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 .
Status of Application/Restriction/Claims
Applicant’s election without traverse of Group 1 (Claims 1-8, 11-18 and 21-28) on 6/8/2026 is acknowledged. Claims 1-30 are pending. Claims 9-10, 19-20 and 29-30 are currently withdrawn from further consideration pursuant to 37 CFR 1.142 (b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 1-8, 11-18 and 21-28 are examined.
Priority
Applicant’s claim for the benefit of a prior-filed application CON of 18/279,201, PRO 63/154,639 and 371 of PCT/US2022/018027 filed on 8/28/2023, 2/26/2021 and 2/25/2022, respectively, under 35 U.S.C 119(e) or under 35 U.S.C 120, 121 or 365(c) is acknowledged.
As set forth in the Patent Trial and Appeal Board decision in application 19/215,495 (sharing the same PRO 63/154,639 as the instant application), the instantly claimed genus was not supported by the limited number of species provided in the provisional applications. Accordingly, the effective priority date of the instant application is granted as the PCT/US2022/018027 application filing date 2/25/2022.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 12/9/2025, 2/26/2026 and 6/8/2026 were received. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement was considered by the examiner.
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 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)(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.
Claims 1-8, 11-18 and 21-28 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Russell et al. US 2023/0295332, published 9/21/2023, priority date 12/27/2021 (hereinafter Russell).
Claims 1, 11 and 21: Russell describes a pseudotyped lentivirus that utilizes the fusogenic properties of the glycoprotein of VSV-G in combination with a targeting agent, both of which are expressed on the surface of the virus (Russell, para 3, 9, 46). Russell discloses a VSV-G polypeptide SEQ ID NO: 2 which has a 100% query match to SEQ ID NO: 90 of the instant invention (Polypeptide BLAST alignment shown below). Russell describes amino acid substitutions at position 182 with 96-100% sequence similarity to SEQ ID NO: 2 (Russell, para 11 and claims 71-75).
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Claims 2, 12 and 22: Russell describes T cell targeting domains which specifically bind to T cell parkers like CD8 (Russell, para 166).
Claims 3, 13 and 23: Russell describes substitutions at position 182 from isoleucine to glutamic acid (Russell, para 11 and claims 78-82).
Claims 4, 14 and 24: Russell describes further amino acid substitutions at position 352 (Russell, para 11 and claims 78-82).
Claims 5, 15 and 25: Russell describes substitutions at position 352 from threonine to alanine (Russell, para 11 and claims 78-82).
Claims 6, 16 and 26: Russell describes T cell targeting domains which specifically bind to T cell parkers like CD8, hinge region domains from CD4, CD7, CD28, transmembrane domains from CD28, intracellular signaling domains and costimulatory domains (Russell, para 166-168 and 283).
Claims 7-8, 17-18, 27 and 28: Russell provides alternative embodiments to CAR domains targeting anti-CD19 and anti BCMA CARs (Russel, para 396). Russell describes the use of a CD8a hinge and transmembrane domain (Russell, para 250). Russell describes the use of a CD3 delta effector domain and 4-1BB (CD137) costimulatory domain (Russel, para 283).
Nonstatutory 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 Langi, 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(1)(1) - 706.02(1)(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.
Claims 1-5, 11-15 and 21-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of US Patent No. US 12,312,593. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims would anticipate the instant claims if they were available as prior art.
The patented claims are drawn to a polypeptide encoding an amino acid sequence set forth in SEQ ID NO: 90 with an amino acid substitution at position 182. The patented claims also describe a lentiviral vector further substations to position 352. The patented claims would anticipate the instantly claimed invention, which is drawn to a similar lentiviral vector encoding SEQ ID NO: 90 and a CAR. The claim sets are patentable indistinct therefore.
Claims 1-5, 11-15 and 21-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of application 19/215,495. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims would anticipate the instant claims if they were available as prior art.
The copending claims are drawn to a polypeptide encoding an amino acid sequence set forth in SEQ ID NO: 90 with an amino acid substitution at position 182. The copending claims also describe a lentiviral vector further substations to position 352. The copending claims would anticipate the instantly claimed invention, which is drawn to a similar lentiviral vector encoding SEQ ID NO: 90 and a CAR. The claim sets are patentable indistinct therefore.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Dr. ALEXANDER NICOL whose telephone number is (571)272-6383. The examiner can normally be reached on M-F 8-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maria Leavitt can be reached on (571)272-1085. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Alexander Nicol
Patent Examiner
Art Unit 1634
/ALEXANDER W NICOL/Examiner, Art Unit 1634
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