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 drawn to a compound of formula I in the reply filed on 17 July 2026 is acknowledged.
Claims 10-19 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 17 July 2026.
Applicant’s election without traverse of a species of compound of formula I wherein m=1, R1 and R2 are butyl 2-butyloctanoate, F1 is an ester functional group, and RA is 2-butyloctanoic acid in the reply filed on 17 July 2026 is acknowledged.
Claim 9 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 17 July 2026.
Claims 1-8 and 20 are examined on the merits herein.
Expansion of Election of Species Requirement
As indicated above, the elected species reads upon claims 1-8 and 20. The elected species has been searched and is deemed to be free of the prior art and non-obvious. Accordingly, the search has been expanded as called for under current Office Markush practice - a compound-by-compound search – to include a single additional species (MPEP 803.02). That species is
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wherein, in Formula (I)- each m is 1; F1 is an ester group; RA is a branched C11 alkyl; R1 is -L1N[L2F2RB]2, L1 is C2 alkyl, each L2 is C4 alkyl, each F2 is an ester group, and each RB is a branched C11 alkyl; R2 is -L4F4RD, L4 is C4 alkyl, F4 is an ester group, and RD is a branched C11 alkyl which reads on claims 1-2, 4-8, and 20. A rejection to those claims follows.
Since the search has not been expanded beyond the single additional species identified above, claim 3, which is directed to the elected species but which does not include the single additional species, is objected to.
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.
Claims 4-6 are 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c).
In the present instance:
Claim 4 recites the broad recitation “wherein F1 is an ester”, and the claim also recites “such as wherein -F1RA has a structure according to -O-C(=O)-RA” which is the narrower statement of the limitation;
Claim 5 recites the broad recitation “wherein F2, F3, and F4 is an ester”, and the claim also recites “such as wherein -F2RB, -F3RC, and -F4RD have a structure according to -O-C(=O)-R” which is the narrower statement of the limitation; and
Claim 6 recites the broad recitation “wherein each m is 1, 2, or 3”, and the claim also recites “such as wherein each m is 1” which is the narrower statement of the range.
The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Regarding claims 4-6, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
For examination purposes, the narrower statement of the limitation/range following the phase “such as” are interpreted as being merely exemplary of the remainder of the claim.
Claim Rejections - 35 USC § 103
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.
Claims 1-2, 4-8, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Benenato et al. (WO 2018/232120 cited on Applicant’s IDS filed 26 April 2024).
Claim 1 is drawn to a compound of formula (I) or pharmaceutically acceptable salt, tautomer, or stereoisomer thereof, which embraces the following compound species
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wherein each m is 1; F1 is an ester group; RA is a branched C11 alkyl; R1 is -L1N[L2F2RB]2, L1 is C2 alkyl, each L2 is C4 alkyl, each F2 is an ester group, and each RB is a branched C11 alkyl; R2 is -L4F4RD, L4 is C4 alkyl, F4 is an ester group, and RD is a branched C11 alkyl which reads on instant claims 1-2 and 4-8.
Benenato et al. teach amino lipids (Abstract) including lipids having the formula (Ic):
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(Pg. 11). Benenato et al. further teach in Claim 235 the amino lipids including a compound wherein ring A is
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; A1 and A2 are N; Z is absent; X3 is –(CH2)2-OC(O)-; R4 is C11 alkyl; X2 is -CH2-; RX1 is H; X1 is -CH2-; and R1, R2, and R3 are each -R”MR’ wherein R” is C3 alkyl, M is -OC(O)-, and R’ is C11 alkyl, additionally teaching branched alkyl groups (Pars. [320] and [360]). This compound of Benenato et al. corresponds to a compound of instant claim 1, wherein each m is 1; F1 is an ester group; RA is a branched C11 alkyl; R1 is -L1N[L2F2RB]2, L1 is C2 alkyl, each L2 is C4 alkyl, each F2 is an ester group, and each RB is a branched C11 alkyl; R2 is -L4F4RD, L4 is C4 alkyl, F4 is an ester group, and RD is a branched C11 alkyl.
Based on all of the foregoing, claims 1-2 and 4-8 are rejected as prima facie obvious.
Claim 20 is drawn to the compound according to claim 1 for use in the preparation of a pharmaceutical composition for therapeutic use comprising an RNA encoding a gene of interest.
Claim 20 is an intended use claim and does not impose any further structural limitation on the compound (see MPEP 2111).
Nevertheless, Benenato et al. further teach the lipids for use in delivery RNA as a prophylactic agent (Abstract) and the RNA encoding a molecule of interest for a therapeutic effect (Pars. [384-387]).
As such, claim 20 is rejected as prima facie obvious.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Paul Hoerner whose telephone number is (571)270-0259. The examiner can normally be reached Monday - Friday 9:00am - 5:00pm eastern.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany Barham can be reached at (571)272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
/PAUL HOERNER/Examiner, Art Unit 1611
