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 .
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.
DETAILED ACTION
Claims 1, 2, 5, 7, 9, 15, 19, 20, 22-25, 30, 31, 33, 35, 36, 38, and 39 are pending, claims 3, 4, 6, 8, 10-14, 16-18, 21, 26-29, 32, 34, and 37 are canceled in this application. This application is a national stage entry of PCT/IB2022/059527, filled on 10/06/2022, which claims foreign priority to AU 2021903192, filed on 10/06/2021 in Australia.
Election/Restrictions
Applicant's election with traverse of Group I, claims 1, 2, 5, 7, 9, 15, 19, 20, 22-25, 30, 31, 33, 35, and 36, and subsequent species election of lipidated RNA-binding protein or peptide ((ii) in claim 1, (iii) in claim 2, (ii) in claim 5, claim 7) with phospholipid being the lipid moiety ((b) in claim 7 and (i) in claim 9) linked by a thioester bond (claim 15) to a cysteine residue as a nucleophilic side chain at the N-terminal end (of the protein or peptide) ((c) in claim 7 and (ii) in claim 9) and the protein or peptide binding directly to the RNA (not encapsulating) (claim 20) which is a conventional RNA (cRNA) (claims 35 and 36) (and the protein or peptide being a non-structural protein from an influenza B virus (claim 24 and (d) in claim 25) in the reply filed on 06/25/2026, is acknowledge.
The traversal is on the ground(s) that there will not be serious burden without restriction. This is not found persuasive because as stated in the Restriction Requirement mailed on 04/01/2026 that the special technical feature in all groups cannot be a special technical feature under PCT Rule 13.2 because the special technical feature is shown in prior art US 2021/0009503 A1. Therefore, Unity of Invention is lacking and restriction is deemed proper. Search burden being undue is a moot argument for lack of unity issue.
The requirement is still deemed proper and is therefore made FINAL.
Claims 30, 31, 38, and 39 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected invention, there being no allowable generic or linking claim.
Claims 1, 2, 5, 7, 9, 15, 19, 20, 22-25, 33, 35, and 36 will presently be examined to the extent they read on the elected subject matter of record.
Priority
Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file.
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.
Claims 1, 20, 22, 33, and 35 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by DeRosa et al. (US 2021/0009503 A1).
DeRosa et al. meet all of the limitations of claims 1, 20, 22, 33, and 35. DeRosa et al. disclose lipid nanoparticles (the instant claim 1) compounds as liposomal delivery vehicles to facilitate the delivery of encapsulated polynucleotides to target cells (abstract and paragraph 31) with reduced in vivo toxicity of a liposomal composition (the instant claim 22) (paragraph 31) comprising
one or more formulation reagents including protein that bind directly to RNA (polynucleotide) (the instant claims 1 and 20) (paragraph 90 and 129);
wherein the RNA including mRNA (the instant claim 35) (paragraph 129); and
wherein lipids include a PEG-modified lipid (the instant claim 33) (paragraph 31) and phospholipid (the instant claim 1) (paragraph 34).
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.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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.
Claims 1, 20, 22, 33, 35, and 36 are rejected under 35 U.S.C. 103(a) as being unpatentable over DeRosa et al. (US 2021/0009503 A1).
The teachings of DeRosa et al. are discussed above and applied in the same manner. There are 2 types of mRNA which are conventional (non-amplifying) mRNA (cRNA) and Self-amplifying mRNA (sa-mRNA). DeRosa et al. do not exclude cRNA; thus, mRNA taught by DeRosa et al. would include cRNA (the instant claim 36).
Claims 1, 2, 5, 19, 20, 22, 33, and 35 are rejected under 35 U.S.C. 103(a) as being unpatentable over DeRosa et al. (US 2021/0009503 A1) in view of Papahadjopoulos et al. (US 2006/0147513 A1).
The teachings of DeRosa et al. are discussed above and applied in the same manner.
The limitation in the instant claim 19 is a product-by-process limitation.
DeRosa et al. do not specify the RNA-binding protein being lapidated with phospholipid in claims 2 and 5
This deficiency is cured by Papahadjopoulos et al. who teach liposomes with protein attached to its lipid surface (paragraph 8 and 9); wherein the lipid includes phospholipid (paragraph 33).
It would have been prima facie obvious before the effective filing date of the claimed invention to a person of ordinary skill in the art to combine the teachings in DeRosa et al. and Papahadjopoulos et al. to specify the RNA-binding protein taught by DeRosa et al. being lapidated with phospholipid. Liposomes with protein being attached to the phospholipid surface was well known to a person of ordinary skill in the art before the effective filing date of the claimed invention. The motivation for specifying it flows from its having been used in the prior art, and from its being recognized in the prior art as useful for the same purpose.
Claims 1, 2, 5, 7, 9, 15, 19, 20, 22, 24, 25, 33, 35, and 36 are rejected under 35 U.S.C. 103(a) as being unpatentable over DeRosa et al. (US 2021/0009503 A1) in view of Papahadjopoulos et al. (US 2006/0147513 A1) and Dauber et al. (The Influenza B Virus Nonstructural NS1 Protein Is Essential for Efficient Viral Growth and Antagonizes Beta Interferon Induction, Journal of Virology, Feb. 2004, p. 1865–1872).
The teachings of DeRosa et al. and Papahadjopoulos et al. are discussed above and applied in the same manner.
DeRosa et al. do not specify non-structural protein influenza B virus in claims 24 and 25 on cysteine residue in claims 7 and 9 with a thioester bond in claim 15.
This deficiency is cured by Dauber et al. who teach influenza B virus nonstructural protein termed NS1-B having the ability to bind to RNA targets (abstract and the 1st full paragraph in the left column on page 1866).
It would have been prima facie obvious before the effective filing date of the claimed invention to a person of ordinary skill in the art to combine the teachings in DeRosa et al. and Dauber et al. to specify the RNA binding protein in the composition taught by DeRosa et al. being influenza B virus nonstructural protein. Influenza B virus nonstructural protein having the ability to bind to RNA targets was well known to a person of ordinary skill in the art before the effective filing date of the claimed invention. The motivation for specifying it flows from its having been used in the prior art, and from its being recognized in the prior art as useful for the same purpose.
With the protein taught by DeRosa et al. reacted with lipid in view of Papahadjopoulos et al. and the protein taught by DeRosa et al. being non-structural protein influenza B virus in view of Dauber et al., the knowledge of influenza B virus nonstructural protein having cysteine residue within the N-terminal RNA-binding domain and thioester bond formed between cysteine and fatty acid of a lipid (S-palmitoylation); protein taught by DeRosa et al. being influenza B virus nonstructural reacted with fatty acid of a lipid in view of Papahadjopoulos et al. and Dauber et al. would necessarily have thioester bond between the fatty acid of the lipid and the cysteine residue of the protein.
Claims 1, 2, 5, 19, 20, 22, 23, 33, 35, and 36 are rejected under 35 U.S.C. 103(a) as being unpatentable over DeRosa et al. (US 2021/0009503 A1) in view of Papahadjopoulos et al. (US 2006/0147513 A1) and Lee et al. (US 2020/0128802 A1).
The teachings of DeRosa et al. and Papahadjopoulos et al. are discussed above and applied in the same manner.
DeRosa et al. do not specify the protein or peptide being “modified to remove nuclear localisation signal(s) and/or introduce nuclear export signal(s)” in the instant claim 23. DeRosa et al. teach enhancing residence time in the cytoplasm of a target cell being desirable (paragraph 129).
This deficiency is cured by Lee et al. who teach removing a nuclear localization signal (NLS) for Cas9 (a protein) to be present in the cytoplasm (paragraph 45).
It would have been prima facie obvious before the effective filing date of the claimed invention to a person of ordinary skill in the art to combine the teachings in DeRosa et al. and Lee et al. to remove a nuclear localization signal (NLS) from the RNA binding protein taught by DeRosa et al. Removing a nuclear localization signal (NLS) for Cas9 to be present in the cytoplasm was well known to a person of ordinary skill in the art before the effective filing date of the claimed invention. The motivation for specifying it flows from its having been used in the prior art, and from its being recognized in the prior art as useful for the same purpose.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HONG YU whose telephone number is (571)270-1328. The examiner can normally be reached on 9 am - 5:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached on 571-272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HONG YU/
Primary Examiner, Art Unit 1614
