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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 9/16/2026 has been entered.
Response to Amendment
Applicant' s amendment and response filed 9/16/2026 has been entered and made record. This application contains 6 pending claims.
Claims 1-2, 4, 6-7, and 9 have been amended.
Response to Arguments
Applicant’s arguments filed 9/16/2026 regarding claims rejections under 35 U.S.C. 101 in claim 1-2, 4, 6-7, and 9 have been fully considered but they are not persuasive.
The applicant argues on pages 7-9N of the remark filed on 9/16/2026 that “… Under Step 2A, Prong Two, the claims are integrated into a practical application because they improve chromatographic data-processing technology. Amended claim 1 requires acquiring, from a chromatograph, a three-dimensional chromatogram including a chromatogram and a spectrum. … The claimed process addresses those technical limitations by first fitting the peak model function to obtain estimated peaks for the respective overlapping physical peaks and then using matrix decomposition to adjust the shapes of those estimated peaks until the pseudo chromatogram satisfies the recited similarity condition or converges. This ordered combination improves estimation of peak shapes and sizes, thereby improving quantification accuracy for the respective components. … ”.
The Examiner respectfully disagrees applicant’s argument. Practical application can be demonstrated by additional elements that are sufficient to integrate the judicial exception into a practical application. The additional element “a data receiving part that receives a three-dimensional chromatogram including a chromatogram and a spectrum from a chromatograph” is considered necessary data gathering and thus, not sufficient to integrate the abstract idea into a practical application. As recited in MPEP section 2106.05(g), necessary data gathering (i.e., retrieving data) is considered extra solution activity in light of Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; OIP Techs., Inc. v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1092-93 (Fed. Cir. 2015).
The additional elements “wherein the chromatogram includes an overlapped peak formed by overlapping a first peak of a first component and a second peak of a second component”; “a storage part that stores the three-dimensional chromatogram, and a peak model function prepared in advance and including parameters related to peak shape and peak size”; “wherein the data processor is configured to execute”: and “a concentration displaying step of displaying the quantified concentrations of the first and second components on the display” are not sufficient to integrate the abstract idea into a practical application. The alleged improvement of estimation of peak shapes and sizes, thereby improving quantification accuracy for the respective components relate to improvement to the abstract idea itself. Therefore, the current claims do not recite additional elements that are indicative of integration of an abstract idea into a practical application.
The applicant argues on page 9 of the remark filed that “… Even if the matrix-decomposition operations were viewed as reciting an abstract idea, the claims recite significantly more than that idea. … Even if peak-model fitting and matrix decomposition were individually known, the Office Action does not establish that the claimed arrangement of those techniques to resolve overlapping chromatographic peaks and improve component quantification was well- understood, routine, or conventional.”
The Examiner respectfully disagrees applicant’s argument. Significantly more can be demonstrated by additional elements that are not well-understood and conventional that integrate the abstract idea into a practical application. However, the claim does not recite them. The additional elements “wherein the chromatogram includes an overlapped peak formed by overlapping a first peak of a first component and a second peak of a second component”; “a storage part that stores the three-dimensional chromatogram, and a peak model function prepared in advance and including parameters related to peak shape and peak size”; “wherein the data processor is configured to execute”: and “a concentration displaying step of displaying the quantified concentrations of the first and second components on the display” are routine in
analyzing liquid chromatography data when two or more substance peaks overlap on the same chromatogram; and are well-understood and conventional. Therefore, the claim 1 does not contain additional elements that are not well-understood and conventional that integrate the abstract idea into a practical application.
Claim 6 recites subject matter that are similar to that of claim 1, and therefore, the claims are also patent ineligible.
Dependent claims 2, 4, 7, and 9 provide additional features/steps which are considered part of an expanded abstract idea of the independent claims, and do not integrate the abstract ideas into a practical application. Therefore, claims 2, 4, 7, and 9 are also patent ineligible.
Hence, the Examiner submits that the rejections of Claims 1-2, 4, 6-7, and 9 are proper.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitations are “a chromatogram acquisition step” in claim 1; “an estimated peak obtaining step”, “an adjusted estimated peaks obtaining step”, “a concentrations quantifying step”, and “a concentration displaying step” in claims 1 and 6; and “the data processor is configured to” in claims 6 and 7.
The claim describes the various modules in functional terms of what they do, rather than how they do it. Under 35 USC 112(f), the Specification must identify a specific and readily-identifiable algorithm in the Specification associated with the claimed function.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. For example, [0011] discloses “… The data processing method includes an adjustment target peak acquisition step of obtaining a plurality of adjustment target peaks by applying, to the chromatogram, a peak model function prepared in advance to approximate a waveform of the chromatogram, an estimation data creation step of creating estimation data of a chromatogram and a spectrum on each of a plurality of the components by combining a plurality of the adjustment target peaks obtained in the adjustment target peak acquisition step, and an adjustment target peak adjustment step of setting the estimation data created in the estimation data creation step as an initial value before adjustment … ”; [0032] discloses “ … The data processing method includes an adjustment target peak acquisition step of obtaining a plurality of adjustment target peaks by applying, to the chromatogram, a peak model function prepared in advance to approximate a waveform of the chromatogram, an estimation data creation step of creating estimation data of a chromatogram and a spectrum on each of a plurality of the components by combining a plurality of the adjustment target peaks obtained in the adjustment target peak acquisition step, and an adjustment target peak adjustment step of setting the estimation data created in the estimation data creation step as an initial value before adjustment, … ”.
In order to exam the merit, Examiner interprets the above mentioned limitations performed by a generic computer.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 1-2, 4, 6-7, and 9 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.
As to claim 6, the claim recites “A chromatogram data processing system comprising:
a data receiving part that receives a three-dimensional chromatogram including a chromatogram and a spectrum from a chromatograph, wherein the chromatogram includes an overlapped peak formed by overlapping a first peak of a first component and a second peak of a second component;
a storage part that stores the three-dimensional chromatogram, and a peak model function prepared in advance and including parameters related to peak shape and peak size; and
a data processor configured to perform processing of the three-dimensional chromatogram using the peak model function and processing of quantifying concentrations of the first and second components; and
a display for displaying information output from the data processor,
wherein the data processor is configured to execute:
an estimated peak obtaining step of obtaining a first estimated peak corresponding to the first peak and a second estimated peak corresponding to the second peak using the peak model function, wherein the first estimated peak is generated by adjusting the parameters of the peak model function to fit the first peak and the second estimated peak is generated by adjusting the parameters of the peak model function to fit the second peak;
an adjusted estimated peak obtaining step of obtaining a first adjusted estimated peak by adjusting the shape of the first estimated peak using matrix decomposition and a second adjusted estimated peak by adjusting the shape of the second estimated peak using matrix decomposition so that a similarity between a pseudo chromatogram generated by combining the first and second adjusted estimated peaks and the chromatogram satisfies a preset criterion or converges to a certain value;
a concentration quantifying step of quantifying concentrations of the first and second components by calculating respective areas of the first and second adjusted estimated peaks; and
a concentration displaying step of displaying the quantified concentrations of the first and second components on the display.”
Under the Step 1 of the eligibility analysis, we determine whether the claim is directed 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 (process for claim 1, and apparatus for claim 6).
Under the Step 2A, Prong One, we consider whether the claim recites a judicial exception (abstract idea). In the above claim, the bold type 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 that covers mathematical concepts (mathematical relationships, mathematical formulas or equations, mathematical calculations).
In claim 6, the steps identified in bold type are mathematical concepts, therefore, they are considered to be abstract idea.
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 claim comprises the following additional elements:
a data receiving part that receives a three-dimensional chromatogram including a chromatogram and a spectrum from a chromatograph, wherein the chromatogram includes an overlapped peak formed by overlapping a first peak of a first component and a second peak of a second component; a storage part that stores the three-dimensional chromatogram, and a peak model function prepared in advance and including parameters related to peak shape and peak size; a display for displaying information output from the data processor, wherein the data processor is configured to execute: an estimated peak obtaining step; an adjusted estimated peak obtaining step; a concentration quantifying step; and a concentration displaying step of displaying the quantified concentrations of the first and second components on the display.
The additional element “a data receiving part that receives a three-dimensional chromatogram including a chromatogram and a spectrum from a chromatograph” represents necessary data gathering and does not integrate the limitation into a practical application.
The additional elements “wherein the chromatogram includes an overlapped peak formed by overlapping a first peak of a first component and a second peak of a second component”; “a storage part that stores the three-dimensional chromatogram, and a peak model function prepared in advance and including parameters related to peak shape and peak size”; “a display for displaying information output from the data processor”, “wherein the data processor is configured to execute”: “an estimated peak obtaining step”; “an adjusted estimated peak obtaining step”; “a concentration quantifying step”; and “a concentration displaying step of displaying the quantified concentrations of the first and second components on the display” are not sufficient to integrate the abstract idea into a practical application because they only add insignificant extra-solution activities to the judicial exception.
The additional element “a data processor” is not sufficient to integrate the abstract idea into a practical application because it is considered a generic computer element. As recited in the MPEP, 2106.05(b), merely adding a generic computer, generic computer components, or a programmed computer to perform generic computer functions does not automatically overcome an eligibility rejection. Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 134 S. Ct. 2347, 2359-60, 110 USPQ2d 1976, 1984 (2014). See also OIP Techs. v. Amazon.com, 788 F.3d 1359, 1364, 115 USPQ2d 1090, 1093-94.
In conclusion, the above additional elements, considered individually and in combination with the other claims elements do not reflect an improvement to other technology or technical field, do not reflect improvements to the functioning of the computer itself, do not recite a particular machine, do not effect a transformation or reduction of a particular article to a different state or thing, and, therefore, do not integrate the judicial exception into a practical application. Therefore, the claim is directed to a judicial exception and require further analysis under the Step 2B.
The above claim, does not include additional elements that are sufficient to amount to significantly more than the judicial exception because they are generically recited and are well-understood/conventional in a relevant art as evidenced by the prior art of record (Step 2B analysis).
For example, a data receiving part that receives a three-dimensional chromatogram including a chromatogram and a spectrum from a chromatograph is considered necessary data gathering. As recited in MPEP section 2106.05(g), necessary data gathering (i.e., receiving image data) is considered extra solution activity in light of Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; OIP Techs., Inc. v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1092-93 (Fed. Cir. 2015).
For example, a display for displaying information output from the data processor is disclosed by “Melker US 20060062734”, [0047], [0072]; and “Phoebe US 20190101513”, [0007], [0010], [0052].
The claim, therefore, is not patent eligible.
Independent claim 1 recites subject matter that is similar or analogous to that of claim 1, and therefore, the claim is also patent ineligible.
With regards to the dependent claims, claims 2, 4, 7, and 9 provide additional features/steps which are considered part of an expanded abstract idea of the independent claims, and do not integrate the abstract ideas into a practical application.
The dependent claims are, therefore, also not patent eligible.
Examiner' s Note
Regarding Claims 1-2, 4, 6-7, and 9, the most pertinent prior arts are “Rubinstein US 20160252484”, “Uematsu JP 6862780B2”, “Melker US 20060062734”, “Phoebe US 20190101513”, and “Ivosec US 20170038351”.
As to claims 1 and 6, Rubinstein teaches a chromatogram acquisition step of acquiring from a chromatograph a three- dimensional chromatogram including a chromatogram and a spectrum, wherein the chromatogram includes an overlapped peak formed by overlapping a first peak of a first component and a second peak of a second component (Rubinstein, [0002], [0005], [0034], [0036], [0068], [0079], [0082]);
an estimated peak obtaining step of obtaining a first estimated peak corresponding to the first peak and a second estimated peak corresponding to the second peak using a peak model function including parameters related to peak shape and peak size, wherein the first estimated peak is generated by adjusting the parameters of the peak model function to fit the first peak and the second estimated peak is generated by adjusting the parameters of the peak model function to fit the second peak (Rubinstein, [0002], [0006], [0009], [0018], [0027], [0042], [0069], [0070]).
Uematsu teaches a concentrations quantifying step of quantifying concentrations of the first and second components by calculating respective areas of the first and second adjusted estimated peaks (Uematsu, Abstract, [0002], [0008], [0009], [0011], [0013], Claim 1).
Melker teaches a concentration displaying step of displaying the quantified concentrations of the first and second components on a display (Melker, [0047], [0072]).
However, the prior arts of record, alone or in combination, do not fairly teach or suggest “an adjusted estimated peaks obtaining step of obtaining a first adjusted estimated peak by adjusting the shape of the first estimated peak using matrix decomposition and a second adjusted estimated peak by adjusting the shape of the second estimated peak using matrix decomposition so that a similarity between a pseudo chromatogram generated by combining the first and second adjusted estimated peaks and the chromatogram satisfies a preset criterion or converges to a certain value” including all limitations as claimed.
Dependent claims 2, 4, 7, and 9 are also distinguished over the prior art for at least the same reason as claims 1 and 6.
Examiner notes, however, that claims 1-2, 4, 6-7, and 9 are rejected under 35 U.S.C. 101, and therefore, not patent eligible.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
“Makarov US 20170243728” teaches “A method of analyzing molecules, comprising: generating ions from a sample of molecules; cooling the generated ions below ambient temperature; fragmenting at least some of the cooled ions by irradiating the ions with light at a plurality of different wavelengths (λ) within one or more predetermined spectral intervals; recording a fragment mass spectrum of the fragmented ions comprising a detected signal (I) versus m/z over a predetermined range of m/z values for each of the plurality of different wavelengths (λ), thereby recording a two dimensional dependency of the detected signal (I) on m/z and irradiation wavelength (λ); and determining from the recorded two dimensional dependency an identity of at least one of the generated ions and/or relative abundances of different generated ions and thereby determining an identity of at least of one of the molecules and/or relative abundances of different molecules in the sample.”
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/LAL CE MANG/Primary Examiner, Art Unit 2857
