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 .
Priority
Current application, US Application No. 18/592,087 filed on 02/29/2024, claims foreign priority to IN 202321014227 filed on 03/02/2023.
DETAILED ACTION
This office action is responsive to the application filed on 02/29/2024. Claims 1-17 are currently pending.
Specification
The abstract of the disclosure is objected to because the word “are” in “The biotherapeutic products are a mixture of their charge variants” should be replaced with “include” or with an appropriate word for an accurate description.
The phrase “to implement” in “This allows an operator to monitor charge variant concentrations and obtain an optimal schedule to implement such that a target product composition is achieved” should be replaced with “that can be applied to control the charge variant concentrations” or with an appropriate phrase for a correct grammar and clarity.
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claims 2, 4-7 and 9-16 are objected to because of the following informalities: As per claim 2, the comma, i.e. “,”, in “optimizing, a set of manipulated variables” should be removed for correct grammar.
As per claim 8, the comma, i.e. “,”, in “monitoring, one or more properties of a chromatography column” should be removed for correct grammar.
As per claim 9, the commas, i.e. “,”’s, in “receive, a plurality of data pertaining to a chromatography process”, “preprocess, the received plurality of data”, “obtain, one or more parameters of a plurality of charge variants”, “predict, a value of one or more quality attributes”, “monitoring, a deviation”, and “adaptively update, the prediction model” should be removed for correct grammar.
The limitation “monitoring” in “monitoring, a deviation” should be replaced with “monitor” for correct grammar and consistency.
As per claim 10, the commas, i.e. “,”’s, in “optimize, a set of manipulated variables” and “dynamically modify, the control and optimization model” should be removed for correct grammar.
As per claims 4-7, claims are also objected because base claim 2 is objected.
As per claims 10-16, claims are also objected because base claim 9 is objected.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 1-17 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. The claims contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor at the time the application was filed, had possession of the claimed invention. As per claim 1, the limitation ”one or more models executed by the one or more hardware processors” in “obtaining, via one or more models executed by the one or more hardware processors, a set of data associated with one or more variables of a plurality of charge variants” lacks description support for the one or more models. The specification briefly recites one or more models as physics based and data-based models (see specification – [pg. 13 line 6-3 from the bottom]), but fails to describe the models in terms of model’s minimal specific details such as functionality, inputs, outputs, and characteristics.
As per claims 2-10 and 12-15, claims are also rejected because base claims 1 and 15 are rejected.
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 1-17 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
As per claims 1, 9 and 17, the limitation “as input” in “receiving (or receive) a plurality of data pertaining to a chromatography process at a pre-determined frequency from one or more sub-systems and a plurality of data sources as input” is ambiguous because it is not clear which entity is meant the plurality of data will be input to. For the sake of examination, the limitation is interpreted as “as input to one or more models” according to a context of the claims comprising the succeeding limitation, reciting “obtaining, via one or more models executed by the one or more hardware processors, a set of data associated with one or more variables of a plurality of charge variants”.
Claims recite the limitation “the plurality of data” in “the plurality of data obtained from one or more physical sensors”. There is insufficient antecedent basis for this limitation in the claim.
The limitation “their frequency” in “synchronization and integration of a subset of the plurality of data obtained from one or more physical sensors using their frequency” is not clear which frequency it refers to. For the sake of examination, the limitation is interpreted as “a unified sampling frequency averaging real time data from the one or more physical sensors” (see specification – [pg. 16 line 1-6]).
As per claims 2-8 and 10-16, claims are also rejected because base claims 1 and 9 are rejected.
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 1-17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to nonstatutory subject matter. The claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Specifically, representative claim 1 recites:
“A method for control and optimization of a continuous chromatography process, (1.A) comprising:
receiving, via one or more hardware processors, a plurality of data pertaining to a chromatography process at a pre-determined frequency from one or more sub-systems and a plurality of data sources as input, wherein the plurality of data comprises a plurality of real time data and a plurality of non-real time data; (1.B)
preprocessing, via the one or more hardware processors, the received plurality of data using one or more pre-processing techniques, wherein the one or more preprocessing techniques perform at least one of (i) identification and removal of outliers, (ii) imputation of missing data, and (iii) synchronization and integration of a subset of the plurality of data obtained from one or more physical sensors using their frequency; (1.C)
obtaining, via one or more models executed by the one or more hardware processors, a set of data associated with one or more variables of a plurality of charge variants of a plurality of components from the plurality of preprocessed data using one or more soft sensors; (1.D)
predicting, via a prediction model executed by the one or more hardware processors, value of one or more quality attributes from the set of data associated with the one or more variables of the plurality of charge variants of the plurality of components; (1.E)
monitoring, via the one or more hardware processors, a deviation between an experimental value and predicted value of the one or more quality attributes; (1.F)
and adaptively updating, via the one or more hardware processors, the prediction model when the monitored deviation between the experimental value and the predicted value of the one or more quality attributes exceeds a first predefined threshold. (1.G)”.
The claim limitations in the abstract idea have been highlighted in bold above; the remaining limitations are “additional elements”.
Under the Step 1 of the eligibility analysis, we determine whether the claims are to a statutory category by considering whether the claimed subject matter falls within the four statutory categories of patentable subject matter identified by 35 U.S.C. 101: Process, machine, manufacture, or composition of matter. The above claim is considered to be in a statutory category (Process - Method).
Under the Step 2A, Prong One, we consider whether the claim recites a judicial exception (abstract idea). In the above claim, the highlighted portion constitutes an abstract idea because, under a broadest reasonable interpretation, it recites limitations that fall into/recite an abstract idea exception. Specifically, under the 2019 Revised Patent Subject Matter Eligibility Guidance, it falls into the grouping of subject matter when recited as such in a claim limitation, that covers mathematical concepts (mathematical relationships, mathematical formulas or equations, mathematical calculations), and mental processes (concepts performed in the human mind including an observation, evaluation, judgement, and/or opinion).
For example, highlighted limitations/steps (1.A)-(1.G) are treated by the Examiner as belonging to Mathematical Concept grouping or a combination of Mathematical Concept and Mental Process groupings as the limitations include Mathematical Calculations, or show Mathematical Relationship combined with optional Mental evaluations/judgements.
The highlighted limitation “for control and optimization of a continuous chromatography process” in (1.A) is interpreted under BRI as the mathematical calculation of parameters for the continuous chromatography process for control and optimization of the process.
The highlighted limitation “a plurality of data pertaining to a chromatography process at a pre-determined frequency from one or more sub-systems and a plurality of data sources as input, wherein the plurality of data comprises a plurality of real time data and a plurality of non-real time data” in (1.B) is interpreted as showing mathematical relationship between data and a model (or an entity) combined with mental observation about the nature of the data.
The remaining limitations are interpreted as mathematical calculation.
Next, under the Step 2A, Prong Two, we consider whether the claim that recites a judicial exception is integrated into a practical application.
In this step, we evaluate whether the claim recites additional elements that integrate the exception into a practical application of that exception.
The above claims comprise the following additional elements: (Side Note: duplicated elements are not repeated)
In Claim 1: “A method”, “receiving … a plurality of data” and “via one or more hardware processors”;
In Claim3: “the plurality of real time data is obtained from one or more online analytical instruments”;
In Claim 9: “An apparatus”, and “a memory storing instructions; one or more Input/Output (I/O) interfaces; one more sub-systems; and one or more hardware processors coupled to the memory via the one or more I/O interfaces, wherein the one or more hardware processors are configured by the instructions to”;
In Claim 17: “One or more non-transitory computer readable mediums comprising one or more instructions which when executed by one or more hardware processors cause”;
As per claim 1, the additional element in the preamble “A method” is not a meaningful limitation because the limitation simply links the method with the abstract idea as an intended purpose. The limitations/steps “receiving … a plurality of data” and “via one or more hardware processors” represent the standard data collection activity using a general computer or its subcomponents and only add insignificant extra solution activity to the judicial exception. The limitations “via one or more hardware processors” are not particular in the art.
As per claim 3, the limitation “the plurality of real time data is obtained from one or more online analytical instruments” can be interpreted as am abstract idea which describes the obtained real time data as an observation. Even if the limitation can be interpreted as data collection step from one or more online analytical instruments, the data collection step only adds insignificant extra solution to the judicial exception in the art.
As per claim 9, the additional element in the preamble “An apparatus” is not a meaningful limitation because the limitation simply links the method with the abstract idea as an intended purpose. The limitations/elements “a memory storing instructions; one or more Input/Output (I/O) interfaces; one more sub-systems; and one or more hardware processors coupled to the memory via the one or more I/O interfaces, wherein the one or more hardware processors are configured by the instructions to” represent a general computer sub components and they are not particular in the art.
As per claim 17, the additional element in the preamble “One or more non-transitory computer readable mediums comprising one or more instructions which when executed by one or more hardware processors cause” is not qualified as a meaningful limitation because the preamble even fails to link the mediums to a particular operation or field of use. The limitation/element “One or more non-transitory computer readable mediums comprising one or more instructions which when executed by one or more hardware processors cause” represent use of general computer components and they are not particular in the art.
In conclusion, the above additional elements, considered individually and in combination with the other claim elements as a whole do not reflect an improvement to the computer technology or other technology or technical field, and, therefore, do not integrate the judicial exception into a practical application. No particular machine or real-world transformation are claimed. Therefore, the claims are directed to a judicial exception and require further analysis under the Step 2B.
Under Step 2B analysis, the above claims fail to include additional elements that are sufficient to amount to significantly more than the judicial exception as shown in the prior art of record.
The limitations/elements listed as additional elements above are well understood, routine and conventional steps/elements in the art according to the prior art of record. (See Mao, Zhong, Hincapi, Lacki, and others in the list of prior art cited below)
Claims 1-20, therefore, are not patent eligible.
Notes with regard to Prior Art
The prior arts made of record below are considered pertinent to applicant's disclosure and the claims.
Mao (US 20180113101 A1) discloses
A method for control and optimization of a continuous chromatography process, (methods … for chromatography data analysis … in-process monitoring and control of chromatography systems [0002], profiles … tools for acquiring preferable … data from a chromatography data file, optimization [0093], continuous monitoring and process integrity [0125], optimize [0131, Fig. 23]) comprising:
receiving, via one or more hardware processors (computer, one or more processors [0161-0163, Fig. 22]), a plurality of data pertaining to a chromatography process, wherein the plurality of data comprises a plurality of real time data and a plurality of non-real time data; (receiving raw chromatography data including a plurality of signals [0007-0010], real-time ‘or offline’ [0126, 0130, 133])
preprocessing, via the one or more hardware processors, the received plurality of data using one or more pre-processing techniques, wherein the one or more preprocessing techniques perform at least one of (i) identification and removal of outliers, (ii) imputation of missing data (noise reduction techniques, outlier detection and removal [0076, 0098], outlier [0143-0144, Figs.15-16, 0146, Fig. 18, 0152, Fig. 11], ability to handle multicollinearity … robustness in the face of … missing data … making for stronger predictions [0118])
Zhong (CN 111650540 A) discloses (collecting signal … frequency [pg. 12 line 16], chromatography online monitoring device … sampling … sampling frequency [pg. 12 line 24-27], data collecting frequency, data transmission frequency [pg. 3 line 27-32], integrated monitoring [pg. 5 line 23-34, claim 5], data acquisition frequency, data uploading frequency [pg. 10 line 29-39], chromatography [pg. 3 line 33-38, claims 3 and 6]).
Hincapi (WO 2021061658 A1) discloses systems for measuring a product quality attribute of an analyte of a biological sample include a first flow control device, a sample purification device, a second flow control device in fluid communication with first and second sample analyzers, where the first sample analyzer includes a first chromatography column, and a control unit configured so that during operation of the system, the control unit adjusts a configuration of the second flow control device to direct a portion of the biological sample to one of the first and second sample analyzers, and determines a product quality attribute of an analyte of the biological sample based on an analysis of the portion of the biological sample by the one of the first and second sample analyzers (see – [abs]).
Lacki (WO 2016096790 A1) discloses a method for monitoring level of saturation of a chromatography media in a column, which method comprises measuring a first pressure at the inlet of an unloaded column; measuring a second pressure at the inlet from a loaded column; and comparing the first and second pressure measurement to determine the level of saturation of the chromatography media (see – [abs]).
Rathore (US 20260056171 A1) discloses a system and a method for determining charge variants in monoclonal antibodies using Raman spectroscopy (see – [abs]).
Chmielowski (Chmielowski, Rebecca A., and et al. "Definition and dynamic control of a continuous chromatography process independent of cell culture titer and impurities." Journal of Chromatography A 1526 (2017): 58-69), hereinafter ‘Chmiel’ discloses advances in cell culture technology have enabled the production of antibody titers upwards of 30 g/L. These highly productive cell culture systems can potentially lead to productivity bottlenecks in downstream purification due to lower column loadings, especially in the primary capture chromatography step. Alternative chromatography solutions to help remedy this bottleneck include the utilization of continuous processing (see – [abs]).
Rathore (Rathore, Anurag Singh, and et al. "Digitization in bioprocessing: The role of soft sensors in monitoring and control of downstream processing for production of biotherapeutic products." Biosensors and Bioelectronics: X 12 (2022): 100263) discloses use of soft sensors.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DOUGLAS KAY whose telephone number is (408) 918-7569. The examiner can normally be reached on M, Th & F 8-5, T 2-7, and W 8-1.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Arleen M Vazquez can be reached on 571-272-2619. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DOUGLAS KAY/Primary Examiner, Art Unit 2857
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