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
This Non-Final Office Action is responsive to the communication received 11/07/2025.
Election/Restrictions
Applicant’s election without traverse in the Reply filed on 11/07/2025 of Group I. Claim(s) 28-35 is acknowledged.
Applicant has elected in the Reply filed on 11/07/2025 the following species:
A. the cyclic peptide is the F3 cyclic peptide
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B. the cAA is (1S,2S)-2-ACHC
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Because applicant did not distinctly and specifically point out the supposed errors in the species election requirement, the election has been treated as an election without traverse (MPEP § 818.03(a)).
The Restriction/Election Requirements are thus deemed proper and are made FINAL.
Claims 28-47 are pending.
Claims 36-47 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the Reply filed on 11/07/2025.
Claims 28-35 are under examination in this Office Action.
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 28 and 30-31 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Katoh et al. (2018) Journal of the American Chemical Society volume 140 pages 12159 to 12167 cited in the 5/9/2024 IDS (hereinafter known as "Katoh").
With regards to claims 28 and 30-31, Katoh teaches:
a) as in claims 28 and 30-31, a method of producing a library including two or more cyclic peptides, wherein at least one of the cyclic peptides included in the library has a cyclic structure having 4 to 30 amino acids or derivatives thereof and comprises, in the cyclic structure, at least one selected from cyclic β-, γ-, and δ-amino acids (cAAs), comprising: preparing an mRNA library encoding a peptide comprising a sequence represented by formula (1):
—(Xaa).sub.n1-
(1) wherein each Xaa is independently an arbitrary amino acid or derivative thereof, at least one Xaa is a cyclic β-, γ-, or δ-amino acid (cAA), and n1 is an integer of 2 to 28; and using the mRNA library to express the peptide in a cell-free translation system and produce the library; wherein the cell-free translation system comprises a tRNA charged with an amino acid residue selected from cyclic β-, γ-, and δ-amino acids (cAAs) and the tRNA is a tRNA having a D-arm structure interactive with EF-P or a tRNA not having a D-arm structure interactive with EF-P; wherein the cell-free translation system comprises a tRNA charged with an amino acid residue one selected from cyclic β-, γ-, and δ-amino acids (cAAs) and the tRNA is at least one selected from tRNA.sup.Pro1E2 and tRNA.sup.GluE2 (see whole document especially Figures 1 and 5).
Thus, Katoh anticipates the present claims.
Claim Rejections - 35 USC § 103(a)
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived 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(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.
5. Secondary considerations (objective evidence of nonobviousness): a) commercial success; b) long felt need; c) evidence of unexpected results; d) skepticism of experts; and e) copying.
Common Ownership of Claimed Invention Presumed
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).
Claim 29 rejected under 35 U.S.C. 103(a) as being unpatentable over Katoh et al. (2018) Journal of the American Chemical Society volume 140 pages 12159 to 12167 cited in the 5/9/2024 IDS (hereinafter known as "Katoh") in view of Richardson et al. (08/02/2018) Current Opinion in Chemical Biology volume 46 pages 172 to 179 cited in the 5/9/2024 IDS (hereinafter referred to as "Richardson").
With regards to claim 29, Katoh teaches:
a) as in claim 29, a method of producing a library including two or more cyclic peptides, wherein at least one of the cyclic peptides included in the library has a cyclic structure having 4 to 30 amino acids or derivatives thereof and comprises, in the cyclic structure, at least one selected from cyclic β-, γ-, and δ-amino acids (cAAs), comprising: preparing an mRNA library encoding a peptide comprising a sequence represented by formula (1):
—(Xaa).sub.n1-
(1) wherein each Xaa is independently an arbitrary amino acid or derivative thereof, at least one Xaa is a cyclic β-, γ-, or δ-amino acid (cAA), and n1 is an integer of 2 to 28 (see whole document especially Figures 1 and 5).
Ryo does not explicitly teach:
a) as in claim 29, binding puromycin to the 3′ end of each of the mRNAs of the mRNA library to produce a puromycin-bound mRNA library; and using the puromycin-bound mRNA library to express the peptide in a cell-free translation system and produce a peptide-mRNA complex library.
With regards to claim 29, Richardson teaches:
a) as in claim 29, binding puromycin to the 3′ end of each of the mRNAs of the mRNA library to produce a puromycin-bound mRNA library; and using the puromycin-bound mRNA library to express the peptide in a cell-free translation system and produce a peptide-mRNA complex library (see whole document especially Figures 2 to 4).
One of ordinary skill in the art before the time of the effective filing date of the claimed invention would have had a reasonable expectation of success in arriving at the Applicant's invention as claimed with the above cited references before them. One of ordinary skill in the art before the time of the effective filing date of the claimed invention would have recognized the advantages of substituting Richardson's puromycin labelled mRNA libraries with Katoh's mRNA libraries to screen puromycin labelled mRNA libraries for macrocyclic peptide ligands to identify ligands useful as therapeutics. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the time of the effective filing date of the claimed invention.
Allowable Subject Matter
Claims 32-35 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Christian Boesen whose telephone number is 571-270-1321. The Examiner can normally be reached on Monday-Friday 9:00 AM to 5:00 PM.
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/CHRISTIAN C BOESEN/Primary Examiner, Art Unit 1684