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 .
Receipt and entry of the response dated 9/9/2025 is acknowledged.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1,3-4,6-10,15-20 and 22-25are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This rejection is maintained for reasons made of record in the Office Action dated 6/18/2025 and for reasons set forth below.
Response to Arguments
Applicant's arguments filed 9/9/2025 have been fully considered but they are not persuasive. Applicants essentially assert that: 1) the instant specification provides over 1,900 species of ionizable lipids; 2) US Patent 11,802,144, issued from application 17/384,460 to which the instant application claims priority, includes similar claims with a generic recitation to a transfer vehicle comprising “… an ionizable lipid…”.
Regarding 1), although this assertion may be true, the claims are not directed to ionizable lipids alone, rather, the claims require such lipids to form a transfer vehicle having the function of “delivering the circular RNA polynucleotide” as also recited in the claims. This is the focus of the instant rejection and is not addressed by applicants. Applicants response does not address the shortcomings of the instant specification regarding this structure/function relationship required by the instant claims.
Regarding 2), each application is treated on its own merits. The prosecution of application ’460 is thus not binding to the instant application. Further, the issued claims do not attempt to claim the transfer vehicle with negative limitations regarding the ionizable lipid, i.e. they do not attempt to define such lipids by reciting what they are not. It is noted that the ionizable lipids excluded by the instant claims, but included in the ‘144 claims, include species taught by the relevant art and the instant specification to provide the claimed function of delivering nucleic acids in the context of a transfer vehicle.
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 Michael Burkhart whose telephone number is (571)272-2915. The examiner can normally be reached M-F 8-5.
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/MICHAEL D BURKHART/Primary Examiner, Art Unit 1638
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