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 office action is a response to applicant’s communication submitted November 7, 2025, wherein claims 1 and 11 are amended, claims 2-10 are amended, and new claims 27 and 28 are introduced. This application is a national stage application of PCT/US2021, filed February 15, 2021, which claims benefit of provisional applications 63/001165, filed March 27, 2020, and 62/976672, filed February 14, 2020.
Claims 1, 11-18, and 25-28 are pending in this application.
Claims 12-18, 25, and 26 are withdrawn from consideration for being drawn to non-elected subject matter.
Claims 1, 11, 27, and 28 as amended are examined on the merits herein.
Withdrawn Rejections
Applicant’s amendment, submitted November 7, 2025, with respect to the rejection of claims 1-8 under 35 USC 112(b) for failing to define the symbol *, has been fully considered and found to be persuasive to remove the rejection as the claims have been amended to define * as a point of attachment. Therefore the rejection is withdrawn.
Applicant’s amendment, submitted November 7, 2025, with respect to the rejection of claim 9 under 35 USC 112(d) for failing to further limit the scope of base claim 1, has been fully considered and found to be persuasive to remove the rejection as claim 9 has been canceled. Therefore the rejection is withdrawn.
Applicant’s amendment, submitted November 7, 2025, with respect to the rejection of claims 1, 9, and 10 under 35 USC 102(a)(1) for being anticipated by Suga et al., has been fully considered and found to be persuasive to remove the rejection as claim 1 has been amended to specifically require a narrow definition of R1 and R2 not including the amino acids described by Suga et al., and claims 9 and 10 are canceled. Therefore the rejection is withdrawn.
Applicant’s amendment, submitted November 7, 2025, with respect to the rejection of claims 1, 9, and 10 under 35 USC 102(a)(1) for being anticipated by Bain et al., has been fully considered and found to be persuasive to remove the rejection as claim 1 has been amended to specifically require a narrow definition of R1 and R2 not including the amino acids described by Bain et al., and claims 9 and 10 are canceled. Therefore the rejection is withdrawn.
Applicant’s amendment, submitted November 7, 2025, with respect to the rejection of claims 1, 3, and 8-10 under 35 USC 102(a)(1) for being anticipated by Dedkova et al., has been fully considered and found to be persuasive to remove the rejection as claim 1 has been amended to specifically require a narrow definition of R1 and R2 not including the amino acids described by Dedkova et al., and claims 3 and 8-10 have been canceled Therefore the rejection is withdrawn.
Applicant’s amendment, submitted November 7, 2025, with respect to the rejection of claims 2 and 7 under 35 USC 103 for being obvious over Suga et al. in view of Harker et al., has been fully considered and found to be persuasive to remove the rejection as claims 2 and 7 have been canceled. Therefore the rejection is withdrawn.
Applicant’s amendment, submitted November 7, 2025, with respect to the rejection of claims 2-5, 7, and 8 under 35 USC 103 for being obvious over Suga et al. in view of Surolia et al., has been fully considered and found to be persuasive to remove the rejection as claims 2-5 and 7-8 have been canceled. Therefore the rejection is withdrawn.
Applicant’s arguments, submitted November 7, 2025, with respect to the rejection of claims 1 and 9-11 under 3 5 USC 102(a)(1) for being anticipated by Lee et al., have been fully considered and found to be persuasive to remove the rejection as Applicant has demonstrated that the effective filing date of the present claims is prior to the publication of Lee et al. Therefore the rejection is withdrawn.
The following rejections of record in the previous action are maintained:
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.
Claims 1, 11, 27, and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Suga et al. (US pre-grant publication 2011/0275119, of record in previous action)in view of Cabrele et al. (NPL Reference 2 included with 9/5/2024 PTO-1449)
Suga et al. discloses a method of synthesizing a polypeptide comprising using an ARS ribozyme to acylate tRNA with an amino acid, including nonnatural amino acids such as beta-amino acids, gamma- amino acids, and delta- amino acids, among various other amino acids. (p. 2 paragraph 22, p. 4 paragraph 72, also figure 3)
Suga et al. does not disclose an aminoacyl tRNA wherein the amino acid is a cyclic amino acid as recited in claim 1 as amended. However, Cabrele et al. discloses construction of peptides containing beta amino acid building blocks. (p. 9718 left column first paragraph) Specific beta amino acids discussed as being incorporated into peptides include cyclic amino acids falling within claims 1, 11, 27, and 28 as amended. (p. 9719 figure 1B)
It would therefore have been obvious to one of ordinary skill in the art at the time of the invention to use the method of Suga et al. to make acylated tRNAs bearing any of the beta-amino acids described by Cabrele et al. One of ordinary skill in the art would have seen the disclosure of Cabrele et al. as suggesting that producing peptides containing these amino acids is useful, and would have seen the disclosure of Suga et al. as demonstrating generally that a variety of beta-amino acids could be attached to tRNAs in order to be incorporated into peptides.
Therefore the invention taken as a whole is prima facie obvious.
Claims 1, 11, 27, and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Suga et al. (US pre-grant publication 2011/0275119, of record in previous action)in view of Torres et al. (Reference included with PTO-892)
Suga et al. discloses a method of synthesizing a polypeptide comprising using an ARS ribozyme to acylate tRNA with an amino acid, including nonnatural amino acids such as beta-amino acids, gamma- amino acids, and delta- amino acids, among various other amino acids. (p. 2 paragraph 22, p. 4 paragraph 72, also figure 3)
Suga et al. does not disclose an aminoacyl tRNA wherein the amino acid is a cyclic amino acid as recited in claim 1 as amended. However, Torres et al. discloses that inclusion of unusual beta-amino acids into peptides is useful. (p. 16569 left column first paragraph – right column second paragraph) Thee include cyclobutene peptides having amino acids as recited in present claim 11, (p. 5670 chart 1) as well as beta amino acids having a cyclobutyl in the side chain as recited in claim 6. (p. 5670 scheme 1)
It would therefore have been obvious to one of ordinary skill in the art at the time of the invention to use the method of Suga et al. to make acylated tRNAs bearing any of the cyclobutene acids described by Torres et al. One of ordinary skill in the art would have seen the disclosure of Torres et al. as suggesting that producing peptides containing these amino acids is useful, and would have seen the disclosure of Suga et al. as demonstrating generally that a variety of beta-amino acids could be attached to tRNAs in order to be incorporated into peptides.
Therefore the invention taken as a whole is prima facie obvious.
Response to Arguments
Applicant’s arguments, submitted November 7, 2025, with respect to the above grounds of rejection, have been fully considered and not found to be persuasive to remove the rejections, With respect to Torres et al., Applicant argues that Torres et al. only broadly discloses beta-amino acids and fails to disclose the cyclic amino acid structures of claim 1. However, Torres et al. dies specifically disclose cyclobutyl beta peptides, for example in chart 1 on p. 5670. Therefore Torres et al. does in fact suggest constructing peptides out of cyclobutyl beta-amino acids falling within the scope of the present claims and can be relied upon as a secondary reference.
Furthermore with respect to both Torres et al. and Cabrele et al., Applicant argues that these references only teach peptides containing the recited amino acids, and do not suggest modification of tRNA molecules, such as aminoacylation as disclosed in the present claims. However, there is no need for these secondary references to directly teach aminoacylated tRNAs. The primary reference Suga et al. already discloses that peptides containing unnatural amino acids, such as beta amino acids, can be synthesized by in vitro translation using ribozymes and aminoacylated tRNAs. This is already sufficient motivation to suggest to one of ordinary skill in the art that any particular peptide containing beta-amino acids could be produced by such a method of in vitro translation using an appropriate aminoacylated tRNA. Thus Suga et al. is seen as providing this element of the claimed invention, rendering the claims obvious.
For these reasons the rejection are deemed proper and maintained.
Conclusion
No claims are allowed in this action. THIS ACTION IS MADE FINAL. 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 ANDREA OLSON whose telephone number is (571)272-9051. The examiner can normally be reached M-F 6am-3:00pm.
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, Scarlett Y Goon can be reached at 571-270-5241. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ANDREA OLSON/ Primary Examiner, Art Unit 1693 1/12/2026