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 Amendment
This Office Action is in response to Amendments filed on 01/13/2026, wherein Claims 1, 6-9, and 12 have been amended, Claims 2-5 and 10-11 were cancelled. Claims 13-19 are new. Claims 1, 6-9, and 12-19 are pending.
Response to Arguments
Regarding 35 USC 101 rejection: Applicant's arguments filed on 01/13/2026, with respect to 35 USC 101 rejection, have been fully considered but found not persuasive.
In page 9, Applicant states: “These limitations do not recite any mathematical relationship, calculation, formula, or equation, either explicitly or implicitly. Rather, they recite physical measurements obtained from chromatography and stored correlations derived from empirical reference samples”.
Examiner respectfully disagrees. In Claim 1, it is stated: “the reference correlation being represented by either one of a correlation equation or a correlation table”. Also, in Fig. 7, step S104 states: “Derive correlation equation having index value, retention time of reference peak, and threshold as variables”, and step S105 states: “Store correlation equation”. In specification, para 0048 presents the correlation equation (1) as mathematical expression.
In page 10, applicant argues that the limitation “determine, with reference to the acquired base retention time and the acquired index value, a threshold of the sample by selecting a corresponding reference threshold from the reference correlation” cannot be performed in human mind.
Examiner respectfully disagrees. The limitation states “a threshold of the sample by selecting a corresponding reference threshold from the reference correlation”, which falls under making a selection based on observation/evaluation/judgement, which can be performed in human mind.
According to the 2019 PEG: “If a claim, under its broadest reasonable interpretation, covers performance in the mind but for the recitation of generic computer components, then it is still in the mental processes category unless the claim cannot practically be performed in the mind. See Intellectual Ventures I LLC v. Symantec Corp., 838 F.3d 1307, 1318 (Fed. Cir. 2016) (‘‘[W]ith the exception of generic computer implemented steps, there is nothing in the claims themselves that foreclose them from being performed by a human, mentally or with pen and paper.' ' ); Mortg. Grader, Inc. v. First Choice Loan Servs. Inc., 811 F.3d. 1314, 1324 (Fed. Cir. 2016)(holding that computer-implemented method for ‘‘anonymous loan shopping' ' was an abstract idea because it could be ‘‘performed by humans without a computer' ' ); Versata Dev. Grp. v. SAP Am., Inc., 793 F.3d 1306, 1335 (Fed. Cir. 2015) (‘‘Courts have examined claims that required the use of a computer and still found that the underlying, patent-ineligible invention could be performed via pen and paper or in a person' s mind.' ' ).”
There is no technological advancement in the claims, no improvement for the process, only routine and well-known operations steps.
Practical application must be shown using meaningful additional elements. The additional elements, cited by the Applicant, are recited in generality and do not recite particular machines applying or being used by the abstract idea (see MPEP 2106.05, specifically about the particular machine: see part I, The particularity or generality of the elements of the machine or apparatus; Part II, Whether the machine or apparatus implements the steps of the method, and Part III, Whether its involvement is extra-solution activity of a field-of use). Prior art cited in the rejection, shows claimed additional elements as well-known in the art, routine and conventional.
Regarding Examiner’s objections: Applicant’s arguments, see Remarks filed 01/13/2026 with respect to the objections to claims 1-5 and 9-12, have been fully considered. In view of the amendments to the Claims addressing the informalities raised in the previous Office Action, the objections to the Claims have been withdrawn.
Regarding 35 USC 103 rejection: Applicant’s arguments filed 01/13/2026 with respect to claims 1, 6-9, and 12-19, have been considered and found persuasive. The 35 USC 103 rejection is withdrawn.
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, 6-9, and 12-19 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/product. The below claim is considered to be a statutory category (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 belongs to one of three enumerated groupings: mathematical concepts, mental processes, and certain methods of organizing human activity.
Independent Claim 1 is copied below, with the limitations belonging to an abstract idea highlighted in bold; the remaining limitations are ‘’additional elements’’.
A control device of a separation analysis device that separates and analyzes a sample by chromatography, the sample containing a main component having a plurality of sub- components, the plurality of sub-components including a target component to be analyzed and a base component, the target component being either a first component or a second component, the control device comprising:
a memory storing a reference correlation obtained by performing chromatography on a plurality of reference samples prepared in advance, each containing the base component and the target component, the reference correlation being represented by either one of a correlation equation or a correlation table, and including as variables,
a reference base retention time of a base peak of the base component in each reference sample,
a reference threshold for identifying whether a retention time corresponds to a first peak of the first component and or a second peak of the second component in each reference sample, and
reference index value representing an amount of the main component in each reference sample,
the reference correlation including a first correlation and a second correlation for each reference index value, the first correlation being a correlation between the reference base retention time and a reference retention time of the first peak, the second correlation being a correlation between the reference base retention time and a reference retention time of the second peak; and
a processor connected to the memory,
wherein the processor is configured to:
perform the chromatography on the sample to acquire a base retention time of a base peak of the base component in the sample as an acquired base retention time, an index value representing an amount of the main component in the sample as an acquired index value, and a target retention time of a peak of the target component in the sample as an acquired target retention time;
determine, with reference to the acquired base retention time and the acquired index value, a threshold of the sample by selecting a corresponding reference threshold from the reference correlation; and
identify whether the acquired target retention time corresponds to the first component or to the second component by comparing the threshold of the sample with the acquired target retention time.
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 the broadest reasonable interpretation and in light of the specification, it recites limitations that fall into abstract idea exceptions. Specifically, under the 2019 Revised Patent Subject Matter Eligibility Guidance, it falls into the grouping of subject matter that when recited as such in a claim limitation covers mathematical processes (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).
Steps of “a reference correlation obtained by performing chromatography on a plurality of reference samples prepared in advance, each containing the base component and the target component, the reference correlation being represented by either one of a correlation equation or a correlation table” and “the reference correlation including a first correlation and a second correlation for each reference index value, the first correlation being a correlation between the reference base retention time and a reference retention time of the first peak, the second correlation being a correlation between the reference base retention time and a reference retention time of the second peak” are treated by the Examiner as belonging to mathematical process grouping, and the steps of “determine, with reference to the acquired base retention time and the acquired index value, a threshold of the sample by selecting a corresponding reference threshold from the reference correlation” and “identify whether the acquired target retention time corresponds to the first component or to the second component by comparing the threshold of the sample with the acquired target retention time” are treated by the Examiner as belonging to mental process grouping.
Limitations of “a memory”, “a reference base retention time of a base peak of the base component in each reference sample”, “a reference threshold for identifying whether a retention time corresponds to a first peak of the first component and or a second peak of the second component in each reference sample”, and “reference index value representing an amount of the main component in each reference sample”, “a processor connected to the memory”, “wherein the processor is configured to: perform the chromatography on the sample to acquire a base retention time of a base peak of the base component in the sample as an acquired base retention time, an index value representing an amount of the main component in the sample as an acquired index value, and a target retention time of a peak of the target component in the sample as an acquired target retention time”, are treated as extra solution activities recited in generality (e.g., mere data gathering) and steps recited at a high level of generality. The preamble of Claim 1: “A control device of a separation analysis device that separates and analyzes a sample by chromatography, the sample containing a main component having a plurality of sub- components, the plurality of sub-components including a target component to be analyzed and a base component, the target component being either a first component or a second component, the control device comprising” is a generically recited preamble.
Prong 2 of Step 2A of the 2019 Guidance requires the examiner to determine if the claims recite additional elements or a combination of additional elements which integrate the abstract idea into a practical application. This requires additional elements in the claim to apply, rely on, or use the abstract idea in a manner that imposes a meaningful limit on the abstract idea, such that the claim is more than a drafting effort designed to monopolize the abstract idea.
With regards to the mental steps, according to the 2019 PEG: “If a claim, under its broadest reasonable interpretation, covers performance in the mind but for the recitation of generic computer components, then it is still in the mental processes category unless the claim cannot practically be performed in the mind. See Intellectual Ventures I LLC v. Symantec Corp., 838 F.3d 1307, 1318 (Fed. Cir. 2016) (‘‘[W]ith the exception of generic computer implemented steps, there is nothing in the claims themselves that foreclose them from being performed by a human, mentally or with pen and paper.”); Mortg. Grader, Inc. v. First Choice Loan Servs. Inc., 811 F.3d. 1314, 1324 (Fed. Cir. 2016) (holding that computer-implemented method for ‘‘anonymous loan shopping” was an abstract idea because it could be ‘‘performed by humans without a computer”); Versata Dev. Grp. v. SAP Am., Inc., 793 F.3d 1306, 1335 (Fed. Cir. 2015) (‘‘Courts have examined claims that required the use of a computer and still found that the underlying, patent-ineligible invention could be performed via pen and paper or in a person's mind.”).”
In this step, we evaluate whether the claim recites additional elements that integrate the exception into a practical application of that exception.
The additional elements: “control device”, “separation analysis device”, “the sample”, “memory”, “main component”, “sub-component”, “target component”, “base component”, “retention time”, “reference base retention time”, “base peak of the base component”, “reference sample”, “reference threshold”, “reference index value”, “reference peak”, “reference component”, “index”, “processor”, “chromatography”, add extra-solution activities (i.e., mere data gathering, source/type of data to be manipulated) using elements recited at a high level of generality (see MPEP 2106.05(g)); generally link the use of the judicial exception to a particular technological environment or field of use (see MPEP 2106.05(h)); and add the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely use a computer as a tool to perform an abstract idea (see MPEP 2106.05(f)).
Various considerations are used to determine whether the additional elements are sufficient to integrate the abstract idea into a practical application. In this particular case, the claim does not recite a 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).
Instead the additional elements in the claim appear to be merely insignificant extra-solution activity – merely receiving and manipulating data.
Therefore, the claim is directed to a judicial exception and require further analysis under the Step 2B.
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.
Essentially, the above claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception (Step 2B analysis) because they are well-understood and conventional in the relevant art of US2016216240 to Kamata et al. (hereinafter Kamata) in view of US20030115937A1 to Ishii et al. (hereinafter Ishii).
Therefore, claim 1 is rejected under 35 U.S.C. 101 as directed to an abstract idea without significantly more.
Similar analysis has been applied to independent Claims 9, 12, and 15. The independent claims, therefore, are not patent eligible.
With regards to the dependent claims, Claims 6-8, 13-14, and 16-19 merely add limitations which further detail the abstract idea, namely further mathematical steps detailing how the data processing algorithm is implemented, i.e. additional limitations corresponding to mathematical relationship grouping. These limitations 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).
The dependent claims are, therefore, also ineligible.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter.
Claims 1, 9, 12, and 15 include the allowable subject matter. If the 101 issues are resolved, Claim 1 and dependent claims 6-8; Claim 9, Claim 12 and dependent Claims 13-14, and Claim 15 and dependent claims 16-19 would be allowable if rewritten or amended to overcome the rejection under 35 USC 101, set forth in this Office Action.
In regards to Independent Claim 1, 9, and 12, the teachings of Kamata, Ishii, and Ohira combined show all the elements of the claim except “a memory storing a reference correlation obtained by performing chromatography on a plurality of reference samples prepared in advance, each containing the base component and the target component, the reference correlation being represented by either one of a correlation equation or a correlation table, and including as variables, (i) a reference base retention time of a base peak of the base component in each reference sample, (ii) a reference threshold for identifying whether a retention time corresponds to a first peak of the first component or a second peak of the second component in each reference sample, and (iii) a reference index value representing an amount of the main component in each reference sample, the reference correlation including a first correlation and a second correlation for each reference index value, the first correlation being a correlation between the reference base retention time and a reference retention time of the first peak, the second correlation being a correlation between the reference base retention time and a reference retention time of the second peak”, in combination with the rest of the claim’s limitations as claimed and defined by the applicant.
In regards to Independent Claim 15, the teachings of Kamata, Ishii, and Ohira combined show all the elements of the claim except “storing, in a memory, a reference correlation obtained from the chromatography on the plurality of reference samples, the reference correlation being represented by either one of a correlation equation or a correlation table, and including as variables a reference base retention time of a base peak of the base component in each reference sample, a reference threshold between a reference retention time of a first peak of the first component and a reference retention time of a second peak of the second component in each reference sample, and a reference index value representing an amount of the main component in each reference sample, the reference correlation including a first correlation and a second correlation for each reference base retention time, the first correlation being a correlation between the reference index value and the reference retention time of the first peak, and the second correlation being a correlation between the reference index value and the reference retention time of the second peak”, in combination with the rest of the claim’s limitations as claimed and defined by the applicant.
The combination of the closest prior art references of record, Kamata, Ishii, and Ohira, while disclosing individual features of the invention, however, would not create an obvious combination to a person having ordinary skill in the art due to a complexity of such combination and /or different fields of endeavors related to the above references, in combination with the rest of the claim limitations as claimed and defined by the applicant.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
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.
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/LYUDMILA ZAYKOVA-FELDMAN/ Examiner, Art Unit 2857
/LINA CORDERO/ Primary Examiner, Art Unit 2857
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