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 .
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.
DETAILED ACTION
Election/Restrictions
Applicant’s election without traverse of 1) belantamab mafodotin, 2) cevostamab, and 3) multiple myeloma in the reply filed on 7/1/26 is acknowledged.
Claims 1-2, 5, 7-9, 11, 14, 16-19, 21-23, 30, 32-34, and 41 are pending.
Claims 21 and 22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/1/26.
Claim 33 is directed to the elected species of multiple myeloma and will be examined.
Claims 1-2, 5, 7-9, 11, 14, 16-19, 23, 30, 32-34, and 41 are under examination.
Claim Objections
Claim 1 is objected to because of the following informalities:
Only one period is allowed in a claim except for when used with abbreviations (MPEP §608.01(m)). The use of “a.” and “b.” in claim 1 does not appear to be an abbreviation and so should not be accompanied by a period. Further, if these are in fact abbreviations, it is not a common abbreviation and must be accompanied by the full name of what is being abbreviated at its first recitation.
Appropriate correction is required. While Applicant may choose any acceptable way to create a list, the Examiner notes that “a)” and “(a)” are both acceptable.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-2, 5, 7, 8, 30, 32-33, and 41 is/are rejected under 35 U.S.C. 102(a)(1-2) as being anticipated by Daley (WO2018201051; IDS 11/21/23 FOR citation 1).
Regarding claim 1, Daley teaches a bispecific antibody (antigen binding protein; ABP) that binds BCMA at one portion (BCMA antigen binding protein) and CD3 in another (CD3 antigen binding protein); see for example claim 1. See also figure 5 and the description on p.24, which measures a BCMA x CD3 bispecific antibody via a T-cell cytotoxicity killing assay. Thus, the bispecific antibody is a combination (two antigen binding proteins) comprising a BCMA ABP and a CD3 ABP. A composition that meets all of the structural requirements of the instant combination must necessarily have the same function as structure dictates function. Further, Daley uses a T-cell assay to measure the antibody, supporting the conclusion that the CD3 ABP is a “T cell engager”.
Regarding claim 2, the BCMA ABP is part of the bispecific antibody of Daley and therefore the BCMA ABP comprises an antibody. See also Daley claim 25 teaching the BCMA agent is an antibody.
Regarding claim 5, Daley teaches the antibody is afucosylated (claim 29).
Regarding claim 7, Daley teaches the BCMA x CD3 combination comprises SEQ ID NOs: 1118 and 1119 (table 26). These sequences contain the instant sequences of SEQ ID NOs: 1-6 at the relevant CDR positions.
Regarding claim 8, Daley teaches the BCMAxCD3 antibody comprises SEQ ID NOs: 1118 and 1119 (table 26). SEQ ID NO: 1118 comprises instant SEQ ID NO: 7 and Daley SEQ ID NO: 1119 comprises instant SEQ ID NO: 8.
Regarding claims 30, 32, and 33, Daley teaches administering the above antibody to treat multiple myeloma (claim 69, 70, 75).
Regarding claim 41, Daley teaches administering 1-25 mg/kg (p.152).
Therefore, claims 1-2, 5, 7, 8, 30, 32-33, and 41 are anticipated.
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.
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.
Claim(s) 9, 11, 14, and 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Daley (WO2018201051; IDS 11/21/23 FOR citation 1) as applied to claims 1-2, 5, 7, 8, 30, 32-33, and 41 above, and further in view of Becnel (IDS 11/21/23 NPL citation 4).
The teachings of Daley are discussed above and incorporated herein.
With respect to the antibody, Daley teaches the antibody as multispecific (e.g., p.2 L33). Daley teaches the BCMA portion of this antibody comprises SEQ ID NOs: 1118 and 1119 as discussed above. Daley further teaches the antibody comprising SEQ ID NOs: 1120 and 1121, where SEQ ID NO: 1120 is 98% identical to instant SEQ ID NO: 9 and Daley SEQ ID NO: 1121 comprises instant SEQ ID NO: 10. As above, Daley teaches this antibody in the treatment of multiple myeloma.
Becnel is also concerned with using BCMA antibodies to treat multiple myeloma (abstract). Becnel teaches belantamab mafodotin is approved for treatment of relapsed/refractory multiple myeloma (abstract).
Regarding claim 14, it would have been obvious to substitute the BCMA binding portion of the Daley antibody with belantamab mafodotin. Both the BCMA antibody of Daley and the BCMA antibody of Becnel are taught as effective for the treatment of multiple myeloma. There would have been a reasonable expectation of success because both are taught as effective for the stated therapeutic purpose.
Regarding claim 9, the remarks filed 7/1/26 state that instant SEQ ID NOs: 9 and 10 are the sequences of belantamab mafodotin (p.5) and so the inclusion of belantamab mafodotin also meets these limitations. This also adds evidence to the reasonable expectation of success since the antibody of Daley is nearly identical to belantamab mafodotin with an identical light chain and 98% identity to the heavy chain including 100% identity to the variable region.
Regarding claim 11, Daley teaches conjugating the BCMA with MMAE (p.198). It would have been obvious to conjugate the multispecific antibody with MMAE to gain the same benefits, e.g., as a cytotoxic payload to treat cancer (Daley: “enhanced potency of BCMA antibody drug conjugates” p.199).
Regarding claim 34, administering the combination to treat multiple myeloma is taught as above. Further, Becnel teaches this applies to relapsed and/or refractory multiple myeloma as above. Such a teaching would have made treatment of RRMM obvious with a reasonable expectation of success since the construct is taught as treating MM and Becnel teaches the BCMA itself is approved to treat RRMM.
Regarding claim 41, the dosage is taught as above. Further, in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). See MPEP §2144.05(I). Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP §2144.05(II). “[I]t is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions” (MPEP §2144.05(II)(A)).
Therefore, claims 1-2, 5, 7-9, 11, 14, 30, 32-34, and 41 would have been obvious.
Claim(s) 16-19 and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Daley (WO2018201051; IDS 11/21/23 FOR citation 1) as applied to claims 1-2, 5, 7, 8, 30, 32-33, and 41 above, and further in view of Cohen (form 892) as evidenced by Conference (form 892).
The teachings of Daley are discussed above and incorporated herein.
Cohen teaches the compound BFCR4350A targets FcRH5 and CD3 on T cells with the result of efficient immune synapse formation and T cell killing of myeloma cells (p.1). The compound demonstrates “potent killing of…patient-derived myeloma cells”.
It would have been obvious to combine the BCMAxCD3 therapeutic for treating myeloma with the FcRH5xCD3 therapeutic for treating myeloma because both are taught as effective for treating myeloma. “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). See MPEP § 2144.06(I). As evidenced by Conference the compound BFCR4350A is also known as Cevostamab (p.1). Including Cevostamab meets the limitations of instant claims 16 (bispecific; binds FcRH5 and CD3), 17 (is cevostamab), 18 (binds FcRH5 and engages T cells), 19 (is cevostamab), and 23 (binds FcRH5 and engages T cells).
Therefore, claims 1-2, 5, 7, 8, 16-19, 23, 30, 32-33, and 41 would have been obvious.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ADAM M WEIDNER whose telephone number is (571)272-3045. The examiner can normally be reached M-T 9-18; W-R 9-15.
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/Adam Weidner/Primary Examiner, Art Unit 1675
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