DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Responsive to the communication dated 09/11/2025
Claims 1-13, 15-21 are presented for examination.
Information Disclosure Statement
The IDS dated 09/11/2025 has been reviewed. See attached.
Finality
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Response to Arguments - 101
Applicant's arguments filed 09/11/2025 have been fully considered but they are not persuasive.
Applicant argues that the claims do not recite an abstract idea.
Examiner responds by explaining that several abstract ideas are recited by the claims. Particularly:
Claim 1:
generating, via at least one processor, a plurality of base datasets using a random number generator, wherein the base datasets correspond to one or more clinical trial designs wherein the plurality of base datasets includes a survival time dataset, a treatment ID dataset, and a dropout time dataset;
A person could generate a set of random numbers in their by coming up with a series of arbitrarily chosen values. For example, a person could flip a coin a hundred times and tabulate the results using a pen and paper.
Doing so “via at least one processor” and “using a random number generator” amounts to mere instructions to apply this exception using a computer.
determining, via the at least one processor, scenario specifications corresponding to the one or more clinical trial designs;
Determining specifications for a clinical trials is practical to perform in the human mind, and consists of deciding arbitrary trial conditions, such as the length of the trial, how results should be analyzed, etc.
Doing so “via the at least one processor” amounts to mere instructions to apply this exception using a computer.
identifying, via the at least one processor, a plurality of distinct transformation functions each corresponding to a distinct one of the plurality of base datasets based on the scenario specifications;
A human mind could reasonably come up with a distinct function for a number of datasets to transform the data therein. For example, a person could write down several numeric datasets with a pencil and paper, then decide that the transformation function for the first set is to add 1 to every number, a second function to add 2 to every number in a second set, and so on.
Doing so “via the at least one processor” amounts to mere instructions to apply this exception using a computer.
generating, via the at least one processor, scenario parameters based on the transformed datasets and corresponding to the one or more clinical trial designs;
Generating arbitrary parameters based on observed data is a mental process equivalent to observing that data and judging what kind of parameters best suit that data. For example if the datasets suggest high dropout rates, parameters that work better for small sample size trials may be chosen.
Doing so “via the at least one processor” amounts to mere instructions to apply this exception using a computer.
simulating, via the at least one processor, the one or more clinical trial designs using the scenario parameters to generate one or more clinical trial design simulation results;
This is a mental process; a person could reasonably imagine a theoretical trial design in their mind, writing aspects of it such as desired target sample size on a piece of paper. A person could then reasonably imagine the outcome of said imagined trial, and write down statistics. For example, a person could imagine a trial to determine how many people with peanut allergies have allergic reactions, deciding to the use the parameters of a sample size of 100 and the use of a particular brand of peanut. They could imagine gathering the patients, testing each for the allergy, and reasonably estimate that near 100% of the patients would have an adverse reaction, noting the 100% on the paper.
Doing so “via the at least one processor” amounts to mere instructions to apply this exception using a computer.
Should it be found that this element is not a mental process, it is also both mere instructions to apply an exception and Well-Understood, Routine, Conventional Activity.
transforming, via the at least one processor, the each of the plurality of base datasets using the corresponding one of the plurality of distinct transformation functions, wherein the treatment ID dataset influences at least one of the transformed survival time dataset or the transformed dropout time dataset;
Transforming data through the use of a mathematic “transformation function” is an explicit recitation of a math operation in the claim, and is thus a mathematic concept. In other words, the claim element does not merely “involve” math; it explicitly discloses it in the claim itself.
Doing so “via at least one processor” amounts to mere instructions to apply this exception using a computer.
determining, via the at least one processor, a distribution of simulations for the clinical trial designs, wherein the distribution of simulations is based on a time of the simulations;
Determining the statistical distribution of the simulation output is merely the act of determining the distribution of a set of numeric data. This can be done both mentally and purely mathematically; to perform this process mentally, data can be drawn on a plot and the shape of the resulting plot can give insight into the distribution of the data, for example data that is normally distributed will approximate a bell curve.
To determine such distribution purely numerically other tests can be used, for example the Shapiro–Wilk test for checking for normal distribution.
Claim 9:
determining, via at least one processor, information fraction sets for a set of a plurality of designs, wherein at least one of the information fraction sets corresponds to a number of patients observed divided by a target patient sample size at each of a plurality of look positions
A person could reasonably mentally design a set of theoretical clinical trials and write down target sample sizes for each, as with a pen and paper. That person could then observe the actual number of patients that show up to the trial, marking the number. Dividing the number of observed patients by the target sample size is a case of simple mental math. This kind of simple division, done with or without a paper and pencil, is something taught to school children at a young age.
Doing so “via the at least one processor” amounts to mere instructions to apply this exception using a computer.
This element is also a mathematic process, as analyzed below.
wherein determining information fraction sets comprises: determining, via the at least one processor, the look positions, wherein the look positions are for each of the plurality of designs; determining, via the at least one processor, available information at each of the look positions; determining, via the at least one processor, total expected information for a trial design;
Determining the “look position” is a mental process equivalent to observing the time index of a set of data, for example if a graph plots distance on one axis and time on the other, determining the look position for a certain data point is equivalent to observing its location on the time axis.
Determining how much information is available is a mental process equivalent to observing a set of data and judging how much data there is; for example a person could observe the data set {1, 2, 3} and judge that there are three data elements available.
Determining how much data is expected is a mental process equivalent to making an arbitrary decision about the volume of data a researcher would like to have; for example, a researcher may decide they’d like to have at least 1000 data points.
Doing so “via the at least one processor” amounts to mere instructions to apply this exception using a computer.
Should it be found that these elements are not mental processes, they are also examples of mere data gathering.
determining, via the at least one processor, a ratio of the available information to the total expected information;
Dividing the number of available data points by the expected data point count is a case of simple mental math. This kind of simple division, done with or without a paper and pencil, is something taught to school children at a young age.
Doing so “via the at least one processor” amounts to mere instructions to apply this exception using a computer.
This element is also a mathematic process, as analyzed below.
simulating, via the at least one processor, a design to determine test statistics for the design;
This is a mental process; a person could reasonably imagine a theoretical trial design in their mind, writing aspects of it such as desired target sample size on a piece of paper. A person could then reasonably imagine the outcome of said imagined trial, and write down statistics. For example, a person could imagine a trial to determine how many people with peanut allergies have allergic reactions, deciding to the use the parameters of a sample size of 100 and the use of a particular brand of peanut. They could imagine gathering the patients, testing each for the allergy, and reasonably estimate that near 100% of the patients would have an adverse reaction, noting the 100% on the paper.
Doing so “via the at least one processor” amounts to mere instructions to apply this exception using a computer.
Should it be found that this element is not a mental process, it is also both mere instructions to apply an exception and Well-Understood, Routine, Conventional Activity.
generating, via the at least one processor, a decision to stop or proceed with sample size re-estimation for the simulated design based on the test statistics and the precomputed boundary condition;
Deciding whether or not to change the sample size is a mental process that involves observing the results of the simulation, and judging if the sample population was the right size to get meaningful results. For instance, if a trial to determine what percentage of all people are over the age of 80 has a sample size of two and returns a result that indicates that 100% of the global population is over the age of 80, a researcher would reasonably conclude that the sample size was not large enough to be representative of the general population. Additionally, a person could look at statistics indicating a performance rating of 2 out of 10 and associated boundary conditions and decide to change the sample size to get better results.
Doing so “via the at least one processor” amounts to mere instructions to apply this exception using a computer.
determining, via at least one processor, information fraction sets for a set of a plurality of designs, wherein at least one of the information fraction sets corresponds to a number of patients observed divided by a target patient sample size at each of a plurality of look positions
Determining fractions by calculating “a number of patients observed divided by a target patient sample size” is an explicit mathematic calculation and thus a mathematic process.
Doing so “via the at least one processor” amounts to mere instructions to apply this exception using a computer.
determining, via the at least one processor, a ratio of the available information to the total expected information;
Determining a ratio between two numbers is an explicit mathematic calculation and thus a mathematic process.
Doing so “via the at least one processor” amounts to mere instructions to apply this exception using a computer.
Wherein the method further comprises precomputing, via at least one processor and for each information fraction set, a boundary condition for a test statistic;
Precomputing (i.e. calculating) a numeric boundary condition is a mathematic calculation and thus a mathematic concept.
Doing so “via the at least one processor” amounts to mere instructions to apply this exception using a computer.
determining, via the at least one processor, a distribution of simulations for the clinical trial designs, wherein the distribution of simulations is based on a time of the simulations;
Determining the statistical distribution of the simulation output is merely the act of determining the distribution of a set of numeric data. This can be done both mentally and purely mathematically; to perform this process mentally, data can be drawn on a plot and the shape of the resulting plot can give insight into the distribution of the data, for example data that is normally distributed will approximate a bell curve.
To determine such distribution purely numerically other tests can be used, for example the Shapiro–Wilk test for checking for normal distribution.
Claim 21:
generating, via at least one processor, a set of scenario parameters from a plurality of base datasets, wherein the plurality of base datasets includes a survival time dataset, a treatment ID dataset, and a dropout time dataset,
Generating arbitrary parameters based on observed data is a mental process equivalent to observing that data and judging what kind of parameters best suit that data. For example if the base data suggests high dropout rates, parameters that work better for small sample size trials may be chosen.
Doing so “via at least one processor” amounts to mere instructions to apply this exception using a computer.
wherein the generating includes identifying, via the at least one processor, a plurality of distinct transformation functions each corresponding to a distinct one of the plurality of base datasets based on the scenario parameters,
A human mind could reasonably come up with a distinct function for a number of datasets to transform the data therein. For example, a person could write down several numeric datasets with a pencil and paper, then decide that the transformation function for the first set is to add 1 to every number, a second function to add 2 to every number in a second set, and so on.
Doing so “via the at least one processor” amounts to mere instructions to apply this exception using a computer.
identifying, via the at least one processor, look positions for a plurality of designs;
The specification describes look positions as “In embodiments, analysis times may be referred to as looks or look positions.” Determining the relevant time of a piece of data is a mental process that involves observing that data and finding the relevant time index, as with observing data on a time-indexed graph. This limitation is therefore mental process.
Doing so “via the at least one processor” amounts to mere instructions to apply this exception using a computer.
determining, via the at least one processor, information fraction sets for the look positions for the plurality of designs, wherein determining information fraction sets comprises: … wherein at least one of the information fraction sets corresponds to a number of patients observed divided by a target patient sample size at each of a plurality of look positions.
This element is mental math process. The specification describes the information fraction as ([Par 873] “In one example, an information fraction may be defined as the number of patients observed divided by the target patient sample size at each look position. In another example, an information fraction may be defined as the number of observed deaths at a look position versus the total number of expected deaths.”) In light of this, determining the information faction sets is equivalent to observing a number of patients and dividing that number by the target patient sample size. This kind of simple division, done with or without a paper and pencil, is something taught to school children at a young age.
This element is also a mathematic process, as analyzed below.
Doing so “via the at least one processor” amounts to mere instructions to apply this exception using a computer.
determining, via the at least one processor, the look positions, wherein the look positions are for each of the plurality of designs; determining, via the at least one processor, available information at each of the look positions; determining, via the at least one processor, total expected information for a trial design;
Determining the “look position” is a mental process equivalent to observing the time index of a set of data, for example if a graph plots distance on one axis and time on the other, determining the look position for a certain data point is equivalent to observing its location on the time axis.
Determining how much information is available is a mental process equivalent to observing a set of data and judging how much data there is; for example a person could observe the data set {1, 2, 3} and judge that there are three data elements available.
Determining how much data is expected is a mental process equivalent to making an arbitrary decision about the volume of data a researcher would like to have; for example, a researcher may decide they’d like to have at least 1000 data points.
Doing so “via the at least one processor” amounts to mere instructions to apply this exception using a computer.
Should it be found that these elements are not mental processes, they are also examples of mere data gathering.
determining, via the at least one processor, a ratio of the available information to the total expected information;
Dividing the number of available data points by the expected data point count is a case of simple mental math. This kind of simple division, done with or without a paper and pencil, is something taught to school children at a young age.
This element is also a mathematic process, as analyzed below.
Doing so “via the at least one processor” amounts to mere instructions to apply this exception using a computer.
evaluating, via the at least one processor, designs at the look positions using the computed boundaries to generate one or more evaluation results;
This is a mental process; a person could reasonably imagine a theoretical trial design in their mind, writing aspects of it such as desired target sample size on a piece of paper. A person could then reasonably imagine the outcome of said imagined trial, and write down statistics. For example, a person could imagine a trial to determine how many people with peanut allergies have allergic reactions, deciding to the use the parameters of a sample size of 100 and the use of a particular brand of peanut. They could imagine gathering the patients, testing each for the allergy, and reasonably estimate that near 100% of the patients would have an adverse reaction, noting the 100% result on the paper.
Doing so “via the at least one processor” amounts to mere instructions to apply this exception using a computer.
Should it be found that this element is not a mental process, it is also both mere instructions to apply an exception and Well-Understood, Routine, Conventional Activity.
transforming, via the at least one processor, the each of the plurality of base datasets using the corresponding one of the plurality of distinct transformation functions, wherein the treatment ID dataset influences at least one of the transformed survival time dataset or the transformed dropout time dataset;
Transforming data through the use of a mathematic “transformation function” is an explicit recitation of a math operation in the claim, and is thus a mathematic concept. In other words, the claim element does not merely “involve” math; it explicitly discloses it in the claim itself.
Doing so “via at least one processor” amounts to mere instructions to apply this exception using a computer.
determining, via the at least one processor, information fraction sets for the look positions for the plurality of designs, wherein determining information fraction sets comprises: … wherein at least one of the information fraction sets corresponds to a number of patients observed divided by a target patient sample size at each of a plurality of look positions.
This element is mental math process. The specification describes the information fraction as ([Par 873] “In one example, an information fraction may be defined as the number of patients observed divided by the target patient sample size at each look position. In another example, an information fraction may be defined as the number of observed deaths at a look position versus the total number of expected deaths.”) In light of this, determining the information faction sets is equivalent to observing a number of patients and dividing that number by the target patient sample size. This kind of simple division, done with or without a paper and pencil, is something taught to school children at a young age.
This element is also a mathematic process, as analyzed below.
Doing so “via the at least one processor” amounts to mere instructions to apply this exception using a computer.
determining, via the at least one processor, the look positions, wherein the look positions are for each of the plurality of designs; determining, via the at least one processor, available information at each of the look positions; determining, via the at least one processor, total expected information for a trial design;
Determining the “look position” is a mental process equivalent to observing the time index of a set of data, for example if a graph plots distance on one axis and time on the other, determining the look position for a certain data point is equivalent to observing its location on the time axis.
Determining how much information is available is a mental process equivalent to observing a set of data and judging how much data there is; for example a person could observe the data set {1, 2, 3} and judge that there are three data elements available.
Determining how much data is expected is a mental process equivalent to making an arbitrary decision about the volume of data a researcher would like to have; for example, a researcher may decide they’d like to have at least 1000 data points.
Doing so “via the at least one processor” amounts to mere instructions to apply this exception using a computer.
Should it be found that these elements are not mental processes, they are also examples of mere data gathering.
determining, via the at least one processor, a ratio of the available information to the total expected information;
Dividing the number of available data points by the expected data point count is a case of simple mental math. This kind of simple division, done with or without a paper and pencil, is something taught to school children at a young age.
This element is also a mathematic process, as analyzed below.
Doing so “via the at least one processor” amounts to mere instructions to apply this exception using a computer.
evaluating, via the at least one processor, designs at the look positions using the computed boundaries to generate one or more evaluation results;
This is a mental process; a person could reasonably imagine a theoretical trial design in their mind, writing aspects of it such as desired target sample size on a piece of paper. A person could then reasonably imagine the outcome of said imagined trial, and write down statistics. For example, a person could imagine a trial to determine how many people with peanut allergies have allergic reactions, deciding to the use the parameters of a sample size of 100 and the use of a particular brand of peanut. They could imagine gathering the patients, testing each for the allergy, and reasonably estimate that near 100% of the patients would have an adverse reaction, noting the 100% result on the paper.
Doing so “via the at least one processor” amounts to mere instructions to apply this exception using a computer.
Should it be found that this element is not a mental process, it is also both mere instructions to apply an exception and Well-Understood, Routine, Conventional Activity.
determining, via the at least one processor, information fraction sets for the look positions for the plurality of designs, wherein determining information fraction sets comprises: … wherein at least one of the information fraction sets corresponds to a number of patients observed divided by a target patient sample size at each of a plurality of look positions.
Determining the value of a fraction is the act of mathematically calculating that fraction.
Doing so “via the at least one processor” amounts to mere instructions to apply this exception using a computer.
determining, via the at least one processor, a ratio of the available information to the total expected information;
Determining a ratio between two numbers is an explicit mathematic calculation and thus a mathematic process.
Doing so “via the at least one processor” amounts to mere instructions to apply this exception using a computer.
wherein the method further comprises: computing, via the at least one processor and for each information fraction set, a boundary for a test statistic;
Computing (i.e. calculating) a numeric boundary condition is a mathematic calculation and thus a mathematic concept.
Doing so “via the at least one processor” amounts to mere instructions to apply this exception using a computer.
In addition to the above explained elements, the applicant argues that: a person could not simulate a clinical trial design because it is too complex, and that the use of a clinical trial design with a sample size of one would be unreasonable.
Examiner responds by explaining that the term “clinical trial design” does not imply a numeric minimum sample size. While using a sample size of one may not be what the applicants envision, it nonetheless reads on the plain language of the claim. Even if a larger sample size was used, for example 15-20, this is still possible to perform in the human mind. The use of such a small sample size was merely used in previous arguments to highlight the simplicity. The arguments hold whether the sample size is 1, 5, 20, etc.
Once again, the examiner notes the claim does not require the consideration of numerous variables, parameters, tradeoffs, and the like resulting in a very large number of possible variations or that the system would “require 50,000 hours or more to complete” as argued by the applicants. Further the only “complexity” required by the claims is that there are a plurality of datasets including a survival time dataset, a treatment ID dataset, a dropout time dataset, scenario parameters and scenario specifications. A minimum size for any of these sets is not specified, and thus under BRI considering the data used for the simulations could involve the use of as little as 5 data points. Given the survival time dataset, a treatment ID dataset, a dropout time dataset, scenario parameters and scenario specifications {[5 min], [Peanut Butter],[Never], [Sample size: 6 people, half of which are extremely allergic to peanuts], [Performance criteria: Patient stays alive]} a person could “simulate” the trial in their mind and assume that the trial of giving a group of people comprised 50% of those extremely allergic to peanut butter will result in about half the patients having an allergic reaction.
Secondly, even if the complexity requirements were claimed, the element of simulating the trial is extremely high-level, generic, and results-oriented; the improvement in speed and capability to handle more data is merely a side effect of applying the abstract idea on a generic computer. See MPEP 2106.05(f): "The court thus held the claims ineligible, because the additional limitations provided only a result-oriented solution and lacked details as to how the computer performed the modifications, which was equivalent to the words "apply it". 850 F.3d at 1341-42; 121 USPQ2d at 1947-48 (citing Electric Power Group., 830 F.3d at 1356, 1356, USPQ2d at 1743-44 (cautioning against claims "so result focused, so functional, as to effectively cover any solution to an identified problem"))" and "TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Similarly, "claiming the improved speed or efficiency inherent with applying the abstract idea on a computer" does not integrate a judicial exception into a practical application or provide an inventive concept." As well as MPEP 2106.05(a): "a claim to "collecting information, analyzing it, and displaying certain results of the collection and analysis," where the data analysis steps are recited at a high level of generality such that they could practically be performed in the human mind, Electric Power Group v. Alstom, S.A., 830 F.3d 1350, 1353-54, 119 USPQ2d 1739, 1741-42 (Fed. Cir. 2016);"
Applicant argues that transforming data is not a mathematic process.
Examiner responds by explaining that while the claims themselves may not explicitly recite an equation in numeric form (i.e. claiming “y=mx+b”), it is clear that this transformation is a textual placeholder for a mathematic equation. Transforming data through the use of a mathematic “transformation function” is an explicit recitation of a math operation in the claim, and is thus a mathematic concept. In other words, the claim element does not merely “involve” math; it explicitly discloses it in the claim itself. For further evidence see the specification at ([Par 738] “In some cases, the score components may be normalized or transformed before the score component is used in the computation of a score. Score components may be normalized according to the type of data (i.e. Boolean, integer, float, string, etc.), number of possible values (i.e. a set of possible values, continuous values), range of values (i.e. difference between maximum and minimum values in the simulation data), and the like. … For example, a score component x may be normalized to a score component x' according to x '= (x - x min ) / (xmax- x min ).”)
Applicant argues that the limitations of simulating, via the at least one processor, a design to determine test statistics for the design; … generating, via the at least one processor, a decision to stop or proceed with sample size re-estimation for the simulated design based on the test statistics and the precomputed boundary condition; and transmitting, via the at least one processor, the decision. are not mathematic processes.
Examiner responds by explaining that, none of these steps were alleged to have been math concepts, and therefore this argument is moot.
Applicant argues that the steps of wherein determining information fraction sets comprises: determining, via the at least one processor, the look positions, wherein the look positions are for each of the plurality of designs; determining, via the at least one processor, available information at each of the look positions; determining, via the at least one processor, total expected information for a trial design; determining, via the at least one processor, a ratio of the available information to the total expected information; do not recite a math concept.
Examiner responds by explaining that these elements do in fact describe a math concept in concert with a mental process, specifically:
Determining the “look position” is a mental process equivalent to observing the time index of a set of data, for example if a graph plots distance on one axis and time on the other, determining the look position for a certain data point is equivalent to observing its location on the time axis.
Determining how much information is available is a mental process equivalent to observing a set of data and judging how much data there is; for example a person could observe the data set {1, 2, 3} and judge that there are three data elements available.
Determining how much data is expected is a mental process equivalent to making an arbitrary decision about the volume of data a researcher would like to have; for example, a researcher may decide they’d like to have at least 1000 data points.
Determining a ratio between two numbers is an explicit mathematic calculation and thus a mathematic process.
In short the elements describe a mathematic calculation based on a series of mental observations and judgements.
Note that these arguments apply for the relevant limitations of both claims 9 and 21.
Applicant argues that the claims provide an improvement to technology by reducing the computation time associated with clinical trial simulation.
Examiner responds by explaining that this alleged improvement arises from generating and transforming the data. Both of these operations are abstract ideas analyzed under Step 2A Prong 1, and thus cannot provide an improvement to technology. Further, any alleged improvement to speed or data scale capability (i.e. that such a process “would require 50,000 hours or more to complete” if done by hand) is merely a side effect of using a generic computer to perform the process. (MPEP 2106.05(f)(2): … Similarly, "claiming the improved speed or efficiency inherent with applying the abstract idea on a computer" does not integrate a judicial exception into a practical application or provide an inventive concept. Intellectual Ventures I LLC v. Capital One Bank (USA), 792 F.3d 1363, 1367, 115 USPQ2d 1636, 1639 (Fed. Cir. 2015).)
Applicant argues that the computer components, in combination, perform functions that are not merely generic.
Examiner responds by explaining that this is not the case. Even if, for the sake of argument, elements such as the simulation that are primarily treated as part of the abstract idea are treated as additional elements, the claims still do not recite a combination of additional elements that is anything more than generic. For example, the additional elements of claim 1, under such an assumption, consist of a generic processor, a “simulation” recited at an extremely high level of generality with no specifics recited, and a step of transmitting data. These are all very generic features that are not sufficient to provide significantly more.
Claims 9 and 21 add the step of generically obtaining data to this process, also recited with very little specificity. A claim element that amounts to merely gathering data is not indicative of integration into a practical solution nor evidence that the claim provides an inventive concept, as exemplified by ((MPEP 2106.05)(g)(Mere Data Gathering) i. Performing clinical tests on individuals to obtain input for an equation, In re Grams, 888 F.2d 835, 839-40; 12 USPQ2d 1824, 1827-28 (Fed. Cir. 1989); iv. Obtaining
information about transactions using the Internet to verify credit card transactions, CyberSource v.
Retail Decisions, Inc., 654 F.3d 1366, 1375, 99 USPQ2d 1690, 1694 (Fed. Cir. 2011);
For the features not explicitly recognized by the courts as being WURC (as generic data transmission over a network is. See MPEP 2106.05(d)(II) i. 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); TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 610, 118 USPQ2d 1744, 1745 (Fed. Cir. 2016) (using a telephone for image transmission); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network)) A preponderance of evidence is provided to the WURC nature of those elements. For example:
simulating, via the at least one processor, a design to determine test statistics for the design;
The courts have found that claim elements that are understood to be Well-Understood, Routine, Conventional Activity are not indicative of Integration into a Practical Solution nor evidence of an Inventive Concept or Significantly More (MPEP 2106.05(d))
Evidence that simulating a clinical trial is WURC can be found in:
Fundamentals of Clinical Trials ([Section 6 Page 108 Par 1])
The Role Of Modeling & Simulation In Clinical Trials ([Page 1 Par 1-2])
Clinical trial optimization: Monte Carlo simulation Markov model for planning clinical trials recruitment ([Page 221 Par 2 – Page 222 Par 1])
How Simulation Can Transform Regulatory Pathways ([Page 1 Par 1-3])
Response to Arguments - 103
Applicant's arguments filed 09/11/2025 have been fully considered but they are not persuasive.
Applicant argues that no prior art teaches wherein the treatment ID dataset influences at least one of the transformed survival time dataset or the transformed dropout time dataset; nor determining, via the at least one processor, a distribution of simulations for the clinical trial designs, wherein the distribution of simulations is based on a time of the simulations;
Examiner responds by explaining that, firstly, Springer teaches wherein the treatment ID dataset influences at least one of the transformed survival time dataset or the transformed dropout time dataset. Specifically, it teaches transforming datasets ([Section 8 Page 147 Par 2] “… When this is not the case, a transformation of values, such as taking their logarithm, can still make the normality assumption approximately correct.” [Section 13 Page 246 Par 4] “In utility approaches, one or more scaling methods are used to assign a numerical value from 0.0 (death) to 1.0 (full health) to indicate an individual’s quality of life.” [Section 5 Page 75 Fig. 5.1] Shows data taken from a plurality of datasets [Section 6 Page 99 Par 3] “For large studies, a more convenient method … is to use a … algorithm, available on most computer systems.” ) and describes associating treatments with survival time. ([Section 8 Page 147 Par 2] “… When this is not the case, a transformation of values, such as taking their logarithm, can still make the normality assumption approximately correct.” [Section 12 Page 220 Table 1] Shows a dataset including the use of different treatments [Section 16 Page 301 Fig. 16.4] Shows a graph of a dataset with separately identified treatments and survival rates over time per treatment {dataset including different treatment IDs with associated survival information over time})
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Further, Abbas teaches determining, via the at least one processor, a distribution of simulations for the clinical trial designs, wherein the distribution of simulations is based on a time of the simulations; and ([Section 2.3.2 Page 1057 Col 1 Par 6-7] “Assuming that the patient attends the next visit, then the value of the outcome variable (cholesterol level) will be updated according to the sum of the new mean level: the value generated from the first normal distribution Dist1 at the baseline visit and the new value generated by the second normal distribution Dist2. That is, Li = Meanv + (dist1v = dist1v=1) + (dist2v = N{0;sv}). This process is repeated until the patient either reaches the last visit of the trial or the point when they drop out.”) [Section 2.3.2 Page 1057 Col 1 Par 5] “After generating the cholesterol value, the model applies the probability of a patient dropping out through another uniform distribution generator between 0 and 1. If the generated probability is equal to or less than the dropout probability, then the patient will continue receiving the treatment in the next visit; if not, the patient will drop out from the trial. In order to account for centrespecific dropout probability, we converted the probability of the trial shown in Table 1, Pd(v), into the k(v) rate given by formula 5. Then, we used the rate found to calculate the intended probability depending on c centre, Pd(v, c), given by formula 6. This equation assumes that this dropout probability increases as the number of centres increases according to an exponential distribution…. where Pd(v,c) is the dropout probability at visit v (v = 0, 1, 2,...) and centre c (c = 1, 2, 3,...). [Examiner’s note: the distribution for dropout depends on both the ordered simulated visit number through time, i.e. is based on the time of the simulation, and the center location, i.e. the simulation location])
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 1-13, 15-21 are rejected under 35 U.S.C. 101 because they are directed to an abstract idea without significantly more.
Claim 1(Statutory Category – Process)
The claim recites a mental process, specifically:
generating, via at least one processor, a plurality of base datasets using a random number generator, wherein the base datasets correspond to one or more clinical trial designs wherein the plurality of base datasets includes a survival time dataset, a treatment ID dataset, and a dropout time dataset;
A person could generate a set of random numbers in their by coming up with a series of arbitrarily chosen values. For example, a person could flip a coin a hundred times and tabulate the results using a pen and paper.
Doing so “via at least one processor” and “using a random number generator” amounts to mere instructions to apply this exception using a computer.
determining, via the at least one processor, scenario specifications corresponding to the one or more clinical trial designs;
Determining specifications for a clinical trials is practical to perform in the human mind, and consists of deciding arbitrary trial conditions, such as the length of the trial, how results should be analyzed, etc.
Doing so “via the at least one processor” amounts to mere instructions to apply this exception using a computer.
identifying, via the at least one processor, a plurality of distinct transformation functions each corresponding to a distinct one of the plurality of base datasets based on the scenario specifications;
A human mind could reasonably come up with a distinct function for a number of datasets to transform the data therein. For example, a person could write down several numeric datasets with a pencil and paper, then decide that the transformation function for the first set is to add 1 to every number, a second function to add 2 to every number in a second set, and so on.
Doing so “via the at least one processor” amounts to mere instructions to apply this exception using a computer.
generating, via the at least one processor, scenario parameters based on the transformed datasets and corresponding to the one or more clinical trial designs;
Generating arbitrary parameters based on observed data is a mental process equivalent to observing that data and judging what kind of parameters best suit that data. For example if the datasets suggest high dropout rates, parameters that work better for small sample size trials may be chosen.
Doing so “via the at least one processor” amounts to mere instructions to apply this exception using a computer.
simulating, via the at least one processor, the one or more clinical trial designs using the scenario parameters to generate one or more clinical trial design simulation results;
This is a mental process; a person could reasonably imagine a theoretical trial design in their mind, writing aspects of it such as desired target sample size on a piece of paper. A person could then reasonably imagine the outcome of said imagined trial, and write down statistics. For example, a person could imagine a trial to determine how many people with peanut allergies have allergic reactions, deciding to the use the parameters of a sample size of 100 and the use of a particular brand of peanut. They could imagine gathering the patients, testing each for the allergy, and reasonably estimate that near 100% of the patients would have an adverse reaction, noting the 100% on the paper.
Doing so “via the at least one processor” amounts to mere instructions to apply this exception using a computer.
Should it be found that this element is not a mental process, it is also both mere instructions to apply an exception and Well-Understood, Routine, Conventional Activity.
determining, via the at least one processor, a distribution of simulations for the clinical trial designs, wherein the distribution of simulations is based on a time of the simulations;
Determining the statistical distribution of the simulation output is merely the act of determining the distribution of a set of numeric data. This can be done both mentally and purely mathematically; to perform this process mentally, data can be drawn on a plot and the shape of the resulting plot can give insight into the distribution of the data, for example data that is normally distributed will approximate a bell curve.
Doing so “via the at least one processor” amounts to mere instructions to apply this exception using a computer.
See below for analysis as a math process.
The claim also recites a mathematical process, specifically:
MPEP 2106.4(a)(2)(I): “The mathematical concepts grouping is defined as mathematical relationships, mathematical formulas or equations, and mathematical calculations.”
Further, the MPEP recites: “For example, a step of "determining" a variable or number using mathematical methods or "performing" a mathematical operation may also be considered mathematical calculations when the broadest reasonable interpretation of the claim in light of the specification encompasses a mathematical calculation.”
transforming, via the at least one processor, the each of the plurality of base datasets using the at least one the corresponding one of the plurality of distinct transformation functions, wherein the treatment ID dataset influences at least one of the transformed survival time dataset or the transformed dropout time dataset;
Transforming data through the use of a mathematic “transformation function” is an explicit recitation of a math operation in the claim, and is thus a mathematic concept. In other words, the claim element does not merely “involve” math; it explicitly discloses it in the claim itself.
Doing so “via at least one processor” amounts to mere instructions to apply this exception using a computer.
determining, via the at least one processor, a distribution of simulations for the clinical trial designs, wherein the distribution of simulations is based on a time of the simulations;
To determine such a distribution purely numerically several mathematic tests can be used, for example the Shapiro–Wilk test for checking for normal distribution.
Doing so “via at least one processor” amounts to mere instructions to apply this exception using a computer.
Step 2A – Prong 2: Integrated into a Practical Solution?
Mere Instructions to Apply (MPEP 2106.05(f)) has found that merely applying a judicial exception such as an abstract idea, as by performing it on a computer, does not integrate the claim into a practical solution.
simulating, via the at least one processor, the one or more clinical trial designs using the scenario parameters to generate one or more clinical trial design simulation results;
Applying a computer to perform a generic simulation at a high level of generality is simply the act of instructing a computer to perform generic functions to perform that simulation, which is merely an instruction to apply a computer to the judicial exception. The claim only recites the idea of a solution or outcome, i.e. that the clinical trial is “simulated” without reciting how this simulation is actually accomplished. Further, the computer elements claimed are cited as merely generic tools to perform the operations; for additional clarity on the generic nature of the application of a general purpose computer, see ([Par 210] “A user may interact with the platform 104 through one or more user devices 102 (e.g., computer, laptop computer, mobile computing device, and the like). The platform 104 may be implemented and/or leverage one or more computing resources 150 such as a cloud computing service 152,servers 154, software as a service (SaaS), infrastructure as a service (IaaS), platform as a service (PaaS), desktop as a Service (DaaS), managed software as a service (MSaaS), mobile backend as a service (MBaaS), information technology management as a service (ITMaaS), and the like.”)
Should it be found that this element is not a mental process or mere instructions to apply an exception, it is also an example of Well-Understood, Routine, Conventional Activity.
transmitting, via the at least one processor, the one or more clinical trial design simulation results.
Transmitting and receiving data over a network has been explicitly identified by the courts as an example of Mere Instructions to Apply(MPEP 2106.05(f)(1) i. Remotely accessing user-specific information through a mobile interface and pointers to retrieve the information without any description of how the mobile interface and pointers accomplish the result of retrieving previously inaccessible information, Intellectual Ventures v. Erie Indem. Co.,