Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
Applicant’s arguments filed 07/23/2025 have been entered. The112(b) rejections previously set forth are withdrawn in view of the arguments and amendment.
Response to Arguments
Applicant's arguments filed 07/23/2025 have been fully considered but they are not persuasive.
In response to applicant's argument that Rodrigues and Frey do not teach adding the feedforward signal to a flow rate feedback signal for the pumps to provide a mix ratio of solvents, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Witt and Paul each teach control of mix ratio of first and second solvents as discussed below. Witt teaches modifying the mixing ratio of solvents using flow rates, control of the pistons/pumps, and control using known relations to forecast pressure, Paul teaches feedback control including using PID controllers (0053), while the taught combination does not explicitly teach adding a feedforward signal to a flow rate feedback signal of one or both of the pumps, the use of feedforward/feedback hybrid systems is known in the art as illustrated by Rodrigues and Frey, Rodrigues teaches feedback-feedforward control in chromatography, using PID control (p. 255, abstract, introduction), with a feedforward algorithm in addition to the feedback term it is possible to combine the advantages of both controller configurations (p. 258 Feedforward – Feedback Controller, see equation 7, adding); Frey teaches feedback regulation in elution chromatography (abstract) and that feedback control has an advantage of only requiring limited measurements, when disturbances are measured it is often desirable to supplement feedback regulation with feedforward compensation (Introduction). It would have been obvious to one of ordinary skill in the art before the invention was made to provide combined feedback-feedforward control as described by Rodrigues and Frey in the taught combination in order to combine the advantages of both configurations, as according to Frey it is desirable to supplement feedback regulation with feedforward compensation, according to Rodrigues the combination provides better performance (Conclusion), and the courts have held that combining prior art elements according to known methods to yield predictable results would have been obvious to a person of ordinary skill in the art before the filing date, see MPEP §2143.
Additionally, see Berger (DE 19625648) and De Corral (US PG Pub 2008/0206067), provided as evidence that the feedback/feedforward control were known for use for controlling chromatography pumps before the invention was made.
De Corral teaches feedback control (0080-0082) and that a feed forward control algorithm compensates for pressure errors and provides a velocity contribution (0083-0085, Fig. 7); Berger control of pumps in chromatography (p. 1) and in a preferred embodiment proportional control in a feedforward system and a feedback process takes place at high frequency, which results in very smooth and repeatable pressure control (p. 8 third paragraph).
Examiner notes instant specification 0048 discloses "signal communication" refers to electrical connections or circuits, optical connections, wireless communications through radio waves, internet connections, and other means by which equipment may communicate, and the use of PID control (0122).
Claim Interpretation
The claims recite the limitation feed forward control, this is interpreted in view of the instant specification to include at least the generation anticipatory control signals (instant specification [0019]).
Claims 75-77, and 85 recite a disturbance value, this is interpreted in light of the instant specification to include at least a pressure measurement or change ([0140-0142]).
The claims recite signals as encoded, encoded is interpreted as determining or calculated based on.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 81, 87-89, 92, 95-98, 101-106 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Witt (US PG Pub 2006/0219418), in view Laurent (Computer-controlled single-pump solvent programmer for high-performance liquid chromatography¸ 1981), in view of Paul (US PG Pub 2003/00520007), in view of Munk (US 4,032,445), in view of Rodrigues (A Procedure for Feasible and Optimal Operational Strategies for Control of CARE Systems, 1997) and Frey (Elution Feedback in Regulation Preparative Chromatography, 1991), with evidence from Berger (DE 19625648) and De Corral (US PG Pub 2008/0206067, also published as WO2006017121, examiner notes the US document used for convenience).
With respect to claims 81, 89, and 98, Witt teaches a solvent supply path for use in liquid chromatography and a method for supplying solvent (abstract, [0001, 0029, 0040, 0053-0057]), Fig. 1 illustrates the solvent delivery system comprising first and second solvent delivery line
s 1 and 5, first and second metering pumps 2 and 6 (a first leg including a first pump; a second leg including a second pump, [0013]); mixing tee 3 (a mixing tee positioned at a junction between the first leg and the second leg, [0053]); a control unit and a pressure determination unit 9 ([0005-0033], Fig. 1), comprising software executed in or by any suitable processing unit ([0041], a controller comprising a processor), the control unit adapted to control the first and second metering pumps/devices comprising pistons ([0013], control of the first pump and the second pump), deriving compression or expansion from determined solvent volume, pressure variation, and compressibility, and the control unit uses a known relation between solvent pressure and solvent composition, for example as a function of the mixing ratio of the solvents which is used to forecast pressure, such that it is not necessary to measure the composite solvent pressure ([0031-0033], providing open loop feed forward control based on a parameter of stored energy), and is adapted for compensating for variation of the solvent volume by a corresponding corrective movement of the piston.
Flow sensors:
Witt teaches the flow rate of solvents determined by the movement of the metering pump's piston ([0053]), and the mixing ratio of solvents might be modified with dependence on the flow rates and on the compressibilities in the two supply flow paths ([0023], providing first and second flow sensors configured to provide flow rate measurements to the controller). Alternatively, while Witt does not explicitly state that a flow rate sensor is included to measure flow rate in the solvent lines, one having ordinary skill in the art may envisage that a flow rate sensor is included in the system to make the above determination of the flow rate. Alternatively, it would have been obvious to one having ordinary skill in the art to include a flow rate sensor in the system of Witt in order to monitor the flow rates of the solutions.
Alternatively, Paul teaches precision fluid control for liquid chromatography (abstract, [0001-00012]), mixing two fluids and measuring the flow of each fluid before mixing ([0014, 0022], Fig. 1), comprising flowmeters for each fluid ([0035-0039], Figs.). It would have been obvious to one of ordinary skill in the art at the time the invention was made to incorporate flowmeters as described by Paul into Witt’s system to determine the flow rate, as flow meters are known in the art for determining flow as illustrated by Paul.
Fluid capacitance:
Witt teaches deriving compression or expansion from solvent volume, pressure variation, and compressibility, determining respective compressibilities in the first and second flow paths, and the control unit uses a known relation between solvent pressure and solvent composition, for example as a function of the mixing ratio of the solvents which is used to forecast pressure ([0031-0034]), in dependence on the respective compressibilities KA of solvent A and KB of solvent B, volumes of solvent A and solvent B are set free ([0061-0065]), and the control unit adapted for counteracting expansion or compression of the solvent volumes ([0019]), and controlling the first and second metering devices ([0013]), flow rate of solvents determined by the movement of the metering pump's piston ([0053]); Alternatively, Paul teaches flow meters as discussed above, and capacitance is dominated by volume and compressibility of the fluid ([0044-0045]), .
Feedforward correction:
Witt teaches determining the solvent volume (captive volume) and compressibility in the respective supply flow path ([0030-0034], compressibility and solvent volume in the path providing fluid capacitance, Paul teaches flow meters as discussed above, and that capacitance is dominated by volume and compressibility of the fluid ([0044-0045]). Witt does not explicitly teach fluid capacitance as a product of a fluid compressibility constant for and a captive fluidic volume from the pump to the flow sensor.
Laurent teaches a solvent programmer for HPLC with a mixture of two solvents programmed with a correction for solvent compressibility (abstract, introduction), that the compressibility contribution of a minor component provides a deviation proportional to the concentration of the minor component, that compressibility, back pressure, and decompression of dead volume (a captive fluidic volume) in the pump chamber and connection tubes influences piston movement and length, where β is the compressibility, l is the equivalent length of the dead volume, ҩ is volume (p. 89 last paragraph – p. 91 second paragraph, equations 3 and 4).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to incorporate a correction factor, including relating any dead volume (which would include connection tubes from the pump to the flow sensor) of the system to the compressibility, such that the controller is configured for determining a function including a product of a fluid compressibility and a captive fluidic volume from the pump to the flow sensor), as taught by Laurent, into Witt’s taught system and method, for each solvent line, as according to Laurent, with the correction, the calibration curve becomes very accurate, and the correction can easily be incorporated into computer programs.
Witt teaches control of first and second metering devices as discussed above, determining flow rate of solvents ([0053]), the mixing ratio of solvents might be modified with dependence on the flow rates and on the compressibilities in the two supply flow paths ([0023]), and the solvent system is capable of providing a highly precise gradient dependent on the precision of the mixing ratio (to provide a desired mix ratio of the first solvent to the second solvent for the solvent gradient, [0029, 0036, 0038]), but does not explicitly teach adding the feedforward signal to a flow rate feedback signal.
Paul teaches a precision controller capable of providing both predictable and reproducible flow in HPLC, gradient HPLC utilizes fluid output from multiple pumps summed to provide varying compositions, and in background, desired flow rate can be achieved using feedback loops ([0001-0010, 0041], a flow rate feedback signal), the controller compares the respective measured flow rate to a respective desired flow rate and adjusts respective pressure source (pumps) to achieve the desired flow rate ([0014-0015]). It would have been obvious to one of ordinary skill in the art before the invention was made to incorporate flow rate feedback as described by Paul, into Witt’s taught apparatus, as flow rate feedback is known in the art for achieving precision gradients, as illustrated by Paul, and as the courts have held that combining prior art elements according to known methods to yield predictable results would have been obvious to a person of ordinary skill in the art before the filing date, see MPEP §2143.
Additional limitations of : generating a feedforward signal for the first pump and/or a feedforward signal for the second pump to control the first pump and/or the second pump to compensate for bulk liquid capacitance load or disturbance at the first pump and/or the second pump, wherein each of the feedforward signals encodes the product of the fluid capacitance for the respective leg and a change in pressure over time for the respective leg, and adding the feedforward signal for the first pump to a flow rate feedback signal for the first pump and/or adding the feedforward signal for the second pump to a flow rate feedback signal for the second pump to provide a desired mix ratio of the first solvent to the second solvent for the solvent gradient.
Witt teaches the control unit controls the pumps respectively ([0013]), using a known relation between solvent pressure and solvent composition, for example as a function of the mixing ratio of the solvents which is used to forecast pressure as discussed above ([0031-0033], generating a feedforward signal (see claim interpretation above for feedforward), adapted for compensating for variation of the solvent volume by a corresponding corrective movement of the piston (to compensate for bulk liquid capacitance load or disturbance at the first pump and/or the second pump), the mixing ratio of solvents might be modified with dependence on the flow rates and on the compressibilities in the two supply flow paths ([0023]), and the solvent system is capable of providing a highly precise gradient dependent on the precision of the mixing ratio (to provide a desired mix ratio of the first solvent to the second solvent for the solvent gradient, [0029, 0036, 0038]).
Witt teaches deriving compression or expansion from solvent volume (a captive volume), pressure variation (a disturbance value), and compressibility using a known relation between solvent pressure and composition, and correction of the piston movement is derived from parameters including actual pressure of individual solvents ([0030]). Witt does not explicitly teach encoding (encoding interpreted as determining based on) the product of the fluid capacitance and a change in pressure over time.
However, Munk teaches compensation for liquid chromatography and control to form a gradient for use in systems comprising first and second pumps/solvents and mixing junction, automatic compensation for variation in system pressure and specifically the recited relationship of the product of the fluid capacitance and a change in pressure over time (C4/L28-C6/L60), in particular equations 3 to 7, Fig. 1).
It would have been obvious to one of ordinary skill in the art before the invention was made that as Witt teaches the use of known relationships to derive changes in volume to use the product of the fluid capacitance and a change in pressure over time as taught by Munk, since when a primary reference is silent as to a certain detail, one of ordinary skill would be motivated to consult a secondary reference which satisfies the deficiencies of the primary reference, and according to Munk the automatic compensation nullifies the effect of the compressibility of the solvents (C7/L30-C8/L2). Further, the courts have held that combining prior art elements according to known methods to yield predictable results would have been obvious to a person of ordinary skill in the art before the filing date, see MPEP §2143.
While the taught combination does not explicitly teach adding the feedforward signal for a pump to a flow rate feedback signal, the use of feedforward/feedback hybrid systems is known in the art as illustrated by Rodrigues and Frey, Rodrigues teaches feedback-feedforward control in chromatography (p. 255, abstract, introduction), with a feedforward algorithm in addition to the feedback term it is possible to combine the advantages of both controller configurations (p. 258 Feedforward – Feedback Controller, see equation 7, adding); Frey teaches feedback regulation in elution chromatography (abstract) and that feedback control has an advantage of only requiring limited measurements, when disturbances are measured it is often desirable to supplement feedback regulation with feedforward compensation (Introduction). It would have been obvious to one of ordinary skill in the art before the invention was made to provide combined feedback-feedforward control as described by Rodrigues and Frey in the taught combination in order to combine the advantages of both configurations, as according to Frey it is desirable to supplement feedback regulation with feedforward compensation, according to Rodrigues the combination provides better performance (Conclusion), and the courts have held that combining prior art elements according to known methods to yield predictable results would have been obvious to a person of ordinary skill in the art before the filing date, see MPEP §2143.
Additionally, see Berger (DE 19625648) and De Corral (US PG Pub 2008/0206067), provided as evidence that the feedback/feedforward control were known for use for controlling chromatography pumps before the invention was made.
De Corral teaches feedback control (0080-0082) and that a feed forward control algorithm compensates for pressure errors and provides a velocity contribution (0083-0085, Fig. 7); Berger control of pumps in chromatography (p. 1) and in a preferred embodiment proportional control in a feedforward system and a feedback process takes place at high frequency, which results in very smooth and repeatable pressure control (p. 8 third paragraph).
Examiner notes instant specification 0048 discloses "signal communication" refers to electrical connections or circuits, optical connections, wireless communications through radio waves, internet connections, and other means by which equipment may communicate, and the use of PID control (0122).
With respect to claim 87, the method of claim 85 is taught above. Witt teaches pumps comprising pistons ([0045, 0053-0056] the first pump has a plunger and the second pump has a plunger), and that the controller controls movement of the piston, and provides corrective movement that corresponds to the pressure-induced variation of the solvent volume in the supply flow path compensating for the expansion or compression of the solvent volume contained in the supply flow path ([0007], and solvent volume contained in the respective supply flow path determined from a metering device's piston position, as soon as the pressure variation, the system elasticity, the compressibility in a supply flow path and the solvent volume stored in the supply flow path are known (compressibility and solvent volume in the path providing the fluid capacitance, or as discussed with respect to Laurent above), compressibilities in the first and the second supply flow path are determined before delivering the composite solvent, the resulting compression or expansion of the solvent volume then derived to determine the required compensatory displacement of the piston ([0030-0034], the controller is configured to correct the fluid capacitance based on position of the plunger of the first pump before generating the feedforward correction for the first pump).
With respect to claim 88, method of claim 81 is taught above. Witt teaches at least one of the first and second supply flow paths comprises a dampening unit ([0034, 0057], conduits or series restrictors in the first leg and/or the second leg to provide passive fluidic decoupling between the first pump and the second pump.
With respect to claims 92 and 101, the solvent delivery system of claim 89, is taught above. Witt teaches deriving compression or expansion from solvent volume, pressure variation, and compressibility using a known relation between solvent pressure and composition, and correction of the piston movement is derived from parameters including actual pressure of individual solvents ([0030]), Munk teaches the recited relationship of compressibility, volume, and the change in pressure over time as discussed above, it would have been obvious to one of ordinary skill in the art before the invention was made to apply Munk’s known relationship to each individual solvent pathway such that pressure over time is calculated as a partial derivative of change is pressure relative to change in time, to provide more precise control and accurately nullify the effect of the compressibility of the solvents.
With respect to claim 95, the solvent delivery system of claim 89, is taught above. Paul teaches the controller compares the respective measured flow rate to a respective desired flow rate and adjusts respective pressure source (pumps) to achieve the desired flow rate ([0014-0015], the feedback signals for the first pump reflects a difference between a set flow rate for the first pump and the actual flow rate for the first pump.).
With respect to claim 96, the solvent delivery system of claim 89, is taught above. Examiner notes the material on worked upon by a system does not impart patentability to the claims (see MPEP 2115), the solvents used would be drawn to a material worked upon. Witt teaches the first solvent is an organic solvent and the second solvent is an inorganic solvent ([0037]).
With respect to claim 97, the solvent delivery system of claim 89, is taught above. Witt teaches solvent pressure is monitored and tracking solvent pressure in the flow path ([0007-0009, 0031, claim 10], a respective pressure sensor for each of the legs); Paul teaches flowmeters and pressure sensors for each fluid ([0035-0039, 0054-0058, 0063], Fig. 6), and that flow meters can comprise pressure sensors ([0015], a respective pressure sensor for each of the legs), Munk teaches pressure sensing transducers 72 (Fig. 3, C7/L30-C8/L2).
With respect to claim 101, the solvent delivery system of claim 99, is taught above. Witt teaches deriving compression or expansion from solvent volume, pressure variation, and compressibility using a known relation between solvent pressure and composition, and correction of the piston movement is derived from parameters including actual pressure of individual solvents ([0030]), Munk teaches the recited relationship of compressibility, volume, and the change in pressure over time as discussed above, it would have been obvious to one of ordinary skill in the art before the invention was made to apply Munk’s known relationship to each individual solvent pathway such that pressure over time is calculated as a partial derivative of change is pressure relative to change in time, to provide more precise control and accurately nullify the effect of the compressibility of the solvents.
With respect to claim 102, Examiner notes the material on worked upon by a system does not impart patentability to the claims (see MPEP 2115). Munk teaches solvents with different compressibilities (eq 8).
With respect to claims 103 and 104, the controller of claim 98, is taught above. The taught combination provides individual control of pumps, and feedforward and feedback control as discussed above.
With respect to claim 105, the controller of claim 98, is taught above. Witt teaches software executed in or by any suitable processing unit ([0041]), the use of PID controllers would have been obvious to one of ordinary skill in the art before the invention was made, as PID controllers are known in the art, alternatively, Rodrigues teaches PID controllers (abstract). It would have been obvious to one of ordinary skill in the art before the invention was made to use a PID controller as PID controllers are known in the art as illustrated by Rodrigues.
With respect to claim 106, the controller of claim 98, is taught above. See 112(b) rejection above. Witt teaches providing a time dependent composition ([0055]), and control of individual pumps as discussed above and providing a highly precise gradient dependent on the precision of the mixing, [0029, 0036, 0038]).
Claim 90, 93, 94 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Witt (US PG Pub 2006/0219418), in view of Paul (US PG Pub 2003/00520007), in view Laurent (Computer-controlled single-pump solvent programmer for high-performance liquid chromatography¸ 1981), , in view of Munk (US 4,032,445), in view of Rodrigues (A Procedure for Feasible and Optimal Operational Strategies for Control of CARE Systems, 1997) and Frey (Elution Feedback in Regulation Preparative Chromatography, 1991), with evidence from Berger (DE 19625648) and De Corral (US PG Pub 2008/0206067).
in view of Foley (Unavoidable flow-rate errors in high-performance liquid chromatography, 1989).
With respect to claims 90, 93, 94, the liquid chromatography system of claim 89 is taught above. Witt teaches forecasting pressure, determining flow rate of solvents ([0053]), the mixing ratio of solvents might be modified with dependence on the flow rates and on the compressibilities in the two supply flow paths ([0023]), and the flow rate of the solvent dependent on pressure, and viscosity (([0053-0062]), and the solvent system is capable of providing a highly precise gradient dependent on the precision of the mixing ratio; Paul teaches comparing measured flow rate values to desired flow rate values. However, the taught combination does not explicitly teach the controller estimates charge or discharge flow for each of the pumps to maintain a correct compositional mix ratio for the solvent gradient and generates the feedforward signals to realize the charge or discharge flow for the pumps.
Foley teaches correction of flow rate errors in HPLC, including equations relating pressure and compressibility, and that accurate estimate of the pertinent properties can be obtained by the equations, or alternatively, most of the data are easily measured (p. 291-306), including calculations of linear velocity and flow rate, based on compressibility, pressure and volume, see in particular equations 10-23, pages 290-294. It would have been obvious to one of ordinary skill in the art at the time the invention was made to use either estimated value, as according to Foley, accurate estimate of the pertinent properties can be obtained by equations.
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.
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/JEANNIE MCDERMOTT/Examiner, Art Unit 1777
/BRADLEY R SPIES/ Primary Examiner, Art Unit 1777
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