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 .
Response to Arguments
Applicant's arguments filed 11/26/2025, with respect to claim rejections under 35 U.S.C. 101 have been fully considered but they are not persuasive.
Beginning on page 5, Applicant states that the amended claim is applied to a physical real-world dataset generated by chromatography hardware to perform a concrete lab quantification task, and directly improve the accuracy and robustness of chromatographic qualification. This is not persuasive, because the claim itself recites only a memory device and a processor to perform the claimed functions. The chromatogram and spectrum data only link the processing device to a specific field of use. Additionally, the quantifying step has the scope of a calculation, and displaying the results can be considered both a mental step of sharing results and an expected function of a computer. Additionally, the claims do not seem to clearly reflect the described improvement. The claims merely recite a seemingly arbitrarily imposed limit for ending processing.
Applicant’s arguments, beginning on page 6, filed 11/26/2025, with respect to claim rejections under 35 U.S.C. 102 have been fully considered, along with amendments, and are persuasive insofar that the cited prior art of record does not seem to fairly teach or suggest in a case where it is judged by the judging step that the number of estimated peaks has not reached the maximum number, the processor is configured to execute a synthesizing step of synthesizing the estimated peaks to form a synthesized peak waveform portion and a difference calculating step of calculating a difference between the synthesized peak waveform portion and the peak waveform portion, to execute a next peak estimation step when the difference exceeds a threshold value, and to finish the peak estimation processing when the difference is less than or equal to the threshold value. The rejections of claims 1-6 under 35 U.S.C. 102 have been withdrawn.
Claim Objections
Claim 1 objected to because of the following informalities:
In the last limitation “configured to executing a quantifying step” should be amended to “configured to execute a quantifying step”. 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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 3, 4, and 6 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Specifically, representative Claim 1 recites:
A data processing system comprising a processor and a data memorizing device and configured to process a three dimensional chromatogram obtained by chromatography analysis, including chromatogram data and a spectrum, wherein
the data memorizing device is configured to
memorize original data of the three-dimensional chromatogram and a maximum number of an estimated peak for analyzing the original data,
the processor is configured to execute peak estimation processing of estimating peaks included in a peak waveform portion, formed by overlapping a plurality of peaks, of the original data by repeating a peak estimation step of estimating one peak in the peak waveform portion,
the processor is configured, in the peak estimation processing, to execute a judging step of judging whether a number of estimated peaks, which are peaks estimated by the peak estimation steps that have been executed previously, has reached the maximum number after executing the peak estimation step,
in a case where it is judged by the judging step that the number of estimated peaks has not reached the maximum number, the processor is configured to execute a synthesizing step of synthesizing the estimated peaks to form a synthesized peak waveform portion and a difference calculating step of calculating a difference between the synthesized peak waveform portion and the peak waveform portion, to execute a next peak estimation step when the difference exceeds a threshold value, and to finish the peak estimation processing when the difference is less than or equal to the threshold value,
in a case where it is judged by the judging step that the number of estimated peaks has reach the maximum number. the processor is configured to finish the peak estimation processing without executing steps of the synthesizing step and the difference calculation step, and
the processor is configured to executing a quantifying step of quantifying concentration of components corresponding to the estimated peaks by calculating area of the estimated peaks and to display a result of the quantifying step on a display after the peak estimation processing is finished.
The claim limitations in the abstract idea have been highlighted in bold above; the remaining limitations are “additional elements”.
Under the Step 1 of the eligibility analysis, we determine whether the claims are to a statutory category by considering whether the claimed subject matter falls within the four statutory categories of patentable subject matter identified by 35 U.S.C. 101: Process, machine, manufacture, or composition of matter. The above claim is considered to be in a statutory category (machine).
Under the Step 2A, Prong One, we consider whether the claim recites a judicial exception (abstract idea). In the above claim, the highlighted portion constitutes an abstract idea because, under a broadest reasonable interpretation, it recites limitations that fall into/recite an abstract idea exceptions. Specifically, under the 2019 Revised Patent Subject matter Eligibility Guidance, it falls into the grouping of subject matter when recited as such in a claim limitation, that covers mathematical concepts (mathematical relationships, mathematical formulas or equations, mathematical calculations) and mental processes – concepts performed in the human mind including an observation, evaluation, judgement, and/or opinion.
For example, the step of “execute peak estimation processing of estimating peaks included in a peak waveform portion, formed by overlapping a plurality of peaks, of the original data by repeating a peak estimation step of estimating one peak in the peak waveform portion (estimations by mathematical unit); and
to execute a synthesizing step of synthesizing the estimated peaks to form a synthesized peak waveform portion and a difference calculating step of calculating a difference between the synthesized peak waveform portion and the peak waveform portion, to execute a next peak estimation step when the difference exceeds a threshold value (combining waveforms and calculations)” are treated by the Examiner as belonging to mathematical concept grouping, while the steps of “memorize original data of the three-dimensional chromatogram and a maximum number of an estimated peak for analyzing the original data (record data and a decided parameter);
to execute a judging step of judging whether a number of estimated peaks, which are peaks estimated by the peak estimation steps that have been executed previously, has reached the maximum number after executing the peak estimation step (make a determination based on information);
and to finish the peak estimation processing when the difference is less than or equal to the threshold value (stop based on a determination and subsequent decision); and
in a case where it is judged by the judging step that the number of estimated peaks has reach the maximum number, finish the peak estimation processing without executing steps of the synthesizing step and the difference calculation step, and (stop based on a determination and subsequent decision), and
to executing a quantifying step of quantifying concentration of components corresponding to the estimated peaks by calculating area of the estimated peaks and to display a result of the quantifying step on a display after the peak estimation processing is finished (organize and share results)” are treated as belonging to mental process grouping.
Next, under the Step 2A, Prong Two, we consider whether the claim that recites a judicial exception is integrated into a practical application.
In this step, we evaluate whether the claim recites additional elements that integrate the exception into a practical application of that exception.
The above claims comprise the following additional elements:
Claim 1: A data processing system comprising a processor and a data memorizing device and configured to process a three dimensional chromatogram obtained by chromatography analysis, including chromatogram data and a spectrum.
The additional element in the preamble of “A data processing system […] configured to process a three dimensional chromatogram obtained by chromatography analysis, including chromatogram data and a spectrum” is not qualified for a meaningful limitation because it only generally links the use of the judicial exception to a particular technological environment or field of use. A data memorizing device (generic memory) and a processor (generic processor) are generally recited and are not qualified as particular machines. Additionally, the data memorizing device being configured to memorize original data of the three-dimensional chromatogram and a maximum number of an estimated peak for analyzing the original data, is considered mere instructions to apply an exception, as a memory device is expected to be able to collect and store data and is therefore invoked as a tool to perform an existing process (see MPEP 2106.05(f)(2) Use of a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not integrate a judicial exception into a practical application or provide significantly more.).
In conclusion, the above additional elements, considered individually and in combination with the other claim elements do not reflect an improvement to other technology or technical field, and, therefore, do not integrate the judicial exception into a practical application. Therefore, the claims are directed to a judicial exception and require further analysis under the Step 2B.
However, the above claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception (Step 2B analysis).
The claims, therefore, are not patent eligible.
With regards to the dependent claims, claims 3, 4, and 6 provide additional features/steps which are part of an expanded algorithm, so these limitations should be considered part of an expanded abstract idea of the independent claims.
Conclusion
The Examiner notes that there are no prior art rejections for claims 1, 3, 4, and 6. Noda (US 20170336370 A1) is still considered by the Examiner to be the closest prior art of record, however, Noda does not seem to fairly teach or suggest in a case where it is judged by the judging step that the number of estimated peaks has not reached the maximum number, the processor is configured to execute a synthesizing step of synthesizing the estimated peaks to form a synthesized peak waveform portion and a difference calculating step of calculating a difference between the synthesized peak waveform portion and the peak waveform portion, to execute a next peak estimation step when the difference exceeds a threshold value, and to finish the peak estimation processing when the difference is less than or equal to the threshold value.
Regarding Claim 1, the cited Noda reference determines if a solution has converged, then decides to iterate further based on whether the processing has repeated a specified number of times, while the claimed invention checks the amount of times first, then determines iteration based on whether the difference between the synthesized peak waveform and original peak waveform is greater than a threshold.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Kozawa (US 20160238575 A1) discloses an In-Waveform Peak End Point Detecting Method And Detecting Device.
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.
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/CHRISTIAN T BRYANT/Examiner, Art Unit 2863