DETAILED ACTION 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. 1. C laims 1, 3, 5, 8, 11, 16, 19, 20, 22, 24-25, 26, 27, 28, 30, and 33-41 as amended on Augus t 20, 2024 are pending and under consideration. Claim Rejections - 35 USC § 112 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. 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 appl icant regards as his invention. 2. Claims 3, 5, 8, and 11 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claims 3, 5, 8, and 11 recites the limitation "the antibody that specifically binds to IL-38" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim because claim 1, from which the claims depend, does not recite "an antibody that specifically binds to IL-38". Claim Rejections - 35 USC § 102 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 – (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale , or otherwise available to the public before the effective filing date of the claimed invention. (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. 3. Claim(s) 1, 3, 5, 8, 11, 16, 19, 20, 22, 25-27 and 38-41 are rejected under 35 U.S.C. 102 (a)(1) and 102 (a)(2) as being anticipated by WO 2021/022037 A1 (Robinson et al. Feb. 04, 2021), “Robinson” evidenced by Cytion (A549 Cell Line: A Keystone in Lung Cancer Research, downloaded March 02, 2026). Robinson tea ches antibodies specific for human interleukin-38 (IL-38) . Robinson teaches t he antibodies, or antigen-binding fragments thereof partially or fully block, inhibit, or neutralize a biological activity of IL 38. Robinson teaches m ethods described here relate to inhibiting tumor growth or metastasis in an individual afflicted by tumor growth and/or metastasis . See Abstract and ¶¶ 0009-0011. Robinson teaches anti-IL-38 antibody CD1- M3 which comprises SEQ ID NOs: 22 and 57, which are the same as the currently claimed SEQ ID NOs: 22 and 57. See Appendix. SEQ ID NO: 22 comprises the VH CDRs1-3 of SEQ ID NOs: 23-25. See Appendix. SEQ ID NO: 57 comprises the VL CDRs1-3 of SEQ ID NOs: 58-60. See Appendix. Robinson teaches that treatment with 10 mg/kg of the CD1-M3 antibody in B16.F10 tumor model reduced tumor growth. See ¶¶ 0030 and 00110 and Fig. 18 . B16.F10 cells are melanoma tumor cells. See p.8-¶ 0047 of the instant specification. Robinson teaches that treatment with 10 mg/kg of the CD1-M3 antibody in a MMT- PyMT breast tumor model reduced tumor growth. See ¶¶ 0032 and 00112 and Fig. 20. Robinson teaches the anti-IL-38 antibody CD1-M26 with a KD of 6.6 x 10 -9 for IL-38 See Table 3-p. 29. Although Robinson does not the antibody sequences of CD1-M26 , the CD1-M26 has the same name and binding affinity as the CD1-M26 disclosed in the instant specification. See Table 3-p. 45 of the instant specification. Thus, the anti-IL-38 antibody CD1-M26 of Robinson appears to be the same of as the CD1-M26 disclosed in the instant specification and would have the same sequences, i.e. SEQ ID NOs: 87 and 92 and the CDRs of SEQ ID NOs: 88-90 and 93-95, as claimed in claims 1, 3, and 25-27. Robinson teaches treating A549 tumor cells in a mouse tumor model with the CD1-M3 and CD1-M26 antibodies. See ¶¶ 0033 and 0113 and Fig. 21. A549 tumor cells are lung cancer cells with a squamous morphology , i.e. they are a squamous cell cancer of the lung. See Cytion p. 1- A549 Origins and Cellular Profile . Robinson teaches the antibodies of the invention can be a humanized or a fully human antibody. See ¶¶ 0053 and claim 22. Robinson teaches t he antibodies, or antigen-binding fragments thereof partially or fully block, inhibit, or neutralize a biological activity of IL 38. See abstract and ¶¶ 0011 and Example 5. Robinson teaches treating cancers of prostate, breast, renal, colorectal, pancreatic, melanoma, uterine, head & neck and lung cancer with the IL-38 antibodies of the invention . See ¶¶ 0059 and 0066. Robinson teaches host cell expression / nucleic acid vector systems for expression of the antibodies of the invention. See ¶¶ 0085-0090. Robinson teaches using CHO cells as host cells for expression of the antibodies. See ¶¶ 0085 and 0093. 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. 4. Claim (s) 1, 3, 5, 8, 11, 16, 19, 20, 22, 24, 25-27 and 38-41 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2021/022037 A1 (Robinson et al. Feb. 04, 2021), “Robinson” evidenced by Cytion (A549 Cell Line: A Keystone in Lung Cancer Research, downloaded March 02, 2026). . Robinson teaches as set forth above. Robinson also teaches that IL-38 is expressed prostate adenocarcinoma (PRAD), colorectal adenocarcinoma (COAD), lung adenocarcinoma (LUAD), skin cutaneous melanoma (SKCM), uterine corpus endometrial carcinoma (UCEC), head & neck squamous cell carcinoma (HNSC) and pancreatic adenocarcinoma (PAAD). See ¶ 0018 and Fig. 7. Although Robinson does not teach treating HNSC with the IL -38 antibodies of the invention, it would have been prima facie obvious at the time the invention was filed given that the level of skill in the art was high to combine the teachings of Robinson and treat HNSC with the IL -38 antibodies of the invention, like CD1-M3 and CD1-M26, because Robinson teaches treating head & neck and lung cancer and other cancers with the IL-38 antibodies of the invention and teaches that HNSC expresses IL-38. O ne would have been motivated to treat IL-38 expressing cancers like HNSC with the IL -38 antibodies of the invention given the anti-cancer activities of the IL-38 antibodies and because Robinson teaches IL-38 may be an immunosuppressive cytokine in the tumor microenvironment and blocking IL-38 could trigger an anti-tumor response. See ¶ 0018 and Fig. 2. Conclusion 5. Claim (s) 1, 3, 5, 8, 11, 16, 19, 20, 22, 24, 25-27 and 38-41 are rejected. Claims 28, 30 and 33- 3 6 are allowable. 6. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT PETER J REDDIG whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-9031 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT M-F 8:30-5:30 Eastern Time . 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, FILLIN "SPE Name?" \* MERGEFORMAT Greg Emch can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT 571-272-8149 . 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. /PETER J REDDIG/ Primary Examiner, Art Unit 1646 APPENDIX SEQ ID NO: 22 alignment with SEQ ID NO: 22 of Robinson BIY86160 (NOTE: this sequence has 1 duplicate in the database searched. See complete list at the end of this report) ID BIY86160 standard; protein; 117 AA. XX AC BIY86160; XX DT 01-APR-2021 (first entry) XX DE Anti-IL-38 antibody (Clone M3 IL38-C) VH region, SEQ 22. XX KW IL-38 protein; antibody; antibody production; antibody therapy; KW breast tumor; cancer; colon tumor; cytostatic; diagnostic test; KW head and neck tumor; heavy chain variable region; immuno-diagnosis; KW interleukin 38; metastasis; monoclonal antibody; prophylactic to disease; KW prostate tumor; protein inhibition; rectal tumor; renal tumor; KW skin cancer; therapeutic. XX OS Mus sp. XX CC PN WO2021022037-A1. XX CC PD 04-FEB-2021. XX CC PF 30-JUL-2020; 2020WO-US044260. XX PR 30-JUL-2019; 2019US-0880265P. XX CC PA (IMMU-) IMMUNOME INC. XX CC PI Robinson MK, Lundgren K, Harman B, Nikitin PA, Dowling JP; XX DR WPI; 2021-129425/016. DR N-PSDB; BIY86159. XX CC PT New isolated interleukin-38 (IL-38)-binding antibody or antigen-binding CC PT fragment comprises optionally contiguous amino acids of complementary- CC PT determining region (CDR) contained within variable heavy chain (VH), for CC PT inhibiting tumor growth. XX CC PS Claim 1; SEQ ID NO 22; 61pp; English. XX CC The present invention relates to an isolated interleukin-38 (IL-38) CC binding antibody or an antigen-binding fragment, which is useful for CC inhibiting tumor growth or metastasis. The antibody comprises a heavy CC chain variable region (VH) of SEQ ID NO: 2, 7, 22, 27, 32, 37, 42, 47 and CC 52 (see BIY86140, BIY86145, BIY86160, BIY86165, BIY86170, BIY86175, CC BIY86180, BIY86185 and BIY86190), light chain variable region (VL) of SEQ CC ID NO: 4, 9, 57, 62, 67, 72, 77 and 82 (see BIY86142, BIY86147, BIY86195, CC BIY86200, BIY86205, BIY86210, BIY86215 and BIY86220), framework region CC (FR), heavy and light chain constant regions and complementarity CC determining region (CDR). The invention further claims a method for CC inhibiting the tumor growth or metastasis in a subject, which involves CC administering to a subject a therapeutically effective amount of a CC composition comprising the antibody, which partially or fully blocks, CC inhibits or neutralizes the biological activity of the IL-38. The CC invention also discloses a method for producing the antibody. The CC antibody of the invention is useful for diagnosing, treating and CC preventing cancer, which includes cancer of prostate, breast, kidney, CC colon and rectum, pancreas, skin uterus, head and neck and lung. XX SQ Sequence 117 AA; Query Match 100.0%; Score 630; Length 117; Best Local Similarity 100.0%; Matches 117; Conservative 0; Mismatches 0; Indels 0; Gaps 0; Qy 1 EVQLQQSGPELVKPGASVKIPCKASGYTFTDYNMDWVKQSHGKSLEWIGDINPNNGGTIY 60 |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| Db 1 EVQLQQSGPELVKPGASVKIPCKASGYTFTDYNMDWVKQSHGKSLEWIGDINPNNGGTIY 60 Qy 61 NQKFKGKATLTVDKSSSTAYMELRSLTSEDTAVYYCSRPYYGYFAYWGQGTLVTVSA 117 ||||||||||||||||||||||||||||||||||||||||||||||||||||||||| Db 61 NQKFKGKATLTVDKSSSTAYMELRSLTSEDTAVYYCSRPYYGYFAYWGQGTLVTVSA 117 SEQ ID NO: 2 3-25 alignment with SEQ ID NO: 22 of Robinson ID BIY86160 standard; protein; 117 AA. XX AC BIY86160; XX DT 01-APR-2021 (first entry) XX DE Anti-IL-38 antibody (Clone M3 IL38-C) VH region, SEQ 22. XX KW IL-38 protein; antibody; antibody production; antibody therapy; KW breast tumor; cancer; colon tumor; cytostatic; diagnostic test; KW head and neck tumor; heavy chain variable region; immuno-diagnosis; KW interleukin 38; metastasis; monoclonal antibody; prophylactic to disease; KW prostate tumor; protein inhibition; rectal tumor; renal tumor; KW skin cancer; therapeutic. XX OS Mus sp. XX CC PN WO2021022037-A1. XX CC PD 04-FEB-2021. XX CC PF 30-JUL-2020; 2020WO-US044260. XX PR 30-JUL-2019; 2019US-0880265P. XX CC PA (IMMU-) IMMUNOME INC. XX CC PI Robinson MK, Lundgren K, Harman B, Nikitin PA, Dowling JP; XX DR WPI; 2021-129425/016. DR N-PSDB; BIY86159. XX CC PT New isolated interleukin-38 (IL-38)-binding antibody or antigen-binding CC PT fragment comprises optionally contiguous amino acids of complementary- CC PT determining region (CDR) contained within variable heavy chain (VH), for CC PT inhibiting tumor growth. XX CC PS Claim 1; SEQ ID NO 22; 61pp; English. XX CC The present invention relates to an isolated interleukin-38 (IL-38) CC binding antibody or an antigen-binding fragment, which is useful for CC inhibiting tumor growth or metastasis. The antibody comprises a heavy CC chain variable region (VH) of SEQ ID NO: 2, 7, 22, 27, 32, 37, 42, 47 and CC 52 (see BIY86140, BIY86145, BIY86160, BIY86165, BIY86170, BIY86175, CC BIY86180, BIY86185 and BIY86190), light chain variable region (VL) of SEQ CC ID NO: 4, 9, 57, 62, 67, 72, 77 and 82 (see BIY86142, BIY86147, BIY86195, CC BIY86200, BIY86205, BIY86210, BIY86215 and BIY86220), framework region CC (FR), heavy and light chain constant regions and complementarity CC determining region (CDR). The invention further claims a method for CC inhibiting the tumor growth or metastasis in a subject, which involves CC administering to a subject a therapeutically effective amount of a CC composition comprising the antibody, which partially or fully blocks, CC inhibits or neutralizes the biological activity of the IL-38. The CC invention also discloses a method for producing the antibody. The CC antibody of the invention is useful for diagnosing, treating and CC preventing cancer, which includes cancer of prostate, breast, kidney, CC colon and rectum, pancreas, skin uterus, head and neck and lung. XX SQ Sequence 117 AA; Query Match 86.6%; Score 162.9; Length 117; Best Local Similarity 39.3%; Matches 33; Conservative 0; Mismatches 0; Indels 51; Gaps 2; Qy 1 KASGYTFTDYNMD--------------DINPNNGGTI----------------------- 23 ||||||||||||| |||||||||| Db 23 KASGYTFTDYNMDWVKQSHGKSLEWIGDINPNNGGTIYNQKFKGKATLTVDKSSSTAYME 82 Qy 24 --------------SRPYYGYFAY 33 |||||||||| Db 83 LRSLTSEDTAVYYCSRPYYGYFAY 106 SEQ ID NO: 57 alignment with SEQ ID NO: 57 of Robinson ID BIY86195 standard; protein; 112 AA. XX AC BIY86195; XX DT 01-APR-2021 (first entry) XX DE Anti-IL-38 antibody (Clone M3 IL38-C) VL region, SEQ 57. XX KW IL-38 protein; antibody; antibody production; antibody therapy; KW breast tumor; cancer; colon tumor; cytostatic; diagnostic test; KW head and neck tumor; immuno-diagnosis; interleukin 38; KW light chain variable region; metastasis; monoclonal antibody; KW prophylactic to disease; prostate tumor; protein inhibition; KW rectal tumor; renal tumor; skin cancer; therapeutic. XX OS Mus sp. XX CC PN WO2021022037-A1. XX CC PD 04-FEB-2021. XX CC PF 30-JUL-2020; 2020WO-US044260. XX PR 30-JUL-2019; 2019US-0880265P. XX CC PA (IMMU-) IMMUNOME INC. XX CC PI Robinson MK, Lundgren K, Harman B, Nikitin PA, Dowling JP; XX DR WPI; 2021-129425/016. DR N-PSDB; BIY86194. XX CC PT New isolated interleukin-38 (IL-38)-binding antibody or antigen-binding CC PT fragment comprises optionally contiguous amino acids of complementary- CC PT determining region (CDR) contained within variable heavy chain (VH), for CC PT inhibiting tumor growth. XX CC PS Claim 1; SEQ ID NO 57; 61pp; English. XX CC The present invention relates to an isolated interleukin-38 (IL-38) CC binding antibody or an antigen-binding fragment, which is useful for CC inhibiting tumor growth or metastasis. The antibody comprises a heavy CC chain variable region (VH) of SEQ ID NO: 2, 7, 22, 27, 32, 37, 42, 47 and CC 52 (see BIY86140, BIY86145, BIY86160, BIY86165, BIY86170, BIY86175, CC BIY86180, BIY86185 and BIY86190), light chain variable region (VL) of SEQ CC ID NO: 4, 9, 57, 62, 67, 72, 77 and 82 (see BIY86142, BIY86147, BIY86195, CC BIY86200, BIY86205, BIY86210, BIY86215 and BIY86220), framework region CC (FR), heavy and light chain constant regions and complementarity CC determining region (CDR). The invention further claims a method for CC inhibiting the tumor growth or metastasis in a subject, which involves CC administering to a subject a therapeutically effective amount of a CC composition comprising the antibody, which partially or fully blocks, CC inhibits or neutralizes the biological activity of the IL-38. The CC invention also discloses a method for producing the antibody. The CC antibody of the invention is useful for diagnosing, treating and CC preventing cancer, which includes cancer of prostate, breast, kidney, CC colon and rectum, pancreas, skin uterus, head and neck and lung. XX SQ Sequence 112 AA; Query Match 100.0%; Score 580; Length 112; Best Local Similarity 100.0%; Matches 112; Conservative 0; Mismatches 0; Indels 0; Gaps 0; Qy 1 DVVMTQSPLSLPVSLGDQASISCRSSQSLVHSHENTFLHWYLQKPGQSPKLLIYRVSNRF 60 |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| Db 1 DVVMTQSPLSLPVSLGDQASISCRSSQSLVHSHENTFLHWYLQKPGQSPKLLIYRVSNRF 60 Qy 61 SGVPDRFSGSGSGTDFTLKISRVEAEDLGVYFCSQSTHVPLTFGAGTKLELK 112 |||||||||||||||||||||||||||||||||||||||||||||||||||| Db 61 SGVPDRFSGSGSGTDFTLKISRVEAEDLGVYFCSQSTHVPLTFGAGTKLELK 112 SEQ ID NO s : 58-60 alignment with SEQ ID NO: 57 of Robinson ID BIY86195 standard; protein; 112 AA. XX AC BIY86195; XX DT 01-APR-2021 (first entry) XX DE Anti-IL-38 antibody (Clone M3 IL38-C) VL region, SEQ 57. XX KW IL-38 protein; antibody; antibody production; antibody therapy; KW breast tumor; cancer; colon tumor; cytostatic; diagnostic test; KW head and neck tumor; immuno-diagnosis; interleukin 38; KW light chain variable region; metastasis; monoclonal antibody; KW prophylactic to disease; prostate tumor; protein inhibition; KW rectal tumor; renal tumor; skin cancer; therapeutic. XX OS Mus sp. XX CC PN WO2021022037-A1. XX CC PD 04-FEB-2021. XX CC PF 30-JUL-2020; 2020WO-US044260. XX PR 30-JUL-2019; 2019US-0880265P. XX CC PA (IMMU-) IMMUNOME INC. XX CC PI Robinson MK, Lundgren K, Harman B, Nikitin PA, Dowling JP; XX DR WPI; 2021-129425/016. DR N-PSDB; BIY86194. XX CC PT New isolated interleukin-38 (IL-38)-binding antibody or antigen-binding CC PT fragment comprises optionally contiguous amino acids of complementary- CC PT determining region (CDR) contained within variable heavy chain (VH), for CC PT inhibiting tumor growth. XX CC PS Claim 1; SEQ ID NO 57; 61pp; English. XX CC The present invention relates to an isolated interleukin-38 (IL-38) CC binding antibody or an antigen-binding fragment, which is useful for CC inhibiting tumor growth or metastasis. The antibody comprises a heavy CC chain variable region (VH) of SEQ ID NO: 2, 7, 22, 27, 32, 37, 42, 47 and CC 52 (see BIY86140, BIY86145, BIY86160, BIY86165, BIY86170, BIY86175, CC BIY86180, BIY86185 and BIY86190), light chain variable region (VL) of SEQ CC ID NO: 4, 9, 57, 62, 67, 72, 77 and 82 (see BIY86142, BIY86147, BIY86195, CC BIY86200, BIY86205, BIY86210, BIY86215 and BIY86220), framework region CC (FR), heavy and light chain constant regions and complementarity CC determining region (CDR). The invention further claims a method for CC inhibiting the tumor growth or metastasis in a subject, which involves CC administering to a subject a therapeutically effective amount of a CC composition comprising the antibody, which partially or fully blocks, CC inhibits or neutralizes the biological activity of the IL-38. The CC invention also discloses a method for producing the antibody. The CC antibody of the invention is useful for diagnosing, treating and CC preventing cancer, which includes cancer of prostate, breast, kidney, CC colon and rectum, pancreas, skin uterus, head and neck and lung. XX SQ Sequence 112 AA; Query Match 85.6%; Score 146.4; Length 112; Best Local Similarity 41.8%; Matches 33; Conservative 0; Mismatches 0; Indels 46; Gaps 2; Qy 1 RSSQSLVHSHENTFLH--------------YRVSNRFS---------------------- 24 |||||||||||||||| |||||||| Db 24 RSSQSLVHSHENTFLHWYLQKPGQSPKLLIYRVSNRFSGVPDRFSGSGSGTDFTLKISRV 83 Qy 25 ----------SQSTHVPLT 33 ||||||||| Db 84 EAEDLGVYFCSQSTHVPLT 102