Detailed Action
► The applicant's response (filed 17 FEB 026) to the Office Action has been entered. Following the entry of the claim amendment(s), Claim(s) 32-50 is/are pending. Rejections and/or objections not reiterated from the previous office action are hereby withdrawn. The following rejections and/or objections are either newly applied or reiterated. They constitute the complete set presently being applied to the instant application.
► The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
NSODP rejections
► Claims 32-41, 45-47, and 49-50 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 12,234,446 (hereinafter "the '446 patent") in view of Pokrovskaya et al. (1994, Analytical Biochemistry; hereinafter "Pokrovskaya") and Weide et al. (2008, Journal of Immunology; hereinafter "Weide") for the reason(s) of record.
► Claims 42-44 and 48 are rejected on the ground of nonstatutory double patenting, as allegedly being unpatentable over claims 1-15 of the '446 patent in view of Pokrovskaya and Weide and further in view of Melton and Krieg (1984, Nucleic Acids Research; hereinafter "Melton") for the reason(s) of record.
Response to applicant Response
► The applicant has traversed the double patenting rejection of at least Claim 32 over US -446’ arguing that Pokrovskaya “teaches away” because they teach a LiCl based method of extraction. In response the examiner notes that the MPEP at 2122 addresses ‘teaching away’ as a important concept in patent law related to obviousness rejections. A prior art reference is said to ‘teach away’ from the claimed invention if it criticizes, discredits, or otherwise discourages the solution claimed. Such, is not the case in the instant application.
An example of a “teaching away” constitutes a reference teaching that a certain method (e.g. using a specific material) will fail or is unsafe.
The applicant has also traversed the use of Weide, alone or in combination with Pokrovskaya, because these references fail to teach the required motivation to combine. In response the examiner points to motivation provided in the Non-final Office Action mailed 10 OCT 2025 : which reads. “The PHOSITA would have been motivated to make the modification recited above in order to produce a "large amount" pharmaceutical grade mRNA at scale”
As such, the ODP rejection has been reconsidered in light of applicant’s response, and is hereby maintained over US-446’ in view of with Pokrovskaya and Weide.
Conclusion
C1. THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 C.F.R. § 1.136(a).
A SHORTENED STATUTORY PERIOD FOR RESPONSE TO THIS FINAL ACTION IS SET TO EXPIRE THREE MONTHS FROM THE DATE OF THIS ACTION. IN THE EVENT A FIRST RESPONSE 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 EXTENSION FEE PURSUANT TO 37 C.F.R. § 1.136(a) WILL BE CALCULATED FROM THE MAILING DATE OF THE ADVISORY ACTION. IN NO EVENT WILL THE STATUTORY PERIOD FOR RESPONSE EXPIRE LATER THAN SIX MONTHS FROM THE DATE OF THIS FINAL ACTION.
C2. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ethan Whisenant whose telephone number is (571) 272-0754. The examiner can normally be reached Monday-Friday from 8:30 am -5:30 pm EST or any time via voice mail. If repeated attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Anne Gussow, can be reached at (571) 272-6047.
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/ETHAN C WHISENANT/Primary Examiner, Art Unit 1683 ethan.whisenant@uspto.gov