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 with traverse of Group I claims 1 -10, in the reply filed on November 14, 2025 is acknowledged. The traversal is on the ground(s) that the compounds of Group I and Group II possession unity of invention because they share a special technical feature in that the compounds of both groups comprise a structure of Formula (I):
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with the substituents as defend in claim 1. This is found persuasive because of the amendment to claim 11. The restriction between Groups I and II is withdrawn.
However, the restriction requirement between Groups III – VI is still deemed proper and is therefore made FINAL
Applicant’s election without traverse the following species in the reply filed on November 14, 2025 is acknowledged.
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Applicant was required to elect a single disclosed species, or a single grouping of patentably indistinct species, for prosecution on the merits to which the claims shall be restricted if no generic claim is finally held to be allowable. Applicant elected for Group I, the species set out above. Applicant’s elected species according to Formula (I) was not found to be anticipated by or obvious over the prior art. As such, the examination of the claims was extended by the Examiner. The search and examination was continued for all non-elected species of Formula (I).
Status of Claims
Claims 1 – 11 and 26 – 33 are pending.
Claim 11 is rejected.
Claims 12 – 25 have been canceled.
Claim 1 – 10 and 26 – 33 are allowed.
Response to Amendment
The amendment to claims 6, 7, 9, 11 and new claims 26 - 33, submitted November 14, 2025 is acknowledge and entered.
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.
Claim 11 is rejected under 35 U.S.C. 112(b), 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.
Claim 11 sets out structurally the cationic lipid of claim 1. In claim 11 there is a listing with structure numbers 1 – 12. Additionally, Applicant identifies other listings of structures for the cationic lipid of claim 1 under the headings of a syringic acid core, a Sinapinic acid core, a vanillic acid core, a ferulic acid core or a p-coumaric acid core; and structure numbers 562 – 564. However, the structures numbered 1 – 12 are listed again under one of separate headings of Sinapinic acid core, vanillic acid core, ferulic acid core or p-coumaric acid core. The combination of listings adds indefiniteness to the claim.
Allowable Subject Matter
Claims 1- 10 and 26 - 33 are allowed.
Claim 11 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b), set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter: None of the prior art of record teaches or suggest replacing the central moiety in a cationic lipid with a phenyl ring substituted by L1-C(O)-X- of Formula (I).
The Examiner has considered the cited references and conducted a thorough search of the appropriate data bases for the claimed subject matter and did not discover any reference which anticipates that claimed subject atter or would form the basis for concluding the claimed subject matter would have been obvious.
Art Made of Record
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. WO2018/089801 (Translate Bio, Inc.) discloses process for preparing mRNA-loaded lipid nanoparticles. WO2017/201346 (Modernatx, Inc.) discloses pharmaceutical composition comprising lipid nanoparticle encapsulated mRNA wherein the lipid nanoparticle comprises a compound of formula (I) having a central amine moiety and at least one biodegradable group. (WO2018/170306) (Modernatx 2), which discloses novel lipids and compositions comprising such compounds useful for delivery of one or more therapeutic and/or prophylactics to and/or produce polypeptides in mammalian cells or organs. The lipids of Modernatx 2 include a central amine moiety and at least one biodegradable group. (see Formula (I).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YATE' K. CUTLIFF whose telephone number is (571)272-9067. The examiner can normally be reached Monday-Friday (8:30 - 5:30).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Scarlett Y. Goon can be reached at (571) 270-5241. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/YATE' K CUTLIFF/Primary Examiner, Art Unit 1692