CTNF 18/025,883 CTNF 87366 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. DETAILED ACTION 2. The election with traverse filed 01/05/2026 in response to the Office Action of 11/04/2025 is acknowledged and has been entered. Applicant has elected Group V, claims 80 and 98, drawn to a method of treating cancer involving administering to a cancer patient an antibody drug conjugate (ADC) that includes an ADC payload and an ADC antibody that targets a protein on a cancer cell, wherein the protein is B7-H4, the method comprising: staining a tissue sample of the cancer patient immunohistochemically, using a dye linked to a diagnostic antibody, wherein the diagnostic antibody binds to the protein on the cancer cells in the tissue sample; acquiring a digital image of the tissue sample; detecting cancer cells in the digital image; computing for each cancer cell a single-cell ADC score based on the staining intensities of the dye in the membrane; generating a treatment score by aggregating all single-cell ADC scores of the tissue sample using a statistical operation; and administering a therapy involving the ADC to the cancer patient if the treatment score exceeds a predetermined threshold. 3. Claims 1-20, 39, 59, 80 and 98 are pending in the application. Claims 1-20, 39 and 59 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 01/05/2026. Claims 80 and 98 are currently under prosecution. Election/Restrictions 5. Applicant's traversal of the propriety of the restriction and election requirement set forth in the Office action mailed 11/04/2025 is acknowledged. Applicant’s arguments have been carefully considered but not found persuasive for the following reasons: For the reasons set forth in the preceding Office action mailed 11/04/2025, the different inventions or different species thereof listed, as listed therein, do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2. Then, in light of the grounds of rejection of the claims directed to the elected invention that follow, it is apparent that although the inventions appear to be linked by a common concept, or special technical feature, namely an anti-B7-H4 antibody drug conjugate, because the prior art, Hua et al. (CA 3142641, filed on 06/08/2020) teach an anti-B7-H4 antibody or antigen-binding fragment thereof, and a method of treating cancer in a subject, comprising administering an anti-B7-H4 antibody-drug conjugate to the subject (see entire document, e.g., abstract, Examples 12-14). Thus, any minor differences in the subject matter claimed in the instant application would be seen as an obvious variation of subject matter described by the prior art, this technical feature that appears to link the inventive concepts of the different inventions does not constitute a special technical feature as defined by PCT Rule 13.1, as it does not define a contribution over the prior art. Accordingly, the restriction and election requirement set forth in the Office action mailed 11/04/2025 is deemed proper and therefore made FINAL. Priority 6. Applicant’s claim under 35 U.S.C. §§ 119(e) and/or 365(c) for benefit of the earlier filing date of applications, is acknowledged. Claim Rejections - 35 USC § 112 07-30-02 AIA 7. The following is a quotation of 35 U.S.C. 112(b): (B) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. 8. The following is a quotation of 35 U.S.C. 112 (pre-AIA), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention. 07-34-01 AIA 9. Claim s 80 and 98 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention. Claims 80 and 98 are indefinite because claims recite “a diagnostic antibody”. It is unclear what the diagnostic antibody refers, is it anti-B7-H4 antibody or other anti-cancer antigen antibodies? If B7-H4 protein is not overexpressed on cancer cells, the claimed anti-B7-H4 antibody-drug conjugate should be no target for the cancer cells. For these reasons, it is submitted that the claims fail to delineate the metes and bounds of the subject matter that is regarded as the invention with the requisite clarity and particularity to permit the skilled artisan to know or determine infringing subject matter. 07-06 AIA 15-10-15 10. 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 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. Claim Rejections - 35 USC § 103 07-20-aia AIA 11. 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 of this title, 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. 07-23-aia AIA 12. The factual inquiries set forth in Graham v. John Deere Co. , 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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. 07-21-aia AIA 13. Claim s 80 and 98 are rejected under 35 U.S.C. 103 as being unpatentable over Hua et al. (CA 3142641, filed on 06/08/2020) in view of Chukka et al. (WO 2015/124777, published on 27 August 2015, IDS) . Claims 80 and 98 are herein drawn to a method of treating cancer involving administering to a cancer patient an antibody drug conjugate (ADC) that includes an ADC payload and an ADC antibody that targets a protein on a cancer cell, wherein the protein is B7-H4, the method comprising: staining a tissue sample of the cancer patient immunohistochemically, using a dye linked to a diagnostic antibody, wherein the diagnostic antibody binds to the protein on the cancer cells in the tissue sample; acquiring a digital image of the tissue sample; detecting cancer cells in the digital image; computing for each cancer cell a single-cell ADC score based on the staining intensities of the dye in the membrane; generating a treatment score by aggregating all single-cell ADC scores of the tissue sample using a statistical operation; and administering a therapy involving the ADC to the cancer patient if the treatment score exceeds a predetermined threshold. Hua et al. teach an anti-B7-H4 antibody or antigen-binding fragment thereof, and a method of treating cancer in a subject, comprising administering an anti-B7-H4 antibody-drug conjugate to the subject; see entire document, e.g., abstract, Examples 12-14. Hua et al. do not teach a method of detecting a cancer antigen on a cancer cell. However, this deficiency is remedied by Chukka et al. Chukka et al. teach a method of identifying biomarker-positive cancer cells and generating a response score to predict a response of a cancer patient to an antibody that targets a protein on cancer cells (see figures 1A and 3A; see page 1-lines 10-12), comprising: staining a tissue sample immunohistochemically using a dye linked to a diagnostic antibody, wherein the diagnostic antibody binds to the protein on the cancer cells in the tissue sample (see from page 28, line 21, to page 29, line 11); acquiring a digital image of the tissue sample (see figure 1A, ref. 102); detecting cancer cells in the digital image (see figure 1A, ref. 114, 115, and, figure 3A, ref. S302, S303); computing for each cancer cell a single-cell ADC score based on staining intensities of the dye in the membrane and the cytoplasm of the cancer cell (see figure 1A, ref. 117; see also page 46, lines 23-28, where a score is calculated for each cell based on staining intensities in the membrane and in the cytoplasmic region; see also page 45, lines 9-12); and generating the response score by aggregating all single-cell ADC scores of the tissue sample using a statistical operation (see figure 1, ref. 118, and figure 3A, ref. S305; see pages 48-49, TABLE 1, and page 49, lines 1-5, where a statistical operation is performed on the single-cell scores in order to generate a clinical score per slide). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of the references so as to determining B7-H4 expression on a cancer cell of a patient and then treating the patient using an anti-B7-H4 antibody-drug conjugate. One would have been motivated to do so because Hua et al. teach an anti-B7-H4 antibody and a method of treating cancer in a subject, comprising administering an anti-B7-H4 antibody-drug conjugate to the subject; Chukka et al. teach a method of identifying biomarker-positive cancer cells and generating a response score to predict a response of a cancer patient to an antibody that targets a protein on cancer cells. Thus, one of ordinary skill in the art would have a reasonable expectation of success that by combining the teachings of the references so as to determining B7-H4 expression on a cancer cell of a patient and then treating the patient using an anti-B7-H4 antibody-drug conjugate, because it is obvious to treat the patient once the cancer was diagnosed, and a response score to predict a response of a cancer patient to an antibody that targets a protein on cancer cells has been generated. Conclusion 14. No claim is allowed. 15. Any inquiry concerning this communication or earlier communications from the examiner should be directed to YAN XIAO whose telephone number is (571)270-3578. The examiner can normally be reached M-F 8-5 EST. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. 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If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /YAN XIAO/Primary Examiner, Art Unit 1642 Application/Control Number: 18/025,883 Page 2 Art Unit: 1642 Application/Control Number: 18/025,883 Page 3 Art Unit: 1642 Application/Control Number: 18/025,883 Page 4 Art Unit: 1642 Application/Control Number: 18/025,883 Page 5 Art Unit: 1642 Application/Control Number: 18/025,883 Page 6 Art Unit: 1642 Application/Control Number: 18/025,883 Page 7 Art Unit: 1642