DETAILED ACTION
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 .
Claim Status
Claims 6, 9, 11, 13, 18-24, 26-28, 32-38, 41-79, 81-82 and 84-92 have been cancelled.
Claims 1-5, 7-8, 10, 12, 14-17, 25, 29-31, 39, 40, 80 and 83 are currently pending.
Claims 40, 80 and 83 have been withdrawn.
Claims 1-5, 7-8, 10, 12, 14-17, 25, 29-31 and 39 are being examined in this application.
Election/Restrictions
Applicant’s election without traverse of Group I invention (Claims 1-5, 7-8, 10, 12, 14-17, 25, 29-31 and 39) in the reply filed on 6/16/25 is acknowledged.
Claims 40, 80 and 83 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/16/25.
Priority
This application is filed under 35 U.S.C 371 of PCT/US2021/015267 (filed on 01/27/2021), which claims priority to US provisional applications 60/968,028 (filed on 01/30/2020).
Information Disclosure Statement
The IDS filed on 12/12/2022, 10/26/2023 and 6/16/2025 have been considered. See the attached PTO 1449 forms.
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.
Zhang
Claim(s) 1-5, 7-8, 10, 12, 14-17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhang et al (Journal of Hematology and Oncology. 10(56): 1-14; 2017).
Zhang et al., throughout the reference, teach bi-specific antibodies and administering thereof (e.g. Abstract).
For Claims 1-5, 7-8 and 16-17, Zhang teaches a bispecific antibody (which reads on multispecific) comprising antibody made from two or more different antibodies: anti-CD19 and anti-CD3 (e.g. Abstract; Page 6, Figure 1), which anti-CD3 reads on the first antigen binding domain and T-cell immune cell antigen of claims 2, 4 and 5, and anti-CD19 reads on the second antigen binding domain of claims 1 and 7-8. The antibody has been show to induce immune responses from mice (e.g. Abstract; pp5. left col., para 2), which reads on the administering step.
The reference also teaches using lentivirus vector to transduce immune response (e.g. pp.7, left col., para 2; pp.12, left col., para 2) comparing to negative control (e.g. pp.6, Figure 1), which reads on the administering a vector of claims 1, 3 and 16 as well as increase immune response comparing to a control of claim 17
For claim 10, CD3 can be expressed on a subpopulation of myeloid cell surface, and CD19 can be expressed on subpopulation of dendritic cell surface. Thus, the reference teaching reads on the antigen of claim 10.
For claims 12, 14-15, the reference teaches “BiTE” format of anti-CD19/CD3 antibodies and blinatumomab (e.g. pp.2, left col., para 2).
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.
Zhang, Chang, Kloss and Humbert
Claim(s) 1-5, 7-8, 10, 12, 14-17, 25, 29-31 and 39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al (Journal of Hematology and Oncology. 10(56): 1-14; 2017), and Chang et al (Nature Chemical Biology. 14(3): 317-324; 2018), Kloss et al. (Molecular Therapy. 26(7):1855-1866; 2018), and Humbert et al. (Molecular Therapy. 24(7): 1237-1246; 2016; cited in IDS 12/12/22).
Zhang et al., throughout the reference, teach bi-specific antibodies and administering thereof as discussed supra.
Zhang et al do not explicitly teach the viral vector comprise polynucleotide encoding for T-cell receptor or chimeric antigen receptor of claims 25 and 31, transgenes (TGFbeta) of claims 29-30, and 39.
Zhang et al., teach using gene-modified T Cells with CAR combining a desired antigen-recognition fragment of an antibody provide promising antitumor effect (e.g. pp.11, right col., para 2), and the other anti-tumor approach issuing bispecific antibody (e.g. pp.11-12 bridging para), which provide suggestions for utilizing both bispecific antibody and CAR approach since both are based on T-Cell activation.
However, Chang et al, throughout the reference teaches chimeric antigen receptor (CAR)-expressing T cells targeting surface-bound tumor antigen and use thereof for treating cancers (e.g. Abstract).
Chang teaches chimeric antigen receptor comprising “TGF-beta” and CD19 (e.g. pp.3-4).
In addition, Kloss et al., throughout the reference teaches CAR T Cell co-expressing TGF-beta Dominant-negative (e.g. Abstract), which improve prostate cancer treatment (e.g. Abstract).
Further, Humbert et al., throughout the reference teaches using Cocal Envelope lentiviral vector for transferring genes into cells such as T-cells (e.g. Abstract).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to utilize bispecific antibody and CAR for T-cell related cancer/tumor treatment as both methods are known as taught in the above cited references. It would also be prima facie obvious to utilize lentiviral vector to transform T-cell with desired transgenes as taught by Chang, Kloss and Humber, to improve cancer treatment by using proven and known viral vector. In addition, because both the Chang and Kloss teach CAR containing TGF-beta, it would have been obvious to one skilled in the art to substitute one TGF-beta for the other TGF-beta dominant negative to achieve the predictable result of expressing the desired transgene.
It would also have been obvious to one of ordinary skill in the art to utilize the Cocal envelope lentiviral vector as taught by Humbert, to improve introducing transgenes in T-cells for the predicable result of enabling using proven lentiviral vector for transgene expression in desired cells.
A person of ordinary skill in the art would have reasonable expectation of success of achieving such modifications since all the cited references have demonstrated successful generation of lentiviral vector containing desired transgenes, and making bispecific antibodies, as well as method of administering.
Pertinent Art
Runcie
Runcie et al., (Molecular Medicine. 24(50): 1-15; 2018), throughout the reference, teach various bi-specific and tri-specific antibodies (e.g. Abstract). Runcie teaches a bispecific or trispecific antibody (which reads on multispecific) comprising antibody made from two or more different antibodies (e.g. Abstract; Page 3, Figure 1; page 4, Figure 2). One example in the reference is “BiTE” bispecific antibody (e.g. pp3-4 bridging paragraph; Figure 2), which comprise CD3 of T-Cell binding domain (reads on the first antigen binding domain), and another binding domain for tumor cell surface antigen (reads on the second antigen binding domain). The reference also teaches the bispecific antibody Blinaturmomab (e.g. pp.5, right col., para 2), which comprises binding sites for both CD19 expressed on B cell surface and CD3 of T-Cell receptor. The antibody has been show to induce durable immune responses from patients (pp.5, right col., para 2).
Conclusion
No claims are allowed.
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/SUE X LIU/Supervisory Patent Examiner, Art Unit 1616