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 .
Priority
This application is a CON of PCT/EP2025/061273 filed 04/24/2025.
PCT/EP2025/061273 has PRO of 63638647 filed 04/25/2024.
Accordingly, claims 1-20 are afforded the effective filing date of 04/25/2024.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/23/2025 has been considered by the examiner and initialed copies of the IDS are included with the mailing of this office action.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-9 and 20, in the reply filed on 01/26/2026 is acknowledged.
Claims 10-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group/invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 01/26/2026.
Status of the Claims
Claims 1-20 are pending in this instant application, of which claims 10-19 are withdrawn at this time being as being drawn to a nonelected group/invention.
Claims 1-9 and 20 are examined herein on the merits for patentability.
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 2 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, 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.
Regarding claim 2, the recitation of “the method of clause 1” renders the claim indefinite because the metes and bounds of “the method of clause 1” is unclear, as it is not clear what is “clause 1” or what method of clause 1 is claim 2 referring to. Clarification by amendment in claim 2 is required. For art rejection purpose, “the method of clause 1” in claim 2 is interpreted as “the method of claim 1.”
Furthermore, the recitation of “further including filtering the retentate through a sterile filtration apparatus before or after filtering the nanoparticle from the reaction mixture via the single-pass tangential follow filtration system” in claim 2 also the renders the claim indefinite because claim 1 recited that the retentate is provided after filtering the nanoparticle from the reaction mixture via a single-pass tangential flow filtration system. Thus, it is not clear how one can further filter the retentate through a sterile filtration apparatus BEFORE filtering the nanoparticle from the reaction mixture, as before filtering the nanoparticle from the reaction mixture, it is not a retentate yet per claim 1. Clarification by amendment in claim 2 is required.
As a result, claim 2 does not clearly set forth the metes and bounds of patent protection desired.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-8 and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by DeRosa et al (US 2017/0348244 A1).
Regarding claim 1, DeRosa teaches a method of preparing a lipid nanoparticle composition comprising separately generating a nucleic acid solution (mRNA solution) and a lipid solution containing an ionizable lipid, and mixing the mRNA solution and the lipid solution in a reactor, wherein the mRNA solution is mixed at a flow rate ranging from about 150-250 ml/minute and the lipid solution is mixed at a flow rate ranging from about 25-75 ml/minute, thereby providing a suspension of lipid nanoparticles (Abstract; [0003]-[0115], [0117]-[0121]; Figures 1-3 and 5; claims 1-3, 5, 9-12, 14, 23-26, 30, and 32-35). DeRosa teaches the suspension of lipid nanoparticle is purified to filter the lipid nanoparticles from the suspension using a tangential flow filtration system to provide a retentate ([0012], [0027], [0101]-[0106], [0119]-[0121], [0127]; Figures 1-3 and 5; claim 25).
Regarding claim 2, DeRosa teaches retentate is diafiltrated via tangential flow filtration system ([0012], [0027], [0101]-[0106], [0119]-[0121], [0127]; Figures 1-3 and 5).
Regarding claim 3, DeRosa teaches the filtering of the suspension of lipid nanoparticles include concentrating the suspension of lipid nanoparticles to provide concentrated nanoparticles; diafiltrating the concentrated nanoparticles to provide a diafiltrated nanoparticles; and further concentrating the diafiltrated nanoparticles to provide resultant lipid nanoparticles for storage ([0012], [0027], [0101]-[0106], [0119]-[0121], [0127]; Figures 1-3 and 5).
Regarding claim 4, DeRosa teaches the concentrating of the suspension of lipid nanoparticles is performed once via tangential flow filtration system ([0012], [0027], [0101]-[0106], [0119]-[0121], [0127]; Figures 1-3 and 5).
Regarding claim 5, DeRosa teaches the filtering of the suspension of lipid nanoparticles is done continuously ([0092], [0103], [0105], [0127]).
Regarding claims 6 and 7, as discussed above, DeRosa teaches the nucleic acid is a mRNA.
Regarding claim 8, DeRosa teaches the lipid solution contains phospholipid and sterol ([0064]-[0087], [0117]-[0121]; claim 23).
Regarding claim 20, nowhere in the method from DeRosa does it mention an evaporation step, and thus, the method from DeRosa is free of an evaporation step.
As a result, the aforementioned teachings from DeRosa are anticipatory to claims 1-8 and 20 of the instant invention.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-9 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over DeRosa et al (US 2017/0348244 A1), and further in view of Bowman et al (US 2017/0196809 A1).
The methods of claims 1-8 and 20 are discussed above, said discussion being incorporated herein in its entirety.
Regarding claim 9, DeRosa teaches the lipid solution contains ionizing lipid (a cationic lipid), a phospholipid, a sterol, and pegylated lipid (a stabilizing agent), wherein the relative molar ratio of such lipids to each other can be adjusted accordingly to provide the desired lipid nanoparticles ([0064]-[0087], [0117]-[0121]; claim 23).
While DeRosa does not expressly the particular mol% ranges for the ionizing lipid, phospholipid, sterol (cholesterol), and stabilizer of claim 9, it would have been obvious to routine optimize the molar % ionizing lipid, phospholipid, sterol, and stabilizer in the lipid solution of DeRosa to the molar % as recited in claim 9 in view of the guidance from Bowman.
Bowman teaches a method for encapsulating a nucleic acid (i.e., mRNA and siRNA) in a lipid nanoparticle in which the lipid solution contains 40-55 mol% of a cationic lipid, 40-55 mol% of a sterol (cholesterol), 5-15 mol% of a phospholipid, and 1-10 mol% of a pegylated lipid (a stabilizing agent) (Abstract; [0009]-[0024]], [0062]-[0318], and [0363]-[0373]).
It would have been obvious to one of ordinary skill in the art to routinely optimize the mol% of ionizing lipid (a cationic lipid), a phospholipid, a sterol, and pegylated lipid (a stabilizing agent) in the lipid solution of DeRosa to the mol% amounts as claimed in claim 9, and produce the claimed invention. One of ordinary skill in the art would have been motivated to do so because as discussed above, Bowman provided the guidance for optimizing the lipid solution to contain cationic lipid 40-55 mol% of a cationic lipid, 40-55 mol% of a sterol (cholesterol), 5-15 mol% of a phospholipid, and 1-10 mol% of a pegylated lipid (a stabilizing agent), which are mol% ranges that falls within or substantially overlaps the claimed mol% ranges for the ionizing lipid, phospholipid, sterol (cholesterol), and stabilizer of claim 9. Thus, it is noted that the courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists (see In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985). Absent some demonstration of unexpected results showing criticality from the claimed parameters, the optimization of mol% for the ionizing lipid, phospholipid, sterol (cholesterol), and stabilizer in the second composition would have been obvious before the effective filing date of Applicant’s invention. See MPEP §2144.05 (I)-(II).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of Applicant’s invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
No claim is allowed.
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/DOAN T PHAN/ Primary Examiner, Art Unit 1613