DETAILED ACTION
Previous Rejections
Applicant’s arguments, filed 07/02/2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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, 3-10 and 12-19 are rejected under 35 U.S.C. 103 as being unpatentable over Yamamoto et al (WO 2019/235635 A1, with an English translation provided by Tanabe et al (US 2021/0085604A1)), in view of Almarsson et al (US 2022/0031631 A1).
Tanabe taught compounds constituting lipid particles that achieved nucleic acid encapsulation and delivery of nucleic acids. According to an aspect of Tanabe’s disclosure, a compound represented by Formula (2) was provided, as instantly claimed. At [claim 10], Tanabe taught:
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. Tanabe also taught sterol (e.g., cholesterol, at least one non-cationic lipid) [0356]. PEG and PEG-modified polymers were generally taught [0366 and 0368-0369].
Although Tanabe generally taught PEG and PEG-modified polymers, Tanabe was specifically silent R51-L-(OCH2CH2)n-O-R52, as recited in claim 1.
Nevertheless, Almarsson taught
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(e.g., PEG-stearate) [face page] as a high-purity PEG [abstract] that, when included within lipid particle compositions or formulations, the said compositions resulted in improved physical and biological properties, including being less susceptible to recognition and clearance by the body [0010-0012].
Since Tanabe taught delivery of nucleic acids with lipid particles, generally comprised of PEG polymers, it would have been prima facie obvious to one of ordinary skill in the art to include, within the teachings of Tanabe, PEG-stearate, as taught by Almarsson. The ordinarily skilled artisan would have been so motivated, because PEG-stearate is of a high purity, and when included within lipid particle compositions or formulations, therein results improved physical and biological properties of the composition, including being less susceptible to recognition and clearance by the body, as taught by Almarsson [0010-0012].
Tanabe, in view of Almarsson, reads on claims 1, 4 and 6-7.
Claim 3 is rendered prima facie obvious because Tanabe taught the compound of Formula (1) at 20 mol % to 80 mol % [0353].
The instant claim 3 recites the lipid present at 30 to 70 mol %.
Tanabe taught the lipid present at 20 mol % to 80 mol %. 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.
Claims 5, 9 and 10 are prima facie obvious because Tanabe taught cholesterol, as discussed, and sphingomyelin [0362], reading on non-ionic and zwitterionic, respectively. Sphingomyelin was taught at 3 mol % to 55 mol % [see ¶ 0364].
Further regarding the instant claim 10, the claim recites the zwitterionic lipid at 1 to 30 mol %. Tanabe taught sphingomyelin at 3 mol % to 55 mol %. A prima facie case of obviousness exists because of overlap, as discussed above.
Claim 8 is rendered prima facie obvious because Tanabe taught cholesterol at 10 mol % to 60 mol % [0357].
The instant claim 8 recites non-ionic lipid at 10 to 60 mol %.
Tanabe taught cholesterol at 10 mol % to 60 mol %. A prima facie case of obviousness exists because of overlap, as discussed above.
Claim 12 is rendered prima facie obvious because Tanabe taught PEG and PEG-containing polymers included from 0.25 mol % to 12 mol % [0372].
The instant claim 12 recites the lipid represented by R51-L-(OCH2CH2)n-O-R52 present at 0.1 to 10 mol %. Tanabe taught PEG and PEG-containing polymers included from 0.25 mol % to 12 mol %. A prima facie case of obviousness exists because of overlap, as discussed above.
Claim 13 is rendered prima facie obvious because Tanabe taught 0.01% to 50% by weight nucleic acid [0375]; the compound of Formula (1) at 20 mol % to 80 mol %.
The Examiner notes that the instant claim 13 recites a weight ratio of lipid to nucleic acid. Tanabe disclosed the lipid of Formula (1) in mole %, and the amount of nucleic acid in weight %. It would be prima facie obvious to one of ordinary skill in the art to mathematically determine the amount of Tanabe’s lipid in weight, in order to obtain the weight ratio of the lipid to the nucleic acid, as recited.
Claim 14 is rendered prima facie obvious because Tanabe taught pharmaceutically acceptable carriers [0398].
Claims 15-18 are rendered prima facie obvious because Tanabe taught pharmaceutical use to introduce a nucleic acid into a cell; for delivery into a living body; by rectal administration (e.g., a type of topical administration); nasal administration (e.g., reads on in vivo administration to the central nervous system) [0396, 0399].
Claim 19 is rendered prima facie obvious because Tanabe taught nucleic acid delivery carriers [0401-0402].
Response to Arguments
Applicant's arguments filed 04/02/2026 have been fully considered but they are not persuasive.
Applicant argued that Yamamoto did not disclose the lipid represented by R51-L-(OCH2CH2)n-O-R52; Almarsson did not disclose the lipid compounds having the structure of Formula (2).
The Examiner advises the Applicant against attacking references individually, where the rejection was based upon a combination. One cannot show nonobviousness by attacking references individually, where the rejections are based on combinations of references. See 2145 (IV). In the instant case, Yamamoto (Tanabe) was relied upon to teach Formula (2) [see the Obviousness rejection], while Almarsson was relied upon to teach the lipid represented by R51-L-(OCH2CH2)n-O-R52.
Applicant argued advantageous effects obtained by the instant invention, citing Examples of the Specification. Applicant cited Tables 3-4 and Figures 1-6.
The Examiner disagrees that the Applicant has shown advantageous effects of the instant invention. The instant Table 3 appears to show encapsulation rate (62 % - 98 %) versus comparative (76 % - 96 %), which does not appear advantageous. Applicant’s arguments regarding Table 4, as well as Figures 1-6, appear moot, since the data regards Formula (1), which is not claimed [see instant ¶s 0203-0207].
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 1-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of copending Application No. 17/743,584.
Claims 1-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of copending Application No. 17/457,793.
Claims 1-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of copending Application No. 18/884,577.
Although the claims at issue are not identical, they are not patentably distinct from each other because the species (lipid composition comprising nonionic lipids, non-cationic lipids and nucleic acids) recited in the copending claims falls within the genus (lipid composition) recited in the claims of the instant application, and thus read on the instant claims.
These are provisional nonstatutory double patenting rejections because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments filed 04/02/2026 have been fully considered but they are not persuasive.
Applicant argued that the '793 application issued as U.S. Patent No. 12,508,226 on 12/30/2025, so this rejection is non-provisional in nature.
The Examiner agrees. If the Applicant chooses a next round of prosecution (RCE), then the correction, from provisional to non-provisional, will be made at that time.
Regarding the rejections over copending applications ‘584 and ‘577, Applicant argued that the cited art does not disclose obvious variants of the claimed lipid, and that the instant invention evidences superior results.
The Examiner disagrees. Tanabe teaches the claimed lipid of the instant Formula (2) [see the Obviousness rejection]. Furthermore, the Examiner disagrees that the Applicant has shown evidence of superior results [see the above discussion of the Applicant’s evidence].
The nonstatutory double patenting rejections are maintained. Terminal disclaimers are required.
Conclusion
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CELESTE A RONEY whose telephone number is (571)272-5192. The examiner can normally be reached Monday-Friday; 8 AM-6 PM.
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/CELESTE A RONEY/Primary Examiner, Art Unit 1612
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