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 .
Status of Claims
The claim set submitted on 10 JULY 2026 is acknowledged and considered. In the claim set, Claims 1, 2, 6, 9, 10, 16, 22, 26 and 29-31 are ‘Previously Presented’; Claims 3, 4, 5, 17, 21, 23 and 24 are ‘Currently Amended’; Claims 7, 8, 11-15, 18-20, 25, 27, 28, 32-35 and 38-42 are ‘Cancelled’ ; and Claims 36 and 37 are ‘Withdrawn’.
Response to Arguments/Amendments
Applicant’s arguments, see REMARKS, filed 10 JULY 2026, with respect to the objections to some of the claims, the drawings and the specifications and the 112(b) rejections, have been fully considered and are persuasive. The objections to some of the claims, the drawings and the specifications and the 112(b) rejections have has been withdrawn.
Applicant's arguments filed 10 JULY 2026 have been fully considered but they are not persuasive.
In the REMARKS filed on 10 JULY 2026 Applicant asserts that the BECKMAN reference does not ‘discloses that a set of values is obtained by the mass spectrometer and then used to calibrate a different analyzer that is not the mass spectrometer in the system. Rather, the set of values is used to calibrate the analyzing component.’
Examiner respectfully disagrees. While the Examiner has cited [0033]; this paragraphs recite the parameters that relates to ‘a condition of operation of an instrument such as an analyzer. Parameters may relate to detection ranges for different analyzers, types of measurement values obtainable by the analyzers, the costs of operating various analyzers, the availability (or scheduling) of analyzers, when calibrations were last completed, availability of personnel to perform manual sample preparation or operate analyzers; etc’; which reads on the language of ‘a mass spectrometer configured to evaluate at least a characteristic of the least one fluid, and thereby produce a corresponding set of values’. The following paragraph of [0033], in [0034], BECKMAN goes on to describe the term “condition set” may include one or more rules for handling specific types of biological samples. Each condition set may include a plurality of variables that may be associated with the one or more rules. Laboratory rules may include rules for handling samples, detection ranges needed to meet orders, etc. In the example in [0034], a condition is determined a mass spectrometer if the sample is from a female or male, then the parameters of the mass spectrometer has a condition set, which reads on the ‘corresponding values’. If the condition set may specify that a mass spectrometer versus an immunoanalyzer is to be used; the condition set is then used to specify if retest or reflex processing is to occur on another analyzer.
Basically, it is interpreted by the Examiner that if a sample is determined to be male, i.e. the characteristic of the fluid, the parameters of the mass spectrometer with the male sample is then used to calibrate then immunoanalyzer, which can also examine the male sample.
In response to applicant's arguments against the references individually, FITZGERALD, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 18 MAY 2026 was filed after the mailing date of the Non-Final Office Action on 20 APRIL 2026. 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 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)(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.
(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.
Claims 1-6, 9, 10, 16, 17, 21-23, 26, 29-31 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by BECKMAN, WO 2019/126363, submitted on the Information Disclosure Statement on 26 JUNE 2023 and 02 APRIL 2026.
Applicant’s invention is directed towards a device.
Regarding Claim 1, the reference BECKMAN reference discloses clinical laboratory automation system, abstract, system 100, [0064], Figure 1A, comprising:
a fluid handling system including a container handler, Figure 1A, apparatus 140, [0082], at least one fluid container, Figure 1B, unit 140A, [0082], and a pipettor arrangement, [0067], the fluid handling system configured to dispense at least one fluid into the at least one fluid container, [0104, 0113]; an analyzing component, , Figure 1A, analyzer 101/102, [0082]; and a mass spectrometer configured to evaluate at least a characteristic of the at least one fluid, and thereby produce a corresponding set of , Figure 1A, mass spectrometer 106, [0082] , wherein the analyzer is calibrated at least in part using the corresponding set of values, [0033, 0034, 0062].
Additional Disclosures Included are: Claim 2: wherein the clinical laboratory automation system of claim 1, wherein the clinical laboratory automation system is further configured to evaluate for dispensing inaccuracies in the pipettor arrangement using at least the corresponding set of values, Claim 1 and 2, [0074, 0075], condition sets. ; Claim 3: wherein the clinical laboratory automation system of claim 1, wherein the analyzing component [[includes]] comprises an immunoassay analyzer, [0006].; Claim 4: wherein the clinical laboratory automation system of claim 1, wherein the analyzing component [[includes]] comprises a clinical chemistry analyzer, protein chemistry analyzer, hematology analyzer, or urinalysis analyzer, [0041].; Claim 5: wherein the clinical laboratory automation system of claim 1, further comprising a sample pipettor station, [0067].; Claim 6: wherein the clinical laboratory automation system of any of the preceding claims, wherein the pipettor arrangement comprises a pump, wherein the pump is driven by an actuator, [0050, 0098, 0114].; Claim 9: wherein the clinical laboratory automation system of claim 1, wherein the at least one fluid is selected from the group consisting of a calibrator, [0033, 0062], a diagnostic reagent, [0049, 0051], a diluent, [0144], or mixtures, [0147, 0190, 0199, 0212], thereof. ; Claim 10: wherein the clinical laboratory automation system of claim 9, wherein the calibrator contains at least one type of analyte or antibody, [0057, 0058, 0062].; Claim 16: wherein the clinical laboratory automation system of claim 5, wherein the pipettor arrangement further comprises at least a first pipettor, wherein the first pipettor is configured to dispense at least one requested volume of a fluid, [0067, 0141].; Claim 17: wherein the clinical laboratory automation system of claim 16, wherein the fluid handling system is configured to dispense at least two fluids, wherein the at least two fluids comprise a first fluid and a second fluid, Figure 4A, [0114, 0115, 0181, 0182].; Claim 21: wherein the clinical laboratory automation system of claim 17, wherein the first fluid is the diluent and the second fluid is [[the]] a calibrator, [0033, 0062, 0144].; Claim 22: wherein the clinical laboratory automation system of claim 21, wherein the fluid handling system is configured to produce a dilution series of the calibrator, the dilution series comprising at least one dilution of the calibrator, [0033, 0062]. ; Claim 23: wherein the clinical laboratory automation system of claim 22, wherein the characteristic evaluated is a concentration of the at least one dilution of the calibrator from [[the]] a set of the dilution series of the calibrator, [0033, 0062]. ; Claim 26: wherein the clinical laboratory automation system of claim 17 , wherein the first fluid is a first diagnostic reagent and the second fluid is a second diagnostic reagent, wherein the characteristic evaluated is a quantitation of a mixture of the first diagnostic reagent and the second diagnostic reagent, [0051, 0052, 0060, 0111-0115].; Claim 29: wherein the clinical laboratory automation system of claim 26, wherein the quantitation of the mixture of diagnostic reagents comprises quantifying the mixture of the first diagnostic reagent and the second diagnostic reagent by molecular weight shift, [0045, 0051, 0052, 0182]. ; Claim 30: wherein the clinical laboratory automation system of claim 29, wherein if the dispensing inaccuracies are determined, motor steps of the actuator are adjusted as necessary to dispense the respective volumes, [0074, 0075, 0155]. ; and Claim 31: wherein the clinical laboratory automation system of claim 29, wherein if the dispensing inaccuracies are determined, the pipettor arrangement is calibrated at least in part with the corresponding set of values, [0074, 0075, 0155]. Examiner’s Note: It should be noted that the language recited in this claim is directed towards how the device is to be operated when it is intended to be used. Since the prior art teaches and discloses all the structural limitation of the invention, it will inherently possesses the functionally defined limitations of the claimed apparatus. In re Schreiber, 128 F.3d at 1478, 44 USPQ2d at 1432. In addition, “[A]pparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co.v.Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990). A claim containing a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
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.
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.
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.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over BECKMAN, WO 2019/126363, submitted on the Information Disclosure Statement on 26 JUNE 2023, and further in view of FITZGERALD, US Patent 6,498,010 B1.
Regarding Claim 24, the reference BECKMAN discloses the claimed invention, but is silent in regards to wherein an RLU- dose conversion curve is generated from the corresponding set of values and the analyzing component is calibrated at least in part using the RLU-dose conversion curve.
The FITZGERALD discloses a clinical laboratory automation system, Column 4 line 9-21, Column 8 line 63-67, comprising: a fluid handling system, Column 9 line 63-67, a pipettor station, Column 13 line 10-16, and an RLU- dose conversion curve that is generated from a corresponding set of values, Column 10 line 41-47, and an analyzing component is calibrated at least in part using the RLU-dose conversion curve, Column 12 line 26-32.
It would have been obvious to one having ordinary skill in the art before the effective filing date to modify the data obtained to generate an RLU- dose conversion curve is generated from the corresponding set of values and the analyzing component is calibrated at least in part using the RLU-dose conversion curve to have high sensitivity with low background and a wide dynamic range.
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 CHRISTINE T MUI whose telephone number is (571)270-3243. The examiner can normally be reached M-Th 5:30 -15:30 EST.
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CTM
/CHRISTINE T MUI/Primary Examiner, Art Unit 1797
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