure 4-2, [0097, 0098]; a data alarm determination unit configured to compare the data output information of the data alarm database with the reference data output information of the normal data alarm database and apply a data alarm to an item of the data output information of the data alarm database determined to be in an abnormal state, Figure 3, item 62, [0052-0058], Figure 4-2, [0097, 0098];; a system alarm database that stores system output information including at least one item generated based on a detection result from a sensor provided in the analyzer, Figure 3, item 57, 59, 65, [0052-0058, 0087]; a normal system alarm database that stores predetermined reference system output information to determine whether the system output information is in a normal state or in an abnormal state, Figure 3, item 57, 58, 63 [0052-0058], Figure 5, S13, [0081-0084]; and a system alarm determination unit configured to compare the system output information of the system alarm database with the reference system output information of the normal system alarm database and apply a data alarm to an item of the data output information of the system alarm database determined to be in an abnormal state, Figure 3, item 63/64, [0052-0058], Figure 5, S13, [0081-0084], and the control device is configured to execute a predictive diagnosis of a failure state of the automatic analyzer based on a temporal change of the data output information that is obtained by the analyzer using an internal standard substance as the sample and is stored in the data alarm database and a temporal change of the system output information of the system alarm database, [0062, 0091, 0098, 0099, 0103, 0107, 0108, 0113, 0114], Figure 3, 57, 63, 64, Figure 9, S119-S123, Figure 10, S149. The WAKO reference discloses the claimed invention, but is silent in regards to wherein the separation unit is a HPLC, the detection unit is a MS, based on the 112(f) analysis. HITACHI discloses an automatic analyzer, [0006, 0008], Figure 1, device 100, comprising: an analyzer including a separation unit configured to perform separation of a sample to be measured subjected to a pretreatment, [0011, 0017], and a detection unit configured to detect a substance to be measured of the sample separated by the separation unit, [0011, 0018]; and a control device configured to control an operation of the analyzer, wherein the control device, [0019], includes : a data alarm database that stores data output information including at least one item generated based on a detection result of the sample of the analyzer, [0019]; a normal data alarm database that stores predetermined reference data output information to determine whether the data output information is in a normal state or in an abnormal state, [0019]; a data alarm determination unit configured to compare the data output information of the data alarm database with the reference data output information of the normal data alarm database and apply a data alarm to an item of the data output information of the data alarm database determined to be in an abnormal state, [0020], Figure 4 and 5; a system alarm database that stores system output information including at least one item generated based on a detection result from a sensor provided in the analyzer, [0013, 0019]; a normal system alarm database that stores predetermined reference system output information to determine whether the system output information is in a normal state or in an abnormal state; and a system alarm determination unit configured to compare the system output information of the system alarm database with the reference system output information of the normal system alarm database and apply a data alarm to an item of the data output information of the system alarm database determined to be in an abnormal state, [0034-0041], Fig. 6, [0052-0055], and the control device is configured to execute a predictive diagnosis of a failure state of the automatic analyzer based on a temporal change of the data output information that is obtained by the analyzer using an internal standard substance as the sample and is stored in the data alarm database and a temporal change of the system output information of the system alarm database, [0073], Fig. 6. It would be obvious to one having ordinary skill in the art before the effective filing date to modify the WAKO reference with the HPLC separation unit and MS detection device as taught by HITACHI to increase the sensitivity, selectively and accuracy of the substance for determining an abnormality. Regarding Claim 2 , the reference WAKO and HITACHI suggest the claimed invention, but is silent in regards to wherein the automatic analyzer according to claim 1, wherein the system output information stored in the system alarm database by the control device includes at least one of: a peak area ratio of the substance to be measured and the internal standard substance; a peak intensity ratio of the substance to be measured and the internal standard substance; a peak area of the substance to be measured; a peak intensity of the substance to be measured; a retention time of the substance to be measured; a peak width of the substance to be measured; a full width at half maximum of the substance to be measured; an S/N ratio which is a ratio of the peak intensity to a background of the substance to be measured; a leading factor of the substance to be measured; a tailing factor of the substance to be measured; a peak area of the internal standard substance; a peak intensity of the internal standard substance; a retention time of the internal standard substance; a peak width of the internal standard substance; a full width at half maximum of the internal standard substance; an S/N ratio which is a ratio of the peak intensity to a background of the internal standard substance; a leading factor of the internal standard substance; and a tailing factor of the internal standard substance. WAKO does teach though that the analysis conditions includes information such as parameters (specimen quantity to be consumed, reagent quantity to be consumed, measurement wavelength (main wavelength and sub-wavelength), reaction time, measurement point and the like) as conditions causing the analysis apparatus to operate in order to carry out the analysis, dilution condition (the kind of dilution solution and dilution rate) and the calibration method, [0062]. There are also other parameters and information about components of the sample are disclosed in [0061-0069]. In addition, WAKO does teach curves of the calibrator, [0062]. HITACHI teaches the system output information stored in the system alarm database by the control device includes a peak area of the substance to be measured and a peak intensity of the substance to be measured, [0020, 0037]. Therefore, it would be obvious to one having ordinary skill in the art before the effective filing date to modify the parameters measured in WAKO as those taught by HITACHI to reliability detect parameters which indicate abnormalities and suppress deterioration of analysis accuracy, HITACHI [0007, 0009]. Regarding Claim 3 , WAKO and HITACHI suggest the claimed invention. WAKO further discloses wherein the automatic analyzer according to claim 1, wherein the data output information stored in the data alarm database by the control device includes at least one of: a signal value of the internal standard substance, WAKO [0062]; an identification check (the retention time, the peak width, the full width at half maximum, and the S/N (the ratio of the peak intensity to the background) of the internal standard substance) of the internal standard substance; a signal value of the substance to be measured; an identification check (the retention time, the peak width, the full width at half maximum, HITACHI, [0033-0037, 0044-0046], and the S/N (the ratio of the peak intensity to the background) of the internal standard substance) of the substance to be measured; a HPLC performance check (a HPLC pressure curve, an ESI probe current, and the peak width, a peak symmetry, and the retention time of the internal standard substance), HITACHI, [0033-0037, 0044-0046]; an MS performance check (a peak parameter, a background intensity, a noise value, and contamination information) , HITACHI, [0062, 0070], Fig. 8, calibration curve information; and a QC check, WAKO [0062]. Regarding Claim 4 , the references WAKO and HITACHI suggest the claimed invention. WAKO further discloses wherein the automatic analyzer according to claim 1, wherein a predictive diagnosis is executed using the internal standard substance as an index without using any of a calibration reagent, a QC reagent, and a sample in a pre- measurement preparation step of a user or a service person selecting and executing a maintenance item after a start-up step of checking communication between the analyzer and the control device and checking a state of each sensor and each consumable after power is turned on, [0062]. Applicant’s invention is directed towards a method. Regarding Claim 5 , the reference WAKO discloses a predictive diagnosis method for a failure state of an automatic analyzer, abstract, [0010, 0012-0017, 0031], including a separation unit configured to perform separation of a sample to be measured subjected to a pretreatment, Figure 2, 3, 4-1, 4-2 analysis apparatus 3a, 3b, [0049], a detection unit configured to detect a substance to be measured of the sample separated by the separation unit, Figure 3, 4-1, 4-2, [0062] , and a control device configured to control an operation of the analyzer, Figure 3, controller 51, [0056], the predictive diagnosis method, Figure 5-10, comprising: a step of storing, in a data alarm database, data output information including at least one item generated based on a detection result of the sample of the analyzer, Figure 3, item 61, [0052-0058], Figure 5, S1-S11, [0070-0072]; a step of comparing the data output information of the data alarm database with predetermined reference data output information, Figure 3, item 62, [0052-0058], and applying a data alarm to an item of the data output information of the data alarm database determined to be in an abnormal state, [0054, 0058], Figure 5, S13, [0070-0072]; a step of storing, in a system alarm database, system output information including at least one item generated based on a detection result from a sensor provided in the analyzer, Figure 3, item 65, [0052-0058, 0087], Figure 5, S17, [0073-0075]; a step of comparing the system output information of the system alarm database with predetermined reference system output information, and applying a data alarm to an item of the data output information of the system alarm database determined to be in an abnormal state; and a step of executing a predictive diagnosis of a failure state based on a temporal change of the data output information that is obtained by the analyzer using an internal standard substance as the sample and is stored in the data alarm database and a temporal change of the system output information of the system alarm database, Figure 3, item 63/64, [0052-0058], Figure 5, S19-S25, [0073-0075]. The WAKO reference discloses the claimed invention, but is silent in regards to wherein the separation unit is a HPLC, the detection unit is a MS, based on the 112(f) analysis. HITACHI discloses a predictive diagnosis method for a fail state of an automatic analyzer, [0006, 0008, 0034, 0039, 0063-0065], Figure 1, device 100, comprising: an analyzer including a separation unit configured to perform separation of a sample to be measured subjected to a pretreatment, [0011, 0017], and a detection unit configured to detect a substance to be measured of the sample separated by the separation unit, [0011, 0018]; and a control device configured to control an operation of the analyzer, wherein the control device, [0019]. It would be obvious to one having ordinary skill in the art before the effective filing date to modify the WAKO reference with the HPLC separation unit and MS detection device as taught by HITACHI to increase the sensitivity, selectively and accuracy of the substance for determining an abnormality. Pertinent Prior Art 07-96 AIA The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US Patent 7,86,0727 B2 to SHOWALTER discloses a method for communication with a laboratory information system, which includes steps of configuring, using a computer, a host to have at least one local data element associated with a first staining protocol used only by said host, said at least one local data element having a data definition and data value used only by said host; configuring, using a computer, said host to have global data elements each having a common data definition and data value used by said host and by one or more other hosts connected to said host; providing a template including a first set of one or more erroneous test patterns and, for each of said erroneous test patterns in the first set, an associated action that is performed upon detection of an occurrence of said each erroneous test pattern, each of said erroneous test patterns specifying results and processing parameters for a plurality of slides; staining a set of slides and producing first results, said staining performed in accordance with the first staining protocol using a first reagent and a stainer controlled by the host; performing first processing by the host using the template, said first processing including determining a match between a first of the erroneous test patterns and the first results, and in response to determining the match, determining a testing failure and performing an associated action specified in the template for the first erroneous test pattern, wherein said associated action includes performing lockout processing, said lockout processing comprising: identifying reagents used on said set of slides, said reagents including said first reagent and a second reagent; and disallowing further processing of slides using said reagents including: disallowing processing using any of said reagents used by said host; and updating a plurality of said global data elements associated with said reagents to indicate that processing using the reagents is on hold; and wherein, after said updating, said plurality of global data elements are communicated to said one or more other hosts and each of said one or more other hosts disallows further processing using the second reagent . While the instant invention and the SHOWALTER differ in sense that the instant invention is directed to an automatic analyzer, the reference basically teaches the same steps of data gathering and comparing steps. The method as claimed is well known in the art for determining abnormality/failure of data. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINE T MUI whose telephone number is (571)270-3243. The examiner can normally be reached M-Th 5:30 -15:30 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, LYLE ALEXANDER can be reached at (571) 272-1254. 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CTM /CHRISTINE T MUI/Primary Examiner, Art Unit 1797 Application/Control Number: 18/556,160 Page 2 Art Unit: 1797 Application/Control Number: 18/556,160 Page 3 Art Unit: 1797 Application/Control Number: 18/556,160 Page 4 Art Unit: 1797 Application/Control Number: 18/556,160 Page 5 Art Unit: 1797 Application/Control Number: 18/556,160 Page 6 Art Unit: 1797 Application/Control Number: 18/556,160 Page 7 Art Unit: 1797 Application/Control Number: 18/556,160 Page 8 Art Unit: 1797 Application/Control Number: 18/556,160 Page 10 Art Unit: 1797 Application/Control Number: 18/556,160 Page 11 Art Unit: 1797 Application/Control Number: 18/556,160 Page 12 Art Unit: 1797 Application/Control Number: 18/556,160 Page 13 Art Unit: 1797 Application/Control Number: 18/556,160 Page 14 Art Unit: 1797 Application/Control Number: 18/556,160 Page 15 Art Unit: 1797 Application/Control Number: 18/556,160 Page 16 Art Unit: 1797 Application/Control Number: 18/556,160 Page 17 Art Unit: 1797 Application/Control Number: 18/556,160 Page 18 Art Unit: 1797 Application/Control Number: 18/556,160 Page 19 Art Unit: 1797 Application/Control Number: 18/556,160 Page 20 Art Unit: 1797