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 .
Claims Status
The amendments and remarks filed 06/30/2026 are acknowledged.
Claims 1-15, 19, and 26-29 are pending.
Claims 16-18 and 20-25 are canceled.
Claims 1, 7-12, and 26-28 are amended.
Claim 29 is new.
Claims 1-15, 19, and 26-29 are under examination.
Withdrawn
The objections to claims 1, 7, 11-12, and 27 are withdrawn. Applicant has amended the claims to overcome the objections.
The rejections of claims 7-10 under 35 U.S.C. 112(b) are withdrawn. Applicant has amended the claims to overcome the rejections.
The rejections of claims 26-28 under 35 U.S.C. 112(a) are withdrawn. Applicant has amended claim 26 to overcome the rejections.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05/06/2026 is in compliance with the provisions of 37 CFR 1.97, except where noted. Accordingly, the information disclosure statement is being considered by the examiner.
The foreign patent documents lined through were not considered because they were not attached. The NPL document lined through (i.e. Cite No. 18) was not considered because it was not in English.
Notably, the disclosure statement filed lists a Search Report. The listing of the references cited in a Search Report itself is not considered to be an information disclosure statement (IDS) complying with 37 CFR 1.98. 37 CFR 1.98(a)(2) requires a legible copy of: (1) each foreign patent; (2) each publication or that portion which caused it to be listed; (3) for each cited pending U.S. application, the application specification including claims, and any drawing of the application, or that portion of the application which caused it to be listed including any claims directed to that portion, unless the cited pending U.S. application is stored in the Image File Wrapper (IFW) system; and (4) all other information, or that portion which caused it to be listed. In addition, each IDS must include a list of all patents, publications, applications, or other information submitted for consideration by the Office (see 37 CFR 1.98(a)(1) and (b)), and MPEP § 609.04(a), subsection I. states, "the list ... must be submitted on a separate paper." Therefore, the references cited in the Search Report have not been considered. Applicant is advised that the date of submission of any item of information or any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the IDS, including all "statement" requirements of 37 CFR 1.97(e). See MPEP § 609.05(a).
Note: If copies of the individual references cited on the Search Report are also cited separately on the IDS (and these references have not been lined-through) they have been considered.
Claim Objections
Claims 2-3, 5-6, and 11-14 are objected to as being dependent upon a rejected base claim (i.e. claim 1), but would be allowable if the above corrections are made and if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Maintained Rejections
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. 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 § 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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 1, 4, 15, 19, 26, and 28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6-7, 9, 12, 15, and 18-19 of copending Application No. 18/260,691 (‘691) in view of Shi et al., 2020 (04/06/2026 PTO-892).
Regarding claim 1 of the instant application, claim 1 of ‘691 teaches an isolated anti-human PD-L1 antibody or antigen-binding fragment thereof, wherein said antibody or antigen-binding fragment thereof comprises a light chain variable region and/or a heavy chain variable region, wherein, the light chain variable region comprises a LCDR1 of the amino acid sequence set forth in SEQ ID No. 20, a LCDR2 of the amino acid sequence set forth in SEQ ID No. 21, and a LCDR3 of the amino acid sequence set forth in SEQ ID No. 22; and the heavy chain variable region comprises a HCDR1 of the amino acid sequence set forth in SEQ ID No. 23, a HCDR2 of the amino acid sequence set forth in SEQ ID Nos. 24, 45, 46 or 47; and a HCDR3 of the amino acid sequence set forth in SEQ ID No. 25.
SEQ ID NOs: 20-22 for the LCDRs 1-3 and SEQ ID NOs: 23, 47, and 35 for the HCDRs 1-3 of ‘691 have 100% sequence identity to SEQ ID NOs: 37-39 for the LCDRs 1-3 and SEQ ID NOs: 40-42 for the HCDRs 1-3, respectively, of instant claim 1.
However, ‘691 does not specifically teach a bispecific antibody comprising the PD-L1 antigen-binding domain and a CD47 antigen-binding domain.
Shi teaches a CD47/PD-L1 dual-specific (bispecific) antibody with limited hemagglutination [page 3, left column, first-second paragraphs].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the CD47/PD-L1 dual-specific antibody of Shi to comprise the CDR sequences of the anti-PD-L1 of ‘691. One would have been motivated to have used these sequences because they are known sequences in the art, and it is obvious to use known variations in the art for predictable outcomes. See MPEP 2143 (F).
Regarding claim 4 of the instant application, claim 6 of ‘691 teaches the anti-human PD-L1 antibody or antigen-binding fragment thereof according to claim 1, wherein (c) the light chain variable region has the amino acid sequence set forth in SEQ ID No. 44; and the heavy chain variable region has the amino acid sequence selected from those set forth in SEQ ID Nos. 40-43 or 51-53, and claim 7 of ‘691 teaches the anti-human PD-L1 antibody or antigen-binding fragment thereof according to claim 6, wherein (b) the light chain variable region has the amino acid sequence set forth in SEQ ID No. 44; and the heavy chain variable region has the amino acid sequence selected from those set forth in SEQ ID Nos. 41 or 51-53.
SEQ ID NOs: 44 and 53 have 100% sequence identity to SEQ ID NOs: 2 and 6, respectively, of the instant claim.
Regarding claim 15 of the instant application, claim 9 of ‘691 teaches an isolated nucleic acid molecule selected from the group consisting of: (1) DNA or RNA encoding the anti-human PD-L1 antibody or antigen-binding fragment thereof according to claim 1; (2) a nucleic acid that is completely complementary to the nucleic acid defined in (1).
Regarding claim 19 of the instant application, claim 12 of ‘691 teaches a composition comprising the anti-human PD-L1 antibody or antigen-binding fragment thereof according to claim 1, and one or more pharmaceutically acceptable carriers, diluents or excipients.
Regarding claims 26 and 28 of the instant application, claim 15 of ‘691 teaches a method of treating PD-L1-mediated diseases or disorders, including administering to a subject in need thereof the anti-human PD-L1 antibody or antigen binding fragment thereof according to claim 1, claim 18 teaches that the diseases or disorders are tumors, and claim 19 teaches that the tumors are one or more selected from the group consisting of leukemia, lymphoma, myeloma, brain tumor, head and neck squamous cell carcinoma, non-small cell lung cancer, nasopharyngeal cancer, esophageal cancer, gastric cancer, pancreatic cancer, gallbladder cancer, liver cancer, colorectal cancer, breast cancer, ovarian cancer, cervical cancer, endometrial cancer, uterine sarcoma, prostate cancer, bladder cancer, renal cell carcinoma, and melanoma.
This is a provisional nonstatutory double patenting rejection.
Claims 1, 4, 7-9, 15, 19, 26, and 28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6-7, 9, 12, 15, and 18-19 of copending Application No. 18/260,691 (‘691) in view of Shi et al., 2020 (04/06/2026 PTO-892), as applied to claims 1, 4, 15, 19, 26, and 28 above, and further in view of Wu et al., 2015 (04/06/2026 PTO-892).
The teachings of ‘691 and Shi are above.
However, ‘691 and Shi do not specifically teach that the first antigen-binding functional region and the second antigen-binding functional region are both Fabs.
Regarding claims 7 and 8, Wu teaches that Fab-based BsAbs have superior biophysical properties compared to the scFv-based BsAbs [see Abstract].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the bispecific antibody, as taught by ‘691 and Shi, to specifically have the first antigen-binding functional region and the second antigen-binding functional region both be Fabs. One would have been motivated to make this modification because Wu teaches that Fab-based BsAbs have superior biophysical properties compared to the scFv-based BsAbs
Regarding claim 9, since each antigen-binding functional region binds to a different antigen (i.e. PD-L1 and CD47), then each necessarily has a different heavy chain region and light chain variable region than the other.
This is a provisional nonstatutory double patenting rejection.
New Grounds of Rejection Necessitated by Amendment
Claims 1, 4, 10, 15, 19, 26, and 28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6-7, 9, 12, 15, and 18-19 of copending Application No. 18/260,691 (‘691) in view of Shi et al., 2020 (04/06/2026 PTO-892), as applied to claims 1, 4, 15, 19, 26, and 28 above, and further in view of Nesspor et al., 2020 (instant PTO-892).
The teachings of ‘691 and Shi are above.
However, ‘691 and Shi do not specifically teach that one of the first antigen-binding functional region and the second antigen-binding functional region is a Fab and the other is a scFv.
Regarding claim 10, Nesspor teaches an alternative bispecific scaffold (Bipod) comprising an scFv and a Fab on a heterodimeric Fc eliminates the possibility of light chain mispairing p[see Abstract].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the bispecific antibody, as taught by ‘691 and Shi, to specifically have one of the first antigen-binding functional region and the second antigen-binding functional region be a Fab and the other be a scFv. One would have been motivated to make this modification because Nesspor teaches that an alternative bispecific scaffold (Bipod) comprising an scFv and a Fab on a heterodimeric Fc eliminates the possibility of light chain mispairing.
Claims 1, 4, 15, 19, and 26-29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6-7, 9, 12, 15, and 18-19 of copending Application No. 18/260,691 (‘691) in view of Shi et al., 2020 (04/06/2026 PTO-892), as applied to claims 1, 4, 15, 19, 26, and 28 above, and further in view of NCT04338659, 2020 (instant PTO-892).
The teachings of ‘691 and Shi are above.
However, ‘691 and Shi do not specifically teach that the subject is a human.
Regarding claims 27 and 29, NCT04338659 teaches administering an anti-human CD47/PD-L1 bispecific antibody (i.e. IBI322) to human subjects (i.e. mammal) with cancer [see Study Description and Eligibility sections].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have administered the PD-L1/CD47 bispecific antibody, as taught by ‘691 and Shi, to human subjects. One would have been motivated to have administered the bispecific antibody to human subjects because NCT04338659 teaches administering an anti-human CD47/PD-L1 bispecific antibody (i.e. IBI322) to human subjects (i.e. mammal) with cancer. Thus, this is a known patient population to administer CD47/PD-L1 bispecific antibodies to in order to treat cancer.
Response to Arguments
The double patenting rejections over copending Application No. 18/260,691 are maintained. On page 10 of the remarks, Applicant argues that the bispecific antibody of present application targets both PD-L1 and CD47 and in contrast, the isolated anti-PD-L1 antibody [of the copending Application] only comprises the PD-L1 binding moiety, and thus, the scope of the instant claims are patentably distinct from the claims of the copending Application. This is not found persuasive because the Examiner did not make an anticipatory double patenting rejection, which would be based solely on the content of the claims of the copending application, but rather properly relied on a secondary reference (i.e. Shi), as well as additional references, based on the content of the claims to make an obviousness type double patenting rejection. The Examiner provided a proper explanation of the differences between the invention claimed in the examined application and the invention claimed in the reference application, and explained why the invention claimed in the examined application, upon reading the secondary prior art references cited by the Examiner, would have been obvious to a person of ordinary skill in the art. Applicant does not provide any arguments against the rejections over the copending application in view of Shi.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Brittney E Donoghue whose telephone number is (571)272-9883. The examiner can normally be reached Mon - Fri 7:30 - 3:30.
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/B.E.D./Examiner, Art Unit 1675
/JEFFREY STUCKER/Supervisory Patent Examiner, Art Unit 1675
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