DETAILED ACITON
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 .
1. Formal Matters
A. In the response filed 3/16/26, Applicants elected Group I, without traverse, drawn to the indicated species. Therefore, this restriction is deemed proper and is made FINAL. However, upon further consideration, all species have been examined. Applicants filed a supplemental response on 4/2/26, Applicants reiterated their elections.
B. Claims 1-7, 9-14 and 16-23 are pending. Claims 20 and 21 are withdrawn as being drawn to a non-elected invention. Claims 1-7, 9-14, 16-19, 22 and 23 are the subject of this Office Action.
2. Claim Objections
A. Claim 6 is objected to since the sequences need to be accompanied by SEQ ID NOs. These identifiers are found in paragraph [0051] of the specification.
B. Claim 11 is objected to since the sequences need to be accompanied by SEQ ID NOs. These identifiers are found in paragraph [0071] of the specification.
3. 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.
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.
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.
Claims 1-5, 7, 9, 10, 12, 16-19, 22 and 23 are rejected under 35 U.S.C. 103 as being obvious over Liao et al. (WO 2020/038454; cited as JIANGSU on the IDS filed 6/16/23) in view of Papadopoulos et al. (U.S Patent No. 9,302,015).
Liao (see the attached English machine translation for paragraph references regarding the instant claim limitations) teaches a fully human IL-4R comprising SEQ ID NO:44 and 45, which are identical to instant SEQ ID NO:44 and 45, respectively (see sequence alignment below). See also the Abstract and paragraph [0064]. Therefore, Liao meet the sequence limitations for instant claims 1, 2, 7 and 9. Liao also teaches the germlines in instant claims 3 (paragraph [0067] and 4 ([0073]), as well as scFv and the IgG regions and of claim 5 ([0078]). Liao also teaches the pharmaceutical composition of claim 19 [0156], as well as the polynucleotide, vector, host cells and methods of preparing antibody in instant claims 16-18 and 22 ([0129]). Regarding claim 23, Liao also teaches fusion proteins ([0142]).
Liao does not teach antibody-drug conjugates (ADCs). However, Papadopoulos does teach IL4R ADCs (Example 9 and Table 28 - columns 55 and 56). Claims 10 is taught in column 16, lines 1-52 of Papadopoulos, whereas claim 12 is taught in column 15, lines 54-58. Given this, it would have been obvious at the time of the instant invention to have used the IL4R complex of Liao in the IL4R ADC of Papadopoulos given the teachings of Papadopoulos regarding linking a toxin to a cell-/protein-targeting antibody for therapeutic purposes.
Furthermore, though Liao does provide teachings regarding instant claim 16-18, 19 and 22, it is noted that Papadopoulos also meets these limitations. Regarding claims 16-18 and 22, see column 3, line 56 to column 5, line 36. Regarding claim 19, see column 23, lines 60-66.
The applied reference has a common inventor/assignee 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.
SEQ ID NO:44
AC BHK60188;
XX
DT 16-APR-2020 (first entry)
XX
DE Anti-IL-4R humanized antibody heavy chain, SEQ ID 44.
XX
OS Synthetic.
OS Unidentified.
XX
CC PN WO2020038454-A1.
XX
CC PD 27-FEB-2020.
XX
CC PF 23-AUG-2019; 2019WO-CN102169.
XX
PR 24-AUG-2018; 2018CN-10971269.
PR 04-DEC-2018; 2018CN-11472752.
PR 22-MAR-2019; 2019CN-10221311.
PR 15-MAY-2019; 2019CN-10401923.
XX
CC PA (JSHR ) JIANGSU HENGRUI MEDICINE CO LTD.
CC PA (JSHR ) SHANGHAI HENGRUI PHARM CO LTD.
XX
CC PI Liao C, Xu Z, Jiang J, Zhang L, Qian X, Teng F;
XX
DR WPI; 2020-176023/022.
XX
XX
CC PS Claim 8; SEQ ID NO 44; 44pp; Chinese.
XX
SQ Sequence 445 AA;
Query Match 100.0%; Score 2367; Length 445;
Best Local Similarity 100.0%;
Matches 445; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 EVQLVESGGGLVQPGGSLRLSCAASGFTFSDYGMHWVRQAPGKGLEWVAFISSGSSIIYY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 EVQLVESGGGLVQPGGSLRLSCAASGFTFSDYGMHWVRQAPGKGLEWVAFISSGSSIIYY 60
Qy 61 ADIVKGRSTISRDNAKNTLYLQMNSLRAEDTAVYYCTRGNKRGFFDYWGQGTLVTVSSAS 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 ADIVKGRSTISRDNAKNTLYLQMNSLRAEDTAVYYCTRGNKRGFFDYWGQGTLVTVSSAS 120
Qy 121 TKGPSVFPLAPCSRSTSESTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGL 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 TKGPSVFPLAPCSRSTSESTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGL 180
Qy 181 YSLSSVVTVPSSSLGTKTYTCNVDHKPSNTKVDKRVESKYGPPCPPCPAPEFLGGPSVFL 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 YSLSSVVTVPSSSLGTKTYTCNVDHKPSNTKVDKRVESKYGPPCPPCPAPEFLGGPSVFL 240
Qy 241 FPPKPKDTLMISRTPEVTCVVVDVSQEDPEVQFNWYVDGVEVHNAKTKPREEQFNSTYRV 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 FPPKPKDTLMISRTPEVTCVVVDVSQEDPEVQFNWYVDGVEVHNAKTKPREEQFNSTYRV 300
Qy 301 VSVLTVLHQDWLNGKEYKCKVSNKGLPSSIEKTISKAKGQPREPQVYTLPPSQEEMTKNQ 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 VSVLTVLHQDWLNGKEYKCKVSNKGLPSSIEKTISKAKGQPREPQVYTLPPSQEEMTKNQ 360
Qy 361 VSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSRLTVDKSRWQEGNV 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 VSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSRLTVDKSRWQEGNV 420
Qy 421 FSCSVMHEALHNHYTQKSLSLSLGK 445
|||||||||||||||||||||||||
Db 421 FSCSVMHEALHNHYTQKSLSLSLGK 445
SEQ ID NO:45
CC PS Claim 8; SEQ ID NO 45; 44pp; Chinese.
XX
SQ Sequence 215 AA;
Query Match 100.0%; Score 1119; Length 215;
Best Local Similarity 100.0%;
Matches 215; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 EIVLTQSPATLSLSPGERATLSCRASSSVPYMYWYQQKPGQAPRLLIYLTSNLASGIPAR 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 EIVLTQSPATLSLSPGERATLSCRASSSVPYMYWYQQKPGQAPRLLIYLTSNLASGIPAR 60
Qy 61 FSGSGSGTDFTLTISSLEPEDFAVYYCQQWRAYPPMLTFGGGTKVEIKRTVAAPSVFIFP 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 FSGSGSGTDFTLTISSLEPEDFAVYYCQQWRAYPPMLTFGGGTKVEIKRTVAAPSVFIFP 120
Qy 121 PSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTL 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 PSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTL 180
Qy 181 TLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC 215
|||||||||||||||||||||||||||||||||||
Db 181 TLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC 215
B. Claim 6 is rejected under 35 U.S.C. 103 as being obvious over Liao et al. (WO 2020/038454; cited as JIANGSU on the IDS filed 6/16/23) in view of Papadopoulos et al. (U.S Patent No. 9,302,015) further in view of Holliger et al.
The teachings of Liao and Papadopoulos are seen in paragraph A, above. Neither teaches a linker as recited in claim 6 for linking the heavy chain to the light chain in an scFv. However, as discussed in paragraph [00141] of Applicants’ specification, Holliger (Figure 1) does teach a GGGGS linker for this purpose.
C. Claims 11 and 13 are rejected under 35 U.S.C. 103 as being obvious over Liao et al. (WO 2020/038454; cited as JIANGSU on the IDS filed 6/16/23) in view of Papadopoulos et al. (U.S Patent No. 9,302,015) further in view of Tsutsumi et al..
The teachings of Liao and Papadopoulos are seen in paragraph A, above. Neither teaches the linker recited in claim 11, nor a PE of claim 13. However, Tsutsumi does teach instant SEQ ID NO:62 linked to PE38 (Abstract) and states “[r]ecombinant immunotoxins are chimeric proteins in which a truncated toxin that serves as the cytotoxic moiety is fused to an Fv portion of an antibody that serves as the targeting moiety”. This meets the essential concept of the instant claims.
Conclusion
A. No claim is allowable.
B. Claim 14 is objected to since it depends from a rejected base claim, but is otherwise allowable since SEQ ID NO:52 and 53 are free of the prior art.
Advisory information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT S LANDSMAN whose telephone number is 571-272-0888. The examiner can normally be reached M-F 8 AM – 6 PM (eastern).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Hama, can be reached at 571-272-2911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROBERT S LANDSMAN/Primary Examiner, Art Unit 1647
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