DETAILED ACTION
Notice of Pre-AIA or AIA Status
This office action is intended to supersede the Office Action previously issued on 03 November 2025.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
The instant application was filed 13 June 2023 and claims priority to provisional application 63/390,751 filed 20 July 2022. The effective filing date of the instant application is therefore 20 July 2022.
Election/Restrictions
Applicant’s election without traverse of Group I and 1,4-Bis(2-hydroxyethyl) piperazine, linoleic acid, DOPE, DMG-PEG, and AA3-Dlin in the reply filed on 30 September 2025 is acknowledged.
Claims 22-30 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 30 September 2025.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
Claim(s) 1-7, 9-21, 31-36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Horhota et al. (WO 2020/061457 A1).
Horhota teaches a lipid nanoparticle composition (abs) comprising an ionizable cationic lipid (para. 109), helper lipids, such as DOPE (para. 213), PEG-modified lipids, such as DMG-PEG (para. 213), and cholesterol (para. 213), addressing claims 5 and 6 and partially claim 1. Horhota describes a method of processing using mRNA, DOPE, PEG-DMG, and cholesterol (para. 694). The composition may comprise about 30-60 mol % of an ionizable cationic lipid (paras. 213, 283), about 0-30 mol % of a phospholipid, such as DOPE (para. 213), about 0-10 mol % or about 18.5-48.5 mol% (para. 213) of cholesterol, and about 0-10 mol% of DMG-PEG (para. 213), where it is understood that the amounts of components would add up to 100 mol %, addressing the ratios and amounts in claims 9, 12, and 13. The composition may comprise mRNA as a therapeutic agent (paras. 398, 695), addressing claims 14-16. The average particle size of the lipid nanoparticle may be from about 40-150 nm (para. 220), addressing claim 17. The zeta potential of the lipid nanoparticle may be from about -10 mV to about +20 mV (para. 224), addressing claim 19. The composition may be formulated for controlled or sustained release (paras. 639, 642), addressing claim 20.
Claim 11 is interpreted as a product-by-process limitation and is given minimal patentable weight (see MPEP 2113(I)).
Horhota does not teach the amino alcohol ((1,4-Bis(2-hydroxyethyl)piperazine), Applicant’s election) and the ionizable cationic lipid, AA3-Dlin (Applicant’s election), in claims 1-4, 7, and 31-36. Horhota does not teach a pKa range in claim 18 and a weight ratio of lipid phase:nucleic acid agent of 1:1 to about 1:100 in claim 21.
Dcchemicals.com teaches that AA3-Dlin is a lipid nanoparticle carrier suitable for mRNA-based cancer therapy and exhibits superior serum stability, maintains consistent particle size, and low turbidity under physiological conditions, and protects mRNA from degradation, all which result in effective delivery (pg. 2).
In regards to the amino alcohol and Applicant’s election of 1,4-Bis(2-hydroxyethyl)piperazine) in claims 1 and 31, AA3-Dlin is formed through the reaction of 1,4-Bis(2-hydroxyethyl) piperazine and linoleic acid, as evidenced by the instant specification (para. 6), and is interpreted as necessarily occurring and present as a result.
In regards to the molecular weight limitation of claim 10, the molecular weight is interpreted as an inherent property of AA3-Dlin.
Since Horhota does not specifically teach AA3-Dlin in claims 1-4, 7, and 31-36, but does teach several different ionizable cationic lipids, one of ordinary skill in the art would have been motivated to use Dcchemical.com’s teaching of AA3-Dlin with a reasonable expectation of success. A skilled artisan would have been highly motivated to combine the teachings because Dcchemicals.com teaches that AA3-Dlin is a superior lipid nanoparticle carrier for mRNA-based cancer therapy and results in effective delivery. Since Horhota teaches treating cancer using several different ionizable cationic lipids (para. 281) and mRNA, a person of ordinary skill in the art would have recognized the benefit of combining the teachings to result in a superior and improved product. “Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use (see MPEP § 2144.07).”
In regards to the pKa range and ratio in claims 18 and 21, Horhota teaches a buffer solution with a pH range from about 4-6 (paras. 143-147, 161). Horhota also teaches a lipid component to nucleic acid agent ratio of about 5:1 to about 60:1 (para. 215). That being said and in lieu of objective evidence of unexpected results, the pKa range and ratios can be viewed as a variable that achieves the recognized result of successfully making the lipid nanoparticle composition, which a skilled artisan would have been easily motivated to modify and adjust. The optimum or workable range of ratios and suitable pKa range can be accordingly characterized as routine optimization and experimentation (see MPEP 2144.05 (II)B). “[Discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” In re Boesch, 617 F.2d 272, 276 (CCPA 1980). Applicants provide no evidence of any secondary consideration, such as unexpected results, that would render the optimized ratio of components and pKa range as nonobvious.
Response to Arguments
Applicant's arguments filed 03 February 2026 have been fully considered but they are not persuasive.
The Applicant argues that Qian does not have an effective filing date of 09 May 2022.
The teachings from Qian have been removed as prior art and the arguments against them will not be addressed.
Conclusion
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/D.A.K./Examiner, Art Unit 1613
/ANDREW S ROSENTHAL/Primary Examiner, Art Unit 1613
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