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 .
Status of Application/Amendments/Claims/RCE under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e) was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114 and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicants’ submission filed on 5/21/2026 has been considered.
Claims 52 and 60 have been amended. Claims 1-5, 13-17, 33-35, 46-52 and 59-60 are pending. Claims 1-5, 13-17, 33-35 and 46-51 are withdrawn without traverse from further consideration pursuant to 37 CFR 1.142 (b) as being drawn to a nonelected invention, there being no allowable generic or linking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. Claims 52, 59 and 60 are the subject of the present Official action. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Priority
Applicant’s claim for the benefit of a prior-filed application EP17168805.4, PCT/EP2018/060887 and CON of 16/607,069 filed on 4/28/2017, 4/27/2018 and 10/21/2019, respectively, under 35 U.S.C 119(e) or under 35 U.S.C 120, 121 or 365(c) is acknowledged.
Accordingly, the effective priority date of the instant application is granted as 4/28/2017.
Withdrawn Objections
The 35 U.S.C. 112(d) rejection of claim 60 has been withdrawn in light of applicants claim amendments which make claim 60 and independent claim.
The 35 U.S.C. 103 rejection of claims 52, 59 and 60 has been withdrawn in light of applicants claim amendments canceling the embodiment towards a humanized antibody binding domain comprising SEQ ID Nos 1 and 2.
The nonstatutory double patenting rejection of claims 52, 59 and 60 over US Patent No. 11,149,073 has been withdrawn in light of applicant’s submission of a terminal disclaimer on 5/21/2026.
New Claim Rejections - 35 USC § 103
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 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.
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.
Claims 52, 59 and 60 are rejected under 35 U.S.C. 103 as being unpatentable over Waldmeier et al. US 2019/0153092, published 5/23/2019 (hereinafter Waldmeier) in view of Hudecek et al. "Receptor affinity and extracellular domain modifications affect tumor recognition by ROR1-specific chimeric antigen receptor T cells." Clinical cancer research 19.12 (2013): 3153-3164 (hereinafter Hudecek, reference of record). This rejection is newly applied to address applicants claim amendments on 5/21/2026.
Claims 52 and 60: Waldmeier describes recombinant T cell that expresses a chimeric antigen receptor (CAR) comprising a humanized monoclonal antibody (mAb) binding domain specific for receptor tyrosine kinase-like orphan receptor 1 (ROR1) and therapeutic applications thereof (Waldmeier, abstract, para 2, 8, 12, 139). Waldmeier describes engineering ROR1 targeting mAbs from R11, R12 and 2A2 (Waldmeier, para 16). Waldmeier describes administering the recombinant T cells to a patient in need thereof (Rader, para 148 and claim 27). Waldmeier provides motivation for experimenting with different heavy and light chain CDRs in order to engineer desired mAb specificity (Waldmeier, para 132, 133, 135, 139). Waldmeier discloses SEQ ID NO: 138 which has a 100% sequence match to the heavy chain CDRs 1-3 of the heavy chain amino acid sequence of instant SEQ ID NO: 3 (sequence search results below).
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Sequence search results for SEQ ID NO: 3
Similarly, Waldmeier also discloses SEQ ID NO: 129 which has a 100% sequence match to the light chain CDRs 1-3 of the light chain amino acid sequence of instant SEQ ID NO: 4 (sequence search results below).
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Sequence search results for SEQ ID NO: 4
Claim 59: Waldmeier describes treating patients with ROR-1 positive cancers (Waldmeier, para 146, 148 and claim 28). Waldmeier provides specific embodiments towards treating ROR1-possitive breast and lung cancers (Waldmeier, para 146 and claim 28).
Although Waldmeier discloses the claimed heavy and light chain CDR sequences, Waldmeier does not describe the specific combination of heavy and light chain CDRs 1-3 of SEQ ID Nos 1 and 2 together in a single humanized antibody binding domain as required by claim 52 and 60. However, Waldmeier provides motivation for experimenting with different heavy and light chain CDRs in order to engineer desired mAb specificity (Waldmeier, para 132, 133, 135, 139).
Claims 52 and 60: Hudecek investigates the therapeutic utility of ROR1-targeting mABs as an adoptive cellular therapy (Hudecek, abstract). Hudecek describes constructing ROR1-CARs from scFVs with different affinities and evaluates their antitumor reactivity (Hudecek, pg 3157 col 1 and Fig 2). Hudecek describes predictable methodological steps for generating the various T cells modified with ROR1-CARs (Hudecek, Methods – Vector construction and generation of T cel lines).
It would have been prima facie obvious to one of ordinary skill in the art to generate a humanized antibody biding domain comprising the heavy chain amino acid sequence of SEQ ID NO: 3 and the light chain amino acid sequence of SEQ ID NO: 4 in the ROR1-specific CAR T cell described by Waldmeier. It would have been a matter of combining prior art elements according to known methods to yield predictable results since Waldmeier discloses the heavy and light chain CDRs encoded by SEQ ID Nos 3 and 4. One would have been motivated to select this specific combination of heavy and light chain CDRs in order to optimize for antibody binding domain affinity against ROR-1 positive cancers. One would have a reasonable expectation of success since both Waldmeier and Hudecek present methods for predictably generating T cells with different CDRs and experimental protocols for evaluating their antitumor reactivity (Hudecek, pg 3157 col 1 and Fig 2). Accordingly, in the absence of evidence to the contrary, one of ordinary skill in the art would have considered the claimed invention to have been prima facie obvious to at the time the invention was made.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Dr. ALEXANDER NICOL whose telephone number is (571)272-6383. The examiner can normally be reached on M-F 8-5 EST.
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Alexander Nicol
Patent Examiner
Art Unit 1634
/ALEXANDER W NICOL/Examiner, Art Unit 1634
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