DETAILED ACTION
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. Claims 1-16 are pending upon entry of amendment filed on 7/7/26
Applicant’s election of group I, claims 1-7, 9-13 without traverse in the reply filed on 7/7/26 has been acknowledged.
Accordingly, claims 8 and 14-16 are withdrawn from further consideration by the examiner, 37 CFR 1.142 (b) as being drawn to a nonelected invention.
Claims 1-7, 9-13 readable upon SEQ ID NO:1-4 are under consideration in the instant application.
3. Applicant’s IDS filed on 11/25/25 has been acknowledged.
4. The oath filed on 9/18/23 has been acknowledged.
5. The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
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.
6. Claims 1, 2, 4, 6, 9 and 11-13 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
The use of the term “optional” in claims 11-13 renders the claim indefinite because it is unclear whether the limitations following such terms or phrases are part of the claimed invention. See MPEP 2173.05 (h).
Claims 1 and 6 are missing a conjunction. Appropriate correction is required.
Claims 2 and 9 use improper Markush group. The recitation of “selected from the group consisting of A, B, C and D” format is required.
7. A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
8. Claims 1, 3-5 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 1, 3-5 of copending Application No. 18/847,303.
Both applications recite:
(Original) An antibody-drug conjugate or a pharmaceutically acceptable salt thereof, wherein the structure of the antibody-drug conjugate is as shown in formula I: Ab-(J-U)n (I) wherein, Ab is a PD-L1 antibody; U is each independently a TLR agonist; J is a chemical bond or linker; n is 0 or a positive integer; "-"is a chemical bond or linker or connector.
3. (Original) An antibody-drug conjugate or a pharmaceutically acceptable salt thereof according to claim 1, wherein the TLR agonist is a TLR7 agonist. 4. (Original) An antibody-drug conjugate or a pharmaceutically acceptable salt thereof according to claim 3, wherein the TLR7 agonist comprises: SZU-101: NH2 N N oH N z 0 H 0 N OH (II).
This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
9. 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 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.
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 of this title, 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
11. Claims 1, 3-7 are rejected under 35 U.S.C. 103(a) as being unpatentable over WO2019/226977 in view of U.S. Pub. 2019/0151462.
The ‘977 publication teaches compounds and pharmaceutical compositions thereof set forth in structure II of claim 4 that works as TLR7 agonist “associated” with PD-L1 antibody (p. [151-165] 31-50). The compound is used in inducing antitumor activity and improve NK, DC cell activities (p. 30, 33) and claim 5 is included in this rejection.
The disclosure of the ‘977 publication differs from the instant claimed invention in that it does teach conjugating with a linker or conjugation of TLR7 agonist with PD-L1 antibody as in claim 1 of the instant application.
The ‘462 publication teaches the conjugation of TLR7/8 agonist with various antibody to improve targeting and improve bioavailability ([003-007]). Further, the conjugates with or without a linker reduces unwanted systemic proinflammatory cytokine responses and improve effective immune response (p. 1-2).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to conjugate TLR7 agonist and PD-L1 antibody taught by the ‘977 publication into the immunoconjugate taught by the ‘462 publication.
One of ordinary skill in the art at the time the invention was made would have been motivated to do so because the conjugation of effective drug and antibody pair into immunoconjugate format would improve bioavailability and targeting.
From the teachings of references, it would have been obvious to one of ordinary skill in art to combine the teachings of the references and there would have been a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of the ordinary in the art at the time of invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
12. 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. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); 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); 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 §§ 706.02(l)(1) - 706.02(l)(3) 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.
13. Claims 1-7 and 9-13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Application No. 18/847,303.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘303 application recites an antibody conjugate comprising TLR7agonist, PD-L1 antibody set forth in SEQ ID NO:1-4, 22-26.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
14. No claims are allowable. SEQ ID NO:1-4 are free of art.
15. Any inquiry concerning this communication or earlier communications from the examiner should be directed to YUNSOO KIM whose telephone number is (571)272-3176. The examiner can normally be reached Mon-Fri 8:30-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached at 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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Yunsoo Kim
Patent Examiner
Technology Center 1600
August 20, 2026
/YUNSOO KIM/Primary Examiner, Art Unit 1641
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