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 .
Formal Matters
Several attempts were made to reach Attorney Eileen Sun (206) 389-1502 to discuss the provisional nonstatutory double patenting issues presented herewith, however, no return call was received.
Claim Status
Applicant’s amendment filed December 19, 2025 has been received and entered.
Claims 86, 88, 92-93, 95-96, 98-99, and 100-101 have been amended.
Claim 97 has been canceled.
Claims 1-85, 87, 91, and 94 were previously canceled.
Claims 106-108 have been added.
Claims 86, 88-90, 92-93, 95-96, and 98-108 are pending and under consideration.
Priority - Updated
This application is a 371 of PCT/US2021/046014 filed August 13, 2021, which claims the benefit of US Provisional Application No. 63/226,643 filed July 28, 2021, which claims the benefit of US Provisional Application No. 63/066,085 filed August 14, 2020. Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
The previous objection to the date of priority for the instant application has been withdrawn.
Specifically, support for a T cell comprising a chimeric engulfment receptor, wherein the CER-T comprises a TLR2 signaling domain can be found in prior application 63/226,643 filed July 28, 2021 as Applicant has asserted in the reply received December 19, 2025, which the Examiner concedes. Accordingly, the instant application is entitled to the benefit of prior application 63/226,643 filed July 28, 2021.
Claim Objections
In view of Applicant’s amendment, the previous objections to the claims are withdrawn.
Claim Rejections - 35 USC § 112(b) - Withdrawn
In view of Applicant’s amendment, the previous rejections of claims 86, 88-90, 92-93, and 95-105 under 35 U.S.C. 112(b) are withdrawn.
In addition, claim 88 was also previously rejected under 35 U.S.C. 112(b) for reciting the term “mediastinal (thymic) large B-cell lymphoma”.
Applicant has argued in the reply received December 19, 2025 (pg. 9), that the term “mediastinal (thymic) large B-cell lymphoma” is a term well known in the art, having its own code in the International Classification of Diseases.
Applicant’s arguments have been considered and were deemed persuasive.
Accordingly, the previous rejection is withdrawn.
Double Patenting
Pursuant to 37 CFR 1.78(f), when two or more applications filed by the same applicant or assignee contain patentably indistinct claims, elimination of such claims from all but one application may be required in the absence of good and sufficient reason for their retention during pendency in more than one application. Applicant is required to either cancel the patentably indistinct claims from all but one application or maintain a clear line of demarcation between the applications. See MPEP § 822.
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.
Double Patenting - New
The following rejection is necessitated by the filing of copending Application No. 19/412,654 on December 8, 2025, which occurred after the last Office Action mailed September 22, 2025.
Claims 86, 88-90, 92-93, 95-96, and 98-108 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of copending Application No. 19/412,654. Although the claims at issue are not identical, they are not patentably distinct from each other because they are directed to the identical engineered T cell comprising a chimeric engulfment receptor recited in the instant claims comprising from N-terminus to C-terminus: a Tim4 binding domain comprising the amino acid sequence of SEQ ID NO: 42; a CD28 transmembrane domain comprising the amino acid sequence of SEQ ID NO: 7; a CD28 signaling domain comprising the amino acid sequence of SEQ ID NO: 4; a CD3z signaling domain comprising the amino acid sequence of SEQ ID NO:27; and a TLR2 signaling domain comprising the amino acid sequence of SEQ ID NO:122.
The amino acid sequences and the limitations associated with the chimeric TIM4 receptor complex recited in the copending application are identical to the CER-CAR construct recited in the instant claims. As such, the copending claims anticipate the instantly claimed invention.
This is a provisional nonstatutory double patenting rejection
Double Patenting - Maintained
Claims 86, 88-90, 92-93, 95-96, and 98-108 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-6, 8, 11-13, 15, 17-20, and 22-26, 28, 31, and 48 of copending Application No. 18/292,782. Although the claims at issue are not identical, they are not patentably distinct from each other because they are directed to the identical engineered T cell comprising a chimeric engulfment receptor recited in the instant claims comprising a single chain chimeric protein comprising an extracellular domain comprising a Tim4 binding domain of SEQ ID NO:6, intracellular signaling domains of CD28 with the amino acid sequence of SEQ ID NO: 12, CD3z with the amino acid sequence of SEQ ID NO: 14, and TLR2 with the amino acid sequence of SEQ ID NO: 17, an expression vector comprising the polynucleotide, an engineered human CD4+ T cell, CD8+ T cell, or CD4+/CD8+ T cell comprising the expression vector. Also claimed is a pharmaceutical composition comprising the engineered T cell, a method of treating cancer including those selected from claim 17, administering an additional therapeutic agent such as a BTK inhibitor (e.g., ONO-4059).
The amino acid sequences for the chimeric TIM4 receptor complex recited in the copending application are identical to the CER-CAR construct recited in the instant claims. As such, the copending claims anticipate and/or render obvious the instantly claimed invention.
This is a provisional nonstatutory double patenting rejection
Response to Arguments
Applicant has argued that the provisional nonstatutory double patenting rejection over US Application No. 18/292,782 is improper because the '782 application is a national phase application of PCT/US2022/074281, filed on July 28, 2022, which is later than the effective filing date of the present application. Applicant further asserts that in accordance with MPEP § 804, it is standard procedure to withdraw provisional obviousness-type double patenting rejections in the earlier filed application when they are the only rejections remaining.
Applicant’s arguments have been fully considered but they are not persuasive because the aforementioned rejection is not the only rejection remaining.
Accordingly the rejection is maintained.
Double Patenting - Withdrawn
The terminal disclaimers filed December 19, 2025 to obviate the nonstatutory double patenting rejections over US Provisional applications 18/041,200 and 19/019111 are compliance with 37 CFR 1.321(c) or 1.321(d). Accordingly, the previous nonstatutory double patenting rejections are withdrawn.
Allowable Subject Matter - Updated
The following is a statement of reasons for the indication of allowable subject matter:
The instant claims are drawn to a method of treating cancer in a subject comprising administering an engineered T cell comprising a chimeric engulfment receptor comprising a single chain chimeric protein, the single chain chimeric protein comprising from N-terminus to C-terminus: (a) an extracellular domain comprising a Tim4 IgV and a Tim4 mucin domain; (b) a CD28 transmembrane domain: and (c) an intracellular signaling domain, wherein the intracellular signaling domain comprises a CD28 signaling domain, a CD3z signaling domain, and TLR2 signaling domain.
There is no prior art that teaches administration of an engineered T cell comprising the CER-CAR construct as recited in the instant claims, and the specific amino acid sequences are free of prior art.
The closest prior art, Corey et al. (WO 2019/191340), teaches cellular immunotherapy compositions comprising a combination of immune cells modified with chimeric engulfment receptors and chimeric antigen receptors, but does not teach or suggest the presently claimed method with the specific amino acid sequences. Although Corey et al. teaches individual components of the instant invention (e.g., a TIM4 CER and a CAR-T cell comprising CD28 and TLR2 transmembrane domains), there is no teaching that would suggest combining the components into a single CER-CAR construct.
The subject matter is deemed allowable in view of the Brandon Cieniewicz Declaration under 37 C.F.R. § 1.132 filed July 31, 2025 that was submitted in reply to an Office Action for copending Application No. 19/019,111. The Cieniewicz Declaration provided evidence to obviate the rejection of the claims under 35 U.S.C. 103 over Corey et al. (WO 2019/191340) (see 19/019,111 Notice of Allowance 9/2/2025, pg. 3-4).
For completeness of the record, Applicant must submit the Cieniewicz Declaration under 37 C.F.R. § 1.132 in reply to this Office Action to obviate any potential rejection under 35 U.S.C. 103.
Conclusion
No claim is allowed.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAUREEN DRISCOLL whose telephone number is (571)270-0730. The examiner can normally be reached Monday through Friday.
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, Samira Jean-Louis can be reached on (571) 270-3503. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/MAUREEN VARINA DRISCOLL/ Examiner, Art Unit 1642
/SAMIRA J JEAN-LOUIS/Supervisory Patent Examiner, Art Unit 1642
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