DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . This is an initial office action in response to communication(s) filed on October 11, 2024.
Claims 1-21 are pending.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on March 28, 2025 was filed in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Interpretation under 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.
Claim 1 recite(s) a computer-implemented method for classifying a patient into a tumor-immune phenotype, the method comprises the processes of: receiving or obtaining the digital microscopy image of an immunofluorescence pathology slide of a patient, producing a plurality of color-based channel images…, aggregating tile level results from at least some of the plurality of tiles …, and classifying the patient into a tumor-immune phenotype (see MPEP §2106, III. Summary of Analysis and Flowchart, in the Flowchart, Step 1 (Yes) ).
The claimed limitations of receiving or obtaining the digital microscopy image of an immunofluorescence pathology slide of a patient, producing a plurality of color-based channel images…, aggregating tile level results from at least some of the plurality of tiles …, and classifying the patient into a tumor-immune phenotype, is a process that, under its broadest reasonable interpretation, covers performance of the limitations in the human mind. For example, the processes of “receiving or obtaining” and “producing” images, in the context of this claim encompasses the user manually receiving and producing such images. Further, the processes of “aggregating” and “classifying the patient…”, in the context of this claim encompasses the user performing such process(es) in human mind. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind of a human being, then it falls within the “Mental Processes” grouping of abstract ideas (i.e. observation, evaluation, judgment, opinion and etc.). Accordingly, the claim recites an abstract idea (see MPEP §2106, III. Summary of Analysis and Flowchart, in the Flowchart, Step 2A; and in MPEP §2106.04 II. A. Step 2A, Prong One (Yes)).
This judicial exception recite additional element(s) has integrated into a practical application because the claim recites the method to be computer-implemented method executed by one or more processors, and comprises the step of classifying the patient into a tumor-immune phenotype of a plurality of tumor-immune phenotypes including immune deserts, immune-excluded tumors and inflamed tumors based on the patient level tumor infiltrating lymphocytes score, the patient level non-tumor infiltrating lymphocytes score, and the patient level non-tumor infiltrating lymphocytes at the tumor margin score. Although each of the receiving or obtaining, producing, aggregating and classifying processes recited in the claim analyzed individually may be viewed as mere pre- or post-solution activity, the claim as a whole is directed to a particular improvement in classifying and/or identifying a patient’s tumor-immune phenotype enables the application of a treatment strategy to target the individual immune biology, and can increase the chance that an individual responds to a specific treatment. The claim as a whole integrates the mental process(es) into a practical application. Thus, the claim is eligible because it is not directed to the recited judicial exception (see MPEP §2106, III. Summary of Analysis and Flowchart, in the Flowchart, Step 2A; and in MPEP §2106.04 II. A. Step 2A, Prong Two (Yes)).
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 1-21 are rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-21 of prior U.S. Patent No. 2025/0037279 A1 (w. Patent Application No. 18/913,485). This is a statutory double patenting rejection.
Allowable Subject Matter
With regard to Claims 1-21, claims 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 and overcoming the corresponding rejections and/or objection (if any) set forth in the Office Action above.
The following is a statement of reasons for the indication of allowable subject matter:
With regard to Claim 1, the closest prior arts of record, Li et al., discloses an invention relates to image processing of digital pathology images to generate outputs characterizing spatial information of particular types of objects in the images. More particularly, a digital pathology image can be processed to generate a metric characterizing a spatial distribution and interrelation of depictions of biological objects of one or more types across all or part of the image. Image analysis includes processing individual images to generate image-level results. For example, a result may be a binary result corresponding to an assessment as to whether the image includes a particular type of object. As another example, a result may include an image-level count of a number of objects of a particular type detected within an image. In the context of digital pathology, a result can include a count of cells of a particular type detected within an image of a sample, a ratio of a count of one type of cell relative to a count of another type of cell across the entire image, and/or a density of a particular type of cell. However, Li et al. do not disclose or suggest fully, among the other limitations, the additional required limitation of “… producing a plurality of color-based channel images each corresponding to a different color-based channel in a plurality of color-based channels for each tile in a plurality of tiles cumulatively corresponding to the at least one digital microscopy image of the IF pathology slide, wherein the plurality of color-based channels comprises an epithelial cell channel including epithelial cell image data, a cell nuclei channel including cell nuclei image data, and at least one lymphocyte channel including lymphocyte image data; for at least some of the tiles in the plurality of tiles, segmenting the epithelial cell image data for the tile into a tumor region and a non-tumor region based on the tissue level tumor mask and the epithelial cell image data; for at least some of the tiles in the plurality of tiles, determining a tumor margin region for the tile based on a pre-specified margin outside a boundary of the tumor region based on the tissue level tumor mask;
for the tiles including lymphocyte image data, determining a location and an area for each lymphocyte within the tile; for at least some of the tiles in the plurality of tiles, calculating a tumor infiltrating lymphocytes score (TILS) based on a total area of the lymphocytes in the tumor region and a total area of the tumor region for the tile; for at least some of the tiles in the plurality of tiles, calculating a non-tumor infiltrating lymphocytes score (NTILS) based on a total area of the lymphocytes in the non-tumor region and a total area of the non-tumor region for the tile; for at least some of the tiles in the plurality of tiles, calculating a non-tumor infiltrating lymphocytes at tumor margin score (NTILSMargin) based on a total area of lymphocytes in the tumor margin and a total area of the tumor margin for the tile; aggregating tile level results from at least some of the plurality of tiles to determine a patient level tumor infiltrating lymphocytes score, a patient level non-tumor infiltrating lymphocytes score, and a patient level non-tumor infiltrating lymphocytes at tumor margin score; and classifying the patient into a tumor-immune phenotype of a plurality of tumor-immune phenotypes including immune deserts, immune-excluded tumors and inflamed tumors based on the patient level tumor infiltrating lymphocytes score, the patient level non-tumor infiltrating lymphocytes score, and the patient level non-tumor infiltrating lymphocytes at the tumor margin score”. These additional features in combination with all the other features required in the claimed invention, are not fully disclosed by Li et al.
With regard to Claims 2-16, the claims are depending from the independent Claim 1, each encompasses the required limitations recited in the independent claim discussed above.
With regard to Claim 17, the closest prior arts of record, Li et al., discloses an invention relates to image processing of digital pathology images to generate outputs characterizing spatial information of particular types of objects in the images. More particularly, a digital pathology image can be processed to generate a metric characterizing a spatial distribution and interrelation of depictions of biological objects of one or more types across all or part of the image. Image analysis includes processing individual images to generate image-level results. For example, a result may be a binary result corresponding to an assessment as to whether the image includes a particular type of object. As another example, a result may include an image-level count of a number of objects of a particular type detected within an image. In the context of digital pathology, a result can include a count of cells of a particular type detected within an image of a sample, a ratio of a count of one type of cell relative to a count of another type of cell across the entire image, and/or a density of a particular type of cell. However, Li et al. do not disclose or suggest fully, among the other limitations, the additional required limitation of “…
produce a plurality of color-based channel images each corresponding to a different color-based channel in a plurality of color-based channels for each image tile in a plurality of image tiles cumulatively corresponding to the at least one digital microscopy image of the IF pathology slide, wherein the plurality of color-based channels comprises: an epithelial channel including epithelial cell image data, a nuclei channel including nuclei image data, and at least one lymphocyte channel including lymphocyte image data; for at least some of the tiles in the plurality of tiles, segment the epithelial channel image for the tile into a tumor region and a non-tumor region based on the tissue level tumor mask and the epithelial cell image data; for at least some of the tiles in the plurality of tiles, determine a tumor margin region for the tile based on a pre-specified margin outside a boundary of the tumor region based on the tissue level tumor mask; for the tiles including lymphocyte image data, determine a location and an area for each lymphocyte within the tile; for at least some of the tiles in the plurality of tiles, calculate a tumor infiltrating lymphocytes score (TILS) based on a total area of the lymphocytes in the tumor region and a total area of the tumor region for the tile; for at least some of the tiles in the plurality of tiles, calculate a non-tumor infiltrating lymphocytes score (NTILS) based on a total area of the lymphocytes in the non-tumor region and a total area of the non-tumor region for the tile; for at least some of the tiles in the plurality of tiles, calculate a non-tumor infiltrating lymphocytes at tumor margin score (NTILSMargin) based on a total area of lymphocytes in the tumor margin and a total area of the tumor margin for the tile; aggregate tile level results from at least some of the plurality of tiles to determine a patient level tumor infiltrating lymphocytes score, a patient level non-tumor infiltrating lymphocytes score, and a patient level non-tumor infiltrating lymphocytes at tumor margin score; and classify the patient into a tumor-immune phenotype of a plurality of tumor- immune phenotypes including immune deserts, immune-excluded tumors and inflamed tumors based on the patient level tumor infiltrating lymphocytes score, the patient level non-tumor infiltrating lymphocytes score, and the patient level non-tumor infiltrating lymphocytes at the tumor margin score”. These additional features in combination with all the other features required in the claimed invention, are not fully disclosed by Li et al.
With regard to Claims 18-21, the claims are depending from the independent Claim 17, each encompasses the required limitations recited in the independent claim discussed above.
Therefore, claims 1-21 are objected to.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Madabhushi et al. (U.S. Pat/Pub No. 10,956,795) disclose an invention relates to predicting recurrence in early stage of non-small cell lung cancer (NSCLC) using spatial arrangement of clusters of tumor infiltrating lymphocytes and cancer nuclei.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jacky X. Zheng whose telephone number is (571) 270-1122. The examiner can normally be reached on Monday - Friday, 9:00 am - 5:00 pm, alt. Friday Off.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Akwasi Sarpong can be reached on (571) 272-3438. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JACKY X ZHENG/Primary Examiner, Art Unit 2681
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