Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
1. Claims 1-3, 5-13, 15-21 have been presented for examination based on the amendment filed on 06/30/2026.
2. Claim interpretation under USC 112(f) of Claims 11 and 17 and subsequent rejection of Claims 11-20 under USC 112(b) is withdrawn based on the persuasive argument presented on the amendment filed on 06/30/2026.
Information Disclosure Statement
3. As required by M.P.E.P. 609(C), the Applicant’s submissions of the Information Disclosure Statement dated June 30, 2026 is acknowledged by the Examiner and the cited references have been considered in the examination of the claims now pending. As required by M.P.E.P. 609 C(2), a copy of each of the PTOL-1449s initialed and dated by the Examiner is attached to the instant Office action.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
4. Claims 1, 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.
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 1
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, wherein the plurality of contour lines are step contours; 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, 10 and 15 of Patent No. US 12,322,479 B2 to arrive at claims 1 and 11 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 1-3, 5-13, 15-21 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 (underlining is used to indicate conflicting limitations):
Table 1
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, wherein the plurality of contour lines are step contours; 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 1-3, 5-13, 15-21 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 1-3, 5-13, 15-21 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 (17/847025)
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, wherein the plurality of contour lines are step contours; 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 1-3, 5-13, 15-21 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 1-3, 5-13, 15-21 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 (underlining is used to indicate conflicting limitations):
Table 1
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, wherein the plurality of contour lines are step contours; 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 1-19 of Patent No. US 12,051,488 B2 to arrive at claims 1-3, 5-13, 15-21 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 1-3, 5-13, 15-21 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 (underlining is used to indicate conflicting limitations):
Table 1
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, wherein the plurality of contour lines are step contours; 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 1-3, 5-13, 15-21 of the instant application because the person would have realized that the remaining element would perform the same functions as before. “Omission of element and its function in combination is obvious expedient if the remaining elements perform same functions as before.” See In re Karlson (CCPA) 136 USPQ 184, decide Jan 16, 1963, Appl. No. 6857, U.S. Court of Customs and Patent Appeals.
USC 101 argument answer
Applicant’ argument regarding USC 101 rejection is not persuasive. Applicant , in the argument states that human mind is not equipped to present a plot of the simulated performance or present a plurality of contour lines, as recited by amended independent claims 1 and 11. Examiner’s response is that this feature can be easily implemented with simple pen and paper and therefore can be considered as simple enough to be conceived in human mind. Additionally, the additional claimed features that is presented in the argument as an improvement to the technology is in fact is very broad and cannot be considered an improvement to the current technique or be considered as significantly more. Therefore, the USC 101 rejection is maintained in the current office action.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
9. Claims 1-3, 5-13, 15-21 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, wherein the plurality of contour lines are step contours in claims 1 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, wherein the plurality of contour lines are step contours (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 2-3, 8-9, 12-13 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.
The dependent claim 21 recite additional steps of defining step contours in terms of predefined points connecting horizontal and vertical lines - 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.
Response to Applicant’s arguments (USC102/103 rejection)
The examiner respectfully disagrees with applicant’s argument.
The amended limitation of the independent claim is stated very broadly and the arguments does not particularly address what is being claimed. The applicant cites excerpts from the specification regarding support for the amended limitation but examiner would like to respectfully remind that the claims and only the claims define the metes and bounds of the invention. It is noted that Applicant seeks to read limitations from the specification into the claims. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Note that "limitations appearing in the specification will not be read into the claims, and ... interpreting what is meant by a word in a claim is not to be confused with adding an extraneous limitation appearing in the specification, which is improper." Intervet Am., v. Kee-Vet Labs., 887 F.2d 1050, 1053, 12 USPQ2d 1474 1476 (fed. Cir. 1989). Now turning to the prior art rejection, Zink, in Figures 3 and 4 shows that power contour based upon 95% confidence intervals for guselkumab and adalimumab responses for the plaque psoriasis example- which anticipates the claim limitation - presenting, for at least one additional criteria, a plurality of contour lines on the plot- furthermore Zink in Figure 8 plots the contour lines in step format, as stipulated by the claim limitation wherein the plurality of contour lines are step contours.
Therefore, Zink anticipates all the limitations of the amended independent claim including the ones in the argument. Therefore, the prior art rejection is maintained in the current rejection.
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, 5-7, 10-11, 15-17 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), wherein the plurality of contour lines are step contours (Zink: Figure 8); 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 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.
11. 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.
Examiner’s Note
12. Claim 21 distinguish over the prior art of record based on the following reasons:
With regards to Claim 21, the closest prior art, Zink, and Ruetsch, either singularly or in combination, fail to anticipate or render obvious distinguishing,
wherein the step contour includes at least three points,
wherein a first pair of the at least three points is connected by a horizontal line,
wherein a second pair of the at least three points is connected by a vertical line oriented
90 degrees with respect to the horizontal line, and
wherein the horizontal line and the vertical line share a common point of the at least three
points.
Examination Considerations
13. Examiner has cited particular columns and line numbers (or paragraphs) 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 imitations 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. The entire reference is considered to provide disclosure relating to the claimed invention.
14. The claims and only the claims form the metes and bounds of the invention. "Office personnel are to give the claims their broadest reasonable interpretation in light of the supporting disclosure. In re Morris, 127 F.3d 1048, 105455, 44USPQ2d 1023, 1027-28 (Fed. Cir. 1997). Limitations appearing in the specification but not recited in the claim are not read into the claim. In re Prater, 415 F.2d, 1393, 1404-05, 162 USPQ 541, 550-551 (CCPA 1969)" (MPEP p 2100-8, c 2, I 45-48; p 2100-9, c 1, I 1-4). The Examiner has full latitude to interpret each claim in the broadest reasonable sense. Examiner will reference prior art using terminology familiar to one of ordinary skill in the art. Such an approach is broad in concept and can be either explicit or implicit in meaning.
15. Examiner's Notes are provided with the cited references to prior art to assist the applicant to better understand the nature of the prior art, application of such prior art and, as appropriate, to further indicate other prior art that maybe applied in other office actions. Such comments are entirely consistent with the intent and spirit of compact prosecution. However, and unless otherwise stated, the Examiner's Notes are not prior art but a link to prior art that one of ordinary skill in the art would find inherently appropriate.
Conclusion
16. Claims 1-3, 5-13, 15-21 are rejected.
17. THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO
MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Correspondence Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IFTEKHAR A KHAN whose telephone number is (571)272-5699. The examiner can normally be reached on M-F from 9:00AM-6:00PM (CST). If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Emerson Puente can be reached on (571)-272-3652. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/IFTEKHAR A KHAN/Primary Examiner, Art Unit 2187
12/302,697—Analogous or Non-Analogous
the applicant argues that no one skilled in the insulating arts would look to a RFID patent. The examiner respectfully disagrees and points out that the when considering analogous of references, we must look not only into the field of endeavor, but also into the purpose or problem addressed. The instant application is directed not just to insulating glass units but how to incorporate an electronic device in the glass unit.
Therefore, electronic device and their manufacture are pertinent to the claimed invention and thus deemed analogous to the claimed invention.
11/968812: (date 2011/12/19)- Analogous or Non-Analogous
In response to Applicant's remarks that Iseli (Iseli; US 2004/0105533), and Tran (Tran; US Pat. No. 7701331) are nonanalogous art, it has been held that a prior art reference must either be in the field of applicant’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the applicant was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992).
Iseli is only relied on to show it is known in the art of location information to include geographic coordinates in location information. One of ordinary skill in the art of location information would have been apprised to include geographic coordinates where a particular environment or design requirements provides a need for a prompt and accurate location detection.
Tran is only relied on to show that it is known in the art of controllers to include a wireless wrist-mountable device. Additionally, it would have been obvious to one of ordinary skill in the art of controllers to include a hardened case when including a wrist-mountable device in order to protect the controller.
Applicant states “there is no need for a hardened case in a simple door lock system. However, there could be a need for a hardened case in an intrusion detection system, as for example in the harsh and rugged conditions of a military environment or the conditions of a penitentiary environment." While it would have been obvious to one of ordinary skill in the art of controllers to include a hardened case when including a wrist-mountable device to protect a controller in a typical office or residential environment and Tran is only relied upon for a wrist-mountable device.
11/912578 : (prima facie case of obviousness)
On page 8, lines 20-23 and page 9, lines 11-12, the applicant argues that here is no objective reason to combine the memory of Mays with the marking element 14 ofPaquier. MPEP § 2143.01(IV) states that a "statement that modifications of the prior art meet the claimed invention ... is not sufficient to establish a prima facie case of obviousness without some objective reason to combine the references."
The examiner respectfully disagrees and points out that there is enough objective reason to combine the reference of Mays and Paquier to establish a prima facie case of obviousness as Paquier teaches electronic device positioned within the window panel/ glazing unit and to be communicated remotely to identification for the characteristics relating to the glazing unit (paragraph 0011 and 0016) and Mays teaches RFID transponder is embedded in a multi-layer glass panel to provide for storage and retrieval of data (Abstract) which is same as Applicant’s invention as to a window panel including at least one electronic device that includes at least one electronic memory in which is stored information that can be read remotely using an appropriate reading apparatus (Applicant’s Abstract).
Motivation to combine the teaching of Mays and Paquier is sufficient to establish a prima facie case of obviousness as we must look not only into the field of endeavor, but also into the purpose or problem addressed. The instant application is directed not just to insulating glass units but how to incorporate an electronic device in the glass unit.
Therefore, Motivation to combine the teaching of Mays and Paquier are pertinent to the claimed invention and thus is sufficient to establish a prima facie case of obviousness to the claimed invention.
KSR Rationale (Just One)
Smith and Sampath are combinable because they are from the same field of endeavor of image processing; e.g., both references disclose methods of tracking the movement of copy sheets in a printing device. Therefore one of ordinary skill in the art could have combined the elements as claimed by known methods, and that in combination, each element merely performs the same function as it does separately. The results of the combination would have been predictable and resulted in modifying the invention of Smith to include factoring in variations based on properties of the media sheet. The suggestion/motivation for doing so is to control the mixing of copy sheets with different characteristics along the paper path. Sampath discloses in the Background of Invention the difficulty of responding to document and copy sheet characteristics such as size, texture, or weight to adjust the machine processing parameters. Sampath further discloses the need to selectively adjust machine timing and hardware responses based on the different characteristics of the media. Therefore, it would have been obvious to combine Sampath’s determining the characteristic of each copy sheet with Smith’s time to completing for a copier method to obtain the invention as specified to better respond to various document and copy sheet characteristics.
Examiner also respectfully points out regarding “Substituting One Known Element for
Another”:
Agrizap, Inc. v. Woodstream Corp., 520 F.3d 1337 (Fed. Cir. 2008).
Teaching point:
Analogous art is not limited to references in the field of endeavor of the invention,
but also includes references that would have been recognized by those of
ordinary skill in the art as useful for applicant’s purpose.
In re ICON Health & Fitness, Inc., 496 F.3d 1374 (Fed. Cir. 2007)
Teaching point:
When determining whether a reference in a different field of endeavor may be used
to support a case of obviousness (i.e., is analogous), it is necessary to consider the
problem to be solved.
(Response 2) In response to applicant's arguments against the references
individually, one cannot show nonobviousness by attacking references individually
where the rejections are based on combinations of references. See In re Keller, 642
F.2d 413,208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091,231
USPQ 375 (Fed. Cir. 1986). This teaching is specifically shown in the Smith
reference Fig.2 and 3. Argument for Smith is shown in Zachmann Fig.1.
Improper Hindsight reasoning :
(Response 3) In response to applicant's argument that the examiner's conclusion of
obviousness is based upon improper hindsight reasoning, it must be recognized that
any judgment on obviousness is in a sense necessarily a reconstruction based upon
Application/Control Number: 12/277,964
Art Unit: 2128
Page 4
hindsight reasoning. But so long as it takes into account only knowledge which was
within the level of ordinary skill at the time the claimed invention was made, and
does not include knowledge gleaned only from the applicant's disclosure, such a
reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209
(CCPA 1971). None of the rationales to combine are used from applicant's
disclosure and they are present in the Smith as cited. Further, one with the level of
ordinary skill at the time the claimed invention was made would have clearly seen
that running collision check from all components of object P with all components of
object Q (as in Zachmann ColA Lines 1-25) is more processing intensive than
running a check with the of all components of each object with the collision region as
shown in Fig.1-3 of Smith, thereby Smith provides a better algorithm and builds on
algorithm of grouping components (as in Zachmann Fig.1) which can be individually
examined for collision (Smith: Section 4.1 & Fig.3).
Claims define the metes and bounds of the invention
The claims and only the claims define the metes and bounds of the invention. It is noted
that Applicant seeks to read limitations from the specification into the claims. Although the
claims are interpreted in light of the specification, limitations from the specification are not read
into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Note
that "limitations appearing in the specification will not be read into the claims, and ... interpreting
what is meant by a word in a claim is not to be confused with adding an extraneous limitation
appearing in the specification, which is improper." Intervet Am., v. Kee-Vet Labs., 887 F.2d
1050, 1053, 12 USPQ2d 1474 1476 (fed. Cir. 1989).
Broadest Reasonable Interpretation:
Examiner is entitled to give claim limitations their broadest reasonable
interpretation in light of the specification. See MPEP 2111 [R-1]
Interpretation of Claims-Broadest Reasonable Interpretation
During patent examination, the pending claims must be 'given the broadest
reasonable interpretation consistent with the specification.' Applicant always has the
opportunity to amend the claims during prosecution and broad interpretation by the
examiner reduces the possibility that the claim, once issued, will be interpreted more
broadly than is justified. In re Prater, 162 USPQ 541,550-51 (CCPA 1969).
USC 101 argument answer
Regarding claim 10 and dependent claims 11 - 16, the Applicant argues that through the amendments to claim 10 which recite “using a path computation engine” and "outputting, to a user,... a plurality of transmission characteristics...”
The Office has considered this argument, however:
(1) The specification states that “the different components, modules, engines, and services described herein may be implemented as objects or processes that execute on the computing system... as well as being implemented as hardware, firmware, and/or some combination of all three” which means that the recited “path computation engine” may simply be a software "process" which is simply computer code because one combination would be where the engine is only a process.
(2) The limitation which “output, to a user” is extra-solution activity.
Due to these reasons the argument is not persuasive. The rejection under 35 USC 101 of these claims is maintained.
EXAMINER SUGGESTION: While simply outputting result to a user is not considered to be significantly more than the judicial exception If, as outlined on page 74626 of the Federal Register/Vol. 79, No. 241 / Tuesday, December 16, 2014 regarding Diamond V. Diehr, there output was used in some way in the real world the claim, as a whole, might be significantly more than the judicial exception. For example, in Diamond v. Diehr, the judicial exception was the Arrhenius equation, however, it was used such that when the recalculated time equals the actual time that has elapsed the press was closed, the computer signals a device to open the press. Because there was a real-world action/activity/result the claim as a whole was more than just the judicial exception. In the instant application, a statistical result is generated and output to a user but there is no real-world use of this calculated result.
Prosecution Insights