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 .
Double Patenting
1. 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 obviousness-type 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); and 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) maybe used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
2. Claims 1, 5-9, 13-17 and 20 are rejected on the ground of nonstatutory double patenting over claims 1 - 6 of U. S. Patent No. 12,198,334 since the claims, if allowed, would improperly extend the "right to exclude" already granted in the patent.
Claims 1, 5-9, 13-17 and 20 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1 - 6 of U.S. Patent No. 12,198,334. Although the conflicting claims are not identical, they are not patentably distinct from each other because present application is obvious in view of the claims 1 - 2 of the U.S. Patent No. 12,198,334. Specifically, the claims of U.S. Patent (12,198,334) are the same elements, same function, and same result as claims of present application. Omission of element and its function in combination is obvious expedient if remaining elements perform same functions as before. In re KARLSON (CCPA) 136 USPQ 184 (1963).
More specifically, the claims 1, 5-9, 13-17 and 20 of the present application is the same elements, same function, and same result as claims 1 - 6 of the U.S. Patent (12,198,334), specially, the independent claims 1 and 13 of the present application is the same invention as the independent claim 1 of the U.S. Patent (12,198,334).
The subject matter claimed in the instant application is fully disclosed in the patent and is covered by the patent since the patent and the application are claiming common subject matter, as follows, and the difference of the limitations are wordings differently.
For example;
Instant Application
U.S Patent 12,198,334
1. A method for determining tumor status in a subject, the method comprising the steps of:(a) obtaining a first determination of the volume of a brain tumor in a human or animal subject;(b) obtaining a plurality of sectional images of the tumor in the human or animal subject after a period from step (a);(c) computing a second volume of the tumor from a plurality of sectional images from the subject;(d) determining the extent of tumor increase by comparing the first determination of the volume of the tumor from step (a) with the determination of the tumor volume in step (c) by applying an online abrupt change-of-point method to the plurality of sectional images; and(e) modifying a treatment protocol of the human or animal patient to reduce at least one of (i) the rate of increase of the tumor volume and (ii) the volume of the tumor.
13. A method for determining tumor status in a subject, the method comprising the steps of:(a) obtaining a first plurality of sectional images of a brain tumor in a human or animal subject;(b) computing a first volume of the tumor from the first plurality of sectional images;(c) obtaining a second plurality of sectional images of the tumor after a period from step (a);(d) computing a second volume of the tumor from the second plurality of sectional images;(e) determining the extent of tumor increase by comparing the first volume of the tumor from step (b) with the second volume of the tumor volume in step (d) by applying an online abrupt change-of-point method to the plurality of sectional images; and(f) modifying a treatment protocol of the human or animal patient to reduce at least one of (i) the rate of increase of the tumor volume and (ii) the volume of the tumor.
1. A method for determining tumor status in a subject, the method comprising the steps of:(a) obtaining a first plurality of sectional images of a low-grade solid tumor in a human or animal subject; (b) computing a first volume of the tumor from the first plurality of sectional images; (c) obtaining a second plurality of sectional images of the tumor after a period from step (a); (d) computing a second volume of the tumor from the second plurality of sectional images; (e) determining the extent of tumor increase by comparing the first volume of the tumor from step (b) with the second volume of the tumor volume in step (d) by applying an online abrupt change-of-point method to the plurality of sectional images; and (f) modifying a treatment protocol of the human or animal patient to reduce at least one of (i) the rate of increase of the tumor volume and (ii) the volume of the tumor.
The additional limitation is not affecting the scope of the present invention. In addition, even though the claim of present application omitted or rearrangement of the claim structure (simply rearranged and restructured the claim elements using same or similar words), the limitation of independent claim 1 of the U.S. Patent (12,198,334) is encompassed the claimed invention of the independent claim 1 and 13 of the present application.
Therefore, the function and results of the claim invention of present application are same as the claim invention of the U.S. Patent (12,198,334).
Furthermore, the dependent claim 5 of the present application are same function and same result as claim 1 of the U.S. Patent (12,198,334).
The dependent claim 6 of the present application are same function and same result as claim 2 of the U.S. Patent (12,198,334).
The dependent claim 7 of the present application are same function and same result as claim 3 of the U.S. Patent (12,198,334).
The dependent claim 8 of the present application are same function and same result as claim 4 of the U.S. Patent (12,198,334).
The dependent claim 9 of the present application are same function and same result as claim 6 of the U.S. Patent (12,198,334).
The dependent claim 14 of the present application are same function and same result as claim 2 of the U.S. Patent (12,198,334).
The dependent claim 15 of the present application are same function and same result as claim 3 of the U.S. Patent (12,198,334).
The dependent claim 16 of the present application are same function and same result as claim 4 of the U.S. Patent (12,198,334).
The dependent claim 17 of the present application are same function and same result as claim 6 of the U.S. Patent (12,198,334).
The dependent claim 20 of the present application are same function and same result as claim 1 of the U.S. Patent (12,198,334).
Claim Rejections - 35 USC § 102
3. 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 (i.e., changing from AIA to pre-AIA ) 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.
4. Claims 10 - 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Smith (US 2018/0042567).
Regarding claim 10, Smith teaches that a system for determining tumor status in a subject, (system shown in Fig. 1 for determining objective tumor response in a patient, see pages 4, paragraphs 42 – pages 5, paragraphs 50), the system comprising a computing device and logic stored on a non-transitory computer-readable media (computer system (100) with one or more computer readable hardware storage devices that comprise computer executable instructions (logic) (see pages 7, paragraphs 68 and pages 10, paragraphs 91), wherein the logic, when executed by the computing device, generates a determination of the volume of a tumor in the subject from a plurality of sectional images of the tumor (pages 6, paragraphs 60 – 62, Fig. 1, 2, claims 12-13 and 17, and pages 10, paragraphs 91, where teaches a volume metric of the target lesion for each cross-sectional image (102) is determined and summed to calculate the overall tumor burden).
Regarding claim 11, Smith teaches that an imaging scanner operably coupled to the computing device (pages 5, paragraphs 50 – 51 and Fig. 1, where teaches radiologic device (104) such as an MRI or PET device is connected to the computing system (100) via a network (130)), and wherein the imaging scanner generates the plurality of sectional images of the tumor in a human or animal subject (pages 5, paragraphs 50 – 51, Fig. 1, and pages 4, paragraphs 41 - 43 where teaches radiologic device (104) generates cross-sectional images (102) of the tumor in the patient (human or animal)).
Claim Rejections - 35 USC § 103
5. 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.
6. Claims 1-4, 6-8 and 13-19 are rejected under 35 U.S.C. 103 as being unpatentable over Smith in view of JAVED et al. (US 2017/0238867).
Regarding claim 1, Smith teaches that a method for determining tumor status in a subject (abstract, Fig. 1, and pages 4, paragraphs 41 – 43, where teaches method for determining objective tumor response in a patient). Smith teaches that (a) obtaining a first determination of the volume of a brain tumor in a human or animal subject (pages 6, paragraphs 60 – 64, Fig. 1, 2, and claims 12-13 and 17, where teaches a volume metric of the target lesion for each cross-sectional image is determined and summed to calculate the overall tumor burden at a first time point), (b) obtaining a plurality of sectional
images of the tumor in the human or animal subject after a period from step (a) (pages 5, paragraphs 50 – 51, Fig. 1, claims 12-13, 17, and pages 6, paragraphs 60 - 63, where teaches generating cross-sectional images at a second time point), (c) computing a second volume of the tumor from a plurality of sectional images from the subject (pages 6, paragraphs 60 – 64, Fig. 1, 2, and claims 12-13 and 17, where teaches a volume metric of the target lesion for each cross-sectional image is determined and summed to calculate the overall tumor burden at a second time point), (d) determining the extent of tumor increase by comparing the first determination of the volume of the tumor from step (a) with the determination of the tumor volume in step (c) by applying a method to the plurality of sectional images (pages 6, paragraphs 60 – 64, Fig. 1, 2, and claims 12-13 and 17, where teaches calculating a change (method applied) in overall tumor burden between the first and second time points), and (e) modifying a treatment protocol of the human or animal patient to reduce at least one of (i) the rate of increase of the tumor volume and (ii) the volume of the tumor (pages 6, paragraphs 60 – 64, Fig. 1, 2, 10, pages 7, paragraphs 70 – 71, and pages 15, paragraphs 128 - 133, where teaches by determining the change in overall tumor burden between time points, the treatment regimen can be adjusted). Smith does not specifically disclose the limitation “applying an online abrupt change-of-point method”. However, JAVED teaches the limitation “applying an online abrupt change-of-point method” (pages 9, paragraphs 150 – pages 10, paragraphs 157 and Fig. 7, where teaches detecting a change point in the feature using an on-line approach as soon as it occurs) (since it is known that change point methods such as the Bayesian online changepoint detection can be used for modeling and predicting various parameters overtime including various biometric parameters). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention was made to modify the Smith’s method for determining the extent of tumor increase to utilize an online abrupt change-of-point method as taught by JAVED, provide the motivation to achieve an on-line change point detection approach can be used to immediately determine the changes based on the monitored session and furthermore because change-point analysis methods are used in a wide variety of applications for detecting changes in data points overtime.
Regarding claim 2, Smith teaches that the tumor is a high-grade glioma (Fig. 1, 5 and pages 11, paragraphs 94 – 95, where teaches the tumor being a glioma (originating in the brain)).
Regarding claim 3, Smith teaches that the high-grade glioma is a glioblastoma (GBM) (Fig. 1, 5 and pages 11, paragraphs 94 – 95, where teaches the tumor being a glioma (originating in the brain).
Regarding claim 4, Smith teaches that the tumor is a non-solid tumor (Fig. 4, 5 and pages 2, paragraphs 27 – pages 3, paragraphs 37).
Regarding claim 6, Smith teaches that the plurality of sectional images from the subject are generated with an imaging scanner (pages 5, paragraphs 50 – 51, Fig. 1, and pages 6, paragraphs 60 - 63, where teaches cross-sectional images generated by radiologic device such as an MRI, PET, or CT device).
Regarding claim 7, Smith teaches that the plurality of sectional images are magnetic resonance images, positron emission tomography images, or computer tomography images (pages 5, paragraphs 50 – 51, Fig. 1, and pages 6, paragraphs 60 - 63, where teaches radiologic device may be an MRI, PET, or CT device).
Regarding claim 8, Smith teaches that in step (b) the human or animal subject is administered a contrast agent that enhances the plurality of images of the tumor (pages 4, paragraphs 39 – 42, Fig. 1, 2, and pages 5, paragraphs 50 – 52, where teaches the patient may be injected with radiocontrast for contrast-enhanced imaging).
Regarding claim 13, Smith and JAVED teach all the limitations as discussed in claim 1. Furthermore, Smith further teaches that (a) obtaining a first plurality of sectional images of a brain tumor in a human or animal subject (pages 6, paragraphs 60 – 64, Fig. 1, 2, and claims 12-13 and 17, where teaches a volume metric of the target lesion for each cross-sectional image is determined and summed to calculate the overall tumor burden at a first time point), (b) computing a first volume of the tumor from the first plurality of sectional images (pages 5, paragraphs 50 – 51, Fig. 1, claims 12-13, 17, and pages 6, paragraphs 60 - 63, where teaches generating cross-sectional images at a second time point), (c) obtaining a second plurality of sectional images of the tumor after a period from step (a) (pages 6, paragraphs 60 – 64, Fig. 1, 2, and claims 12-13 and 17, where teaches a volume metric of the target lesion for each cross-sectional image is determined and summed to calculate the overall tumor burden at a second time point), (d) computing a second volume of the tumor from the second plurality of sectional images (pages 6, paragraphs 60 – 64, Fig. 1, 2, and claims 12-13 and 17, where teaches a volume metric of the target lesion for each cross-sectional image is determined and summed to calculate the overall tumor burden at a second time point).
Regarding claim 14, Smith and JAVED teach all the limitations as discussed in claims 6 and 13.
Regarding claim 15, Smith and JAVED teach all the limitations as discussed in claims 7 and 13.
Regarding claim 16, Smith and JAVED teach all the limitations as discussed in claims 8 and 13.
Regarding claim 17, Smith and JAVED teach all the limitations as discussed in claims 9 and 13.
Regarding claim 18, Smith and JAVED teach all the limitations as discussed in claims 2 and 13.
Regarding claim 19, Smith and JAVED teach all the limitations as discussed in claims 3 and 13.
7. Claim 5, 9, 12, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Smith in view of JAVED, and in further view of NADOBNY et al. (US 2015/0165225).
Regarding claims 5 and 12, Smith and JAVED do not specifically disclose the limitation “the brain tumor is a low-grade glioma or a glioblastoma”. However, NADOBNY teaches the limitation “the brain tumor is a low-grade glioma or a glioblastoma” (pages 7, paragraphs 45 - 46, where teaches oligodendroglioma or an astroglioma). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention was made to modify the Smith and JAVED method for in order to determine the tumor response for various types of gliomas as taught by NADOBNY, provide the motivation to achieve improving method to determine the tumor response to treatment in a variety of gliomas including an astroglioma.
Regarding claims 9 and 20, Smith and JAVED do not specifically disclose the limitation “the tumor is an oligodendroglioma or an astroglioma”. However, NADOBNY teaches the limitation “the tumor is an oligodendroglioma or an astroglioma” (pages 7, paragraphs 45 - 46, where teaches astrocytoma). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention was made to modify the Smith and JAVED method for in order to determine the tumor response for various types of gliomas as taught by NADOBNY, provide the motivation to achieve improving method to determine the tumor response to treatment in a variety of gliomas including an astroglioma.
Conclusion
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J.L
September 16, 2026
John J Lee
/JOHN J LEE/
Primary Examiner, Art Unit 2649
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