DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Applicant’s reply filed on 9/25/2025 is acknowledged. New claim 53 has been added. Claims 12-14, 16, 45, 49 and 52-53 are pending. Claims 1-11, 15, 17-44, 46-48 and 50-51 are canceled. Claims 49 and 52 are withdrawn. Claims 12-14, 16, 45, 49 and 52 have been amended.
3. Claims 12-14, 16, 45 and 53 are under examination.
Objections and Rejections Withdrawn
4. All objections and rejections in the office action mailed on 6/26/2025 are withdrawn in view of applicant’s amendments.
New Grounds of Rejection
Claim Rejections - 35 USC § 102
5. 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.
6. Claims 12-14, 45 and 53 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Matsumoto et al. (Program and Abstracts for 2016 Annual Meeting of the Society for Glycobiology, Nov 19-22, New Orleans, Louisiana, USA, Abs No. 154, PTO 892 dated 6/26/2025).
Regarding claim 12 and new claim 53, Matsumoto et al teaches a human IgG1 chimeric anti-Tn antibody named Remab6, which is based on a murine anti-Tn monoclonal IgM antibody BaGs6 (Ca3638) that was previously generated (Springer GF et al, Cancer 1985 and Avichezer D et al, Int J Cancer 1997) (abstract). The antibody Remab6 disclosed by the prior art appears to be identical to the antibody Remab6 disclosed in the instant application (see Example 1 of instant specification), as such would inherently comprise the CDR sequences of instant SEQ ID NOs 1-6, respectively, and the heavy and light chain sequences of instant SEQ ID NOs: 11 and 12, respectively (as evidenced by instant specification, see para [00089] and [00090]).
Regarding claim 13, Matsumoto et al. teaches that the antibody Remab6 binds to human colon and breast cancer cell lines that express the Tn antigen (abstract).
Regarding claim 14, the limitation that the antibody does not recognize Tn antigen on IgA1 is considered as an inherent property of the antibody Remab6.
Regarding claim 45, Matsumoto et al. teaches killing tumor cells by the antibody Remab6, which would require the antibody to be in a solution comprising at least water. A solution comprising the antibody Remab6 and water meets the limitation of a composition. The term “pharmaceutical” is an intended use.
The intended use of a product does not impart novelty to a prior art disclosed product. If a prior art structure is capable of performing the intended use as recited in the preamble, then it meets the claim. See, e.g., In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed. Cir. 1997) See also MPEP § 2112.
Claim Rejections - 35 USC § 103
7. 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.
8. Claims 12-14, 16, 45 and 53 are rejected under 35 U.S.C. 103 as being unpatentable over Matsumoto et al. (Program and Abstracts for 2016 Annual Meeting of the Society for Glycobiology, Nov 19-22, New Orleans, Louisiana, USA, Abs No. 154, PTO 892 dated 6/26/2025), in view of Malik et al. (US 2017/0253661A1, pub. date: 9/7/2017, PTO 892 dated 6/26/2025).
The teachings of Matsumoto et al. have been set forth above as they apply to claims 12-14, 45 and 53
Regarding claim 16, Matsumoto et al. does not teach that antibody Remab6 comprises an afucosylated Fc fragment.
Malik et al. teaches that the presence of a terminal fucose residue is known to contribute to reduced Fc-gammaRIIIa binding and to reduced ADCC, and hence, antibodies lacking terminal fucose residues (“afucosylated” antibodies) are associated with an increase of ADCC mediated by the antibody population ([0007]).
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to have modified the antibody Remab6 to comprise a afucosylated Fc in view of Malik et al. One would have been motivated to do so because Malik et al. teaches that antibodies lacking terminal fucose residues (“afucosylated” antibodies) are associated with an increase of ADCC mediated by the antibody population ([0007]). One of ordinary skill in the art would have a reasonable expectation of success because methods of making afucosylated antibodies were known in the art as shown by Malik et al.
9. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
(i) Matsumoto et al., A Well-Characterized Human Chimeric Anti-Ta Monoclonal Antibody with Cytotoxic Potential, Program and Abstracts for 2017 Annual Meeting of the Society for Glycobiology, November 5-8, 2017, Portland, Oregon, USA, Abs No. 128.
(ii) MATSUMOTO et al., A Well-Characterized Human Chimeric Anti-Tn Monoclonal Antibody as a Tumor Diagnostic Biomarker. Glycobiology. 2018 Dec;28(12):1049-50 (IDS filed on 2/6/2024).
Conclusion
10. No claims are allowed.
11. Any inquiry concerning this communication or earlier communications from the examiner should be directed to HONG SANG whose telephone number is (571)272-8145. The examiner can normally be reached Monday-Friday 8am-5pm.
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/HONG SANG/Primary Examiner, Art Unit 1646