DETAILED ACTION
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
The amendment filed on 05/26/2026 has been entered. Claim(s) 1-18, 21, 22 is/are now pending in the application. Applicant's amendments have addressed all informalities as previously set forth in the non-final action mailed on 03/12/2026.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
Claim(s) 1-18, is/are rejected under 35 U.S.C. 103 as being unpatentable over WENNBERG ET AL. (Wennberg, Tero, et al. "Use of DryLab for Simulation of TLC Separation and Method Transfer from TLC to HPLC." JPC-Journal of Planar Chromatography-Modern TLC 19.108 (2006): 118-123.) (hereinafter “WENNBERG”) in view of HULANICKI (Hulanicki, A. "Absolute methods in analytical chemistry (Technical Report)." Pure and applied chemistry 67.11 (1995): 1905-1911.).
With respect to Claim(s) 1, 18, WENNBERG teaches simulation of TLC separations and the BRI of:
A process
of
determining a sample property data set characterizing properties of a prototype fluidic sample to be separated by a sample separation apparatus (See, e.g., Section(s) 3),
the process comprising:
providing a separation method data set, comprising a plurality of data subsets characterizing respective different separation methods for separating the prototype fluidic sample by the sample separation apparatus (See, e.g., Section(s) 3);
operating the sample separation apparatus to perform a plurality of experimental executions of the respective separation methods on the prototype fluidic sample to obtain an experimental result data set, wherein the experimental result data set comprises a plurality of data subsets characterizing respective experimental results obtained from the experimental executions of the respective separation methods (See, e.g., Section(s) 2);
providing an apparatus data set characterizing properties of the sample separation apparatus (See, e.g., Section(s) 2);
and
determining the sample property data set characterizing properties of the prototype fluidic sample, by carrying out a numerical analysis based on the apparatus data set the separation method data set, and the experimental result data set (See, e.g., Section(s) 2, 3; See also, e.g., Table 1).
However, WENNBERG is lacking the explicit language of:
the properties of the prototype fluidic sample comprise absolute analyte properties independent from the sample separation apparatus; and at least part of the absolute analyte properties corresponds to absolute analyte properties of an adaptation fluidic sample to be separated by another sample separation apparatus.
HULANICKI teaches ‘Absolute methods in analytical chemistry’ and the BRI of:
properties of a prototype sample comprise absolute analyte properties independent from the sample apparatus; and at least part of the absolute analyte properties corresponds to absolute analyte properties of an adaptation sample (See, e.g., Section(s) 1-8).
It would have been obvious to one ordinary skill in the art, at the time before the effective filing date of the claimed invention, to modify WENNBERG to include properties of a prototype sample comprise absolute analyte properties independent from the sample apparatus; and at least part of the absolute analyte properties corresponds to absolute analyte properties of an adaptation sample.
One of ordinary skill in the art would have been motivated to modify WENNBERG because it would be beneficial to improve analytical technique for analytes. Further, it would be obvious to combine prior art elements according to known methods to yield predictable results, simply substitute one known element for another to obtain predictable results, use known techniques to improve similar devices in the same way, and/or apply a known technique to a known device ready for improvement to yield predictable results.
With respect to Claim(s) 6, WENNBERG teaches simulation of TLC separations and the BRI of:
A process
of carrying out
a method transfer by determining a target separation method for separating an adaptation fluidic sample by a target sample separation apparatus by modifying an initial separation method for an initial sample separation apparatus (See, e.g., Summary),
the process comprising:
providing a first initial data set characterizing the initial separation method and a second initial data set characterizing properties of the target sample separation apparatus (See, e.g., Section(s) 2);
providing a third initial data set characterizing properties of the adaptation fluidic sample, by: operating the initial sample separation apparatus to perform experimental execution of the initial separation method on a prototype fluidic sample to obtain an experimental result (See, e.g., Section(s) 2);
executing a data determination operation, comprising selecting data from the experimental result according to known analytes of the adaptation fluidic sample under consideration for the method transfer (See, e.g., Section(s) 3);
and
composing the selected data as the third initial data set (See, e.g., Section(s) 3);
and
determining a target data set characterizing the target separation method by carrying out a numerical analysis based on the first initial data set, the second initial data set, and the third initial data set (See, e.g., Section(s) 3, 4).
However, WENNBERG is lacking the explicit language of:
the properties of the adaptation fluidic sample comprise absolute analyte properties independent from the initial sample separation apparatus and from the target sample separation apparatus.
HULANICKI teaches ‘Absolute methods in analytical chemistry’ and the BRI of:
properties of a sample comprise absolute analyte properties independent from the initial sample apparatus and from the target sample apparatus (See, e.g., Section(s) 1-8).
It would have been obvious to one ordinary skill in the art, at the time before the effective filing date of the claimed invention, to modify WENNBERG to include properties of a sample comprise absolute analyte properties independent from the initial sample apparatus and from the target sample apparatus.
One of ordinary skill in the art would have been motivated to modify WENNBERG because it would be beneficial to improve analytical technique for analytes. Further, it would be obvious to combine prior art elements according to known methods to yield predictable results, simply substitute one known element for another to obtain predictable results, use known techniques to improve similar devices in the same way, and/or apply a known technique to a known device ready for improvement to yield predictable results.
With respect to Claim(s) 2, the cited reference(s) of the parent claim(s) teaches the BRI of the parent claim(s).
WENNBERG further teaches the BRI of:
the determining comprises
iteratively varying the sample property data set, starting from an initial guess, until a simulated result of executing at least part of the separation methods, characterized by the data subsets contained in the separation method data set, on the sample separation apparatus, characterized by the apparatus data set, for separating the prototype fluidic sample, matches with at least part of the experimental results obtained from the experimental executions of the respective separation methods on the sample separation apparatus (See, e.g., Section(s) 3, 4).
With respect to Claim(s) 3, the cited reference(s) of the parent claim(s) teaches the BRI of the parent claim(s).
WENNBERG further teaches the BRI of:
simulating execution of at least part of the separation methods, characterized by the data subsets contained in the separation method data set, on the sample separation apparatus to obtain a simulated result data set, wherein the simulated result data set comprises a plurality of data subsets characterizing respective simulated results obtained from the simulated execution of the respective separation methods; and determining the sample property data set based on comparing the simulated results and the experimental results (See, e.g., Section(s) 3, 4).
With respect to Claim(s) 4, the cited reference(s) of the parent claim(s) teaches the BRI of the parent claim(s).
WENNBERG further teaches the BRI of:
at least one of the following features:
the simulating execution of the at least part of the separation methods on the sample separation apparatus is based on the apparatus data set characterizing properties of the sample separation apparatus; the comparing comprises fitting the simulated results to the experimental results using properties of the prototype fluidic sample as fitting parameters; the simulating execution comprises considering differences between an ideal behavior and a real behavior of the sample separation apparatus when executing the separation methods; the determining the sample property data set comprises comparing a simulated chromatogram resulting from the simulated execution with an experimental chromatogram resulting from the experimental executions; the comparing the simulated results and the experimental results comprises carrying out a numerical analysis (See, e.g., Section(s) 3, 4).
With respect to Claim(s) 5, the cited reference(s) of the parent claim(s) teaches the BRI of the parent claim(s).
WENNBERG further teaches the BRI of:
the sample property data set comprises at least one of the following:
information characterizing a behavior of the prototype fluidic sample during separation in the sample separation apparatus; information characterizing an interaction of the prototype fluidic sample with a sample separation unit of the sample separation apparatus; information characterizing a temperature behavior of the prototype fluidic sample; information characterizing properties of one or more different analytes of the prototype fluidic sample (See, e.g., Section(s) 3, 4).
With respect to Claim(s) 7, the cited reference(s) of the parent claim(s) teaches the BRI of the parent claim(s).
WENNBERG further teaches the BRI of:
wherein
the determining comprises
iteratively varying the target data set in comparison with the first initial data set until a simulated result of executing the target separation method, characterized by the varied target data set, on the target sample separation apparatus, characterized by the second initial data set, for separating the adaptation fluidic sample, characterized by the third initial data set, matches with the experimental result obtained from the experimental execution of the initial separation method, characterized by the first initial data set, on the initial sample separation apparatus (See, e.g., Section(s) 3, 4).
With respect to Claim(s) 8, the cited reference(s) of the parent claim(s) teaches the BRI of the parent claim(s).
WENNBERG further teaches the BRI of:
comprising
simulating execution of the initial separation method on the initial sample separation apparatus based on a fourth initial data set characterizing properties of the initial sample separation apparatus (See, e.g., Section(s) 3, 4).
With respect to Claim(s) 9, the cited reference(s) of the parent claim(s) teaches the BRI of the parent claim(s).
WENNBERG further teaches the BRI of:
at least one of the following features:
the simulating execution of the initial separation method on the initial sample separation apparatus comprises considering differences between an ideal behavior and a real behavior of the initial sample separation apparatus when executing the initial separation method; the process comprises comparing a simulated chromatogram resulting from the simulated execution of the initial separation method on the initial sample separation apparatus with an experimental chromatogram resulting from an experimental execution of the initial separation method on the initial sample separation apparatus; the process comprises comparing results from the simulated execution of the initial separation method on the initial sample separation apparatus with results from an experimental execution of the initial separation method on the initial sample separation apparatus by carrying out a numerical analysis (See, e.g., Section(s) 3, 4).
With respect to Claim(s) 10, the cited reference(s) of the parent claim(s) teaches the BRI of the parent claim(s).
WENNBERG further teaches the BRI of:
wherein
determining the target data set comprises
simulating execution of the initial separation method on the target sample separation apparatus (See, e.g., Section(s) 3, 4).
With respect to Claim(s) 11, the cited reference(s) of the parent claim(s) teaches the BRI of the parent claim(s).
WENNBERG further teaches the BRI of:
wherein
the simulating execution comprises considering differences between an ideal behavior and a real behavior of the target sample separation apparatus when executing the initial separation method (See, e.g., Section(s) 3, 4).
With respect to Claim(s) 12, the cited reference(s) of the parent claim(s) teaches the BRI of the parent claim(s).
WENNBERG further teaches the BRI of:
wherein
determining the target data set comprises analyzing a result of the simulated execution together with the third initial data set (See, e.g., Section(s) 3, 4).
With respect to Claim(s) 13, the cited reference(s) of the parent claim(s) teaches the BRI of the parent claim(s).
WENNBERG further teaches the BRI of:
comprising at least one of the following features:
wherein the analyzing comprises carrying out a numerical analysis; wherein determining the target data set comprises determining a simulated chromatogram based on a result of the analyzing (See, e.g., Section(s) 3, 4).
With respect to Claim(s) 14, the cited reference(s) of the parent claim(s) teaches the BRI of the parent claim(s).
WENNBERG further teaches the BRI of:
once or a plurality of times, iteratively repeating at least one of:
the simulating execution of the initial separation method on the target sample separation apparatus; the simulating execution of the initial separation method on the target sample separation apparatus, and analyzing a result of the simulated execution together with the third initial data set; the simulating execution of the initial separation method on the target sample separation apparatus, analyzing a result of the simulated execution together with the third initial data set, and determining a simulated chromatogram based on a result of the analyzing to determine the target data set (See, e.g., Section(s) 3, 4).
With respect to Claim(s) 15, the cited reference(s) of the parent claim(s) teaches the BRI of the parent claim(s).
WENNBERG further teaches the BRI of:
determining the target data set comprises determining a simulated chromatogram based on a result of the analyzing (See, e.g., Section(s) 3, 4),
and
the process further comprises at least one of the following:
comparing the determined simulated chromatogram with an experimental chromatogram of the experimental result obtained from the experimental execution of the initial separation method on the initial sample separation apparatus; comparing the determined simulated chromatogram with an experimental chromatogram of the experimental result obtained from the experimental execution of the initial separation method on the initial sample separation apparatus, and iteratively repeating until the determined simulated chromatogram matches the experimental chromatogram (See, e.g., Section(s) 3, 4).
With respect to Claim(s) 16, the cited reference(s) of the parent claim(s) teaches the BRI of the parent claim(s).
WENNBERG further teaches the BRI of:
wherein
the third initial data set comprises at least one of the following:
information characterizing a behavior of the adaptation fluidic sample during separation in the initial sample separation apparatus; information characterizing an interaction of the adaptation fluidic sample with a sample separation unit of the initial sample separation apparatus; information characterizing a temperature behavior of the adaptation fluidic sample; information characterizing properties of one or more different analytes, of the adaptation fluidic sample (See, e.g., Section(s) 3, 4).
With respect to Claim(s) 17, the cited reference(s) of the parent claim(s) teaches the BRI of the parent claim(s).
WENNBERG further teaches the BRI of:
at least one of the following:
determining an actual composition of a mobile phase present at a sample separation unit of at least one of the initial sample separation apparatus and the target sample separation apparatus; determining an actual composition of a mobile phase present at a sample separation unit of at least one of the initial sample separation apparatus and the target sample separation apparatus, wherein the determining of the actual composition is done experimentally; determining an actual composition of a mobile phase present at a sample separation unit of at least one of the initial sample separation apparatus and the target sample separation apparatus, wherein the determining of the actual composition is done by simulation (See, e.g., Section(s) 3, 4).
Claim(s) 21, 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over the cited reference(s) of the parent claim(s) in view of WITT ET AL. (US 20160327528 A1) (hereinafter “WITT”).
With respect to Claim(s) 21, the cited reference(s) of the parent claim(s) teaches the BRI of the parent claim(s).
WENNBERG teaches the BRI of:
An initial sample separation apparatus for determining the target separation method according to claim 6,
configured to provide the first initial data set, the second initial data set, the third initial data set, and a fourth initial data set characterizing properties of the initial sample separation apparatus set; determine the target data set by carrying out the numerical analysis.
However, WENNBERG is lacking the explicit language of:
a sampling unit configured to introduce the prototype fluidic sample into a mobile phase; a fluid drive configured to drive the mobile phase and the prototype fluidic sample in the mobile phase; a sample separation unit configured to receive the prototype fluidic sample in the mobile phase and separate the prototype fluidic sample; a detector configured to detect the separated prototype fluidic sample, wherein the experimental result comprises data derived from an output of the detector; a control unit configured to control the operating of the initial sample separation apparatus to perform experimental execution of the initial separation method on the prototype fluidic sample to obtain the experimental result, by controlling the sampling unit, the fluid drive, the sample separation unit, and the detector to separate the prototype fluidic sample and to detect the separated prototype fluidic sample according to the initial separation method; and a method transfer device comprising: a data provision unit; and a determining unit
WITT teaches ‘An apparatus for deriving an operation mode from a first fluidic device to a second fluidic device, wherein the first fluidic device has a first target operation mode representing a desired behavior of the first fluidic device and has a first real operation mode representing the actual behavior of the first fluidic device, wherein the second fluidic device has a second target operation mode representing a desired behavior of the second fluidic device and has a second real operation mode representing the actual behavior of the second fluidic device, the apparatus comprising a first determining unit configured for determining the first real operation mode based on the first target operation mode and based on a preknown parameterization of the first fluidic device, and a second determining unit configured for determining the second target operation mode based on the determined first real operation mode and based on a preknown parameterization of the second fluidic device’ and the BRI of:
a sampling unit configured to introduce the prototype fluidic sample into a mobile phase; a fluid drive configured to drive the mobile phase and the prototype fluidic sample in the mobile phase; a sample separation unit configured to receive the prototype fluidic sample in the mobile phase and separate the prototype fluidic sample; a detector configured to detect the separated prototype fluidic sample, wherein the experimental result comprises data derived from an output of the detector; a control unit configured to control the operating of the initial sample separation apparatus to perform experimental execution of the initial separation method on the prototype fluidic sample to obtain the experimental result, by controlling the sampling unit, the fluid drive, the sample separation unit, and the detector to separate the prototype fluidic sample and to detect the separated prototype fluidic sample according to the initial separation method; and a method transfer device comprising: a data provision unit; and a determining unit (See, e.g., ¶ ABSTRACT; See also, e.g., Fig(s). 1, 2).
It would have been obvious to one ordinary skill in the art, at the time before the effective filing date of the claimed invention, to modify WENNBERG to include a sampling unit configured to introduce the prototype fluidic sample into a mobile phase; a fluid drive configured to drive the mobile phase and the prototype fluidic sample in the mobile phase; a sample separation unit configured to receive the prototype fluidic sample in the mobile phase and separate the prototype fluidic sample; a detector configured to detect the separated prototype fluidic sample, wherein the experimental result comprises data derived from an output of the detector; a control unit configured to control the operating of the initial sample separation apparatus to perform experimental execution of the initial separation method on the prototype fluidic sample to obtain the experimental result, by controlling the sampling unit, the fluid drive, the sample separation unit, and the detector to separate the prototype fluidic sample and to detect the separated prototype fluidic sample according to the initial separation method; and a method transfer device comprising: a data provision unit; and a determining unit.
One of ordinary skill in the art would have been motivated to modify WENNBERG because it would be beneficial to derive operation mode from one fluidic device to another. Further, it would be obvious to combine prior art elements according to known methods to yield predictable results, simply substitute one known element for another to obtain predictable results, use known techniques to improve similar devices in the same way, and/or apply a known technique to a known device ready for improvement to yield predictable results.
With respect to Claim(s) 22, the cited reference(s) of the parent claim(s) teaches the BRI of the parent claim(s).
WENNBERG teaches the BRI of:
A target sample separation apparatus for determining the target separation method according to claim 6,
configured to provide the first initial data set, the second initial data set, the third initial data set, and a fourth initial data set characterizing properties of the initial sample separation apparatus set; configured to determine the target data set by carrying out the numerical analysis.
However, WENNBERG is lacking the explicit language of:
a sampling unit configured to introduce the adaptation fluidic sample into a mobile phase; a fluid drive configured to drive the mobile phase and the adaptation fluidic sample in the mobile phase; a sample separation unit configured to receive the adaptation fluidic sample in the mobile phase and separate the adaptation fluidic sample; a detector configured to detect the separated adaptation fluidic sample; a method transfer device comprising: a data provision unit; a determining unit; and a control unit configured to control the sampling unit, the fluid drive, the sample separation unit, and the detector to produce the separated adaptation fluidic sample according to the determined target data set and to detect the separated adaptation fluidic sample.
WITT teaches ‘An apparatus for deriving an operation mode from a first fluidic device to a second fluidic device, wherein the first fluidic device has a first target operation mode representing a desired behavior of the first fluidic device and has a first real operation mode representing the actual behavior of the first fluidic device, wherein the second fluidic device has a second target operation mode representing a desired behavior of the second fluidic device and has a second real operation mode representing the actual behavior of the second fluidic device, the apparatus comprising a first determining unit configured for determining the first real operation mode based on the first target operation mode and based on a preknown parameterization of the first fluidic device, and a second determining unit configured for determining the second target operation mode based on the determined first real operation mode and based on a preknown parameterization of the second fluidic device’ and the BRI of:
a sampling unit configured to introduce the adaptation fluidic sample into a mobile phase; a fluid drive configured to drive the mobile phase and the adaptation fluidic sample in the mobile phase; a sample separation unit configured to receive the adaptation fluidic sample in the mobile phase and separate the adaptation fluidic sample; a detector configured to detect the separated adaptation fluidic sample; a method transfer device comprising: a data provision unit; a determining unit; and a control unit configured to control the sampling unit, the fluid drive, the sample separation unit, and the detector to produce the separated adaptation fluidic sample according to the determined target data set and to detect the separated adaptation fluidic sample (See, e.g., ¶ ABSTRACT; See also, e.g., Fig(s). 1, 2).
It would have been obvious to one ordinary skill in the art, at the time before the effective filing date of the claimed invention, to modify WENNBERG to include a sampling unit configured to introduce the adaptation fluidic sample into a mobile phase; a fluid drive configured to drive the mobile phase and the adaptation fluidic sample in the mobile phase; a sample separation unit configured to receive the adaptation fluidic sample in the mobile phase and separate the adaptation fluidic sample; a detector configured to detect the separated adaptation fluidic sample; a method transfer device comprising: a data provision unit; a determining unit; and a control unit configured to control the sampling unit, the fluid drive, the sample separation unit, and the detector to produce the separated adaptation fluidic sample according to the determined target data set and to detect the separated adaptation fluidic sample.
One of ordinary skill in the art would have been motivated to modify WENNBERG because it would be beneficial to derive operation mode from one fluidic device to another. Further, it would be obvious to combine prior art elements according to known methods to yield predictable results, simply substitute one known element for another to obtain predictable results, use known techniques to improve similar devices in the same way, and/or apply a known technique to a known device ready for improvement to yield predictable results.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
PIROK ET AL. (Pirok, Bob WJ, Andrea FG Gargano, and Peter J. Schoenmakers. "Optimizing separations in online comprehensive two‐dimensional liquid chromatography." Journal of separation science 41.1 (2018): 68-98.).
Response to Arguments
Applicant’s amendments, filed on 05/26/2026, have been entered and fully considered. In light of the applicant’s amendments changing the scope of the claimed invention, the rejection(s) have been withdrawn or updated. However, upon further consideration, a new or updated ground(s) of rejection(s) have been made, and applicant's argument(s)/remark(s) pertaining to the amended language have been rendered moot.
Applicant's argument(s)/remark(s), see page(s) 21, filed 05/26/2026, with respect to the 112 rejection(s) has/have been fully considered.
-Applicant states
“CLAIM REJECTIONS - 35 U.S.C. § 112
Claims 18 and 19 are rejected under 35 U.S.C. § 112(d) or pre-AIA 35 U.S.C. § 112, further paragraph, as allegedly being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 18 has been amended to remove the phrase "one or more". Claim 19 has been cancelled. Therefore, Applicant respectfully requests that this rejection be withdrawn.”.
Examiner agrees with the underlined argument(s)/remark(s).
Said rejection(s) has/have been withdrawn.
Applicant's argument(s)/remark(s), see page(s) 21-23, filed 05/26/2026, with respect to the 101 rejection(s) has/have been fully considered.
-Applicant states
“CLAIM REJECTIONS - 35 U.S.C. § 101
Claim 19 is rejected under 35 U.S.C. § 101 as allegedly being directed to non-statutory subject matter. Without reaching the merits of this rejection, claim 19 has been cancelled, thereby rendering the rejection moot.
Claims 1-20 are rejected under 35 U.S.C. § 101 as allegedly being directed to an abstract idea without significantly more. Applicant respectfully traverses this rejection for the following reasons.
Claim 1 is directed to a "process of determining a sample property data set characterizing properties of a prototype fluidic sample to be separated by a sample separation apparatus". Claim 1 has been amended to clarify that "determining the sample property data set" comprises "carrying out a numerical analysis based on the apparatus data set, the separation method data set, and the experimental result data set." Claim 1 as amended further clarifies that the "experimental result data set" is obtained by actually "operating the sample separation apparatus to perform a plurality of experimental executions of the respective separation methods on the prototype fluidic sample." Thus, the process of claim 1 is not merely abstract but instead involves actual manipulation and transformation of a fluidic sample (i.e., separation followed by detection/measurement). Such process cannot be performed in the human mind but instead requires the instrumentation of a sample separation apparatus.
Moreover, the process specifically recited in claim 1 improves the operation of a sample separation apparatus, particularly when the sample separation apparatus is involved in a "method transfer", i.e., the transfer of a sample separation method from an initial sample separation apparatus to a target sample separation apparatus. See, e.g., Applicant's specification,1 [0027]:
According to an exemplary embodiment of the present disclosure, an adaptation of an existing initial separation method for separating a fluidic sample developed for an initial sample separation apparatus may be carried out for execution by another target sample separation apparatus for fulfilling a corresponding sample separation task. Unlike conventional approaches, an exemplary embodiment of the present disclosure uses as a starting point for the separation method conversion between different sample separation apparatuses at least three different initial data sets: A first initial data set is defined for describing the initial separation method, and a second initial data set is defined for describing the target sample separation apparatus. Highly advantageously, a third initial data set is also defined or derived which is indicative of properties of the fluidic sample to be separated, and which may be indicative of an interaction of the fluidic sample with a sample separation apparatus. In form of the third initial data set, absolute analyte properties of the fluidic sample may be taken into account for the separation method adaptation from one sample separation apparatus to another one.
See also, Applicant's specification, [0027]:
On the basis of the three mentioned initial data sets, a target data set indicating the target separation method to be executed on the target sample separation apparatus may then be determined by carrying out a numerical analysis (e.g., including a finite element analysis) considering each of the first initial data set, the second initial data set, and the third initial data set. Highly advantageously, the described separation method transfer architecture may save time to be spent by a user for method development and for occupying sample separation apparatuses with experiments in terms of method development. Beyond this, fluidic sample material used for the method transfer may be significantly reduced. Moreover, the described method transfer architecture can be easily automated and may be carried out without requiring specific skills of a user. For instance, an exemplary embodiment of the present disclosure can calculate an optimum in an experimental space (that may be not identical with an experimental point, but interpolated). Thus, an excellent quality of the transferred separation method may be achieved.
See also, Applicant's specification,1 [0089]:
In particular, exemplary embodiments of the present disclosure may at least partially overcome at least part of the following and/or other conventional issues: The described method transfer architecture may save time, may reduce the amount of fluidic sample needed for method transfer, and/or may reduce the required work labor. A process according to an exemplary embodiment of the present disclosure can be automated and can be performed even by less experienced users. During execution of such a process, it may be possible to calculate the optimum in the experimental space that is not identical with an experimental point but interpolated.
In view of the foregoing, claim 1 is directed to "significantly more" than an abstract idea and therefore is directed to patent-eligible subject matter under 35 U.S.C. § 101.
Claims 2-5 depend directly or indirectly from claim 1 and thus are patent-eligible for at least the same reasons as set forth above regarding claim 1.
Similar to claim 1, independent claim 6 recites: "operating the initial sample separation apparatus to perform experimental execution of the initial separation method on a prototype fluidic sample to obtain an experimental result". Thus, claim 6 is patent-eligible for at least the same reasons as set forth above regarding claim 1.
Claims 7-17 depend directly or indirectly from claim 6 and thus are patent-eligible for at least the same reasons.
Claim 18 depends from claim 1 and thus is patent-eligible for at least the same reasons.
Claims 19 and 20 have been cancelled.
In view of the foregoing, claims 1-18 are directed to patent-eligible subject matter under 35 U.S.C. § 101. Therefore, Applicant respectfully requests that this rejection be withdrawn.”.
Examiner agrees with the underlined argument(s)/remark(s).
Said rejection(s) has/have been withdrawn.
Applicant's argument(s)/remark(s), see page(s) 24-25, filed 05/26/2026, with respect to the art rejection(s) has/have been fully considered.
-Applicant states
“CLAIM REJECTIONS - 35 U.S.C. § 102
Claims 1-20 are rejected under 35 U.S.C. § 102(a)(1) as allegedly being anticipated by Wennberg (NPL: "Use of DryLab for Simulation of TLC Separation and Method Transfer from TLC to HPLC"). Applicant respectfully traverses this rejection for the following reasons.
Claim 1 has been amended to clarify that "the properties of the prototype fluidic sample comprise absolute analyte properties independent from the sample separation apparatus". See, e.g., Applicant's specification, 1 [0026] ("absolute analyte properties may be properties, which may be completely independent from the actual used sample separation apparatus. Hence, the physical process of separation may be understood solely by taking the absolute analyte properties and the actual physical conditions during the separation into account"). At the least, Wennberg does not teach this feature as recited in claim 1. Instead, Wennberg teaches the making of certain assumptions about instrument properties for use in simulating sample properties. These sample properties are dependent on in the corresponding sample separation instrument for which the sample was done-that is, the sample properties are not independent of the sample separation instrument. Wennberg's method transfer, particularly the use of the DryLab software, relies on the retardation times obtained from or simulated for the TLC instrument. For any given sample, such retardation times, like the retention times obtained by HPLC, depend on the stationary phase (adsorbent) utilized in the instrument (TLC plate or HPLC column). See Wennberg, section 3, Table 1. Wennberg is silent regarding the determination of "absolute analyte properties" in the manner recited in claim 1.
In view of the foregoing, claim 1 does not read on Wennberg and thus is not anticipated by Wennberg.
Claims 2-5 depend directly or indirectly from claim 1 and thus are patentable for at least the same reasons as set forth above regarding claim 1.
Similar to claim 1, independent claim 6 recites: "the properties of the adaptation fluidic sample comprise absolute analyte properties independent from the initial sample separation apparatus and from the target sample separation apparatus". Thus, claim 6 is patentable for at least the same reasons as set forth above regarding claim 1.
Claims 7-17 depend directly or indirectly from claim 6 and thus are patentable for at least the same reasons.
Claim 18 depends from claim 1 and thus is patentable for at least the same reasons.
Claims 19 and 20 have been cancelled.
In view of the foregoing, claims 1-18 are patentable under 35 U.S.C. § 102(1)(a) over Wennberg. Therefore, Applicant respectfully requests that this rejection be withdrawn.”.
The underlined argument(s)/remark(s) are moot because the arguments do not apply to any of the previous rejected limitations.
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 extension fee 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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RAYMOND NIMOX
Primary Examiner
Art Unit 2857
/RAYMOND L NIMOX/Primary Examiner, Art Unit
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