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 invention group I, claims 1-4, 10, 12-16, 18, 21 and 24-26, in the reply filed on 05/21/2026 is acknowledged.
Claims 27, 60, 70-72 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 05/21/2026.
Applicants further elect Lipid 88 (in claim 26) as specific compound of formula (I). Lipid 88 is free of art. The examination moves to next species lipid 1 at the examiner’s choice. Claims 1-2, 4, 10, 16, 18, 24 read on the examined species lipid 1 and are under examination, claims 3,12-15, 21 and 25-26 do not read on the examined species lipid 1 and are withdrawn from consideration.
Claims 1-4, 10, 12-16, 18, 21 and 24-26, 27, 60, 70-72 are pending; claims 1-2, 4, 10, 16, 18, 24 are under examination.
Priority
Acknowledge is made that this application is national stage of international patent application PCT/US23/15119, filed on 03/13/2023; which claims priority from US provisional application 63/318971, filed on 03/11/2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/10/2024 is being considered by the examiner.
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.
Claim(s) 1-2, 4, 10, 16, 18, 24 are rejected under 35 U.S.C. 102(a)(1) & (a)(2) as being anticipated by Xu et al. (WO2020247604).
The limitation of claims 1-2 is met by Xu et al. disclosing a lipidoid nanoparticle composing a CRISPR/Cas9 mRNA and a lipid 1 with the following structure (claims 1 and 23). This lipid falls into claimed lipid of formula (I), Ra is -CH3; n1=n2=3; Rb1=Rb2=Rb3=Rb4=CH2CH2-C(=O)O-(CH2)2-S-S-(CH2)7-CH3. Since both CRISPR/Cas9 mRNA (pharmaceutical agent ) and the lipid in the lipid nanoparticle, this meets the limitation of “pharmaceutical agent is assembled with the lipid”.
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Lipid 1
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 1-2, 4, 10, 16, 18, 24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 22-23, 38-39 of copending Application No. 17543173 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference teaches lipid nanoparticle comprises mRNA and a lipid (claims 1 and 23) having following structure fall into claimed lipid of formula (I).
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This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-2, 4, 10, 16, 18, 24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1,4, 24 and 28 of copending Application No. 18265561 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application teaches a lipid composition comprising a nucleic acid and a lipid having a amine head (claim 4) and hydrophobic tail claim 28) which falls into a claimed lipid of formula (I).
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This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-2, 4, 10, 16, 18, 24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 57 and 85 of copending Application No. 18272024 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application teaches a composition comprising a pharmaceutical assembled with a lipid (claim 85) having structure falls into claimed lipid of formula (I).
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This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-2, 4, 10, 16, 18, 24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 154 of copending Application No. 18288484 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application teaches a nanoparticle comparing a nucleic acid and a lipid having structure fall into claimed lipid of formula (I).
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This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-2, 4, 10, 16, 18, 24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 86 of copending Application No. 18998674 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application teaches a nanoparticle comparing a nucleic acid and a lipid having structure fall into claimed lipid of formula (I).
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This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-2, 4, 10, 16, 18, 24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 23 of copending Application No. 19708055 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application teaches a nanoparticle comparing a MRNA and a lipid having structure fall into claimed lipid of formula (I).
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This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JIANFENG SONG. Ph.D. whose telephone number is (571)270-1978. The examiner can normally be reached M-F 8-5.
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, Brian-Yong Kwon can be reached at (571)272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JIANFENG SONG/Primary Examiner, Art Unit 1613
Prosecution Insights