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 exam herein.
Claims 1-20 are rejected.
Priority
The instant application does not claim benefit to any preceding applications. Therefore, the effective filing date of claims 1-20 is 25 July 2022.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 27 July 2022, 3 October 2023, 23 February 2024, 12 April 2024, 13 October 2025 comply with 37 CFR 1.98. Accordingly, all references listed have been considered by the examiner.
Drawings
The drawings filed on 25 July 2022 have been received and are accepted.
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 11-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contain 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, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Independent claims 11 and 16 recite a computer readable medium and a data processing system that perform the step of performing a new operation with the BoC deployment. There is inadequate support in the specification to indicate that a processor is capable of performing a new operation with the BoC deployment. Claims 12-15 and 17-20 are rejected due to their dependency on claims 11 and 16. To overcome this rejection, claim 11 should be amended to indicate in the preamble that the processor is coupled to a BoC and claim 16 should be amended to recite the BoC as a component of the system. For purposes of the present examination, claims 11 and 16 will be interpreted to mean the new process plan is transmitted to a BoC via the processor.
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 a judicial exception (abstract ideas and natural phenomena) without significantly more. Under MPEP § 2106, subject matter is patent eligible when the claimed invention is to one of the four statutory categories of invention [Step 1], and the claim is not directed to a judicial exception [Step 2A] unless the claim as a whole includes additional limitations amounting to significantly more than the exception [Step 2B].
Step 1
Claims 1-20 describe inventions that are to one of the statutory categories. In Step 1, a claim must fall within one of the four enumerated categories of statutory subject matter (process, machine, manufacture, or composition of matter); a claim falling outside these categories is ineligible without further analysis. See MPEP § 2106.03. Claims 1-10 are properly to one of the four statutory categories because the claimed invention is a method, which falls into the process category [Step 1: Yes]. Claims 11-15 are properly to one of the four statutory categories because the claimed invention is a non-transitory computer readable medium having instructions stored therein, which fall into the manufacture category [Step 1: Yes]. Claims 16-20 are properly to one of the four statutory categories because the claimed invention is a system, which falls into the machine category [Step 1: Yes].
Step 2A
Under Step 2A, a claim is directed to a judicial exception if, under the broadest reasonable interpretation, it recites an abstract idea, law of nature, or natural phenomena [Prong One] without the claim as a whole integrating the exception into a practical application [Prong Two]. Abstract ideas include mathematical concepts, mental processes, and certain methods of organizing human activity. Mathematical concepts encompass mathematical relationships, formulas, equations, and mathematical calculations. See MPEP § 2106.04(a)(2)(I). Mental processes involve concepts that can be performed in the human mind or by a human with the aid of pen and paper, such as observations, evaluations, judgments, or opinions. See MPEP § 2106.04(a)(2)(III). Certain methods of organizing human activity include fundamental economic principles, commercial or legal interactions, and managing personal behavior or relationships. See MPEP § 2106.04(a)(2)(II). Laws of nature and 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. See MPEP § 2106.04(b)-(c).
Prong One
A claim recites a judicial exception when it sets forth or describes a law of nature, natural phenomenon, or abstract idea. Claims 1-20 recite abstract ideas that fall into the groupings of mathematical concepts and mental processes.
Claims 1-2, 4-5, 11-12, 14-17, and 19-20 recite the following limitations, which describe abstract ideas and natural phenomena:
Independent claims 1, 11, and 16 recite:
obtaining an approximation function based on the input operation data;
obtaining a causal graph based on the graph representation, the causal graph comprising a first portion of nodes associated with the approximation function, a second portion of nodes corresponding to nodes of the graph representation, and edges between the second portion of the nodes representing causal mechanisms for components of the architecture of the BoC;
identifying the causal mechanisms for the components of the architecture of the BoC using the approximation function and operation data from the previously performed operation with the BoC deployment, the operation data comprising sensor data indicating characteristics of the components of the architecture of the BoC during the previously performed operation;
obtaining a new process plan for the BoC using the identified causal mechanisms, the new process plan being different from a previous process plan used during the previously performed operation.
Dependent claims 2, 12, and 17 recite:
using the graph representation as a template, the template comprising first nodes corresponding to architectural features of the BoC with edges between the first nodes indicating fluid connectivity between the architectural features;
defining the edges of the template to represent the causal mechanisms;
transforming the edges of the template into the second portion of the nodes; and
adding the first portion of the nodes to the template to obtain the causal graph.
Dependent claims 4, 14, and 19 recite:
wherein the identified causal mechanisms indicate causal relationships that are likely to be true during performance of the new operation of the BoC deployment.
Dependent claims 5, 15, and 20 recite:
wherein a causal relationship of the causal relationships indicates a functional relationship between a fluid pressure in the chamber and a fluid flow rate through the channel.
The independent claim limitation of obtaining an approximation function is an abstract idea within the mathematical concepts and/or mental processes groupings because deriving a function from data is a mathematical calculation that could be performable mentally. See MPEP §§ 2106.04(a)(2)(I)(B) and (III). The independent claim limitation of obtaining a causal graph is pure graph reconstructing and edge redefining for mathematical transformation of one graph into another, which is abstract graph-theoretic manipulation that could be performed mentally or with a pen and paper, constituting an abstract idea within the mathematical concepts and mental processes groupings. See MPEP §§ 2106.04(a)(2)(I)(C) and (III). This abstract idea is narrowed by the dependent claim limitations of claims 2, 12, and 17 because they describe purely mathematical acts of copying a graph as a template, redefining its edges, and adding new nodes, all of which constitute abstract graph-theoretic manipulation that can be performed mentally or with pen and paper.
The independent claim limitation of identifying the causal mechanisms is a mathematical inference step using a function and data to compute/derive causal relationships, which can be performed mentally or by simple calculation, constituting an abstract idea within the mathematical concepts and mental processes groupings. See MPEP §§ 2106.04(a)(2)(I), (II)(B), and (III). This abstract idea is narrowed by the dependent claim limitation of claims 4, 14, and 19 because the it merely specifies that the mechanisms indicate relationships that are likely to be true, which is a mental or mathematical evaluation of probabilistic consistency.
The independent claim limitation of obtaining a new process plan is an abstract idea within the mathematical concepts and/or mental processes groupings because selecting or generating a new plan based on previously derived causal relationships is a mental or mathematical optimization step. See MPEP §§ 2106.04(a)(2)(I), (II)(A), and (III). Dependent claims 5, 15, and 20 explicitly recite an inherent physical law of fluid behavior, which constitutes a law of nature or natural phenomenon. See MPEP § 2106.04(b). Dependent claims 3, 6-10, 13, and 18 do not further limit or describe any additional judicial exceptions, but inherit the judicial exceptions from the claims upon which they depend.
Therefore, claims 1-20 recite abstract ideas, mathematical concepts and mental processes [Step 2A, Prong One: Yes].
Prong Two
Claims 1-10 recite additional elements sufficient to integrate the recited judicial exceptions into a practical application; however, claims 11-20 as a whole do not integrate the recited exceptions into a practical application. A claim that recites a judicial exception [Prong One] is deemed to be directed to a judicial exception [Step 2A] unless the claim as a whole contains additional elements that integrate the exception into a practical application [Prong Two]. 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, beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. See MPEP § 2106.04(d) and MPEP § 2106.05(e). A claim does not integrate a judicial exception into a practical application by reciting insignificant extra-solution activity, generally linking the exception to a particular technological environment or field of use, merely reciting to apply the exception, merely including instructions to implement an abstract idea on a computer, or merely using a computer as a tool to perform an abstract idea. See MPEP § 2106.04(d)(I). Insignificant extra-solution activities are nominal or tangential additions to a claim that are incidental to the primary process or product, including both pre-solution and post-solution activity (e.g. pre-solution data gathering for use in a process). If integrated into a practical application, the claim is eligible; otherwise, it is directed to the judicial exception, necessitating further analysis at Step 2B.
Claims 1, 11, 13, 16, and 18 recite the following limitations, which are additional elements:
Independent claims 1, 11, and 16 recite:
a processor; and a memory coupled to the processor to store instructions, which when executed by the processor, cause the processor to perform operations for managing operation of a biosystem on a chip (BoC) deployment;
obtaining: input operation data for a previously performed operation with the BoC deployment, and a graph representation based on an architecture of a BoC of the BoC deployment;
performing a new operation with the BoC deployment based on the new process plan to generate a desired output material.
Dependent claims 13 and 18 recite:
wherein the features of the architecture comprise: a chamber positioned in a body of the BoC; and a channel positioned with the chamber and adapted to place the chamber in fluid communication with another feature of the architecture.
The independent claim limitation of a processor and a memory coupled to the processor to store instructions recites generic computer components that perform generic computer functions that are well-understood, routine and conventional, amounting to nothing more than mere instructions to apply the abstract ideas, which do not integrate the abstract ideas into a practical application. See MPEP § 2106.05(b) and (f); and Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 225, 110 USPQ2d 1976, 1984 (2014). The independent claim limitation of obtaining input operation data and a graph representation constitute insignificant extra-solution activities that indicate a field of use or technological environment in which the judicial exceptions are to be applied because they are data gathering steps that specify a particular type of data and do not transform the nature of the claim into a patent-eligible application of the judicial exception. See MPEP §§ 2106.05(g)-(h).
The independent claim limitation of performing a new operation recited in claim 1 is sufficient to integrate the judicial exceptions into a practical application because it applies the exceptions to effectuate use of a particular machine. See MPEP § 2106.05(b). The specification notes at para. [0089] that the causal mechanism (natural phenomena) determined via execution of the recited abstract ideas may indicate changes that should be made for subsequent operations. The recitation of performing a new operation in claim 1 uses the judicial exceptions to modify the operation of the BoC deployment, which is use of a particular machine sufficient to integrate the exceptions into a practical application. Dependent claims 2 and 4 narrow abstract ideas recited in claim 1 that are integrated into a practical application, and dependent claim 5 specifies the natural phenomena that indicates future changes. Dependent claims 3 and 6-10 do not further set forth any judicial exceptions. Therefore, claims 1-10 are eligible at Pathway B.
However, the limitation of performing a new operation in claims 11 and 16 is merely an indication of the field of use or technological environment in which to apply the judicial exceptions. See MPEP §§ 2106.05(b)(III) & (h). As discussed in the 112(a) rejection above, claims 11 and 16 are interpreted to mean the new process plan is transmitted to a BoC via the processor, which is not equivalent to actually performing the new operation. The BoC does not impose meaningful limits on claims 11 and 16 because it contributes only nominally or insignificantly to the execution of the claimed method, which is insufficient to integrate the judicial exceptions into a practical application.
The dependent claim limitation of claims 13 and 18 constitutes insignificant extra-solution activity because specifying the structure of the device is incidental to the primary process and merely a nominal or tangential addition to the claim. See MPEP § 2106.05(g). Finally, claims 12, 14-15, 17, and 19-20 do not include any additional elements.
Claims 1-10 are eligible at Pathway B because the limitation of performing a new operation is sufficient to integrate the judicial exceptions into a practical application. Conversely, claims 11-20 as a whole merely recite insignificant extra-solution activities that indicate a field of use and abstract ideas implemented on generic computer components without meaningful limitations that tie it to a specific technological improvement. Therefore, claims 11-20 do not contain additional elements that integrate the recited judicial exceptions into a practical application [Step 2A, Prong Two: No].
Step 2B
Claims 11-20 do not include additional elements, whether considered individually or in combination, that are sufficient to amount to significantly more than the judicial exception itself. Under Step 2B, the claim is analyzed to determine whether there are any additional elements that, individually or in combination, constitute an “inventive concept" sufficient to ensure that the claim, as a whole, amounts to significantly more than the judicial exception itself. See MPEP § 2106.05; and Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 217-18, 110 USPQ2d 1976, 1981 (2014).
Claims 11, 13, 16, and 18 recite the following limitations, which are additional elements:
Independent claims 11 and 16 recite:
a processor; and a memory coupled to the processor to store instructions, which when executed by the processor, cause the processor to perform operations for managing operation of a biosystem on a chip (BoC) deployment;
obtaining: input operation data for a previously performed operation with the BoC deployment, and a graph representation based on an architecture of a BoC of the BoC deployment;
performing a new operation with the BoC deployment based on the new process plan to generate a desired output material.
Dependent claims 13 and 18 recite:
wherein the features of the architecture comprise: a chamber positioned in a body of the BoC; and a channel positioned with the chamber and adapted to place the chamber in fluid communication with another feature of the architecture.
The independent claim limitation of a processor and a memory coupled to the processor to store instructions recites generic computer components performing generic computer functions that are well-understood, routine and conventional, amounting to nothing more than mere instructions to apply the abstract ideas, which does not add significantly more. See MPEP § 2106.05(b) and (f); and Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 225, 110 USPQ2d 1976, 1984 (2014). The independent claim limitation of obtaining input operation data and a graph representation indicates a field of use or technological environment because they are conventional data gathering steps that specify a particular type of data, which do not amount to significantly more than the exception itself. See MPEP § 2106.05(h); Gokulkrishnan Vadakkeveedu et al., 14 IET Comput. Digit. Tech. 122, 125 col.2 paras.1-2 (31 March 2020); and Radhakrishna Sanka et al., 9 Scientific Reports article no. 9166, abstract (24 June 2019).
The independent claim limitation of performing a new operation recited in claims 11 and 16 is merely an indication of the field of use or technological environment in which to apply the judicial exceptions. See MPEP §§ 2106.05(b)(III) & (h). As discussed in the 112(a) rejection above, claims 11 and 16 are interpreted to mean the new process plan is transmitted to a BoC via the processor, which is well-understood, routine, and conventional activity. See MPEP § 2106.05(d); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015); and Akhilesh Bendre et al., 13 Mater. Today Adv. no. 100205, 2 col.2 para.2 (March 2022). Finally, the dependent claim limitation of claims 13 and 18 constitutes insignificant extra-solution activity that is well-understood, routine, and conventional in the field of microfluidics. See uFluidix, § Types of Microfluidic Devices (2 December 2020).
Overall, claims 11-20 amount to no more than conventional insignificant extra-solution activities that indicate a field of use and implementing the judicial exceptions on conventional computers in a routine way. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception itself because the claims recite additional elements that equate to conventional insignificant extra-solution activity and mere instructions to apply the recited abstract ideas in a generic way or in a generic computing environment. Therefore, claims 11-20 are rejected for failing to set forth patent eligible subject matter under 35 U.S.C. 101 because the claimed invention recites abstract ideas [Step 2A, Prong One: Yes] and the additional elements do not integrate the judicial exception into a practical application [Step 2A, Prong Two: No] and do not amount to claiming significantly more than the recited exception [Step 2B: No].
Claim Rejections - 35 USC § 103
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.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Julia Sophie Böke et al., 9 Processes no. 8: 1320 (29 July 2021) (hereinafter Böke), Robert W. Epps et al., 12 Chem. Sci. 6025 (9 March 2021) (hereinafter Epps), and Judea Pearl, 3 Stat. Surv. 96 (13 October 2009) (hereinafter Pearl), as evidenced by C3.ai., Infrastructure: Machine Learning Hardware Requirements (15 May 2021) (hereinafter C3.ai.). The italicized text within parenthesis corresponds to the instant claim limitations.
Regarding independent claims 1, 11, and 16, Böke discloses a system that can be used to manage operation of a microfluidic device. At 21 para.1 (managing operation of a biosystem on a chip (BoC) deployment). Böke discloses that the system obtains a Kirchhoff-graph representation of the microfluidic device with nodes representing architectural features such as junctions/ports/chambers and edges corresponding to channels that connect features. At 4 para.5; 5 paras.3-4 (obtaining: a graph representation based on an architecture of a BoC of the BoC deployment). Böke discloses that the characteristics of architectural features are monitored with flow sensors. At 3 para.3 – 4 para.1. Böke teaches that the system obtains desired flow rates at arbitrary edges and uses standard flow rates to predict the corresponding pressure necessary to achieve the desired flow rate. At 9 para.1 (obtaining a new process plan for the BoC). Böke discloses using the predicted pressure as the input for pressure-driven operation during an experimental campaign. At 9 para.1 (performing a new operation with the BoC deployment based on the new process plan to generate a desired output material).
Böke fails to teach obtaining input operation data, obtaining an approximation function, obtaining a causal graph, identifying the causal mechanisms, and obtaining a new process plan for the BoC using the identified causal mechanisms. However, Epps discloses a reinforcement learning framework to improve the efficiency of optimizing microfluidic device campaigns. Abstract. Epps discloses obtaining experimental data from operations previously performed with the microfluidic device. At 6027 col.2 para.1 (obtaining: input operation data for a previously performed operation with the BoC deployment). Epps teaches that the microfluidic device is equipped with spectral sensors to obtain photoluminescence and absorption spectra data during the experiments. At 6027 col.1 para.3 (the operation data comprising sensor data indicating characteristics of the components of the architecture of the BoC during the previously performed operation). Epps discloses that the experimental data is used to train a surrogate model. At 6027 col.2 paras.3-4. (obtaining an approximation function based on the input operation data). Epps teaches that the trained surrogate model accurately predicts the output parameters of a given experiment. At 6026 col.1 para.3; 6027 col.2 para.4. Epps discloses using an objective function to convert the surrogate model predictions into a single quality metric, which is used to select the next experimental conditions. At 6028 col.1 para.2 (obtaining a new process plan for the BoC using the identified causal mechanisms, the new process plan being different from a previous process plan used during the previously performed operation).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Böke’s graph-based control-parameter prediction method with the data-driven surrogate modeling technique of Epps. The disclosures of Böke and Epps are directed to the same field of endeavor – continuous-flow microfluidic/lab-on-a-chip devices for automated materials synthesis and control. Böke acknowledges the need for experimental validation of its physics-based predictions due to real-world deviations. At 11 paras.2-4. Epps demonstrates that a surrogate model dramatically accelerates optimization and improves predicted accuracy in continuous-flow microfluidics. Abstract; 6026 col.1 para.3. Ultimately, physics-based models are fast but brittle, while data-driven models are robust but lack the structural knowledge of the chip architecture. In view of the limitations of pure physics-based and data-driven models, a person having ordinary skill in the art could have implemented Epps’ known surrogate technique to Böke’s known graph model, and the results would have been a predictable variation that yields the expected benefit of more robust data-informed control predictions while retaining the structural knowledge of the device architecture. Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art is likely to be obvious. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007); and MPEP § 2143, F.
Böke and Epps fail to teach obtaining a causal graph based on the graph representation and identifying the causal mechanisms for the components of the architecture. However, Pearl discloses a framework for formulating and analyzing aspects of causation by combining graphical components and algebraic components from prediction analysis. At 98 para.2; 139 para.3. Pearl teaches that prediction analysis can infer associations among variables, estimate beliefs or probabilities of past and future events, and update those probabilities in light of new evidence or new measurements; however, prediction analysis alone cannot answer intervention questions. At 99 para.2. Causal analysis, on the other hand, can infer beliefs or probabilities under static conditions, as well as the dynamics of beliefs under changing conditions, which is necessary to investigate effect of an intervention. Id. Pearl explains that algebraic equations alone cannot properly express causal relationships because equations are symmetrical and can be manipulated to show an incorrect influence of one variable on another, which necessitates the use of a diagram where arrows connect the perceived causes and effects. At 104 para.2. Pearl teaches that each graphical node corresponds to a function, which represents a causal mechanism that determines the output from the input. At 107 para.2 (identifying the causal mechanisms for the components of the architecture of the BoC). Pearl discloses augmenting a mathematical operator to the graph, which simulates a physical intervention for modeling causal effects. At 107 para.3.
The combination of Böke and Epps results in a method of parameter prediction for continuous-flow microfluidic devices from a graph-based architecture and data-driven surrogate modeling. Pearl’s teaching that causal analysis is necessary to study changing conditions and answer questions of intervention would motivate a person having ordinary skill in the art to combine the teachings of Pearl with the teachings of Böke and Epps because optimizing the microfluidic device operation involves analyzing the system under new conditions/interventions. By combining the teachings, one of ordinary skill in the art would obtain a causal graph by using the graph representation at a template where a set of nodes correspond to architectural features, and augmenting a set of notes associated with the surrogate model. One of ordinary skill in the art would stimulate the graph using the surrogate model and previous operation data to identify the causal mechanisms for the components of the architecture, and redefine the edges of the template to represent those causal mechanisms. One of ordinary skill in the art would reasonably expect this combination to result in an improved system for optimizing microfluidic device operations because Pearl’s framework is designed to turn a predictive model on a structural graph into an interpretable causal model capable of identifying causal mechanisms between architectural components for refining process plans. Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention is likely to be obvious. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007); and MPEP § 2143, D.
Böke, Epps, and Pearl fail to explicitly disclose a processor and a non-transitory machine-readable medium storing instructions that cause the processor to execute the method discussed above. However, Böke and Epps both teach that the disclosed method occurs in a computer environment using machine learning techniques. Böke, at 2 para.1; Epps, at 6026 col.1 para.3. Inherent in these teachings are the components essential to the functionality of a machine learning model, which includes a processor to execute instructions that are stored on a non-transitory machine-readable medium. See C3.ai., Infrastructure: Machine Learning
Hardware Requirements, §§ Processors: CPUs, GPUs, TPUs, and FPGAs and Memory and
Storage (15 May 2021).
Regarding dependent claims 2, 12, and 17, Böke discloses that the system obtains a Kirchhoff-graph representation of the microfluidic device with nodes representing architectural features such as junctions/ports/chambers and edges corresponding to channels that connect features. At 4 para.5; 5 paras.3-4 (using the graph representation as a template, the template comprising first nodes corresponding to architectural features of the BoC with edges between the first nodes indicating fluid connectivity between the architectural features). In combining the teachings of Böke, Epps, and Pearl, one of ordinary skill in the art would augment the graph representation with a set of nodes associated with the surrogate model (adding the first portion of the nodes to the template to obtain the causal graph), and stimulate the graph using the surrogate model and previous operation data to identify the causal mechanisms for the components of the architecture, and redefine the edges of the template to represent those causal mechanisms (defining edges of the template to represent the causal mechanisms).
Regarding dependent claims 3, 13, and 18, Böke discloses that the microfluidic device includes five fluid interconnection ports (a chamber positioned in a body of the BoC) and channels to allow for fluid flow between the ports (a channel positioned with the chamber and adapted to place the chamber in fluid communication with another feature of the architecture). At 2 para.6.
Regarding dependent claims 4, 14, and 19, Pearl teaches that the identified causal mechanisms are general relationships that hold under interventions and therefore are likely to be true in new/future operations. At 99 para.2; 107 para.3 – 108 para.2 (wherein the identified causal mechanisms indicate causal relationships that are likely to be true during performance of the new operation of the BoC deployment).
Regarding dependent claims 5, 15, and 20, Böke’s graph explicitly models the functional relationship between the pressure at the nodes and the flow rate through the channels. At 6 para.1. Pearl teaches that simulation of the functional mechanisms on the graph identifies a general causal relationship between components. At 107 para.2 – 108 para.2. In combining the teachings, one of ordinary skill in the art would use Pearl’s framework to identify causal mechanisms that indicate a general causal relationship between a pressure in the graphical nodes and a flow rate through the graphical edges (wherein a causal relationship of the causal relationships indicates a functional relationship between a fluid pressure in the chamber and a fluid flow rate through the channel).
Regarding dependent claim 6, Epps discloses that the experimental data obtained from previous microfluidic campaigns includes the input parameters used to orchestrate the prior campaign, with the inputs defining the actions performed by five active components. At 6027 col.1 para.3; col.2 para.3 (wherein the input operation data comprises control data used to orchestrate performance of the previously performed operation with the BoC deployment, the control data defining actions performed by active components of the BoC deployment during the previously performed operation).
Regarding dependent claim 7, Böke discloses a Kirchhoff-graph representation of the microfluidic device with nodes representing architectural features such as junctions/ports/chambers and edges corresponding to channels that connect features. At 4 para.5; 5 paras.3-4 (wherein the graph representation comprises architectural element nodes with edges that indicate fluid connectivity between elements of the architecture of the BoC corresponding to the architectural element nodes). Böke discloses obtaining the pressure and flow rate at all defined nodes and edges. At 5 para.2. Epps teaches compiling a database of experimental data for optimization of future campaigns. At 6027 col.2 para.1. In combining these teachings, one of ordinary skill in the art would know that experimental data associated with each graphical node should be stored in a database for optimization of future operations (each of the architectural elements nodes being associated with database entries of a database).
Regarding dependent claim 8, Böke discloses obtaining the pressure for each node of a graph representation of the microfluidic device, where nodes represent architectural features. At 4 para.5; 6 para.1. Epps teaches that experimental data, which includes measured output parameters, from prior operations is compiled into a dataset. At 6027 col.2 para.1; Supporting Information § S.1; Figure S1. Pearl teaches that the graph nodes are correlated with a formula that determines the outcome from the input parameters at that node. At 107 para.2. In combining the references, one of ordinary skill in the art would understand that each graphical node acts as an index for the sensor data related to the architectural component associated with that node. (wherein the database entries associated with each of the architectural element nodes comprise related sensor measurements, the architectural elements nodes facilitating identification of all related sensor measurements during the previously performed operation).
Regarding dependent claim 9, Epps teaches that data is unstructured in the case of solution-processed materials. At 6030 col.2 para.1 (wherein the database is an unstructured database).
Regarding dependent claim 10, Epps discloses that the microfluidic device takes input materials and through performance of the campaign generates the desired output material. At 6027 col.1 para.3 (wherein the BoC deployment takes, as input, an input material and through performance of the new operation generates the desired output material).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Radhakrishna Sanka et al., 3DμF - Interactive Design Environment for Continuous Flow Microfluidic Devices, 9 Scientific Reports article no. 9166 (24 June 2019). Discloses a tool for designing continuous flow microfluidic devices that generates a component-connection graph, and includes extensions that calculate the pressure and flow rate at various points of interest.
Radhakrishna Sanka and Douglas Densmore, Integration of Performance Metrics into Microfluidic Design Automation, 11th International Workshop on Bio-Design Automation (IWBDA-19) (2019). Discloses a framework for design and optimization of microfluidic devices that integrates performance metrics.
Ali Lashkaripour et al., Machine learning enables design automation of microfluidic flow-focusing droplet generation, 12 Nat Commun. (4 January 2021). Introduces a tool that predicts the performance and enables design automation of flow-focusing droplet generators that reduces the need for microfluidic expertise and design iterations.
Martin Trapecar et al., Gut-Liver physiomimetics reveal paradoxical modulation of IBD-related inflammation by short-chain fatty acids, 10(3) Cell Syst. 223 (25 March 2020). Investigates the relationship between ulcerative colitis, liver function, and short-chain fatty acids using microfluidic device models.
Nicoló Milani et al., Application of a gut–liver-on-a-chip device and mechanistic modelling to the quantitative in vitro pharmacokinetic study of mycophenolate mofetil, 22 Lab Chip 2853 (14 July 2022). Discloses a mechanistic model that enables robust experimental design and estimation of in vitro pharmacokinetic parameters.
Feroz Ahmed et al., Design and validation of microfluidic parameters of a microfluidic chip using fluid dynamics, 11 AIP Advances no. 075224 (1 July 2021). Discloses a simulation approach for microfluidic devices to validate experimental results, quantify deviations between experimental and simulation results, and analyze the practical causes of such deviations.
X. San Liang, Normalized Multivariate Time Series Causality Analysis and Causal Graph Reconstruction, 23(6) Entropy 679 (28 May 2021). Discloses a framework that can be applied to infer the causal graphs of a continuous flow dynamical system.
Clay Thompson, Causal Graph Analysis with the CAUSALGRAPH Procedure, SAS Institute Inc. SAS2998-2019 (2019). Discloses an overview of using directed acyclic graphs to represent and analyze a causal model.
Nassim Rousset et al., Circuit-Based Design of Microfluidic Drop Networks, 13(7) Micromachines (Basel) no.1124 (16 July 2022). Discloses a circuit-based microfluidics model and a method to determine flow rates and pressures within the system.
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/E.A.D./Examiner, Art Unit 1686
/OLIVIA M. WISE/Supervisory Patent Examiner, Art Unit 1685
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