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 .
Election/Restrictions
Applicant’s election without traverse of claims 1-10 in the reply filed on 3/30/26 is acknowledged.
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 1-10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. The claim(s) recite(s) an abstract idea. This judicial exception is not integrated into a practical application because: see analysis below. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because: see analysis below.
Claim 1 recites receiving measurement data of a variable and determining an output data for a filtration process variable by executing a mathematical model using the measurement data. This in its entirety is an abstract idea, with nothing more.
Subject matter eligibility analysis under MPEP 2106.03: Claim 1 recites a method of monitoring a filtration process, which falls under process control, an eligible subject matter under step -1.
Step 2A, prong 1: the claim recites only an abstract idea or mathematical concepts. Prong 2: the claim does not recite any additional elements that would integrate the abstract idea into a practical application. The determined output data is not used to integrate the exception into a practical application or in any tangible process step.
Step 2B: claim recites nothing that can be considered as “significantly more.”
If the claim does not recite any additional element or combination of elements that integrate the selected exception into a practical application, and also does not recite any additional element or combination of elements that amounts to significantly more than the selected exception, then the claim should be considered ineligible. University of Utah Research Foundation v. Ambry Genetics, 774 F.3d 755, 762, 113 USPQ2d 1241, 1246 (Fed. Cir. 2014) (because claims did not amount to significantly more than the recited abstract idea, court "need not decide" if claims also recited a law of nature)
Claim 2 only adds a time limitation, and/or analyzing the output data to adjust the process when necessary. Nothing more than abstract idea.
Claims 3 and 4 add Poisson-Boltzmann equation and Wigner-Seitz cell model; only abstract idea/mathematical equations.
Claims 5-6 and 10: defines some or all of the variables.
Claim 8: generating control signal based on output data which is configured to or call for controlling a process parameter
Claim 9 recites the composition of the solution to be filtered, which does not further add to the abstract idea.
Claim 7: has action steps of comparing with a reference variable and “adjusting at least one parameter of the filtration process model based on the comparison in order to adapt the at least one modeled process variable to the at least one reference process variable.”
The adjusting step in claim 7 gives an appearance of a reduction to a practical application, but it is not so in reality. The adjustment is recited as “in order to adapt … to a reference process variable,” which amounts to only adds to the abstract idea.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 1-10 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The meaning of every term used in a claim should be apparent from the prior art or from the specification and drawings at the time the application is filed. Claim language may not be "ambiguous, vague, incoherent, opaque, or otherwise unclear in describing and defining the claimed invention." In re Packard, 751 F.3d 1307, 1311, 110 USPQ2d 1785, 1787 (Fed. Cir. 2014). Applicants need not confine themselves to the terminology used in the prior art, but are required to make clear and precise the terms that are used to define the invention whereby the metes and bounds of the claimed invention can be ascertained. During patent examination, the pending claims must be given the broadest reasonable interpretation consistent with the specification. In re Morris, 127 F.3d 1048, 1054, 44 USPQ2d 1023, 1027 (Fed. Cir. 1997); In re Prater, 415 F.2d 1393, 162 USPQ 541 (CCPA 1969). See also MPEP § 2111 - § 2111.01
Claim 1 recites a method of monitoring a filtration process in terms of an input process variable, a parameter of the filtration process, a physical equation, a measurement unit and an output data indicative of at least one modeled process variable. Claim does not provide any light on the solution, what kind of filtration, what is the product, how it is collected, or clearly define any of the above listed terms, which makes the claim indefinite.
Claims 3 and 4: “the equation is based on ..” is indefinite. The “product” is not defined.
Claim 6: unclear if pH is included as a second variable in addition to the measurable process variable, or in the alternate. Also, the claim construction is unclear, because a measurable process variable is included as a separate item, in addition to pH and concentration, which are also measurable. For the purpose of examination, all variables are considered as being recited in the alternative.
Claim 7: “reference variable” is not defined. The element, “adjusting at least one parameter of the filtration process model based on the comparison in order to adapt the at least one modeled process variable to the at least one reference process variable,” is very vague.
Claim 8: “controllable process parameter” is not defined.
Claim 10: the term “absorption” of the solution is unclear. Does applicant mean UV/visible/IR absorbance? Also unclear is how the “information whether the second solution is currently mixed to the first solution” by itself a process input variable as required by the claim. Isn’t it just a yes or no issue?
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
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, 2, 5-8 and 10 are rejected under 35 U.S.C. 102(a1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Subbiah et al (US 2011/0035195).
According to the disclosure at page 17, lines 19-31, the claimed monitoring process works to monitor the output data indicative of the modeled process variable from a measured input process variable.
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Subbiah teaches a process of on-line prediction/monitoring of a filtration process parameter (like fouling with time) based on input variables such as conductivity, flow rate, pressure, tec., and further recommend remedial action with time. The process uses a non-linear mathematical model and measurements and calculations are performed in real time – see abstract, figures and “Summary of the invention.” The process parameters on the right in fig. 3 is dependent on the variables on the left. Conductivity is directly related to concentration. [0022]-[0025] lists additional parameters estimated online. See [0027]-[0032]. This would anticipate claims 1, 2, 5, 6 and 10.
Regarding adjusting at least one parameter, as in claim 7, see [0034], two modes of operation, in which the second mode adjusts a variable. For example, if feed pressure is increased, the permeate flow would increase. This would have been obvious to one of ordinary skill in the art, if not anticipated.
Claim 8: while not explicitly taught, from Subbiah’s teachings, it is readily apparent that the process as depicted in fig. 3 can be controlled for parameters on the right side with the variables on the left using a PLC or a microprocessor, and Subbaiah teaches using them (see claims.)
Claim(s) 1-10 are rejected under 35 U.S.C. 103 as unpatentable over Bowen, et al., DYNAMIC ULTRAFILTRATION MODEL FOR CHARGED COLLOIDAL DISPERSIONS: A WIGNER-SEITZ CELL APPROACH, Chemical Engineering Science, Vol. 50, No. 11, pp. 1707-1736, 1995, in view of Subbiah et al (US 2011/0035195), or alternately, Subbiah in view of Bowen.
Bowen teaches a mathematical model to predict the ultrafiltration of a solution of biological molecules or particles using Poisson-Boltzmann equation and the Wigner-Seitz cell approach as disclosed and claimed. Among the variables considered are pH, zeta potential, ionic strength, concentrations, flow rates, etc.
Bowen only teaches predicting the dynamic process. By dynamic process, the examiner understands “process as it happens,” or a time-wise performance prediction. Therefore, while Bowen is silent on using the model to monitor the process, monitoring only means predicting as it happens, which is implied, such as taught by Subbiah. Since the membrane process depend on the cake layer or the electrical double layer on the surface of the membrane, local concentrations cannot be measured, but can be calculated using the Bowen model. Therefore, it would have been obvious to one of ordinary skill in the art to use the teaching of monitoring the membrane performance using the Bowen methodology.
Alternately, Subbiah teaches mathematical modeling to monitor or control ultrafiltration process. However, since Subbiah does not teach pH, surface charges, and biological solutions for ultrafiltration, it would have been obvious to use the Bowen approach in the Subbiah method to monitor and control the process for biological solutions.
Claim(s) 1, 2, 5-10 are rejected under 35 U.S.C. 102(a1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Lutz (US 5,597,486)
Lutz teaches an optimized diafiltration process in which a mathematical model is used to control addition of diafiltration solution with minimized filtration area and time, and continuously controlling adding the diafiltration solution (the second solution) while maximizing the recovery of the desired component (abstract). The variables are pH, concentrations, flow rates, etc. the process is for purifying proteins and other biological solutions. See examples.
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The equations for the model are seen in columns 3 and 4. The process is actually controlled by the model, which includes monitoring. Measurement includes flow rates, concentrations of components in the feed and passages of components through the membrane (col. 10 lines 5-10; examples.) The working examples describe various scenarios of diafiltration. While not explicitly stated, the measurements are in real time, i.e., in-process. See the claims as well. pH is measured at least in example 2.
Process control is described in “Summary of Invention” and the claims, which requires adjustments of the necessary parameters in response to control signals, which are implied, if not explicit.
"[I]n considering the disclosure of a reference, it is proper to take into account not only specific teachings of the reference but also the inferences which one skilled in the art would reasonably be expected to draw therefrom." In re Preda, 401 F.2d 825, 826, 159 USPQ 342, 344 (CCPA 1968)
Lutz teaches graphical representations (see the figures for each example) of the control strategy in each example, but is silent on applying the strategy in an actual microprocessor or PLC control system. Nonetheless, see “continuous controlling” and “continuously adjusted” in col. 3 lines 29-51, which requires a control system. Therefore, such control systems are implied, or would have been obvious to one of ordinary skill in the art.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Belfort (US 2008/0017576) teaches optimizing micro or ultrafiltration process using similar mathematical model. .
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISHNAN S MENON whose telephone number is (571)272-1143. The examiner can normally be reached Flexible, but generally Monday-Friday: 8:00AM-4:30PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Prem C Singh can be reached at 571-272-6381. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KRISHNAN S MENON/ Primary Examiner, Art Unit 1777
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