DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 01/12/2024, 12/17/2024, 01/16/2025, 04/09/2025, 04/17/2025, 12/02/2025, and 06/16/2026 are being considered by the examiner.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 20 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims recite the judicial exception of a mental process. In essence (aside from the computer / algorithm, discussed below) this claim recites performing “spectral analysis of the pressure slope waveform by computing a moving average or a wavelet transform of the pressure slope waveform”. Calculating a derivative and a moving average of the derivative may be a concept performed in the human mind or with the aid of a pencil and paper. This judicial exception is not integrated into a practical application because the generically recited computer element of “a non-transitory computer-readable storage medium, comprising a processor-executable algorithm” does not add a meaningful limitation to the abstract idea because it amounts to simply implementing the abstract idea on a computer. The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception.
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.
(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 21 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dunfee et al. (US 20190234787 A1).Regarding claim 21:Dunfee teaches a method of detecting a short-sample aspiration fault (title, [0002], [0004], [0040]) in an automated diagnostic analysis system, the method comprising:
deriving an aspiration pressure measurement signal waveform from aspiration pressure measurements made by a pressure sensor as a liquid is being aspirated (e.g., [0004], [0094]) in the automated diagnostic analysis system; identifying a pattern in one or more first aspiration pressure measurement signal waveforms of normal aspirations ([0066]-[0069], [0093]-[0105], [0113], FIG. 15, etc.); defining a time-windowed localization of an aberration identified in one or more second aspiration pressure measurement signal waveforms, the aberration caused by the short-sample aspiration fault ([0066]-[0069], [0093]-[0105], [0113], FIG. 15, etc.); and deriving suitable discriminating metrics to detect the aberration, wherein simple thresholding, an unsupervised classifier, or a supervised learning-based classifier is used with the discriminating metrics to identify the aberration in subsequent aspiration pressure measurement signal waveforms([0066]-[0069], [0093]-[0105], [0113], FIG. 15, etc.)
Allowable Subject Matter
Claims 1-19 are allowed.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 1: The prior art, alone or in combination, fails to anticipate or render obvious a method of detecting a short-sample aspiration fault in an automated diagnostic analysis system, the method comprising: performing aspiration pressure measurements via a pressure sensor as a liquid is being aspirated in the automated diagnostic analysis system; analyzing an aspiration pressure measurement signal waveform via a processor executing an algorithm configured to derive a slope waveform from the aspiration pressure measurement signal waveform and to compute: a moving average of the slope waveform, or a wavelet transform of the slope waveform; and identifying and responding to a short-sample aspiration fault via the processor in response to the analyzing.
Regarding claims 2-10: These claims are allowable due to at least their dependency on claim 1.
Regarding claim 11: This claim is allowable for the same reasons as claim 1.
Regarding claims 12-19: These claims are allowable due to at least their dependency on claim 11.
The closest prior art is cited by the examiner in the conclusion section below. The prior art teaches pressure measurements (thresholds, timing) to detect aspiration faults, sliding windows of pressure measurements, using pressure slope to determine aspiration start and stop times, and transformation of the pressure measurements into the frequency domain; however, the prior art fails to teach the moving average of the slope of the pressure measurements or a wavelet transformation of the slope of the pressure measurements to detect short-sample aspiration faults.
The following claim drafted by the examiner and considered to distinguish patentably over the art of record in this application, is presented to applicant for consideration:
Claim 22. A non-transitory computer-readable storage medium, comprising instructions that, when executed by a processor, perform the steps of:
performing aspiration pressure measurements via a pressure sensor as a liquid is being aspirated in the automated diagnostic analysis system;
analyzing an aspiration pressure measurement signal waveform via a processor executing an algorithm configured to derive a slope waveform from the aspiration pressure measurement signal waveform and to compute:
a moving average of the slope waveform, or
a wavelet transform of the slope waveform; and
identifying and responding to a short-sample aspiration fault via the processor in response to the analyzing.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
WIKHOLM; David et al., (US 20200330977 A1), "AUTOMATIC LIQUID TRANSFER OPTIMIZATION PIPETTING APPARATUS AND METHOD";
Pawlowski; Frank, (US 20190376994 A1), "SYSTEMS AND METHODS FOR DETECTING A LIQUID LEVEL";
Hsieh; Pei-Ying et al., (US 20160157704 A1), "REAL TIME DETECTION OF ASPIRATION SHORT SHOTS USING PRESSURE SIGNAL";
Wang; Litao et al., (US 20160003860 A1), "REAL-TIME VOLUME CONFIRMATION DISPENSING APPARATUS AND METHODS";
Evers; Alexander Vidlak et al., (US 9052300 B2), "Methods, systems, and apparatus to determine a clot carryout condition upon probe retraction during sample aspiration and dispensing";
Beumer; Thomas et al., (US 20130073243 A1), "Method, Computer Program, and Apparatus for Detecting Pipetting Errors";
Ding; Zhong et al., (US 7792647 B1), "Quantitatively measuring error causing parameters in fluid handling";
Ziegler; Guenter et al., (US 20090070049 A1), "METHOD FOR MONITORING A FLUID TRANSFER PROCESS";
Shimase, Akihiro et al., (US 20040034479 A1), "Sample dispensing apparatus and automatic analyzer using the same";
Lipscomb, James H. et al., (US 20020189373 A1), "Fluid dispense and fluid surface verification system and method";
Dunfee; William David et al., (US 6370942 B1), "Method for verifying the integrity of a fluid transfer";
Dorenkott; Jeffrey S. et al., (US 6121049 A), "Method of verifying aspirated volume in automatic diagnostic system"; and
Takeda; Masaaki et al., (US 5540081 A), "Pipetting apparatus with clot detection".
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Herbert Keith Roberts whose telephone number is (571)270-0428. The examiner can normally be reached 10a - 6p MT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Peter Macchiarolo can be reached at (571) 272-2375. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HERBERT K ROBERTS/Primary Examiner, Art Unit 2855
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