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
Status
This instant application No. 17/847040 has claims 1-29 pending.
Priority /Filing Date
2. This application claims the benefit of and is a continuation-in-part of U.S. non-Provisional Application Serial No. 17/163,427, filed January 30, 2021, which claims the benefit of priority to U.S. Provisional Patent Application Serial No 62/968,874 filed January 31, 2020, also to U.S. Provisional Patent Application Serial No. 63/002,197, filed March 30, 2020, also to U.S. Provisional Patent Application Serial No. 63/002,253, filed March 30, 2020, also to U.S. Provisional Patent Application Serial No. 63/037,977, filed June 11, 2020, also to U.S. Provisional Patent Application Serial No. 63/085,700, filed September 30, 2020, also to U.S. Provisional Patent Application Serial No. 63/086,474, filed October 1, 2020, also to U.S. Provisional Patent Application Serial No 63/213,473, filed June 22, 2021, also to U.S. Provisional Patent Application Serial No 63/263,523, filed November 4, 2021, also to U.S. Provisional Patent Application Serial No 63/362,726, filed April 8, 2022.
Information Disclosure Statement
3. As required by M.P.E.P. 609(C), the Applicant’s submissions of the Information Disclosure Statements dated September 28, 2023, April 8, 2024, September 25, 2024 and October 16, 2025 are 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 1-29 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; 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 1-29 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 1-29 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; 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 1-29 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 1-29 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; 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 1-29 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 1-29 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; 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 1-29 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 1-29 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; 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 1-29 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.
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 1-29 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. Said limitations in claims 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. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “mental processes” grouping 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 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 3-6 are directed to the composition of display elements of design interface. This is simply instructions to apply the mental process.
Dependent Claim 7 is directed to generating a line that connects a first point corresponding to a design on a first graph of a 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. The generating 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 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.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
10. Claims 1-7, 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Harder et al. (Pub. No.: US 2017/0147794 A1).
Regarding Claim 1, Harder disclose a method comprising:
interpreting design data corresponding to a plurality of designs (Harder: [0005], [0053], [0064]: The database 400 may be one or a plurality of databases that store electronically encoded information comprising the data required to plan, design, and execute a clinical trial. In one example, the data comprises one or more design elements corresponding to the various elements related to one or more clinical trials);
generating visualization data structured to show a design interface for comparing the plurality
of designs (Harder: Figure 2, Figure 3, [0005], [0042]: view a visualization of the events comprising that clinical trial; [0054]-[0057], [0061]-[0068], [0078]-[0079]: the context map in FIG. 2 depicts the relationships of the objectives associated with a clinical trial); and
transmitting the visualization data (Harder: [0042], [0048]: Also, various other forms of computer-readable media may be embedded in devices that may transmit or carry instructions
to a computer, including a router, private or public network, or other transmission device or channel, both wired and wireless.; [0120], [0124]: display a visualization of a treatment arm 2600).
Regarding Claim 2, Harder disclose the method of claim 1 further comprising:
displaying the design interface (Harder: [0005], [0060], [0061]);
interpreting a user input to the design interface (Harder: [0042]-[0047]); and
adjusting, in response to the user input, the design interface (Harder: [0062]-[0063], [0066]).
Regarding Claim 3, Harder disclose the method of claim 1, wherein the design interface comprises a 3-plot (Harder: Figures 12-24).
Regarding Claim 4, Harder disclose the method of claim 3, further comprising:
changing a first display element of a first graph of the 3-plot responsive to a corresponding
change in a second display element of a second graph of the 3-plot (Harder: Figures 12- 24; Examiner’s Remark (ER): matter of design choice).
Regarding Claim 5, Harder disclose the method of claim 4, wherein the first display element comprises a scale of the first graph (Harder: Figures 12- 24; Examiner’s Remark (ER): matter of design choice).
Regarding Claim 6, Harder disclose the method of claim 4, wherein the first display element comprises a zoom level of the first graph (Harder: Figures 12- 24; Examiner’s Remark (ER): matter of design choice).
Regarding Claim 7, Harder disclose the method of claim 1 further comprising:
generating a line that connects a first point corresponding to a design on a first graph of a 3-
plot with a second point of a second graph of the 3-plot and a third point of a third graph of the
plot, wherein the second point and the third point correspond to the design (Harder: Figures 12- 24; Examiner’s Remark (ER): matter of design choice).
Regarding Claim 9, Harder disclose the method of claim 1, wherein the design interface comprises a time line (Harder: Figures 20, 21).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
11. Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Harder et al., hereafter Harder (Pub. No.: US 2017/0147794 A1), in view of Jia et al., hereafter Jia (Pub. No.: US 2014/0024132 A1).
Regarding Claim 8, Harder do not explicitly disclose wherein the design interface comprises a heatmap.
Jia disclose, wherein the design interface comprises a heatmap (Jia: Figures 4, 5, 11, [0021]).
Harder and Jia are analogous art because they are from the same field of endeavor. They both relate to clinical planning and drug evaluation.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the above predictive clinical planning application, as taught by Harder, and incorporating the use of heat map in the application, as taught by Jia.
One of ordinary skill in the art would have been motivated to do this modification in order to demonstrate biochemical alterations in response to the dynamic multicomponent intervention, as suggested by Jia (Jia: abstract).
12. Claims 10-22, 24-29 are rejected under 35 U.S.C. 103 as being unpatentable over Harder et al., hereafter Harder (Pub. No.: US 2017/0147794 A1), in view of Steven Elliot Stupp, hereafter Stupp (Patent No.: US 11,762,950 B1).
Regarding Claim 10, Harder disclose the method of claim 1, further comprising:
identifying a plurality of design variables (Harder: [0059], [0062], [0098], [0103]);
ordering values of the plurality of design variables according to a preference (Harder: [0059], [0062], [0098], [0103]);
determining a level value to each value of the plurality of design variables according to the
ordering (Harder: [0059], [0105], [0106]);
Harder do not explicitly disclose:
generating a stratification geometry using the determined level values; and
comparing designs using the stratification geometry.
Strupp disclose:
generating a stratification geometry using the determined level values (Stupp: column 41 lines 50-52); and
comparing designs using the stratification geometry (Stupp: column 41 line 50-column 42 line 17; column 18 lines 5-39).
Harder and Stupp are analogous art because they are from the same field of endeavor. They both relate to clinical planning and diverse data evaluation.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the above predictive clinical planning application, as taught by Harder, and incorporating the use of global population stratification technique in the application, as taught by Stupp.
One of ordinary skill in the art would have been motivated to do this modification in order to provides a recommendation for the individual, where the recommendation is based at least in part on one or more attributes associated with one or more other individuals in the predetermined segment, as suggested by Stupp (Stupp: abstract).
Regarding Claim 11, the combinations of Harder and Stupp further disclose the method of claim 10, wherein comparing the designs comprises determining a Manhattan distance between designs using the stratification geometry (Stupp: column 45 line 64-column 46 line 13; column 18 lines 5-39).
Regarding Claim 12, the combinations of Harder and Stupp further disclose the method of claim 10, wherein the level values are whole numbers (Stupp: column 13 lines 30-63).
Regarding Claim 13, the combinations of Harder and Stupp further disclose the method of claim 10, wherein the plurality of design variables are a surrogate for qualitative criteria (Harder: [0041], [0058], [0078]).
Regarding Claim 14, the combinations of Harder and Stupp further disclose the method of claim 10, further comprising generating prose language comparing designs (Harder: [0047], [0048]).
Regarding Claim 15, the combinations of Harder and Stupp further disclose the method of claim 10, where comparing designs comprises comparing designs that are twins (Harder: [0078]; Stupp: column 48 lines 43-51).
Regarding Claim 16, the combinations of Harder and Stupp further disclose the method of claim 10, wherein comparing designs comprises determining Lexcode for each design based on the stratification geometry (Harder: [0047], [0048]).
Regarding Claim 17, the combinations of Harder and Stupp further disclose the method of claim 10, wherein the plurality of design variables includes at least three design variables (Harder: [0058], [0059], [0105], [0106]).
Regarding Claim 18, the combinations of Harder and Stupp further disclose the method of claim 10, further comprises identifying a plurality of designs based on quantitative criteria and comparing the designs using the stratification geometry (Harder: [0041], [0058], [0078]; Stupp: column 41 line 50-column 42 line 17; column 18 lines 5-39).
Regarding Claim 19, the combinations of Harder and Stupp further disclose the method of claim 10, further comprises identifying a plurality of designs based on
quantitative criteria and comparing the designs using a Manhattan distance between the designs in the stratification geometry (Stupp: column 41 line 50-column 42 line 17; column 18 lines 5-39).
Regarding Claim 20, the combinations of Harder and Stupp further disclose the method of claim 10, further comprises identifying a plurality of designs based on quantitative criteria and comparing the designs using a Lexcode of the designs in the stratification geometry (Harder: [0041], [0058], [0078]; Stupp: column 41 line 50-column 42 line 17; column 18 lines 5-39).
Regarding Claim 21, Harder disclose the method of claim 1, further comprising:
receiving, for each trial design of a plurality of trial designs, a set of simulated performance
criteria for a set of trial designs (Harder: Figure 3, [0041], [0058], [0078]);
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 (Harder: Figure 3, Figures 17-22, Figures 24-25, [0041], [0058], [0078], [0108], [0115]-[0117]).
using a location of points on the graph corresponding to the set of trial designs (Harder: [0067], [0122]);
identifying optimal designs based on an optimality criteria using the set of the simulated
performance criteria (Harder: Figures 24, [0115]-[0116]);
determining a tradeoff metric for the first simulated performance criteria and the second
simulated performance criteria (Harder: Figure 3, Figures 17-22, Figures 24-25, [0041], [0058], [0078], [0108], [0115]-[0117], Examiner’s Remark (ER): Inclusion and exclusion criteria-tradeoff metric); and
displaying, the tradeoff metric as a set of lines on the graph,
(Harder: Figure 3, Figures 17-22, Figures 24-25, [0041], [0058], [0078], [0108], [0115]-[0117]).
Harper donot explicitly disclose:
wherein a slope of the lines corresponds to a value of the tradeoff metric.
Stupp disclose
wherein a slope of the lines corresponds to a value of the tradeoff metric (Stupp: Figure 1A, column 10 line 46- column 11 line 7).
Harder and Stupp are analogous art because they are from the same field of endeavor. They both relate to clinical planning and diverse data evaluation.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the above predictive clinical planning application, as taught by Harder, and incorporating the use of global population stratification technique in the application, as taught by Stupp.
One of ordinary skill in the art would have been motivated to do this modification in order to provides a recommendation for the individual, where the recommendation is based at least in part on one or more attributes associated with one or more other individuals in the predetermined segment, as suggested by Stupp (Stupp: abstract).
Regarding Claim 22, the combinations of Harder and Stupp further disclose the e method of claim 21, wherein the lines include at least one Pareto optimal design (Stupp: column 18 line 56- column 19 line 21, column 26 lines 37-56).
Regarding Claim 24, the combinations of Harder and Stupp further disclose the method of claim 21, wherein a slope of one of the lines is configurable (Stupp: Figure 1A, column 10 line 46- column 11 line 7).
Regarding Claim 25, the combinations of Harder and Stupp further disclose the method of claim 21 further comprising:
selecting the tradeoff metric via a user input value (Harder: Figure 3, Figures 17-22, Figures 24-25, [0041], [0058], [0078], [0108], [0115]-[0117]).
Regarding Claim 26, the combinations of Harder and Stupp further disclose the method of claim 25 further comprising:
determining selected tradeoffs based at least in part on the selected tradeoff metric (Harder: Figure 3, Figures 17-22, Figures 24-25, [0041], [0058], [0078], [0108], [0115]-[0117]); and
identifying optimal designs based at least in part on the selected tradeoffs (Harder: Figures 24, [0115]-[0116]).
Regarding Claim 27, the combinations of Harder and Stupp further disclose the method of claim 21 further comprising:
highlighting optimal designs in response to changes in a slope of at least one of the set lines (Harder: Figures 24, [0115]- [0116]; Stupp: Figure 1A, column 10 line 46- column 11 line 7).
Regarding Claim 28, the combinations of Harder and Stupp further disclose the method of claim 21, wherein the graph is two-dimensional (Harder: Figures 19-21, 24, [0043], [0110, [0111], [0115]-[0116]).
Regarding Claim 29, the combinations of Harder and Stupp further disclose the method of claim 21, wherein the graph is three-dimensional (Harder: Figures 19-21, 24, [0043], [0110, [0111], [0115]-[0116]; Examiner’s Remark(ER): Design choice).
13. Claims 23 is rejected under 35 U.S.C. 103 as being unpatentable over Harder et al., hereafter Harder (Pub. No.: US 2017/0147794 A1), in view of Steven Elliot Stupp, hereafter Stupp (Patent No.: US 11,762,950 B1), further in view of Gregory R. Ruetsch, hereafter Ruetsch (US20080010044A1).
Regarding Claim 23, the combinations of Harder and Stupp method of claim 21.
However, the combinations do not explicitly disclose:
wherein the lines include at least one convex hull design.
Ruetsch discloses:
wherein the lines include at least one convex hull design (Ruetsch: column 18 line 56- column 19 line 21, column 26 lines 37-56).
Harder, Stupp and Ruetsch are analogous art because they are from the same field of endeavor. All of them relate to clinical planning and diverse data evaluation and optimization.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the above predictive clinical planning application, as taught by the combinations of Harder and Stupp, and incorporating the use of convex hull design technique in the application, as taught by Ruetsch.
One of ordinary skill in the art would have been motivated to do this modification in order to provide an optimized solution for the design-optimization problem from the remaining design variable sub-boxes and the associated parametric Pareto fronts., as suggested by Ruetsch (Ruetsch: abstract).
Conclusion
14. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Buscema et al (Pub. No.: US 2008/0256006 A1) teaches a clinical trial phase simulation method for drug trials, which method allows to predict the trend of the results of a clinical trial phase of a drug with the steps of providing a database comprising for each of a certain number of individuals a predefined number of independent variables each of which corresponds to a certain clinical parameter relevant or characteristic for a disease condition against which the drug to be tested.
Boru et al. (Pub. No.: US 2002/0077853 A1) teaches A system for identifying and selecting a clinical trial, suitable for a specific patient, from a database.
Fuertinger et al. (Pub. No.: US 2019/0019570 A1) conceptually presents techniques and apparatus for generating, performing, and evaluating virtual clinical trials that include clinic modules to represent real-world operational aspects of trial entities.
Lee et al. (Design of experiments for a confirmatory trial of precision medicine, Journal of Statistical Planning and Inference 199 (2019) 179–187) propose a design framework for finding an optimal design that could be implemented in a confirmatory trial- Bayesian data analysis of observed data, and design of experiments. The first tool selects subgroups and treatments to be enrolled in the future trial whereas the second tool provides an optimal treatment randomization scheme for each selected/enrolled subgroups.
Ortiz et al. (Improving the visualization of the Pareto-optimal front for the multi-response optimization of chromatographic determinations, Analytica Chimica Acta 687 (2011) 129–136) shows tools to visualize and more easily interpret the effect that some experimental factors may exert on analytical responses of interest when optimization of several responses is needed. It is based on an adaptation of the parallel coordinate plot, a tool for graphical representation of points in multidimensional spaces that, theoretically and contrary to the usual Cartesian plots, does not have limits in the dimension of the points being depicted.
Sánchez et al. (A useful tool for computation and interpretation of trading-off solutions through pareto-optimal front in the field of experimental designs for mixtures, Chemometrics and Intelligent Laboratory Systems 158 (2016) 210–217) presents an algorithmic implementation to deal with several responses in mixtures problems, without theoretical limits on the number of responses or on the factors to be blended. Also, constrained and unconstrained domains are handled, as well as domains with both mixtures and discrete variables.
15. Examiner’s Remarks: Examiner has cited particular columns and line numbers in the references applied to the claims above for the convenience of the applicant. Although the specified citations are representative of the teachings of the art and are applied to specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested from the applicant in preparing responses, to fully consider the references in their entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the Examiner. In the case of amending the claimed invention, Applicant is respectfully requested to indicate the portion(s) of the specification which dictate(s) the structure relied on for proper interpretation and also to verify and ascertain the metes and bounds of the claimed invention.
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