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
Claims 1, 3-4, 6, 9-10, 12, 14, 16, 19, 22-29, 33, 39, 44, and 46-48 are pending in the instant application.
Claims 47-48 are new.
Claim Rejections Withdrawn
The objection to claims 19 and 24-25 is withdrawn in view of claim amendment.
The objection to the specification and sequence listing is withdrawn in view of embedded hyperlink removal and updated sequence listing.
The rejections to claims 1, 12, 16, 24-26, and 44 under 35 USC §112(b) are withdrawn in view of claim amendment.
The rejection to claim 29 under 35 USC §112(a) is withdrawn in view of claim amendment.
The rejections to claims 1, 3-4, 9-10, 12, 14, 16, 19, 24-27, 29, and 44 under 35 USC §103 are withdrawn in view of claim amendment.
The rejections to claims 1, 3-4, 9-10, 12, 14, 16, 19, 24-27, 29, and 44 under Nonstatutory Double Patenting are withdrawn in view of claim amendment.
Claim Status
Applicant’s election without traverse of 1) Group I, claims 1, 3-4, 6, 9-10, 12, 14, 16, 19, 22-29, 33, 39, and 44, drawn to the technical feature of an antibody drug conjugate having a structure of Ab-(L-D)k; and 2) A: the L-D species set forth in claim 25 of:
PNG
media_image1.png
133
555
media_image1.png
Greyscale
and
B: a HCDR 1, a HCDR2 and a HCDR3 set forth in SEQ ID NO: 7, SEQ ID NO: 8 and SEQ ID NO: 9 in the reply filed on 7/14/2025 was addressed and made final in the Non-Final Rejection filed on 11/18/2025. Claims 6, 22-23, 28, 33, 39, and 46 were previously withdrawn in the Non-Final Rejection filed on 11/18/2025 as not containing an elected invention or species.
Claims 1, 3-4, 9, 12, 14, 16, 24-27, 29, 44, and 47-48 read on the Applicant elected invention and species.
Following search, the Examiner further included the L-D species of
PNG
media_image2.png
209
558
media_image2.png
Greyscale
Claims 1, 3-4, 9-10, 12, 14, 16, 19, 24-27, 29, 44, and 47-48 read on the Examiner elected species.
Priority
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C.
119(a)-(d) prior to declaration of an interference, a certified English translation of the
foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and
41.202(e).
Failure to provide a certified translation may result in no benefit being accorded
for the non-English application. The effective priority date is the filing date of
PCT/CN2021/073314 filed on 1/22/2021 in the absence of a certified translation of
CN202010073671.6 filed on 1/22/2020, CN202010114980.3 filed on 2/25/2020, or CN202011153368.3. filed on 10/26/2020.
Claim Rejections – 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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, 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 3-4, 9, 12, 14, 16, 24-27, 29, 44, and 47-48 are rejected under 35 U.S.C. 103 as being unpatentable over US 2017/0252458 (Albone EF et al. reference of record), Narayan S et al. (Bioorganic & Medicinal Chemistry Letters 2011 21(6) 1634-1638), US 2023/0054458 (Yang Y et al. priority to 12/12/2019 reference of record), Ogitani Y et al. (Clin Cancer Res (2016) 22 (20): 5097–5108. reference of record), WO 2019/052405 (Kang Z et al. and Translated WO 2019/052405 reference of record), and WO 2020/156439 (Yang C et al. priority to 01/28/2019 and Translated WO 2020/156439 reference of record).
Albone taught antibody-drug conjugates (ADC) of ER1159569 conjugated to the antibodies trastuzumab or MORAb009 in a pharmaceutical composition with a pharmaceutically acceptable excipient, wherein the ADCs were dose-dependently effective when administered to cancer cells that expressed the antibody target (page 117, Table 49, Row 3 and 4), wherein ER1159569 had the structure of
PNG
media_image3.png
331
725
media_image3.png
Greyscale
(page 79, Table 46, Row 1), wherein the trastuzumab-ER1159569 had a drug to antibody ratio (DAR) of about 3 and MORAb009-ER1159569 had DAR of about 5 (page 112, Table 47, Rows 7-8)
Albone did not teach ADCs with the structure:
PNG
media_image1.png
133
555
media_image1.png
Greyscale
, but this is obvious in view of Narayan, Yang Y, Ogitani, Kang, and Yang C.
Narayan taught conversion of the C34 hydroxyl (OH) to the methyl ether (OCH3 or OMe) was found to enhance potency of the drug in drug resistant cancer cells and lower the fold-resistance ratio (drug resistant cancer cell IC50 value/ cancer cell IC50 value (page 1636-1637, bridging paragraph and Table 1). Narayan taught compound 25, which comprised a C34 substituent of OMe, had better pharmacokinetic properties compared to eribulin, which comprised a C34 substituent of OH, wherein area under the curve and clearance were calculated (Table 2). Narayan taught compound 25, which comprised a C34 substituent of OMe, was effective when administered in a pharmaceutical composition with a pharmaceutically acceptable excipient to a subject with cancer (Fig. 6).
Yang Y taught a drug conjugate of compound 8 with the structure
PNG
media_image4.png
248
631
media_image4.png
Greyscale
(page 36) comprised an exatecan derivative of compound 1
PNG
media_image5.png
233
220
media_image5.png
Greyscale
(page 29) which included a drug attachment moiety of
PNG
media_image6.png
55
86
media_image6.png
Greyscale
, wherein the exatecan derivative compound 1 was dose-dependently effective when administered to cancer cells (page 47, Table 15).
Ogitani taught DS-8201a with a structure of:
PNG
media_image7.png
154
542
media_image7.png
Greyscale
(Figure 1) was dose-dependently effective when administered to cancer cells and to subjects with cancer (Fig 2B-D).
Kang taught a drug conjugate of X70 comprising a maleimide-(PEG)4 linker with the structure:
PNG
media_image8.png
129
738
media_image8.png
Greyscale
(translated page 9), wherein the half-life of the conjugate was increased in comparison to the non-conjugated drug (translated page 15, Table 3) and X70 was effective at inhibiting tumor cell proliferation (translated page 22-23, Table 7 and described in translated page 20, [0207]). Thus, the linker was effective.
Yang C taught mAB015 clone 83B2G2 effectively bound CD79b via ELISA (Fig. 7) and FACS (Fig. 8) and comprised a VH of SEQ ID NO:3 and a VL of SEQ ID NO:4 (translated page 12, [149]). Yang C taught mAB015 effectively bound CD79b to a level similar to the positive control SN38 which is the FDA approved antibody-conjugated drug polatuzumab vedotin (translated page 13, [0155]). Yang C taught an anti-CD79B antibody or an antibody-drug conjugate and a pharmaceutical composition thereof, and a method using the same for treating or delaying cancer, especially hematopoietic tumors (translated page 2, [0010]), wherein the ADC comprises an antibody covalently coupled to a drug through a linker, wherein the drug is a cytotoxic agent (translated page 5, [0069]-[0070]). Yang taught diffuse large B-cell lymphoma (DLBCL) is a B-cell lymphoma, wherein the B cell receptor (BCR) complex is the most major molecule on the surface of B cells, wherein the BCR complex comprises Igβ (CD79B) heterodimers that transmit antigen stimulation signals (translated page 2, [0006]).
Regarding instant claims 1, 3-4, 9, 12, 14, 16, 24-27, 29, 44, and 47-48, it would have been obvious for a person having ordinary skill in the art to take the effective pharmaceutical composition of an ADC of Albone comprising ER1159569 conjugated to trastuzumab with a DAR of about 3 in a pharmaceutically acceptable excipient – and modify the ADC to:
1) exchange the C34 substituent from -OH to methyl ether (-OCH3 or -OMe) in view of Narayan;
2) exchange the protease cleavable Val-Cit-PABC linker for a protease cleavable GGFG conjugated to
PNG
media_image9.png
72
100
media_image9.png
Greyscale
as taught by Yang Y;
[AltContent: textbox ((1)]3) exchange the maleimide (PEG)2 moiety for the maleimide-(PEG)4 moiety of Kang; and 4) exchange the trastuzumab antibody for mAB015 of Yang C.
[AltContent: rect]
PNG
media_image10.png
250
579
media_image10.png
Greyscale
This is obvious because: 1a) Narayan taught conversion of the C34 hydroxyl to the methyl ether was found to enhance potency in drug resistant cancer cells; 1b) Narayan taught compound 25, which comprised a C34 substituent of OMe, was effective at treating cancer cells and had better pharmacokinetic properties compared to eribulin, which comprised a C34 substituent of OH; 2a) Yang Y taught the drug linker attachment moiety of
PNG
media_image11.png
94
281
media_image11.png
Greyscale
; 2b) a drug linker attachment moiety of
PNG
media_image6.png
55
86
media_image6.png
Greyscale
was known to be effective when bound to an effective cancer drug as taught by Yang Y; 2c) GGFG linkers were known to be effective as taught by Ogitani; 3) Kang taught a drug conjugate of X70 comprising a maleimide-(PEG)4 linker was effective, wherein the half-life of the conjugate was increased in comparison to the non-conjugated drug and X70 was effective at inhibiting tumor cell proliferation; and 4) mAB015 effectively binds CD79b, which is expressed on cancer cells, and mAB015 binds CD79b as effectively as the antibody for the FDA approved antibody-conjugated drug polatuzumab vedotin as taught by Yang C.
There is a reasonable expectation of success because: 1a) Narayan taught conversion of the C34 hydroxyl to the methyl ether was found to enhance potency in drug resistant cancer cells; 1b) Narayan taught compound 25, which comprised a C34 substituent of OMe, was effective at treating cancer cells and had better pharmacokinetic properties compared to eribulin, which comprised a C34 substituent of OH; 2) a drug linker attachment moiety of
PNG
media_image6.png
55
86
media_image6.png
Greyscale
and GGFG linkers were known to be effective; 3) Kang taught a drug conjugate of X70 comprising a maleimide-(PEG)4 linker was effective, wherein the half-life of the conjugate was increased in comparison to the non-conjugated drug and X70 was effective at inhibiting tumor cell proliferation; and 4) mAB015 effectively binds CD79b, which is expressed on cancer cells, and mAB015 binds CD79b as effectively as the antibody for the FDA approved antibody-conjugated drug polatuzumab vedotin as taught by Yang C.
This would produce an ADC of mAB015 as the Ab with a drug conjugate structure of
PNG
media_image1.png
133
555
media_image1.png
Greyscale
wherein k is 3 and D has the structure of:
PNG
media_image12.png
168
212
media_image12.png
Greyscale
, wherein R1a is methyl (instant claims 47-48) and R1b is H, in a pharmaceutical composition with a pharmaceutically acceptable excipient and meets the claim limitations of the Applicant elected species present in instant claims 1, 3-4, 9, 12, 14, 16, 24-27, 29, 44, and 47-48.
Response to Arguments
Independent claim 1 has been amended.
The updated rejection is above.
Applicant argues the presently claimed ADCs show surprising and unexpected improved properties. Applicants submit that even assuming arguendo that a prima facie case of obviousness could be established (which Applicants do not concede), evidence of secondary considerations, such as unexpected results, is more than sufficient to overcome it and demonstrate that the claims are patentable over the cited art. MPEP § 2145; see also Graham v. John Deere Co., 383 U.S. 1 (1966). Indeed, as set forth in the MPEP, rebuttal evidence may include evidence that the "claimed invention yield unexpectedly improved properties or properties not present in the art" (MPEP § 2145) and "[n]onobviousness can be shown when a person of ordinary skill in the art would not have reasonably predicted the claimed invention based on the prior art, and the resulting invention would not have been expected." Id. at Example 2, discussing In re Sullivan, 498 F.3d 1345 (Fed. Cir. 2007).
Indeed, the present application demonstrates that the conjugate of the present invention and the corresponding toxin molecule have achieved unexpected technical effect when R1a is an optionally substituted C1-6 alkyl and R1b is hydrogen. Applicants submit that the antibody drug conjugates ADC-3 to ADC-5 formed by the toxin compound D-1 (displayed below) in the present application are covered by the scope of amended claim 1.
PNG
media_image13.png
254
323
media_image13.png
Greyscale
With regard to the toxins, Test Example 1 tested the in vitro cytotoxic activity of different toxins. As shown in Table 5, compound D-1 has strong killing effects in all three tumor cell lines. The IC50 values demonstrate that in vitro effect is significantly better than that of eribulin. Furthermore, Test Example 6 evaluated the pharmacokinetic characteristics of different toxins in animals. The results are shown in Table 9, which is reproduced below.
PNG
media_image14.png
295
752
media_image14.png
Greyscale
The results presented in Table 9 show that the area under the curve (AUC) of compound D-1 in vivo is more than 4 times that of eribulin, and its half-life is more than 8 times that of eribulin. It can be clearly seen that compound D-1 has a longer action time and a higher absorption in vivo compared to eribulin. Therefore, compound D-1 has higher activity and bioavailability compared to eribulin, which exceeds the expectations of those skilled in the art and achieves unexpected technical effects.
With regard to the ADC, Test Example 7 evaluated the efficacy of ADC-2 and ADC-3 on BALB/c Nude Mouse Subcutaneous Xenograft Tumor of Human Pharyngeal Squamous Cell Carcinoma FaDu Cell Line. The structures of ADC-2 and ADC-3 are shown below, with only the difference in the toxin component. For the sake of clarity, Applicants point out that ADC-2 is eribulin, and ADC-3 is compound D-1.
PNG
media_image15.png
506
651
media_image15.png
Greyscale
However, the results of Test Example 7 showed that after administering a dose of 3 mg/kg, the in vivo efficacy of the ADC-3 group is significantly better than that of the ADC-2 group at 25 days, and there is a significant difference between the two (see, for example, Table 11 of the specification as originally filed). This indicates that the unexpected technical effects achieved by the toxin are also observed in the ADC. Therefore, the technical effect of the toxin exceeds the expectations of those skilled in the art, and the technical effect of ADC also exceeded the expectations of those skilled in the art. Applicants submit that in light of these unexpected technical effects, the ADCs of the present application are inventive and unobvious in view of the references cited by the Examiner.
In response, Applicant's arguments filed 2/4/2026 have been fully considered
but they are not persuasive. MPEP 716.02(d) requires unexpected results to be commensurate in scope with the claimed invention. Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." The current scope of the claims are not commensurate with the surprising results. The structure of ADC-3 with surprising results is:
PNG
media_image16.png
246
656
media_image16.png
Greyscale
, which has a different linker-drug (L-D) structure compared to the Applicant’s elected species.
Regarding the species of:
PNG
media_image2.png
209
558
media_image2.png
Greyscale
Claims 1, 3-4, 9-10, 12, 14, 16, 19, 24-27, 29, 44, and 47-48 are rejected under 35 U.S.C. 103 as being unpatentable over US 2017/0252458 (Albone EF et al. reference of record), Narayan S et al. (Bioorganic & Medicinal Chemistry Letters 2011 21(6) 1634-1638), and WO 2020156439 (Yang C priority to 01/28/2019 reference of record).
Albone taught antibody-drug conjugates (ADC) of ER1159569 conjugated to the antibodies trastuzumab or MORAb009 in a pharmaceutical composition with a pharmaceutically acceptable excipient, wherein the ADCs were dose-dependently effective when administered to cancer cells that expressed the antibody target (page 117, Table 49, Row 3 and 4), wherein ER1159569 had the structure of
PNG
media_image3.png
331
725
media_image3.png
Greyscale
(page 79, Table 46, Row 1), wherein the trastuzumab-ER1159569 had a drug to antibody ratio (DAR) of about 3 and MORAb009-ER1159569 had DAR of about 5 (page 112, Table 47, Rows 7-8)
Albone did not teach ADCs with the structure:
PNG
media_image2.png
209
558
media_image2.png
Greyscale
, but this is obvious in view of Narayan and Yang C.
Narayan taught conversion of the C34 hydroxyl (OH) to the methyl ether (OCH3 or OMe) was found to enhance potency of the drug in drug resistant cancer cells and lower the fold-resistance ratio (drug resistant cancer cell IC50 value/ cancer cell IC50 value (page 1636-1637, bridging paragraph and Table 1). Narayan taught compound 25, which comprised a C34 substituent of OMe, had better pharmacokinetic properties compared to eribulin, which comprised a C34 substituent of OH, wherein area under the curve and clearance were calculated (Table 2). Narayan taught compound 25, which comprised a C34 substituent of OMe, was effective when administered in a pharmaceutical composition with a pharmaceutically acceptable excipient to a subject with cancer (Fig. 6).
Yang C taught mAB015 clone 83B2G2 effectively bound CD79b via ELISA (Fig. 7) and FACS (Fig. 8) and comprised a VH of SEQ ID NO:3 and a VL of SEQ ID NO:4 (translated page 12, [149]). Yang C taught mAB015 effectively bound CD79b to a level similar to the positive control SN38 which is the FDA approved antibody-conjugated drug polatuzumab vedotin (translated page 13, [0155]). Yang C taught an anti-CD79B antibody or an antibody-drug conjugate and a pharmaceutical composition thereof, and a method using the same for treating or delaying cancer, especially hematopoietic tumors (translated page 2, [0010]), wherein the ADC comprises an antibody covalently coupled to a drug through a linker, wherein the drug is a cytotoxic agent (translated page 5, [0069]-[0070]). Yang taught diffuse large B-cell lymphoma (DLBCL) is a B-cell lymphoma, wherein the B cell receptor (BCR) complex is the most major molecule on the surface of B cells, wherein the BCR complex comprises Igβ (CD79B) heterodimers that transmit antigen stimulation signals (translated page 2, [0006]).
Regarding instant claims 1, 3-4, 9-10, 12, 14, 16, 19, 24-27, 29, and 44, it would have been obvious for a person having ordinary skill in the art to take the effective pharmaceutical composition of an ADC of Albone comprising ER1159569 conjugated to trastuzumab with a DAR of about 3 in a pharmaceutically acceptable excipient – and modify the ADC to:
1) exchange the C34 substituent from -OH to methyl ether (-OCH3 or -OMe) in view of Narayan; and 2) exchange the trastuzumab antibody for mAB015 of Yang C.
PNG
media_image17.png
274
554
media_image17.png
Greyscale
This is obvious because: 1a) Narayan taught conversion of the C34 hydroxyl to the methyl ether was found to enhance potency in drug resistant cancer cells; 1b) Narayan taught compound 25, which comprised a C34 substituent of OMe, was effective at treating cancer cells and had better pharmacokinetic properties compared to eribulin, which comprised a C34 substituent of OH; and 2) mAB015 effectively binds CD79b, which is expressed on cancer cells, and mAB015 binds CD79b as effectively as the antibody for the FDA approved antibody-conjugated drug polatuzumab vedotin as taught by Yang C.
There is a reasonable expectation of success because: 1a) Narayan taught conversion of the C34 hydroxyl to the methyl ether was found to enhance potency in drug resistant cancer cells; 1b) Narayan taught compound 25, which comprised a C34 substituent of OMe, was effective at treating cancer cells and had better pharmacokinetic properties compared to eribulin, which comprised a C34 substituent of OH; and 2) mAB015 effectively binds CD79b, which is expressed on cancer cells, and mAB015 binds CD79b as effectively as the antibody for the FDA approved antibody-conjugated drug polatuzumab vedotin as taught by Yang C.
This would produce an ADC of mAB015 as the Ab with a drug conjugate structure of
PNG
media_image2.png
209
558
media_image2.png
Greyscale
wherein k is 3 and D has the structure of:
PNG
media_image12.png
168
212
media_image12.png
Greyscale
, wherein R1a is methyl (instant claims 47-48) and R1b is H, in a pharmaceutical composition with a pharmaceutically acceptable excipient and meets the claim limitations of the Examiner elected species present in instant claims 1, 3-4, 9-10, 12, 14, 16, 19, 24-27, 29, 44, and 47-48.
Response to Arguments
Independent claim 1 has been amended.
The updated rejection is above.
Applicant’s arguments regarding unexpected results are described above.
In response, Applicant's arguments filed 2/4/2026 have been fully considered
but they are not persuasive. MPEP 716.02(d) requires unexpected results to be commensurate in scope with the claimed invention. Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." The current scope of the claims are not commensurate with the surprising results. The structure of ADC-3 with surprising results is:
PNG
media_image16.png
246
656
media_image16.png
Greyscale
. While the Examiner elected species has the same (L-D) as the ADC with surprising results, the instant claims are not commensurate in scope with a single surprising ADC species in the claim.
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.
Regarding the Examiner elected species of
PNG
media_image2.png
209
558
media_image2.png
Greyscale
Claims 1, 3-4, 9-10, 12, 14, 16, 19, 24-27, 29, 44, and 47-48 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6-8, 11-13, 23-26, 35, 37-39, and 41-42 of copending Application No. 18/018,241. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding instant claims 1, 3-4, 9-10, 12, 14, 16, 19, 24-27, 29, 44, and 47-48 ‘241 claim 13 taught a ligand drug conjugate comprising an anti-CD79B antibody comprising a VH of HCDR1-3 of SEQ ID NO:24-26 (GSSFTSY.*FPRSGN.*GDLGDFDY) and a VL of LCDR1-3 of SEQ ID NO:27, 11, and 12 (RSSQSIVHSDGNTYFE.* KVSNRFS.* FQGSHVPWT) in copending claim 1, which is identical to the Applicant elected antibody of instant SEQ ID NO:7-9 and instant SEQ ID NO:10-12, wherein in copending claim 13 the formula is Pc-(L-D)k wherein
PNG
media_image18.png
363
624
media_image18.png
Greyscale
wherein R1a is methyl and R1b is H, which is identical to the compound structure of instant claim 1, wherein the ligand conjugate comprises
PNG
media_image19.png
104
342
media_image19.png
Greyscale
with a k of 1-10, R1a is methyl and R1b is hydrogen in copending claim 23,
wherein the ligand conjugate is
PNG
media_image20.png
180
556
media_image20.png
Greyscale
in copending claim 37, which is the Examiner elected species, wherein the ligand drug is present in a pharmaceutical composition further comprising a pharmaceutically acceptable excipient and a therapeutically effective amount in claim 39, which is identical to instant claim 44.
This meets the claim limitations of instant claims 1, 3-4, 9-10, 12, 14, 16, 19, 24-27, 29, 44, and 47-48.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicants would like to point out that the application filing date of the '241 Application is later than the filing date of the instant application (i.e., the instant application was filed on January 22, 2021, and the cited application was filed on July 27, 2021). Applicants submit that the rejection is improper because the present application has an earlier effective filing date than the '241 Application. Even in the context of a provisional double patenting rejection, a later-filed application cannot serve as the basis for an obviousness-type double patenting rejection against an earlier filed application.
In response, Applicant's arguments filed 2/4/2026 have been fully considered
but they are not persuasive. According to the MPEP 804 section I.B.1.B.i., if a provisional nonstatutory double patenting rejection is the only rejection remaining in an application having the earlier patent term filing date, the examiner should withdraw the rejection in the application having the earlier patent term filing date and permit that application to issue as a patent, thereby converting the provisional nonstatutory double patenting rejection in the other application into a nonstatutory double patenting rejection upon issuance of the patent. While ‘241 has a later effective filing date compared to the instant application, the provisional nonstatutory double patenting rejection is not only rejection remaining in an application.
Claims 1, 3-4, 9-10, 12, 14, 16, 19, 24-27, 29, 44, and 47-48 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5-7, 9-13, 15-20, and 22-24 of copending Application No. 18/290,721 in view of WO 2020156439 (Yang C priority to 01/28/2019).
‘721 taught an antibody drug conjugate of Formula I of Ab-(L-D)k
PNG
media_image21.png
281
578
media_image21.png
Greyscale
in copending claim 1, wherein k is between 1 and 10 in copending claim 2, wherein the linker contains cleavable peptides in copending claims 2-3 or other moieties in copending claims 5-7, wherein further spacer units are claimed in copending claims 9-13, wherein further linkers are claimed in copending claims 15-16, wherein the ADC further comprises the structure
PNG
media_image22.png
130
386
media_image22.png
Greyscale
and k is between 1 and 10 in copending claim 17, wherein the ADC is present in a pharmaceutical composition further comprising a pharmaceutically acceptable excipient and a therapeutically effective amount in copending claim 22.
The claims of ‘721 do not teach an antibody if instant SEQ ID NO:7-9 and instant SEQ ID NO:10-12, but this is obvious in view of Yang C.
Yang C taught mAB015 clone 83B2G2 effectively bound CD79b via ELISA (Fig. 7) and FACS (Fig. 8) and comprised a VH of SEQ ID NO:3 and a VL of SEQ ID NO:4 (translated page 12, [149]). Yang C taught mAB015 effectively bound CD79b to a level similar to the positive control SN38 which is the FDA approved antibody-conjugated drug polatuzumab vedotin (translated page 13, [0155]). Yang C taught an anti-CD79B antibody or an antibody-drug conjugate and a pharmaceutical composition thereof, and a method using the same for treating or delaying cancer, especially hematopoietic tumors (translated page 2, [0010]), wherein the ADC comprises an antibody covalently coupled to a drug through a linker, wherein the drug is a cytotoxic agent (translated page 5, [0069]-[0070]). Yang taught diffuse large B-cell lymphoma (DLBCL) is a B-cell lymphoma, wherein the B cell receptor (BCR) complex is the most major molecule on the surface of B cells, wherein the BCR complex comprises Igβ (CD79B) heterodimers that transmit antigen stimulation signals (translated page 2, [0006]).
Regarding instant claims 1, 3-4, 9-10, 12, 14, 16, 19, 24-27, 29, 44, and 47-48, it would have been obvious for a person having ordinary skill in the art to take the pharmaceutical composition comprising a pharmaceutically acceptable excipient and ADC of copending claims 1, 17, and 22 – and modify the ADC to:
1) exchange the antibody for mAB015 of Yang C.
This is obvious because: 1) mAB015 effectively binds CD79b, which is expressed on cancer cells, and mAB015 binds CD79b as effectively as the antibody for the FDA approved antibody-conjugated drug polatuzumab vedotin as taught by Yang C.
There is a reasonable expectation of success because: 1) mAB015 effectively binds CD79b, which is expressed on cancer cells, and mAB015 binds CD79b as effectively as the antibody for the FDA approved antibody-conjugated drug polatuzumab vedotin as taught by Yang C.
This meets the claim limitations of the Examiner elected species present in instant claims 1, 3-4, 9-10, 12, 14, 16, 19, 24-27, 29, 44, and 47-48.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicants would like to point out that the application filing date of the '721 Application is later than the filing date of the instant application (i.e., the instant application was filed on January 22, 2021, and the cited application was filed on July 22, 2022). Applicants submit that the rejection is improper because the present application has an earlier effective filing date than the '721 Application. Even in the context of a provisional double patenting rejection, a later-filed application cannot serve as the basis for an obviousness-type double patenting rejection against an earlier filed application.
In response, Applicant's arguments filed 2/4/2026 have been fully considered
but they are not persuasive. According to the MPEP 804 section I.B.1.B.i., if a provisional nonstatutory double patenting rejection is the only rejection remaining in an application having the earlier patent term filing date, the examiner should withdraw the rejection in the application having the earlier patent term filing date and permit that application to issue as a patent, thereby converting the provisional nonstatutory double patenting rejection in the other application into a nonstatutory double patenting rejection upon issuance of the patent. While ‘721 has a later effective filing date compared to the instant application, the provisional nonstatutory double patenting rejection is not only rejection remaining in an application.
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 JOHN J SKOKO III whose telephone number is (571)272-1107. The examiner can normally be reached M-F 8:30 - 5:00.
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, Julie Z Wu can be reached at (571)272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/J.J.S./Examiner, Art Unit 1643
/Karen A. Canella/Primary Examiner, Art Unit 1643