. 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 .
Election/Restrictions
Claims 36 and 37 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected methods, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 30 MARCH 2026.
Applicant’s election without traverse of Group I: Claims 1-6, 9, 10, 16, 17, 21-24, 26, 29-31 in the reply filed on 30 MARCH 2026 is acknowledged.
Status of Claims
Applicant has elected Group I: Claims 1-6, 9, 10, 16, 17, 21-24, 26, 29-31 in the reply filed on 30 MARCH 2026 without traverse.
Claims 36 and 37 are ‘Withdrawn’; and Claims 7, 8, 11-15, 18-20, 25, 27, 28, 32-35 and 38-42 are ‘Cancelled’.
Current pending claims for consideration are Claims Group I: Claims 1-6, 9, 10, 16, 17, 21-24, 26, 29-31 and are considered on the merits below.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 26 JUNE 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.
The information disclosure statement (IDS) submitted on 27 JULY 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.
The information disclosure statement (IDS) submitted on 30 MAY 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.
The information disclosure statement (IDS) submitted on 02 APRIL 2026 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.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: Figure 3, character 302, 306; Figure 4, character 302, 308; Figure 8, character 812; Figure 9, character 916. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: Figure 6, [0074], introduction apparatus 619. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “621”, in Figure 6 has been used to designate both what is interpreted by the Examiner to be both the introduction apparatus and the nebulization capillary, [0074]. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
The use of the terms listed in [0053], which include “MD's Athlon, Duron and/or Opteron; IBM and/or Motorola's PowerPC; IBM's and Sony's Cell processor; Apple's M1, Intel's Celeron, Itanium, Pentium, Xeon, and/or XScale;”, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Appropriate correction is required.
Claim Interpretation
Instant Claims 3-5 recite the language ‘includes’. It is interpreted by the Examiner that this transition word is the same as ‘comprises’.
For example, it is interpreted by the Examiner that Claim 3 is read as ‘The clinical laboratory automation system of claim 1, wherein the analyzing component comprises an immunoassay analyzer.’
Claim Objections
Claim 5 is objected to because of the following informalities: In the instant claim, the wording is awkward/repetitive. For clarity, Examiner suggest Claim 5 to recite : “5. (Previously presented) The clinical laboratory automation system of claim 1, comprises a sample pipettor station.” Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claims 17, 21, 23 and 24 are 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.
Regarding claim 17, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 21 recites the limitation "the calibrator" in the last line. There is insufficient antecedent basis for this limitation in the claim.
Claims 22-24 are also rejected under 112(b) as being dependent upon a rejected claim.
Claim 23 recites the limitation "the set of dilution series" in the last line. There is insufficient antecedent basis for this limitation in the claim.
Claim 23 recites the limitation "the set of dilution series" in the last line. There is insufficient antecedent basis for this limitation in the claim.
Claim 24 recites the limitation "the corresponding set of values" . There is insufficient antecedent basis for this limitation in the claim.
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 lest 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, 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 an immunoassay analyzer, [0006].; Claim 4: wherein the clinical laboratory automation system of claim 1, wherein the analyzing component includes a clinical chemistry analyzer, protein chemistry analyzer, hematology analyzer, or urinalysis analyzer, [0041].; Claim 5: wherein the clinical laboratory automation system of claim 1, wherein the clinical laboratory automation system further includes 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, preferably 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 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 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
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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