DETAILED ACTION
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/13/2022 follows the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Amendment/ Arguments
This office action is in response to communication received on 12/15/2025. The response presented amendment to claim 1 is hereby acknowledged. No new matter is introduced.
Applicant’s arguments (see pages 6-7), with respect to IDS objection and claim rejections set forth in the Non-Final Office Action, have been fully considered. Applicant argument with respect to Objected IDS is persuasive, and the objection is withdrawn. However, applicant argument with respect to the claim rejection is not persuasive, and the rejection is maintained for the following reason.
Although claim 1 has been amended to include sub-step (d0), which recites comparing the experimental vector to the theoretical vector according to lipophilicity values of the solutes expressed as a function of Dk, the amendment does not integrate the abstract idea into a practical application. The additional step merely refines the mathematical comparison and analysis of data derived from experimental and theoretical models to obtain information about impurities, without reciting a technological improvement or a specific practical application beyond the abstract idea itself. As set forth in the rejection, the claim continues to recite mathematical concepts involving organizing, comparing, and analyzing data, implemented using generic experimental measurements, and therefore amounts to no more than applying the abstract idea using conventional laboratory techniques. Accordingly, the rejection of claims 1-14 under 35 USC § 101 is maintained.
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 1-14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Is the Claim to a Process, Machine, Manufacture or Composition of Matter?
Claims 1-14 recite a series of steps for characterizing a solution S0 comprising a plurality of solutes. Thus, these claims are to a process, which is one of the statutory categories of invention.
Step 2A: Prong One: Does the Claim Recite an Abstract Idea?
Representative claim 1 recites:
A method for characterizing a solution S0 comprising a plurality of solutes, which comprises at least the steps consisting in:
a) subjecting the solution S0 to a sequence of N rows i of partitions, i ranging from 1 to N and N being greater than or equal to 2, the rows i of partitions comprising: [the examiner finds that the foregoing underlined elements recites a mathematical concept, refer to equation 4-9b see specification]
for i=1, a mixture of a sample of the solution S0 with a volume of an organic Sorg or aqueous Saq solution immiscible with the solution S0 to obtain, after separation of the mixture into two phases, an aqueous phase ϕ(i=1,aq) and an organic phase ϕ(i=1,org); and
for i=2 to N:
a mixture of each aqueous phase ϕ(i-1,aq) with a volume of the solution Sorg to obtain, after separation of the mixture into two phases, an aqueous phase ϕ(i,aq) and an organic phase ϕ(i,org); a mixture of each organic phase ϕ(i-1,org) with a volume of the solution Saq to obtain, after separation of the mixture into two phases, an aqueous phase ϕ(i,aq) and an organic phase ϕ(i,org);
b) subjecting all the aqueous and organic phases obtained at the row N to a measurement of an extensive and conservative quantity X to obtain an experimental vector Vexp comprising 2N measured values of X; [the examiner finds that the foregoing underlined elements recite routine data gathering broadly and generically recited, see paragraphs [0017], [0082], [0152]]
c) defining theoretical vectors Vtheor(Dk) for y partition coefficient values Dk, with y greater than or equal to 2 and k ranging from 1 to y, each theoretical vector comprising 2N values of X calculated for the aqueous and organic phases obtained at the row N and for one of the y values Dk; [the examiner finds that the foregoing underlined elements recites a mathematical concept, namely constructing mathematical models/theoretical simulations, see paragraphs [0120]-[0142]]
d) carrying out a parametric adjustment between the vectors Vtheor(Dk) and the vector Vexp to obtain a distribution of the solutes of the solution S0, which contribute to the 2N measured values of X, as a function of to the y values Dk., comparinq the experimental vector
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exp to the theoretical vectors Vtheor(Dk) according to lipophilicity values of the solutes expressed as a function of Dk, wherein step d) provides lipophilicity information of the solutes in the solution So. [the examiner finds that the foregoing underlined elements recites a mathematical concept, namely mathematical comparison of data and models to derive information(solute distribution), see paragraphs [0143]-[0145]]
Step 2A: Prong Two: Does the Claim Recite Additional Elements That Integrate the Abstract Idea into a Practical Application?
The elements that are not underlined above are the additional elements.
The examiner finds that each of the following additional elements merely recites the words “apply it” (or an equivalent) with the abstract idea, or merely includes instructions to implement the abstract idea on a computer, or merely uses a computer as a tool to perform the abstract idea:
Thus, taken alone, the additional elements do not integrate the abstract idea into a practical application. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. For example, there is no indication that the combination of elements improves the functioning of a computer or improves any other technology.
Step 2B: Does the Claim Recite Additional Elements That Amount to Significantly More Than the Abstract Idea?
The examiner finds that the additional elements do not amount to significantly more than the abstract idea for the same reasons discussed above with respect to the conclusion that the additional elements do not integrate the abstract idea into a practical application.
Claims 2-14 remain directed to the abstract idea, namely the mathematical concepts of organizing, representing, and manipulating data. The additional elements recited in the claims, such as specifying the number of partitions (claim 2), limiting the type of solution to aqueous or organic and defining solvent classes (claims 3-8, 14), identifying the measurable quantity X (claim 9), applying mathematical equations to define theoretical vectors (claim 10), performing weighting and adjustment calculations (claims 11-12), or expressing distributions in histogram form (claim 13), merely add field-of -use limitations, data gathering, or post solution presentation of results. These steps represent conventional chemical environments and routine laboratory activities that do not integrate the abstract idea into a practical application. Accordingly, when considered as an ordered combination, claims 2-14 do not amount to significantly more than the abstract idea itself.
Conclusion
THIS ACTION IS MADE FINAL. 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 GEDEON M KIDANU whose telephone number is (571)270-0591. The examiner can normally be reached 8-4.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kristina DeHerrera can be reached at 303-297-4237. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GEDEON M KIDANU/Examiner, Art Unit 2855
/KRISTINA M DEHERRERA/Supervisory Patent Examiner, Art Unit 2855 1/20/26