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 .
Claim Status
Claims 1-20 are currently pending.
Claims 5-20 have been withdrawn.
Claims 1-4 are being examined in this application.
Election/Restrictions
Applicant’s election without traverse of Group I invention (Claims 1-4) and species of SEQ ID NO:1, without a co-stimulatory domain, IL7Rα and TIM-3 in the reply filed on 7/13/2026 is acknowledged.
Claims 5-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/13/2026.
Priority
This application is filed under 35 U.S.C 371 of PCT/US2022/073079 (filed on 06/22/2022), which claims priority to US provisional applications 63/332,060 (filed on 04/18/2022), 63/214,433 (filed on 06/24/2021) and 63/213,960 (filed on 06/23/2021).
Information Disclosure Statement
The IDS filed on 11/30/2023, 7/22/2024 and 02/02/26 have been considered. See the attached PTO 1449 forms.
Specification
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant's cooperation is requested in correcting any errors of which applicant may become aware in the specification. MPEP 608.01.
Claim Rejections - 35 USC § 112
112(b) Rejection
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 4 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.
Claim 4 recites “an amino acid sequence selected…” which recitation renders the claim indefinite since “an” AA sequence can read on any fragment of the recited SEQ ID NOs. It is suggested to change the term “an” to “the”.
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.
(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.
Chaudhary et al
Claims 1 and 3-4 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Chaudhary et al (WO 2020/028444; 2/6/2020; filed on 7/30/2019 or earlier).
The instant claims recite “A chimeric receptor comprising an extracellular domain of TIM-3, LAG-3, DR5, or CD112R and an intracellular domain of a pro-inflammatory interleukin and/or a co-stimulatory domain.”
Chaudhary et al, throughout the publication, teach various chimeric antigen receptor (CAR) comprising domains from different proteins (e.g. Abstract; Claims). The reference teaches a CAR comprising DR5 as the extracellular domain, and CD27 or OX40 as the co-stimulatory domain (e.g. [0013]). The reference also teaches a CAR with DR5 and CD27 having amino acid sequence of SEQ ID NO:2435 (e.g. Claim 47; [0013]), which SEQ ID NO:2435 contains the same exact sequence as the instant SEQ ID NO:30. Thus the reference’s teaching read on the instant claims 1, 3 and 4.
Jarjour et al
Claims 1-3 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Jarjour et al (US 2019/0241910; 8/8/2019; filed on 3/10/2017 or earlier; cited in IDS).
Jarjour et al, throughout the publication, teach various chimeric antigen receptor (CAR) comprising domains from different proteins (e.g. [0008]).
For claim 1, the reference teaches “flip receptor” comprising exodomain (i.e. extracellular domain), intracellular, and co-stimulatory signaling domain (e.g. [0051]). The reference teaches the “exodomain” can be Lag-3, TIM-3 (e.g. [0053]), and the co-stimulatory signaling domain can be CD28 or CD27, or CD278 (ICOS) or CD134 (OX40) (e.g. 0058)).
For claim 2, the reference teaches “flip receptor” with exodomain of LAG-3 or TIM-3 extracellular ligand binding domain (e.g. [0411]-[0412]), and endodomains (i.e. intracellular domain) of the flip receptor maybe IL-7 receptor (e.g. [0418]), which the IL-7 receptor encompasses alpha and gamma subunits, as evidenced by McElroy et al. (PNAS. Vol.109(7): 2503-2508; 2012). Thus, one of skilled in the art would immediately envisage either the IL-7 receptor alpha or the gamma subunit endodomain is used to generate the flip receptor since it is one of the two choices.
For claim 3, the reference teaches co-stimulatory signaling domain can be CD28 or CD27, or CD278 (ICOS) or CD134 (OX40) (e.g. 0058).
Claim Rejections - 35 USC § 103
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.
Jarjour and Chaudhary
Claims 1-4 are rejected under 35 U.S.C. 103(a) as being unpatentable over Jarjour et al (US 2019/0241910; 8/8/2019; filed on 3/10/2017 or earlier; cited in IDS), in view of Chaudhary et al (WO 2020/028444; 2/6/2020; filed on 7/30/2019 or earlier).
Jarjour et al, throughout the publication, teach various chimeric antigen receptor (CAR) comprising domains from different proteins (e.g. [0008]), as discussed supra.
Jarjour et al do not explicitly teach the chimeric receptor has the amino acid sequence selected from SEQ ID NO: 1 to 32 as recited in claim 4.
However, Chaudhary et al, throughout the publication, teach various chimeric antigen receptor (CAR) comprising domains from different proteins (e.g. Abstract; Claims). The reference teaches a CAR comprising DR5 as the extracellular domain, and CD27 or OX40 as the co-stimulatory domain (e.g. [0013]). The reference also teaches a CAR with DR5 and CD27 having amino acid sequence of SEQ ID NO:2435 (e.g. Claim 47; [0013]), which SEQ ID NO:2435 contains the same exact sequence as the instant SEQ ID NO:30.
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to generate a CAR with the DR5 extracellular domain and CD27 intracellular domain with the specific sequence of SEQ ID NO: 30, because Chaudhary teaches various CAR of various sequences are routine and known in the art.
In addition, because both the Jarjour and Chaudhary references teach making various chimeric receptors by combining extracellular domains, intracellular domain, and co-stimulatory signaling domain from various known proteins, it would have been obvious to one skilled in the art to substitute one protein domain for another (such as IL-7Rα) to achieve the predictably result of generating chimeric receptors with desired functions.
A person of ordinary skill in the art would have reasonable expectation of success of achieving such modifications since both cited references have demonstrated generating various chimeric receptors using domains of various proteins.
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.
Claims 1-4 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of copending Application No. 19/611,925 in view of Jarjour et al (US 2019/0241910; 8/8/2019; filed on 3/10/2017 or earlier; cited in IDS), and Chaudhary et al (WO 2020/028444; 2/6/2020; filed on 7/30/2019 or earlier).
This is a provisional nonstatutory double patenting rejection.
The reference application claims the followings:
A chimeric receptor that binds CD 112, wherein the chimeric receptor comprises a CD112R extracellular domain (ECD).
4. (Original) The chimeric receptor of claim 1, wherein the chimeric receptor comprises an intracellular or transmembrane co-stimulatory signaling motif.
5. (Original) The chimeric receptor of claim 4, wherein the intracellular or transmembrane co-stimulatory signaling motif comprises of CD28, 41BB, OX40, Myd88, ICOS, CD2, CD226, BAFF-R, TACI, CD3( or IL2RB.
26. (Currently amended) The pharmaceutical composition of any of claims 23-24 claim 23,further comprising: an antagonist of PD-1, PD-Ll, CTLA-4, Lag-3, TIM-3, TIGIT, CD96, PVRL1, PVRL2, PVRL3, PVRL4, CD155, CD47, CD39 and/or IL-27 and/or an agonist of OX40, CD28, CD40L, LFA-1, ICOS, and/or 4-1BB.
The reference application does not claim the intracellular domains are from IL-7Rα, and the co-stimulatory signaling domain is from CD27.
However, Chaudhary et al, throughout the publication, teach various chimeric antigen receptor (CAR) comprising domains from different proteins (e.g. Abstract; Claims). The reference teaches a CAR comprising DR5 as the extracellular domain, and CD27 or OX40 as the co-stimulatory domain (e.g. [0013]). The reference also teaches a CAR with DR5 and CD27 having amino acid sequence of SEQ ID NO:2435 (e.g. Claim 47; [0013]), which SEQ ID NO:2435 contains the same exact sequence as the instant SEQ ID NO:30.
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to generate a CAR with the DR5 extracellular domain and CD27 intracellular domain with the specific sequence of SEQ ID NO: 30, because Chaudhary teaches various CAR of various sequences are routine and known in the art.
In addition, because both the Jarjour and Chaudhary references teach making various chimeric receptors by combining extracellular domains, intracellular domain, and co-stimulatory signaling domain from various known proteins, it would have been obvious to one skilled in the art to substitute one protein domain for another (such as IL-7Rα) to achieve the predictably result of generating chimeric receptors with desired functions.
A person of ordinary skill in the art would have reasonable expectation of success of achieving such modifications since both cited references have demonstrated generating various chimeric receptors using domains of various proteins.
Allowable Subject Matter
The amino acid sequences of SEQ ID NO: 1-29, and 31-32 are free of prior art searched.
Conclusion and Correspondence
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUE LIU whose telephone number is (571)272-5539. The examiner can normally be reached M-F 9-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor (director), Jennifer Michener can be reached at 571-272-1424. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SUE X LIU/
Supervisory Patent Examiner, Art Unit 1616
Prosecution Insights