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 .
RCE
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 January 29, 2026 has been entered.
Response to Amendment
Applicant's arguments filed on January 29, 2026 with respect to the rejection of claims 12-15, 17-24 and 26 under 35 U.S.C. §101 as the claimed invention being directed to abstract idea without significantly more have been fully considered but they are not persuasive for the reasons noted below. The Examiner acknowledges the cancellation of claims 4, 5, 7, 8, 15-17, 19-20, 25, and 27-84; and the withdrawal of claims 1-3, 6 and 9-11 as nonelected claims. Claims 12-14, 18, 21-24 and 26 are now pending in the application. No claims are allowed.
IDS
The information disclosure statement (IDS) submitted on December 22, 2025 is being considered by the Examiner.
Explanation of Rejection
Claim rejection – 35 U.S.C. §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.
In reference to claims 12-14, 18, 21-24 and 26: the claimed invention is directed to a judicial exception (i.e., abstract idea) without significantly more.
The requirement for subject matter eligibility test for products and processes requires first, the claimed invention must be to one of the four statutory categories. 35 U.S.C. §101 defines the four categories of invention that Congress deemed to be the appropriate subject matter of a patent: processes, machines, manufactures and compositions of matter. The latter three categories define "things" or "products" while the first category defines "actions" (i.e., inventions that consist of a series of steps or acts to be performed).
Second, the claimed invention also must qualify as patent-eligible subject matter, i.e., the claim must not be directed to a judicial exception unless the claim as a whole includes additional limitations amounting to significantly more than the exception. The judicial exceptions (also called "judicially recognized exceptions" or simply "exceptions") are subject matter that the courts have found to be outside of, or exceptions to, the four statutory categories of invention, and are limited to abstract ideas, laws of nature and natural phenomena (including products of nature).
In the first step, it is to be determined whether the patent claim under examination is directed to an abstract idea. If so, in the second step of analysis, it is to be determined whether the patent adds to the idea “something more” or "significantly more” that embodies an “inventive concept.”
In the instant case, claim 12 is representative and it is reproduced here with the limitations that are part of the abstract idea in bold:
A computer-implemented method, comprising:
(a) receiving, using a processor:
(i) a first data set comprising a plurality of intensity or absorbance measurements as a function of length along a separation channel from an isoelectric focusing separation performed in the separation channel; and
(ii) a second data set comprising a plurality of mass spectrometer total ion measurements as a function of time;
(b) converting the second data set, using the processor, into a third data set comprising ion count measurements as a function of mass;
(c) overlaying, using the processor, plots of the first data set and the third data set;
(d) mapping, using the processor, a first peak in intensity or absorbance of the first data set to a set of peaks of the third data set and/or mapping the first data set to the set of peaks of the third data set using the second data set, the mapping [is] based on the correlation of the second data set to the first data set;
(e) correlating, using the processor, the first peak to the set of peaks to determine a mass distribution and an isoelectric point of at least one analyte species of said first peak; and
(f) determining, using the processor, the identities of the one or more analyte species in the analyte peak.
Step 2A:
Prong I: The claim recites the steps of “receiving a first data set”, “receiving a second data set”, “converting the second data set ...into a third data set”; “overlaying a plot of the second data set with the plots of the first data set and the third data set’. These limitations could be carried out as a purely mental process (at least in a some relatively simple situations) and/or they could amount to a mathematical calculation (for example, converting a data set into a plot requires some mathematical conversion or evaluation); mapping … a first peak in intensity or absorbance of the first data set to a set of peaks of the third data set and/or mapping the first data set to the set of peaks of the third data set using the second data set; correlating … the first peak to the set of peaks to determine a mass distribution and an isoelectric point of at least one analyte species of said first peak, and determining, …the identities of the one or more analyte species in the analyte peak”. Therefore, the recited method falls in the abstract idea grouping of mental processes and/or mathematical concepts at Prong 1 of the §101 analysis.
Prong II:
This abstract idea is not integrated into a practical application at Prong 2 of the §101 analysis because the claim does not recite sufficient additional elements to integrate the abstract idea into a practical application. The claim recites the method comprising the additional element steps of "receiving using a processor’ and “using the processor” to carry out the computation. However, the “receiving by the processor” is considered to be merely a data gathering step recited at a high level of generality, and the following “the conversion”, “the overlaying”, “mapping” and “correlating” of the plots “by the processor” language in the context of the instant claim may encompass the user manually computing these steps. The processor is merely a generic computer processing component that is invoked as a tool to perform the abstract idea, which does not cause the claim as a whole to integrate the abstract idea into a particular practical application or provide significantly more than the recited abstract idea (see MPEP 2106.05(b)).
The courts have found that adding insignificant extra-solution activity to the judicial exception, e.g., mere data gathering in conjunction with a law of nature or abstract idea (such as a step of obtaining information about credit card transactions so that the information can be analyzed by an abstract mental process, as discussed in CyberSource v. Retail Decisions, Inc., 654 F.3d 1366, 1375, 99 USPQ2d 1690, 1694 (Fed. Cir. 2011)) is not enough to integrate the abstract idea into a particular practical application or make the claim qualify as “significantly more” (see MPEP § 2106.05(g)).
The claim does not recite applying the abstract idea with, or by use of, any particular machine, nor does the claim affect a real-world transformation or reduction of a particular article to a different state or thing. The claim amounts to processes data sets and overlaying one value over on another, mapping and correlating those data sets. The claim does not recite any particular real-world actions that are taken as a result of the notification that is output. The claim compares two or three sets of values” as the general field-of-use, but does not recite a particular practical application being carried out within that field-of-use. Therefore, the claimed invention does not appear to be limited to the use of the mental process or math in a particular practical application, but instead the claim appears to monopolize the mental process or the computational analysis itself, in any practical application where it might conceivably be used.
Step 2B: Finally, at Step 2B, the claim does not include additional elements that are sufficient to amount to significantly more than the abstract idea for the same reasons as discussed above with regard to Prong 2. Claim 12 is rejected as ineligible under 35 USC §101.
Dependent claim 13: the instant claim is directed to overlaying the second data set over the first and third data set, and the recited method falls in the abstract idea grouping of mental processes and/or mathematical concepts at Prong 1 of the §101 analysis.
Dependent claim 14: the instant claim is directed to deconvolving the second data set to generate the third data set, and the recited method falls in the abstract idea grouping of mental processes and/or mathematical concepts at Prong 1 of the §101 analysis.
Dependent claim 18: the instant claim is directed to the first peak corresponds to analyte peak, and the recited method falls in the abstract idea grouping of mental processes and/or mathematical concepts at Prong 1 of the §101 analysis.
Dependent claim 21: the instant claim is directed to identifying the content of analyte species; and the recited method falls in the abstract idea grouping of mental processes and/or mathematical concepts at Prong 1 of the §101 analysis.
Dependent claim 22: the instant claim is directed selection of post-translation modification, and the recited method falls in the abstract idea grouping of mental processes and/or mathematical concepts at Prong 1 of the §101 analysis.
Dependent claim 23: the instant claim is directed to what the overlay plot shows, and the recited method falls in the abstract idea grouping of mental processes and/or mathematical concepts at Prong 1 of the §101 analysis.
Dependent claim 24: the instant claim is directed to the data gathering steps for the first and second data set, and the recited method falls a generic data gathering step, and it is insignificant extra solution activity.
Dependent claim 26: the instant claim is directed to the data gathering steps for acquiring electrospray ionization-mass spectrometry (ESI-MS) data, and the recited method falls a generic data gathering step, and it is insignificant extra solution activity.
Response to Argument
Applicant's arguments filed on January 29, 2026 with respect to the rejection of claims 12-15, 17-24 and 26 under 35 U.S.C. §101 as the claimed invention being directed to abstract idea without significantly more have been fully considered but they are not persuasive for the reasons noted above, and further explained below.
Applicant(s) argued that “the first data set obtained from an imaging system that images imaging an isoelectric focusing separation performed on the sample in the separation channel...., (and then applicant stated that) the actions of claim 12 cannot be practically be performed by purely mental process nor amount to a mathematical calculation” (see argument, page 8, first paragraph and second paragraph).
The Examiner respectfully disagrees for the following reason. Under the broadest reasonable interpretation (BRI), the steps noted as “a”, “b”, “c”, “d”, “e” and “f” are directed to “receiving” a first and a second data sets, “converting” the second data set to a third data set; “overlaying” plots of the first data set and the third data set; “mapping” a first peak in intensity or absorbance of the first data set of the peaks of the third data set; and “correlating” the first peak to the set of peaks to determine a mass distribution and an isoelectric point of at least one analyte species of said first peak. In this instant, all the actions are considered abstract idea because in the simplest manageable data, an ordinary skill in the art would be able to map “first data” to a “third data”, and correlates “the first peak to the set of peaks” for its intended purpose.
Prong II:
Dealing with bigger and more complex data set, a computer or any programable device would be able to help processing those data. In a sense the computer, just like a pencil and paper would be considered an extension of a human thought process. The way and the manner those data sets processed and how the result is analyzed to obtain or establish a correlation is an abstract idea.
Applicant argued that “a claim is not directed to a judicial exception if the claim recites additional elements demonstrating that the claim as a whole integrates the exception into a practical application. MPEP §2106.04 (d)(1)” (see argument, page 9, third paragraph) in that referenced Diamond v. Diehr, §101 S.Ct. 1048 (1981). However, in Diamond v. Diehr, the summary of judgement states:
In Diehr, by contrast [with Flook], we held that a computer-implemented process for curing rubber was patent eligible, but not because it involved a computer. The claim employed a "well-known" mathematical equation, but it used that equation in a process designed to solve a technological problem in "conventional industry practice." The invention in Diehr used a "thermocouple" to record constant temperature measurements inside the rubber mold — something "the industry ha[d] not been able to obtain." The temperature measurements were then fed into a computer, which repeatedly recalculated the remaining cure time by using the mathematical equation. These additional steps, we recently explained, "transformed the process into an inventive application of the formula." Mayo, supra, at ___, 132 S.Ct., at 1299. In other words, the claims in Diehr were patent eligible because they improved an existing technological process, not because they were implemented on a computer. (134 S. Ct. at 2358).
In the instant case, an ordinary skill in the art would be able to map “first data” to a “third data”, and correlates “the first peak to the set of peaks” for its intended purpose. In other words, the instant claim is different from Diamond v. Diehr because the recited method falls in the abstract idea grouping of mental processes and/or mathematical concepts at Prong 1 and Prong II of the §101 analysis.
Further, Applicant(s) argued that “additionally, another way to demonstrate such integration into a practical application is when the claimed invention improves the functioning of a computer or improves another technology or technical field. MPEP §2106.04(d)(1). See also, Desjardins at page 8 “claims directed to an improvement …to other technology or technical field are patent eligible). (see page 10, third paragraph).
However, the instant application, as noted in claim 12, the steps “a’” through “f” are characterized as an abstract idea because they read on human thought process and/or a mathematical algorithm per se. In fact, Alice Corp. v. CLS Bank Int’l 573 U.S. 208, simply correlating, collecting, and sorting data (such as overlapping values as the instant case) is generally considered an abstract idea. These actions are considered fundamental mental processes and/or mathematical concepts, and performing them using a conventional computer does not make them patent eligible.
Eligibility under step 2B. Finally, at Step 2B, the claim does not include additional elements that are sufficient to amount to significantly more than the abstract idea for the same reasons as discussed above with regard to Prong 2. Claim 1 is rejected as ineligible under 35 USC §101.
Applicant(s) further argued that “the first data set is obtained from an imaging system that images an isoelectric focusing separation performed on the sample in the separation channel…” (see argument, page 13, 2nd paragraph towards the middle).
However, first the manner in which the data is collected is not even part of claim 12, even if that is the case, at some point data values are collected by at least some means, in other words, data gathering is not considered significantly more than the abstract concept described in claim 12, as stated above, steps “a” through “f” are the main parts of claim 12 and in view of the broadest reasonable interpretation (BRI) they amount to be abstract idea and reads on human thought process and/or mathematical or computational analysis. Therefore, the recited method falls in the abstract idea grouping of mental processes and/or mathematical concepts at Prong 1 and Prog 2, and steps 2B of the §101 analysis.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Geromanos et al. (U.S. Patent No. 10, 573,501) discloses techniques for performing data acquisition and analysis using a multi-mode strategy by using mass isolation windows of different sizes in a different scan cycle to obtain experimental data for further analysis.
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/ELIAS DESTA/
Primary Examiner, Art Unit 2857