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 .
Election/Restrictions
Applicant’s election without traverse of the following species, the first anti-BCMA sdAb comprising SEQ ID NO: 7 and the second anti-BCMA sdAB comprising SEQ ID NO: 8, filed in the reply on
10/31/2025 is acknowledged. Although this species was not expressly included among the species originally enumerated by the Examiner in the Office Action dated 09/08/2025, it is a disclosed species and has now been expressly incorporated as species (16) of amended claim 2. The election is therefore accepted, and the record is clarified to identify the SEQ ID NO: 7/SEQ ID NO: 8 combination as the elected species. Claim 42, which is directed to an anti-BCMA sdAb comprising SEQ ID NO: 9, does not read on the elected species and is withdrawn from further consideration as nonelected.
Claims 5, 7, 9, 11, 16, 19-21, 23-25, 28, 29, 31-34, and 39-41 are cancelled. Claims 1, 2, 4, 10, 22, and 30 are amended. Claims 42-44 are added. Claims 1-4, 6, 8, 10, 12-15, 17-18, 22, 26-27, 30, 35-38, and 43-44 are currently pending and under examination.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d) of Application PCT/CN2019/125681. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Priority date of 12/16/2019 is acknowledged.
Claim Rejections - 35 USC § 112
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.
Claim 30 is 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.
Regarding claim 30, the phrase "optionally" renders the claim indefinite because it is unclear which alternatives are covered by the claim and whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(h).
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 44 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 44 recites “the CAR of claim 27,” whereas claim 27 is directed to a method of treating a disease or disorder by administering an engineered immune effector cell. Accordingly, claim 44 does not incorporate all limitations of claim 27 and does not further limit the subject matter of claim 27 as required for a dependent claim. Applicant may cancel the claim, amend the claim to place the claim in proper dependent form, rewrite the claim in independent form, or present a sufficient showing that the dependent claim complies with the statutory requirements.
Claim Rejections - 35 USC § 102
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 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)(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.
Claims 1-3 and 30 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Zhang et al. (US20220265709).
The applied reference has a common Assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. Regarding claims 1-3, Zhang teaches a CAR comprising an antigen-binding domain, transmembrane domain, and intracellular signaling domain, and further teaches CARs comprising at least two antigen-binding domains linked in tandem (Claims 1, 128-129). Zhang teaches that the antigen-binding domains may be anti-BCMA single domain antibodies and identifies BCMA4 and BCMA5, corresponding respectively to instant SEQ ID NOs: 7 and 8 (see alignment below). Zhang further expressly discloses the BCMA4/BCMA5 tandem combination (Example 6, Fig. 10). Accordingly, Zhang teaches a tandem anti-BCMA CAR comprising the elected SEQ ID NO: 7/SEQ ID NO: 8 pair together with a transmembrane and intracellular signaling domain, thereby meeting the limitations of claims 1-3.
[AltContent: textbox (1. Instant SEQ ID NO: 7 with Zhang BCMA 4)]
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[AltContent: textbox (2. Instant SEQ ID NO: 8 with Zhang BCMA 5 )]
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Regarding claim 30, Zhang teaches anti-BCMA single domain antibodies, including the BCMA5 VHH corresponding to instant application SEQ ID NO: 8 as SEQ ID NO: 15 with a 100% query match (see alignment above). Zhang’s disclosed BCMA5 sequence contains the amino acid sequences corresponding to instant Application CDR1 SEQ ID NO: 4, CDR2 SEQ ID NO: 5, and CDR3 SEQ ID NO: 6.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-4, 6, 10, 12-15, 17, 18, 26, 27, 35-38, and 43 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al (cited above) in view of Sadelain et al. (WO2019133969, cited on pg. 4 of IDS filed on 12/09/2022).
Zhang teaches the anti-BCMA single domain antibodies and corresponding to instant SEQ ID NOs: 7 and 8 (BCMA4 and BCMA5), including use of BCMA4 and BCMA5 together in a tandem antigen binding construct, and teaches anti-BCMA CAR technology. Sadelain teaches conventional CARs employing VHH antigen binding domains together with known CAR components including CD8α signal peptide, hinge and transmembrane domains, 4-1BB costimulatory signaling, and CD3ζ primary signaling. It would have been obvious to incorporate Zhang’s known functional tandem BCMA4/BCMA5 VHH pair into the VHH compatible CAR architecture of Sadelain to obtain a BCMA specific CAR using known components according to their established functions, with a reasonable expectation of success. The combination further renders obvious the recited VHH orientation, CAR signaling components, encoding nucleic acids and vectors, engineered CAR-T cells, pharmaceutical compositions, and therapeutic use thereof.
With respect to claim 14, instant application SEQ ID NO: 23 corresponds to LIC9848A22 comprising CD8α signal peptide-269A37498-linker-269AS34822-CD8α hinge-CD8α transmembrane domain-4-1BB-CD3ζ (Example 6.1). Zhang teaches the corresponding BCMA4/BCMA5 sdAbs together as a functional tandem anti-BCMA binding pair and further teaches CAR configurations comprising transmembrane and intracellular signaling domains, while Sadelain teaches uses of VHH antigen binding domains in conventional CARs comprising CD8 leader/hinge/transmembrane, 4-1 BB, and CD3ζ components. Accordingly, it would have been obvious to incorporate Zhang’s known BCMA4/BCMA5 tandem binding pair into Sadelain’s conventional CAR architecture to obtain the SEQ ID NO: 23 species.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Zhang and Sadelain as applied above, and further in view of Rosenthal et al. (US20180186878). Rosenthal teaches chimeric receptor intracellular signaling domains comprising a plurality of ITAM motifs, including two, three, four, or more ITAMs, and identifies CD3γ, CD3δ, and CD3ε and DAP12 as suitable ITAM containing signaling components (paragraph 0086, pgs. 12-13). It would have been obvious to employ Rosenthal’s known multi ITAM signaling domain in the Zhang/Sadelain CAR to provide signaling through multiple known immune receptor activation motifs.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Zhang and Sadelain as applied above, and further in view of Sentman et al. (US9663763) and Schaefer et al. (Virology, 302(1): 106-122, 2002, cited on pg. 9 of IDS filed 12/09/2022). Sentman teaches engineered T cells having reduced or absent endogenous TCR expression while expressing a functional chimeric receptor, thereby facilitating allogenic use and reducing undesirable T cell responses (Summary). Schaefer teaches that wild-type SIV Nef interacts with TCR ζ and potently down-modulates surface TCR/CD3 expression and further demonstrates that mutant SIV Nef proteins can retain or alter such TCR/CD3 down modulating activity (Abstract). It would have been obvious to express the known TCR/CD3-down-modulating SIV Nef of Schaefer in the Zhang/Sadelain CAR-T cell in view of Sentman’s teach that reduction of endogenous TCR is desirable for engineered allogenic T cells, with a reasonable expectation that SIV Nef would reduce endogenous TCR/CD3 expression.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
1. Claims 1-4, 6, 10, 12-13, 18, 26-27, and 43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 11186647 (‘647) in view of Zhang et al. (cited above). The ‘647 patent claims a tandem anti-BCMA VHH CAR having transmembrane and intracellular signaling domains and further claims the recited VHH orientation, CD8α transmembrane/hinge/signal peptide, CD3ζ and CD137 signaling, engineered T cells, pharmaceutical compositions, and treatment of multiple myeloma, differing principally in the VHH pair employed. Zhang teaches the presently claimed 269A37948/269AS34822 tandem anti-BCMA VHH pair. It would have been obvious to substitute Zhang’s known functional tandem BCMA-binding pair for that of the ‘647 claims to obtain the predictable BCMA-targeting function.
Claim 8 is rejected over the ‘647 patent and Zhang as above, and further in view of Rosenthal et al. (cited above). Rosenthal teaches chimeric receptor signaling domains comprising multiple ITAMs, including two, three, four or more ITAMs, and identifies CD3γ, CD3δ, and CD3ε and DAP12 as suitable ITAM containing signaling components (paragraph 0086, pgs. 12-13). It would have been obvious to employ such a known multi-ITAM signaling domain in the otherwise obvious tandem BCMA CAR.
Claim 22 is rejected over the ‘647 patent and Zhang as above, and further in view of Sentman et al. (cited above) and Schaefer et al. (cited above). Sentman teaches reducing endogenous TCR expression in engineered chimeric receptor T cells to facilitate allogenic use, while Schaefer teaches that SIV Nef down modulates TCR/CD3. It would have been obvious to express SIV Nef in the otherwise obvious BCMA CAR-T cell to reduce endogenous TCR/CD3 expression.
2. Claims 1-4, 6, 10, 12-13, 15, 17-18, 26-27, and 43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 11535677 (‘677) in view of Zhang et al. (cited above). The ‘677 patent claims tandem anti-BCMA VHH CAR subject matter together with nucleic acid, vector, CAR, engineered cell, pharmaceutical composition, and BCMA-cancer/multiple-myeloma treatment embodiments, differing principally in the specific tandem VHH pair. Zhang teaches the presently claimed tandem VHH pair. Substitution of Zhang’s known pair for that of the ‘677 claims would have been an obvious use of known BCMA-binding elements for their established function.
3. Claims 15 and 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 8 of U.S. Patent No. 12351638 (‘638) in view of Zhang et al. (cited above) for the same reasons discussed above.
4. Claims 1-4, 6, 10, 12-13, 15, 17-18, 26, and 43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 10934363 (‘363) in view of Zhang et al. (cited above) for the same reasons discussed above.
5. Claim 27 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12522645 (‘645) in view of Zhang et al. (cited above) for the same reasons discussed above.
6. Claims 1-4, 6, 10, 12-13, 18, 26, and 43 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 44, 58, 61-72, and 75-77 of copending Application No. 17/164,125 (‘125) in view of Zhang et al. (cited above) for the same reasons discussed above. This is a provisional nonstatutory double patenting rejection.
7. Claims 30, 35-36, and 38 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 44, 47, 56-58 of copending Application No. 18/818,153 (‘153) in view of Zhang et al. (cited above) for the same reasons discussed above. This is a provisional nonstatutory double patenting rejection.
Claim 37 is provisionally rejected over claims 47-54 of Application ‘153 in view of Zhang and Sadelain et al. (cited above). The copending claims and Zhang render the recited 269AS34822-containing CAR obvious, while Sadelain teaches the conventional use of nucleic acids/vectors to encode CAR constructs. It would have been obvious to encode the otherwise obvious CAR in such a nucleic acid/vector for expression in immune cells.
8. Claim 26 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 66 of copending Application No. 19/409,583 (‘583) in view of Zhang et al. (cited above) for the same reasons discussed above. This is a provisional nonstatutory double patenting rejection.
9. Claim 27 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/039,420 (‘420) in view of Zhang et al. (cited above) for the same reasons discussed above. This is a provisional nonstatutory double patenting rejection.
10. Claim 27 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 85 of copending Application No. 19/315,170 (‘170) in view of Zhang et al. (cited above) for the same reasons discussed above. This is a provisional nonstatutory double patenting rejection.
11. Claim 27 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 and claims 307-309 of copending Application No. 18/052,349 (‘349) in view of Zhang et al. (cited above) for the same reasons discussed above. This is a provisional nonstatutory double patenting rejection.
12. Claim 27 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/175,347 (‘347) in view of Zhang et al. (cited above) for the same reasons discussed above. This is a provisional nonstatutory double patenting rejection.
13. Claim 27 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 85 of copending Application No. 17/540,736 (‘736) in view of Zhang et al. (cited above) for the same reasons discussed above. This is a provisional nonstatutory double patenting rejection.
14. Claims 1-3, 14-15, 17, 18, and 43 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, and 27-29 of copending Application No. 17/916,370. Claim 29, through its dependency from claims 28, 27, and 1, recites a modified therapeutic cell comprising a vector containing heterologous nucleic acids and further requires that the vector comprise a nucleic acid encoding an amino acid selected from SEQ ID NOs: 12-27. SEQ ID NO 23 recited in claim 29 is the LIC948A22 CAR amino acid sequence. Sequence comparison establishes that residues 22 to 140 of SEQ ID NO: 23 recited in the co-pending claim 29 is same as the instant SEQ ID NO: 7 and residues 146 to 262 are same as the instant SEQ ID NO:8. See the sequence alignment below.
SEQ ID NO 23
LENGTH: 487
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: LIC948A22 CAR amino acid sequence
Query Match 100.0%; Score 614; Length 487;
Best Local Similarity 100.0%;
Matches 119; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 AVQLVESGGGLVQAGDSLRLTCTASGRAFSTYFMAWFRQAPGKEREFVAGIAWSGGSTAY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 22 AVQLVESGGGLVQAGDSLRLTCTASGRAFSTYFMAWFRQAPGKEREFVAGIAWSGGSTAY 81
Qy 61 ADSVKGRFTISRDNAKNTVYLQMNSLKSEDTAVYYCASRGIEVEEFGAWGQGTQVTVSS 119
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 82 ADSVKGRFTISRDNAKNTVYLQMNSLKSEDTAVYYCASRGIEVEEFGAWGQGTQVTVSS 140
SEQ ID NO 23
LENGTH: 487
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: LIC948A22 CAR amino acid sequence
Query Match 100.0%; Score 616; Length 487;
Best Local Similarity 100.0%;
Matches 117; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 QVQLEESGGGSVQAGGSLRLSCAYTYSTYSNYYMGWFREAPGKARTSVAIISSDTTITYK 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 146 QVQLEESGGGSVQAGGSLRLSCAYTYSTYSNYYMGWFREAPGKARTSVAIISSDTTITYK 205
Qy 61 DAVKGRFTISKDNAKNTLYLQMNSLKPEDSAMYRCAAWTSDWSVAYWGQGTQVTVSS 117
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 206 DAVKGRFTISKDNAKNTLYLQMNSLKPEDSAMYRCAAWTSDWSVAYWGQGTQVTVSS 262
Thus, the co-pending claims expressly encompass a vector encoding the same tandem SEQ ID NO: 7/SEQ ID NO: 8 CAR presently claimed. The presently claimed CAR, nucleic acid/vector encoding the CAR, and engineered-cell embodiments would therefore have been obvious variations of, and are not patentably distinct from, the subject matter of the copending claims.
This is a provisional nonstatutory double patenting rejection.
15. Claim 18 is provisionally rejected provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 33, and 40 of copending Application No. 18/683,208. Claim 40, through its dependency from claims 33 and 1, claims a modified immune cell comprising an engineered receptor having an amino acid sequence from SEQ ID NOs: 65, 72, and 73. These receptor sequences comprise the tandem anti-BCMA sdAb of SEQ ID NO: 44 (see first alignment below), which contains the same tandem anti-BCMA VHH pair corresponding to instant SEQ ID NOs: 7-8 (see second two alignments below), together with CAR components including CD8α hinge/transmembrane, 4-1BB costimulatory, and CD3ζ signaling domains. Accordingly, the modified immune-cell subject matter of instant claim 18 is not patentably distinct from the expressly claimed modified immune-cell species of the copending application.
This is a provisional nonstatutory double patenting rejection.
[AltContent: textbox (3. SEQ ID NO: 65 alignment with SEQ ID NO: 44 from application 18/683,408)]
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[AltContent: textbox (4. SEQ ID NO: 7 alignment with SEQ ID NO: 44)]
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Conclusion
No claim is allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DENNIS GEORGE whose telephone number is (571)270-0340. The examiner can normally be reached M-F 8:30am - 5pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached at (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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/DENNIS GEORGE/Examiner, Art Unit 1644
/MISOOK YU/Supervisory Patent Examiner, Art Unit 1641
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