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
Status of Application/Amendment/Claims
Applicant's response filed 05/14/2026 has been considered. The rejections of record have been withdrawn in response to Applicant’s Rule 1.132 Declaration from Dr. Hari Bhaskaran which has been acknowledged.
Claims 1-7 and 10-25 are free off the prior art.
Claims 1-7, 10-15 and 17-25 are on condition for allowance.
Claim 16 is rejected.
Drawings
Figure 3(a) of the Drawings filed 11/30/2022 has colored arrows. Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted.
Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via EFS-Web or three sets of color drawings or color photographs, as appropriate, if not submitted via EFS-Web, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
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.
Claim 16 is 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 pre-AIA the applicant regards as the invention.
Claim 16 recites “The method of claim 4, wherein the linker sequence…”. The claims is indefinite because it lacks antecedent basis as claim 4 does not recite a linker sequence.
This claim appears to depend from claim 15 which recites a linker sequence and therefore will be interpreted as such.
Reasons for claims being free of the prior art
The claims were rejected under 112(a) lack of enablement for being broadly drawn to using any type of adapter and any ribozyme sequence in methods of purification of mRNA.
The previously cited prior art of Baiersdörfer, Markus, et al. ("A facile method for the removal of dsRNA contaminant from in vitro-transcribed mRNA." Molecular therapy Nucleic acids 15 (2019): 26-35 of record on 892 mailed 07/16/2025) and Lee et al. (Structural and biochemical properties of novel self-cleaving ribozymes. Molecules 22.4 (2017)) does not provide methods of mRNA purification by using a mRNA-ribozyme-adapter and magnesium or any other type of divalent ion that allows folding of the ribozyme, wherein the ribozyme is a substrate-dependent ribozyme
Applicant summited a Rule 1.132 Declaration from Dr. Hari Bhaskaran that provides experimental data which supports the enablement of the presently claimed method.
The Declaration demonstrates that six different mRNA-ribozyme-adapter nucleic acid constructs were expressed and the resulting mRNA-ribozyme-adapter RNA precursors were successfully processed using the presently claimed method to release target mRNAs encoding for six different protein. Applicant submits the claimed method resulted in greater purity and quality of the target mRNA when compared to standard oligo dT purification methods.
The Declaration further provides evidence to demonstrate that mRNA-ribozyme-adapter nucleic acid constructs containing DNA sequences for two different adapter RNAs, poly(CA) and poly(UA), were successfully expressed, and the resulting mRNA-ribozyme-adapter RNA precursors successfully bound to their complementary poly(GT) or poly(AT) DNA oligonucleotides bound to a column, leading to the successful processing of the bound RNA-ribozyme-adapter RNA precursors using the presently claimed.
The data presented in the Declaration provides an enabling disclosure and supports the breath of the structural and functional diversity recited in the claims and establishes that one of ordinary skill in the art could practice the full scope of the claims and the prior art does not teach or make obvious the claimed method.
Conclusion
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/KIMBERLY CHONG/Primary Examiner, Art Unit 1636
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