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
This office action is written in response to the papers received 6/23/2023.
Claims 1-15 are pending and examined for a fusion protein comprising antibody to PD-L1 comprising the VHCDR1-3 and VLCDR1-3 within the sequences of VH and VL of SEQ ID NOs: 6 and 5 respectively fused to a VEGF inhibitory domain having the sequence of SEQ ID NO: 9 on merits.
Claim Rejections - 35 USC § 103
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
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 applied reference has a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Claims 1-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over You et al (US 20200270357, effective filing Dec 2017) in view of Hu et al (WO2019062642-A1 (priority to Sep 29, 2017, English translation is provided) as evidenced by sequence alignments.
You et al teach anti-PD-L1 antibody fusion protein comprising anti-PD-L1 antibody fused to an endothelial cell growth factor (entire document, [0019] in particular), wherein the anti-PD-L1 antibody comprises the identical VH and VL domains as set forth in the sequences of the instant SEQ ID NO: 6 and 5, which would comprise the identical VHCDR1-3 and VLCDR1-3 sequences within the sequences of SEQ ID NOs: 6 (121aa) and SEQ ID NO: 5 (110aa) respectively as claimed and as evidenced by sequence alignment below.
QY=SEQ ID NO: 6 (anti-PD-L1 VH)
US-16-871-799-4
Sequence 4, US/16871799
Publication No. US20200270357A1
APPLICANT: AP Biosciences, Inc.
TITLE OF INVENTION: MONOSPECIFIC AND BISPECIFIC PROTEINS WITH IMMUNE CHECKPOINT
TITLE OF INVENTION: REGULATION FOR CANCER THERAPY
CURRENT APPLICATION NUMBER: US/16/871,799
CURRENT FILING DATE: 2020-05-11
PRIOR APPLICATION NUMBER: PCT/US2018/067868
PRIOR FILING DATE: 2018-12-28
PRIOR APPLICATION NUMBER: US 62/611,543
PRIOR FILING DATE: 2017-12-29
NUMBER OF SEQ ID NOS: 43
SEQ ID NO 4
LENGTH: 121
Query Match 100.0%; Score 628; Length 121;
Best Local Similarity 100.0%;
Matches 121; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 QVQLVQSGAKVKKPGSSVKVSCKASGGTFSSYAISWVRQAPGQGLEWMGRIIPILGIANY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 QVQLVQSGAKVKKPGSSVKVSCKASGGTFSSYAISWVRQAPGQGLEWMGRIIPILGIANY 60
Qy 61 AQKFQGRVTITADKSTSTAYMELSSLRSEDTAVYYCARVVPGYSYGPFDYWGQGTTVTVS 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 AQKFQGRVTITADKSTSTAYMELSSLRSEDTAVYYCARVVPGYSYGPFDYWGQGTTVTVS 120
Qy 121 S 121
|
Db 121 S 121
QY=SEQ ID NO: 5 (anti-PD-L1 VL)
US-16-871-799-3
Sequence 3, US/16871799
Publication No. US20200270357A1
MONOSPECIFIC AND BISPECIFIC PROTEINS WITH IMMUNE CHECKPOINT
TITLE OF INVENTION: REGULATION FOR CANCER THERAPY
FILE REFERENCE: 9022-1808584
CURRENT APPLICATION NUMBER: US/16/871,799
CURRENT FILING DATE: 2020-05-11
PRIOR APPLICATION NUMBER: PCT/US2018/067868
PRIOR FILING DATE: 2018-12-28
PRIOR APPLICATION NUMBER: US 62/611,543
PRIOR FILING DATE: 2017-12-29
NUMBER OF SEQ ID NOS: 43
SEQ ID NO 3
LENGTH: 216
Query Match 100.0%; Score 566; Length 216;
Best Local Similarity 100.0%;
Matches 110; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 QSALTQPASVSGSPGQSITISCTGTSNDVGSYNSVSWYQQHPGKAPKLVIYEVANRPSGV 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 QSALTQPASVSGSPGQSITISCTGTSNDVGSYNSVSWYQQHPGKAPKLVIYEVANRPSGV 60
Qy 61 PDRFSGSKSGNTASLTISGLQAEDEADYYCSSYTSSSTLVFGGGTKLTVL 110
||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 PDRFSGSKSGNTASLTISGLQAEDEADYYCSSYTSSSTLVFGGGTKLTVL 110
You’s light chain having over 200 amino acids comprises VL domain (121aa) and Fc domain. You’s antibody has the identical VH and VL domain which must be a human antibody as set forth in the instant claim 9.
You et al also teach that the antibody is IgG comprising IgG1, 2, 3 and 4 and is IgE, IgM etc [0026-0028] and teach pharmaceutical composition comprising the antibody fusion protein (claims 17-19). You et al further teach the antibody fusion protein being antibody-drug conjugate comprising therapeutic agent that is conjugated to the antibody by a linker ([0029, claims 15-16). You et al then teach a method of generating the antibody fusion protein (examples [0115]+).
You et al teach the anti-PD-L1 antibody fused to an endothelial cell growth factory inhibitory domain, but do not teach fusion protein comprising VEGR inhibitory domain as claimed.
Hu et al teach double targeting fusion protein targeting PD-L1 and VEGF, wherein the fusion protein comprises anti-PD-L1 antibody fused to VEGF inhibitory domain (VID, abstract), wherein the VID has identical amino acid sequence as the instant SEQ ID NO: 9 as evidenced by sequence alignment below.
QY=SEQ ID NO: 9 VEGR VID
DT 16-MAY-2019 (first entry)
DE VEGFR1-D2/VEGFR2-D3-D4 fusion protein, SEQ ID 64.
KW VEGFR1 protein; VEGFR2 protein; antibody therapy; breast tumor; cancer;
KW colon tumor; cytostatic; diagnostic test; esophagus tumor;
KW fusion protein; gastrointestinal tumor; head and neck tumor;
KW hematological neoplasm; immuno-diagnosis; liver tumor; lymphoma;
KW melanoma; non-small-cell lung cancer; ovary tumor; pancreas tumor;
KW prostate tumor; protein production; protein targeting; protein therapy;
KW renal cell carcinoma; renal tumor; soft tissue sarcoma; solid tumor;
KW stomach tumor; therapeutic;
KW vascular endothelial cell growth factor receptor 1;
KW vascular endothelial cell growth factor receptor 2.
OS Unidentified.
CC PN WO2019062642-A1.
CC PD 04-APR-2019.
CC PF 20-SEP-2018; 2018WO-CN106741.
PR 29-SEP-2017; 2017CN-10905683.
CC PA (BEIJ-) BEIJING BEYOND BIOTECHNOLOGY CO LTD.
CC PI Hu P, Zou J, Hong W, He Y, Bai J, Song L, Yang W;
CC PT New dual targeting fusion protein that targets programmed cell death
CC PT protein 1 (PD-1) or programmed death-ligand 1 and vascular endothelial
CC The present invention relates to a novel dual targeting fusion protein
CC useful for treating diseases associated with programmed cell death
CC protein 1 (PD-1) activity in an individual. The dual targeting fusion
CC protein comprises an anti-PD-1 antibody and a vascular endothelial cell
CC growth factor (VEGF) family-inhibiting domain (VID) operably linked to
CC the anti-PD-1 antibody or the anti-PD-L1 antibody and the diseases
CC include cancerous disease, solid tumor, soft tissue tumor, melanoma,
CC breast cancer, colon cancer, esophageal cancer, gastrointestinal stromal
CC tumor (GIST), renal cancer (renal cell carcinoma), liver cancer, non-
CC small cell lung cancer (NSCLC), ovarian cancer, pancreatic cancer,
CC prostate cancer, head and neck cancer, gastric cancer and hematological
CC malignancies (lymphoma). The dual targeting fusion protein is also used
CC for targeting PD-1 or programmed death-ligand 1 (PD-L1) and vascular
CC endothelial growth factor (VEGF). The invention further provides: a
CC nucleotide sequence encoding the dual targeting fusion protein; a vector, an expression vector or a glutamine synthetase expression vector having a double expression cassette comprising the nucleotide sequence; a host cell comprising the nucleotide sequence or vector; a method for producing the dual targeting fusion protein; a pharmaceutical composition
comprising the dual targeting fusion protein and a carrier; and a
diagnostic kit comprising the fusion protein. The present sequence
represents a VEGFR1 immunoglobulin (Ig)-like domain 2 (D2)-VEGFR2 Ig-like domain 3 (D3)-domain 4 (D4), which is a VID and used in the invention for preparing the novel dual targeting fusion protein.
SQ Sequence 303 AA;
Query Match 99.4%; Score 1065; Length 303;
Best Local Similarity 100.0%;
Matches 204; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 2 DTGRPFVEMYSEIPEIIHMTEGRELVIPCRVTSPNITVTLKKFPLDTLIPDGKRIIWDSR 61
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 2 DTGRPFVEMYSEIPEIIHMTEGRELVIPCRVTSPNITVTLKKFPLDTLIPDGKRIIWDSR 61
Qy 62 KGFIISNATYKEIGLLTCEATVNGHLYKTNYLTHRQTNTIIDVVLSPSHGIELSVGEKLV 121
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 62 KGFIISNATYKEIGLLTCEATVNGHLYKTNYLTHRQTNTIIDVVLSPSHGIELSVGEKLV 121
Qy 122 LNCTARTELNVGIDFNWEYPSSKHQHKKLVNRDLKTQSGSEMKKFLSTLTIDGVTRSDQG 181
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 122 LNCTARTELNVGIDFNWEYPSSKHQHKKLVNRDLKTQSGSEMKKFLSTLTIDGVTRSDQG 181
Qy 182 LYTCAASSGLMTKKNSTFVRVHEK 205
||||||||||||||||||||||||
Db 182 LYTCAASSGLMTKKNSTFVRVHEK 205
Hu et al further teach that the VID is fused to the C terminus of the Fc domain of anti-PD-L1 antibody with a linker (figure 1) that meet the limitation set forth in claim 2. Hu et al also teach pharmaceutical composition comprising the double targeting fusion protein and pharmaceutically acceptable carrier used for cancer treatment (claim 13).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention was made to combine the teachings to form a fusion protein comprising anti-PD-L1 to VID with expected result. One of ordinary skill in the art before the effective filing date of was made would have been motivated with reasonable expectation of succuss to apply the teaching of Hu et al to the teachings of You et al in order to benefit the treatment for VEGF expressed cancers because Hu et al have shown the fusion protein comprising anti-PD-L1 antibody fused to VID and both Hu and You et al have shown the identical sequences of anti-PD-L1 antibody and VID and because You et al teach and suggest the fusion protein comprising anti-PD-L1 antibody and endothelial cell inhibitory domain and method of using the fusion protein for cancer treatment. Therefore, the references in combination teach every limitation of the claims and the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention was made, absent unexpected results.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Lei Yao, whose telephone number is (571) 272-3112. The examiner can normally be reached on 8:00am-6:00pm Monday-Friday.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis, can be reached on (571) 270-3503. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LEI YAO/Primary Examiner, Art Unit 1642
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