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 . 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 (i.e., changing from AIA to pre-AIA ) 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.
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-8, drawn to a lipid nanoparticle comprising a pH-sensitive cationic lipid and a polyalkylene glycol-modified lipid, in the reply filed on 02/25/2026, is acknowledged.
Applicant's election with traverse of (species):
Cationic lipid: CL4H6
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Nucleic acid: mRNA
in the reply filed on 02/25/2026, is acknowledged.
The traversal is on the ground(s) that WO 2018/230710 does not teach all of the elements in combination as recited in claim 1, and that the claims involve a special technical feature that makes a contribution over the cited prior art and relate to a single general inventive concept. Additionally, Applicant argued that an undue search burden does not exist in examining Groups II-V along with the elected Group I.
This is not found persuasive because search burden is not a criterion used to support restriction requirements of applications filed under 35 USC § 371. Instead, unity of invention and a special technical feature are criteria used to support restriction requirements of applications filed under 35 USC § 371, and Groups I-V lack unity of invention for the reasons set forth in the office action mailed 11/25/2025. In the instant case, Hokkaido University taught lipid nanoparticles comprising pH-sensitive cationic lipids and PEG-modified lipids [please see the below Obviousness rejection, applied over Harashima et al, which is the corresponding US publication of Hokkaido University).
The requirement is still deemed proper, and is therefore made FINAL.
Claims 6 and 9-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species or invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 02/25/2026.
Claim Rejections - 35 USC § 103 - Obviousness
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-5 and 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Harashima et al (US 2020/0129431 A1), in view of WO 2015/178343 A1 (with an English translation provided by Sato et al (US 10,182,987 B2)).
Harashima taught a lipid nanoparticle (LNP), comprising a pH-sensitive cationic lipid (CL4H6), disclosed as CL4H6-LNP, and modified with methoxy polyethyleneglycol 2000 distearoylglycerol (PEG-DSG 2000). The molar ratio of the cationic lipid to the PEG lipid was 50:0.75 to 1.5 [0256, 0270]. The structure of CL4H6 was shown on the bottom of page 17 [last compound], and is reproduced below:
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.
The LNP of Harashima was as a lipid membrane structure for delivering a target substance, such as mRNA (e.g., as instantly elected; also reads on nucleic acid as a gene that is expressed in a splenic dendritic cell) [0116].
Harashima was not specific the particle diameter as equal to or greater than 150 nm, as recited in claim 1.
However, at ¶ [0143], Harashima incorporated by reference patent literature 6, disclosed at ¶ [0018] as WO 2015/178343 (e.g., with an English translation provided by Sato et al.)
Sato taught lipid membrane structures with particle sizes of about 120 to 300 nm, preferably about 150 to 250 nm, more preferably about 180 nm [col 9, lines 18-21].
The instant claim 1 recites 40 to 70 mol % of the pH-sensitive cationic lipid; 0.5 to 1.75 mol % of the PEG-modified lipid; particle diameter equal to or greater than 150 nm.
The instant claim 2 recites a particle diameter of equal to or smaller than 600 nm.
Harashima taught 50 mol % of the pH-sensitive cationic lipid; 0.75 to 1.5 mol % of the PEG-modified lipid. Harashima incorporated Sato by reference to teach particle sizes of about 120 to 300 nm. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art", a prima facie case of obviousness exists. MPEP 2144.05 A.
Harashima, in view of Sato, reads on claims 1-3, 5 and 7-8.
Claim 4 is rendered prima facie obvious because Harashima taught cholesterol [0112].
Nonstatutory Double Patenting
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 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 12,458,605, in view of Harashima et al (US 2020/0129431 A1), further in view of WO 2015/178343 A1 (with an English translation provided by Sato et al (US 10,182,987 B2)).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims require that the pH-sensitive cationic lipid is further limited to CL4H6, which is not required of the issued claims. Additionally, the instant claims are further limited to amounts of the CL4H6 and PEG, and to a particle size of the LNP, each of which are not required by the issued claims.
Harashima taught a lipid nanoparticle (LNP), comprising a pH-sensitive cationic lipid (CL4H6), disclosed as CL4H6-LNP, and modified with methoxy polyethyleneglycol 2000 distearoylglycerol (PEG-DSG 2000). The molar ratio of the cationic lipid to the PEG was 50:0.75 to 1.5.
Harashima incorporated by reference patent literature 6, disclosed as WO 2015/178343 (with an English translation provided by Sato et al).
Sato taught lipid membrane structures with particle sizes of about 120 to 300 nm, preferably about 150 to 250 nm, more preferably about 180 nm.
It would have been prima facie obvious to one of ordinary skill in the art to include, within the issued claims, CL4H6, and at amounts disclosed by Harashima; amounts of the modified-PEG; and, particle sizes of the LNP, as taught by Harashima. The ordinarily skilled artisan would have been motivated to provide a lipid membrane structure for delivering a delivery target substance, as taught by Harashima.
Claims 1-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of copending Application No. 18/277,409, in view of Harashima et al (US 2020/0129431 A1), further in view of WO 2015/178343 A1 (with an English translation provided by Sato et al (US 10,182,987 B2)).
Claims 1-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of copending Application No. 18/851,300, in view of Harashima et al (US 2020/0129431 A1), further in view of WO 2015/178343 A1 (with an English translation provided by Sato et al (US 10,182,987 B2)).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims require that the pH-sensitive cationic lipid is further limited to CL4H6, which is not required of the copending claims. Additionally, The instant claims are further limited to amounts of the CL4H6 and PEG, and to a particle size of the LNP, each of which are not required by the copending claims.
Harashima taught a lipid nanoparticle (LNP), comprising a pH-sensitive cationic lipid (CL4H6), disclosed as CL4H6-LNP, and modified with methoxy polyethyleneglycol 2000 distearoylglycerol (PEG-DSG 2000). The molar ratio of the cationic lipid to the PEG was 50:0.75 to 1.5.
Harashima incorporated by reference patent literature 6, disclosed as WO 2015/178343 (with an English translation provided by Sato et al).
Sato taught lipid membrane structures with particle sizes of about 120 to 300 nm, preferably about 150 to 250 nm, more preferably about 180 nm.
It would have been prima facie obvious to one of ordinary skill in the art to include, within the copending claims, CL4H6, and at amounts disclosed by Harashima; amounts of the modified-PEG; and, particle sizes of the LNP, as taught by Harashima. The ordinarily skilled artisan would have been motivated to provide a lipid membrane structure for delivering a delivery target substance, as taught by Harashima.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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/CELESTE A RONEY/Primary Examiner, Art Unit 1612