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 .
DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/27/2026 has been entered.
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, 16, 17, 19, and 20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims recite an abstract idea as discussed below. This abstract idea is not integrated into a practical application for the reasons discussed below. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the reasons discussed below.
Step 1 of the 2019 Guidance requires the examiner to determine if the claims are to one of the statutory categories of invention. Applied to the present application, the claims belong to one of the statutory classes of a process or product as a computer implemented method or a computer system/product.
Step 2A of the 2019 Guidance is divided into two Prongs. Prong 1 requires the examiner to determine if the claims recite an abstract idea, and further requires that the abstract idea belong to one of three enumerated groupings: mathematical concepts, mental processes, and certain methods of organizing human activity.
Claim 1 is copied below, with the limitations belonging to an abstract idea being underlined/.
A waveform processing assistance device including a processor that assists processing by a user of a waveform data piece representing an analysis result of an analysis device,
wherein the processor
performs, using the analysis device, two analyses for an identical sample under a same analysis condition to acquire a first waveform data piece and a second waveform data piece from the analysis device and stores the acquired first waveform data piece and the acquired second waveform data piece, the first waveform data piece having a first peak representing a certain component,
extracts a first peak feature amount and a second peak feature amount of the first peak by applying a first waveform processing parameter and a second waveform processing parameter to the first waveform data piece,
determines a second peak in the second waveform data piece, the second peak corresponding to the first peak and representing an identical component to the first peak,
extracts a third peak feature amount and a fourth peak feature amount of the second peak by applying the first waveform processing parameter and the second waveform processing parameter to the second waveform data piece, the third peak feature amount and the fourth peak feature amount corresponding to the first peak feature amount and the second peak feature amount, respectively,
calculates a first variation of the first peak feature amount and the third peak feature amount, and a second variation of the second peak feature amount and the fourth peak feature amount, the first variation and the second variation representing reproducibility for the first wave from processing parameter and the second wave from processing parameter, respectively, and
creates an analysis method file including the first waveform processing parameter or the second wave form processing parameter, based on whether the first variation is higher than the second variation.
The limitations underlined can be considered to describe a mathematical concept, namely a series of calculations leading to one or more numerical results or answers, obtained by a sequence of mathematical operations on numbers and/or mental steps. The lack of a specific equation in the claim merely points out that the claim would monopolize all possible appropriate equations for accomplishing this purpose in all possible systems. These steps recited by the claim therefore amount to a series of mental and/or mathematical steps, making these limitations amount to an abstract idea.
In summary, the highlighted steps in the claim above therefore recite an abstract idea at Prong 1 of the 101 analysis.
The additional elements in the claim have been left in normal font.
The new amendments (underline) of the claim 1 are merely extend the details of the abstract idea of mathematical concepts, more particularly mathematical calculations or mental steps.
The additional limitations in relation to the processor, i.e. a computer, does not offer a meaningful limitation beyond generally linking the use of the method to a computer (see ALICE CORP. v. CLS BANK INT’L 573 U. S. 208 (2014)). The claim does not recite a particular machine applying or being used by the abstract idea.
The additional limitations of causing a display to display the results of the abstract idea equates to extra-solution data activity, i.e. data reporting (see MPEP 2106.05(g)). The recited “analysis device” is an additional element, but it does not make the claim eligible as a particular machine since it is not sufficiently specific and merely defines a very broad range of technological environments or fields-of-use where the abstract idea can be used. (The applicant argues that the invention is an improvement in the chromatographic waveform processing, but neither chromatograms nor chromatography are recited in the claims, so the claims do not reflect this.)
The claims do not integrate the abstract idea into a practical application. Various considerations are used to determine whether the additional elements are sufficient to integrate the abstract idea into a practical application. The claim does not recite a sufficiently particular machine applying or being used by the abstract idea. The claim does not effect a real-world transformation or reduction of any particular article to a different state or thing. (Manipulating data from one form to another or obtaining a mathematical answer using input data does not qualify as a transformation in the sense of Prong 2.)
The claim does not contain additional elements which describe the functioning of a computer, or which describe a particular technology or technical field, being improved by the use of the abstract idea. (This is understood in the sense of the claimed invention from Diamond v Diehr, in which the claim as a whole recited a complete rubber-curing process including a rubber-molding press, a timer, a temperature sensor adjacent the mold cavity, and the steps of closing and opening the press, in which the recited use of a mathematical calculation served to improve that particular technology by providing a better estimate of the time when curing was complete. Here, the claim does not recite carrying out any comparable particular technological process.) In all of these respects, the claim fails to recite additional elements which might possibly integrate the claim into a particular practical application. Instead, based on the above considerations, the claim would tend to monopolize the abstract idea itself, rather than integrate the abstract idea into a practical application.
Step 2b of the 2019 Guidance requires the examiner to determine whether the additional elements cause the claim to amount to significantly more than the abstract idea itself. The considerations for this particular claim are essentially the same as the considerations for Prong 2 of Step 2a, and the same analysis leads to the conclusion that the claim does not amount to significantly more than the abstract idea.
Therefore, claim 1 is rejected under 35 U.S.C. 101 as directed to an abstract idea without significantly more.
Dependent claims 16, 17, 19, and 20 are similarly ineligible. The dependent claims merely add limitations which further detail the abstract idea, namely further mathematical/mental steps detailing how the data processing algorithm is implemented, i.e. additional software limitations, and/or further define the type of data acquired and being evaluated by the abstract idea, i.e. extra-solution data activity. These do not help to integrate the claim into a practical application or make it significantly more than the abstract idea (which is recited in slightly more detail, but not in enough detail to be considered to narrow the claim to a particular practical application itself).
Response to Arguments
Applicant’s arguments, filed (05/27/2026), with respect to pending claims 1, 16, 17, 19, and 20 have been fully considered and are directed to claims as amended. The arguments addressed to the 101 rejection is not persuasive.
Applicant argues (page 5, lines 13-22):
“…The relevant issue is whether the claimed result of calculation is applied to a technical process in a manner that improves that process.
According to the USPTO Guidance, including Example 45 (Controller for Injection Mold), a configuration that sends signals to open a mold when a target percentage has been reached based on a result of calculation is recognized as a technical improvement. Likewise, the analysis method file of the present application is not directed to mere storage of data, but to an aggregation of specific control information for defining an operation of an analysis device and improving accuracy of a chemical analysis. The claims therefore do more than merely analyze or store information; they use the comparison result to generate a concrete technical output for waveform processing.”
Applicant argues that the claim is similar to example patent-eligible claim 45 (Controller for Injection Mold), but this is not persuasive, because Claim 1 is not analogous to Example 45 of the Patent Subject Matter Eligibility Guidance (PEG). Example 45 of the PEG provides a controller for an injection molding apparatus, wherein the controller is configured to (a) send a control signal to the injection molding apparatus to regulate injection of uncured polyurethane into the mold, and to heat the mold to a target temperature to cure the polyurethane; (b) repeatedly obtain temperature measurements of the mold; (c) compare the obtained temperatures to a target temperature; and (d) maintain temperature of the mold within two degrees of the target temperature by sending a control signal to the apparatus to selectively heat or cool the mold when the obtained temperature of the mold is more than two degrees different than the target temperature.
In this instance, the current set of claims do include any active step analogous to controlling an injection molding apparatus. Rather, it merely creates a file that may be used in future analysis.
The current set of claims equate to selecting a parameter value that produces a higher degree of reproducibility. The argued analysis method file is broadly recited, and can be equated to the creation, selection, or storage of a parameter value. As indicated, the parameter is selected based on calculations and a comparison, i.e. mathematical and mental steps. The step of creating an analysis method file, i.e. choosing the first waveform processing parameter, based on the determined reproducibility values is part of the abstract idea of the claimed invention, i.e. another algorithm step performed by the computer. Furthermore, storing the optimal parameter in a file could also be considered insignificant post-solution data activity such as saving the parameter in a database/file.
Applicant argues (page 5, lines 23-27, and further on page 6, lines 10-19):
“Also, MPEP 2106.05(a) recognizes that a specific improvement in a technical field constitutes a practical application. With the claimed invention, it is possible to select a parameter having high reproducibility in waveform processing for peaks derived from the same component in different chromatograms. The current application describes that it is essential for improvement of accuracy of a quantitative analysis to automatically select a parameter having high reproducibility while the shape of peaks changes due to analysis conditions or deterioration of the column. Thus, the present invention represents a technical improvement in the field of chromatograms and is integrated into a practical application”
“The claims are further tied to a specific technological implementation. The claims require acquisition of first and second waveform data pieces for an identical sample under the same analysis condition, identification of corresponding peaks representing an identical component in different chromatograms, extraction of peak feature amounts under different waveform processing parameters, calculation of respective variations representing reproducibility, and creation of an analysis method file based on comparison of those variations. These concrete limitations show that the claims are directed to improving chromatographic waveform processing in a defined analytical environment, not to a generalized idea of comparing data.”
Applicant argues that they are reciting a specific improvement in chromatography, e.g., identification of corresponding peaks representing an identical component in different chromatograms. However, the claims do not explicitly mention chromatography (they only refer to analyzing samples, which is not specific to chromatography). There is no sufficiently particular machine recited to tie the claim to a particular practical application, and the step of creating the analysis method file is the only thing close to a real-world transformation which occurs in the claim, and that is just an insignificant extra-solution step analogous to outputting the results of the calculations.
The Examiner respectfully suggests that the claims might be moved towards eligibility by specifically reciting the claims be amended to explicitly recite a specific device, e.g. a chromatographic device, etc., in order to reinforce the argument that the claim reflects an improvement in chromatographic waveform processing.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL J DALBO whose telephone number is (571)270-3727. The examiner can normally be reached M-F 9AM - 5PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Schechter can be reached on (571) 272-2302. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KALERIA KNOX/
Examiner, Art Unit 2857
/ANDREW SCHECHTER/Supervisory Patent Examiner, Art Unit 2857
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