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 Claims
Claims 2-4, 8-9, 12, 18-19, 22, 26, 28-30, 33-34, 37, 39, and 46-48 are pending as of the response and amendments filed on 4/20/26. Claims 1, 5-7, 10-11, 13-17, 20-21, 23-25, 27, 31-32, 35-36, 38, and 40-45 have been canceled. Claims 47-48 have been newly added. Claims 28-30, 33-34, 37, 39, and 46 are currently withdrawn from examination as being drawn to a non-elected invention. Claims 2-4, 8-9, 12, 18-19, 22, 26, and 47-48 are currently under examination.
The 103 rejection of record over Frederick as evidenced by PubChem is withdrawn in consideration of the amendments.
The provisional nonstatutory double patenting rejection over the claims of 17769858 is withdrawn in consideration of the terminal disclaimer filed and approved on 4/20/26.
Regarding the provisional nonstatutory double patenting rejection over the claims of 18695471, Applicants have requested in the response filed on 4/20/26 this rejection be withdrawn as it is the only remaining rejection and has a later patent term filing date compared to the instant application. However, currently there remain withdrawn process claims which have not been examined. The withdrawn process claims have not been rejoined, since the elected product claims are still rejected for nonstatutory double patenting. As there remains unexamined process claims in this application which are not yet eligible for rejoinder, the provisional double patenting rejection over the claims of 18695471 is maintained.
In a telephone call on 5/11/26, the examiner discussed with Applicants’ representative, Kevin O’Brien, the withdrawn process claims 39 and 46 would potentially be rejected under 35 USC 112(a) for lack of written description. The examiner suggested that cancellation of withdrawn claims 39 and 46 by examiner’s amendment would overcome the provisional nonstatutory double patenting rejection over 18695471, potential issues under 35 USC 112(a), and place the application in condition for allowance. However, no agreement was reached.
Claims 2-4, 8-9, 12, 18-19, 22, 26, and 47-48 were examined and are rejected.
Claim Rejections-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 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 2-4, 8-9, 12, 18-19, 22, 26, and 47-48 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 12, 19, 26, 28, 30, and 37 of copending Application No. 18695471 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to a lipid nanoparticle (LNP) comprising a lipid selected from formula (III) and at least one mRNA molecule, wherein the mRNA molecule encodes a CAR. Formula (III) is substantially similar between the copending and instant claims. See copending claims 1-3, 26, and 30; and instant claim 2. Moreover, the LNP of new claims 47-48 is also encompassed by the copending claims. In particular, the lipid of formula (III) of the copending claims includes C14-4 of instant claim 47 (see copending claim 5); and lipids C14-2, C14-5, C16-2, and C12-4 of instant claim 48 is included within formula (III) of the copending claims. For instance,
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is included within formula (III) of copending claim 3, wherein b3=2; b4=2; b5=2; c2=2; R1, R2, R3, R4, and R5=hydrogen; a4, a5=11; b2=2; b1=2; c1=2; a1, a2, and a3=11. As such, the instant and copending claims are not patentably distinct.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Applicant's amendment necessitated the new ground(s) of rejection (over new claims 47-48) 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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH PIHONAK whose telephone number is (571)270-7710. The examiner can normally be reached Monday-Friday 9:00-5:30 EST.
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, Kortney Klinkel can be reached at 571-270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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SARAH . PIHONAK
Primary Examiner
Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627
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