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 .
DETAILED ACTION
1. Claims 1-2, 4-6, 8-29 have been presented for examination based on the amendment filed on 08/10/2026.
2. Claim rejection of Claims 1-29 under USC 102 and USC 103 is withdrawn based on the amendment filed on 08/10/2026.
Information Disclosure Statement
3. As required by M.P.E.P. 609(C), the Applicant’s submissions of the Information Disclosure Statement dated August 10, 2026 is acknowledged by the Examiner and the cited references have been considered in the examination of the claims now pending. As required by M.P.E.P. 609 C(2), a copy of each of the PTOL-1449s initialed and dated by the Examiner is attached to the instant Office action.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
4. Claims 1-2, 4-6, 8-29 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-20 of Patent No. US 12,211,593 B2 from the same inventors.
For the purpose of illustration, only claim 1 of the instant application is compared with claim 1 of the '593 patent in the following table:
Table 1
Instant application (17/847040)
Patent No. US 12,211,593 B2
Claim 1 A method comprising: interpreting design data corresponding to a plurality of designs; generating visualization data structured to show a design interface for comparing the plurality of designs,
wherein:
the design interface comprises a 3-plot comprising a set of three graphs
comprising a base graph, a first companion graph, and a second companion graph;
the base graph has a first common axis with the first companion graph and has a
second common axis with the second companion graph; and the first and second common axes are distinct from each other;
generating a line that connects a first point corresponding to a design on a first graph of
the 3-plot with a second point of a second graph of the 3-plot and a third point of a third graph of the 3-plot, wherein the second point and the third point correspond to the design; and transmitting the visualization data.
Claim 1 A method comprising: generating simulation parameters, wherein at least one parameter includes a placeholder value comprising an estimated value and/or a predicted value; simulating trial designs based on the simulation parameters; obtaining trial design simulation results for a set of trial designs; supplementing the placeholder value of the trial design simulation results with substitute data comprising historical data and/or real-world data; determining a set of Pareto designs in the set of trial designs based at least in part on the trial design simulation results and one or more performance parameters; determining a set of convex hull designs in the set of trial designs; determining a set of recommended designs based at least in part on the set of Pareto designs and the set of convex hull designs; and transmitting the set of recommended designs.
Although the claims at issue are not identical, they are not patentably distinct from each other because they are substantially similar in scope and they use the similar limitations to produce the same end result of globally optimum designs based on the optimality criteria.
It would have been obvious to a person with ordinary skills in the art at the time of the invention was made to modify or to omit the additional elements of claims 1-20 of Patent No. US 12,211,593 B2 to arrive at claims 1-2, 4-6, 8-29 of the instant application because the person would have realized that the remaining element would perform the same functions as before. “Omission of element and its function in combination is obvious expedient if the remaining elements perform same functions as before.” See In re Karlson (CCPA) 136 USPQ 184, decide Jan 16, 1963, Appl. No. 6857, U.S. Court of Customs and Patent Appeals.
5. Claims 1-2, 4-6, 8-29 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over Claims 1-15 of Patent No. US 12,322,479 B2 from the same inventors.
For the purpose of illustration, only claim 1 of the instant application is compared with claim 1 of the '479 patent in the following table:
Table 1
Instant application (17/847040)
Patent No. US 12,322,479 B2
Claim 1 A method comprising: interpreting design data corresponding to a plurality of designs; generating visualization data structured to show a design interface for comparing the plurality of designs,
wherein:
the design interface comprises a 3-plot comprising a set of three graphs
comprising a base graph, a first companion graph, and a second companion graph;
the base graph has a first common axis with the first companion graph and has a
second common axis with the second companion graph; and the first and second common axes are distinct from each other;
generating a line that connects a first point corresponding to a design on a first graph of
the 3-plot with a second point of a second graph of the 3-plot and a third point of a third graph of the 3-plot, wherein the second point and the third point correspond to the design; and transmitting the visualization data.
Claim 1 A method for determining trial designs, the method comprising: obtaining, via at least one processor, simulation data for a set of trial designs that includes all combinations of design options for a set of criteria, wherein the simulation data includes performance parameters and performance parameter values associated with each design in the set of trial designs for the set of criteria; determining, via the at least one processor, an optimality criteria for evaluating the trial designs, wherein the optimality criteria includes Pareto optimality and convex hull optimality for clinical trial design performance values; determining, via the at least one processor and based at least in part on the simulation data, a cooling cycle, a parameter change, and a direction; searching, via the at least one processor and within the set of trial designs, for a set of globally optimum designs based on the optimality criteria using simulated annealing, wherein the simulated annealing is based at least in part on the cooling cycle, the parameter change, and the direction; and recommending, via the at least one processor, the set of globally optimum designs to a user via a user interface.
Although the claims at issue are not identical, they are not patentably distinct from each other because they are substantially similar in scope and they use the similar limitations to produce the same end result of globally optimum designs based on the optimality criteria.
It would have been obvious to a person with ordinary skills in the art at the time of the invention was made to modify or to omit the additional elements of claims 1-15 of Patent No. US 12,322,479 B2 to arrive at claims 1-2, 4-6, 8-29 of the instant application because the person would have realized that the remaining element would perform the same functions as before. “Omission of element and its function in combination is obvious expedient if the remaining elements perform same functions as before.” See In re Karlson (CCPA) 136 USPQ 184, decide Jan 16, 1963, Appl. No. 6857, U.S. Court of Customs and Patent Appeals.
6. Claims 1-2, 4-6, 8-29 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-20 of Patent No. US 12,040,059 B2 from the same inventors.
For the purpose of illustration, only claim 1 of the instant application is compared with claim 1 of the '059 patent in the following table (underlining is used to indicate conflicting limitations):
Table 1
Instant application (17/847040)
Patent No. US 12,040,059 B2
Claim 1 A method comprising: interpreting design data corresponding to a plurality of designs; generating visualization data structured to show a design interface for comparing the plurality of designs,
wherein:
the design interface comprises a 3-plot comprising a set of three graphs
comprising a base graph, a first companion graph, and a second companion graph;
the base graph has a first common axis with the first companion graph and has a
second common axis with the second companion graph; and the first and second common axes are distinct from each other;
generating a line that connects a first point corresponding to a design on a first graph of
the 3-plot with a second point of a second graph of the 3-plot and a third point of a third graph of the 3-plot, wherein the second point and the third point correspond to the design; and transmitting the visualization data.
Claim 1 A method for determining trial designs, the method comprising: receiving, via at least one processor, one or more trial design criteria and one or more scenarios corresponding to a set of trial designs; generating, via the at least one processor, simulation data based at least in part on replicating each of the set of trial designs with the one or more trial design criteria and the one or more scenarios, wherein the simulation data includes performance parameters and performance parameter values associated with each design in the set of designs for a set of criteria, wherein the performance parameters are grouped into two or more distinct types and prioritized based at least in part on a user preference; determining, via the at least one processor, an optimality criteria for evaluating the trial designs; searching, within the set of trial designs, via the at least one processor, for globally optimum designs based on the optimality criteria; evaluating historical clinical trial design selections to identify one or more trial design parameters based at least in part on one or more trial design criteria determined from a user via an interactive interface, wherein generating the simulation data is based at least in part on a quick search data structure and the one or more trial design parameters, wherein evaluating the historical clinical trial design selections comprises generating, as part of the interactive interface, a visualization that depicts a comparison between at least two or more of the historical trial design selections; generating a substitute for at least some of the simulation data based at least in part on a relationship between the simulation data and supplemental data; generating a performance surface based at least in part on the set of trial designs; evaluating one or more trial designs based at least in part on the performance surface; calculating a score based on normalized score component values corresponding to the simulation data; and transmitting, via the at least one processor, globally optimum designs.
Although the claims at issue are not identical, they are not patentably distinct from each other because they are substantially similar in scope and they use the similar limitations to produce the same end result of globally optimum designs based on the optimality criteria.
It would have been obvious to a person with ordinary skills in the art at the time of the invention was made to modify or to omit the additional elements of claims 1-20 of Patent No. US 12,040,059 B2 to arrive at claims 1-2, 4-6, 8-29 of the instant application because the person would have realized that the remaining element would perform the same functions as before. “Omission of element and its function in combination is obvious expedient if the remaining elements perform same functions as before.” See In re Karlson (CCPA) 136 USPQ 184, decide Jan 16, 1963, Appl. No. 6857, U.S. Court of Customs and Patent Appeals.
7. Claims 1-2, 4-6, 8-29 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-19 of Patent No. US 12,051,488 B2 from the same inventors.
For the purpose of illustration, only claim 1 of the instant application is compared with claim 1 of the '488 patent in the following table:
Table 1
Instant application (17/847040)
Patent No. US 12,051,488 B2
Claim 1 A method comprising: interpreting design data corresponding to a plurality of designs; generating visualization data structured to show a design interface for comparing the plurality of designs,
wherein:
the design interface comprises a 3-plot comprising a set of three graphs
comprising a base graph, a first companion graph, and a second companion graph;
the base graph has a first common axis with the first companion graph and has a
second common axis with the second companion graph; and the first and second common axes are distinct from each other;
generating a line that connects a first point corresponding to a design on a first graph of
the 3-plot with a second point of a second graph of the 3-plot and a third point of a third graph of the 3-plot, wherein the second point and the third point correspond to the design; and transmitting the visualization data.
Claim 1 A method comprising: presenting on a graphical interface, via at least one processor, a set of cards wherein each card in the set is representative of a different trial design from a set of trial designs; monitoring, via the at least one processor, a first set of user interactions with the set of cards; determining, via the at least one processor, a user preference for one or more values of one or more parameters of the set of trial designs from the first set of user interactions; presenting on the graphical interface, via the at least one processor, a new card that is representative of a trial design consistent with the determined user preference; monitoring, via the at least one processor, a second set of user interactions with the new card; and refining, via the at least one processor, the determined user preference based at least in part on the second set of user interactions with the new card.
Although the claims at issue are not identical, they are not patentably distinct from each other because they are substantially similar in scope and they use the similar limitations to produce the same end result of globally optimum designs based on the optimality criteria.
It would have been obvious to a person with ordinary skills in the art at the time of the invention was made to modify or to omit the additional elements of claims 1-20 of Patent No. US 12,051,488 B2 to arrive at claims 1-2, 4-6, 8-29 of the instant application because the person would have realized that the remaining element would perform the same functions as before. “Omission of element and its function in combination is obvious expedient if the remaining elements perform same functions as before.” See In re Karlson (CCPA) 136 USPQ 184, decide Jan 16, 1963, Appl. No. 6857, U.S. Court of Customs and Patent Appeals.
8. Claims 1-2, 4-6, 8-29 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-20 of Patent No. US 12,400,743 B2 from the same inventors.
For the purpose of illustration, only claim 1 of the instant application is compared with claim 1 of the '743 patent in the following table:
Table 1
Instant application (17/847040)
Patent No. US 12,400,743 B2
Claim 1 A method comprising: interpreting design data corresponding to a plurality of designs; generating visualization data structured to show a design interface for comparing the plurality of designs,
wherein:
the design interface comprises a 3-plot comprising a set of three graphs
comprising a base graph, a first companion graph, and a second companion graph;
the base graph has a first common axis with the first companion graph and has a
second common axis with the second companion graph; and the first and second common axes are distinct from each other;
generating a line that connects a first point corresponding to a design on a first graph of
the 3-plot with a second point of a second graph of the 3-plot and a third point of a third graph of the 3-plot, wherein the second point and the third point correspond to the design; and transmitting the visualization data.
Claim 1 A method for determining trial designs, the method comprising: receiving, via at least one processor, one or more trial design criteria and one or more scenarios corresponding to a set of trial designs; generating, via the at least one processor, simulation data corresponding to the set of trial designs, wherein the simulation data includes performance parameters grouped into two or more distinct types and prioritized based at least in part on a user preference; determining, via the at least one processor, an optimality criteria for evaluating the trial designs; searching, within the set of trial designs, via the at least one processor, for globally optimum designs based on the optimality criteria; evaluating historical clinical trial design selections to identify one or more trial design parameters based at least in part on one or more trial design criteria determined from a user via an interactive interface; generating, as part of the interactive interface, a visualization that depicts a comparison between at least two or more of the historical clinical trial design selections; generating a substitute for at least some of the simulation data; generating a performance surface based at least in part on the set of trial designs; evaluating one or more trial designs based at least in part on the performance surface; calculating a score based on normalized score component values corresponding to the simulation data; and transmitting, via the at least one processor, globally optimum designs.
Although the claims at issue are not identical, they are not patentably distinct from each other because they are substantially similar in scope and they use the similar limitations to produce the same end result of globally optimum designs based on the optimality criteria.
It would have been obvious to a person with ordinary skills in the art at the time of the invention was made to modify or to omit the additional elements of claims 1-20 of Patent No. US 12,400,743 B2 to arrive at claims 1-2, 4-6, 8-29 of the instant application because the person would have realized that the remaining element would perform the same functions as before. “Omission of element and its function in combination is obvious expedient if the remaining elements perform same functions as before.” See In re Karlson (CCPA) 136 USPQ 184, decide Jan 16, 1963, Appl. No. 6857, U.S. Court of Customs and Patent Appeals.
USC 101 argument answer
Applicant’s arguments regarding the rejection under 35 USC 101 have been fully considered but are not persuasive. To summarize, applicant argues that the claim as a whole, provides an improvement to the functioning of computers or an improvement to other technology or technical field. Examiner disagrees with this assessment and notes that all the claim limitations (including the amended ones), either explicitly receits an abstract idea (e.g. mental process and/or mathematical concept) or is an extra solution activity and there is not a single limitation that can be considered an integration of the abstract idea into a practical application and/or significantly more. As a result , the claim, as a whole fails to show an improvement to the functioning of computers or an improvement to other technology or technical field Therefore, the USC 101 rejection is maintained in the current office action.
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.
9. Claims 1-2, 4-6, 8-29 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 2A Prong One:
Independent Claim 1 recites “interpreting design data corresponding to a plurality of designs; and generating visualization data structured to show for comparing the plurality of designs” all of which can be considered as mental step- which include analyzing/judging or evaluating mentally or using simple pen and paper and thereby these limitations fall within the “mental processes” grouping of abstract ideas.
The claim further recites:
the design interface comprises a 3-plot comprising a set of three graphs comprising a base graph, a first companion graph, and a second companion graph;
the base graph has a first common axis with the first companion graph and has a second common axis with the second companion graph; and
the first and second common axes are distinct from each other; generating a line that connects a first point corresponding to a design on a first graph of the 3-plot with a second point of a second graph of the 3-plot and a third point of a third graph of the 3-plot, wherein the second point and the third point correspond to the design;
all of which can be considered process step that covers both a mathematical concept including mathematical calculations/mathematical relationships and a mental process including an observation, evaluation, judgment or opinion that could be performed in the human mind or with the aid of pencil and paper.
Said limitations in claim 1 are a process that under its broadest reasonable interpretation, covers performance of the limitations in the mind but for the recitation of generic computer components. Other than reciting “a design interface” in the claims nothing in the claim elements precludes the steps from practically being performed in the mind and/or a mathematical step. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind and/or considered a mathematical concept but for the recitation of generic computer components, then it falls within the “mental processes” and “mathematical concept” groupings of abstract ideas. As such Claim 1 recites an abstract idea.
Step 2A Prong Two:
This judicial exception is not integrated into a practical application. The claims recite the additional element of a “a design interface” to perform the method steps at a high level of generality such that it amounts to no more than mere instructions to apply the exception using a generic computer component. This additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
The additional element of “transmitting the visualization data” is simply transmission of data over a network and therefore is a form of extra-solution activity per MPEP 2106.05(d). As such this additional element also does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
Step 2B:
Finally, the post-processing step of transmitting data is categorized as insignificant extra solution activity under 2106.05(d). Claim 1 only recites “a design interface” to perform the method steps and therefore only recite a general purpose computer rather than a specific machine under MPEP 2106.05(b), and are directed to mere instructions to apply the exception under MPEP 2106.05(f), and do not result in anything significantly more than the judicial exception. The additional elements have been considered both individually and as an ordered combination in the significantly more consideration. The inclusion of the computer or memory and interface to perform the interpreting and generating steps amount to nor more than mere instructions to apply the exception using generic computer components. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. Claim 1 is not patent eligible.
The dependent claims include the same abstract ideas recited in the independent claims, and merely incorporate additional details that narrow the abstract ideas and fail to add significantly more to the claims.
Dependent Claim 2 is directed to displaying the design interface; interpreting a user input to the design interface; and adjusting, in response to the user input, the design interface. Displaying the design interface is considered an insignificant extra-solution activity under 2106.05. The interpreting and adjusting steps are process that, under its broadest reasonable interpretation, is a process step that covers mental processes including an observation, evaluation, judgment or opinion that could be performed in the human mind or with the aid of pencil and paper. Thus, the claim is directed to the abstract idea of a mental process performed in the human mind, or with the aid of pencil and paper.
Dependent Claims 4-6 are directed to the composition of display elements of design interface. This is simply instructions to apply the mental process.
Dependent Claims 8-9 are directed to the composition of design interface. This is simply instructions to apply the mental process.
Dependent Claim 10 is directed to identifying a plurality of design variables; ordering values of the plurality of design variables according to a preference; determining a level value to each value of the plurality of design variables according to the ordering; generating a stratification geometry using the determined level values; and comparing designs using the stratification geometry. The ordering, determining, generating and comparing steps are process that, under its broadest reasonable interpretation, is a process step that covers mental processes including an observation, evaluation, judgment or opinion that could be performed in the human mind or with the aid of pencil and paper. Thus, the claim is directed to the abstract idea of a mental process performed in the human mind, or with the aid of pencil and paper.
Dependent Claims 11-16 are directed to the different criteria of comparing the designs. This is simply instructions to apply the mental process.
Dependent Claims 17-20 are directed to the quantitative criteria of identifying a plurality of designs. This is simply instructions to apply the mental process.
Dependent Claim 21 is directed to receiving, for each trial design of a plurality of trial designs, a set of simulated performance criteria for a set of trial designs; visualizing, on a graph, values for a first simulated performance criteria and a second simulated performance criteria from the set of simulated performance criteria for each trial design using a location of points on the graph corresponding to the set of trial designs; identifying optimal designs based on an optimality criteria using the set of the simulated performance criteria; determining a tradeoff metric for the first simulated performance criteria and the second simulated performance criteria; and displaying, the tradeoff metric as a set of lines on the graph, wherein a slope of the lines corresponds to a value of the tradeoff metric. receiving and displaying steps are just data gathering and data display steps and are considered an insignificant extra-solution activity under 2106.05. The visualizing, identifying and determining steps are process that, under its broadest reasonable interpretation, is a process step that covers mental processes including an observation, evaluation, judgment or opinion that could be performed in the human mind or with the aid of pencil and paper. Thus, the claim is directed to the abstract idea of a mental process performed in the human mind, or with the aid of pencil and paper.
Dependent Claims 22- 27 are directed to the quantitative criteria of the tradeoff metric as a set of lines on the graph. This is simply instructions to apply the mental process.
Dependent Claims 28- 29 are directed to the types of graphs. This is simply instructions to apply the mental process.
Conclusion
8. Claims 1-2, 4-6, 8-29 are rejected.
9. 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.
Correspondence Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IFTEKHAR A KHAN whose telephone number is (571)272-5699. The examiner can normally be reached on M-F from 9:00AM-6:00PM (CST). If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Emerson Puente can be reached on (571)272-3652. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/IFTEKHAR A KHAN/Primary Examiner, Art Unit 2187
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