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 .
DETAILED ACTION
Pursuant to the preliminary amendment dated 2/26/2024, claims 16 and 19 are amended. No claims are newly added or canceled.
Claims 1-20 are pending in the instant application and are examined on the merits herein.
Priority
This application is a National Stage Application of PCT/CN2022/113813, filed on 8/22/2022. The instant application claims foreign priority to CN 202110995875.X filed on 8/27/2021. Acknowledgment is made of applicant's claim for foreign priority under 35 U.S.C. 119(a)-(d). The certified copy has been filed in the instant application on 2/26/2024.
Information Disclosure Statement
The information disclosure statements (IDS) dated 2/26/2024, 6/12/2024 and 3/4/2026 comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609, except where noted. Accordingly, the IDS documents have been placed in the application file and the information therein has been considered as to the merits.
Claim Rejections - 35 USC § 112(b)
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.
Claims 1-20 are rejected for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
The use of parenthetical statements renders the claim indefinite. Specifically, the statement, “(when R₅ is substituted or unsubstituted C2-20 alkyl)” is indefinite because it is unclear whether the limitation(s) within the parentheses are part of the claimed invention or meant as options or examples. See MPEP § 2173.05(d). For examination purposes, the broadest claim limitation(s) will be considered without taking into account preferences or examples.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 13-15 are rejected under 35 U.S.C. 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Base claim 1 requires than when R1 forms a bridged ring with the ribose that the connections are as follows “O taken together with carbon atoms at 3' position and 5' position form a bridged ring” (emphasis added), which can be depicted as shown below:
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In contrast, the structures of claim 13 depict the bridged ring systems as shown below, where in both cases the ring is formed between the 2’O and the 4’ carbon, neither the 3’ nor the 5’ carbons are involved in forming the ring system, and even if either the 3’ or the 5’ carbon was involved in forming the ring neither structure shows both the 3’ and the 5’ carbons simultaneously involved in the ring system:
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153
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or
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Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jooss et al. (WO 2021/216776A2, filed 3/21/2021, PTO-892).
Jooss et al. discloses a trinucleotide cap with the following formula: (Claim 1)
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Jooss further specifies that R3 is -OCH2CH2OCH3 (a.k.a. MOE) and that the nucleoside may be adenine, N6-methylated adenine or uracil. (Claims 2-4) Jooss also discloses that the cap of formula (I) may be a component in a pharmaceutical composition with pharmaceutically acceptable carriers, such as lipid nanoparticles. (¶0125-0127; Claim 58) Jooss discloses a method for preparing an RNA polynucleotide by providing a DNA template then contacting the DNA template with an RNA polymerase (e.g. bacteriophage polymerase) and the cap of formula (I), where the RNA polynucleotide produced by the in vivo transcription reaction contains a 3’ UTR, an open reading frame (ORF) with conserved sequence elements (CSE) and a 5’ UTR. (¶00144, 00216-00219; Claim 132, 143, 155)
Accordingly, the instant claims are anticipated by the prior art.
Claims 1-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Warminski et al. (US 2023/0295215A1, filed 2/12/2021, PTO-892).
Warminski et al. discloses a trinucleotide cap with the following formula: (Claim 1)
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Warminski exemplifies the following compounds: (Claim 2)
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With respect to instant substituent R3, the functional group OCH3 at position R1 of Warminski meets the claimed limitation where R3=R5-R6 and R5 is a substituted C1 alkyl and R6=H. As per the 112b rejection above, the proviso within the parentheses, as part of the definition of R6, is not considered limiting and the claim is interpreted in the broadest reasonable manner, to include R3=OCH3.
Accordingly, the instant claims are anticipated by the prior art.
Claims 13 and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Senthilvelan et al. (Org. Lett., May 2021, IDS).
Senthilvelan et al. discloses a trinucleotide cap with the following formula: (Abstract)
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, which meets the instant limitations where R2=OH; E=1; F=0; Y1=Y2=X1=X2=O; B1=adenine. B2=guanine, R3=O-CH2-H and R4=OH. Particularly with respect to R3, the functional group OCH3 meets the claimed limitation where R5 is a substituted C1 alkyl and R6=H, as per the 112b rejection above, the proviso within the parentheses, as part of the definition of R6, is not considered limiting and the claim is interpreted in the broadest reasonable manner, to include R3=OCH3.
Accordingly, the instant claims are anticipated by the prior art.
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 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 of this title, 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 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.
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 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 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Jooss et al. (WO 2021/216776A2, filed 3/21/2021, PTO-892), in view of Westaway et al. (US 6,893,866B1, 2005, PTO-892).
The disclosure of Jooss et al. is referenced as discussed above. Jooss does not disclose a 5’ UTR comprising a Kozak sequence.
Westaway et al. discloses that optimal flavivirus replicon design for transfection into eukaryotic cells might also include sequences inserted into the replicon…such as the Kozak consensus sequence; internal ribosomal entry site (IRES) of picornaviruses; an alphavirus subgenomic 26S promoter to enhance expression of inserted genes if co-transfection with alphavirus replicon RNA is used (Col. 7, Ln 60)… To optimize expression of the flavivirus structural genes, the second vector might include such sequences as: sequences to promote expression of the genes of interest, including appropriate transcription initiation, termination, and enhancer sequences: as well as sequences that enhance translation efficiency, such as the Kozak consensus sequence. (Col. 9, Ln. 48)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of preparing an RNA polynucleotide encoding an alphavirus antigen of Joss, to include a Kozak sequence as part of the 5’UTR, thereby arriving at the instant invention. One would be motivated to modify Jooss in this way because Westaway teaches that optimal replicon design may include a Kozak consensus sequence, to enhance translation efficiency.
Accordingly, the instant claims are prima facie obvious over the teachings of the prior art.
Claim 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over Warminski et al. (US 2023/0295215A1, filed 2/12/2021, PTO-892).
The disclosure of Warminski et al. is referenced as discussed above. Warminski does not exemplify or claim that R1 may be other than OCH3.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the R1=OCH3 group of Warminski with any O-alkyl group, such as OEt or OPr or OBu, thereby arriving at the instant invention. One would be motivated to substitute the R1 groups of Warminski in this manner because Warminski teaches that R1 may be H, CH3 or alkyl.
Accordingly, the instant claims are prima facie obvious over the teachings of the prior art.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Senthilvelan et al. (Org. Lett., May 2021, IDS).
The disclosure of Senthilvelan et al. is referenced as discussed above. Senthilvelan does not teach that R3 may be OCH2CH3.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the R3=OCH3 group of Senthilvelan with a group where R3=O(CH2)nCH3, where n=1-3, thereby arriving at the instant limitation that R3-OCH2CH3. The rationale to support a case of prima facie obviousness is that compounds which are homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). See also MPEP § 2144.09.
Accordingly, the instant claims are prima facie obvious over the teachings of the prior art.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DALE R MILLER whose telephone number is (571) 272-6146. The examiner can normally be reached on M-F 7:00 AM – 3:30 PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Scarlett Goon can be reached on (571) 270-5341. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DALE R MILLER/Primary Examiner, Art Unit 1693
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