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 .
Applicant’s remarks, filed 3/30/2026, are acknowledged and entered into the record. Applicants amended claims 1-4, 6-8, 13 and 22, and canceled claims 11-12, 14 and 20-21, in the remarks of 3/30/2026.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. The present application is drawn from PCT/US2021/071718, filed 10/5/2021; and claims benefit under 35 U.S.C. 119(e) to U.S. Provisional application 63/088,879, filed 10/7/2020.
Status of Claims
Claims 1-10, 13, 15-19 and 22 are pending and are being examined on the merits.
Claim Rejections – Withdrawn
All claim objections have been withdrawn in view of the claim amendments, dated 03/30/2026.
Claim Rejections – Withdrawn
Claim Rejections - 35 USC § 112
The rejection of claim 14 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends, is withdrawn. Applicants canceled claim 14.
The rejection of claims 2-4, 6-8, 11-12 and 22 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or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention, is withdrawn.
Regarding claims 2-4 and 6-8, the applicants deleted the phrase “or consisting of” from the claim, thereby obviating the indefiniteness issues.
Regarding claims 11-12, applicants canceled claims 11-12, thus obviating the rejections.
Regarding claim 22; the applicants have deleted the phrase “clinically significant”, thereby obviating the indefiniteness issue. Further, applicants amended the claim to delete reference to “TPP-1360”, thereby obviating the issue of proper antecedent basis.
Double Patenting
The provisional rejection of claim 20 on the ground of nonstatutory double patenting as being unpatentable over claims 43, 53-60, 75-77 and 80-81 of copending Application No. 17/594,134 in view of Chao et al., (US 2019/0248915; published 8/15/2019) and Cheson et al., (from IDS of 4-6-2023, NPL cite No. 19; J. Clin Oncol., 2014, 32(27)), is withdrawn. Applicants canceled claim 20; thereby obviating recitation of the Cheson et al. reference in the NSDP rejection.
Claim Rejections – Maintained, Amended
The following claim rejections are maintained from the Office Action of 12/29/2025, but are amended as a result of applicant’s amendments to the claims of 3/30/2026. Specifically, the reference application, 17/594,134, has since issued as US Patent 12,545,740 on 2/10/2026; thus the rejections are now non-provisional. Further, applicants amended instant claim 1, thereby necessitating amended rejections to address the alternate claim limitations.
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 1-10, 13, 15-19 and 22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 9-16, 28-30 and 33-34 of U.S. Patent No. 12,545,740 in view of Chao et al., (US 2019/0248915; published 8/15/2019).
US ‘740 claims a CD47/CD20 bispecific antibody (claim 1) comprising a Fab portion that binds CD47 and a Fab portion that binds CD20, wherein the anti-CD20 binding domain comprises the VL CDRs 1-3 of SEQ ID NOs: 353-355, respectively, and the VH CDRs 1-3 of SEQ ID NOs: 356-358, respectively. The anti-CD20 VL and VH CDR sequences of US ‘740 SEQ ID NOs: 353-358 are 100% identical to instant SEQ ID NOs: 37-42, respectively, of the anti-CD20 binding domain. The anti-CD47 binding domain of US ‘740 comprises (a) VL CDRs 1-3 of SEQ ID NOs: 359-361 and VH CDRs 1-3 of SEQ ID NOs: 362-364; or (c) VL CDRs 1-3 of SEQ ID NOs: 371-373 and VH CDRs 1-3 of SEQ ID NOs: 374-376. The anti-CD47 VL and VH CDR sequences of US ‘740 (a) SEQ ID NOs: 359-364 are 100% identical to instant SEQ ID NOs: 43, 50, 51, 52, 53 and 54, respectively; and US ‘740 (c) SEQ ID NOs: 371-376 are 100% identical to instant SEQ ID NOs: 49, 56, 51, 52, 53 and 54, respectively. Note that US ‘740 SEQ ID NOs: 362-364 and SEQ ID NOs: 374-376 are identical, respectively; corresponding to the VH CDRs 1-3.
Thus, the CD47/CD20 bispecific antibodies of US ‘740, claims 1 and 11-16, are identical to the CD47/CD20 bispecific antibodies of the method of instant claim 1. Further, US ‘740 claims a method of treating cancer (claim 33) or wherein the cancer is a B-cell disorder/malignancy (claim 34), comprising administering the bispecific antibody of claim 1.
However, US ‘740 does not claim wherein the subject for treatment with the method of instant claim 1 has an absolute neutrophil count (ANC) ≥ 1.0 x 109/L of the method of instant claim 1(a).
Chao teaches the art of treating a CD20+ cancer using anti-CD20 and anti-CD47 antibodies (abstract). Chao teaches CD47 is a key molecule mediating cancer evasion, representing an anti-phagocytic checkpoint signal (pg. 1, para. 3). Chao teaches CD47 expression is increased on the surface of many cancer cells and that CD47-blocking antibodies inhibit cancer growth and metastasis (pg. 1, para. 3). Therefore, Chao discloses a method of treating a human subject having a CD20+ cancer comprising administering an anti-CD47 antibody and an anti-CD20 antibody (pg. 1, para. 0007). Chao teaches that the CD20+ cancer is a B cell cancer – which is equivalent to a lymphoid malignant neoplasm (see instant specs., pg. 13, para. 0053). Chao teaches the anti-CD20 antibody can comprise an Fc capable of ADCC (pg. 11, para. 0134); thus suggesting that the anti-CD20 antibody promotes killing of CD20+ cancer cells, while the anti-CD47 antibody blocks the “don’t eat me” CD47 signal, and thus promotes the anti-cancer effectiveness of the anti-CD20 antibody.
It would have been obvious to one of skill in the art to use the CD47/CD20 bispecific antibody, of US ‘740, in the methods of treating cancer, as taught by Chao et al. One would have been motivated to do so given that co-targeting CD20 for cell phagocytosis with an anti-CD20 antibody and CD47 inhibition with an inhibitory anti-CD47 antibody is a useful therapeutic strategy for treating B-cell malignancies, as taught by Chao et al. There would have been a reasonable expectation for success given that the CD47/CD20 bispecific antibody combines an anti-CD47 binding domain with an anti-CD20 binding domain into a single construct, for the same purpose of treating B-cell disorders/malignancies, as claimed in US ‘740.
Regarding claim 1; Chao teaches patient eligibility for inclusion in a study combining the anti-CD47 antibody (Hu5F9-G4) with the anti-CD20 antibody (Rituximab; pg. 22, Example 1, para. 0255). Chao teaches inclusion criteria including an ANC ≥ 1.0 x 109/mL (pg. 22, para. 0266); which is greater than 1.0 x 109/L of the method of instant claim 1(a). Thus, the combination method of US ‘740 and Chao makes obvious instant claim 1.
Regarding claims 2-8. US ‘740 claims wherein the bispecific antibody anti-CD47 VL is SEQ ID NO: 317, 319 or 321 (claims 9-10); and the anti-CD47 VH is SEQ ID NO: 318, 320 or 322 (claims 9-10). US ‘740 claims wherein the anti-CD47 light chain (LC) is SEQ ID NO: 333 (claim 29) or 335 (claim 30) and the anti-CD47 heavy chain (HC) is SEQ ID NO: 334 (claim 29) or 336 (claim 30). US ‘740 claims wherein the anti-CD20 LC is SEQ ID NO: 331 and the HC is SEQ ID NO: 332 (claim 28).
The anti-CD47 VL of US ‘740 SEQ ID NOs: 317 and 319 are identical to instant SEQ ID NOs: 1 and 3, respectively. The anti-CD47 VH of US ‘740 SEQ ID NOs: 318 and 320 are identical to instant SEQ ID NOs: 2 and 4, respectively. The anti-CD47 LC of US ‘740 SEQ ID NOs: 333 and 335 are identical to instant SEQ ID NOs: 17 and 19, respectively. The anti-CD47 HC of US ‘740 SEQ ID NOs: 334 and 336 are identical to instant SEQ ID NOs: 18 and 20, respectively. The anti-CD20 LC of US ‘740 SEQ ID NO: 331 is identical to instant SEQ ID NO: 15, and the anti-CD20 HC of US ‘740 SEQ ID NO: 332 is identical to instant SEQ ID NO: 16.
Therefore, the bispecific antibody of US ‘740, claims 9-10 and 28-30, and the methods of claims 33-34, for use in the methods of Chao, make obvious instant claims 2-8. Instant claims 4, 6 and 8 recite the antibody comprises the corresponding HC amino acid sequences, but wherein the HC sequences lack the C-terminal lysine (CTK); however, the identical sequences of US ‘740 have the CTK, and therefore comprise the same sequences, with or without the CTK.
Regarding claims 9-10, 13 and 15-19, Chao teaches the method of administering anti-CD20/anti-CD47 antibodies for treating a subject having a CD20+ cancer (pg. 45, claim 1); wherein the CD20+ cancer is Non-Hodgkin’s lymphoma (NHL), follicular lymphoma, DLBCL, marginal zone lymphoma, mantle cell lymphoma or primary mediastinal B-cell lymphoma (pg. 45, claim 2). Chao teaches wherein the subject is relapsed or refractory to previous cancer treatments (pg. 45, claim 3). Thus, the combination of US ‘740 and Chao makes obvious instant claims 9-10, 13 and 15-19.
Regarding claim 22; Chao teaches an exclusion criteria, including that the subject does not have active hepatitis B virus (pg. 23, para. 0282). Thus, the combination methods of US ‘740 and Chao makes obvious instant claim 22.
Response to Arguments
Applicant's arguments filed 3/30/2026 have been fully considered but they are not persuasive. Applicants contend that claim 1 has been amended such that the instant claims are patentably distinct for the claims of US Patent ‘740. Specifically, applicants suggest that the added limitations describing the suitable subject population for treatment with the methods impart patentable distinctness over the claims of US ‘740, in view of Chao or Cheson (remarks, pgs. 9-10).
The examiner disagrees with applicant’s contention that the amendments to claim 1 provide patentable distinctness from the claims of US ‘740 in view of Chao. US ‘740 teaches the CD47/CD20 bispecific antibody species of the instant claims with 100% structural identity; therefore the antibody species of the instant claims are not novel. Further, US ‘740 teaches the antibodies may be used in methods to treat B cell lymphomas. Chao teaches inclusion criteria for patients to be selected for treatment with generic CD47/CD20 antibodies, specifically patients with lymphoid malignancies. For example Chao teaches a bilirubin count ≤ 1.5x or 3.0x ULN as described in the office action of 12/29/2025. Applicants removed this particular inclusion criteria in the amended claims. Nonetheless, Chao also teaches the criteria of an absolute neutrophil count (ANC) which is ≥ 1.0 x 109/mL. The concentration of ANC of the inclusion criteria of Chao is greater than an ANC of ≥ 1.0 x 109/L as recited in amended claim 1, which is more dilute. Thus, the ANC concentration criteria of Chao is well above that of amended claim 1. Chao is silent as to growth factor support, and thus encompasses no growth factor support for 7 days. Therefore the combination methods of US ‘740 and Chao meet every limitation of the methods of the instant claims. Further, Chao teaches hemoglobin counts, platelet counts, AST/SGOT and ALT/SGPT blood counts, as well as serum creatine levels and filtration rates (pg. 22, Patient Eligibility, paras. 0257-0272). Thus demonstrating that these criteria are known in the art for patient eligibility for lymphoid malignancy treatments with bispecific antibodies. Applicants are reminded that MPEP section 2144.05 discusses the obviousness of similar and overlapping ranges, amounts and proportions; as well as 2144.05(II) which supports routine optimization of parameters disclosed in the prior art. Therefore, unless there is evidence indicating such ranges and parameter limitations are crucial, or impart a specific technical advantage over the ranges taught in the art, it would be obvious to optimize the parameters of patient inclusion criteria as disclosed by Chao. Therefore the examiner does not agree that including patient criteria limitations into the methods of instant claim 1 distinguishes the use of the same antibodies as described in US ‘740, in the same methods as described in US ‘740, and following art recognized patient eligibility criteria as described by Chao, offers patentable distinctness from the invention of US ‘740. The examiner does not find that the current disclosure distinguishes a particular technical advantage to the methods that relies on any specific patient inclusion criteria beyond what is known in the art. Therefore, the rejections for non-statutory double patenting over the claims of US Patent 12,545,740, in view of Chao et al., are maintained.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES R. MELCHIOR whose telephone number is (703)756-4761. The examiner can normally be reached M-F 8:00-5:00 CST.
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/JAMES RYLAND MELCHIOR/Examiner, Art Unit 1644
/NELSON B MOSELEY II/Primary Examiner, Art Unit 1642
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