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 .
2. Applicant’s response filed on 01/20/2026 is acknowledged.
3. Claims 1-19 are pending.
4. Applicant’s election without traverse of Group I and the species of full-length antibody-scFv-GGGGS-LPETGG (SEQ ID NO:41) in the reply filed on 01/20/2026 is acknowledged.
5. Claims 5-13 and 16-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 01/20/2026.
6. Claims 1-4 and 14-15 are under consideration as they read on the species of full-length antibody-scFv-GGGGS-LPETGG (SEQ ID NO:41). The Examiner has extended the search to the species of the prior art.
7. Applicant’s IDS document filed on 04/18/2023 has been considered.
8. 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)(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.
9. Claims 1-3 and 14-15 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by WO 2021/000767 (PTO-892; Reference N) as evidenced by the translation in U.S. Patent Application Publication 2022/032359 (PTO-892; Reference A) (reference made to sections in U.S. Patent Application Publication 2022/032359) as evidenced by the attached sequence alignments.
U.S. Patent Application Publication 2022/032359 teaches the sequence of reference SEQ ID Nos 18, 20, 22 and 24 which comprise instant SEQ ID NO:41. SEQ ID NOs 18, 20, 22 and 24 have the following structures, respectively: FIX-C1-IgG1Fc-L2-P; FIX-C2-IgG1Fc-L2-P; FIX-C3-IgG1Fc-L2-P and FIX-C4-IgG1Fc-L2-P. FIX-C1, FIX-C2, FIX-C3 and FIX-C4 are Factor X (FIX) and a linker (C1-C4) (In particular, Table 1). These portions correspond to the “first moiety” and ligand recited in the claims1 and 2. L2 corresponds to instant ‘GGGS’ and P corresponds with instant LPETGG. (In particular, sequences, paragraphs [0046]-[0048], [0098], [0105]-[0110], whole document).
The fusion proteins are formulated into medicaments to treat hemophilia and coagulation dysfunction diseases (In particular, paragraphs [0006]-[0007], claims, whole document).
The reference teachings anticipate the claimed invention.
10. 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.
11. Claims 1 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2021/000767 (PTO-892; Reference N) as evidenced by the translation in U.S. Patent Application Publication 2022/032359 (PTO-892; Reference A) in view of U.S. Patent Application Publication 2016/122707 (IDS filed on 04/18/2023).
WO 2021/000767 as evidenced by the translation in U.S. Patent Application Publication 2022/032359 have been discussed supra.
The claimed invention differs from the prior art in the recitation of full length antibody and scFv in claim 4.
U.S. Patent Application Publication 2016/122707 teaches protein modification of living cells using sortase. The reference further teaches: in paragraph [0009] In some embodiments a sortase substrate comprises an antibody, e.g., a single chain antibody such as a camelid antibody, a single-domain antibody, a VHH domain, a nanobody, or an scFv. In some embodiments a sortase substrate comprises a binding moiety. In some embodiments a binding moiety may comprise an antibody, polypeptide, affibody, adnectin, anticalin, or aptamer. In some embodiments a binding moiety may serve as a targeting moiety. In some embodiments a binding moiety binds to a cell surface marker of a target cell. In some embodiments, a protein is modified by the conjugation of a sortase substrate comprising an amino acid, a polypeptide, a protein, and a linker; the antibody is a glycoprotein; the linker refers to a chemical group or molecule for linking molecules such as proteins and chemical groups, and can be, for example, (Gly-Gly- Gly-Gly Ser)n, wherein n is a number sufficient to produce a desired linker length; substrates recognized by a sortase comprise a sortase recognition molecule, e.g., LPXTG; for example, the sortase substrate comprises LPXTGG, e.g., LPETGG; and proteins herein comprise IL-2, and any proteins comprised herein, e.g., antibodies, antibody fragments, antibody domains, scFvs, Ig superfamily proteins, cytokines, etc. (see description, paragraphs [0007] - [0094] and [0310] - [0316], and table T).
It would have been obvious to one of ordinary skill in the art at the time of invention of WO 2021/000767 to have substituted the Fc portion of the fusion protein with a full length antibody and/or a scFv to bind to additional components or to alter function of the components.
From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
12. No claim is allowed.
13. Any inquiry concerning this communication or earlier communications from the examiner should be directed to NORA MAUREEN ROONEY whose telephone number is (571)272-9937. The examiner can normally be reached on M-F from 8:00am to 4:30pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner' s supervisor, Misook Yu, can be reached at telephone number (571) 272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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May 14, 2026
/Nora M Rooney/
Primary Examiner, Art Unit 1641
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