Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
Restriction/Election
1. Applicant’s election without traverse of Group II (claims 27-31 and 33-34) in the reply filed on 09/24/2026 is acknowledged. In response to species election requirement, Applicants elected the two specific nucleic acids that encode a specific heavy chain and light chain of an antibody M43 (i.e., antigen binding protein comprising the amino acid sequences of SEQ ID NO: 15 and SEQ ID NO: 16).
2. Claims 1-55 are pending. Claims 27-31 and 33-34 are currently under consideration. Claims 1-26, 32, and 35-55 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention.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 09/24/2026 has been considered by the Examiner and an initialed copy of the form PTO-1449 is attached to this communication.
Drawings
4. The drawings filed on 10/19/2023 and 06/20/2024 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) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent is shown to be commonly owned with this application. See 37 CFR 1.130(b).
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
6. Claims 27-31 and 33-34 are rejected on the ground of nonstatutory obviousness-type double5patenting as being unpatentable over claims 7-13 of US Patent No. 9,453,080 B2. Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons.
Claims 7-13 of US Patent No. 9,453,080 B2 are drawn to an isolated nucleic acid encoding an antigen-binding protein comprising a first polypeptide comprising SEQ ID NO: 3, SEQ ID NO: 4, and SEQ ID NO: 5 and a second polypeptide comprising SEQ ID NO: 6, SEQ ID NO: 7, and SEQ ID NO: 8, wherein the antigen-binding protein specifically binds to SEQ ID NO: 2 and SEQ ID NO: 18, an expression vector, a host cell and a method of producing an antigen-binding protein. On the other hand, claims 27-31 and 33-34 of the instant application are drawn to an isolated nucleic acid encoding an antigen-binding protein (M43 antibody), wherein the nucleic acid comprises the sequence in SEQ ID NOS: 22 and 23 (actually SEQ ID NOS: 21 and 22), an expression vector, a host cell, and a method of producing an antigen-binding protein.
It is noted that the amino acid sequence of SEQ ID NO: 15, which is the heavy chain of the M43 antibody, comprises the three amino acid sequences of SEQ ID NOS: 3-5, whereas the amino acid sequence of SEQ ID NO: 16, which is the light chain of the M43 antibody, comprises the three amino acid sequences of SEQ ID NOS: 6-8. Thus, claims 7-13 of US Patent No. 9,453,080 B2 and claims 27-31 and 33-34 of the instant application vary in scopes and are obvious over each other.
7. Claims 27-31 and 33-34 are rejected on the ground of nonstatutory obviousness-type double5patenting as being unpatentable over claims 1-7 of US Patent No. 10,981,999 B2. Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons.
Claims 1-7 of US Patent No. 10,981,999 B2 are drawn to an isolated nucleic acid encoding an antigen-binding protein comprising a first polypeptide comprising SEQ ID NO: 15 and a second polypeptide comprising SEQ ID NO: 16, wherein the antigen-binding protein specifically binds to SEQ ID NO: 2 and SEQ ID NO: 18, an expression vector, a host cell and a method of producing an antigen-binding protein. On the other hand, claims 27-31 and 33-34 of the instant application are drawn to an isolated nucleic acid encoding an antigen-binding protein (M43 antibody), wherein the nucleic acid comprises the sequence in SEQ ID NOS: 22 and 23 (actually SEQ ID NOS: 21 and 22), an expression vector, a host cell, and a method of producing an antigen-binding protein.
It is noted that the amino acid sequence of SEQ ID NO: 15 is the heavy chain of the M43 antibody, whereas the amino acid sequence of SEQ ID NO: 16 is the light chain of the M43 antibody. Thus, claims 1-7 of US Patent No. 10,981,999 B2 and claims 27-31 and 33-34 of the instant application vary in scopes and are obvious over each other.
Claim Objections
8. Claim 27 is objected to because of a typographic error: “SEQ ID NOs: 22 and 23” should be amended to –SEQ ID NOS 21 and 22 -- (see Figure 2B).
Conclusion
9. 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.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, please contact the Electronic Business Center (EBC) at the toll-free phone number 866-217-9197.
/RUIXIANG LI/Primary Examiner, Art Unit 1674
October 8, 2026
Prosecution Insights