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 election without traverse of group I, claims 1-5, in the reply filed on 4/27/26 is acknowledged. Applicant has further elected CD19 as the species of second antigen and ab T cells as the species of T cells. Claims 6-9 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claims 1-5 read on the elected invention and are being acted upon.
Claim 5 is objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim cannot depend from another multiple dependent claim. See MPEP § 608.01(n). In the interest of compact prosecution, the claim is being included in the examination and is being treated as if it depends from claim 1.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-5 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 is directed to a method comprising obtaining immune effector cells and engineering the immune effector cells to express an anti-CD3 multi-specific antibody, wherein the antibody is “configured to bind a CD3 complex on the immune effector cells”. The scope of the claimed immune effector cells and/or configurations is unclear and indefinite. The claim recites that the antibody is configured to bind to a CD3 complex “on the immune effector cells”, which would appear to require that the immune effect cells express CD3 on the cell surface, and the multi-specific antibody binds thereto. However, the specification specifically discloses that immune effector cells encompass, for example NK cells that are CD3-. See also claim 5, which recites that the immune effector cell can be, for example, a B cell, an NK cell, or ILC, which do not express CD3. Therefore, for example, a B cell engineered to express an anti-CD3 multiple specific antibody would not bind to a CD3 complex on the B cell, and it is not clear what the claims encompass. Do the claims require immune effector cells that express CD3 on the cells? Would the claims encompass non-CD3 expressing immune effector cells, such as B cells that express the anti-CD3 multispecific antibody, wherein the antibody is configured to bind a CD3 on other immune effector cells? The scope of the claimed configurations and immune effector cells is unclear an indefinite.
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.
Claim(s) 1-5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 9,765,156 (of record).
The ‘156 patent teaches a method of treating cancer comprising administering a T cell that is genetically engineered to co-express a CAR and a bispecific antibody, wherein the bispecific antibody binds to CD3 and CD19 tumor antigen (see claims 1-10, claim 10 in particular claims that the bispecific antibody is encoded by SEQ ID NO: 1, which encodes a CD3 and CD19 bispecific antibody). The ‘156 patent teaches that the CD3 bispecific antibody binds to the CD3 complex on the T cells (see Fig. 2-3, and description thereof, in particular). The ‘156 patent teaches that the T cells are isolated from a subject (i.e. obtained from a donor, see columns 36-37, in particular). The ‘156 patent teaches peripheral blood T cells or CD4 or CD8 T cells (i.e. ab T cells, see column 37, in particular). The ‘156 patent teaches that the cells are administered for a therapeutic benefit in a recipient subject, wherein the cells are isolated and genetically modified to express the compositions disclosed herein, and that the cells can be allogeneic with respect to the recipient (see column 46, lines 18-27, in particular). Thus, the ordinary artisan would at once envisage that in the claimed therapeutic cancer treatment method, the administered T cells can be from an allogeneic subject, i.e. a donor. However in the event that Applicant may disagree, the claims are also being rejected as obvious over the ‘156 patent for the reasons set forth below.
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) 1-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over US US 9,765,156, in view of Depil, published Jan. 3 2020 (of record).
The teachings of the ‘156 patent are described above. The ‘156 patent teaches an embodiment of administering the bispecific antibody expressing CAR T cells to treat B cell lymphoma post allogeneic bone marrow transplant (See paragraphs, columns 45-46, in particular).
Depil teach that donor derived allogeneic CAR T cells are particularly useful in the context of treating stem cell transplant recipients from a donor, since the CAR T cells can be derived from the original donor and they would have a reduced risk of GVHD (see page 187-188, in particular). Depil teaches that allogeneic CAR T cells have advantages such as immediate availability of cryopreserved batches and standardization of the product (see abstract in particular).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to use allogeneic donor T cells, as taught by Depil, as the source of T cells, when treating B cell lymphoma post allogeneic bone marrow transplant, in the method taught by the ‘169 publication. The ordinary artisan at the time the invention was made would have been motivated to do so with a reasonable expectation of success, because Depil teach that donor derived allogeneic T cells are advantageous and are particularly useful in the context to treating stem cell transplant recipients, since they would have a reduced risk of GVHD.
No claim is allowed.
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
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