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 .
DETAILED ACTION
Restriction/Election
1. Applicant’s election without traverse of Group I (claims 1-11 and 15-19) in the reply filed on 06/22/2026 is acknowledged.
2. Claims 1-19 are pending. Claims 1-11 and 15-19 are under consideration. Claims 12-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention.
Information Disclosure Statement
3. The information disclosure statement filed on 11/21/2023 has been considered by the Examiner and an initialed copy of the form PTO-1449 is attached to the office action.
Drawings
4. The drawings filed on 02/13/2024 are accepted by the Examiner.
Claim Rejections[Symbol font/0xBE] Nonstatutory Obviousness-Type Double Patenting
5. Basis for nonstatutory double patenting:
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the "right to exclude" granted by a patent and to prevent possible harassment by multiple assignees. See In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970);and, In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission.
For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/ guidance/eTD-info-I.jsp.
6. Claims 1-11 and 15-19 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-17 of US Patent No. 11,873,347 B2. Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons.
Both claims 1-17 of US Patent No. 11,873,347 B2 and claims 1-11 and 15-19 of the instant application are drawn to an antigen-binding chimeric protein comprising an antigen-binding domain of an immunoglobulin-like protein fused with a scaffold protein. Claims 1-17 of US Patent No. 11,873,347 B2 and claims 1-11 and 15-19 of the instant application vary in scope and are obvious over each other.
Claim Rejections[Symbol font/0xBE]35 USC § 112 (b)
7. The following is a quotation of the second paragraph of 35 U.S.C. 112:
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.
8. Claims 1-11 and 15-19 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
(i). Claims 1 and 19 recite “wherein the scaffold protein interrupts the primary topology of the antigen-binding domain at one or more exposed regions of the antigen-binding domain”. It is unclear how an antigen-binding chimeric protein that has an antigen-binding domain with an interrupted primary topology can still function as an antigen-binding protein. Moreover, it is unclear what are being considered as exposed regions of an antigen-binding domain.
(ii). Claim 19 (in last two lines) are indefinite because they recite “wherein the antigen-binding domain of the second antigen-binding chimeric protein specifically binds the scaffold protein of the antigen-binding chimeric protein”. It is unclear whether “the scaffold protein of the antigen-binding chimeric protein” refers to the scaffold protein of the first antigen-binding chimeric protein or the scaffold protein of the second antigen-binding chimeric protein.
(iii). Claim 11 recites “wherein the antigen-binding chimeric protein is comprised is a virus-like particle”. The claim language is ambiguous and renders the claim indefinite.
Claims 2-10 and 15-18 are rejected as dependent claims.
Claim Rejections[Symbol font/0xBE]35 USC § 102 (a)(1)
9. 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.
10. Claims 1-2, 4-6, 8-9, 11, and 15-19 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Zhang et al. (J. Am. Chem. Soc. 2015, 137 (1): 38–41).
Zhang et al. teach a fusion protein comprising Ab-CDR3H-beta-hEPO and Ab-CDR3H-coil-hEPO (Figure 1B). The EPO is fused to antigen-binding domain through two linkers, GGGGS, and β-strands or coiled-coil (Fig. 1C). The human EPO has a molecular mass of 30.4 kDa. Zhang et al teach a fusion protein comprising Ab-CDR2H-coil-hGCSF and Ab-CDR3L-coil-hGCSF (Figure 1B and 1C). Zhang et al teach the fusion proteins expressed in a mammalian cell (see, e.g., Abstract).
Zhang et al. teach that the fusion of hEPO into CDR3H abrogates the binding of Herceptin to its cognate antigen (page 40, left column, line 11-16) and the fusion of hGCSF into CDR3L of Herceptin eliminates its binding to HER2 receptor (page 40, right column, lines 13-16). However, Herceptin-CDR2H-hGCSF shows significant binding to HER2 receptor at 100 nM (page 40, right column, lines 16-20).
Thus, the teachings of Zhang et al. meet the limitations of claims 1-2, 4-6, 8-9, 11, and 15-19.
Prior Art on the Record
11. The Examiner makes the following notes regarding the prior art on the record:
Manglik et al. (Annu. Rev. Pharmacol. Toxicol. 57:19–37, 2017, First published online as a Review in Advance on December 7, 2016).
Manglik et al. teach the study on GPCR activation by agonist using nanobody assisted crystallography (Figure 4). Whereas complementarity-determining region 3 (CDR3) most commonly extends into the core of the receptor, Nanobody39 (Nb39) uses framework residues, CDR1, and CDR2 to engage with the μ-opioid receptor (μOR). However, Manglik et al. do not teach an antigen-binding chimeric protein comprising an antigen-binding domain fused with a scaffold protein.
Conclusions
12. No claims are allowed.
Advisory Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ruixiang Li whose telephone number is (571) 272-0875. The examiner can normally be reached on Monday through Friday from 8:30 am to 5:00 pm. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Vanessa Ford, can be reached on (571) 272-0857. The fax number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/RUIXIANG LI/Primary Examiner, Art Unit 1674 July 23, 2026
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