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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 9/30/2022 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Priority
Acknowledgment is made of applicant’s claim for priority. Application claims benefit of U.S. Provisional Application No. 63/167,673 filed on 3/30/2021. As such, the effective filing date of claims 1-27 is 3/30/2021.
Claim Status
Claims 1-27 are pending.
Claims 1-27 are rejected.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-27 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract ideas without significantly more. The claims recite a method, system, and CRM for simulating immune response. The judicial exception is not integrated into a practical application because while claims 1-27 attempt to integrated the exception into a practical application, said application is either generically recited computer elements that do not add a meaningful limitation to the abstract idea or it is insignificant extra solution activity and merely implementing the abstract idea on a computer. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the computer elements only store and retrieve information in memory as well as perform basic calculations that are known to be well-understood, routine and conventional computer functions as recognized by the decisions listed in MPEP § 2106.05(d).
Framework with which to Analyze Subject Matter Eligibility:
Step 1: Are the claims directed to a category of stator subject matter (a process, machine,
manufacture, or composition of matter)? [see MPEP § 2106.03]
Claims are directed to statutory subject matter, specifically a method (Claims 1-13),
a system (Claims 14-26), and a CRM (Claim 27).
Step 2A Prong One: Do the claims recite a judicially recognized exception, i.e., an abstract idea, a law of nature, or a natural phenomenon? [see MPEP § 2106.04(a)]
The claims herein recite abstract ideas, specifically mental processes and mathematical concepts.
With respect to the Step 2A Prong One evaluation, the instant claims are found herein to recite abstract ideas that fall into the grouping of mental processes and mathematical concepts.
Claim 1: Determining a number of naïve T-cells within a system boundary, determining a number of antigen-presenting cells within the system boundary, determining a number of bound naïve T-cells within the system boundary, determining a number of bound primed T-cells within the system boundary, and determining a number of activated T-cells within the system boundary are all processes of counting and/or calculating that can be done via pen and paper or within the human mind and are therefore abstract ideas, specifically mental processes.
Claim 2: Determining a number of naïve T-cells entering a system boundary, determining a number of antigen-presenting cells entering a system boundary, determining the number of naïve T-cells within the system boundary, and determining the number of antigen-presenting cells within the system boundary are all processes of counting and/or calculating that can be done via pen and paper or within the human mind and are therefore abstract ideas, specifically mental processes.
Claim 3: Determining a number of bound primed T-cells leaving the system boundary, and determining the number of bound primed T-cells within the system boundary are processes of counting and/or calculating that can be done via pen and paper or within the human mind and are therefore abstract ideas, specifically mental processes.
Claim 4: Determining a number of descendent activated T-cells within the system boundary is a process of counting and/or calculating that can be done via pen and paper or within the human mind and is therefore an abstract idea, specifically a mental process.
Claim 5: Determining a number of second-generation matured T-cells within the system boundary, and determining a number of third-generation matured T-cells within the system boundary are processes of counting and/or calculating that can be done via pen and paper or within the human mind and are therefore abstract ideas, specifically mental processes. The descendent T-cells comprising second generation T-cells and third-generation T-cells that have divided once and twice respectively is merely further limiting the type of information being analyzed in the mental process without any additional element steps associated and is therefore an abstract idea, specifically a mental process.
Claim 6: Determining a number of activated T-cells leaving the system boundary, and determining the number of activated T-cells leaving the system boundary are processes of counting and/or calculating that can be done via pen and paper or within the human mind and are therefore abstract ideas, specifically mental processes.
Claim 7: The number of activated T-cells leaving the system boundary being determined based on a number of activated T-cells that have divided at least twice within the system boundary is merely defining what certain kinds of data represent without any kind of additional element associated and is therefore an abstract idea, specifically a mental process.
Claim 8: Determining a number of activated T-cells outside the system boundary is a process of counting and/or calculating that can be done via pen and paper or within the human mind and is therefore an abstract idea, specifically a mental process.
Claim 9: Determining a probability of a naïve T-cell binding to an antigen-presenting cell, determining a probability of a bound naïve T-cell maturing to a bound primed T-cell, determining a probability of a bound primed T-cell separating from an antigen-presenting cell and dividing, generating at least one random number, determining the number of bound naïve T-cells within the system boundary, determining the number of bound primed T-cells within the system boundary, and determining the number of activated T-cells within the system boundary, are all processes of generating, counting and/or calculating that can be done via pen and paper or within the human mind and are therefore abstract ideas, specifically mental processes.
Claim 10: The probability of a naive T-cell binding to an antigen-presenting cell being determined based on the number of naïve T-cells within the system boundary and the number of antigen-presenting cells within the system boundary is a verbal articulation of a mathematical processes which is an abstract idea, specifically a mathematical concept.
Claim 11: Generating a random number of bound naïve T-cells, generating a random number of bound primed T-cells for each age group of bound naïve T-cells within the system boundary, generating a random number of activated T-cells for each age group of bound primed T-cells within the system boundary, determining the number of bound naïve T-cells within the system boundary, determining the number of bound primed T-cells within the system boundary, and determining the number of activated T-cells within the system boundary are all processes of generating, counting and/or calculating that can be done via pen and paper or within the human mind and are therefore abstract ideas, specifically mental processes.
Claim 12: The random number of bound naïve T-cells, the random number of bound primed T-cells and the random number of activated T-cells being binomial variables is directed to the data itself which is an abstract idea, specifically a mental process.
Claim 13: Determining a subsequent number of naïve T-cells within the system boundary, determining a subsequent number of antigen-presenting cells within the system boundary, determining a subsequent number of bound naïve T-cells within the system boundary, determining a subsequent number of bound primed T-cells within the system boundary, and determining a subsequent number of activated T-cells within the system boundary are all processes of counting and/or calculating that can be done via pen and paper or within the human mind and are therefore abstract ideas, specifically mental processes.
Claim 14: Determining a number of naïve T-cells within a system boundary, determining a number of antigen-presenting cells within a system boundary, determining a number of bound naïve T-cells within the system boundary, determining a number of bound primed T-cells within the system boundary, and determining a number of activated T-cells within the system boundary are all processes of counting and/or calculating that can be done via pen and paper or within the human mind and are therefore abstract ideas, specifically mental processes.
Claim 15: Determining a number of naïve T-cells entering the system boundary, determining a number of antigen-presenting cells entering the system boundary, determining the number of naïve T-cells within the system boundary, and determining the number of antigen-presenting cells within the system boundary are all processes of counting and/or calculating that can be done via pen and paper or within the human mind and are therefore abstract ideas, specifically mental processes.
Claim 16: Determining a number of bound primed T-cells leaving the system boundary, and determining the number of bound primed T-cells within the system boundary are both processes of counting and/or calculating that can be done via pen and paper or within the human mind and are therefore abstract ideas, specifically mental processes.
Claim 17: Determining a number of descendent activated T-cells within the system boundary is a process of counting and/or calculating that can be done via pen and paper or within the human mind and is therefore an abstract idea, specifically a mental process.
Claim 18: Determining a number of second-generation matured T-cells within the system boundary, and determining a number of third-generation matured T-cells within the system boundary are both processes of counting and/or calculating that can be done via pen and paper or within the human mind and are therefore abstract ideas, specifically mental processes. The descendent T-cells comprising second generation T-cells and third-generation T-cells that have divided once and twice respectively is merely further limiting the type of information being analyzed in the mental process without any additional element steps associated and is therefore an abstract idea, specifically a mental process.
Claim 19: Determining a number of activated T-cells leaving the system boundary, and determining the number of activated T-cells outside the system boundary are both processes of counting and/or calculating that can be done via pen and paper or within the human mind and are therefore abstract ideas, specifically mental processes.
Claim 20: The number of activated T-cells leaving the system boundary being determined based on a number of activated T-cells that have divided at least twice within the system boundary is merely defining what certain kinds of data represent without any kind of additional element associated and is therefore an abstract idea, specifically a mental process.
Claim 21: Determining a number of activated T-cells outside the system boundary is a process of counting and/or calculating that can be done via pen and paper or within the human mind and is therefore an abstract idea, specifically a mental process.
Claim 22: Determining a probability of a naïve T-cell binding to an antigen-presenting cell, determining a probability of a bound naïve T-cell maturing to a bound primed T-cell, determining a probability of a bound primed T-cell separating from an antigen-presenting cell and dividing, generating at least one random number, determining the number of bound naive T-cells within the system boundary, determining the number of bound primed T-cells within the system boundary, and determining the number of activated T-cells within the system boundary are all processes of counting and/or calculating that can be done via pen and paper or within the human mind and are therefore abstract ideas, specifically mental processes.
Claim 23: The probability of a naïve T-cell binding to an antigen-presenting cell being determined by the number of naïve T-cels within the system boundary and the number of antigen-presenting cells within the system boundary is a verbal articulation of a mathematical processes which is an abstract idea, specifically a mathematical concept.
Claim 24: Generating a random number of bound naïve T-cells, generating a random number of bound primed T-cells for each age group of bound naïve T-cells within the system boundary, generating a random number of activated T-cells for each age group of bound primed T-cells within the system boundary, determining the number of bound naïve T-cells within the system boundary, determining the number of bound primed T-cells within the system boundary, and determining the number of activated T-cells within the system boundary are all processes of generating, counting and/or calculating that can be done via pen and paper or within the human mind and are therefore abstract ideas, specifically mental processes.
Claim 25: The random number of bound naïve T-cells, the random number of bound primed T-cells and the random number of activated T-cells being binomial variables is directed to the data itself which is an abstract idea, specifically a mental process.
Claim 26: Determining a subsequent number of naïve T-cells within the system boundary, determining a subsequent number of antigen-presenting cells within the system boundary, determining a subsequent number of bound naïve T-cells within the system boundary, determining a subsequent number of bound primed T-cells within the system boundary, and determining a subsequent number of activated T-cells within the system boundary are all processes of counting and/or calculating that can be done via pen and paper or within the human mind and are therefore abstract ideas, specifically mental processes.
Step 2A Prong Two: If the claims recite a judicial exception under prong one, then is the judicial exception integrated into a practical application? [see MPEP § 2106.04(d) and MPEP § 2106.05(a)-(c) & (e)-(h)]
Because the claims do recite judicial exceptions, direction under Step 2A Prong Two provides that the claims must be examined further to determine whether they integrate the abstract ideas into a practical application.
The following claims recite the following additional elements in the form of non-abstract elements:
Claim 1: A computer and a processor are all generic and nonspecific elements of a computer that do not improve the functioning of any computer or technology described herein [See MPEP § 2106.04(d)(1) and MPEP § 2106.05(d)].
Claim 14: A system, processor, and storage component communicatively coupled to the processor are all generic and nonspecific elements of a computer that do not improve the functioning of any computer or technology described herein [See MPEP § 2106.04(d)(1) and MPEP § 2106.05(d)].
Claim 27: A non-transitory computer readable medium, instructions and a processor are all generic and nonspecific elements of a computer that do not improve the functioning of any computer or technology described herein [See MPEP § 2106.04(d)(1) and MPEP § 2106.05(d)].
Step 2B: If the claims do not integrate the judicial exception, do the claims provide an inventive concept? [see MPEP § 2106.05]
Because the additional claim elements do not integrate the abstract idea into a practical application, the claims are further examined under Step 2B, which evaluates whether the additional elements, individually and in combination, amount to significantly more than the judicial exception itself by providing an inventive concept.
The claims do not recite additional elements that are sufficient to amount to significantly more than the judicial exception because the claims recite additional elements that are generic, conventional or nonspecific. These additional elements include:
The additional elements of a non-transitory computer readable medium, a computer, a system, instructions, a processor, and a storage component communicatively coupled to the processor are generic and nonspecific elements of a computer that are well-understood, routine and conventional within the art and therefore do not improve the functioning of any computer or technology described therein (Receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information), Performing repetitive calculations, Flook, 437 U.S. at 594, 198 USPQ2d at 199 (recomputing or readjusting alarm limit values), and Storing and retrieving information in memory, Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015)) [See § MPEP 2106.05(d)(II)]. Therefore, taken both individually and as a whole, the additional elements do not amount to significantly more than the judicial exception by providing an inventive concept.
The additional element of the descendent T-cells comprising second generation T-cells and third-generation T-cells that have divided once and twice respectively (Conventional: Alberts et al. 2002), is an insignificant extra solution activity, specifically merely selecting a particular data source and type, which is merely selecting a particular data source [see MPEP § 2106.5(g)]. Therefore, taken both individually and as whole, the additional elements do not amount to significantly more than the judicial exception by providing an inventive concept.
Therefore, claims 1-6, 8-19, and 21-27, when the limitations are considered individually and as a whole, are rejected under 35 USC § 101 as being directed to non-statutory subject matter.
Subject Matter Free from Prior Art
Examiner submits both Delitala et al. (Computers & Mathematics with Applications (2013) 1010-1023), Bouchnita et al. (BMC immunology (2017) 11-22), Fachada et al. (EPIA 2007-13th Portuguese Conference on Artificial Intelligence (2008) 1-17), and Castiglione et al. (Proceedings of the sixteenth international symposium on mathematical theory of networks and systems (2004) 1-7) as prior art for the instant application with a review of what each is able to read on and what they are incapable of reading on.
Claim 1 is directed to a computer implemented method for simulation immune response via the determination of concentrations of various immune cells at various stages of development.
Claim 14 is directed to a system for simulation immune response via the determination of concentrations of various immune cells at various stages of development.
Delitala et al. teaches in the abstract “we propose a model describing the evolution of a sample composed of immune cells and cells expressing self and non-self-antigens. The model is stated in terms of integro-differential equations for structured populations and ordinary differential equations for unstructured populations”, and on page 1011, paragraph 9 “When an APC detects a foreign antigen, this is presented to naïve T -cells. Thus, those naïve T -cells that recognize this antigen as their cognate one become active. Activated T -cells start to proliferate (i.e. they undergo clonal expansion) and differentiate into effector T -cells”, and on page 1013under section 2.2 The Model “The multicellular system at hand is divided into six populations [19,20] as follows: population i = 1: host cells (i.e. cells that express self-antigens only); population i = 2: foreign cells (i.e. cells that express non-self-antigens); population i = 3: APCs that are not exposing any antigen on their surface; population i = 4: APCs that are exposing a certain antigen; population i = 5: naïve TCs; population i = 6: activated TCs”, reading on determining the number of naïve T-cells, antigen-presenting cells, and activated T-cells.
Delitala et al. fails to teach the determining of the number of bound naïve T-cells, or the number of bound primed T-cells.
Bouchnita et al. teaches on page 12, column 2, paragraph 2 “To formulate the mathematical model, we consider a part of the lymph node, i.e., the T cell zone, which contains various cell types, mainly the antigen presenting cells (APCs) and subsets of T lymphocytes”, which reads on the use of a system boundary.
Fachada et al. teaches on page 2, paragraph 3 “Agent-based and CA approaches are well suited for modelling complex systems in general and IS in particular, providing a way to represent the true diversity of IS entities and substances”, and on pages 4-12, provides a review of current methods of agent-based models of the immune system. More specifically Fachada et al. teaches on page 4, paragraph 4 “AbAIS (Agent-based Artificial IS) framework uses a hybrid approach that supports the evolving of an heterogeneous population of agents over a CA environment; each cell on the CA may contain several agents and substances, and serves as an indirect platform for agent communication, though agents can also communicate directly”, on page 5, paragraph 2 “CAFISS presents a different approach on agent-based modelling of the IS. Like most of agent-based models, CAFISS divides the simulation using a rectangular grid, where each division represents a spatial location; but what differentiates CAFISS is the multithreaded asynchronous updating of the simulation [14], where each IS cell instance runs in its own thread, communicating with other cells using events”, on page 4, paragraph 5 “ImmSim is one of the most referenced and peer reviewed IS simulators available, and many of the underlying ideas have been used in other models and frameworks… ImmSim is based on a CA with probabilistic rules, representing an average piece of the IS, like a section of a lymph node [8]. At each time step, cellular and molecular entities in the same CA site can interact with each other and diffuse through the lattice. Entities consider all possible interactions, and choose one stochastically, with probability given by the respective interaction rule. Entities take on a number of states based on their repertoire, which also influence the chosen interaction and the respective action”, on page 7, paragraph 2 “C-ImmSim and the correspondent parallel variant, ParImm, are versions of Imm-Sim developed by F. Castiglione and M. Bernaschi in the C programming language, with focus on improved efficiency and simulation size and complexity… Currently, C-ImmSim is the most advanced IS simulator based on the original Celada-Seiden automaton, with consistent publication throughput. Regarding the model itself, the most recent upgrades include, among other features, the use of three-dimensional shapes, inclusion of the chemotaxis phenomena and consideration of different cell speeds”, and on page 8, paragraph 3 “Simmune, developed by Meier-Schellersheim and Mack, is a tool to investigate how context adaptive behaviour of the IS might emerge from local cell-cell and cell-molecule interactions. It is based on molecule interactions on a cell’s surface. Cells don’t have states like in the Celada-Seiden model, instead they have behaviours that depend on rules based on cellular response to external stimuli, usually external molecule interactions. Cells can have intracellular compartments with connections between them, and perform actions like secretion of molecules, expression of receptors, etc., that depend on the number of stimulated superficial receptors or the presence of intracellular molecules”, which would read on determining a number of naive T-cells within a system boundary; determining a number of antigen-presenting cells within the system boundary; determining a number of bound naive T-cells within the system boundary based on the number of naive T-cells within the system boundary and the number of antigen-presenting cells within the system boundary, each bound naive T-cell corresponding to a naive T-cell that is bound to an antigen-presenting cell.
Castiglione et al. teaches on page 1, paragraph 4 “C-ImmSim consider a variety of cellular and molecular entities. In particular, the following cells: lymphocyte B (B), lymphocyte T helper (Th) with possibility to distinguish among Th1, Th2 and Th0, lymphocyte T killer (cytotoxic) (Tk), Macrophage (MA), Epithelial cell (as generic target cell) (EP), Plasma Lymphocyte B (PLB); and the molecules: antigen (bacteria or generic virus) (Ag), antibody (Ab) with possibility to distinguish among IgM, IgG and IgE, and immune complexes or Ab-Ag binding (IC). On top of that, some intracellular signals are explicitly represented like for example, interferon (IFN), interleukin-4 (IL-4), interleukin-2 (IL-2), interleukin-12 (IL-12), histamine (HIS), and a generic danger signal (D), while other cytokines are just “implicitly” taken into account in the interaction rules”, and on page 2, paragraph 8 “In this model two entities interact with a probability which is a function of the Hamming distance between the binary strings representing the entities’ binding site. This probability is called the affinity potential”.
Specifically, while the references are not silent to number of bound T-cells, the concept of of primed T-cells is wholly lacking. Within the art primed T-cells is term used to refer to T-cells which have been activated, being synonymous with “activated T-cells”. However, within the instant application the term is used for those T-cells which have been bound to antigen presenting cells that are expressing an antigen which is paired with the T-cell cognate, but also have not released from the antigen presenting cell. While methods such as C-ImmSim from Castiglione et al. account for bound T-cells, no differentiation is given to those that are matured and bound to a corresponding cognate vs those who are transitively bound to the antigen presenting cells. More specifically Castiglione et al. identifies such binding of T-cells and antigen presenting cells as merely a probability which is a function of the Hamming distance between the binary strings representing the entities’ binding site. Therefore, both claims 1 and 14 are potentially free from the prior art and as such, so too are their dependent claims.
Conclusion
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/K.N.A./Examiner, Art Unit 1687
/OLIVIA M. WISE/Supervisory Patent Examiner, Art Unit 1685