DETAILED ACTION
Status of Application
The Examiner acknowledges receipt of the arguments filed on 5/18/2026.
Claims 1-20 are presented for examination on the merits. The following rejections are made.
Response to 1.132 Declaration
The declaration under 37 CFR 1.132 filed 5/18/2026 is insufficient to overcome the rejection of claims 1-20 based upon Bartolozzi et al. (US 2025/0205167) as set forth in the last Office action.
In the declaration, data is provided which demonstrates that the cis form of the claimed lipids exhibit superior LNP zeta potential and transfection efficiency comparted to the trans isomers.
First, it is noted that Bartolozzi teaches that their lipids may have cis/trans isomer confiugrations. [0093] teaches that their compounds include all isomers, such as geometrical isomers, optical isomers based on an asymmetrical carbon, stereoisomers, tautomers, and the like. For instance, the compounds can contain one or more stereocenters and may thus give rise to geometric isomers (e.g., double bond causing geometric E/Z isomers), enantiomers, diastereomers (e.g., enantiomers (i.e., (+) or (−)) or cis/trans isomers). Thus, identifying the trans configurations for the lipids of the prior art would have been obvious.
Second, the results provided in the declaration are acknowledged and appear to demonstrate some unexpectedness. However, as far as the Examiner can tell, the claims are not directed to trans isomers specifically or are reflective of the unexpected properties, e.g. zeta potential. Instant claim 1 is inclusive of cis/trans isomers as claim 1 recites “[A] lipid of Formula(I), or pharmaceutically acceptable salts, solvates, hydrates, polymorphs, tautomers, stereoisomers, or isotopically enriched derivatives thereof…” Cis and trans denotes are descriptive of stereoisomers. Moreover, the properties which are yielding the unexpectedness being pointed to by the declaration are not presently claimed. As such, the rejections over Bartolozzi are maintained as the declaration is arguing properties for a specific subgroup of compounds which are not presently the focus of the claimed invention.
Response to Applicants’ Arguments
Applicant’s arguments filed 5/18/2026 regarding the rejection of claims 1 and 6 made by the Examiner under 35 USC 102(a)(2) over Bartolozzi et al. (US 2025/0205167) have been fully considered but they are not found persuasive and is MAINTAINED for the reasons of record in the office action mailed on 2/26/2026.
Applicant’s arguments filed 5/18/2026 regarding the rejection of claims 1 and 6 made by the Examiner under 35 USC 103 over Bartolozzi et al. (US 2025/0205167) have been fully considered but they are not found persuasive and is MAINTAINED for the reasons of record in the office action mailed on 2/26/2026.
In regards to the 102(a)(1) and 103 rejections, Applicant asserts the following:
A) The invention defined by the claims has been demonstrated to have unexpected properties when the O-:-X-R substituents of the claimed structure are in a cis conformation.
In response to A, the Examiner acknowledges that the properties described by the cis isomers are surprising when compared to the trans isomers. However, the presently claimed invention is not directed to the cis isomer configuration and so the argument pointing to unexpected results, although interesting, is considered moot as it is not reflective of what is being claimed. See sections 3-6 above which discusses the declaration.
Maintained Rejections, of Record
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)(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.
Claims 1 and 6 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Bartolozzi et al. (US 2025/0205167; filed 03/25/2022).
Bartolozzi discloses the following compound:
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(compound 2240: see Table 1) for use in lipid nanoparticles. Compound 2240 anticipates the structure of instant claim 1:
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as n =1, R1 is hydroxy, R2 and R3 are alkyl groups having 5-30 carbon atoms, L1 is an alkyl having 2-6 carbon atoms, L2 and L3 are alkyl groups having 2-9 carbons and X and Y are each C(O)O. Claim 6 is anticipated as being a ‘active agent delivery vehicle’ is intended use limitation of the compound. However, [0101] discloses that the lipid nanoparticles can be used for encapsulation of active agents.
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 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bartolozzi et al. (US 2025/0205167; filed 03/25/2022).
Bartolozzi teaches a lipid having the generic structure:
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wherein Y Y is
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with A being absent, t1 being 0-10 (see [0018]) (overlaps with L1 of 2-6 carbon atoms; see instant claim 1-3), W can be a hydroxyl, substituted or unsubstituted amino, or a heterocycle (see [0019]) (overlaps with R1 being amino, monoalkylamino, hydroxy, etc; see instant claims 1-3), the cycle can be that of pyrrolidine (see [0059]) (see instant claims 1-3), X and Z may be O, R30, R40, R50 and R60 may be H wherein m and l is from 1-10 (see [0016, 0017]) (overlaps with L2 and L3 being an alkyl with 2-9 carbon atoms), M is a biodegradable moiety such as OC(O) or C(O)O (see [0071]) (overlaps with X and Y being OC(O) or C(O)O; see instant claims 1-13), R70, R80, R90, R100, R110 and R120 are selected from H, C1-16 branched or unbranched (see [0016]), more specifically R70 is to be H, R100 is to be H and R80, R90, R110 and R120 may be selected from
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(see [0258]) (overlap with the R2 and R3 structures of instant claims 2 and 3). The properties associated with the resulting lipids would necessarily occur and upon identifying a lipid which overlaps with that claimed, the result would be one that possess a pKa of between about 5-9 (see instant claim 5).
Regarding instant claim 4, these structures claimed therein are all derivative of the generic structure set forth by Bartolozzi. For instance, bis(2-butyloctyl)5,5′-(((3R,4S)-1-(3-hydroxypropyl)pyrrolidine-3,4-diyl)bis(oxy))dipentanoate of instant claim 4 has the chemical structure:
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. This structure is obvious over the generic structure discussed above wherein 2-butylocytyl substituents are suggested by Bartolozzi for the R80, R90, R110 and R120 substituents (
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;see [0258]).
Bartollozi’s lipid is to be used to prepare a composition in the form of a liposome (see [0100]) (see instant claims 6 and 7) wherein the liposome encapsulates active agents, such as nucleic acids (e.g. mRNA) that encode antigens and antibodies (see [0084, 0574]) (see instant claims 12-16). The composition may comprise additional lipids such as neutral lipids (e.g. DOPC, DLPC; see [0364]) (see instant claims 8 and 9), sterol lipids (e.g. cholesterols, sitosterols; see [0090, 0367]) (see instant claim 10) and PEGylated lipids (e.g. PEG-DMG; see 0358]) (see instant claim 11). Neutral lipids, sterol lipids and PEGylated lipids encompass excipients or adjuvants (see instant claim 17).
The composition may be used in a method of treating disease by administering the composition comprising the active agent (see [0008]) (see instant claim 18) such that the composition is contacted with a target cell so as to modulate the expression of a gene (see [0571, 0575]) (see instant claims 19 and 20).
The only difference between Bartolozzi and the instant claims is that Bartolozzi does not teach the specific combination of components as claimed in a single embodiment, or with sufficient specificity to be anticipatory. The specific combination of features claimed is disclosed within the teaching of Bartolozzi, but ‘such ‘picking and choosing’ within several variable does not give rise to anticipation. However, when a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious. See MPEP 2141(I). Consistent with this reasoning, it would have been obvious to have selected various combinations from Bartolozzi’s teaching to arrive at compositions and method of treatment overlapping with that claimed.
Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was filed, as evidenced by the references, especially in absence of evidence to the contrary.
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 extension fee 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 KYLE A PURDY whose telephone number is (571)270-3504. The examiner can normally be reached from 9AM to 5PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Bethany Barham, can be reached on 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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/KYLE A PURDY/Primary Examiner, Art Unit 1611
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