DETAILED ACTION
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 .
Allowable Subject Matter
Claims 25-28 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Reasons for allowance will be provided in the event the application becomes in condition for allowance.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 21, 23, 24, 29-36, and 38-40 are rejected under 35 U.S.C. 103 as being unpatentable over Pataer et al. (“Histopathologic Response Criteria Predict Survival of Patients with Resected Lung Cancer After Neoadjuvant Chemotherapy”, copy provided, see PTO-892) in view of SPSS (“SPSS Base 15.0 User’s Guide”, copy provided, see PTO-892).
Regarding claim 21, Pataer et al. (“Histopathologic Response Criteria Predict Survival
of Patients with Resected Lung Cancer After Neoadjuvant Chemotherapy”, copy provided, see PTO-892) discloses:
A method comprising:
receiving one or more images corresponding to a set of samples (see Figure 1, see samples, a-j);
generating, based on the one or more images, one or more sets of parameters, each set of the one or more sets of the parameters comprising dimensions of a sample area of a respective sample, a percentage of the sample area of the respective sample comprising viable cells, a percentage of the sample area of the respective sample comprising necrosis, a percentage of the sample area of the respective sample comprising stroma, or any combination thereof (page 826, Figure 1, the diagram depicts a percentage of stroma, a percentage of necrosis, and a percentage of viable tumor cells; the dimensions are also shown (5-10mm));
displaying, via a first user interface of a computing device, the one or more sets of parameters; receiving at least one user input indicative of a confirmation or a modification of the one or more sets of parameters (page 826, “Statistical Analysis”, the statistical analysis was performed on SPSS Software version 15; SPSS is a statistical software package that operates on a computer an includes a graphical user interface for display that accepts user input)
determining, based on the at least one user input and the one or more sets of parameters, that a weighted percentage of viable cells in the set of samples satisfies a threshold condition (pages 826-827, “Statistical Analysis” and “Patient Demographics and Treatment Characteristics”, it is assessed whether the p value is less than 0.05);
in accordance with a determination that that the weighted percentage of viable cells in the set of samples satisfies the threshold condition, determining that a specified condition is detected in the set of samples (pages 826-827, “Statistical Analysis” and “Patient Demographics and Treatment Characteristics”, if the p value is less than 0.05, the result is taken to be significant); and
displaying, via a second user interface of the computing device, the specified condition (page 826, “Statistical Analysis”, the statistical analysis was performed on SPSS Software version 15;
Even assuming arguendo that Pataer et al. does not explicitly disclose:
displaying, via a first user interface of a computing device, the one or more sets of parameters;
receiving at least one user input indicative of a confirmation or a modification of the one or more sets of parameters
displaying, via a second user interface of the computing device, the specified condition
SPSS (“SPSS Base 15.0 User’s Guide”, copy provided, see PTO-892) discloses:
displaying, via a first user interface of a computing device, the one or more sets of parameters (page 406, Figure 22-1, the parameters are output);
receiving at least one user input indicative of a confirmation or a modification of the one or more sets of parameters (page 407, Figure 22-2, the parameters analyzed can be changed; also see page 409, Figure 22-4, the type of test can also be configured);
determining, based on the at least one user input and the one or more sets of parameters, that the set of samples satisfies a threshold condition (pages 406, 409, Figure 22-4, the threshold condition of a significance level can be specified – for example, .05)
in accordance with a determination that the set of samples satisfies the threshold condition, determining that a specified condition is detected in the set of samples (pages 406, 409, Figure 22-1, 22-4, if the condition is met, the result is significant)
displaying, via a second user interface of the computing device, the specified condition (Figure 22-1, pages 406-409, the results of the test are output)
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to combine the system of SPSS with the system of Pataer such that the system was configured to display, via a first user interface of a computing device, the one or more sets of parameters and received at least one user input indicative of a confirmation or a modification of the one or more sets of parameters as described in SPSS. The suggestion/motivation would have been in order to implement a “comprehensive system for analyzing data” (page iii of the SPSS reference) to help better understand the data at issue.
Regarding claim 23, the combination of Pataer et al. and SPSS discloses the method of the parent claim (claim 21).
SPSS further discloses:
wherein the at least one user input is received in response to a prompt requesting review of the one or more images, the one or more sets of parameters, or both (page 407, Figure 22-2, the parameters analyzed can be changed; also see page 409, Figure 22-4, the type of test can also be configured)
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to combine the system of SPSS with the system of Pataer such that the system was configured such that the at least one user input is received in response to a prompt requesting the one or more sets of parameters as described in SPSS. The suggestion/motivation would have been in order to implement a “comprehensive system for analyzing data” (page iii of the SPSS reference) to help better understand the data at issue.
Regarding claim 24, Pataer et al. additionally discloses:
wherein the specified condition is determined further based on an average percentage of viable cells in the set of samples satisfying a second threshold condition (pages 825-826, as noted previously, mean percentage of viable cells is calculated – see Figure 1; in addition to 0.05, p value being < 0.25 is used to filter variables for further analysis)
Regarding claim 29, the combination of Pataer et al. and SPSS discloses the method of the parent claim (claim 21).
Pataer et al. discloses:
wherein the generating the one or more sets of parameters comprises receiving a portion of the one or more sets of parameters via one or more inputs to a third user interface of the computing device (page 826, “Statistical Analysis”, the statistical analysis was performed on SPSS Software version 15; SPSS is a statistical software package that operates on a computer an includes a graphical user interface for display that accepts user input)
Even assuming arguendo that Pataer et al. does not disclose:
wherein the generating the one or more sets of parameters comprises receiving a portion of the one or more sets of parameters via one or more inputs to a third user interface of the computing device
SPSS discloses:
wherein the generating the one or more sets of parameters comprises receiving a portion of the one or more sets of parameters via one or more inputs to a third user interface of the computing device (pages 21-90, “Chapter 3 Data Files”, the associated interfaces are used for receiving/inputting data)
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to combine the system of SPSS with the system of Pataer et al. such that the generating of the one or more sets of parameters comprised receiving a portion of the one or more sets of parameters via one or more inputs to a third user interface of the computing device as described in SPSS as described. The suggestion/motivation would have been in order to implement a system capable of implementing a “comprehensive system for analyzing data” (page iii of the SPSS reference) to help better understand the data at issue.-
Regarding claim 30, Pataer et al. additionally discloses:
wherein the one or more images correspond to a sample of the set of samples (Figure 1, page 826, the images correspond to samples)
Regarding claim 31, the combination of Pataer et al. and SPSS discloses the method of the parent claim (claim 30).
Pataer et al. does not explicitly disclose:
Displaying, via the first user interface, one or more identifiers of the sample.
SPSS discloses:
Displaying, via the first user interface, one or more identifiers of the sample (page 406, Figure 22-1, the parameters are output; the data is labelled);
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to combine the system of SPSS with the system of Pataer et al. such that the generating of the one or more sets of parameters comprised receiving a portion of the one or more sets of parameters via one or more inputs to a third user interface of the computing device as described in SPSS as described. The suggestion/motivation would have been in order to implement a system capable of implementing a “comprehensive system for analyzing data” (page iii of the SPSS reference) to help better understand the data at issue.
Regarding claim 32, the combination of Pataer et al. and SPSS discloses the method of the parent claim (claim 21).
SPSS additionally discloses:
in response to selection of a user interface object of the second user interface, transmitting, by the computing device, the specified condition to a second computing device (pages 646-660, the data can be exported, including via web server)
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to combine the system of SPSS with the system of Pataer et al. such that in response to selection of a user interface object of the second user interface, the system would transmit, by the computing device, the specified condition to a second computing device as described in SPSS. The suggestion/motivation would have been in order to implement a system capable of implementing a “comprehensive system for analyzing data” (page iii of the SPSS reference) to help better understand the data at issue.
Regarding claim 33, the combination of Pataer et al. and SPSS discloses the method of the parent claim (claim 21).
SPSS additionally discloses:
in response to selection of a user interface object of the second user interface, transmitting, by the computing device, the one or more sets of parameters to a second computing device (pages 646-660, the data can be exported, including via web server)
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to combine the system of SPSS with the system of Pataer et al. such that in response to selection of a user interface object of the second user interface, the system would transmit, by the computing device, the one or more sets of parameters to a second computing device as described in SPSS. The suggestion/motivation would have been in order to implement a system capable of implementing a “comprehensive system for analyzing data” (page iii of the SPSS reference) to help better understand the data at issue.
Regarding claim 34, the combination of Pataer et al. and SPSS discloses the method of the parent claim (claim 21).
Pataer et al. additionally discloses:
the weighted percentage of viable cells in the set of samples, a non-weighted percentage of viable cells in the set of samples, an average percentage of sample areas of the set of samples comprising necrosis, an average percentage of sample areas of the set of samples comprising stroma, a total assessed area of the set of samples, or any combination thereof (page 826, Figure 1, the diagram depicts a percentage of stroma, a percentage of necrosis, and a percentage of viable tumor cells; the dimensions are also shown (5-10mm));
Pataer et al. does not explicitly disclose:
displaying, via the second user interface, the data
SPSS discloses:
displaying, via the second user interface, the data (Figure 22-1, pages 406-409, the results of the test are output)
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to combine the system of SPSS with the system of Pataer such that the system displaying, via the second user interface, the data as described in SPSS. The suggestion/motivation would have been in order to implement a “comprehensive system for analyzing data” (page iii of the SPSS reference) to help better understand the data at issue.
Regarding claim 35, Pataer additionally discloses:
wherein: the weighted percentage is determined based on each sample area of the respective sample relative to a total area of the set of samples (page 826, Figure 1, the diagram depicts a percentage of stroma, a percentage of necrosis, and a percentage of viable tumor cells; the dimensions are also shown (5-10mm));; and
the satisfying of the threshold condition indicates occurrence of the specified condition (pages 826-827, “Statistical Analysis” and “Patient Demographics and Treatment Characteristics”, if the p value is less than 0.05, the result is taken to be significant)
Regarding claim 36, Pataer additionally discloses:
wherein:
a ratio between the each sample area of the respective sample to the total sample area of the set of samples is a weighting factor of the respective sample (page 826, see, for example, the 10 sample areas a-j); and
the weighted percentage is determined by: applying each weighting factor to the percentage of the sample area of the respective sample comprising viable cells to generate an individual weighted percentage of the respective sample and summing the individual weighted percentages (page 826, see, for example, the calculation of mean viable tumor cells in Figure 1)
Regarding claim 38, the combination of Pataer et al. and SPSS discloses the method of the parent claim (claim 21).
SPSS additionally discloses:
further comprising in response to a selection of a user interface element of the first interface, displaying a third user interface of the computing device for receiving one or more sets of second parameters corresponding to a second set of samples (pages 21-90, “Chapter 3 Data Files”, the associated interfaces are used for receiving/inputting data; additional databases/datafiles can be added for modeling)
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to combine the system of SPSS with the system of Pataer et al. such that in response to a selection of a user interface element of the first interface, a third user interface of the computing device was displayed for receiving one or more sets of second parameters corresponding to a second set of samples as described in SPSS. The suggestion/motivation would have been in order to implement a system capable of implementing a “comprehensive system for analyzing data” (page iii of the SPSS reference) to help better understand the data at issue.
Regarding claim 39, arguments analogous to claim 21 are applicable. The processor and computer readable medium is implicitly taught through the use of SPSS in both Pataer et al. (page 826) and in SPSS (throughout).
Regarding claim 40, arguments analogous to claim 21 are applicable. The computer readable medium is implicitly taught through the use of SPSS in both Pataer et al. (page 826) and in SPSS (throughout).
Claim(s) 22 and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Pataer in view of SPSS, in further view of Palk et al. (U.S.P.G. Pub. No. 2021/0216822).
Regarding claim 22, the combination of Pataer et al. and SPSS discloses the method of the parent claim (claim 21).
The combination of Pataer et al. and SPSS does not explicitly disclose:
wherein the generating the one or more sets of parameters comprises applying one or more computer vision models to the one or more images.
Palk et al. (U.S.P.G. Pub. No. 2021/0216822) discloses:
wherein the generating the one or more sets of parameters comprises applying one or more computer vision models to the one or more images (see, for example, paragraph [0010] regarding applying the image analysis algorithm to the medical image)
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to combine the system of Palk with the combination of Pataer et al. and SPSS such that generating the one or more sets of parameters comprised applying one or more computer vision models to the one or more images as described in Palk. The suggestion/motivation would have been in order to implement a system capable of “more accurate labelling…[and] shifting the workload…onto the computer system” (paragraph [0006] of the Palk reference).
Regarding claim 37, the combination of Pataer et al. and SPSS discloses the method of the parent claim (claim 21).
The combination of Pataer et al. and SPSS does not explicitly disclose:
displaying, via the first user interface, the one or more images.
Palk et al. discloses:
displaying, via the first user interface, the one or more images (paragraph [0120], the images are presented the user with prompting)
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to combine the system of Palk with the combination of Pataer et al. and SPSS such that the system would display, via the first user interface, the one or more images as described in Palk. The suggestion/motivation would have been in order to implement a system capable of “more accurate labelling…[and] shifting the workload…onto the computer system” (paragraph [0006] of the Palk reference).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN R WALLACE whose telephone number is (571)270-1577. The examiner can normally be reached Monday-Friday from 8:30-5 PM.
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/JOHN R WALLACE/ Primary Examiner, Art Unit 2682