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 the Claims
Claims 1-3, 16, 17, 24, 25, 31, 33, 42, 43, 47, 48, 56-58, 61, 63-66, 69, 82, and 83 are pending.
Claims 47, 48, 56-58, 63-66, 69, 82, and 83 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/10/2025
Claims 1-3, 16, 17, 24, 25, 31, 33, 42, 43, and 61 are examined.
Claim Objections
Claims 1-3 are objected to as they refer to certain tables in the specification. Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table 'is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience.' Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993)" (MPEP 2173.05(s))
Appropriate correction is required.
Claim interpretation
Regarding option (a) claim 1, this will be interpreted as requiring a an ANTI-ALK CAR comprising at least 80% of one of the following combinations of SEQ IDs from Table 4, pg 121 :
2, 3, and 4,
8, 9, and 10,
14, 15, and 16
20, 3, and 21
8, 25 and 16
26, 27, and 28
8, 15, and 16.
Regarding option (b) of claim 1, this will be interpreted as requiring a an ANTI-ALK CAR comprising a heavy chain that is at least 80% identical to SEQ ID NO: 33, 35, 37, 39, 41, 43, or 45 (AA Sequences from Table 2, pg. 111 of the Specification).
Regarding claim 2, 100% identity version of claim 1. Comprises each and every sequence.
Regarding claim 3, the sequence limitations will be interpreted as encompassing the ALK CAR of claim 1, where the LCDR1, 2, and 3 each are at least 80% identical to one of the following combinations of sequences from table 3, pg 117 of the specification.
5, 6, and 7
11, 12, and 13
17, 18, and 19
22, 23, and 24
17, 18, and 19
29, 30, and 31
17, 18 and 32
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 (i.e., changing from AIA to pre-AIA ) 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.
Alvarado and Orentas
Claims 1-3, 16, 17 , 31, 33, 42, 43, and 61 are rejected under 35 U.S.C. 103 as being unpatentable over:
Alvarado WO2017035430-A2, and
Orentas EP3066118B1
Regarding claim 1, 2, and 16, SEQ ID Nos 2, 3, and 4 (one of the claimed HCDR1, 2, and 3 combinations in table 4) are a 100% match for an anti-ALK antibody, Ab320, taught by Alvarado. WO2017035430-A2. Alvarado teaches that their antibodies may be in the form of scFv. (Alvarado claim 39, [0047]).
SEQ ID 2 is a 100% Match for Anti-ALK antibody AB320 VH CDR1 (Kabat), SEQ ID:4.
SEQ ID 3 is a 100% match for Anti-ALK antibody Ab320 VH domain, SEQ ID:396.
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708
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SEQ ID 4 is a 100% match for anti-ALK antibody AB320 VH CDR3 (Kabat), SEQ ID:6.
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136
667
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Alvarado does not explicitly teach the formation of a CAR with their anti-ALK scFv, but Alvarado does cite another patent application, Orentas, that does teach the formation of Anti-ALK CARs using ALK scFv antibody fragments (Orentas [0016]). Orentas further also teaches that their CAR comprises the additionally claimed elements of a transmembrane region and a signalling domain.
It would have been prima facie obvious to a person of ordinary skill in the art prior to the effective filing date of the Alvarado’s anti-ALK scFv as the anti-ALK scFv component of a CAR as taught by Orentas. One of ordinary skill in the art would have been motivated to do so, since this combination would be combining prior art elements according to known methods to yield predictable results. The skilled artisan would readily recognize that Alvarado’s anti-ALK scFv could be used as the antigen-binding scFv component of an anti-ALK CAR as taught by Orentas.
One of ordinary skill in the art would have had a reasonable expectation of success, since Alvarado teaches that the claimed scFv component is an anti-ALK antibody/scFv.
Regarding claim 3 and 17, Alvarado’s Ab320 antibody also comprises sequences that are a 100% match for SEQ ID Nos 5, 6, and 7.
SEQ ID 5 is a 100% match for Anti-ALK antibody Ab320 VL domain, SEQ ID:395.
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666
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SEQ ID 6 is a 100% match for Anti-ALK antibody Ab320 VL domain, SEQ ID:395.
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142
692
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SEQ ID 7 is a 100% match for Anti-ALK antibody Ab320 VL domain, SEQ ID:395.
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157
657
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Regarding claim 31 and 33, Orentas teaches that their anti-ALK car may comprise 41BB transmembrane and signalling domains. (Orentas [0016]).
Regarding claim 42 and 43, Orentas teaches that their anti-ALK CAR may be encoded in a nucleic acid (Orentas claim 13), and that a vector may comprise said nucleic acid (Orentas claim 12)
Regarding claim 61, Orentas teaches a pharmaceutical composition comprising their anti-ALK CAR and a pharmaceutical acceptable carrier. (Orentas [0081]).
Allowable subject matter
Claims 24 and 25 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Regarding claim 24, SEQ ID NO: 33 and 34 are free of the art.
Regarding claim 25, SEQ ID NO: 35 and 45 are free of the art.
Conclusion
Claims 1-3, 16, 17 , 31, 33, 42, 43, and 61 are rejected.
Claims 1-3, 24 and 25 are objected to.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THOMAS RUSSE AMICK whose telephone number is (571)272-5474. The examiner can normally be reached 7:30-5 M-F.
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/THOMAS R. AMICK/Examiner, Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638
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