Office Action 2: Notice of Allowance (2025-01-27)

CLAIMS:
AMENDMENTS TO THE CLAIMS

Please enter the following amendments into the application.

1\. - 34. (Canceled)233

35\. (Previously Presented) A cell penetrating antibody that binds to DNA, wherein the antibody comprises:- a heavy chain variable region (VH) comprising:
a complementarity determining region (CDR) 1 comprising the sequence NYGMH (SEQ ID NO:
1),a CDR2 comprising the sequence YISSGSSTIYYADSVKG (SEQ ID NO: 3), and
a CDR3 comprising the sequence RGLLLDY (SEQ ID NO: 4); and- a light chain variable region (VL) comprising:
a CDR1 comprising the sequence RASKTVSTSSYSYMH (SEQ ID NO: 6),
a CDR2 comprising the sequence YASYLES (SEQ ID NO: 7), and a CDR3 comprising the sequence QHSREFPWT (SEQ ID NO: 8),
wherein the antibody is conjugated to a therapeutic compound.

36\. (Previously Presented) The antibody of claim 35, wherein:(i) the VH comprises a sequence at least 95% identical to the sequence as shown in any one of SEQ ID NOs: 21 to 23; and
(ii) the VL comprises a sequence at least 95% identical to the sequence as shown in any one of SEQ ID NOs: 27 to 29.

37\. (Previously Presented) The antibody of claim 35, wherein the therapeutic compound comprises a cytotoxic agent.

38\. (Previously Presented) The antibody of claim 35, wherein the therapeutic compound
USSN: 18/164,444 comprises a chemotherapeutic agent.

39\. (Previously Presented) The antibody of claim 35, wherein the therapeutic compound comprises an anti-inflammatory agent.

40\. (Previously Presented) The antibody of claim 35, wherein the therapeutic compound comprises a radioisotope.

41\. (Previously Presented) A composition comprising:
the antibody of claim 35; and
a pharmaceutically acceptable carrier.

42\. (Previously Presented) A method of treating cancer in a subject, the method comprising administering to the subject an effective amount of the antibody of claim 35.

43\. (Previously Presented) The method of claim 42, wherein the cancer is glioblastoma.

44\. (Previously Presented) The method of claim 42, wherein the cancer is substantially BRCA2 deficient.

45\. (Previously Presented) The method of claim 42, wherein the cancer is substantially PTEN deficient.

46\. (Previously Presented) A cell penetrating antibody that binds to DNA, wherein the antibody comprises:- a heavy chain variable region (VH) comprising:
a complementarity determining region (CDR) 1 comprising the sequence NYGMH (SEQ ID NO:
1),a CDR2 comprising the sequence YISSGSSTIYYADSVKG (SEQ ID NO: 3), and

a CDR3 comprising the sequence RGLLLDY (SEQ ID NO: 4); and- a light chain variable region (VL) comprising:
a CDR1 comprising the sequence RASKTVSTSSYSYMH (SEQ ID NO: 6),
a CDR2 comprising the sequence YASYLES (SEQ ID NO: 7), and a CDR3 comprising the sequence QHSREFPWT (SEQ ID NO: 8),
wherein the antibody is conjugated to a nucleic acid.

47\. (Previously Presented) The antibody of claim 46, wherein:(i) the VH comprises a sequence at least 95% identical to the sequence as shown in any one of SEQ ID NOs: 21 to 23; and
(ii) the VL comprises a sequence at least 95% identical to the sequence as shown in any one of SEQ ID NOs: 27 to 29.

48\. (Previously Presented) A composition comprising:
the antibody of claim 46; and
a pharmaceutically acceptable carrier.

49\. (Previously Presented) A method of treating cancer in a subject, the method comprising administering to the subject an effective amount of the antibody of claim 46.

50\. (Previously Presented) The method of claim 49, wherein the cancer is glioblastoma.

51\. (Previously Presented) The method of claim 49, wherein the cancer is substantially BRCA2 deficient.

52\. (Previously Presented) The method of claim 49, wherein the cancer is substantially PTEN deficient.

53\. (New) The antibody of claim 35, wherein the antibody is conjugated to the therapeutic
USSN: 18/164,444 compound via a linker cleavable by cathepsin.

54\. (New) The antibody of claim 46, wherein the antibody is conjugated to the nucleic acid via a linker cleavable by cathepsin.

OFFICE ACTION:
DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 35-52 are pending and under examination.
35 USC § 112 rejections withdrawn
Upon review and reconsideration the rejections of claims 35 and 46 under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter are withdrawn.
Double Patenting rejections withdrawn
The rejections of claims 35-52 on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No.11,613,590 are withdrawn in view of Applicant’s filing of a terminal disclaimer.
The rejections of claims 35-52 on the ground of nonstatutory double patenting as being unpatentable over claim 1-15 and 17-21 of copending Application No. 18561018 are withdrawn in view of Applicant’s argument that the present application has an earlier patent term filing date and the application is in condition of allowance with the ODP as the remaining rejection.g date and permit that application to issue as a    patent
REASONS FOR ALLOWANCE
The following is an examiner’s statement of reasons for allowance:
Claims 35-52 are found to be allowable because the art does not disclose or make obvious a cell penetrating antibody that binds to DNA, comprising a heavy chain variable region (VH) comprising: a complementarity determining region (CDR) 1 comprising the sequence NYGMH (SEQ ID NO: 1), a CDR2 comprising the sequence YISSGSSTIYY ADSVKG (SEQ ID NO: 3), and a CDR3 comprising the sequence RGLLLDY (SEQ ID NO: 4); and a light chain variable region (VL) comprising: a CDR1 comprising the sequence RASKTVSTSSYSYMH (SEQ ID NO: 6), a CDR2 comprising the sequence YASYLES (SEQ ID NO: 7), and a CDR3 comprising the sequence QHSREFPWT (SEQ ID NO: 8), wherein the antibody is conjugated to a therapeutic compound.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee.  Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”

APPLICANT REBUTTAL: REMARKS
Formal Matters
Claims 35-52 and new claims 53-54 are pending after entry of the amendments set forth herein.
Claims 1-34 were previously canceled.
Claims 53-54 are added. Support for new claims 53-54 is found throughout the specification, including the following exemplary locations: page 43, lines 24 to 24, particularly line 31. Accordingly, no new matter is added by new claims 53-54.
Applicant respectfully requests reconsideration of the application in view of the remarks made herein.
Examiner Interview
The Applicant thanks the Examiner for telephonically discussing the §112(b) rejection with the Applicant's representative, Shweta Chandra, on November 13, 2024. The Examiner indicated that since the parenthesis in claims 35 and 46 recite the sequence identifiers for the listed sequences, the §112(b) rejection is not proper and will be withdrawn.
Nonstatutory double patenting
Claims 35-52 are rejected on the ground of nonstatutory obviousness-type double patenting as allegedly unpatentable over claims 1-20 of U.S. Patent No. 11,613,590.
Applicants enclose herewith a terminal disclaimer, disclaiming patent term beyond the
expiration date of U.S. Patent No. 11,613,590. Thus, this rejection of claims 35-52 may be withdrawn.
Claims 35-52 are rejected on the ground of nonstatutory obviousness-type double patenting as allegedly unpatentable over claims 1-15 and 17-21 of copending US Application No. 18/561,018.
Applicant submits that other than the provisional nonstatutory double patenting rejection over copending Application No. 18/561,018, this application is in condition for allowance. MPEP § 804
(I)(B)(1)(b)(i) states:
"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.
Applicant submits that this provisional double-patenting rejection is the only rejection
remaining in this application. Moreover, the present application has the earlier patent term filing date (priority date Jul 17, 2017and PCT filing date 07/17/2018), relative to US 18/561,018 (priority date May 25, 2021 and PCT filing date May 25, 2022). Accordingly, this rejection may be withdrawn at least for the reasons set forth in MPEP § 804 (I)(B)(1)(b)(i), which action is respectfully requested.
Withdrawal of this rejection is respectfully requested.
Rej
ection under
§
112(b)
Claims 35 and 46 are rejected under 35 U.S.C.112(b) as allegedly being indefinite for failing to particularly point out and distinctly claim the subject matter the inventor or a joint inventor regards as the invention.
As indicated by the Examiner in the afore-mention Examiner interview, since the parenthesis in claims 35 and 46 recite the sequence identifiers for the listed sequences, the §112(b) rejection is not proper and will be withdrawn.
CONCLUSION


CITED REFERENCE SUMMARIES: Ref US11613590: Claims:
1. A cell penetrating anti-DNA binding protein having an antigen binding domain, wherein the antigen binding domain binds to DNA and comprises:
a heavy chain variable region (VH) having a complementarity determining region (CDR) 1 as shown in SEQ ID NO: 1, a CDR2 as shown in SEQ ID NO: 3 and a CDR3 as shown in SEQ ID NO: 4; and
a light chain variable region (VL) having a CDR1 as shown in SEQ ID NO: 6, a CDR2 as shown in SEQ ID NO: 7 and a CDR3 as shown in SEQ ID NO: 8.
2. The binding protein of claim 1 comprising:
(i) a VH comprising a sequence at least 95% identical to the sequence as shown in any one of SEQ ID NOs: 21 to 23;
(ii) a VL comprising a sequence at least 95% identical to the sequence as shown in any one of SEQ ID NOs: 27 to 29; or
(iii) a VH comprising a sequence at least 95% identical to the sequence as shown in any one of SEQ ID NOs: 21 to 23 and a VL comprising a sequence at least 95% identical to the sequence as shown in any one of SEQ ID NOs: 27 to 29.
3. The binding protein according to claim 1, wherein the VH and a VL are separated by a linker which comprises the sequence shown in SEQ ID NO: 30.
4. The binding protein of claim 1, wherein, the VH and VL are in a single polypeptide chain.
5. The binding protein of claim 4, which is:
(i) a single chain Fv fragment (scFv);
(ii) a dimeric scFv (di-scFv);
(iii) a trimeric scFv (tri-scFv); or
(iv) any one of (i), (ii) or (iii) linked to a constant region of an antibody, Fc or a heavy chain constant domain CH 2 and/or CH 3.
6. The binding protein of claim 4, which is a scFv.
7. The binding protein of claim 4, which is a di-scFv.
8. The binding protein according to claim 1, wherein, the VH and VL are in a separate polypeptide chain.
9. The binding protein of claim 8, which is:
(i) a diabody;
(ii) a triabody;
(iii) a tetrabody;
(iv) a Fab;
(v) a F(ab')2;
(vi) a Fv; or
(vii) one of (i) to (vi) linked to a constant region of an antibody, Fc or a heavy chain constant domain CH 2 and/or CH 3; or,
(viii) an antibody.
10. The binding protein according to claim 1, which comprises an amino acid sequence as shown in any one of SEQ ID NOs: 41-47.
11. The binding protein of claim 1, which is conjugated to another compound.
12. The binding protein of claim 1, wherein the VH comprises a sequence at least 99% identical to the sequence as shown in SEQ ID NO: 21 and the VL comprises a sequence at least 99% identical to the sequence as shown in SEQ ID NO: 27.
13. The binding protein of claim 1, wherein the VH comprises the sequence shown in SEQ ID NO: 21 and the VL comprises the sequence shown in SEQ ID NO: 27.
14. A nucleic acid encoding a binding protein defined by claim 1.
15. An expression construct or recombinant cell comprising a nucleic acid defined by claim 14.
16. A method of treating cancer in a subject, the method comprising administering to the subject and effective amount of a binding protein defined claim 1.
17. A method of treating cancer in a subject in need thereof, the method comprising administering to the subject a binding protein or Fv fragment defined by claim 1 and a PARP inhibitor.
18. The method of claim 17, wherein the PARP inhibitor is olaparib.
19. The method of claim 17, wherein the cancer is substantially HDR deficient, substantially BRCA2 deficient, substantially PTEN deficient or resistant to PARP inhibition.
20. The method of claim 17, wherein the cancer is colon cancer, brain cancer, prostate, ovarian, breast, endometrial, melanoma, or pancreatic cancer, a triple negative breast cancer or glioblastoma.