DETAILED ACTION
Status of Claims
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This action is in reply to a response filed 11 June 2026 on an application filed 20 January 2021, which claims priority to 6 provisional applications with filing dates as early as 30 March 2020.
Claims 596, 603, 606 and 611 have been amended.
Claims 602 and 610 have been canceled.
Claims 596-601, 603-609 and 611-615 are currently pending.
Claims 614-615 were withdrawn as being directed to a non-elected invention.
Claims 596-601, 603-609 and 611-613 have been examined.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 11 June 2026 have been considered by the Office to the extent indicated.
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 596-601, 603-609 and 611-613 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Step 1
Claims 596-601, 603-609 and 611-613 are within the four statutory categories. Claims 596-601 and 603-605 are drawn to a method for trial design evaluation, which is within the four statutory categories (i.e. process). Claims 606-609 and 611-613 are drawn to an apparatus for trial design evaluation, which is within the four statutory categories (i.e. machine).
Prong 1 of Step 2A
Claim 596 recites: A method comprising:
obtaining criteria data defining requirements for a clinical trial design study;
determining a plurality of design permutations responsive to the criteria data, wherein each design permutation comprises a unique combination of clinical trial protocol parameters including at least one of drug dosage, drug frequency, trial duration, patient inclusion criteria, or randomization type;
determining a plurality of scenario permutations responsive to the criteria data, wherein each scenario permutation comprises a unique combination of environmental parameters including at least one of population enrollment rate, patient dropout rate, or population statistics that define conditions under which a clinical trial design is evaluated;
generating trial evaluation combinations by combining the design permutations with the scenario permutations by forming a cross-product of the design permutations and the scenario permutations, wherein each trial evaluation combination comprises a unique pairing of clinical trial protocol design with a specific set of environmental conditions;
predicting performance metrics of the trial evaluation combinations;
removing a subset of the trial evaluation combinations, prior to simulating the trial evaluation combinations, based on the predicted performance metrics;
simulating the trial evaluation combinations to determine trial outcomes under the environmental parameters for each clinical trial protocol design; and
determining performance metrics of for the simulated trial evaluation combinations based on the trial outcomes.
Claim 606 recites: An apparatus comprising:
a space definition circuit structured to interpret criteria data for a trial design;
a design parameter circuit structured to determine a plurality of permutations for designs in response to the criteria data, wherein each design permutation comprises a unique combination of clinical trial protocol parameters;
a scenario parameter circuit structured to determine a plurality of permutations for scenarios in response to the criteria data, wherein each scenario permutation comprises a unique combination of environmental parameters;
a combinations circuit structured to generate combinations of permutations for designs and permutations for scenarios by forming a cross-product of the design permutations and the scenario permutations, wherein each trial evaluation combination comprises a unique pairing of clinical trial protocol design with a specific set of environmental conditions;
a validity checker circuit configured to:
predict performance of the combinations;
remove a subset of the combinations prior to simulating based on the predicted performance; and
a simulation circuit structured to evaluate a performance of each combination.
The underlined limitations as shown above, given the broadest reasonable interpretation, cover the abstract ideas of “mathematical concepts” (the recitation of the cross product) and/or the abstract idea of a certain method of organizing human activity because they recite managing personal behavior or relationships or interactions between people (i.e. social activities, teaching, and following rules or instructions, i.e. in this case a clinical trial designer determines permutations of designs and scenarios for a trial criteria, considers their combined effects on patient numbers and outputs the performance thereof), e.g. see MPEP 2106.04(a)(2). Any limitations not identified above as part of the abstract idea are deemed “additional elements,” and will be discussed in further detail below.
Dependent claims 597-601, 603-605, 607-609 and 611-613 include other limitations, for example claims 597-601, 603-605, 607-609 and 611-613 give further details on the combinations, permutations and the prediction functions described in the independent claims, but these only serve to further narrow the abstract idea, and a claim may not preempt abstract ideas, even if the judicial exception is narrow, e.g. see MPEP 2106.04. Hence dependent claims 597-601, 603-605, 607-609 and 611-613 are nonetheless directed towards fundamentally the same abstract idea as independent claims 596 and 606.
Prong 2 of Step 2A
Claims 596 and 606 are not integrated into a practical application because the additional elements (i.e. any limitations that are not identified as part of the abstract idea) amount to no more than limitations which:
amount to mere instructions to apply an exception – for example, the recitation of the structural components of the computer and circuits, which amounts to merely invoking a computer as a tool to perform the abstract idea, see MPEP 2106.05(f); and/or
generally link the abstract idea to a particular technological environment or field of use – for example, the claim language limiting the data to drug and patient data, which amounts to limiting the abstract idea to the field of healthcare, see MPEP 2106.05(h); and/or
adding insignificant extrasolution activity to the abstract idea, for example mere data gathering, selecting a particular data source or type of data to be manipulated, and/or insignificant application (e.g. see MPEP 2106.05(g)).
Additionally, dependent claims 597-601, 603-605, 607-609 and 611-613 include other limitations, but these limitations also amount to no more than amount to mere instructions to apply the exception (e.g. the various circuits disclosed in claims 607-610), generally linking the abstract idea to a particular technological environment or field of use (e.g. the types of data disclosed in claims 597-601, 603-605, 608, 609 and 611-613) and/or do not include any additional elements beyond those already recited in independent claims 596 and 606, and hence also do not integrate the aforementioned abstract idea into a practical application.
Step 2B
Claims 596 and 606 do not include additional elements that are sufficient to amount to “significantly more” than the judicial exception because the additional elements (i.e. the elements other than the abstract idea), as stated above, are directed towards no more than limitations that amount to mere instructions to apply the exception, and/or generally link the abstract idea to a particular technological environment or field of use, and/or add insignificant extra-solution activity to the abstract idea, wherein the insignificant extra-solution activity comprises limitations which:
amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields, as demonstrated by:
The Specification expressly disclosing that the additional elements are well-understood, routine, and conventional in nature:
paragraphs 839, 842, 1101 and 1102 and of the Specification discloses that the additional elements (i.e. the recitation of the structural components of the computer and circuits) comprise a plurality of different types of generic computing systems that are configured to perform generic computer functions (i.e. receive and process data) that are well-understood, routine, and conventional activities previously known to the pertinent industry (i.e. healthcare);
Relevant court decisions: The following are examples of court decisions demonstrating well-understood, routine and conventional activities, e.g. see MPEP 2106.05(d)(II):
Performing repetitive calculations, Flook, 437 U.S. at 594, 198 USPQ2d at 199 (recomputing or readjusting alarm limit values); Bancorp Services v. Sun Life, 687 F.3d 1266, 1278, 103 USPQ2d 1425, 1433 (Fed. Cir. 2012) ("The computer required by some of Bancorp’s claims is employed only for its most basic function, the performance of repetitive calculations, and as such does not impose meaningful limits on the scope of those claims."); 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); OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
Dependent claims 597-601, 603-605, 607-609 and 611-613 include other limitations, but none of these limitations are deemed significantly more than the abstract idea because, as stated above, the aforementioned dependent claims do not recite any additional elements not already recited in independent claims 596 and 606, and/or the additional elements recited in the aforementioned dependent claims similarly amount to mere instructions to apply the exception (e.g. the various circuits disclosed in claims 607-609) and/or generally linking the abstract idea to a particular technological environment or field of use (e.g. the types of data disclosed in claims 597-601, 603-605, 607-609 and 611-613, and hence do not amount to “significantly more” than the abstract idea.
Thus, taken alone, the additional elements do not amount to significantly more than the abstract idea identified above. Furthermore, looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually, and there is no indication that the combination of elements improves the functioning of a computer or improves any other technology, and their collective functions merely provide conventional computer implementation.
Therefore, whether taken individually or as an ordered combination, claims 596-601, 603-609 and 611-613 are nonetheless rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
A NOTE ON CLAIM LANGUAGE
The Office notes that the claims as currently written comprise very broad material, and are interpretable in many ways. As a non-limiting example, there is no meaningful distinguishable difference between the terms scenario and design as claimed, as the specification does not limit the interpretation of the terms scenario and design as distinguishable items, e.g., see paragraphs 205, 206, 208-210, 217 and 268 of the current specification. The Office invites the applicant to provide further details in the claim language.
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 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 of this title, 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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 596, 600, 601, 603-606 and 608-613 are rejected under 35 U.S.C. 103 as being obvious over Kahn et al. (U.S. PG-Pub 2013/0346101 A1), hereinafter Kahn, in view of Boru et al. (U.S. PG-Pub 2002/0077853 A1), hereinafter Boru, further in view of Dias et al. (U.S. Patent 10,839,042 B1), hereinafter Dias.
As per claims 596 and 606, Kahn discloses a method comprising:
obtaining criteria data defining requirements for a clinical trial design study (Kahn discloses a system comprised of an intelligent protocol database [“ICP”] that is used to evaluate eligibility criteria data for the design of a clinical trial, see Figs. 9 and 10 #914 and paragraphs 126-130.);
determining a plurality of design permutations responsive to the criteria data, wherein each design permutation comprises a unique combination of clinical trial protocol parameters including at least one of drug dosage, drug frequency, trial duration, patient inclusion criteria, or randomization type (Kahn provides various attributes [designs and scenarios] for a plurality of criteria, the combination of which are used in an accrual simulation step in order to determine whether there is an appropriate number of eligible patients, see Fig. 10 #s1012-104 and paragraphs 128-129. Paragraphs 124-125 discloses selection of patient eligibility criteria in an iterative process, which would comprise patient inclusion criteria.);
determining a plurality of scenario permutations responsive to the criteria data, wherein each scenario permutation comprises a unique combination of environmental parameters including at least one of population enrollment rate, patient dropout rate, or population statistics that define conditions under which a clinical trial design is evaluated (Kahn discloses selection of a meta-model including preliminary patient eligibility attribute list, which would comprise population statistics that define conditions under which a clinical trial design is evaluated, see Fig. 9 #910A and paragraph 124.);
generating trial evaluation combinations by combining the design permutations with the scenario permutations … to form clinical trial protocol design with a specific set of environmental conditions (See Kahn, Fig. 9, wherein the scenario #910A and the design permutations #912 are evaluated.);
predicting performance metrics of the trial evaluation combinations (Kahn examines the combinations through the accrual simulation to determine if patient with combined attributes [designs and scenarios] meet the eligibility criteria, see Fig. 10 #s1012-104 and paragraphs 128-129. The combination would comprise a patient evaluated under all proposed attributes [designs and scenarios].);
utilizing the trial evaluation combinations to determine trial outcomes under the environmental parameters for each clinical trial protocol design (See Kahn, Figs. 9 and 10.); and
determining performance metrics for the simulated trial evaluation combinations based on the trial outcomes (System determines whether the number of eligible patients is adequate, see Fig. 10 #1024 and paragraph 130.).
Kahn fails to explicitly disclose:
forming a cross-product of the design permutations and the scenario permutations, wherein each trial evaluation combination comprises a unique pairing parameters;
remove a subset of the trial evaluation combinations prior to simulating based on the predicted performance metrics; and
a simulation circuit and simulating trials.
Boru teaches that it was old and well known in the art of healthcare communications before the effective filing date of the claimed invention to provide a simulation circuit and simulating trials, see Boru, Fig. 4, including Fig. 3, wherein the criteria list is modified/simulated.), as well as remove a subset of the trial evaluation combinations prior to simulating based on the predicted performance metrics (Boru, Fig. 3 discloses removing trials with out of bounds data to generate a list of non-excluded trials, which in Fig. 4 is simulated in a criteria loop.) in order to provide a proper criteria list for a clinical trial by generating “a minimal list of questions that exclude the greatest number of trials for which a patient's medical condition does not qualify him or her” (Boru, paragraph 20.).
Therefore, it would have been obvious to one of ordinary skill in the art of healthcare communications before the effective filing date of the claimed invention to modify the clinical trials management system of Kahn to include a simulation circuit and simulating trials and removing a subset of the combinations prior to simulating, as taught by Boru, in order to arrive at a clinical trials management system that determines a proper criteria list for a clinical trial by generating “a minimal list of questions that exclude the greatest number of trials for which a patient's medical condition does not qualify him or her” (Boru, paragraph 20.). Moreover, merely adding a well-known element into a well-known system, to produce a predictable result to one of ordinary skill in the art, does not render the invention patentably distinct over such combination (see MPEP 2141).
Dias teaches that it was old and well known in the art of healthcare communications before the effective filing date of the claimed invention to provide forming a cross-product of the various permutations, such that each trial evaluation combination comprises a unique pairing of parameters, see Dias, C8L11-21.) in order to simulate the set of all possible combinations of input parameters (Dias, C8L19-20.). Moreover, merely adding a well-known element into a well-known system, to produce a predictable result to one of ordinary skill in the art, does not render the invention patentably distinct over such combination (see MPEP 2141).
Therefore, it would have been obvious to one of ordinary skill in the art of healthcare communications before the effective filing date of the claimed invention to modify the clinical trials management system of Kahn/Boru to include forming a cross-product of input variables for simulation analysis, as taught by Dias, in order to arrive at a he clinical trials management system that can simulate the set of all possible combinations of input parameters.
Kahn and Boru are directed to the electronic processing of patient healthcare data and specifically to the determination of clinical trials criteria. Kahn and Dias are directed to the electronic processing of data to optimize systems.
As per claims 600, 601, 603, 604, 608, 609, 611 and 612, Kahn/Boru/Dias discloses claims 596 and 606, discussed above. Kahn also discloses:
600,608. examining the trial evaluation combinations for invalid combinations (System examines the combinations through the accrual simulation to determine if patient with combined attributes [designs and scenarios] meet the eligibility criteria, see Fig. 10 #s1012-104 and paragraphs 128-129. The combination would comprise a patient evaluated under all proposed attributes [designs and scenarios].);
601,609. examining the design permutations for invalid permutations (System examines the combinations through the accrual simulation to determine if patient with combined attributes [designs and scenarios] meet the eligibility criteria, see Fig. 10 #s1012-104 and paragraphs 128-129. An invalid permutation would be one that leads to an ineligible patient.].);
603,611. wherein the performance is predicted based on historical data (Kahn evaluates based on established ICP database library, see Fig. 1 and corresponding text.); and
604,612. wherein the trial evaluation combinations are exhaustive for the criteria data (System evaluates every provided permutation, see Figs. 9 and 10, and corresponding text.).
As per claims 605 and 613, Kahn/Boru/Dias discloses claims 596 and 606, discussed above.
Kahn fails to explicitly disclose determining optimality from the performance metrics of the simulated trial evaluation combinations.
Boru teaches that it was old and well known in the art of healthcare communications before the effective filing date of the claimed invention to provide determining optimality from the performance metrics of the simulated trial evaluation combinations (Boru, Fig. 4 provides an analysis circuit to determine optimality, see paragraphs 24, 88 and 99.), in order to provide a proper criteria list for a clinical trial (Boru, paragraph 20.).
Therefore, it would have been obvious to one of ordinary skill in the art of healthcare communications before the effective filing date of the claimed invention to modify the clinical trials management system of Kahn/Boru/Dias to include determining optimality from the performance metrics of the simulated trial evaluation combinations, as taught by Boru,
in order to arrive at a clinical trials management system that determines a proper criteria list for a clinical trial (Boru, paragraph 20.). Moreover, merely adding a well-known element into a well-known system, to produce a predictable result to one of ordinary skill in the art, does not render the invention patentably distinct over such combination (see MPEP 2141).
Claims 597-599 and 607 are rejected under 35 U.S.C. 103 as being obvious over Kahn/Boru/Dias, further in view of Young et al. (U.S. PG-Pub 2011/0307267 A1), hereinafter Young.
As per claims 597-599 and 607, Kahn/Boru/Dias discloses claims 596 and 606, discussed above. Kahn/Boru/Dias also discloses:
597,607. estimating a number of … combinations using the criteria data (System returns the number of eligible patients, see paragraph 128.);
598. in response to the estimated number being greater than a threshold, suggesting modifications to the criteria data (If the number is not adequate, the user revises the criteria, see Fig. 10 #1016 and paragraph 130 and claim 22. It is the Office’s position that the indication “reaches an accrual threshold” would expressly or inherently comprise the number being greater or being less than a threshold previous to adjustments to the criteria.);
599. in response to the estimated number being less than a threshold, suggesting modifications to the criteria data (If the number is not adequate, the user revises the criteria, see Fig. 10 #1016 and paragraph 130 and claim 22. It is the Office’s position that the indication “reaches an accrual threshold” would expressly or inherently comprise the number being greater or being less than a threshold previous to adjustments to the criteria.).
Kahn fails to explicitly disclose trial evaluation combinations.
Young teaches that it was old and well known in the art of healthcare communications before the effective filing date of the claimed invention to determine a number of trial evaluation combinations, see the number of simulation execution runs of Young at paragraph 114, which is the result of the number of executed combinations in order to provide a simulation system that determines potential processing requirements before executing simulations.
Therefore, it would have been obvious to one of ordinary skill in the art of healthcare communications before the effective filing date of the claimed invention to modify the clinical trials management system of Kahn/Boru/Dias to include determining a number of trial evaluation combinations, as taught by Young, in order to arrive at a clinical trials management system that determines potential processing requirements before executing simulations. Moreover, merely adding a well-known element into a well-known system, to produce a predictable result to one of ordinary skill in the art, does not render the invention patentably distinct over such combination (see MPEP 2141).
Both Kahn and Young are directed to the electronic processing of patient healthcare data and specifically to the determination of clinical trials criteria.
Response to Arguments
Applicant’s arguments filed 11 June 2026 concerning the rejection of all claims under 35 U.S.C. 101 and 112 have been fully considered and are deemed persuasive in view of the amendments to the claims.
Applicant’s arguments filed 11 June 2026 concerning the rejection of all claims under 35 U.S.C. 101 and 103(a) have been fully considered but they are not persuasive.
With regard to the rejection of the claims under 35 USC 101, Applicant argues on pages 7-8 that:
A. The claims are directed to patent-eligible subject matter because they are not directed to an abstract idea as they cannot be described as a certain method of organizing human activity due to the recitation of use of a cross product of design and scenario permutations.
B. The claims integrate any alleged abstract idea into a practical application as the ordered combination provides an improvement to the operation of the trial-design evaluation process.
The Office respectfully disagrees. Please see the statutory rejection of the claims issued above, where the claims are shown to be directed to an abstract idea without significantly more.
Regarding A., as shown in the amended statutory rejection, the recitation of the cross product is an abstract idea covered by the “mathematical concepts” category, and is not considered part of the methods of organizing human activity category.
Regarding B., MPEP 2106.04(d)(1) states that a practical application may be present where the claimed invention improves another technology. See also MPEP 2106.05(a)(II). Applicant’s claim is confined to a general-purpose computer (see Specification paragraphs 839, 842, 1101 and 1102) and does not recite “another technology.” Because no other technology is recited in the claim, the claim cannot improve another technology (see, e.g., MPEP 2106.05(I)(A)(i) describing an example of an improvement to another technology where the abstract idea implemented on a computer improved the claimed additional element of a rubber molding machine).
Accordingly, the statutory rejection is upheld.
With regard to the rejection of the claims under 35 USC 103, Applicant argues on pages 8-9 that Khan and Boru fail to disclose the entire set of amendments to the claims.
The Office respectfully disagrees. As shown above, Khan and Boru in combination disclose the contested amendments, not either reference separately. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Here the combination of the cited references disclose the contested limitation.
The remainder of Applicant's arguments have been fully considered but are moot because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
Accordingly, the rejection is upheld.
In conclusion, all of the limitations which Applicant disputes as missing in the applied references, including the features newly added by amendment, have been fully addressed by the Office as either being fully disclosed or obvious in view of the collective teachings of Kahn, Boru, Dias and Young, based on the logic and sound scientific reasoning of one ordinarily skilled in the art at the time of the invention, as detailed in the remarks and explanations given in the preceding sections of the present Office Action and in the prior Office Actions (12 December 2025, 9 April 2025, 15 July 2024), and incorporated herein.
Conclusion
Unused but cited relevant prior art includes:
Gardner et al. (U.S. PG-Pub 2019/0286086 A1) discloses an apparatus and method for processing data inputs in computing devices via generation of a multi-dimensional computer model.
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 nonprovisional extension fee (37 CFR 1.17(a)) 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.
Any inquiry of a general nature or relating to the status of this application or concerning this communication or earlier communications from the Examiner should be directed to Mark Holcomb, whose telephone number is 571.270.1382. The Examiner can normally be reached on Monday-Friday (8-5). If attempts to reach the examiner by telephone are unsuccessful, the Examiner’s supervisor, Kambiz Abdi, can be reached at 571.272.6702.
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/MARK HOLCOMB/
Primary Examiner, Art Unit 3685
25 June 2026
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