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 .
1. The Amendment filed January 26, 2026 in response to the Office Action of July 24, 2025, is acknowledged and has been entered. Claims 1, 4-8, 10, 13-25 are pending. Claims 2, 3, 9, 11, and 12 are canceled. Claims 1, 4, 6-8, 10, 13, 17, and 18 are amended. Claims 21-25 remain withdrawn. Claims 1, 4-8, 10, 13-20 are currently being examined.
Claim 1 is amended and altered in scope to require a cell comprising: (a) a chimeric antigen receptor (CAR) that binds to a tumor antigen; and (b) a membrane-bound IgG-degrading enzyme or a fragment thereof.
Claim 17 is amended and altered in scope to require a nucleic acid composition comprising a first polynucleotide encoding a chimeric antigen receptor (CAR) and (b) a second polynucleotide encoding an IgG-degrading enzyme or fragment thereof.
Claim Objections
2. Claim 4 is objected to because of the following informalities: Claim 4 contains a typo where the word “comprises” is missing in the phrase: “wherein the IgG-degrading enzyme further comprises a transmembrane domain attached to its C-terminus”. Appropriate correction is required.
New Rejections
(necessitated by amendments)
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.
3. Claim(s) 17-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2017/123646, Kahvejian et al, published July 2017.
Kahvejian teaches an enucleated red blood cell comprising:
(a) a first nucleic acid encoding a first exogenous protein encoded, wherein the first exogenous protein is a cell surface expressed chimeric antigen receptor comprising a receptor fused to a transmembrane domain that binds to and captures a target antibody; and
(b) a second nucleic acid encoding a second exogenous protein, wherein the second exogenous protein is a cell surface-expressed IdeS polypeptide fused to a transmembrane domain, wherein the IdeS polypeptide can cleave the target antibody as a clearing agent;
wherein the first and second nucleic acids can be operatively linked, and optionally comprise a promoter sequence;
wherein a single vector can comprise the first and second nucleic acids; and
methods for producing a cell, comprising introducing into the cell the first and second nucleic acids of (a) and (b) above (p. 7, 9,15-16, 63-64; Table 4; claim 41; Figures 6 and 7 below).
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Claim Interpretation
4. Claim 1 recites the cell comprises (b) a membrane bound IgG-degrading enzyme or a fragment thereof. The “fragment thereof” is not required to have any enzymatic activity of the IgG-degrading enzyme, and broadly encompasses any fragment of an IgG-degrading enzyme as few as two consecutive amino acids long. Therefore claim 1 encompasses membrane-bound fragments of IgG-degrading enzymes.
Similarly, claim 17 encompasses introducing into a cell (b) a second polynucleotide encoding a fragment of an IgG-degrading enzyme.
5. Claim(s) 1, 4-8, 10, and 13-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent Application Publication 2016/0362472, Bitter et al, published December 2016; as evidenced by NCBI GenBank CAR4986216.1, IdeS protein sequence.
Bitter teaches a dual CAR T cell expressing at its cell surface:
(a) a CAR that binds to CD19 tumor antigen, wherein the CAR comprises an anti-CD19 scFv; and
(b) a CAR that binds to CD22 tumor antigen and comprises a transmembrane domain fused to the C-terminus of the CD22 binding domain (Example 22; Figures 66-68; [79]; [148]; [152]; [207-213]; [230-239]; claims 2, 6, 12, 14-19, 22-27, 37, and 52).
Bitter teaches a first nucleic acid encoding the anti-CD19 CAR and a second nucleic acid encoding the anti-CD22 CAR;
wherein the first and second nucleic acids encoding the two CARs are bicistronic and are operably linked in a single nucleic acid and vector, and the CARs are recombinantly expressed from a vector (Figure 66; [65];[68]; [78]; claim 40).
Bitter teaches a method of producing a dual CAR T cell expressing the CARs comprising transducing T cells with the nucleic acids encoding the CARs (Example 22; [68-70]).
Bitter teaches the anti-CD19 CAR comprises anti-CD19 scFv – CD8α transmembrane domain – CD28 - 41BB – CD3ζ (Figures 1 and 28A; claims 24-27; [120-130]; [207-213]).
Bitter teaches pharmaceutical compositions comprising the dual CAR T cell with a pharmaceutically acceptable excipient ([118]; [1113]; [945]).
Bitter teaches kits comprising the dual CAR T cell ([118]; [1118]).
As evidenced by NCBI GenBank CAR4986216.1, the CD22 CAR SEQ ID NO:1109 of Bitter inherently comprises fragments of IdeS IgG-degrading enzyme (see underlined/bold font fragments below comprised by both sequences):
CD22 CAR SEQ ID NO:1109 (Table 6B).
MALPVTALLLPLALLLHAARPEVQLQQSGPGLVKPSQTLSLTCAISGDSVSSNSAAWNWIRQSPSRGLEWLGRTYYRSKWYSDYAVSVKSRITINPDTSKNQFSLQLNSVTPEDTAVYYCARDPYDFWSGYPDAFDIWGQGTMVTVSSGGGGSGGGGSGGGGSQSALTQPASVSGSPGQSITISCTGTSSDVGGYNYVSWYQQHPGKAPKVIISEVNNRPSGVSHRFSGSKSGNTASLTISGLQAEDEADYFCSSYTSGRTLYVFGTGSKVTVLGTTTPAPRPPTPAPTIASQPLSLRPEACRPAAGGAVHTRGLDFACDIYIWAPLAGTCGVLLLSLVITLYCKRGRKKLLYIFKQPFMRPVQTTQEEDGCSCRFPEEEEGGCELRVKFSRSADAPAYKQGQNQLYNELNLGRREEYDVLDKRRGRDPEMGGKPRRKNPQEGLYNELQKDKMAEAYSEIGMKGERRRGKGHDGLYQGLSTATKDTYDALHMQALPPR
NCBI GenBank CAR4986216.1, IdeS (IgG-degrading enzyme):
mrkrcystsaavlaavtlfvlsvdrgviadsfsanqeirysevtpyhvtsvwtkgvtppa
nftqgedvfhapyvanqgwyditktfngkddllcgaatagnmlhwwfdqnkdqikrylee
hpekqkinfngeqmfdvkeaidtknhqldsklfeyfkekafpylstkhlgvfpdhvidmf
ingyrlsltnhgptpvkegskdprggifdavftrgdqsklltsrhdfkeknlkeisdlik
keltegkalglshtyanvrinhvinlwgadfdsngnlkaiyvtdsdsnasigmkkyfvgv
nsagkvaisakeikednigaqvlglftlstgqdswnqtn
Therefore, the cell taught by Bitter comprises: (a) a chimeric antigen receptor (CAR) binding to CD19 tumor antigen; and (b) a membrane-bound fragment of IdeS IgG-degrading enzyme. The nucleic acid sequences taught by Bitter encode the same.
6. All other rejections and objections recited in the Office Action mailed July 24, 2025 are hereby withdrawn in view of amendments and arguments.
7. Conclusion: No claim is allowed.
Conclusion
8. 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
9. Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA B GODDARD whose telephone number is (571)272-8788. The examiner can normally be reached Mon-Fri, 7am-3:30pm.
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/Laura B Goddard/ Primary Examiner, Art Unit 1642
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