DETAILED ACTION
This office action is in response to the communication received on November 18, 2025 concerning application No. 17/866,246 filed on July 15, 2022.
Claims 1, 3-7 and 15-20 are currently pending.
Claims 15-20 are withdrawn.
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on November 18, 2025 has been entered.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 and 3-7 regarding the prior art rejection have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
Claims 1 and 3-7 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim 1 recites “the computing device…adjusting a clinical prognosis, decision of care, or treatment plan of the subject based on the overall survival value”.
The limitation of adjusting, by the computing device a clinical prognosis, decision of care, or treatment plan of the subject based on the overall survival value is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind exception for the recitation of a generic computer component. That is, other than reciting “computing device”, nothing in the claim element precludes the step from practically being performed in the mind. For example, but for the “computing device” language, “adjusting” in the context of the claim encompasses the user either manually or mentally making a note of a change in the clinical prognosis, decision of care, or treatment plane of the subject by analyzing the overall survival value. If a claim, 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. Accordingly, the claim recites an abstract idea. Additionally, the step of “outputting the clinical prognosis, decision of care, or treatment plan” is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind. For example, “outputting” in the context of the claim encompasses the user manually or mentally outputting the clinical prognosis, decision of care, or treatment plan. Further, the step of “determining, by the processor, a subcortical volume and a cortical thickness of the GBM patient’s brain at a location distant from a primary tumor mass”, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind exception for the recitation of a generic computer component. That is, other than reciting “by the processor”, nothing in the claim element precludes the step from practically being performed in the mind. For example, but for the “processor” language, “determining” in the context of the claim encompasses the user either manually or mentally making note of the overall size of the subcortical space and width of the cortex at a location distant from a primary tumor mass within an image of the patient’s brain. The limitation can additionally encompass a user simply identifying the location of the subcortical volume and cortical thickness within an image of the patient’s brain. The additional steps of “comparing the determined cortical thickness with a cortical thickness in a healthy control” and “comparing the determined subcortical volume with a subcortical volume in a healthy control”, are processes that, under their broadest reasonable interpretation, cover performance of the limitations in the mind. For example, “comparing” in the context of the claim encompasses the user manually or mentally comparing the subcortical volume and cortical thickness of the patients brain image to an image of a healthy control that contains the subcortical volume and cortical thickness.
The judicial exception is not integrated into a practical application. The additional steps of claim 1 are a capturing step and a generating step. The capturing of MRI data from a scan of the brain of the GBM patient amounts to data gathering recited at a high level of generality which is required to obtain the image used in the determining of the subcortical volume and cortical thickness step. Additionally, the generating of morphometric image of the GBM patient amounts to data gathering recited at a high level of generality which is required to obtain the image used in the determination of the subcortical volume and cortical thickness step. Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose meaningful limits on practicing the abstract idea.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. The capturing of the MRI data from a scan of a GBM patient and generating of the morphometric image of the GBM patient from the MRI data have been determined to be well-understood, routine, and conventional activity in the field, as evidenced by Zhang et al. (US 20220343475) which discloses in [0003], “many different types of MRI sequence or ‘Modality’, such as T1-weighted, T2-weighted or T2*-weighted MRI, are well-known. These sequences are routinely pre-programmed into MRI scanners”. This is consistent with the description of morphometric image in [0015] of the present applications specification. For at least these reasons, the additional elements do not result in the claim, as a whole, amounting to significantly more than the judicial exception.
Claims 3-7 further limit the determining of the subcortical volume and cortical thickness step by providing examples of where to determine the subcortical volume and cortical thickness. The claims do not recite additional elements.
Examiner notes that after further consideration of the claims, they are not eligible under 35 USC 101 as discussed above. Applicant is reminded that abstract ideas cannot provide a practical application or significantly more (e.g., an improvement). Both Step 2A Prong 2 and Step 2B require an additional element, not an abstract idea, to provide a practical application or significantly more (e.g., an improvement). See MPEP 2106.05.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1 and 3-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Addanki (US 20220254490) in view of Kinno et al. (“Differential Effects of a Left Frontal Glioma on the Cortical Thickness and Complexity of Both Hemispheres”, hereinafter Kinno) and Yuan et al. (“Structural plasticity of the bilateral hippocampus in glioma patients”, hereinafter Yuan).
Regarding claim 1, Addanki teaches a computer-implemented method ([0040] the computer system 100 which implements the methods) of identifying the overall survival of a glioblastoma (GBM) patient ([0005] “a noninvasive method and data processing system to estimate disease progression, such as a tumor growth rate for GBM”, the estimated disease progression is considered the overall survival), the computer-implemented method implemented by a computing device including at least one processor in communication with a memory device (fig. 10 shows the computer 1002 includes a processor 1005 in communication with memory 1007), the computer-implemented method comprising, the computing device (computer 1002 in fig. 10):
obtaining, from a magnetic resonance imaging (MRI) device, MRI data from a scan of the brain of the GBM patient ([0008] “the data processing system is configured to obtain image data (e.g., an fMRI scan) of the GBM cells”. [0073] “the fMRI image data of a brain region of patient”. The device that obtains the fMRI data is considered the MRI device the generates the image data);
determining by the processor, cortical thickness at a location within the brain of the GBM patient ([0078] “the data processing system is configured to determine a cortical mean thickness…for each region of interest”. [0082] discloses the thickness is determined for the frontal lobe);
comparing the determined cortical thickness with a cortical thickness in a healthy control ([0071] discloses feature vectors are generated from the features extracted from the images. The features include cortical thickness as disclosed in [0078]. The feature vectors are input into a machine learning model which also received baseline image data. The machine learning model associates the input data with data stored in a data store. [0060] additionally discloses the machine learning model compares the feature vectors and image data to the baseline data to generate an output that matches the image data/feature vector. [0073] further discloses the baseline data includes images of tissue of a typical (healthy) patient. Therefore by comparing the image data/feature vectors of the input image data to the baseline data the determined cortical thickness is being compared to a cortical thickness of a healthy control); and
determining an overall survival value based on the comparison ([0061] “the data processing device 120 uses the output classification of the machine learning model 170 to generate (232) a score for a rate of disease progression for the patient”, the generated score is considered the overall survival value);
adjusting a clinical prognosis, decision of care, or treatment plane of the subject based on the overall survival value ([0026] “a length of one or more of the time intervals is automatically adjusted based on a determined growth rate of the diseased cells”, the growth rate corresponds to the overall survival value and the adjustment of the time interval corresponds to at least adjusting a decision of care of the subject. Also see [0085]. [0072] further teaches adjusting a disease progression prediction for the patient based on the scores which reads on adjusting a clinical prognosis); and
outputting the clinical prognosis, decision of care, or treatment plan ([0054] discloses automatically adjusting a length of predefined time intervales to obtain image data which corresponds to outputting the decision of care. [0072] further disclosed generating visualizations of the disease progressions).
Addanki does not specifically teach capturing, from a magnetic resonance imaging (MRI) device, MRI data from a scan of the brain of a GBM patient; generating from the captured MRI data, by the processor, a morphometric image of the GBM patient’s brain; and determining by the processor, cortical thickness at a location distant from a primary tumor mass.
However,
Kinno in a similar field of endeavor teaches capturing, from a magnetic resonance imaging (MRI) device, MRI data from a scan of the brain of a brain tumor patient (pg. 2, “MRI Data Acquisition” subsection discloses conducting MRI scans on participants to acquired brain images. Abstract discloses, the patients have gliomas (brin tumor));
generating from the captured MRI data, by the processor, a morphometric image of the brain tumor patient’s brain (pgs. 2-3, “MRI Data Acquisition” and “MRI Data Processing” subsections disclose the MRI scans are used for acquiring T-1 weighted images of the brain and are used for determining the tumor location); and
determining by the processor, cortical thickness at a location distant from a primary tumor mass (pg. 3, “Cortical Thickness and Central Surface Estimation” subsection discloses estimating cortical thickness (CT) using the MR images. Abstract discloses the patients all had a left lateral frontal glioma and figure 2 on pg. 5 discloses the cortical thickness was determined in the right hemisphere of the patient group, which is a location distant from a primary tumor mass).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the known technique of capturing, from a magnetic resonance imaging (MRI) device, MRI data from a scan of the brain of a GBM patient and generating from the captured MRI data, by the processor, a morphometric image of the GBM patient’s brain of Kinno to the method of Addanki to allow for the predictable results of being able to perform analysis on an image in real time without having to wait for images from an outside source. Thereby reducing overall wait times of the procedure.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Addanki to have determined by the processor, cortical thickness at a location distant from a primary tumor mass in order to more accurately predict the presence of a tumor and thereby more accurately identifying the overall survival of a patient, as recognized by Kinno (Discussion).
Addanki in view of Kinno does not specifically teach determining, by the processor, a subcortical volume of the GBM patient’s brain; comparing the determined subcortical volume with a subcortical volume in a healthy control; and determining an overall survival value based on the comparison.
However,
Yuan in a similar field of endeavor teaches determining, by a processor, a subcortical volume of the GBM patient’s brain (pg. 10265, col. 1, para. 2-col. 2 para. 1, “we performed ROI-based hippocampal volume analysis which can reveal total volume alterations in the hippocampus”, where the volume of the hippocampus represents the subcortical volume. Pg. 10259, “Abstract” further discloses analyzing the hippocampal volume of high-grade glioma patients. Pg. 10260, col. 1, para. 2 further discloses high grade gliomas are graded as class IV which corresponds to a glioblastoma. ); comparing the determined subcortical volume with a subcortical volume in a healthy control (pg. 10261, col. 1 discloses comparing the hippocampal volume in the HCG (high grade glioma) group to the HC (healthy control)); and determining an overall survival value based on the comparison (pg. 10267, col. 1, para 1 discloses “our results showed that a large hippocampal volume was associated with poor overall survival”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the known technique of determining, by the processor, a subcortical volume of the GBM patient’s brain; comparing the determined subcortical volume with a subcortical volume in a healthy control; and determining an overall survival value based on the comparison of Yuan to the method of Addanki in view of Kinno to allow for the predictable results of adding an additional metric to the overall survival determination, thereby increasing the accuracy of the determination.
Regarding claim 3, Addanki in view of Kinno and Yuan teaches the method of claim 1, as set forth above. Kinno further teaches the location distant from the primary tumor mass comprises a right precuneus (pg. 4, “Decreased CT in the Right Hemisphere of the Patient Group” discloses a determining the cortical thickness (CT) in the bilateral parietal lobe, specifically the medial parietal cortex, which corresponds to the right precuneus as observed in fig. 3A of the present applications specification. The cortical thickness was determined to be lower in patient group which consists of patients having a glioma, meaning the presence of lower cortical thickness in the right precuneus corresponds to the presence of a glioma, which can be used to determine overall survival).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the methods disclosed by Addanki in view of Kinno and Yuan to have the location distant from the primary tumor mass comprises a right precuneus in order to determine the progression of the brain tumor.
Regarding claim 4, Addanki in view of Kinno and Yuan teaches the method of claim 1, as set forth above. Kinno further teaches the location distant from the primary tumor mass comprises a temporal lobe (pg. 8, col. 2, para. 2 discloses “rightward asymmetry of the CT in the frontotemporal regions of the normal brain would make it easier to detect the CT decrease in the right hemisphere”, meaning the cortical thickness (CT) of the temporal region (lobe) is utilized for determining the overall cortical thickness. The abstract further discloses cortical thickness is a characteristic that can be used to determine the presence and location of a glioma, thereby determining overall survival).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method disclosed by Addanki in view of Kinno and Yuan to have the location distant from the primary tumor mass comprises a temporal lobe in order to more easily detect the change in cortical thickness of the brain, as recognized by Kinno (pg. 8, col. 2, para. 2).
Regarding claim 5, Addanki in view of Kinno and Yuan teaches the method of claim 1, as set forth above. Kinno further teaches the location distant from the primary tumor mass comprises an occipital lobe (pg. 4, “Decreased CT in the Right Hemisphere of the Patient Group” discloses a lower cortical thickness (CT) in the occipital cortex was determined to be present in the patient group which consists of patients having a glioma, meaning the presence of lower cortical thickness in the occipital lobe corresponds to the presence of a glioma, which can be used to determine overall survival).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method disclosed by Addanki in view of Kinno and Yuan to have the location distant from the primary tumor mass comprises an occipital lobe in order to determine the progression of a tumor within the brain.
Regarding claim 6, Addanki in view of Kinno and Yuan teaches the method of claim 1, as set forth above. Kinno further teaches the location distant from the primary tumor mass comprises sensory cortex (figure 2 on pg. 5 shows the location distant from the primary tumor mass in the left hemisphere for which cortical thickness was determined includes the sensory cortex).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method disclosed by Addanki in view of Kinno and Yuan to have the location distant from the primary tumor mass comprises sensory cortex in order to determine the progression of a tumor within the brain.
Regarding claim 7, Addanki in view of Kinno and Yuan teaches the method of claim 1, as set forth above. Kinno further teaches the location distant from the primary tumor mass comprises right superior parietal areas (pg. 4, “Decreased CT in the Right Hemisphere of the Patient Group” discloses a lower cortical thickness (CT) in the parietal cortex was determined to be present in the patient group which consists of patients having a glioma, meaning the presence of lower cortical thickness in the parietal lobe corresponds to the presence of a glioma, which can be used to determine overall survival. Figure 2 on pg. 5 specifically shows cortical thickness was determined in the right superior parietal areas).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method disclosed by Addanki in view of Kinno and Yuan to have the location distant from the primary tumor mass comprises right superior parietal areas in order to determine the progression of a tumor within the brain.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW BEGEMAN whose telephone number is (571)272-4744. The examiner can normally be reached Monday-Thursday 8:30-5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Keith Raymond can be reached at 5712701790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ANDREW W BEGEMAN/Examiner, Art Unit 3798