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 .
Response to Arguments
Applicant's arguments filed 01/27/2026 have been fully considered but they are not persuasive.
In regards to the applicant’s arguments that the reference to Tsuruoka differs from the claimed invention in that it is silent to: “a value 50% higher than an expected target value of a calibration system” or “voltage values at least 20% higher compared to the defined voltage values of a noise or a fallback level”, the Examiner respectfully disagrees.
Attention is brought to paragraphs 51-59 of Tsuruoka, wherein a measurement apparatus and method performs various iterative calculations to determine: median values; upper and lower limits; and desired ranges and thresholds. Tsuruoka explicitly discloses various measured median voltage values (A1 to A5) (550v, 775v, 887v, 831v, 803v), and wherein a final measured value of A5 (803v) is within 5% of a reference value (par. 55-59). Specifically, the initial median voltage of 550v is understood to be outside of a tolerance range by a value of more than 50% from the final value of 803v.
Further, attention is brought to the 112b rejections presented below. The claims appear to be a literal translation into English, and are replete with grammatical and idiomatic errors. The claims include a series of run-on sentences which are difficult to follow and comprehend. Additionally, all of the limitations following “performing a check”, are recited by an “or” statement, and include conditional limitations that occur only if certain conditions are met. For example, the claims recite “proceeding with the method”, when certain conditions are meet. As discussed above, the required conditions are difficult to ascertain.
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 1-10 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.
The claims appear to be a literal translation into English from a foreign document and are replete with grammatical and idiomatic errors.
The claims contain numerous run-on sentences, which are difficult to follow and comprehend.
Additionally, the bulk of the claimed limitations are recited by an “or” statement, and they include conditional limitations that occur only if certain conditions are met. For example, the claims recite “proceeding with the method”, when certain conditions are meet. For the purpose of examination, the examiner may view the conditions as not being met, and therefore the method will not proceed.
Appropriate correction is required.
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.
Claims 1-10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim(s) recite(s) “a method for monitoring washing processes in automated analyzer systems”. The claims merely recite the judicial exception of a mathematical concept involving data manipulation. This judicial exception is not integrated into a practical application because the claims merely amount to insignificant extra-solution activity. The claims are directed to performing repetitive calculations to obtain various median voltage values and determining whether the voltage data values are within a predetermined threshold range (See Flook, 437 U.S. at 594, 198 USPQ2d at 199). The claim(s) do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claimed elements are well-understood, routine and conventional.
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.
Claim(s) 1-10 are rejected under 35 U.S.C. 102(a1) as being anticipated by US Publication 2021/0018438 to Tsuruoka et al.
In regards to claims 1-10, Tsuruoka discloses and shows in Figures 2 and 4-11, a method for adaptive signal processing, comprising the steps of:
illuminating the content in a container with a light source (20) from one side of the container (10) (par. 7, 29-30, 42);
measuring the optical signal with a sensor (30) resulting from light shining through the container and its content (par. 7, 29-30, 43);
a voltage application unit (50) configured to assigning voltage values to the measured optical signals (par. 5, 25, 55-59);
a controller (40) (par. 26, 47-51) configured for:
preparing a voltage curve (Figures 4 and 7) from sampled measurements of voltage values over time (par. 5, 47-51, 55-59);
determining a voltage level of a background noise level (Figure 7) (par. 5, 47-51, 55-59; wherein a noise signal is included in the measurements);
performing a value comparison (applicant’s first check) to verify whether a target signal is already present at the beginning of the measurement by reducing the voltage values by a defined factor to a present fallback level when the median of measured voltage values at the beginning of the voltage curve is outside a tolerance range with a value that is more than 50% higher than an expected target value of a system calibration (Figures 7 and 9) (par. 9, 51-52, 55-59, 61; wherein a median voltage value of a fluorescence intensity is measured and compared to a reference voltage value, if the measured voltage value is not equal to a reference voltage value, the measured voltage value is set to an upper or lower voltage limit; the measurements, comparisons and adjustments are repeated until the measured voltage value is equal to the reference value); or
wherein the measured voltage at the beginning of the voltage curve is within the tolerance range or is lower than the expected target value of the system calibration (Figures 7 and 9) (par. 9, 51-52, 55-59, 61; wherein a median voltage value of a fluorescence intensity is measured and compared to a reference voltage value, if the measured voltage value is not equal to a reference voltage value, the measured voltage value is set to an upper or lower voltage limit; the measurements, comparisons and adjustments are repeated until the measured voltage value is equal to the reference value);
determining the voltage level of a target signal by calculating the median of a group of the highest voltage values (Figures 7 and 9) (par. 9, 51-52, 55-59, 61; wherein a median voltage value of a fluorescence intensity is measured and compared to a reference voltage value, if the measured voltage value is not equal to a reference voltage value, the measured voltage value is set to an upper or lower voltage limit; the measurements, comparisons and adjustments are repeated until the measured voltage value is equal to the reference value);
performing a second check by determining whether the median of a group of highest target voltage values is at least 20% higher compared to the defined voltage values of the background noise level or a fallback level (Figures 7 and 9) (par. 9, 51-52, 55-59, 61; wherein a median voltage value of a fluorescence intensity is measured and compared to a reference voltage value, if the measured voltage value is not equal to a reference voltage value, the measured voltage value is set to an upper or lower voltage limit; the measurements, comparisons and adjustments are repeated until the measured voltage value is equal to the reference value);
wherein the median of the group of the highest voltage values is at least 20% higher compared to the defined voltage values of a noise level or a fallback level (Figures 7 and 9);
determining discrimination limits between the voltage values relating to a noise level and a target level, respectively, by setting the discrimination limit in the middle between the noise level and signal level (Figures 4-5, 7 and 9) (par. 9, 51-52, 55-59, 61; wherein a median voltage value of a fluorescence intensity is measured and compared to a reference voltage value, if the measured voltage value is not equal to a reference voltage value, the measured voltage value is set to an upper or lower voltage limit; the measurements, comparisons and adjustments are repeated until the measured voltage value is equal to the reference value);
[claim 2] comprising the step of determining voltage values in a running process for process control (par. 6-9; wherein the apparatus is a flow cytometer for analyzing a flow a sample through the apparatus);
[claim 3] wherein the median of voltage values from the beginning comprises the median value of pre-defined number of measured voltage values (Figure 7) (par. 55-59; wherein the median value is determined between an upper and lower limit (applicant’s pre-defined number of values));
[claim 4] wherein the median of the group of highest voltage values is defined from a pre-defined number of measured highest voltage values (Figure 7) (par. 23, 55-59; wherein the median value is determined between an upper and lower limit (applicant’s pre-defined number of values));
[claim 5] wherein the method is stopped when the median of the measured voltage values is at least 50% higher than an expected target value of a system calibration (Figures 4 and 7) (par. 9, 23, 51-52, 55-59, 61; wherein the voltage is continually re-recalibrated when the value is more than 5% different than the reference value) (this claim is deemed indefinite, as discussed above);
[claim 6] comprising the step of measuring optical signal in a sample with a known concentration of a target for obtaining a voltage value for an expected target signal (par. 47, 55-57, 63; wherein the apparatus measures a positive control sample and a negative control sample);
[claim 7] comprising the step of measuring optical signal in a sample without a target for obtaining a voltage value for a noise level (par. 47, 63, 91; wherein the negative control sample is an unlabeled sample, and can also be set to zero by a user);
[claim 8] wherein a container is bottle, vessel, cuvette, tube, hose or a channel (Figure 2) (par. 7-9; wherein the container is a flow cell);
[claim 9] a method for process control of samples which are optically evaluated in a device comprising the step of applying a method (par. 7-9).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 JONATHAN M HANSEN whose telephone number is (571)270-1736. The examiner can normally be reached Monday to Friday, 8am to 4pm.
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, Michelle Iacoletti can be reached at 571-270-5789. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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JONATHAN M. HANSEN
Primary Examiner
Art Unit 2877
/JONATHAN M HANSEN/Primary Examiner, Art Unit 2877
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