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. 17/847025 has Claims 1-20 pending.
Priority / Filing Date
Current Application-filed 06/22/2022, is a continuity-in-part of application 17163423- filed 01/30/2021 (Now Issued patent No. US 12322479) - which claimed priority from U.S. provisional application No. 62/968,874, 63/002,253, 63/002,197, 63/037,977, 63/085,700 and 63/086,474. The priority filing date of this application is October 1, 2020.
Information Disclosure Statement
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 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, 11 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over Claims 1, 10 and 15 of Patent No. US 12,322,479 B2 from the same inventors.
Table 1
Instant application (17/847025) claims
Patent No.
US 12,322,479 B2
Similar limitation claims
Claim 1,11
Claims 1, 10, 15
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 (underlining is used to indicate conflicting limitations):
Table 2
Instant application (17/847025)
Patent No. US 12,322,479 B2
Claim 1 A method for trial design analysis, the method comprising:
receiving, for each trial design of a set of trial designs, simulated performance;
presenting, for at least two criteria, a plot of the simulated performance;
presenting, for at least one additional criteria, a plurality of contour lines on the plot; and selecting a subset of the set of trial designs based on the plurality of contour lines.
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 1-20 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 1-20 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.
Table 1
Instant application (17/847025) claims
Patent No.
US 12,211,593 B2
Similar limitation claims
Claim 1
Claim 1
Claim 2
Claim 2
Claim 3
Claim 3
Claim 4
Claim 4
Claim 5
Claim 5
Claim 6
Claim 6
Claim 7
Claim 7
Claim 8
Claim 8
Claim 9
Claim 9
Claim 10
Claim 10
Claim 11
Claim 11
Claim 12
Claim 12
Claim 13
Claim 13
Claim 14
Claim 14
Claim 15
Claim 15
Claim 16
Claim 16
Claim 17
Claim 17
Claim 18
Claim 18
Claim 19
Claim 19
Claim 20
Claim 20
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 (underlining is used to indicate conflicting limitations):
Table 2
Instant application (17/847025)
Patent No. US 12,211,593 B2
Claim 1 A method for trial design analysis, the method comprising:
receiving, for each trial design of a set of trial designs, simulated performance;
presenting, for at least two criteria, a plot of the simulated performance;
presenting, for at least one additional criteria, a plurality of contour lines on the plot; and selecting a subset of the set of trial designs based on the plurality of contour lines.
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 1-20 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 1-20 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.
Table 1
Instant application (17/847025) claims
Patent No.
US 12,040,059 B2
Similar limitation claims
Claim 1
Claim 1
Claim 2
Claim 2
Claim 3
Claim 3
Claim 4
Claim 4
Claim 5
Claim 5
Claim 6
Claim 6
Claim 7
Claim 7
Claim 8
Claim 8
Claim 9
Claim 9
Claim 10
Claim 10
Claim 11
Claim 11
Claim 12
Claim 12
Claim 13
Claim 13
Claim 14
Claim 14
Claim 15
Claim 15
Claim 16
Claim 16
Claim 17
Claim 17
Claim 18
Claim 18
Claim 19
Claim 19
Claim 20
Claim 20
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 2
Instant application (17/847025)
Patent No. US 12,040,059 B2
Claim 1 A method for trial design analysis, the method comprising:
receiving, for each trial design of a set of trial designs, simulated performance;
presenting, for at least two criteria, a plot of the simulated performance;
presenting, for at least one additional criteria, a plurality of contour lines on the plot; and selecting a subset of the set of trial designs based on the plurality of contour lines.
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 1-20 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 1-20 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.
Table 1
Instant application (17/847025) claims
Patent No.
US 12,051,488 B2
Similar limitation claims
Claim 1
Claim 1
Claim 2
Claim 2
Claim 3
Claim 3
Claim 4
Claim 4
Claim 5
Claim 5
Claim 6
Claim 6
Claim 7
Claim 7
Claim 8
Claim 8
Claim 9
Claim 9
Claim 10
Claim 10
Claim 11
Claim 11
Claim 12
Claim 12
Claim 13
Claim 13
Claim 14
Claim 14
Claim 15
Claim 15
Claim 16
Claim 16
Claim 17
Claim 17
Claim 18
Claim 18
Claim 19
Claim 19
Claim 20
Claim 20
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 (underlining is used to indicate conflicting limitations):
Table 2
Instant application (17/847025)
Patent No. US 12,051,488 B2
Claim 1 A method for trial design analysis, the method comprising:
receiving, for each trial design of a set of trial designs, simulated performance;
presenting, for at least two criteria, a plot of the simulated performance;
presenting, for at least one additional criteria, a plurality of contour lines on the plot; and selecting a subset of the set of trial designs based on the plurality of contour lines.
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 1-20 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 1-20 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.
Table 1
Instant application (17/847025) claims
Patent No.
US 12,400,743 B2
Similar limitation claims
Claim 1
Claim 1
Claim 2
Claim 2
Claim 3
Claim 3
Claim 4
Claim 4
Claim 5
Claim 5
Claim 6
Claim 6
Claim 7
Claim 7
Claim 8
Claim 8
Claim 9
Claim 9
Claim 10
Claim 10
Claim 11
Claim 11
Claim 12
Claim 12
Claim 13
Claim 13
Claim 14
Claim 14
Claim 15
Claim 15
Claim 16
Claim 16
Claim 17
Claim 17
Claim 18
Claim 18
Claim 19
Claim 19
Claim 20
Claim 20
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 (underlining is used to indicate conflicting limitations):
Table 2
Instant application (17/847025)
Patent No. US 12,400,743 B2
Claim 1 A method for trial design analysis, the method comprising:
receiving, for each trial design of a set of trial designs, simulated performance;
presenting, for at least two criteria, a plot of the simulated performance;
presenting, for at least one additional criteria, a plurality of contour lines on the plot; and selecting a subset of the set of trial designs based on the plurality of contour lines.
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 1-20 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 Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
9. This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitations use a generic placeholder (such as “configured to”) that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitations are: “a boundary defining circuit” in Claims 11 and 17.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
10. Claims 11-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
For Claims 11 and 17, the claim limitations “a boundary defining circuit” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The Specification does not disclose the specific algorithm or functional logic of the claim limitations beyond what is recited in the claim limitations themselves. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Any claim not specifically treated is rejected by virtue of its dependency.
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.
11. Claims 1-20 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 claims 1 and 11 recite
Select(ing) a subset of the set of trial designs based on the plurality of contour lines,
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.
Said limitation in claims 1 and 11 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. 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 claims 1 and 11 recite an abstract idea.
Step 2A Prong Two:
This judicial exception is not integrated into a practical application. The claims recite the additional element of “an apparatus”(Claims 11-20) to perform the claimed 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 receive(ing), for each trial design of a set of trial designs, simulated performance (claims 1 & 1) is a data gathering step and is an insignificant pre-solution activity. Additionally, the element of presenting, for at least two criteria, a plot of the simulated performance; presenting, for at least one additional criteria, a plurality of contour lines on the plot in claims 41 and 11 are data display/presentation steps and is insignificant post-solution activity. As such these additional elements also do 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 pre-processing step of receiving simulated performance (claims 1 and 11) and presenting plots of simulated values and contour lines on the plot (claims 1 and 11) is categorized as insignificant extra solution activity under 2106.05(g). Claim 11 only recite “an apparatus” (claim 11) to perform the claimed steps and therefore only recite a general purpose computing element 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 controller to perform the selecting 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. Claims 1 and 11 are 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.
The dependent claims 2-4, 8-9, 12-14 and 18-19 recite additional steps of connection details and criteria of the contour lines- which are additional data representation steps which is categorized as insignificant extra solution activity under 2106.05(g).
The dependent claims 5-6, 15-16 recite additional steps of selection of the subsets- which are process steps that could be performed in the human mind or with the aid of pencil and paper -hence these limitations all encompass “mental process” categorizations of judicial exception without any steps of integrations these exceptions into practical application or significantly more.
The dependent claims 7, 17 recite additional steps of storing the simulated performance - which are additional data storing steps which is categorized as insignificant extra solution activity under 2106.05(g).
The dependent claims 10, 20 recite additional steps of defining a density of the counter lines in terms of a predefined threshold of the design space- which are process steps that could be performed in the human mind or with the aid of pencil and paper -hence these limitations all encompass “mental process” categorizations of judicial exception without any steps of integrations these exceptions into practical application or significantly more.
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.
12. Claims 1, 4-7, 10-11, 14-17 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zink et al. hereafter Zink (“Using Contour Plots to Assess the Sensitivity of Clinical Trial Design Assumptions”, Therapeutic Innovation & Regulatory Science (2016) 496–509).
Regarding Claim 1, Zink discloses a method for trial design analysis (Zink: abstract), the method comprising:
receiving, for each trial design of a set of trial designs, simulated performance (Zink: Figure 1: Sample size versus power for varying sets of treatment response for the plaque psoriasis example);
presenting, for at least two criteria, a plot of the simulated performance (Zink: Figure 2: Power contour for all possible responses for guselkumab and adalimumab for the plaque psoriasis example; Examiner’s Remark (ER): guselkumab and adalimumab-the two criteria);
presenting, for at least one additional criteria, a plurality of contour lines on the plot (Zink: Figure 3 and 4: Power contour based upon 95% confidence intervals for guselkumab and adalimumab responses for the plaque psoriasis example); and
selecting a subset of the set of trial designs based on the plurality of contour lines (Zink: Figures 5-9: final selected sample size based on the plurality of contour lines).
Regarding Claim 11, the claim recites the same substantive limitations as Claim 1 and is rejected using the same teachings.
Regarding Claim 4, Zink further disclose the method of claim 1, wherein the plurality of contour lines are step contours (Zink: Figure 8).
Regarding Claim 14, the claim recites the same substantive limitations as Claim 4 and is rejected using the same teachings.
Regarding Claim 5, Zink further disclose the method of claim 1, wherein selecting the subset comprises selecting a set of designs between two contour lines of the plurality of contour lines (Zink: Figures 3 and 4: Power contour based upon 95% confidence intervals for guselkumab and adalimumab responses for the plaque psoriasis example).
Regarding Claim 15, the claim recites the same substantive limitations as Claim 5 and is rejected using the same teachings.
Regarding Claim 6, Zink further disclose the method of claim 1, wherein selecting the subset comprises selecting a set of designs bounded by at least two contour lines (Zink: Figures 3 and 4: Power contour based upon 95% confidence intervals for guselkumab and adalimumab responses for the plaque psoriasis example).
Regarding Claim 16, the claim recites the same substantive limitations as Claim 6 and is rejected using the same teachings.
Regarding Claim 7, Zink disclose the method of claim 1, further comprising: storing the simulated performance according to a grouping defined by the plurality of contour lines (Zink: Figures 5-9: Examiner’ Remark (ER): storing the simulated performance is an inherent feature of a simulation analysis system).
Regarding Claim 17, the claim recites the same substantive limitations as Claim 7 and is rejected using the same teachings.
Regarding Claim 10, Zink further disclose the method of claim 1, wherein a density of the plurality of contour lines is configured to partition a design space into groups of less than a threshold of designs (Zink: page 501, column 1- page 502 column 2, Figure 5).
Regarding Claim 20, the claim recites the same substantive limitations as Claim 10 and is rejected using the same teachings.
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.
13. Claims 2-4, 8-9, 12-13 and 18-19 are rejected under 35 U.S.C. 103 as being obvious over Zink et al. hereafter Zink (“Using Contour Plots to Assess the Sensitivity of Clinical Trial
Design Assumptions”, Therapeutic Innovation & Regulatory Science (2016) 496–509), in view of Gregory R. Ruetsch, hereafter Ruetsch (Pub. No.: US 2008/0010044 A1).
Regarding Claim 2, Zink do not explicitly disclose wherein the plurality of contour lines connect Pareto optimal designs.
Ruetsch discloses, wherein the plurality of contour lines connect Pareto optimal designs (Ruetsch: Figure 3, [0039], [0063]).
It would have been obvious to one of ordinary skill in the art to combine the sample size calculations steps as taught by Zink with the optimization as taught by Ruetsch since doing so would improve the efficiency and accuracy of the optimization.
Regarding Claim 12, the claim recites the same substantive limitations as Claim 2 and is rejected using the same teachings.
Regarding Claim 3, Zink do not explicitly disclose, wherein the plurality of contour lines connect convex hull designs.
Ruetsch discloses, wherein the plurality of contour lines connect convex hull designs (Ruetsch: Figure 3, [0007], [0015], [0039]).
It would have been obvious to one of ordinary skill in the art to combine the sample size calculations steps as taught by Zink with the optimization as taught by Ruetsch since doing so would improve the efficiency and accuracy of the optimization.
Regarding Claim 13, the claim recites the same substantive limitations as Claim 3 and is rejected using the same teachings.
Regarding Claim 8, Zink do not explicitly disclose, wherein the plurality of contour lines connect Pareto optimal designs of equal values for the least one additional criteria.
Ruetsch discloses, wherein the plurality of contour lines connect Pareto optimal designs of equal values for the least one additional criteria (Ruetsch: Figure 3, Figure 6, [0039], [0063], [0092]-[0100]).
It would have been obvious to one of ordinary skill in the art to combine the sample size calculations steps as taught by Zink with the optimization as taught by Ruetsch since doing so would improve the efficiency and accuracy of the optimization.
Regarding Claim 18, the claim recites the same substantive limitations as Claim 8 and is rejected using the same teachings.
Regarding Claim 9, Zink do not explicitly disclose, wherein the plurality of contour lines connect convex hull designs of equal values for the least one additional criteria.
Ruetsch discloses, wherein the plurality of contour lines connect convex hull designs of equal values for the least one additional criteria (Ruetsch: Figure 3, Figure 6, [0007], [0015], [0039], [0092]-[0100]).
It would have been obvious to one of ordinary skill in the art to combine the sample size calculations steps as taught by Zink with the optimization as taught by Ruetsch since doing so would improve the efficiency and accuracy of the optimization.
Regarding Claim 19, the claim recites the same substantive limitations as Claim 9 and is rejected using the same teachings.
Conclusion
14. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Gravier et al. (Pub. No.: US 2018/0046780 A1) relates to systems for structuring clinical trials protocols into machine interpretable form. A hybrid human and natural language processing system is used to generate a structured computer parseable representation of a clinical trial protocol and its eligibility criteria.
Li et al. (Pub. No.: US 20190355459 A1) teaches methods for adaptive design of a treatment regimen for treatment of subjects with a therapeutic agent. In some embodiments, the methods can determine the optimal dosing regimen, such as dose level and/or schedule to administer to a subject.
Sánchez et al. ("On the construction of experimental designs for a given task by jointly optimizing several quality criteria: Pareto-optimal experimental designs", Analytica Chimica Acta 754 (2012) 39– 46) pertains to ad hoc experimental designs that are generated with an algorithm based on evolutionary algorithms to find the Pareto-optimal front.
Grayling et al. (“Admissible multiarm stepped-wedge cluster randomized trial designs”,2017, John Wiley & Sons Ltd, pp 1103-1119) pertains to the design and analysis of multi-arm stepped-wedge cluster randomized trials, utilized to evaluate the effectiveness of multiple experimental interventions by explaining how the required sample size in these multi-arm trials can be ascertained when data are to be analyzed using a linear mixed model.
Sverdlov et al. (“On Optimal Designs for Clinical Trials: An Updated Review”, 2019, Springer, pp 1-29) provides an overview of optimal designs for various important problems that arise in different stages of clinical drug development, including phase I dose–toxicity studies; phase I/II studies that consider early efficacy and toxicity outcomes simultaneously.
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.
16. 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)272-2. 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