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 .
Status of Application
Receipt of Applicant’s remarks and the amended claims filed on March 30, 2026 is acknowledged.
Claims 1-6, 10-16, 18-20 are pending in this application.
Claims 1, 10, 13-16 and 19 have been amended.
Claim 20 is new.
Claims 7-9 and 17 have been cancelled.
All claims are under examination in this application.
Withdrawn Rejections
Claim Rejections - 35 USC § 112
The rejection of claims 16-17 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 because the claims recite “A method of treating a disease, disorder, or condition in a subject in need of such treatment comprising administering a lipid nanoparticle of claim 1, to a subject to thereby treat the disease, disorder, or condition.” However, no specific disease, disorders, or conditions are recited has been withdrawn in view of the amendment to claim 16 to recite “wherein the disease, disorder, or condition is selected from the group consisting of an infectious disease, a cancer, and a proliferative disease” and the cancellation of claim 17.
The rejection of claim 19 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 because the phrase "including" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention has been withdrawn in view of the amendment to claim 19 to delete the phrase “including a SARS CoV-2 vaccine.”
Claim Rejections - 35 USC § 103
The rejection of claims 1-19 under 35 U.S.C. 103 as being unpatentable over Harashima et al. (US 2020/0129431) in view of Derosa et al. (WO 2020/106903) (both references cited on the ISR dated April 19, 2024) has been withdrawn in view of the amendment to claim 1 to recite a “self-amplifying mRNA comprises a sequence encoding an antigenic peptide or protein, or a fragment, variant, or derivative thereof.”
Newly Applied Rejections
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-6, 10-16, and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Bevers et al. (WO 2019141814) in view of Harashima et al (US 2020/0129431).
Bevers discloses lipid nanoparticles (LPNs) comprising an ionizable lipids, a phospholipid, a sterol, a PEG lipid and one or more nucleic acids and uses of the LNPs for immunogenic delivery of nucleic acid molecules, especially mRNA. The nanoparticles are disclosed to produce an immune response (abstract).
The mRNA molecules are mRNA molecules encoding antigen and/or disease specific proteins. The antigens include peptides and proteins (page 11, lines 35-37).
Regarding claim 2, as noted above, the LNP’s comprise ionizable lipids, a phospholipid, a sterol, and a PEG lipid.
Regarding claim 3, the phospholipid can be DOPE, DOPC, DMPC, DLPC, 18:0 Diether PC, OChemPC, C16 Lyso PC, ME 16.0 PE (Page 2, line 30 through page 3, line 12), for example.
Regarding claim 4, the sterol can be cholesterol, ergosterol, campesterol, oxysterol, antrosterol, desmosterol, nicasterol, sitosterol, and stigmasterol (page 2, lines 25-28).
Regarding claim 5, the PEG lipid can be PEG-modified phosphatidylethanolamine, a PEG-modified phosphatidic acid, a PEG-modified ceramide, a PEG-modified dialkylamine, (page 3, lines 18-21), for example.
Regarding claim 6, the LNP comprises:
about and between 10 mol% and 60 mol% of said ionizable lipid;
about and between 15 mol% and 50 mol% of said sterol;
about and between 0.5 mol% and 10 mol% of said PEG lipid; and/or
about and between 5 mol% and 40 mol% of said phospholipid (page 3, lines 23-27).
Regarding claim 10, the target specific antigen which can be a tumor antigen, or a bacterial, viral, or fungal antigen (page 12, lines 3-4).
Regarding claim 11, the LNPs have a particle size of about 140 nm (page 2, line 11).
Regarding claim 12, Bever discloses a pharmaceutical composition comprising one or more LNPs (page 12, lines 21-22). The pharmaceutical composition can be in the form of vaccines for intravenous administration (page 13, lines 8-15). The intravenous compositions comprises alcohol and aqueous solvents (page 13, lines 35-40).
Regarding claims 13-14, the pharmaceutical compositions and vaccines are for use in human and veterinary medicine (page 13, lines 16-17).
Regarding claim 15, since the prior art disclose administration of the composition or vaccine, therefore, it would necessarily contact the human cells.
Regarding claim 16, the vaccine is used to treat cancer or infectious diseases (column 14).
Regarding claim 18, as noted above, the composition can be a vaccine.
Regarding claim 19-20, while Bevers discloses the disease associated antigen in a tumor antigen (page 13, lines 3-4), the intended use of the vaccine recited in claim 18 is not given patentable weight.
Bevers does not disclose the ionizable cationic lipid compound of formula 1.
Harashima discloses in Example 6 lipid nanoparticles (LNPs) comprising compound CL4H6 were prepared (paragraph 0265) comprising a messenger RNA (siRNA is a preferable substance to be delivered by lipid compounds in addition to nucleic acids such as mRNA; paragraphs 0046, 0117) and an ionizable cationic lipid compound of structure, as shown (formula CL4H6, or 7-(4-(Disopropylamino)butyl)-7-hydroxytridecane-1,13-diyl dioleate (paragraph 0147, 0155-0156), meeting the limitation of structure 1 in the instant claims.
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It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to have used CL4H6 as taught by Harashima in the LNPs of Bevers since it is disclosed as a pH sensitive cationic lipid having a high level of biodegradability.
Response to Arguments
Applicant’s arguments with respect to the rejection(s) of claim(s) 1-19 under 35 USC 112 and 103 have been fully considered and are persuasive. Therefore, the rejections have been withdrawn. However, upon further consideration, a new ground(s) of rejection is made as discussed above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 MELISSA S MERCIER whose telephone number is (571)272-9039. The examiner can normally be reached M-F 6:30 am to 4 pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A Wax can be reached at 571-272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MELISSA S MERCIER/Primary Examiner, Art Unit 1615
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