DETAILED ACTION
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 1 and 4-6 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 3 recites “a first analysis step acquiring a first three-dimensional chromatogram of the sample,” and “a second analysis step of acquiring a second three-dimensional chromatogram including third and forth peaks each corresponding to the first and second components by executing second chromatography analysis of the sample….” but said limitation of involving the same sample for both the first and second analysis is not supported in the original disclosure.
To further explain, various paragraphs throughout the original disclosure [0006]-[0008], [0019], etc., discloses the second analysis is performed for different sample. As an example, the Paragraph [0006] (portion of which is reproduced below for convenience) discloses that the second analysis is performed on another sample.
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Furthermore, the claim 3 recites that the first and second peaks each corresponding to first and second components in a sample and third and fourth peaks each corresponding to the first and second components of the sample, but said limitations are also not supported in the original disclosure. To further explain, the original disclosure in Paragraphs [0006]-[0007], as an example, discloses “a common main component” or one common component in all the samples, and not multiple common components.
Previous rejection is withdrawn in view of the Applicant’s amendment filed on 01/23/2026.
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.
4. Claims 1 and 4-6 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 being integrated into a practical application and do not include additional elements that amount to significantly more than the judicial exception.
Utilizing the two step process adopted by the Supreme Court (Alice Corp vs CLS Bank Int'l, US Supreme Court, 110 USPQ2d 1976 (2014) and the recent 101 guideline, Federal Register Vol. 84, No., Jan 2019)), determination of the subject matter eligibility under the 35 USC 101 is as follows: Specifically, the Step 1 requires claim belongs to one of the four statutory categories (process, machine, manufacture, or composition of matter). If Step 1 is satisfied, then in the first part of Step 2A (Prong one), identification of any judicial recognized exceptions in the claim is made. If any limitation in the claim is identified as judicial recognized exception, then proceeding to the second part of Step 2A (Prong two), determination is made whether the identified judicial exception is being integrated into practical application. If the identified judicial exception is not integrated into a practical application, then in Step 2B, the claim is further evaluated to see if the additional elements, individually and in combination, provide “inventive concept” that would amount to significantly more than the judicial exception. If the element and combination of elements do not amount to significantly more than the judicial recognized exception itself, then the claim is ineligible under the 35 USC 101.
Looking at the claims, the claims satisfy the first part of the test 1A, namely the claims are directed to one of the four statutory class, a method. In Step 2A Prong one, we next identify any judicial exceptions in the claims. In Claim 1 (as a representative example), we recognize that the limitations “extracting spectrum data of the first and second components from the first three-dimensional chromatogram, a peak separation step of estimating a shape and size of the third and fourth peaks by inputting the first spectrum data of first and second components into to an algorithm configured to estimate shape and a size of peaks overlapping with each other and applying algorithm to the second three-dimensional chromatogram, and quantifying concentrations of the first and second components in the second three-dimensional chromatogram based on the shape and size of the third and fourth peaks,” are abstract ideas, as they are directed to a combination of mental process and usage of mathematical concept (as a support for mathematical concept usage, see the dependent Claim 6 that recites usage of mathematical concept). Similar rejections are made for other dependent claims. With the identification of abstract ideas, we proceed to Step 2A, Prong two, where with additional elements and taken as a whole, we evaluate whether the identified abstract idea is being integrated into a practical application.
In Step 2A, Prong two, the claims additionally recite “a first analysis step of acquiring a first three-dimensional chromatogram of the sample by executing first chromatography analysis under a first condition, wherein the first three-dimensional chromatogram includes first and second peaks each peak corresponding to the first and second components respectively in a state where the first and second peaks are completely separated from each other, a second analysis step of acquiring a second three-dimensional chromatogram including third and fourth peaks each corresponding to the first and second components by executing second chromatography analysis of the sample, wherein the third and fourth peaks overlap with each other and form unseparated peak of the first and second components, and the second chromatography analysis can be completed in a shorter time than the first chromatography analysis under a second condition which a mobile phase flow rate and/or an analysis column is different from the first condition,” but said limitations are directed to insignificant data collection activity recited at high level of generality. The claims do not improve the functioning of any chromatography. The claims also do not improve other technology, as the claims lack sufficient detail as to how the peak separation processing is being performed and how that necessarily leads to any kind of improvement when the claims simply estimates the number, shape and/or size of each peak, using generically recited model function or an algorithm to mathematically perform the estimating. Even if the claims had recited specific algorithm, claims are at most an improvement in the abstract idea of said estimating, but new or improved abstract idea is still an abstract idea and not eligible. As such, the abstract idea is not integrated into a practical application. Consequently, with the identified abstract idea not being integrated into a practical application, we proceed to Step 2B and evaluate whether the additional elements provide “inventive concept” that would amount to significantly more than the abstract idea.
In Step 2B, the claims additionally recite “a first analysis step of acquiring a first three-dimensional chromatogram of the sample by executing first chromatography analysis under a first condition, wherein the first three-dimensional chromatogram includes first and second peaks each peak corresponding to the first and second components respectively in a state where the first and second peaks are completely separated from each other, a second analysis step of acquiring a second three-dimensional chromatogram including third and fourth peaks each corresponding to the first and second components by executing second chromatography analysis of the sample, wherein the third and fourth peaks overlap with each other and form unseparated peak of the first and second components, and the second chromatography analysis can be completed in a shorter time than the first chromatography analysis under a second condition which a mobile phase flow rate and/or an analysis column is different from the first condition,” but said limitations are directed to insignificant data collection activity recited at high level of generality, that is well-understood, routine and conventional. As such, the claims do not provide additional elements that would amount to significantly more than the abstract idea.
In Summary, the claims recite abstract idea without being integrated into a practical application, and do not provide additional elements that would amount to significantly more than the abstract idea. As such, taken as a whole, the claims are ineligible under the 35 USC 101.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1 and 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Mito et al., US-PGPUB 2014/0257712 (hereinafter Mito) in views of Wyndham et al., US-PGPUB 2019/0376933 (hereinafter Wyndham) and Chaintreau et al., US-PGPUB 2007/0039375 (hereinafter Chaintreau)
Regarding Claim 1. Mito discloses a multiple sample analysis method (Paragraph [0051], samples), comprising:
a first analysis step of acquiring a first three-dimensional chromatogram of the sample by executing first chromatography analysis under a first condition, for the one sample (Paragraphs [0122]-[0123], standard sample to obtain 3D chromatogram; [0131]), and extracting step of extracting spectrum data of the first and second components from the first three-dimensional chromatogram (Paragraphs [0132]-[0136]),
a second analysis step of acquiring a second three-dimensional chromatogram, including third and fourth peaks each corresponding to the first and second components by executing, second chromatography analysis of the sample wherein the third and fourth peaks overlap with each other and form unseparated peak of the first and second components (Paragraphs [0022], [0127], cannot be sufficiently separated); Paragraph [0018], target sample at different time; [0019]; Figs. 8-9; 13A-B; [0101]-[0102]; [0138], unknown sample); and
a peak separation step of estimating a shape and a size of the third and fourth peaks by inputting into an algorithm configured to estimate a shape and a size of peaks overlapping with each other and applying the algorithm to the second three-dimensional chromatograph (Figs. 15A-B; Paragraphs [0080]-[0087]; [0128]-[0129]; [0141]-[0143], differential chromatogram with the calibration curve generated from the standard samples), quantifying step of quantifying concentrations of the first and second components in the second three-dimensional chromatogram based on the shape and size of the first and fourth peaks (Paragraphs [0129]-[0131]; [0135]-[0142])
Mito does not disclose wherein the first three-dimensional chromatogram includes first and second peaks each corresponding to the first and second components respectively in a state where the first and second peaks are completely separated from each other, and the second chromatography analysis can be completed in a shorter time than the first chromatography analysis under a second condition, in which a mobile phase flow rate and/or analysis column is different from the first condition.
Wynham discloses improving the speed and separations of chromatography, which includes at least one sample under a condition that a three-dimensional chromatogram can be obtained in a shorter time than the first three dimensional chromatogram (Abstract Paragraph [0008]-[0010], [0021]; speed the time of analysis), wherein a mobile phase flow rate of the second condition is larger than a mobile phase flow rate of the first condition a mobile phase flow rate in the second chromatography analysis is larger than a mobile phase flow rate in the first chromatography analysis (Paragraph [0021], fast flow rates, from 0.3 to 3 or greater to speed the time of analysis), and/or total length of a second analysis column of the second condition is shorter than total length of a first analysis column of the first condition (Paragraph [0021], different lengths), and/or inner diameter of the second analysis column of the second condition is larger than inner diameter of the first analysis column of the first condition (Paragraph [0015], column with different sized diameters; Paragraph [0021], different diameters).
Chaintreau discloses a well-known muti-dimensional GC technique, that involves transferring some parts of the peaks from the first column to the second column for further analysis (Paragraphs [0007]-[0016]), where a completely separated single peak can obviously occur in the first column in certain elute conditions)
At the time of the invention filed, it would have been obvious to use the teachings of Wyndham and Chaintreu in Mito and have the first three-dimensional chromatogram includes first and second peaks each corresponding to the first and second components respectively in a state where the first and second peaks are completely separated from each other, and the second chromatography analysis can be completed in a shorter time than the first chromatography analysis under a second condition, in which a mobile phase flow rate and/or analysis column is different from the first condition, so as to enhance chromatography results in separating and detecting the peaks, based on well-known multi-dimensional chromatography technique.
Regarding Claim 4. Mito discloses in a case where there are two or more samples comprising the first and second components, the first analysis step is executed on one sample among the two or more samples to extract the spectrum data of the first and second components, and the second analysis step is executed on remaining samples among the two or more samples to acquire the second three-dimensional chromatograms for each of the remaining samples, and the peak separation step is executed on the acquired second three-dimensional chromatogram (Paragraphs [0131]-[0136], standard samples)
Regarding Claim 5. Mito discloses the first chromatography analysis and the second chromatography analysis are liquid chromatography analysis (Paragraph [0002], liquid chromatograph)
9. Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Mito, US-PGPUB 2014/0257712 in views of Wyndham, US-PGPUB 2019/0376933, Chaintreau, US-PGPUB 2007/0039375, in view of Claim 1, and further in view of Noda, US-PGPUB 2017/0336370 (hereinafter Noda) (cited by the Applicant)
Regarding Claim 6. The modified Mito does not disclose in the peak separation processing, an algorithm for estimating a shape and a size of each peak overlapping with each other by applying a model function or an algorithm for mathematically estimating a shape and a size of each overlapping with each other by matrix decomposition without using the model function is used
Noda disclose in the peak separation processing, an algorithm for estimating a peak of each component by applying a model function (Abstract, estimation of a chromatogram using Gaussian functions; Paragraph [0073], Gaussian function; Paragraphs [0084]-[0094]) or an algorithm for mathematically estimating a peak of each component by matrix decomposition without using the model function is used (Paragraph [0051]; [Paragraph [0019])
At the time of the invention filed, it would have been obvious to a person of ordinary skill in the art to use the teaching of Noda in the modified Mito and use an algorithm for estimating a peak of each component by applying a model function or an algorithm for mathematically estimating a peak of each component by matrix decomposition without using the model function is used, so as to have the peaks from the components are appropriately separates.
Response to Arguments
Applicant’s arguments with respect to claims have been considered but are moot in view of the updated new grounds of rejection. Furthermore, the 101 rejection is maintained based on the updated rejection and the reasons given in previous Office Actions that are still valid and applicable, particularly given that there is only a minor variation in the scope of the new claim. In short, the claimed invention is an abstract idea of quantifying concentrations of generic components in the three-dimensional chromatogram based on the peaks using generic algorithm and generic model functions that lacks details as to how. In such broad and generically recited claims, any improvements in the technology are simply not evident. As such, the 101 rejection is maintained.
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 HYUN D PARK whose telephone number is (571)270-7922. The examiner can normally be reached 11-4.
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/HYUN D PARK/Primary Examiner, Art Unit 2857
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