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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/10/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 (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 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.
Claims 1-4, 7-8, 10-20 is/are rejected under 35 U.S.C. 103 as being obvious over Sakurai et. al. (United States Patent Application Publication US 2018/0330500 A1) in view of Japanese Patent (JP 2023505386 A).
The applied reference has a common applicant (Canon Medical Systems Corporation) with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Regarding claim 1, Sakurai et. al. discloses a medical information processing apparatus comprising: processing circuitry configured to execute a first analysis based on a medical image of a subject, execute a second analysis based on a specimen examination result of the subject (Sakurai et. al. Abstract, Fig. 8, [0046] More specifically, the first obtaining function 452 compares the first medical image data with second medical image data represented by an image of the target site acquired after the tissue was collected and further obtains the image feature value of the tissue based on a change between the first medical image data and the second medical image data. [0057] The second obtaining function 453 obtains an examination result related to expression of a molecular marker at the tissue.), and execute a third analysis based on the medical image and the specimen examination result (Sakurai et. al. [0048]-[0049] By comparing the difference value for each of the corresponding set of pixels between the first medical image and the second medical image, the first obtaining function 452 judges whether or not the pixel is a pixel corresponding to the tissue collected for the biopsy.) and determine diagnosis support information based on the medical image and the specimen examination result under analysis conditions based on the determination result of the matching degree (Sakurai et. al. [0077] The medical information processing apparatus according to the first embodiment is able to have the pieces of relevance information accumulated in each of which an image feature value of a tissue on which a pathological examination was performed is kept in correspondence with the result of the pathological examination performed on the tissue. Accordingly, by using the pieces of relevance information, it is possible to make a prediction for the examination result of the pathological examination based on the medical image, with a high level of precision).
However, Sakurai et. al. fails to disclose execute determination of a matching degree between a result of the first analysis and a result of the second analysis.
The Japanese Patent JP 2023505386 A teaches execute determination of a matching degree between a result of the first analysis and a result of the second analysis (JP 2023505386 A pg. 16, paragraphs 2-3: At 612, the disease designation of 608 may be compared to the external designation of 610 to output a degree of “match”, “no match”, or both. If the disease designation and the external designation match, as indicated via the match branch, the external designation may be cleared and used as the legal designation at 614. Digital images may also be stored to a file at 616 for future use, analysis, or reference). This is important to the claimed invention because the medical image and biopsy match process allows for a greater precision of the correct diagnosis being made between cancer types. Thus, it would have been obvious to one skilled in the art prior to the effective filing date of the claimed invention to have combined the teachings Sakurai et. al. and the Japanese Patent JP 2023505386 A to include matching in the solution of the claimed invention.
Regarding claim 2, Sakurai et. al. and the Japanese Patent JP 2023505386 A disclose the medical information processing apparatus according to claim 1, and the Japanese Patent JP 2023505386 A further discloses wherein the specimen examination result includes a value of a biomarker included in a specimen collected from the subject, and the processing circuitry is further configured to execute the second analysis based on the value of the biomarker, execute the third analysis using machine learning, set the analysis conditions by setting at least one of a parameter, a mode, and a network of the machine learning, and execute the third analysis according to the set analysis conditions (Japanese Patent JP 2023505386 A pg. 16, paragraph 6, Fig. 7).
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Regarding claim 3, Japanese Patent JP 2023505386 A discloses the medical information processing apparatus according to claim 2, wherein the parameter is a weight of an attribute of the biomarker contributing to the third analysis using the machine learning (Japanese Patent JP 2023505386 A pg. 18, paragraph 7: A system for matching a disease designation is a memory storing instructions and receiving at least one digital image corresponding to a target specimen associated with a pathology category, the digital image being an image of human tissue, and/or are images that are algorithmically generated to replicate human tissue; and quality assurance (QA) machine learning to predict disease designation based on one or more biomarkers).
Regarding claim 4, Japanese Patent JP 2023505386 A discloses the medical information processing apparatus according to claim 3, wherein the processing circuitry is further configured to set the weight of the attribute of the biomarker contributing to the third analysis by determining a purpose of the third analysis based on the determination result of the matching degree, the first analysis result, and the second analysis result, determining an attribute of a biomarker to be noted based on the determined purpose of the third analysis, and weighting the determined attribute according to a degree of contribution of the determined attribute contributing to the second analysis (Japanese Patent JP 2023505386 A, pg. 18, paragraph 7: A system for a disease designation is a memory storing instructions and receiving at least one digital corresponding to a target associated with a pathology category, the digital being an of human tissue. and/or are that are algorithmically generated to replicate human tissue; and quality assurance (QA) to predict disease designation based on one or more . Determining a model, wherein the QA model is generated by processing multiple training from the pathology category, and providing the digital as input to the QA model. receiving a disease designation for the digital as an output from the QA model; receiving an external designation for the digital ; comparing the disease designation to the external designation; comparing the disease designation to the external designation; and a processor executing the instructions to perform the process including outputting a comparison result based on doing.).
Regarding claim 7, Sakurai et. al. and the Japanese Patent JP 2023505386 A disclose the medical information processing apparatus according to claim 1, and the Japanese Patent JP 2023505386 A further discloses wherein the processing circuitry is further configured to execute the first analysis further based on the past medical information of the subject (JP 2023505386 A pg. 5, paragraph 2: physician server 21, hospital server 122, clinical trial server 123, research laboratory server 124, and/or laboratory information system 125 may also collect information such as age, medical history, cancer treatment history, family history, previous biopsies, or any combination of patient-specific information, such as cytological information, may be obtained).
Regarding claim 8, Sakurai et. al. and the Japanese Patent JP 2023505386 A disclose the medical information processing apparatus according to claim 1, and the Japanese Patent JP 2023505386 A further discloses wherein the processing circuitry is further configured to execute the second analysis further based on the past medical information of the subject (JP 2023505386 A pg. 10, paragraphs 4-5: QC machine learning algorithms are also trained based on clinical information (e.g. patient information, surgical information, diagnostic information, etc.) laboratory information and/or may receive it as an input).
Regarding claim 10, Japanese Patent JP 2023505386 A discloses the medical information processing apparatus according to claim 2, wherein the processing circuitry is further configured to, in a case where the matching degree is greater than a first threshold and the first and second analysis results are benign, set the analysis conditions for reducing false negative determination (JP 2023505386 A, pg. 16, paragraphs 3-4: At 620, an alert is generated based on a no-match determination, e.g., based on the type of discrepancy if the degree of difference between the disease diagnosis and the external diagnosis exceeds a , or based on the equivalent. good too. Additionally, at 622, redesignation of the digital or corresponding sample may be initiated based on discrepancies between the disease diagnosis and the external diagnosis.)
Regarding claim 11, Japanese Patent JP 2023505386 A discloses the medical information processing apparatus according to claim 10, wherein the processing circuitry is further configured to, in a case where the matching degree is greater than the first threshold and the first and second analysis results are malignant, set the analysis conditions for reducing false positive determination or detecting metastasis and recurrence of a lesion (JP 2023505386 A, pg. 16, paragraphs 3-4: At 620, an alert is generated based on a no-match determination, e.g., based on the type of discrepancy if the degree of difference between the disease diagnosis and the external diagnosis exceeds a , or based on the equivalent. good too. Additionally, at 622, redesignation of the digital or corresponding sample may be initiated based on discrepancies between the disease diagnosis and the external diagnosis.).
Regarding claim 12, Japanese Patent JP 2023505386 A discloses the medical information processing apparatus according to claim 10, wherein the processing circuitry is further configured to, in a case where the matching degree is equal to or less than the first threshold and is equal to or greater than a second threshold, which is less than the first threshold, set the analysis conditions for reducing false negative determination or detecting metastasis and recurrence of a lesion (JP 2023505386 A, pg. 16, paragraphs 3-4: At 620, an alert is generated based on a no-match determination, e.g., based on the type of discrepancy if the degree of difference between the disease diagnosis and the external diagnosis exceeds a , or based on the equivalent. good too. Additionally, at 622, redesignation of the digital or corresponding sample may be initiated based on discrepancies between the disease diagnosis and the external diagnosis.).
Regarding claim 13, Japanese Patent JP 2023505386 A discloses the medical information processing apparatus according to claim 10, wherein the processing circuitry is further configured to, in a case where the matching degree is less than a second threshold, which is less than the first threshold, and the first analysis result is benign or absent, set the analysis conditions for early detection of a lesion (JP 2023505386 A, pg. 16, paragraphs 3-4: At 620, an alert is generated based on a no-match determination, e.g., based on the type of discrepancy if the degree of difference between the disease diagnosis and the external diagnosis exceeds a , or based on the equivalent. good too. Additionally, at 622, redesignation of the digital or corresponding sample may be initiated based on discrepancies between the disease diagnosis and the external diagnosis.).
Regarding claim 14, Japanese Patent JP 2023505386 A discloses the medical information processing apparatus according to claim 10, wherein the processing circuitry is further configured to, in a case where the matching degree is less than a second threshold, which is less than the first threshold, and the first analysis result is benign, set the analysis conditions for reducing false positive determination based on an image or detecting metastasis and recurrence of a lesion (JP 2023505386 A, pg. 16, paragraphs 3-4: At 620, an alert is generated based on a no-match determination, e.g., based on the type of discrepancy if the degree of difference between the disease diagnosis and the external diagnosis exceeds a , or based on the equivalent. good too. Additionally, at 622, redesignation of the digital or corresponding sample may be initiated based on discrepancies between the disease diagnosis and the external diagnosis.).
Regarding claim 15, Japanese Patent JP 2023505386 A discloses the medical information processing apparatus according to claim 10, wherein the processing circuitry is further configured to, in a case where the matching degree is less than a second threshold, which is less than the first threshold, and the first analysis results is malignant, set the analysis conditions for reducing false negative determination based on an image or detecting metastasis and recurrence of a lesion (JP 2023505386 A, pg. 16, paragraphs 3-4: At 620, an alert is generated based on a no-match determination, e.g., based on the type of discrepancy if the degree of difference between the disease diagnosis and the external diagnosis exceeds a , or based on the equivalent. good too. Additionally, at 622, redesignation of the digital or corresponding sample may be initiated based on discrepancies between the disease diagnosis and the external diagnosis.).
Regarding claim 16, Japanese Patent JP 2023505386 A discloses the medical information processing apparatus according to claim 4, wherein the attribute of the biomarker is use of the biomarker (Japanese Patent JP 2023505386 A pg. 10, paragraph 6: A disease designation may be generated based on detection of one or more biomarkers, cancer detection, cancer grade, cancer origin, diagnosis, presence or absence of microorganisms, sample type, cancer type, cancer status, may include one or more tumor size, lesion risk level, grade, or the like).
Regarding claim 17, Japanese Patent JP 2023505386 A discloses the medical information processing apparatus according to claim 1, wherein the specimen examination result includes values of a plurality of kinds of biomarkers, and the processing circuitry execute the second analysis based on the values of the plurality of kinds of biomarkers (Japanese Patent JP 2023505386 A pg. 10, paragraph 6: A disease designation may be generated based on detection of one or more biomarkers, cancer detection, cancer grade, cancer origin, diagnosis, presence or absence of microorganisms, sample type, cancer type, cancer status, may include one or more tumor size, lesion risk level, grade, or the like).
Regarding claim 18, Japanese Patent JP 2023505386 A discloses the medical information processing apparatus according to claim 16, wherein the attribute of the biomarker includes at least one of a general-purpose tumor marker, determination of triple negative breast cancer, determination of a subtype other than triple negative breast cancer, detection of metastasis, early detection, determination of fibroadenoma and determination of cancer recurrence (Japanese Patent JP 2023505386 A pg. 10, paragraph 6: A disease designation may be generated based on detection of one or more biomarkers, cancer detection, cancer grade, cancer origin, diagnosis, presence or absence of microorganisms, sample type, cancer type, cancer status, may include one or more tumor size, lesion risk level, grade, or the like).
Regarding claim 19, which is a medical information processing method comprising of the apparatus of claim 1, which the rejection analysis is incorporated herein.
Regarding claim 20, which is a non-transitory computer-readable storage medium recording a program, the program causing a computer to execute, the medical information processing method of claim 19, which the rejection analysis is incorporated herein.
Allowable Subject Matter
Claims 5, 6, and 9 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.
With regards to claims 5, 6, and 9, the subject-matter does not appear to be part of the prior art. None of the cited documents discloses a medical information processing apparatus that when the degree of contribution of the determined attribute contributing to the second analysis is low, weight the determined attribute more heavily than when the degree of contribution is high, execute the second analysis using machine learning, acquire the degree of contribution from a result of the machine learning used in the second analysis, calculate a score according to the acquired degree of contribution, and weight the determined attribute based on the calculated score, and further configured to determine the matching degree in consideration of likelihood of the first analysis result and likelihood of the second analysis result
The above distinguishing features are considered to be the key inventive solutions of how to predict and diagnosis cancer subtypes more precisely with a machine learning algorithm (see specification [0033]-[0038]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSICA YIFANG LIN whose telephone number is (571)272-6435. The examiner can normally be reached M-F 7:00am-6:15pm, with optional day off.
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/JESSICA YIFANG LIN/Examiner, Art Unit 2668 June 8, 2026
/VU LE/Supervisory Patent Examiner, Art Unit 2668
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