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 .
Preliminary Amendment
The preliminary amendments of claims, filed 03/26/2024, has been fully considered.
Status of Claims
Claim 1-16 are pending and under examination.
Information Disclosure Statement
The information disclosure statement (IDS) document(s) submitted on 04/09/2024 is compliant with the provisions of 37 CFR 1.97. Accordingly, the IDS document(s) has/have been fully considered by the examiner.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: “100” in paragraph [0037-0038, 0040-0041, 0043, 0048-0049] and “150” in paragraph [0053]. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
Paragraphs [0037-0038, 0040-0041, 0043, 0048-0049] of applicant’s printed publication refer to reference character “100”, but is not shown in the figures.
Paragraph [0053] of applicant’s printed publication refers to reference character “150”, but is not shown in the figures.
Appropriate correction is required.
Claim Objections
Claims 2-3 is objected to because of the following informalities:
Claim 2 recites “a valid or an invalid range”. Claim 1 line 12 previously refers to “a valid range”. The examiner respects applicant amend claim 2 to recite “the valid range or an invalid range”. A similar objection is also made over “the valid and/or invalid range” recited in claim 3 where “the invalid range” should recite “an invalid range”. Likewise, claim 11 recites “a valid range”. The examiner requests applicant amend the claim to recite “the valid range”.
Claim 3 recites “use*d” which appears to be a clerical mistake and should recite “used”.
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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claims 1-16 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for specific processes including deviations in an amount of sugar, fermentation, and polymerization, it does not reasonably provide enablement for any “chemical and/or biological production process” having an input and/or output product. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make or use the invention commensurate in scope with these claims.
Case law holds the applicant’s specification must be “commensurately enabling [regarding the scope] of the claims” Ex Parte Kung, 17 USPQ2d 1545, 1547 (Bd. Pat. App. Inter. 1990). Otherwise, undue experimentation would be involved in determining how to practice and use applicant’s invention. The test for undue experimentation as to whether or not all chemical and/or biological production processes within the scope of claims 1-16 can be used as claimed and whether claims 1-16 meet the test is stated in Ex parte Forman, 230 USPQ 546, 547 (Bd. Pat. App. Inter. 2986) and In re Wands, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988). Upon applying this test to claims 1-16, it is believed that undue experimentation would be required because:
(a) The quantity of experimentation necessary is great since the claims read on controlling and/or monitoring any chemical and/or biological production process based on any spectral data from any input product and/or any an output product by determining any performance indicators using the spectral data.
(b) There is no direction or guidance presented in the specification for controlling/monitoring any chemical and/or biological production process based on any spectral data from any input product and/or any output product by determining any performance indicators using the spectral data other than the specific examples for validating a recipe, and monitoring/controlling a fermentation process or polymerization process which may satisfy the broadly claimed chemical and/or biological production process that use spectral data for controlling and/or monitoring a process.
(c) There is an absence of working examples concerning controlling and/or monitoring a chemical and/or biological production process using performance indicators from spectral measurement data other than the specific fermentation and polymerization process. Additionally, there appears to be no indication what would or would not be covered by the claimed “performance indicator” or “spectral measurement data” as a performance indicator could be any one of pH, temperature, color, shape, texture, density, strength, conductivity, concentration, etc. and spectral measurement data could be any one of aerial photos, digital images, infrared spectra, mass spectrometry data, NMR spectra, UV-Vis spectra, etc.
That is, the factors described in In re Wand have been fully considered and are specifically addressed as follows:
(A) The breadth of the claims:
Claim 1 is directed toward a computer implemented method for monitoring and/or controlling a chemical and/or biological production process. Claim 12 is directed towards a computer-implemented method for selecting a chemical and/or biological production facility process. However, controlling/monitoring/selecting any chemical and/or biological process using any spectral measurement data associated with any performance indicator does not appear to be enabled by the original disclosure.
(B) The nature of the invention:
The method broadly claim “controlling/monitoring/selecting a chemical and/or biological production process of an output product, wherein the output product is produced from one or more input products … providing spectral measurement data associated with characteristics of the input product and/or the output product, determining at least one performance indicator based on the spectral measurement data using a data-driven model, wherein the data-driven model is parameterized according to historical data comprising spectral measurement data associated with characteristics of the input product and/or the output product, wherein the at least one performance indicator is a validation indicator indicting that spectral measurement data lies in a valid range, and providing the at least one performance indicator for monitoring and/or controlling the chemical and/or biological production process of the output product”. In the present case, the specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to create and use the invention commensurate in scope with the claims. Specifically, with respect to the claimed “providing the at least one performance indicator for monitoring and/or controlling the chemical and/or biological production process of the output product”.
(C) The State of the prior art:
Wasalathanthri disclose a control system configured to determine a baseline concentration of a protein based on the vibration spectral information. During elution as the protein substances breaks through, an increase in the measured protein concentration increases above a baseline concentration, and when a predetermined threshold value is reached, the flow-through from column 1 is directed onto column 2 instead of to the waste; [0193, 0212]. The spectral information is also used to determine the amount of buffer/reagent to add to process fluid; [0218, 0221-0222].
(D) The level of one of ordinary skill:
The level of one of ordinary skill in the art is high as it would require controlling any chemical/biological process by determining any performance indicator based on any spectra measurement data from an input and/or output product.
(E) The level of predictability in the art:
The level of predictability in the art based on Wasalathanthri is that protein production may be controlled using FTIR analysis by determining when to switch an effluent stream to the next stage using FTIR spectral data to obtain a concentration. However, controlling/monitoring of any chemical/biological process using any spectral measurement data to determine any performance indicator is not predicable in the art.
(F) The amount of direction provided by the inventor and (G) The existence of working examples:
Applicants printed publication discloses the following structure related to the claimed examples:
(i) An example for validating a recipe formulation; fig. 7, [0094-0096]
(ii) An example for monitoring and/or controlling a fermentation process; fig. 9, [0106-0108]
(iii) An example for monitoring and/or controlling a polymerization process; fig. 10, [0109-0112].
(iv) An example for monitoring and/or controlling bacteria cells in a fermentation process; fig. 11, [0114-0115].
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
There is an absence of working examples concerning controlling and/or monitoring a chemical and/or biological production process using performance indicators from spectral measurement data other than the specific fermentation and polymerization process. Additionally, there appears to be no indication what would or would not be covered by the claimed “performance indicator” or “spectral measurement data” as a performance indicator could be any one of pH, temperature, color, shape, texture, density, strength, conductivity, concentration, etc. and spectral measurement data could be any one of aerial photos, digital images, infrared spectra, mass spectrometry data, NMR spectra, UV-Vis spectra, etc.
In light of the above factors, it is seen that undue experimentation would be necessary to make and use the invention of claims 1-16.
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 9, 11, 13-15 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 pre-AIA the applicant regards as the invention.
Claim 9 recites “the production facility or process”. There is insufficient antecedent basis for this term in the claims and it is unclear what applicant is referring to as the production facility.
Claim 11 recites “the analytical measurement data”. There is insufficient antecedent basis for this term in the claims. Claim 1 previously refers to “spectral measurement data”. However, the claims do not recite “analytical measurement data”. Perhaps applicant is intending to recite “spectral measurement data”?
Claim 11 refers to “the operation parameters”. However, claim 11 is dependent from claim 1 which does not previously define “operation parameters”. Accordingly, it is unclear what operation parameters applicant is referring to in claim 11.
Claim 13 recites “a data driven model for providing spectral measurement data”. Claim 13 incorporates the limitations of claim 1. Claim 1 previously refers to “a data driven model” and “spectral measurement data”. It is unclear if applicant is referring to the data driven model and the spectral measurement data from claim 1, or if applicant is referring to another model with spectral data.
Claim 14 refers to “a computer element”. The written description does not provide an explicit definition for the claim “computer element” and it is unclear what would or would not be covered by this phrase.
Claim 15 is draft to incorporate the limitation of claim 1, but recites many of the same limitations that are previously introduced in claim 1. It is unclear if applicant is intended to refer to the features of claim 1 or if applicant is intended to recite additional features. Further, the claim is ambiguous in that it is directed to “an apparatus”, but then later recites “a data driven model, which when executed by one or more computing apparatus(es)…”. It is unclear if the claim is directed to a single apparatus or one or more apparatus(es).
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.
Claim 14 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because Claim 14 is not directed to a process, machine, manufacture or composition of matter because it is directed towards a machine readable medium and therefore is directed to non-statutory subject matter under 35 U.S.C. 101. Applicant’s written description does not provide an explicit definition for the claimed “computer element”, and therefore could encompass transitory signals which is at least one of the four categories of patent eligible subject matter.
It is noted page 2 line 33 of applicants written description disclose “In another aspect a computer element with instructions is provided…”. Accordingly, it cannot be determined whether the claimed “computer element” is one of the four categories of subject matter deemed to be appropriate subject matter for a patent.
Claims 1-13 and 15-16 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Claim 1 is directed toward a method. Claim 12 is directed towards a method. Claim 13 is directed toward a method. Claim 15 is directed toward an apparatus.
Step 2A, Prong One: Claims 1, and 12 recites the abstract ideas, “determining at least one performance indicator”.
These abstract ideas are mental processes that could be performed by a human person by pen and paper or by a black box computer. The computer to perform the recited steps/processes is simply a general-purpose computer for which to apply the abstract ideas, but does not preclude the steps from being considered an abstract idea. See MPEP 2106.04(a)(2)(III).
Step 2A, Prong Two: Has the abstract idea been integrated into a particular practical application?
No. These judicial exceptions are not integrated into a practical application because the additional elements recited in the claims do not impose any meaningful limits on practicing the abstract ideas.
The determination is performed by a computer which is just a general-purpose computer. However, use of conventional computer functions to apply the judicial exception does not qualify as a particular machine (MPEP § 2106.05(b)(I), MPEP § 2106.05(b)(II) and MPEP § 2106.05(b)(III)).
The claims also recite controlling a chemical and/or biological production process of an output product produced from an input product by providing spectral measurement data associated with either the input or output product, the determination is based on the spectral measurement data using a data-driven model that’s parameterized according to historical data associated with characteristics of the input or output product, indicating that the spectral measurement is valid using a validation indicator, and providing the performance indicator for monitoring and/or controlling the production process.
The computer very generally controls the production process based on the performance indicator. However, this is just using the device to gather data and provide instructions to be apply the abstract idea (See MPEP § 2106.05(g), Insignificant Extra-Solution Activity and MPEP § 2106.05(f), Mere Instructions To Apply An Exception). Further, these additional elements are recited at such a high level of generality that it amounts to generally applying the abstract idea or generally linking the abstract idea to a field of use. However, indicating a field of use or technological environment in which to apply a judicial exception do not amount to significantly more than the exception itself and cannot integrate a judicial exception into a practical application (see MPEP § 2106.05(h), Field of Use and Technological Environment).
Step 2B: Does the claim recite any elements which are significantly more than the abstract idea?
Claims 1 and 12 recite the additional elements of controlling a chemical and/or biological production process of an output product produced from an input product by providing spectral measurement data associated with either the input or output product, the determination is based on the spectral measurement data using a data-driven model that’s parameterized according to historical data associated with characteristics of the input or output product, indicating that the spectral measurement is valid using a validation indicator, and providing the performance indicator for monitoring and/or controlling the production process.
These additional elements do not amount to significantly more as they are well-understood, routine, and conventional (WURC) in the art as evidenced by Wasalathanthri et al. (US 2019/0272894 – hereinafter “Wasalathanthri”) and Wasalathanthri (Technology outlook for real-time quality attribute and process parameter monitoring in biopharmaceutical development – A review, Biotechnology Bioengineering, 2020; 117, 3182-3198). Wasalathanthri teach controlling a chemical and/or biological production process of an output product produced from an input product by providing spectral measurement data associated with either the input or output product, the determination is based on the spectral measurement data using a data-driven model that’s parameterized according to historical data associated with characteristics of the input or output product, indicating that the spectral measurement is valid using a validation indicator, and providing the performance indicator for monitoring and/or controlling the production process (Wasalathanthri disclose a biomanufacturing system 1 for production of a recombinant therapeutic protein or other substance from a bioreactor 25; fig. 10, [0171-0225]. The control unit 120; fig. 1, [0086-0098] performs computer-implemented instructions to monitor and control a variety of attributes at each stage in the biomanufacturing process; figs. 8-9, [0119-0144]).
Claim 2 limits the validation indicator as either valid or invalid. However, this is interpreted as merely using the device to gather data and provide instructions to apply the abstract idea(s) does not amount to significantly more than the exception itself and cannot integrate the judicial exception into a practical application (See MPEP § 2106.05(g), Insignificant Extra-Solution Activity, MPEP § 2106.05(f), Mere Instructions To Apply An Exception, MPEP § 2106.05(h), Field of Use and Technological Environment).
Claims 3 recites at least one value for indicating a valid or invalid range is used for determining at least one performance indicator. However, this is interpreted as merely using the device to gather data and provide instructions to apply the abstract idea(s) does not amount to significantly more than the exception itself and cannot integrate the judicial exception into a practical application (See MPEP § 2106.05(g), Insignificant Extra-Solution Activity, MPEP § 2106.05(f), Mere Instructions To Apply An Exception, MPEP § 2106.05(h), Field of Use and Technological Environment).
Claim 4 recites an operation parameter is provided if the input is valid or the output is not valid. However, this is interpreted as merely using the device to gather data and provide instructions to apply the abstract idea(s) does not amount to significantly more than the exception itself and cannot integrate the judicial exception into a practical application (See MPEP § 2106.05(g), Insignificant Extra-Solution Activity, MPEP § 2106.05(f), Mere Instructions To Apply An Exception, MPEP § 2106.05(h), Field of Use and Technological Environment).
Claim 5-8 limits the spectral measurement data to infrared spectra and/or interferograms, different measurement equipment, and time dependent indicators. The type of spectra are interpreted as insignificant extra-solution activity and generally linking the abstract idea to the field of endeavor, but does not integrate the exception into a practical application (See MPEP § 2106.05(g), Insignificant Extra-Solution Activity and MPEP § 2106.05(h), Field of Use and Technological Environment).
Claims 9 recites the performance indicator associated with the performance characteristic of the output product is determined and used for monitoring and/or controlling the production facility process in real-time. However, this is interpreted as merely using the device to gather data and provide instructions to apply the abstract idea(s) does not amount to significantly more than the exception itself and cannot integrate the judicial exception into a practical application (See MPEP § 2106.05(g), Insignificant Extra-Solution Activity, MPEP § 2106.05(f), Mere Instructions To Apply An Exception, MPEP § 2106.05(h), Field of Use and Technological Environment).
Claim 10 recites the abstract idea “operation parameters for monitoring and/or controlling the chemical and/or biological production are determined”, but does not integrate the abstract idea under step 2A prong 2 because using the device to gather data and provide instructions to apply the abstract idea(s) does not amount to significantly more than the exception itself and cannot integrate the judicial exception into a practical application (See MPEP § 2106.05(g), Insignificant Extra-Solution Activity, MPEP § 2106.05(f), Mere Instructions To Apply An Exception, MPEP § 2106.05(h), Field of Use and Technological Environment).
Claim 11 recites the input product is excluded from production if the measurement data does not lie in a valid range and/or the operation parameter of the input product are used if the measurement data is in a valid range. However, generally linking the abstract idea to the field of endeavor is nothing more than insignificant extra-solution activity, but does not integrate the exception into a practical application (See MPEP § 2106.05(g), Insignificant Extra-Solution Activity and MPEP § 2106.05(h), Field of Use and Technological Environment).
Claim 13 recites providing an identifier and retrieving a model based on the identifier. However, generally linking the abstract idea to the field of endeavor is nothing more than insignificant extra-solution activity, but does not integrate the exception into a practical application (See MPEP § 2106.05(g), Insignificant Extra-Solution Activity and MPEP § 2106.05(h), Field of Use and Technological Environment).
Claim 15 recites an apparatus for performing the steps in claim 1. However, use of conventional computer functions to apply the judicial exception does not qualify as a particular machine (MPEP § 2106.05(b)(I), MPEP § 2106.05(b)(II) and MPEP § 2106.05(b)(III)).
Claim 16 further limits the historical data to include spectral measurement data from different equipment. However, these additional elements are merely using the device to gather data and provide instructions to apply the abstract idea(s) (See MPEP § 2106.05(g), Insignificant Extra-Solution Activity, MPEP § 2106.05(f) and Mere Instructions To Apply An Exception).
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wasalathanthri et al. (US 2019/0272894 – hereinafter “Wasalathanthri”).
Regarding claim 1, Wasalathanthri disclose a computer-implemented method for monitoring and/or controlling a chemical and/or biological production process of an output product, wherein the output product is produced from one or more input product(s) (Wasalathanthri disclose a biomanufacturing system 1 for production of a recombinant therapeutic protein or other substance from a bioreactor 25; fig. 10, [0171-0225]. The control unit 120; fig. 1, [0086-0098] performs computer-implemented instructions to monitor and control a variety of attributes at each stage in the biomanufacturing process; figs. 8-9, [0119-0144]), the method comprising:
providing spectral measurement data associated with characteristics of the input product and/or the output product (Wasalathanthri disclose infrared spectroscopic measurements are implemented in-line between components of the biomanufacturing system 1; fig. 10, [0171, 0187, 0193, 0195, 0198-0199, 0211-0212, 0218]),
determining at least one performance indicator based on the spectral measurement data using a data-driven model (Wasalathanthri disclose quality attributes are determined for process fluids at one or more locations within the system to ensure that the system operates within acceptable ranges; [0212, 0193, 0218-0222], by correlating measured spectroscopic intensity values at one or more wavelengths or frequencies with previously stored values of the coefficients from a storage medium; fig. 9, [0120-0131]), wherein the data-driven model is parameterized according to historical data comprising spectral measurement data associated with characteristics of the input product and/or the output product (Wasalathanthri disclose a principal component analysis on multiple calibration data sets which can be retrieved from a storage medium to determine measured wavelengths or frequencies in the process streams; [0119-0131]),
wherein the at least one performance indicator is a validation indicator indicating that spectral measurement data lies in a valid range (Wasalathanthri disclose a range in vibrational spectral information is used to determine attributes of interest; [0117, 0153-0164, 0193, 0212, 0220-0225]),
providing the at least one performance indicator for monitoring and/or controlling the chemical and/or biological production process of the output product (Wasalathanthri disclose control system can determine a baseline concentration of a protein based on the vibration spectral information. During elution as the protein substances breaks through, an increase in the measured protein concentration increases above a baseline concentration, and when a predetermined threshold value is reached, the flow-through from column 1 is directed onto column 2 instead of to the waste; [0193, 0212]).
Regarding claim 2, Wasalathanthri disclose the method of claim 1 above, wherein the validation indicator is a classifier indicating that the spectral measurement data associated with the input product and/or the output product lies in a valid or an invalid range (Wasalathanthri disclose vibrational spectral measurements are compared with a principal component analysis on multiple calibration data sets stored in a storage medium to determine an attribute of interest, and control system can determine a baseline concentration of a protein based on the vibration spectral information. During elution as the protein substances breaks through, an increase in the measured protein concentration increases above a baseline concentration, and when a predetermined threshold value is reached, the flow-through from column 1 is directed onto column 2 instead of to the waste; [0117, 0119-0131, 0153-0164, 0193, 0212, 0220-0225]).
Regarding claim 3, Wasalathanthri disclose the method of claim 1 above, wherein at least one value indicating the valid and/or invalid range is provided and/or used for determining the at least one performance indicator (Wasalathanthri disclose vibrational spectral measurements are compared with a principal component analysis on multiple calibration data sets stored in a storage medium to determine an attribute of interest, and control system can determine a baseline concentration of a protein based on the vibration spectral information. During elution as the protein substances breaks through, an increase in the measured protein concentration increases above a baseline concentration, and when a predetermined threshold value is reached, the flow-through from column 1 is directed onto column 2 instead of to the waste; [0117, 0119-0131, 0153-0164, 0212, 0220-0225]).
Regarding claim 4, Wasalathanthri disclose the method of claim 1 above, wherein an operation parameter of the production process is provided, if the input product is classified valid and/or if the output product is classified not valid (Wasalathanthri disclose control system can determine a baseline concentration of a protein based on the vibration spectral information. During elution as the protein substances breaks through, an increase in the measured protein concentration increases above a baseline concentration, and when a predetermined threshold value is reached, the flow-through from column 1 is directed onto column 2 instead of to the waste; [0193, 0212]. The spectral information is also used to determine the amount of buffer/reagent to add to process fluid; [0218, 0221-0222]).
Regarding claim 5, Wasalathanthri disclose the method of claim 1 above, wherein the spectral measurement data includes one or more infrared spectra and/or one or more interferograms (Wasalathanthri disclose infrared spectroscopic measurements are implemented in-line between components of the biomanufacturing system 1; fig. 10, [0171, 0187, 0193, 0195, 0198-0199, 0211-0212, 0218]).
Regarding claim 6, Wasalathanthri disclose the method of claim 1, wherein the historical data includes spectral measurement data provided from different measurement equipment (Wasalathanthri disclose quality attributes are determined for process fluids at one or more locations (up to 10 measurement systems at MCCS1 and up to 10 measurement systems at MCCS2) within the system to ensure that the system operates within acceptable ranges; [0193, 0212, 0218-0222], by correlating measured spectroscopic intensity values at one or more wavelengths or frequencies with previously stored values of the coefficients from a storage medium; fig. 9, [0120-0131]. Accordingly, the vibrational spectral measurements from at least some of the locations would be from different equipment).
Regarding claim 7, Wasalathanthri disclose the method of claim 1, wherein the historical data includes time-dependent spectral measurement data (Wasalathanthri disclose the spectral measurements are performed using a Fourier transform infrared spectrometer (FTIR) using real-time analysis; [0093, 0115-0116]. Accordingly, the historical calibration data being derived from time-dependent spectral measurement data).
Regarding claim 8, Wasalathanthri disclose the method of claim 7 above, wherein time-dependent spectral measurement data is used to determine a time-dependent product performance indicator (Wasalathanthri disclose control system can determine a baseline concentration of a protein based on the vibration spectral information. During elution as the protein substances breaks through, an increase in the measured protein concentration increases above a baseline concentration, and when a predetermined threshold value is reached, the flow-through from column 1 is directed onto column 2 instead of to the waste; [0193, 0212]. The spectral information is also used to determine the amount of buffer/reagent to add to process fluid; [0218, 0221-0222]).
Regarding claim 9, Wasalathanthri disclose the method of claim 7 above, wherein the time-dependent product performance indicator associated with performance characteristics of the output product is determined and used for monitoring and/or controlling the production facility or process in real-time during the production process (Wasalathanthri disclose control system can determine a baseline concentration of a protein based on the vibration spectral information. During elution as the protein substances breaks through, an increase in the measured protein concentration increases above a baseline concentration, and when a predetermined threshold value is reached, the flow-through from column 1 is directed onto column 2 instead of to the waste; [0193, 0212]. The spectral information is also used to determine the amount of buffer/reagent to add to process fluid; [0218, 0221-0222]).
Regarding claim 10, Wasalathanthri disclose the method of claim 1 above, wherein the chemical and/or biological production process of the output product is monitored and/or controlled based on the performance indicator, wherein operation parameters for monitoring and/or controlling the chemical and/or biological production process are determined based on the performance indicator (Wasalathanthri disclose column-switching when a measured baseline concentration is above a threshold value to reach a desired output purity of recombinant therapeutic protein [0193, 0198, 0212, 0216, 0218]).
Regarding claim 11, Wasalathanthri disclose the method of claim 1 above, wherein the input product is excluded from production and/or associated operation parameters are adjusted if the analytical measurement data does not lie in a valid range and/or the operation parameters associated with the input product are used if the analytical measurement data lies in a valid range (Wasalathanthri disclose directing the effluent to waste when a measured baseline concentration is below a threshold purity of recombinant therapeutic protein, and column switching to further purify the effluent when the concentration is above a threshold baseline; [0193, 0198, 0212, 0216, 0218]).
Regarding claim 12, Wasalathanthri disclose a computer-implemented method for selecting a chemical and/or biological production facility or process (Wasalathanthri disclose a biomanufacturing system 1 for production of a recombinant therapeutic protein or other substance from a bioreactor 25; fig. 10, [0171-0225]. The control unit 120; fig. 1, [0086-0098] performs computer-implemented instructions to monitor and control a variety of attributes at each stage in the biomanufacturing process; figs. 8-9, [0119-0144]), the method comprising:
providing spectral measurement data associated with characteristics of one or more input product(s) and/or the output product(s) (Wasalathanthri disclose infrared spectroscopic measurements are implemented in-line between components of the biomanufacturing system 1; fig. 10, [0171, 0187, 0193, 0195, 0198-0199, 0211-0212, 0218]),
determine at least one performance indicator based on data driven model(s) associated with different production facilities or processes (Wasalathanthri disclose quality attributes are determined for process fluids at one or more locations within the system to ensure that the system operates within acceptable ranges; [0212, 0193, 0218-0222], by correlating measured spectroscopic intensity values at one or more wavelengths or frequencies with previously stored values of the coefficients from a storage medium; fig. 9, [0120-0131]), wherein the data driven models are parametrized based on historical data associated with each production facility or process (Wasalathanthri disclose a principal component analysis on multiple calibration data sets which can be retrieved from a storage medium to determine measured wavelengths or frequencies in the process streams; [0119-0131]) and
wherein the performance indicator is a validation indicator indicating that spectral measurement data lies in a valid range (Wasalathanthri disclose a range in vibrational spectral information is used to determine attributes of interest; [0117, 0153-0164, 0193, 0212, 0220-0225]),
providing the performance indicator for selecting a chemical and/or biological production facility or process (Wasalathanthri disclose control system can determine a baseline concentration of a protein based on the vibration spectral information. During elution as the protein substances breaks through, an increase in the measured protein concentration increases above a baseline concentration, and when a predetermined threshold value is reached, the flow-through from column 1 is directed onto column 2 instead of to the waste; [0193, 0212]).
Regarding claim 13, Wasalathanthri disclose a computer-implemented method for selecting a data driven model used in the method of claim 1 above (The method according to claim 1 has previously been discussed above. Wasalathanthri disclose a control unit 120; fig. 1, [0086-0098] performs computer-implemented instructions to monitor and control a variety of attributes at each stage in the biomanufacturing process; figs. 8-9, [0119-0144]), the method comprising:
providing an input product identifier, an output product identifier, a production facility identifier and/or a production process identifier (Wasalathanthri disclose a chemometric model to determine an antibody concentration value for a process fluid using a range in vibrational spectroscopic information to measure an attribute of interest; [0152-0164]),
retrieving based on the input product identifier, the output product identifier, the production facility identifier and/or the production process identifier, a data-driven model for providing spectral measurement data in association with the provided input product identifier, the provided output product identifier, the provided production facility identifier and/or the provided production process identifier to the data driven model (Wasalathanthri disclose a chemometric model to determine an antibody concentration value for a process fluid using a range in vibrational spectroscopic information to measure an attribute of interest; [0152-0164]).
Regarding claim 14, Wasalathanthri disclose a computer element with instructions, which when executed by one or more computing apparatus cause the one or more computing apparatus to carry out the steps according to claim 1 (The method steps according to claim 1 have previously been discussed above. Wasalathanthri disclose the control unit 120; fig. 1, [0086-0098] performs computer-implemented instructions to monitor and control a variety of attributes at each stage in the biomanufacturing process; figs. 8-9, [0119-0144]).
Regarding claim 15, Wasalathanthri disclose an apparatus for monitoring and/or controlling a chemical and/or biological production process of an output product, for selecting a chemical and/or biological production facility or process and/or for selecting a data driven model, the apparatus comprising processing units with instructions for monitoring and/or controlling a chemical and/or biological production process of an output product, for selecting a chemical and/or biological production facility or process and/or for selecting a data driven model, which when executed by one or more computing apparatus(es) cause the one or more computing apparatus(es) to carry out the steps according to claim 1 (As best understood, Wasalathanthri disclose a biomanufacturing system 1 for production of a recombinant therapeutic protein or other substance from a bioreactor 25; fig. 10, [0171-0225], where a chemometric model is used to determine an antibody concentration value for a process fluid using a range in vibrational spectroscopic information to measure an attribute of interest; [0152-0164]. The control unit 120; fig. 1, [0086-0098] performs computer-implemented instructions to monitor and control a variety of attributes at each stage in the biomanufacturing process; figs. 8-9, [0119-0144]).
Regarding claim 16, Wasalathanthri disclose the method of claim 6 above, wherein the historical data includes spectral measurement data provided from different measurement equipment of one measurement type (Wasalathanthri disclose quality attributes are determined for process fluids at one or more locations (up to 10 measurement systems at MCCS1 and up to 10 measurement systems at MCCS2) within the system to ensure that the system operates within acceptable ranges; [0193, 0212, 0218-0222], by correlating measured spectroscopic intensity values at one or more wavelengths or frequencies with previously stored values of the coefficients from a storage medium; fig. 9, [0120-0131]. Accordingly, the vibrational spectral measurements from at least some of the locations would be from different equipment).
Other References Cited
The prior art of made of record and not relied upon is considered pertinent to Applicant’s disclosure include:
Hu et al. (US Patent No. 11,406,053) disclose a method for monitoring/controlling an agricultural product using areal photos and historical growth/weather patterns to determine a yield and revenue stream.
Subramanian et al. (US 2009/0305423) disclose a method for evaluating cheese using an IR spectra analysis.
Wasalathanthri (Technology outlook for real-time quality attribute and process parameter monitoring in biopharmaceutical development – A review, Biotechnology Bioengineering, 2020; 117, 3182-3198) disclose a method for monitoring and/or controlling a biological production process.
Citations to art
In the above citations to documents in the art, an effort has been made to specifically cite representative passages, however rejections are in reference to the entirety of each document relied upon. Other passages, not specifically cited, may apply as well.
Conclusion
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/C.A.T./Examiner, Art Unit 1798
/BENJAMIN R WHATLEY/Primary Examiner, Art Unit 1798
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