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 .
This Office action is in response to the communication filed 4-30-26.
Claims 1-10, 12-18, 20, 21, and 23 are pending in the instant application.
Response to Arguments and Amendments
Withdrawn Objections/Rejections
Any objections or rejections not repeated in this Office action are hereby withdrawn.
Applicant’s arguments, filed 4-30-26, with respect to the rejection(s) of claim(s) 3 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn as to claim 3.
Maintained Rejections
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, 2, 4-10, 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) as set forth in the Office action mailed 10-30-25, and as set forth below.
Applicant’s Arguments
Applicant argues the following:
Chen teaches that delivery enhancement arises from the conjugation between POH and therapeutic agents. This teaching directly contrasts with the presently claimed methods, which require only contacting a cell or subject with POH and a polynucleotide without any covalent linkage. In the claims, there can be a physical mixture of POH and a polynucleotide, but there is no chemical conjugation of POH and a polynucleotide (see, for example, claims 2 and 4).
Response to Applicant’s Arguments
Applicant's arguments filed 4-30-26 have been fully considered but they are not persuasive. Applicant is correct that Chen does not teach POH and a polynucleotide in separate compositions. But, contrary to Applicant’s assertions, Chen, in combination with Ferreira and Lee, properly render obvious claims 1, 2, 4-10, 12-18, 20, 21, and 23 for the reasons set forth below.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., POH and polynucleotides in separate compositions) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
The claims are drawn to methods of delivering a polynucleotide to a cell comprising contacting the cell with a composition comprising a polynucleotide and perillyl alcohol (POH), which polynucleotide optionally comprises miR-18a, an siRNA or shRNA, and which composition optionally further comprises an Argonaute-2 protein.
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.
Allowable Subject Matter
Claim 3 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
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.
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
6-10-26
/JANE J ZARA/Primary Examiner, Art Unit 1637
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