DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Applicant's amendment and remarks filed on 07/30/2026 are acknowledged.
Claims 2, 5, 14, 20-21, 27-28, 31-32, 44-45, 48 and 85-94 are pending.
3. 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.
4. Claim 94 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 94 is indefinite in the recitation of the limitation “lymphodepletion is not required prior to administration,” because the nature of the “requirement” (e.g. legal, institutional, clinical, etc.) is not defined
In view of the above, a person of ordinary skill in the art cannot unequivocally interpret the metes and bounds of the claims so as to understand how to avoid infringement. Applicant is reminded that any amendment must point to a basis in the specification so as not to add New Matter. See MPEP 714.02 and 2163.06.
5. 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.
6. Claims 85, 5, 27-28, 31-32, 48 and 86-87 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Brogdon et al. (US 20160068601, of record) as evidenced by Srinivasan et al. (2024).
Claim interpretation
Independent claim 85 recites:
“(c) a spacer region connecting the transmembrane and antigen binding regions, wherein the spacer region comprises:
(i) a stalk region comprising at least one dimerization site; and
(ii) a stalk extension region comprising fewer dimerization sites than the stalk region.”
The claim imposes no structural or size limitations on “stalk region” or “stalk extension region.” Therefore, any two stretches of amino acid sequence of any length located between the transmembrane and antigen binding regions are within the scope of the claim, as long as one stretch comprises at least one dimerization site, and the other stretch comprises fewer dimerization sites.
Brogdon teaches CARs wherein the antigen binding domain is connected to the transmembrane domain by CD8 hinge region of SEQ ID NO: 2 (e.g. [0364], claim 35), reproduced herein:
TTTPAPRPPTPAPTIASQPLSLRPEACRPAAGGAVHTRGLDFACD
This sequence contains two cysteine residues at positions 27 and 44 (underlined) which mediate dimerization, as evidenced e.g. by Srinivasan (e.g. Fig. 2). This sequence is within the scope of “spacer region” as defined by claim 85, because the 27-45 region comprises at least one dimerization site and as such is a “stalk region,” and the 1-26 region does not comprise dimerization sites and as such is a “stalk extension region” within the meaning of claim 85 as presently recited.
Brogdon’s CARs comprise an antigen-binding domain specific for CD123 or CD19 (e.g. [0098], claim 25), and 4-1BB and CD3-zeta signaling domains (e.g. claim 39). T cells or NK cells expressing the CARs are administered to patients to treat hyperproliferative disorders (e.g. [0713]). Accordingly, Brogdon teaches all of the limitations of claims 85, 5, 27-28, 31-32, 48 and 86-87, and as such anticipates these claims.
7. 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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
8. Claims 2, 5, 14, 20-21, 27-28, 31-32, 44-45, 48 and 85-94 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patents No. 12275772, 11976134, 11981746, and 11946054 (all of record).
Applicant has not substantively addressed the grounds of rejection presented in sections 12-14 of the previous office action, which are therefore maintained, and incorporated by reference herein as if reiterated in full.
9. Claims 2, 5, 14, 20-21, 27-28, 31-32, 44-45, 48 and 85-94 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending applications USSN 17/572618 (US PG Pub. No. 20220220187), USSN 19/077365 (US PG Pub. No. 20260035432), and USSN 18/426680 (US PG Pub. No. 20240263183) (all of record).
Applicant has not substantively addressed the grounds of rejection presented in sections 15-17 of the previous office action, which are therefore maintained, and incorporated by reference herein as if reiterated in full.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
10. Conclusion: no claim is allowed.
11. 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.
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/ILIA I OUSPENSKI/ Primary Examiner, Art Unit 1644
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