DETAILED ACTION
Applicants amendments to the claims filed 4/5/2024 is acknowledged and entered into the record.
Accordingly, Claims 121-157 are pending and will be examined on the merits.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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, 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 121-157 is/are rejected under 35 U.S.C. 103 as being obvious over Granda et al. (WO2020/236792, cited on IDS filed 9/26/2023) in view of Heusser et al. (WO2010/007082).
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.
The claims are drawn to a combination comprising a CD19 binding molecule comprising an antibody or antigen-binding domain thereof and a BAFF receptor binding molecule comprising an antibody or antigen-binding domain thereof, both comprising CDR sets as recited in instant Claim 121 and/or VH/VL sequences as recited in the claims. The claims are further drawn to wherein the CD19 binding molecule is multispecific or trispecific targeting CD3, CD2 and CD58. The claims are further drawn to variant Fc regions comprises specific substitutions. The claims are drawn to methods of treatment comprising administering the combinations claimed.
Granda et al. teach CD19 binding molecules that specifically bind to CD19, including monospecific, bispecific and trispecific CD19 binding molecules and their use for treating diseases and disorders associated with expression of CD19. Granda et al. teach CD19 binding antibodies having 100% identity to the CDR and VH/VL sequences recited in the instant claims (with same SEQ ID NOs 13, 26, 39, and 52 as instantly claimed and recited in Granda). Granda et al. teach trispecific binding molecules (TBMs) that target CD19, CD3 or other component of a TCR complex on T-cells, and either CD2 or a human tumor-associated antigen (TAA). Granda et al. disclose the CD2 binding moiety is a CD58 moiety comprising 100% identity to instantly claimed SEQ ID NO: 1315 (SEQ ID NO: 760 of Granda). Granda et al. disclose 100% identity to the CDR and heavy and light chain sequences of a CD3 binding moiety recited in instant claim 127-129 (SEQ ID NOs: 767 and 191 of Granda). Granda et al. further disclose the TAA can be BAFFR (also known as TNFRSF13C) and disclose in Table 16 “any TNFRSF13C antibody described in WO 2010/007082, US Pat. No. 9,382,326” (see claims 86-89 of Granda). Granda et al. disclose Fc domain mutations to alter effector function (see paragraph [0229] and specific CH3 domain modifications (see paragraph [0333]). Granda et al. disclose methods of treating B-cell disorders comprising administering the CD19 binding molecules in combination with other known agents or therapies and can be administered prior, concurrently, or post-treatment. Granda et al. does not disclose the BAFF-R binding molecule having the instantly claimed CDR/VH/VL sequences. This deficiency is made up for by Heusser et al.
Heusser et al. teach antibodies that specifically bind to the BAFF receptor (BAFFR) and methods of use comprising administering said antibodies to treat disorders by killing or depleting B cells, such as lymphomas, leukemias and myelomas. Heusser et al. teach 100% identity to the instantly claimed BAFFR CDR/VH/VL sequences.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the CD19 binding molecule taught by Granda et al. with the BAFF-R binding molecule taught by Heusser et al. (cited by Granda et al. - table 16) and use them in therapeutic methods for the treatment of B-cell disorders. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success based on the teachings of Granda et al. and Heusser et al. showing CD19 targeting constructs, including bispecific and trispecific constructs targeting CD19 and BAFF-R, in addition to combination therapy with additional therapeutic agents in the treatment of CD19 associated disorders and thus the instant situation is amenable to the type of analysis set forth In re Kerkhoven, 205 USPQ 1069 (CCPA 1980) wherein the court held that it is prima facie obvious to combine two modes of treatment, each of which is taught by the prior art to be useful for the same purpose in order to make a protocol that is to be used for the very same purpose since the idea of combining them flows logically from their having been taught in the prior art. Applying the same logic to the instantly claimed combination for use in the treatment of B-cell disorders, given the teaching of the prior art of using constructs targeting both CD19 and BAFF-R, it would have been obvious to treat B-cell disorders with a combination of CD19 targeting constructs and BAFF-R targeting constructs because the idea of doing so would have logically followed from their having been taught in the prior art to be useful as combination agents for the same purpose. One of ordinary skill in the art would have reasonably expected to obtain effective treatment with the combination of these agents. Furthermore, It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the specific BAFF-R antibody sequence taught by Heusser et al. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success based on the teachings of Heusser et al. that the antibodies were able to target BAFF-R and induce B-cell responses for clinical therapy.
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.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 121-157 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 169-207 of copending Application No. 18/035,470 in view of Granda et al. (WO2020/236792 cited on IDS) in view of Heusser et al. (WO2010/007082) Heusser et al.
This is a provisional nonstatutory double patenting rejection.
The claims of copending Application 18/035,470 are drawn to the same CD19 binding antibody as recited in the instant claims, as well as the same multispecific CD19 binding molecules targeting additional antigens such as CD3, CD58 in addition to the same Fc region substitutions as instantly claimed all having the same sequences. Copending Application 18/035,470 however does not teach a combination with the CD19 binding molecules with a BAFF-R binding molecule having the sequences in the instant claims. This deficiency is made up for by Granda et al. and Heusser et al.
The teachings of both Granda et al. and Heusser et al. are recited in the 103(a) rejection set forth above.
It would have been prima facie obvious to one of ordinary skill in the art to combine the CD19 binding molecule of copending application 18/035,470, also taught by Granda et al., with the BAFF-R binding molecule taught by Heusser et al. (cited by Granda et al. - table 16) and use them in therapeutic methods for the treatment of B-cell disorders. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success based on the teachings of Granda et al. and Heusser et al. showing CD19 targeting constructs, including bispecific and trispecific constructs targeting CD19 and BAFF-R, in addition to combination therapy with additional therapeutic agents in the treatment of CD19 associated disorders and thus the instant situation is amenable to the type of analysis set forth In re Kerkhoven, 205 USPQ 1069 (CCPA 1980) wherein the court held that it is prima facie obvious to combine two modes of treatment, each of which is taught by the prior art to be useful for the same purpose in order to make a protocol that is to be used for the very same purpose since the idea of combining them flows logically from their having been taught in the prior art and claimed in copending application 18/035,470. Applying the same logic to the claims of copending application 18/035,470 for use in the treatment of B-cell disorders, given the teaching of the prior art of using constructs targeting both CD19 and BAFFR, it would have been obvious to treat B-cell disorders with a combination of CD19 targeting constructs and BAFF-R targeting constructs because the idea of doing so would have logically followed from their having been taught in the prior art to be useful as combination agents for the same purpose. One of ordinary skill in the art would have reasonably expected to obtain effective treatment with the combination of these agents. Furthermore, It would have been prima facie obvious to one of ordinary skill in the art to combine the CD19 binding molecule of copending application 18/035,470 with the specific BAFF-R antibody sequence of Heusser et al. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success based on the teachings of Granda et al. and Heusser et al. that the antibodies were able to target CD19 and BAFF-R and induce B-cell responses for clinical therapy.
Conclusion
Claims 121-157 are rejected.
No Claim is allowed.
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/Meera Natarajan/Primary Examiner, Art Unit 1643