DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The Office action mailed 8-26-25 is hereby withdrawn and a new Office action is set forth below.
This Office action is in response to the communication filed 5-17-23.
Claims 1-10, 12-18, 20, 21, and 23 are pending in the instant application.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-10, 12-18, 20, 21, and 23 is/are rejected under 35 U.S.C. 103 as being obvious over Chen et al (International J. Molecular Sciences, Vol. 17, 1463, pages 1-17 (2018)) in view of Ferreira et al (J. American Heart Association, Vol. 114.000968 (2014)) and Lee, J.S. (US 2019/0192432).
The claims are drawn to methods of delivering a polynucleotide to a cell comprising contacting the cell with the polynucleotide and perillyl alcohol (POH), which POH and polynucleotide are optionally in separate compositions or mixed prior to contacting the cell, which polynucleotide optionally comprises miR-18a, an siRNA or shRNA, and optionally further comprising an Argonaute-2 protein, which are optionally in separate compositions or mixed prior to contacting the cell.
Chen et al (International J. Molecular Sciences, Vol. 17, 1463, pages 1-17 (2018)) teach methods of treating brain cancer comprising the administration of perillyl alcohol (POH) and its drug conjugated derivatives. Chen also teaches the nasal delivery of chemotherapeutic agents and oligonucleotides, and the enhancement of intracranial therapeutic efficacy of existing pharmaceutical agents upon covalently linking the agents to POH (see entire document, esp. the abstract on page 1, Intranasal Drug Delivery on page 3, Intranasal Delivery of Cancer Drugs on page 5, bridging paragraph, pages 5-6, Intranasal Delivery of Perillyl Alcohol, pages 6-7, text on page 9 regarding covalent conjugation of POH to FDA approved drugs).
The primary reference does not teach the administration of miR-18a, siRNA or Ago 2).
Ferreira et al (J. American Heart Association, Vol. 114.000968, pages 1-13 (2014))(see IDS filed 12-8-22) teach the facilitation of miR-18a into brain cells by Argonaute-2 (Ago 2) for providing therapy (see esp. pages 1-2).
Lee, J.S. (US 2019/0192432) teaches the delivery of siRNA to brain cells for treating cancer (see esp. ¶¶ 0209, 0213, Example 4).
It would have been obvious to one of ordinary skill in the art to provide the compositions instantly claimed for delivery to brain cells because Brown teaches the routine use of perillyl alcohol in methods of delivery of therapeutic nucleic acids to target cells. One of ordinary skill would have been motivated to provide compositions further comprising siRNA for targeting aberrantly expressed polynucleotides, relying on the teachings of Lee and Chen. In addition, one would have been motivated and would reasonably expect compositions comprising Ago 2 to enhance the delivery and uptake of miR-18a into appropriate target cells, including brain cells, relying on the teachings of Ferreira. It would have been obvious to administer the components individually or in combination because this requires routine optimization, as illustrated in the teachings of Chen, Ferreira and Lee.
For these reasons, the instant invention would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention.
Conclusion
Certain papers related to this application may be submitted to Art Unit 1637 by facsimile transmission. The faxing of such papers must conform with the notices published in the Official Gazette, 1156 OG 61 (November 16, 1993) and 1157 OG 94 (December 28, 1993) (see 37 C.F.R. ' 1.6(d)). The official fax telephone number for the Group is 571-273-8300. NOTE: If Applicant does submit a paper by fax, the original signed copy should be retained by applicant or applicant's representative. NO DUPLICATE COPIES SHOULD BE SUBMITTED so as to avoid the processing of duplicate papers in the Office.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jane Zara whose telephone number is (571) 272-0765. The examiner’s office hours are generally Monday-Friday, 10:30am - 7pm. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Jennifer Dunston, can be reached on (571)-272-2916. Any inquiry of a general nature or relating to the status of this application should be directed to the Group receptionist whose telephone number is (703) 308-0196.
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Jane Zara
10-28-25
/JANE J ZARA/Primary Examiner, Art Unit 1637