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 .
Status of Claims
The amendments and arguments filed 10 September 2025 are acknowledged and have been fully considered. Claims 1, 11, 21, 35, 41-44, 46, 49-53, 63-64, 68-79, and 72 currently pending. Claims 1 and 44 are amended; claims 2-10, 12-20, 22-34, 36-40, 45, 47-48, 54-62, 65-67, 71, and 73 are cancelled; claims 53, 64, 68-70, and 72 are withdrawn; no claims are new.
Claims 1, 11, 21, 35, 41-44, 46, 49-52, and 63 are examined on the merits herein.
Objections/Rejections Withdrawn
Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn. In particular, the rejection of claims under 35 U.S.C. 102 is withdrawn in view of Applicant’s persuasive argument that Miller et al. does not teach every element of the claims. Further, the objection to the specification has been withdrawn in view of Applicant’s submission of sequence listings and amendment to the specification. The following rejections and/or objections are either reiterated or newly applied, and constitute the complete set presently being applied to the instant application.
Expansion of Election of Species Requirement
Applicant’s elected species reads upon claims 1, 11, 21, 35, 41-44, 46, 49-52, and 63. 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) R1 is C12 alkyl, R2 and R3 are each C5 alkyl, R4 is C4 alkyl substituted by NRaRb, and Ra and Rb are each methyl which reads on claims 1, 35, 41-42, 46, 49-52, and 63. A rejection to those claims follows.
Since the search has not been expanded beyond the additional species identified above, claims 11, 21, and 43-44, which are directed to the elected species but which do not include the additional species, are objected to.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 35, 41-42, and 63 are rejected under 35 U.S.C. 103 as being unpatentable over Wong (US 7,514,574; of record).
Claim 1 is drawn to a compound of formula (I) which embraces the following compound species wherein R1 is C10 alkyl, R2 and R3 are each C5 alkyl, R4 is C3 alkyl substituted by NRaRb, and Ra and Rb are each methyl which reads on instant claims 1, 35, and 41-42.
Wong teaches in Col. 8 compounds having a structure of the formula:
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including compound (p) (Col. 10 lines 5-8):
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Corresponding to a compound of instant formula I wherein R1 is C10 alkyl, R2 is methyl, R3 is hydrogen, and R4 is C3 alkyl substituted by NRaRb, and Ra and Rb are each methyl.
Compound (p) of Wong differs from the instantly claimed compound in the following ways:
The groups corresponding to instantly claimed R2 and R3 are not C5 alkyl.
Yet, as to 1: Wong teaches that the group corresponding to instantly claimed R3 can be an alkyl group (Col. 8 lines 35-36), indicating that larger groups are suitable for compounds of formula (I).
And, as discussed in MPEP 2144.09, Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). In the instant case, the compound of Wong differs from the instantly claimed compound only by repeating -CH2- groups. As such, one of ordinary skill in the art would reasonably expect the compound of Wong to possess similar properties to the instantly claimed compound.
Based on all of the foregoing, claims 1, 35, and 41-42 are rejected as prima facie obvious.
Claim 63 is drawn to a composition comprising a compound of claim 1.
Wong further teaches formulating pharmaceutical compositions for topical administration comprising the compound and pharmaceutically active agents (Col. 8 lines 38-40).
As such, claim 63 is rejected as prima facie obvious.
Claims 46 and 49-52 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wong as applied to claims 1, 35, 41-42, and 63 above, and further in view of Boakye et al. (Journal of Controlled Release, 2017, Vol. 246, 120-132).
The teachings of Wong have been set forth above.
Claim 46 is drawn to a lipid particle comprising the compound of claim 1.
Claim 49 is drawn to the lipid particle of claim 46, wherein the lipid particle further comprises a therapeutic agent (more specifically siRNA (claims 50-52)).
Wong does not teach a lipid particle composition.
However, Wong teaches the compounds being used as a skin penetration enhancer (Col. 8 lines 48-49) to improve the transdermal delivery of pharmaceutically active compounds (Col. 2 lines 14-15).
Boakye et al. teach transdermal delivery of siRNA enhanced by lipid nanoparticles (Abstract).
And as discussed in MPEP 2144.06, "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
In the instant case, both the compound of Wong and the siRNA lipid nanoparticles of Boakye et al. are taught in the art to improve the transdermal delivery of an active agent. As such, it would have been prima facie obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the siRNA lipid nanoparticles of Boakye et al. to include the compound of Wong in order to obtain an siRNA delivery system further capable of enhancing transdermal delivery, with a reasonable expectation of success.
As such, claims 46 and 49-52 are rejected as prima facie obvious.
Response to Arguments
Applicant's arguments filed 10 September 2025 have been fully considered but they are not persuasive.
Applicant argues on pgs. 8-9 of the remarks that there exists no motivation from Wong to replace the methyl group with the instantly claimed C5 alkyl, further arguing on pg. 9-10 that there is no way to bridge the gap between the non-adjacent homologs.
This argument is not persuasive. While C(1) and C(5) alkyl groups are not adjacent homologs, they are considerably closer than the C(1) and C(8) homologs discussed in In re Mills. Further, as Wong broadly teaches the group as an alkyl group (Col. 8 lines 35-36), there does exist in the prior art a way to bridge the factual gap between the C(1) and C(5) homologs. As such, one of ordinary skill in the art would reasonably expect substitution of a C(1) group for a C(5) group to yield a compound with similar properties, based on Wong’s broad teaching of an alkyl group.
Applicant argues on pg. 10 of the remarks that one of ordinary skill in the art would not have a reasonable expectation of success for substitution of a larger alkyl group.
This argument is not persuasive. While Wong does not exemplify a larger alkyl group, Wong does broadly teach the group being an alkyl group, which one of ordinary skill in the art would understand to embrace larger groups. And as discussed in MPEP 2121(I), prior art is presumed to be operable. As such, one of ordinary skill in the art would expect compounds of Wong having a larger alkyl group to be suitable, based on Wong’s disclosure of an alkyl group.
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.
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/PAUL HOERNER/ Examiner, Art Unit 1611
/CRAIG D RICCI/ Primary Examiner, Art Unit 1611