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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on May 15, 2026 has been entered.
Detailed Action
This office action is a response to applicant’s communication submitted May 15, 2026 wherein new claims 29-32 are introduced. This application is a national stage application of PCT/US2021/018134, 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 25-32 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Claims 12-18, 25, and 26 are withdrawn from consideration for being drawn to non-elected subject matter.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, and 27-32 as amended are examined on the merits herein.
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, 28, and 31 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, 28, and 31 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 of record in previous action)
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 May 15, 2026, with respect to the above grounds of rejection, have been fully considered and not found to be persuasive to remove the rejection. Applicant argues that one of ordinary skill in the art at the time of the invention would not have looked to Torres or Cabrele to improve the process of Suga because they are not directed to the preparation of tRNA molecules. However, while these secondary references do not specifically describe aminoacyl-tRNA esters of these cycloalkyl amino acids, they do describe incorporating these amino acids into polypeptides. Therefore because Suga already describes forming aminoacyl-tRNA esters as part of a process of incorporating a wide variety of nonstandard amino acids into polypeptides, any reference to incorporation of a nonnatural amino acid into a polypeptide in the prior art would be seen as suggesting making an aminoacyl-tRNA of that amino acid in order to incorporate it by Suga’s process.
Therefore the rejections are deemed proper and maintained.
The following new grounds of rejection are introduced:
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 and 30 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 Estevez 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, Estevez et al. discloses that cyclopentane beta-amino acids are attractive candidates for the stabilization of bioactive peptides. (p. 583 left column first paragraph) Estevez et al. further discloses polyhydroxylated cyclopentane beta-amino acids, which would meet the definition of a 5-membered carbocycle substituted with one or more hydroxyl substituents as recited in present claims 1 and 30. (p. 583 scheme 1) One of these beta-amino acids is incorporated into a tripeptide. (p. 586 scheme 6_
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 substituted cyclopentane amino acids described by Estevez et al. One of ordinary skill in the art would have seen the disclosure of Estevez 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.
Conclusion
Claims 1, 11, 27, 28, 30, and 31 are rejected. Claims 29 and 32 are objected to for depending from a rejected base claim but would be allowable if rewritten in independent form incorporating all the limitations of the rejected base claim and any intervening claims.
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.
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/ANDREA OLSON/Primary Examiner, Art Unit 1693 5/21/2026
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