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 .
Claim Status
Claims 1-20 are currently pending and under examination herein.
Applicant's preliminary amendments to the claims, filed 01/12/2024, are acknowledged.
Claims 1-20 are rejected.
Priority
The application claims, filed 06/06/2023, is a National Stage entry of PCT/EP2021/076862, International Filing Date: 09/29/2021 and claims foreign priority to IN202011053215, filed 12/07/2020. PCT related documentation reviewed.
In this action, all claims 1-20 are examined for an effective filing date of 12/07/2020. In future actions, the effective filing date of one or more claims may change, due to amendments to the claims, or further analysis of the disclosure(s) of the priority application(s).
Information Disclosure Statement
Information Disclosure Statements, filed 06/06/2023, has been considered. Signed copies of the IDS are included with this Office Action.
.
Drawings
The Drawings submitted, filed 06/06/2023, are accepted. The drawings as filed are suitable to the Examiner. Applicant is encouraged to review the submission in PAIR to ensure all details are readable, particularly FIGs 6, 10-12, 15, 18, and 20.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
Such claim limitation(s) is/are:
“processor circuitry to execute the instructions to identify at least one operating parameter of a target bioreactor…” in claim 1;
“processor circuitry is to identify at least one bioreactor process parameter …” in claim 5;
“processor circuitry is to determine a primary and/or a secondary sparger…” in claim 8; and
"processor circuitry is to calculate viable cell density (VCD) in claim 9.
Said processor circuitry are the generic placeholders, and each respective function is the specialized function.
““to execute the instructions to identify at least one operating parameter of a target bioreactor…” in claim 1;
“to identify at least one bioreactor process parameter …” in claim 5;
“to determine a primary and/or a secondary sparger…” in claim 8; and
" to calculate viable cell density (VCD) in claim 9.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If Applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
However, the instant specification discloses in FIGs 21-24, [00101-00112] specific processor circuitry embodiments with FPGA circuitry, structures programming instructions, switches, registers, and logic gate interconnections configurable to instantiate one or more operations that may correspond to at least some of the machine readable instructions of FIGS. 4-5 and/or other desired operations, and Dedicated Operations Circuitry [FIG 23, 00110]. Therefore, the claim limitation processing circuitry has sufficient structure rooted in the specification written description and the claim limitation is not indefinite.
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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract ideas without significantly more.
The instant rejection reflects the framework as outlined in the MPEP at 2106.04:
Framework with which to Evaluate Subject Matter Eligibility:
(1) Are the claims directed to a process, machine, manufacture, or composition of matter;
(2A) Prong One: Do the claims recite a judicially recognized exception, i.e. a law of nature, a natural phenomenon, or an abstract idea;
Prong Two: If the claims recite a judicial exception under Prong One, then is the judicial exception integrated into a practical application (Prong Two); and
(2B) If the claims do not integrate the judicial exception, do the claims provide an inventive concept.
Framework Analysis as Pertains to the Instant Claims:
With respect to step (1): yes, claims 1-16 are directed to an apparatus/method for scaling and optimization of bioreactors, therefore the answer is "yes".
The computer readable storage medium claims 17-20 do not explicitly claim a non-transitory computer-readable medium, without which they are directed to non-statutory subject matter for not falling within at least one of the four categories of patent eligible subject matter. The MPEP 2106.03 (I) teaches examples of claims that are not directed to any of the statutory categories include: products that do not have a physical or tangible form, such as information (often referred to as "data per se") or a computer program per se (often referred to as "software per se") when claimed as a product without any structural recitations; and transitory forms of signal transmission (often referred to as "signals per se"), such as a propagating electrical or electromagnetic signal or carrier wave. Applicant should consider adding non-transitory, consistent with the instant specification [0066-0067, 0071, 00100], to all instances of claimed computer-readable medium. For compact prosecution, these claims 17-20 are examined as if they claim non-transitory computer-readable medium and Applicant should amend the claims before the next office action.
With respect to step (2A)(1), the claims recite abstract ideas. To determine if the claims recite any concepts that equate to an abstract idea, law of nature, or natural phenomenon, MPEP at 2106.03 teaches abstract ideas include mathematical concepts (mathematical formulas or equations, mathematical relationships, and mathematical calculations), certain methods of organizing human activity, and mental processes (including procedures for collecting, observing, evaluating, and organizing information (see MPEP 2106.04(a)(2)). Laws of nature or natural phenomena include naturally occurring principles/ relations and nature-based products that are naturally occurring or that do not have markedly different characteristics compared to what occurs in nature (MPEP2106(b)). In the instant application, the claims recite the following limitations that equate to an abstract idea with mental steps and mathematical concepts.
Claims 1, 10, and 17 are independent, and all recite nearly identical limitations. Primarily claim 1 is referred to here for clarity.
With respect to the instant claims, under the step (2A)(1) evaluation, the claims are found to direct to abstract ideas that fall into the grouping of abstract ideas: in particular mental steps for identify… determine…simulate… bioprocess/bioreactor in order to determine overall risk and in mathematical concepts for calculate viable cell density …
The claims directing to judicial exceptions are as follows:
Mental processes:
Claims 1, 10, and 17: scaling…identify at least one operating parameter (observing and identifying operating parameters)…determine an upper boundary and/or a lower boundary defining a design space for at least one bioreactor process parameter to match at one or more target parameter ranges based on the at least one operating parameter (observing the parameter, and making a judgement as to the upper limit and lower limit that parameter should fall within)…simulate changes in the one or more target parameter ranges based on an adjustment to the upper boundary and/or the lower boundary in the design space (thinking about a change in the parameter and making a judgement as to what could happen to the bioreactor); … to identify a match between the one or more target parameter ranges and a user-based input of a target bioprocess parameter value.(observing the target parameter range, and the user input of a bioprocess parameter and making some sort of judgement as to whether the bioreactor should be changed)
Claims 5, 12, and 18: to identify at least one bioreactor process parameter for scaling from a reference scale to a target scale.
Claims 6, 13, 19: simulating process parameter adjustments to determine a target bioreactor value range that reduces deviations from the reference scale.
Claims 7, 14, and 20: adjustment of a scaling parameter…
Claims 8 and 15: to determine a primary and/or a secondary sparger mass transfer coefficient, power consumption per liquid volume (PN) mixing time, and/or oxygen transfer rate (OTR).
Mathematical concepts
Claims 9 and 16: to calculate viable cell density (VCD) based on the OTR.
Hence, the claims explicitly recite elements that, individually and in combination, constitute abstract ideas.
With respect to step 2A(2): The claims must therefore be examined further to determine whether they integrate that abstract idea into a practical application (MPEP 2106.04(d). A claim that integrates a judicial exception into a practical application will apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception. The claimed additional elements are analyzed to determine if the abstract idea is integrated into a practical application (MPEP 2106.04(d).I.; MPEP 2106.05(a-h)). If the claim contains no additional elements beyond the abstract idea, the claim fails to integrate the abstract idea into a practical application (MPEP 2106.04(d).III).
With respect to the instant recitations, the claims recite the following additional elements considered for practical application:
Claim 1: bioprocess/bioreactor …and configure the target bioreactor (insignificant extrasolution activity)
Claims 2-4, and 11: target parameter ranges include at least two/three target parameter ranges…an oxygen transfer rate (OTR) range or a ratio of total aeration to the bioreactor working volume (VVM) range
Claims 7, 14, and 20: the scaling parameter including a tip speed, an energy dissipation rate, a mixing time, a mass transfer coefficient, or a shear force.
Claims 1-9, and 17-20 also recite the additional non-abstract elements: apparatus, computer-readable recording medium.
Claims 1, 10, and 17 do not utilize the bioprocess/bioreactor in a real world or practical application, only to predict/optimize data (target parameter ranges, scaling parameters, viable cell density (VCD), primary and/or a secondary sparger mass transfer coefficient, power consumption per liquid volume (PN) mixing time, and/or oxygen transfer rate (OTR).). They also recites known, conventional steps of configure the target bioreactor using output… which is insignificant extrasolution activity and limitations about apparatus with processors/memories are well known as well. (Hoehse et al. WO 2020173844; Neubauer et al. (2016). Scale‐up and scale‐down methodologies for bioreactors. Bioreactors: Design, operation and novel applications, 323-354; Villiger TK et al. (2018) Experimental and CFD physical characterization of animal cell bioreactors: From micro- to production scale. Biochemical Engineering Journal Vol 131: 84-94).
Claims 2-4, 7, 11, 14, and 20 recite additional elements that are not an abstract idea but are data gathering steps. Data gathering steps are not an abstract idea, they are extra-solution activity, as they collect the parameter data needed to carry out the abstract idea. Data gathering does not impose any meaningful limitation on the abstract idea, or how the abstract idea is performed. Data gathering steps are not sufficient to integrate an abstract idea into a practical application. (MPEP 2106.05(g).
Claims 1-9, and 17-20 also recite the additional non-abstract elements: apparatus, computer-readable recording medium, and bioreactor. The claims do not describe any specific computational steps by which the apparatus [00114-00124]related parts perform or carry out the abstract idea, nor do they provide any details of how specific structures of the computer such as the computer readable recording media are used to implement these functions. The claims require nothing more than a minimally described, generic apparatus/CRM [0045: Provided is a computer-readable recording medium having recorded thereon a program for causing a computer to execute a method of predicting the efficiency and an outcome of a BE by using deep learning] and bioreactor [0048-0058: The bioreactor units 202 include an example reference bioreactor 204 and/or an example target bioreactor 206. The bioreactor units 202 can include any type of bioreactor used in a bioprocess. For example, the reference bioreactor 204 can be a microscale bioreactor, while the target bioreactor 206 can be a large-scale bioreactor (e.g., a single use bioreactor, etc.). In some examples, the bioreactors 204, 206 can include any type of commercial bioreactor (e.g., a stirred tank bioreactor, an airlift bioreactor, etc.) such as…] to perform the functions that constitute the abstract idea. Hence, these are mere instructions to apply the abstract idea using a computer, and therefore the claim does not recite integrate that abstract idea into a practical application. (see MPEP 2106.05(f)).
Remaining claims have been analyzed. Dependent claims are directed to further abstract limitations. Further abstract limitations cannot provide a practical application of the judicial exception as they are a part of that exception. Dependent claims 2-4, 7, 11, 14, and 20 are also directed to additional steps of data gathering. Steps of data gathering do not provide a practical application for the judicial exception. Claim 13 is directed to additional computer limitations. These further limitations are still generically stated and require no more than a standard computer to perform them.
Claims 2-4, 7, 11, 14, and 20 recite additional elements that are not an abstract idea but are data gathering steps. Data gathering steps are not an abstract idea, they are extra-solution activity, as they collect the parameter data needed to carry out the abstract idea. Data gathering does not impose any meaningful limitation on the abstract idea, or how the abstract idea is performed. Data gathering steps are not sufficient to integrate an abstract idea into a practical application. (MPEP 2106.05(g).
None of these dependent claims recite additional elements which would integrate a judicial exception into a practical application.
Finally, the (2B) analysis. Because the claims recite an abstract idea, and do not integrate that abstract idea into a practical application, the claims lack a specific inventive concept. The judicial exception alone cannot provide that inventive concept or practical application (MPEP 2106.05). Identifying whether the additional elements beyond the abstract idea amount to such an inventive concept requires considering the additional elements individually and in combination to determine if they provide significantly more than the judicial exception. (MPEP 2106.05.A i-vi).
With respect to the instant claims, the additional elements of data gathering, instructions, and field of use limitations described above do not rise to the level of significantly more than the judicial exception. As directed in the Berkheimer memorandum of 19 April 2018 and set forth in the MPEP, determinations of whether or not additional elements (or a combination of additional elements) may provide significantly more and/or an inventive concept rest in whether or not the additional elements (or combination of elements) represent well-understood, routine, conventional activity. Said assessment is made by a factual determination stemming from a conclusion that an element (or combination of elements) is widely prevalent or in common use in the relevant industry, which is determined by either a citation to an express statement in the specification or to a statement made by an applicant during prosecution that demonstrates a well-understood, routine or conventional nature of the additional element(s); a citation to one or more of the court decisions as discussed in MPEP 2106(d)(II) as noting the well-understood, routine, conventional nature of the additional element(s); a citation to a publication that demonstrates the well-understood, routine, conventional nature of the additional element(s); and/or a statement that the examiner is taking official notice with respect to the well-understood, routine, conventional nature of the additional element(s).
With respect to the instant recitations, the claims recite the following additional elements considered for inventive concept:
Claim 1: bioprocess/bioreactor …and configure the target bioreactor (insignificant extrasolution activity)
Claims 2-4, and 11: target parameter ranges include at least two/three target parameter ranges…an oxygen transfer rate (OTR) range or a ratio of total aeration to the bioreactor working volume (VVM) range
Claims 7, 14, and 20: the scaling parameter including a tip speed, an energy dissipation rate, a mixing time, a mass transfer coefficient, or a shear force.
Claims 1-9, and 17-20 also recite the additional non-abstract elements: apparatus, computer-readable recording medium.
Said steps that are “in addition” to the recited judicial exception in the instant claims represent those of mere data handling instructions or field of use limitations (configure the target bioreactor, target parameter ranges include at least two/three target parameter ranges…an oxygen transfer rate (OTR) range or a ratio of total aeration to the bioreactor working volume (VVM) range…: the scaling parameter including a tip speed, an energy dissipation rate, a mixing time, a mass transfer coefficient, or a shear force.) to implement in the recited judicial exception and do not impart meaning to said recited judicial exception, such that is applied in a practical manner. Further with respect to the additional elements in the instant claims, these steps direct to mere data gathering and handling to carry out the abstract idea without imposing any meaningful limitation on the abstract idea. Thereby these steps are insignificant extra-solutions activity steps and are insufficient to integrate an abstract idea into a practical application. (MPEP 2106.05(g).
With respect to claim 1: The additional element of data gathering does not rise to the level of significantly more than the judicial exception. Steps of target parameter ranges… are merely steps of data handling.
Claim 1 recites conventional laboratory steps of configure the target bioreactor which is insignificant extrasolution activity and limitations about apparatus with processors/memories are well known as well. (Hoehse et al. WO 2020173844; Neubauer et al. (2016). Scale‐up and scale‐down methodologies for bioreactors. Bioreactors: Design, operation and novel applications, 323-354; Villiger TK et al. (2018) Experimental and CFD physical characterization of animal cell bioreactors: From micro- to production scale. Biochemical Engineering Journal Vol 131: 84-94).
Claims 1-20 recite additional elements that are not an abstract idea but are data gathering steps. Data gathering steps are not an abstract idea, they are extra-solution activity, as they collect the data needed to carry out the abstract idea. Data gathering does not impose any meaningful limitation on the abstract idea, or how the abstract idea is performed. Data gathering steps are not sufficient to integrate an abstract idea into a practical application. (MPEP 2106.05(g).
Claims 1-9, and 17-20 also recite the additional non-abstract elements: apparatus, computer-readable recording medium, and bioreactor. The claims do not describe any specific computational steps by which the apparatus [00114-00124]related parts perform or carry out the abstract idea, nor do they provide any details of how specific structures of the computer such as the computer readable recording media are used to implement these functions. The claims require nothing more than a minimally described, generic apparatus/CRM [0045: Provided is a computer-readable recording medium having recorded thereon a program for causing a computer to execute a method of predicting the efficiency and an outcome of a BE by using deep learning] and bioreactor [0048-0058: The bioreactor units 202 include an example reference bioreactor 204 and/or an example target bioreactor 206. The bioreactor units 202 can include any type of bioreactor used in a bioprocess. For example, the reference bioreactor 204 can be a microscale bioreactor, while the target bioreactor 206 can be a large-scale bioreactor (e.g., a single use bioreactor, etc.). In some examples, the bioreactors 204, 206 can include any type of commercial bioreactor (e.g., a stirred tank bioreactor, an airlift bioreactor, etc.) such as…] to perform the functions that constitute the abstract idea. Hence, these are mere instructions to apply the abstract idea using a computer, and therefore the claim does not recite integrate that abstract idea into a practical application. (see MPEP 2106.05(f)).
Remaining claims have been analyzed. Dependent claims are directed to further abstract limitations. Further abstract limitations cannot provide a practical application of the judicial exception as they are a part of that exception. Dependent claims 2-9, 11-16, and 18-20 are also directed to additional steps of data gathering. Steps of data gathering do not provide a practical application for the judicial exception. Dependent claim 13 is directed to additional computer limitations. These further limitations are still generically stated and require no more than a standard computer to perform them.
None of these dependent claims recite additional elements which would integrate a judicial exception into a practical application.
With respect to independent claims with the computer related elements or the general purpose computer do not rise to the level of significantly more than the judicial exception. The specification does not disclose any system architecture or hardware components. The additional elements are set forth at such a high level of generality that they can be met by a general purpose computer. Therefore, the computer components constitute no more than a general link to a technological environment, which is insufficient to constitute an inventive concept that would render the claims significantly more than an abstract idea (see MPEP 2106.05(b)I-III).
For these reasons, the claims, when the limitations are considered individually and as a whole, are rejected under 35 USC § 101 as being directed to non-statutory subject matter (Step 2B: No). As such, claims 1-20 are not patent eligible.
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 (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
(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.
Note: citations from the instant application are italicized in the following section.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by
Trunfio N et al. 2020).
Trunfio N et al. US20230323275A1 (10/02/2020) Monitoring and control of bioprocesses.
Note: citations from the instant application are italicized in the following section.
The independent claims are drawn to an apparatus, method, and CRM for simulating and scaling bioprocesses based on a target operating parameter (within a design space to simulate an upper boundary and lower boundary value), to configure bioreactors. Target parameters include bioreactor oxygen transfer rates (OTR), sparger mass transfer coefficient, viable cell density (VCD), and a scaling parameter (tip speed, an energy dissipation rate, a mixing time, a mass transfer coefficient, or a shear force) from a reference scale to a target scale.
With respect to claims 1, 10, and 17, the prior art to Trunfio et al. provides the overall apparatus, method, and CRM for monitoring a bioprocess comprising a cell culture in a bioreactor. The measurements determine one or more metabolic condition variables (target operating parameter); using a pre-trained multivariate model (design space) to determine the value of one or more latent variables as a function of bioprocess maturity, wherein the multivariate model is a linear model that uses process variables including the metabolic condition variables as predictor variables and maturity as a response variable (within a design space to simulate an upper boundary and lower boundary value); comparing the value(s) of the one or more latent variables to one or more predetermined values as a function of maturity (from a reference scale to a target scale); and determining on the basis of the comparison whether the bioprocess is operating normally [0006]. A user navigates the expanded design space and identifies settings that will support a given bioprocess. As such, the identified design space gives the user flexibility to navigate inside the design space as well as permit improved investigation of process deviations [0038].
With respect to claims 2-3, Trunfio teaches at least some of the plurality of runs used to train the multivariate model are associated with one or more critical quality attributes (CQAs), the values of one or more process variables including one or more metabolic condition variables and a model trained using the values of the one or more metabolic condition variables for the plurality of training runs and the corresponding CQAs to predict one or more CQAs of the bioprocess… one or more of the steps of merging multiple measurements and/or metabolic condition variables into a single table where the measurements/variables are aligned by maturity)[reference Trunfio at claims 12 and 13].
With respect to claims 4 and 11, Trunfio provides scale-up criteria which include consideration of parameters such as oxygen transfer rate, tip speed, mixing time, and/or volumetric mass transfer coefficient (kLa) [0036]. The bioprocess scaler can be used to perform scaling for various bioreactor configurations, taking into consideration fulfillment of requirements associated with oxygen transfer and/or carbon dioxide stripping, resulting in the identification of set points (e.g., agitation speed, sparger configuration, air flow, oxygen flow, etc.) based on the desired set of requirements, allowing comparison of results based on different criteria (e.g., as specified by a user via user input ) [0047].
With respect to claims 5, 12, and 18, Trunfio provides bioprocesses can be developed at smaller scales before stepwise transfer to larger volumes occurs to achieve industrial production-scale levels (e.g., scaling up based on bioreactor operating parameters from a smaller scale to a larger scale the process is transferred to) [0036].
With respect to claims 6, 13, and 19, Trunfio provides a process parameter can be maintained constant throughout the scale-up process to reduce any negative effects of changes in the bioprocess environment… scaling a process from a microbioreactor scale (e.g., 10 microliters) to production scale (e.g., 1000 Liters) requires consideration of multiple scaling criteria including physical operating parameters and their effect on product quality across various scales [0036] The design space within which adjustments to parameters can be made without jeopardizing the integrity of the bioprocess itself. For example, scaling requires staying within the same design space across scales (e.g., when moving from a reference bioreactor where a small-scale bioreactor can be used to initially developed a bioprocess to a target bioreactor where the bioprocess is on a large scale production). Multiple relevant scaling parameters can make it difficult to define the optimal design space. Furthermore, once the design space is defined and upper and/or lower boundaries are set, a user may not be able to modify some parameters without having a clear indication of how the desired changes will affect the resulting parameters that will define the outcome of the bioprocess itself (e.g., oxygen transfer rate, etc) [0037].
. With respect to claims 7, 14, and 20, Trunfio provides scale-up criteria which include consideration of parameters such as oxygen transfer rate, tip speed, mixing time, and/or volumetric mass transfer coefficient (kLa) [0036].
With respect to claims 8 and 15, Trunfio provides a bioprocess scaler can identify anticipated changes in gas flow over time based on the bioreactor sparger type and/or overall mixing speed and aeration. In some examples, the bioprocess scaler can determine the sparger type (e.g., 2 micrometer sparger, 20 micrometer sparger, 1 millimeter sparger, etc.) that meets the carbon dioxide removal requirement and/or achieves a desired volumetric oxygen transfer coefficient (kLa) value. In some examples, the bioprocess scaler identifies reference bioreactor variable values (e.g., tip speed, mixing time, etc.) and calculates the optimal operating parameters for the target bioreactor (e.g., mixing speed, gas flow rates, etc.), as described in connection with FIG. 4 [0047].
With respect to claims 9 and 16, Trunfio provides the communication interface can be used to receive data needed for determining reference bioreactor variable values (e.g., tip speed, mixing time, viable cell density, etc.), data needed for determining operating parameters for the target bioreactor (e.g., top speed, shear rate, etc.), and/or data needed to determine acceptable variable value ranges for the target bioreactor (e.g., agitation, aeration), as described in connection with FIGS. 4 and/or 5 . In addition, the communication interface can be used to monitor scaled target bioreactor variable values during the bioprocess and/or identify potential deviations from the desired design space 114 of FIG. 1 [0044].
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
A. Instant claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 4, 6, 7-9, 11-16, and 18-20 of US Patent No. 12,182,482. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are a species of ‘482 which is a method for predicting outcome of a process used for manufacturing a sample in a bioreactor.
B. Instant claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 8, 11-12, 15-19, 24, and 26-27 of US Application No. 18/948,020. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are a species of ‘020, which is also a method for predicting outcome of a process used for manufacturing a sample in a bioreactor using historic parameters as a reference parameters. This is a provisional nonstatutory double patenting rejections because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
E-mail Communications Authorization
Per updated USPTO Internet usage policies, Applicant and/or applicant’s representative is encouraged to authorize the USPTO examiner to discuss any subject matter concerning the above application via Internet e-mail communications. See MPEP 502.03. To approve such communications, Applicant must provide written authorization for e-mail communication by submitting following form via EFS-Web or Central Fax (571-273-8300): PTO/SB/439. Applicants are encouraged to do so as early in prosecution as possible, so as to facilitate communication during examination.
Written authorizations submitted to the Examiner via e-mail are NOT proper. Written authorizations must be submitted via EFS-Web or Central Fax (571-273-8300). A paper copy of e-mail correspondence will be placed in the patent application when appropriate. E-mails from the USPTO are for the sole use of the intended recipient and may contain information subject to the confidentiality requirement set forth in 35 USC § 122. See also MPEP 502.03.
Inquiries
Papers related to this application may be submitted to Technical Center 1600 by facsimile transmission. Papers should be faxed to Technical Center 1600 via the PTO Fax Center. The faxing of such papers must conform to the notices published in the Official Gazette, 1096 OG 30 (November 15, 1988), 1156 OG 61 (November 16, 1993), and 1157 OG 94 (December 28, 1993) (See 37 CFR § 1.6(d)). The Central Fax Center Number is (571) 273-8300.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Vy Rossi, whose telephone number is (703) 756-4649. The examiner can normally be reached on Monday-Friday from 8:30AM to 5:30PM ET.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Olivia Wise, can be reached on (571) 272-2249. Any inquiry of a general nature or relating to the status of this application or proceeding should be directed to (571) 272-0547.
Patent applicants with problems or questions regarding electronic images that can be viewed in the Patent Application Information Retrieval system (PAIR) can now contact the USPTO’s Patent Electronic Business Center (Patent EBC) for assistance. Representatives are available to answer your questions daily from 6 am to midnight (EST). The toll free number is (866) 217-9197. When calling please have your application serial or patent number, the type of document you are having an image problem with, the number of pages and the specific nature of the problem. The Patent Electronic Business Center will notify applicants of the resolution of the problem within 5-7 business days. Applicants can also check PAIR to confirm that the problem has been corrected. The USPTO’s Patent Electronic Business Center is a complete service center supporting all patent businesses on the Internet. The USPTO’s PAIR system provides Internet-based access to patent application status and history information. It also enables applicants to view the scanned images of their own application file folder(s) as well as general patent information available to the public.
/VR/
Examiner
Art Unit 1685
/MARY K ZEMAN/Primary Examiner, Art Unit 1686
Prosecution Insights