DETAILED ACTION
Election/Restrictions
Applicant’s election without traverse of Group I and formula II in the reply filed on September 17 2024 is acknowledged. Claims 1-2, 6, 8, 12-14, 18, 20-21, 26, 32-33, 36, 39, 41, 45-46 and 49-50 are pending in the application. While Applicants in response indicate that claims 6 reads on the elected species, this is not correct. Claim 6 is directed to formula III which is of a different scope than instantly elected formula II, i.e. none of X’-X””’ can be amine. Claim 8 is examined because although directed to formula IV, this reads on the elected species when R1 is amine. Claim 12 is directed to formula V which is of a different scope than instantly elected formula II, i.e. one of B’-F’ is required a nitrogen. Claims 6, 12-14, 18, 26, 32-33, 36, 39, 41, 45-46 and 49-50 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on September 17 2025. Accordingly, claims 1, 2, 8, 20 and 21 are being examined on the merits herein.
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 371 of PCT/US2020/036089 (06/04/2020) which claims benefit of 62/857,184 (06/04/2019) as reflected in the filing receipt issued on June 24 2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on May 11 2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency – Nucleotide and/or amino acid sequences appearing in the drawings are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). Sequence identifiers for nucleotide and/or amino acid sequences must appear either in the drawings or in the Brief Description of the Drawings.
Here, FIG 7A-7D include peptide sequences with 4 or more specifically defined and enumerated amino acid residues. However, neither the figure nor the brief description includes the correspond SEQ ID No.
Required response – Applicant must provide:
Replacement and annotated drawings in accordance with 37 CFR 1.121(d) inserting the required sequence identifiers;
AND/OR
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers into the Brief Description of the Drawings, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
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.
Claims 1, 2, 8, 20 and 21 are 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.
Claim 1 as currently written is vague and indefinite. Claim 1 recites a functional molecule comprising or consisting of a benzoic acid or benzoic acid derivative acylated to the 3’ nucleotide of a natural or engineered tRNA or tRNA-like molecule. The recitation “comprises or consisting of” creates uncertainty to the claim scope, specifically which is allowed to be included or is required to be excluded from the claim scope. The recitation consisting of excludes components not expressly recited but comprising has the exact opposite scope and can contain non-recited components. Since the claim encompasses derivatives, this recitation creates additional uncertainty as to what is excluded from the claim scope.
Claim 1 as currently written is vague and indefinite. The claim recites “tRNA-like molecule”. The claim recites a natural or engineered tRNA which are not indefinite but the recitation tRNA-like molecule creates uncertainty to the scope of the claim. The specification never defines the term tRNA-like molecule. Since the specification never discusses the term, it is unclear how “like” a tRNA a molecule is to be considered tRNA-like. Since the claim includes elements not actually disclosed (those encompassed by tRNA-like), thereby rendering the scope of the claim unascertainable. See MPEP § 2173.05.
Claims 2, 8, 20 and 21 are included in the rejection as they depend on a rejected base claim and they do not clarify the issues.
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, 2 and 8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Servillo et al. (Eur. J. Biochem, 1993).
Servillo et al. is directed to tRNA fluorescent at 3’ end inducing an aminoacyl-tRNA like behavior. It is taught that the 3’ terminus of tRNA can be directed modified (page 683, left column, second paragraph). Taught is introduction of an anthraniloyl group at the 3’-O position of the ultimate adenosine (page 583, right column first complete paragraph). The structure is shown in Fig. 7 and illustrated below, wherein A corresponds to adenosine:
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. This structure corresponds to the instantly claimed formula II/IV where A’ is a substituted aryl group wherein the substituent is an amine (NH2) also reading on R1.
Thus, Servillo et al. exemplify a functionalized tRNA with the same claimed functionalization at the 3’ position of the tRNA anticipating claims 1, 2 and 8.
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 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.
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.
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, 2, 8 and 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Servillo et al. (Eur. J. Biochem, 1993) as applied to claims 1, 2 and 8 above and in view of Ibba et al (Genes Dev., 2004).
Applicant Claims
The instant application claims the tRNA is an imitator tRNA or an elongator tRNA.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
The teachings of Servillo et al. are set forth above. The modified tRNA is taught as behaving as an aminoacyl-tRNA (page 583, right column, first complete paragraph).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.02)
While Servillo et al. teaches a modified tRNA, Servillo et al. does not expressly teach the tRNA is an initiator tRNA or an elongator tRNA. However, this deficiency is cured by Ibba et al.
Ibba et al. is directed to aminoacyl-tRNAs. Aminoacyl-tRNAs (aa-tRNAs) typically found in the cell can be divided into three main types. The largest group comprises correct pairing of an amino acid and the corresponding tRNA and they serve as substrates for ribosomal translation. The elongator tRNAs are by far the most common. Other translation substrates taught include imitator tRNAs (see table 1) (pages 731, left column and page 732).
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the modification taught in Servillo et al. with either an initiator tRNA or an elongator tRNA. Servillo et al. expressly teaches the modification on a tRNA and that this has aminoacyl-tRNA behavior. As taught by Ibba et al. aminoacyl-tRNAs typically found in the cell can be elongator or initiator tRNAs. Since the tRNA in Servillo et al. is taught as possess aminoacyl-tRNA behavior, one skilled in the art would have a reasonable expectation of success in using the modification with typical aminoacyl-tRNA such as initiator or elongator tRNA.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Acharya et al. (JCS Perkin Trans, 1999) and Narwot et al. (Nucleic acids research, 1997) both teach 3’-O-anthraniloyladenosine analogs.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ABIGAIL VANHORN whose telephone number is (571)270-3502. The examiner can normally be reached M-Th 6 am-4 pm EST.
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/ABIGAIL VANHORN/ Primary Examiner, Art Unit 1636