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 .
Applicant's amendment and remarks, filed 9/3/26, are acknowledged.
Claims 1-4, 6-10 have been amended.
Claims 11-12 have been added.
Claims 1-4, 6-12 are pending.
Claims 7-10 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claims 1-4, 6, and 11-12 are being acted upon.
The previous grounds of rejection are withdrawn in view of Applicant’s claim amendments.
The following are new grounds of rejection necessitated by Applicant’s claim amendments.
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.
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.
Claim(s) 1-4, 6 and 11-12 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over US 2017/0258835 (of record).
The ‘835 application teaches a method of treating cancer, comprising administering modified T cells that are engineered to express a bispecific antibody, wherein the bispecific antibody binds to CD3 and a tumor antigen (see claims 145-148, 165, page 1-2, paragraph 463, and Example 4, in particular). See example 4, in particular, wherein purified T cells (which express surface CD3) are engineered to express the bispecific antibody, and the antibody binds to CD3 on the T cells and activates the T cells (see pages 42 ,62-63, Fig. 38, and description thereof, and Fig. 104, in particular). The ‘835 publication exemplifies using Blinatumomab as the bispecific antibody, i.e. a bispecific antibody that binds to CD3 and CD19, see example 4, in particular). The ‘853 publication teaches embodiments wherein the T cells do not express any CAR (see Fig. 42 and Example 4 and the claims in particular). In example 4, the administered T cells are xenogeneic with respect to the treated subject (see page 43, 64, and Fig. 42). However, the ‘835 application explicitly teaches that the examples are not limiting but encompass all variations that result from the teachings herein, and the ‘835 publication explicitly teaches that T cells may be allogeneic with respect to the subject undergoing therapy (see paragraph page 38 and 465, in particular). Thus, the ordinary artisan would at once envisage that the cancer treating method using T cells engineered to express the bispecific antibody could be allogeneic. Alternatively, it would be obvious to select allogenic T cells for the cancer treating embodiment with the bispecific antibody based on the explicit teachings of the cited reference. The ‘835 publication teaches treating human subjects (See paragraph 463, in particular). The ‘835 publication teaches producing the T cells by a process comprising purifying T cells, such as from peripheral blood (T cells comprising CD3+, ab T cells) and engineering the cells to express the bispecific antibody (see pages 21-22, 34 and the examples, in particular).
No claim is allowed.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY E JUEDES whose telephone number is (571)272-4471. The examiner can normally be reached on M-F from 7am to 3pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached on 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Amy E. Juedes
Patent Examiner
Technology Center 1600
/AMY E JUEDES/Primary Examiner, Art Unit 1644
