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 .
Response to Amendment
The Amendment filed August 12, 2026 in response to the Office Action of February 13, 2026 is acknowledged and has been entered.
Claims 1, 8-10, 12, 19, 35, 55, 90, 92, 125-126, 197-198, and 229-232 are currently under consideration.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office Action.
Rejections Withdrawn
The rejection of Claim(s) 126 and 197 under 35 U.S.C. 102(a)(2) as being anticipated by Daly et al., (US20200179511) is withdrawn in view of applicant’s assertion under 35 U.S.C. § 102(b)(2)(C).
The rejection of claim(s) 126, 197, 229-231 under 35 U.S.C. 102(a)(1) as being anticipated by WO 2018/201051 (Daley et al, November 1, 2018, Applicant’s IDS) is withdrawn in view of applicant’s amendments.
The rejection of Claim(s) 222, 228, and 232 under 35 U.S.C. 103 as being unpatentable over WO 2018/201051 (Daley et al, November 1, 2018) in view of Kang et al. (BioProcess Intl, 14(4) April 2016) and Chim et al. (Leukemia, 32, 2018) is also withdrawn in view of applicants arguments. It is also noted that applicants cancelled claims 222 and 228.
The rejection of Claims 126, 197-198, 229-232 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, (scope of enablement) is withdrawn in view of applicant’s amendments.
Rejections Maintained
The rejection of Claims 1, 8-10, 12, 19, 35, 55, 90, 92, 125-126, 197,198, and 228-232 on the ground of nonstatutory double patenting as being unpatentable over claim 26 of U.S. Patent No. 11492409 in view of Kang et al. (BioProcess Intl, 14(4) April 2016) is maintained.
The rejection of Claims 1, 8-10, 12, 19, 35, 55, 90, 92, 125-126, 197,198, 228-232 on the ground of nonstatutory double patenting as being unpatentable over claim 23 of U.S. Patent No. 12275795 in view of Kang et al. (BioProcess Intl, 14(4) April 2016) is maintained.
Applicants argue that they submitted terminal disclaimers over both US Patent 11,492,409 and 12,275,795. A review of all incoming papers appeared to indicate that a terminal disclaimer was filed with a fee code, however, the actual statutory disclaimers did not appear in the file. A call was placed to applicant’s representative (see telephone interview summary) but did not result in the terminal disclaimers being filed at this time.
New Rejections
Claim Rejections - 35 USC § 102
Claim(s) 126, 197, 229-231 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Vu et al. (US 20170327580, published November 16, 2017)
Vu et al. teach a method of treating a disease associated with BCMA expression in a subject in need thereof comprising administering one or more treatment doses of a multispecific antibody having binding specificity towards at least BCMA and a T-cell engaging arm. Vu et al. teach [0012] a bispecific antibody specifically binding to the extracellular domain of human BCMA and human CD3 (a T-cell engaging arm- see para 0005). Vu et al. teach [0105, 0181] that the disease associated with the BCMA expression is multiple myeloma which is also a cancer or a blood cancer. Vu et al. further teach [0112] that a preferred dose is 5 μg/kg.
Claim Rejections - 35 USC § 103
Claim(s) 232 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vu et al. (US 20170327580, published November 16, 2017) in further view of Chim et al. (Leukemia, 32, 2018, cited previously).
Vu et al. teaches as set forth above but does not explicitly include treating patients with relapsed and/or refractory multiple myeloma.
One of ordinary skill in the art at the time of filing would consider it prima facie obvious to include patients with relapsed and/or refractory multiple myeloma (MM) because it is well known in the art that relapse is common in MM patients. For example, Chim et al. teach (page 252) that despite enormous advances with the advent of proteasome inhibitors (PI) and immunomodulatory agents (IMiDs), management of multiple myeloma (MM) remains challenging, and relapse of MM and disease progression is common even after achievement of a complete remission. Further, clinically significant activity of monoclonal antibodies in relapsed/refractory myeloma has been demonstrated in multiple human studies (page 256-257, under "Major Clinical Trials of Monoclonal Antibodies"). Thus, since relapse is well-known to occur in MM patients, it would be obvious to also include such patient populations.
No claim is allowed.
Conclusion
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 GARY B NICKOL, Ph.D. whose telephone number is (571)272-0835. The examiner can normally be reached M-F 9AM-5:30PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Julie Wu can be reached at 571-272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GARY B NICKOL/Primary Examiner, Art Unit 1643
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