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 20-23 are pending in the instant application.
Priority
This application is a Continuation of application 17/590135 (now U.S. Patent No. 11859005) which claims priority to the provisional applications 63297968 filed on 1/10/2022, and 63144732 filed on 2/2/2021.
Information Disclosure Statement
The information disclosure statement (IDS) dated 4/5/2024 complies with the provisions of 27 CFR 1.97, 1.98, and MPEP § 609. Accordingly, it has been placed in the application file and the information therein has been considered as to the merits.
Objections to the Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code on pg 7, para 023. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Correction is required. See MPEP § 608.01(b).
Objections to the Claims
Claim 20 uses a non-standard way of setting up an optional limitation using “(if present)”. Please replace “wherein L (if present) is a linker” with “wherein L is an optional linker”.
Correction is required. See MPEP § 608.01(m).
Non-Statutory 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.
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Claims 20-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1- 17 of U.S. Patent No. 11859005. Although the claims at issue are not identical, they are not patentably distinct from each other as shown in the claim-by-claim analysis below:
Regarding instant claim 20, the reference claims a compound X-L-M or M-L-X comprising a Fab or Fab’ antibody fragment that binds human GITR comprising the VH of SEQ ID NO: 8 or 9 (reference SEQ ID NO: 8-9) and the VL of SEQ ID NO: 10 (reference SEQ ID NO: 10), wherein M is a VHH that binds human serum albumin and wherein L is a linker (claim 1).
Regarding instant claim 21, the reference claims the VHH is fused to the C-terminus of the heavy chain first constant domain (CH1) (claim 4), wherein the fusion comprises SEQ ID NO: 14-15 (SEQ ID NO: 14-15) and the LC comprises SEQ ID NO: 16 (reference SEQ ID NO: 16) (reference claim 9).
Regarding instant claim 22-23, the reference claims treating arthritis comprising administering a therapeutically effective amount of the compound (reference claim 11).
Allowable Subject Matter
Claims 20-23 are allowable over the prior art.
Claim 20
Claim 20 is drawn to anti-GITR antibody conjugates comprising the VH of instant SEQ ID NO: 8 or 9 and the VL of instant SEQ ID NO: 10. The specific set of six CDRs within these sequences were not found in the prior art.
The closest prior art is that of Nioi et al. (US20170088620, SEQ ID NO: 28462), shown below with the CDR regions underlined.
instant_8 QVQLVESGGGVVQPGRSLRLSCAASGYTFSSYVMHWVRQAPGKGLEWVAVTSYDGTHEYY 60
Nioi_28462 QVQLVESGGGVVQPGRSLRLSCAASGFTFSSYGMHWVRQAPGKGLEWVAVIWYDGNNKYY 60
**************************:***** ***************** ***.::**
instant_8 ADSVKGRFTISRDNSKNTLYLQMNSLRAEDTAVYYCARENNWAPDYWGQGTLVTVSS 117
Nioi_28462 ADSVKGRFTISRDNSKNTLYLQMNSLRAEDTAVYYCARELAWYEDYWGQGTLVTVSS 117
*************************************** * *************
Nioi also teaches a similar VL to that of instant SEQ ID NO: 10 (SEQ ID NO: 24346).
instant_10 DIQMTQSPSSLSASVGDRVTITCRASQDISNSLAWYQQKPGKAPKRLIYAAFSLQSGVPS 60
Nioi_24346 DIQMTQSPSSLSASVGDRVNITCRASQDIRNDLGWYQQKPGKAPKRLIYAASSLQSGVPS 60
*******************.********* *.*.***************** ********
instant_10 RFSGSGSGTEFTLTISSLQPEDFATYYCYQYYNYPSAFGQGTKLEIK 107
Nioi_24346 RFSGSGSGTEFTLTISSLQPEDFATYYCLQHYNYPRAFGQGTKVDIK 107
**************************** *:**** *******::**
Claim 21-23
Claims 21-23 are dependent on claim 20, thus require the novel set of six CDRs required by claim 20, thus are also rendered allowable over the prior art. It is understood in the art that changes to CDRs are unpredictable, thus there was no guidance to arrive at the specific CDR’s recited, given the art of record.
Conclusion
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/L.A.E./
Examiner, Art Unit 1675
/JEFFREY STUCKER/Supervisory Patent Examiner, Art Unit 1675
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