DETAILED ACTION
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 . In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Change of Examiner
This application has been reassigned from Lexus Tatge to Brian Gulledge for the remainder of its prosecution. Applicant is advised that future communications should be directed to Brian Gulledge, who can be contacted at 571-270-5756, Monday–Friday from 7:00 am until 4:00 pm.
Election/Restrictions
Applicant’s election of Group I (claims 1-12, 14-16, 51-52, and 55) and the species in the reply filed on 08 July 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Claims 56 and 58 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 8 and 9 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
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 1-7, 10-12, 14-16, 51-52, and 55 are rejected under 35 U.S.C. 103 as being unpatentable over Mitchell et al. (PCT Patent Publication WO 2021/055892).
Mitchell et al. discloses lipid nanoparticles having mRNA encapsulated therein (abstract) which are useful for delivery to, for example, the liver (page 8, lines 1-19). The lipid nanoparticles can be those known in the art, and generally comprise cholesterol (aids in stability and promotes membrane fusion), phospholipids (provides structure and aids endosomal escape), polyethylene glycol derivatives (reduces aggregation and shields the lipid nanoparticle), and ionizable lipids (complexes the mRNA and enhances endosomal escape) (page 16, lines 15-24).
Mitchell et al. suggests for the phospholipid that one such lipid is DOTAP (page 17, lines 19-31). As for the amount, Mitchell et al. provides guidance that the amounts can be varied in their relative molar amount (page 18, lines 22-30 & claim 18).
As for the amounts, while Mitchell et al. does not state amounts which read upon the ranges instantly recited, generally differences in concentration and tempera-ture will not support the patentability of subject mat-ter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to dis-cover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05(II)(A).
Additionally and alternatively, it is noted that with respect to amounts, obvious to try is an appropriate motivation for a person of ordinary skill in the art to experiment to reach another workable product or process. See MPEP 2144.05(II)(B). And the requirements for an obvious to try rationale are present in the instant situation, as there is a recognized problem in the art and a finite number of identified, predictable potential solutions (Mitchell et al. presents both issues and solutions for delivery for the different types of lipid components), and a finding that one of ordinary skill in the art could have persuade potential solutions with a reasonable expectation of success. There are no functional limitations in the claims, and there is no evidence on the record that the instantly claimed amounts and ranges are critical to achieving any particular outcome. See MPEP 2143(I)(E).
Instant claim 2 further limits the ionizable lipid, and C12-200 (elected species) is suggested by Mitchell et al. as an ionizable lipid (page 17, lines 1-18).
Instant claims 3-4 further limits the particle, and recites that cholesterol is present. And Mitchell et al. suggests cholesterol (cited above).
Instant claims 5-7 further limit the particle to having a non-ionic lipid other than cholesterol, such as including DOPE. And Mitchell et al. suggests such a lipid (page 17, lines 19-31).
Instant claim 10 recites the inclusion of a PEG-lipid conjugate, and the C12-200 cited above reads upon this limitation.
Instant claims 11 and 12 further limit the nucleic acid cargo, and the mRNA disclosed by Mitchell et al. reads upon these limitations (page 15, line 18 – page 16, line 5).
Instant claims 14-16 further limits the amounts of these lipids, and are addressed by the above provided reasoning.
Instant claims 51-52 and 55 further limit the formulation, and Mitchell et al. suggests the lipid nanoparticle formulation may be administered by a variety of ways, which include injection (page 19, lines 3-14).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Brian Gulledge whose telephone number is (571) 270-5756. The examiner can normally be reached Monday - Friday 7am - 4pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fereydoun Sajjadi can be reached at (571) 272-3311. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Brian Gulledge/Primary Examiner, Art Unit 1699
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