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 .
This office action is in response to the amendment filed on December 5, 2025. Claims 10-15 and 18 have been withdrawn. Claims 1-9, 16, and 17 are currently under examination.
Withdrawal of Rejections
The rejection of claims 2, 5, 6, 7, 9, and 17 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite is withdrawn based on the remarks filed on December 5, 2025 citing the specification meaning and the amendment to the claims.
Pending Rejections
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
Claim(s) 1-9, 16, and 17 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Steyaert et al. (WO 2019/086548 A1; 12/19/2022 IDS, Foreign Patent doc #2).
Stevaert et al. disclose a Dodecin Ry1498A monomer conjugated to a GFP-specific Nanobody (SEQ ID NO: 1) via two peptide linkers. Stevaert et al. disclose the self assembly of 12 copies of Dodecin to form a highly thermostable chimeric protein. The scaffold protein used was the monomer of Dodecin Rv1498A of Mycobacterium tuberculosis (SEQ ID NO: 192, GenBank Accession Number : 3205040). Figure 50 shows the termini on the outer face allowing for the Nanobody to be surface exposed. The chimeric protein can be recombinantly expressed in E. coli in a suitable carrier (see page 20, line 1-13, Figure 50 description, and pages 94-95, example 24 section, and table 13).
Response to Remarks
Applicants state the fusion of Steyaert et al. differs from the claimed conjugate, at least, in that the claimed conjugate has the full moiety fused or conjugated at the N- and/or C-terminus of the at least one dodicin protein unit and the desired functions to trigger immune responses and/or catalyze chemical reactions, which has not been disclosed by Steyaert et al. Applicant's arguments filed December 5, 2025 have been fully considered but they are not persuasive. Applicant’s claims are drawn to a conjugate comprising at least dodecin protein unit conjugated and/or fused at the amino- and carboxy-terminus with at least one hapten or one immunogenic or one enzymatically active moiety. Stevaert et al. do disclose a Dodecin Ry1498A monomer conjugated to a GFP-specific Nanobody (SEQ ID NO: 1) via two peptide linkers. Stevaert et al. disclose the self assembly of 12 copies of Dodecin to form a highly thermostable chimeric protein. The scaffold protein used was the monomer of Dodecin Rv1498A of Mycobacterium tuberculosis (SEQ ID NO: 192, GenBank Accession Number : 3205040). Figure 50 shows the termini on the outer face allowing for the Nanobody to be surface exposed. The chimeric protein can be recombinantly expressed in E. coli in a suitable carrier (see page 20, line 1-13, Figure 50 description, and pages 94-95, example 24 section, and table 13). The nanobody is an immunogenic moiety as it is a peptide structure. Stevaert et al. do disclose a Dodecin Ry1498A monomer conjugated to a GFP-specific Nanobody (SEQ ID NO: 1) via two peptide linkers. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir.1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433.
Claim(s) 1-6, 8, and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Grininger et al. (J. Mol. Biol. 357: 842-857 (2006).
Grininger et al. disclose Dodecins as lumichrome binding proteins. Grininger et al. disclose the overexpression of Halobacterium salinarum Dodecin that has a C-terminal His-tag (see page 843, right hand column, Results and Discussion, X-ray structure of holocomplexes). Grininger et al. also produce N-terminally His6-tagged dodecin, which is recombinantly expressed in terrific broth medium. The protein was purified and eluted in a suitable carrier comprising buffer B comprising 20 mM Tris-HCl (pH 7.5), 300 mM NaCl, 5 mM MgCl2 (see page 852, right column, Materials and Methods, Cloning, expression, and purification of dodecin from H. salinarum). Grininger et al. also disclose the use of the dodecameric dodecin for flavin binding measurements (see page 853, right hand column, Size exclusion chromatography, 1st sentence).
Response to Remarks
Applicants state Grininger et al. disclose constructs that structurally differ from the instantly claimed conjugate. The claimed conjugate is a conjugate or fusion having at least one hapten and/or at least one immunogenic and/or at least one enzymatically active moiety at the N- and/or C-terminus of at least one dodecin protein unit such that the claimed conjugate has the ability to trigger an immune response of the immune system in the body of a subject; and/or that the claimed conjugate is enzymatically active for use as a biocatalyst for accelerating chemical reactions. Applicant's arguments filed December 5, 2025 have been fully considered but they are not persuasive. Applicant’s claims are drawn to a conjugate comprising at least dodecin protein unit conjugated and/or fused at the amino- and carboxy-terminus with at least one hapten or one immunogenic or one enzymatically active moiety. The claimed moiety can be a peptide. Grininger et al. disclose the overexpression of Halobacterium salinarum Dodecin that has a C-terminal His-tag (see page 843, right hand column, Results and Discussion, X-ray structure of holocomplexes). Grininger et al. also produce N-terminally His6-tagged dodecin, which is recombinantly expressed in terrific broth medium. The protein was purified and eluted in a suitable carrier comprising buffer B comprising 20 mM Tris-HCl (pH 7.5), 300 mM NaCl, 5 mM MgCl2 (see page 852, right column, Materials and Methods, Cloning, expression, and purification of dodecin from H. salinarum). The His tag is a peptide moiety as is structurally claimed. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir.1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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