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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-6, 8-9,11,13,and 16 in the reply filed on 07/20/2026 is acknowledged.
Claims 18, 21-23, 26, and 29-32 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 07/20/2026.
Information Disclosure Statement
An information statement was filed on 03/26/2024 and 08/05/2026.
A Preliminary Amendment was filed 03/26/2024.
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 13 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 13 sets out “a CAR antigen specific for binding to a surface antigen, a pathogenic cell, or a tumor cell”. The metes ad bounds of this grouping are indefinite since a tumor cell is also a pathogenic cell. Clarification is requested.
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 1-6, 8-9, 11, 13, and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-4, 8, 9, 12, 18, 19, 22, 26, and 40 of U.S. Application No. 17/769,893 (US’893), now allowed. Although the claims at issue are not identical, they are not patentably distinct from each other because US’893 claims:
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Claim 3 sets out the compounds, while claim 4 sets out an ionizable lipid and mRNA. A helper lipid is added at claims 8 and 9 . DOPE is listed among other possible phospholips along with cholesterol and PEG at claim 12. The LNP may comprise a nucleic acid, an adjuvant, and a therapeutic agent at claim 18, whie claim 19more specifically set out what these entail. Antigens and vaccines are found at claims 22 and 26. Claim 40 sets out CAR mRNA and additional compounds. Those of ordinary skill would have been able to claim the instantly claimed targeted LNP with the same expectation of therapeutic results give the claims of US’893. The instantly claimed targeted LNP would have been obvious given the teachings of US’893 at the time of filing.
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.
Claim(s) 1, 5, 11, and 13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Billingsley et al (Lipid Nanoparticles-Mediated Delivery for Human CAR T Cell Engineering).
Billingsley discloses immune cell targeted lipid nanoparticles (LNPs) designed for ex vivo delivery to human T cells (page 4, lines 5-10). LNPs are synthesized using a compound, DOPE, cholesterol and PEG mixed at a molar ratio of 35%, 16%, 46.5 %, and 2.5% ,respectively. After mixing and dialyzing , a cell targeting domain specific toa surface molecule of a target cell are formulated fordeliervy of Chimeric antigen receptor CAR mRNA. The mRNA was produced using vector targeting CAR bearing costimulatory domains. (see Abstract, page C, Figure 2; Page F. Figure 5; page H, first column, second and third paragraphs). The claims are anticipated by Billingsley et al. The claims are anticipated by Billingsley et al
Conclusion
No claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CARLOS A AZPURU whose telephone number is (571)272-0588. The examiner can normally be reached 9 am- 3 pm, 4 pm-8pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue X Liu can be reached at 571-272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CARLOS A AZPURU/Primary Examiner, Art Unit 1617 caz
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