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 .
This office action is in response to an amendment filed 10/24/2025.
Claims 1, 5, 6, 13, 15-23, 29 and 30 are pending. Claims 29 and 30 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
The instant application is a continuation of PCT/EP2021/050145 filed 1/7/2021 which claims priority to EP201510423.5 file3d 1/9/2020.
Response to Amendments
The amendment is sufficient to overcome the objections to the specification and claims. The term “preferably” in claims 2 and 5 were amended but a coordinate amendment to claim 17 wasn’t made. The rejection under 35 USC 112, first has been overcome. Applicants are correct that double patenting rejection was based upon an abandoned application.
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 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.
Claims 1, 5, 6 and 15-23 are rejected under 35 U.S.C. 103 as being unpatentable over Schoeberl et al (WO 2018144514) in view of Chaudbury et al (US 20190107537) and Amann et al (U.S. 20160200833). This rejection is new necessitated by applicants’ amendment.
The applied reference has a common 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). As SEQ ID NO:23 and 24 have been deleted from the claims, reference is made to remaining sequences.
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.
The fusion of 4-1BBL trimers to a F’ab region or an antibody was well known in the art. Schoeberl (¶0012) teaches one such fusion partner is PD-L1. The reference does not provide the sequences. SEQ ID NO:29 and 30 are not found in the art. However, those related to part (b) of claim 1 were known in the art.
Chaudbury et al teaches PD-L1 scFV fusions wherein the heavy and light chains are corresponding to SEQ ID NO:19 and 20.
Sequence 1964, US/16089278
Patent No. 11768203
GENERAL INFORMATION
APPLICANT: UNIVERSITY OF SOUTHERN CALIFORNIA
APPLICANT: Chaudhary, Preet M.
TITLE OF INVENTION: A HIGHLY SENSITIVE AND SPECIFIC LUCIFERASE BASED REPORTER ASSAY
TITLE OF INVENTION: FOR ANTIGEN DETECTION
FILE REFERENCE: 065715-000071WO00
CURRENT APPLICATION NUMBER: US/16/089,278
CURRENT FILING DATE: 2018-09-27
PRIOR APPLICATION NUMBER: 62/316,489
PRIOR FILING DATE: 2016-03-31
NUMBER OF SEQ ID NOS: 2439
SEQ ID NO 1964
LENGTH: 241
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: Synthetic Polypeptide
</pre>
PNG
media_image1.png
707
600
media_image1.png
Greyscale
As to the sequences corresponding to 4-1BB. The heavy chain is well known i.e. SEQ ID NO:25 is disclosed by Amann et al which discloses a construct resembling the instant claims wherein the anti-CEA is replaced by the anti-PD-L1 of Schoeberl.
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media_image2.png
233
210
media_image2.png
Greyscale
The heavy chain is taught by Amann,
RESULT 2
US-15-067-024-115
(NOTE: this sequence has 5 duplicates in the database searched)
Sequence 115, US/15067024
Patent No. 10392445
GENERAL INFORMATION
APPLICANT: Hoffmann-La Roche Inc.
TITLE OF INVENTION: Antigen Binding Molecules comprising a TNF family ligand trimer
FILE REFERENCE: P32429-US-1
CURRENT APPLICATION NUMBER: US/15/067,024
CURRENT FILING DATE: 2016-03-10
PRIOR APPLICATION NUMBER: PCT/EP2015/076528
PRIOR FILING DATE: 2015-11-13
PRIOR APPLICATION NUMBER: EP14193260.8
PRIOR FILING DATE: 2014-11-14
PRIOR APPLICATION NUMBER: EP15183736.6
PRIOR FILING DATE: 2015-09-03
PRIOR APPLICATION NUMBER: EP15188142.2
PRIOR FILING DATE: 2015-10-02
NUMBER OF SEQ ID NOS: 375
SEQ ID NO 115
LENGTH: 722
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: Dimeric hu 4-1BBL (71-254) - CL* Fc knob chain
Query Match 100.0%; Score 3757; Length 722;
Best Local Similarity 100.0%;
Matches 720; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 REGPELSPDDPAGLLDLRQGMFAQLVAQNVLLIDGPLSWYSDPGLAGVSLTGGLSYKEDT 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 REGPELSPDDPAGLLDLRQGMFAQLVAQNVLLIDGPLSWYSDPGLAGVSLTGGLSYKEDT 60
Qy 61 KELVVAKAGVYYVFFQLELRRVVAGEGSGSVSLALHLQPLRSAAGAAALALTVDLPPASS 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 KELVVAKAGVYYVFFQLELRRVVAGEGSGSVSLALHLQPLRSAAGAAALALTVDLPPASS 120
Qy 121 EARNSAFGFQGRLLHLSAGQRLGVHLHTEARARHAWQLTQGATVLGLFRVTPEIPAGLPS 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 EARNSAFGFQGRLLHLSAGQRLGVHLHTEARARHAWQLTQGATVLGLFRVTPEIPAGLPS 180
Qy 181 PRSEGGGGSGGGGSREGPELSPDDPAGLLDLRQGMFAQLVAQNVLLIDGPLSWYSDPGLA 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 PRSEGGGGSGGGGSREGPELSPDDPAGLLDLRQGMFAQLVAQNVLLIDGPLSWYSDPGLA 240
Qy 241 GVSLTGGLSYKEDTKELVVAKAGVYYVFFQLELRRVVAGEGSGSVSLALHLQPLRSAAGA 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 GVSLTGGLSYKEDTKELVVAKAGVYYVFFQLELRRVVAGEGSGSVSLALHLQPLRSAAGA 300
Qy 301 AALALTVDLPPASSEARNSAFGFQGRLLHLSAGQRLGVHLHTEARARHAWQLTQGATVLG 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 AALALTVDLPPASSEARNSAFGFQGRLLHLSAGQRLGVHLHTEARARHAWQLTQGATVLG 360
Qy 361 LFRVTPEIPAGLPSPRSEGGGGSGGGGSRTVAAPSVFIFPPSDRKLKSGTASVVCLLNNF 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 LFRVTPEIPAGLPSPRSEGGGGSGGGGSRTVAAPSVFIFPPSDRKLKSGTASVVCLLNNF 420
Qy 421 YPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQ 480
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 421 YPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQ 480
Qy 481 GLSSPVTKSFNRGECDKTHTCPPCPAPEAAGGPSVFLFPPKPKDTLMISRTPEVTCVVVD 540
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 481 GLSSPVTKSFNRGECDKTHTCPPCPAPEAAGGPSVFLFPPKPKDTLMISRTPEVTCVVVD 540
Qy 541 VSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSN 600
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 541 VSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSN 600
Qy 601 KALGAPIEKTISKAKGQPREPQVYTLPPCRDELTKNQVSLWCLVKGFYPSDIAVEWESNG 660
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 601 KALGAPIEKTISKAKGQPREPQVYTLPPCRDELTKNQVSLWCLVKGFYPSDIAVEWESNG 660
Qy 661 QPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSP 720
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 661 QPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSP 720
And light chain (SEQ ID NO:26 of the instant claims).
RESULT 1
US-15-067-024-116
(NOTE: this sequence has 6 duplicates in the database searched)
Sequence 116, US/15067024
Patent No. 10392445
GENERAL INFORMATION
APPLICANT: Hoffmann-La Roche Inc.
TITLE OF INVENTION: Antigen Binding Molecules comprising a TNF family ligand trimer
FILE REFERENCE: P32429-US-1
CURRENT APPLICATION NUMBER: US/15/067,024
CURRENT FILING DATE: 2016-03-10
PRIOR APPLICATION NUMBER: PCT/EP2015/076528
PRIOR FILING DATE: 2015-11-13
PRIOR APPLICATION NUMBER: EP14193260.8
PRIOR FILING DATE: 2014-11-14
PRIOR APPLICATION NUMBER: EP15183736.6
PRIOR FILING DATE: 2015-09-03
PRIOR APPLICATION NUMBER: EP15188142.2
PRIOR FILING DATE: 2015-10-02
NUMBER OF SEQ ID NOS: 375
SEQ ID NO 116
LENGTH: 297
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: Monomeric hu 4-1BBL (71-254) -CH1*
Query Match 100.0%; Score 1520; Length 297;
Best Local Similarity 100.0%;
Matches 297; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 REGPELSPDDPAGLLDLRQGMFAQLVAQNVLLIDGPLSWYSDPGLAGVSLTGGLSYKEDT 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 REGPELSPDDPAGLLDLRQGMFAQLVAQNVLLIDGPLSWYSDPGLAGVSLTGGLSYKEDT 60
Qy 61 KELVVAKAGVYYVFFQLELRRVVAGEGSGSVSLALHLQPLRSAAGAAALALTVDLPPASS 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 KELVVAKAGVYYVFFQLELRRVVAGEGSGSVSLALHLQPLRSAAGAAALALTVDLPPASS 120
Based on such teachings, it would have prima facie been obvious to one of ordinary skill in the art at the time the invention was made to incorporate the sequences for the constructs recited in Schoeberl et al. As noted above: 1) Schoeberl et al teaches constructs outlined in the instant claims; 2) Chaudbury et al and Amann et al teach the sequences corresponding to those claimed in name in Shoeberl et al. Thus, a person of ordinary skill in the art, absent evidence to the contrary, would have reasonably expected that the sequences cited for the same genes would be useable in construct using those sequences.
Amann et al also teach substitutions that mediate reduced binding as recited in claim 5 and 6, see ¶0050. As well, vectors and pharmaceuticals as claimed in claims 16, 17 and 22 and methods of making with a host cell (see e.g. 0220).
Conclusion
Claims 13 is free of the art.
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 MARIA MARVICH whose telephone number is (571)272-0774. The examiner can normally be reached 8 am - 5 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maria Leavitt can be reached at 571-272-1085. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARIA MARVICH/Primary Examiner, Art Unit 1634