CTNF 18/898,698 CTNF 87854 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia 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 statements (IDS) filed on 12/25/2024 and 9/22/2025 were considered and placed on the file of record by the examiner. Claim Rejections - 35 USC § 102 07-07-aia AIA 07-07 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 – 07-12-aia AIA (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. 07-15-03-aia AIA Claim s 1-3, 7, 10-12 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Metzger et al. (US 2021/0372994) . Regarding claim 1, Metzger teaches a drug discovery support apparatus comprising: a processor configured to: acquire a first section image obtained by imaging a tissue section of at least one of a plurality of subjects constituting an administration group to which a candidate substance for a drug has been administered (see figure 2C, para. 0096, Metzger discusses analyze images from organoids exposed to test molecules); extract a first feature amount from the first section image (see figure 2C, para. 0096, 0111, Metzger discusses analyze images to extract features from organoids exposed to test molecules); acquire a plurality of second section images obtained by imaging tissue sections of a plurality of subjects that have the same attributes and are placed under the same breeding environment as the subjects constituting the administration group and that constitute a control group to which the candidate substance for a drug has not been administered (see para. 0105, Metzger discusses control organoids, which are organoids not exposed to the test molecule and which preferably include non-disease organoids and disease organoids); extract a second feature amount from each of the plurality of second section images (see para. 0105, Metzger discusses the control organoids are imaged and analyzed with the trained neural network that extracts features); acquire third feature amount information related to a third feature amount extracted from each of a plurality of third section images obtained by imaging tissue sections of a plurality of subjects constituting a control group to which the candidate substance was not administered in a past evaluation test (see para. 0056, 0105, 0114, Metzger discusses control organoids, which are organoids not exposed to the test molecule and which preferably include non-disease organoids and disease organoids and extracting image features using a trained neural network); and determine whether or not an abnormality is present in the tissue section included in the first section image on the basis of the first feature amount, the second feature amount, and the third feature amount information (see figure 2C, para. 0096-0101, 0178, Metzger discusses assigning probability score of disease in subject exposed to test molecule). Regarding claim 2, Metzger teaches wherein the processor is configured to: extract the first feature amount and the second feature amount using a machine learning model trained using the plurality of third section images (see para. 0072-0082, 0177-0179, Metzger discusses training a neural network to classify images from subjects). Regarding claim 3, Metzger teaches wherein the first feature amount, the second feature amount, and the third feature amount have the same number of dimensions and are comparable in the same feature amount space (see figures 12A, 13, para. 0177-0179), the third feature amount information is information of a representative position of the plurality of third feature amounts in the feature amount space, and the processor is configured to: calculate a first distance between the representative position and a position of the first feature amount in the feature amount space; (see para. 0178, Metzger discusses representative position is the latent vector of the third cell population); calculate a second distance between the representative position and a position of each of the plurality of second feature amounts in the feature amount space (see para. 0178, Metzger discusses representative position is the latent vector of the third cell population); and perform the determination on the basis of the first distance and the second distance (see figures 12A, 13, para. 0178, 0224, Metzger discusses calculating minimum of distance and standard deviation). Regarding claim 7, Metzger teaches wherein the first feature amount, the second feature amount, and the third feature amount have the same number of dimensions and are comparable in the same feature amount space, the third feature amount information is information of a representative position of the plurality of third feature amounts in the feature amount space, and the processor is configured to: calculate a first distance between the representative position and a position of the first feature amount in the feature amount space; calculate a third distance between a representative position of a plurality of the second feature amounts and the position of the first feature amount in the feature amount space; and perform the determination on the basis of the first distance and the third distance (see figures 12A, 13, para. 0178, 0224, Metzger discusses calculating distance and standard deviation). Regarding claim 10, Metzger teaches wherein the first section image and the second section image are images obtained by imaging a slide specimen on which tissue sections of a plurality of types of organs are placed, and the processor is configured to: identify the tissue sections of each organ from the first section image and the second section image (see para. 0125-0128, 0159, 0178, Metzger discusses identifying tissues); extract the first feature amount and the second feature amount of each of the identified tissue sections of each organ (see figure 2C, para. 0061, 0178, Metzger discusses extracting features from images); and determine whether or not an abnormality is present in each of the tissue sections of each organ included in the first section image on the basis of the first feature amount, the second feature amount, and the third feature amount information (see figure 2C, para. 0096-0101, 0178, Metzger discusses assigning probability score of disease in subject). Claim 11 is rejected as applied to claim 1 as pertaining to a corresponding method. Claim 12 is rejected as applied to claim 1 as pertaining to a corresponding non-transitory computer-readable storage medium . Allowable Subject Matter 12-151-08 AIA 07-43 12-51-08 Claim s 4-6 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. 13-03-01 AIA The following is a statement of reasons for the indication of allowable subject matter: No prior art was found to claim “ 4. The drug discovery support apparatus according to claim 3, wherein the processor is configured to: extract the first feature amount for each of a plurality of first patch images obtained by subdividing the first section image and calculate the first distance for each of the plurality of first patch images; extract the second feature amount for each of a plurality of second patch images obtained by subdividing the second section image and calculate the second distance for each of the plurality of second patch images; and perform the determination on the basis of a first area ratio of the first patch images, for which the first distance is out of a setting range, to the first section image and a second area ratio of the second patch images, for which the second distance is out of the setting range, to the second section image.” 12-151-08 AIA 07-43 12-51-08 Claim s 8-9 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. 13-03-01 AIA The following is a statement of reasons for the indication of allowable subject matter: No prior art was found to claim “8. The drug discovery support apparatus according to claim 7, wherein the processor is configured to: determine that the abnormality is present in the tissue section included in the first section image in a case where a weighted sum of the first distance and the third distance is out of a setting range.” Conclusion 07-96 AIA The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Gregson et al. (US 2019/0164287) discusses administering a drug to a subject and extracting the tissue sample represented by the test image from the subject. Contact Information Any inquiry concerning this communication or earlier communications from the examiner should be directed to KENNY A CESE whose telephone number is (571) 270-1896. The examiner can normally be reached on Monday – Friday, 9am – 4pm. If attempts to reach the primary examiner by telephone are unsuccessful, the examiner’s supervisor, Gregory Morse can be reached on (571) 272-3838. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /Kenny A Cese/ Primary Examiner, Art Unit 2663 Application/Control Number: 18/898,698 Page 2 Art Unit: 2663 Application/Control Number: 18/898,698 Page 3 Art Unit: 2663 Application/Control Number: 18/898,698 Page 4 Art Unit: 2663 Application/Control Number: 18/898,698 Page 5 Art Unit: 2663 Application/Control Number: 18/898,698 Page 6 Art Unit: 2663 Application/Control Number: 18/898,698 Page 7 Art Unit: 2663 Application/Control Number: 18/898,698 Page 8 Art Unit: 2663
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