DETAILED ACTION
Applicant’s amendment and remarks filed December 3, 2025 are acknowledged and entered. Claims 1-3 and 20, and elected species SEQ ID NO: 22-25 are under examination. Claims 4-15, previously under examination as generic claims, now limited to SEQ ID NO: 10 and 11 (non-elected species), are withdrawn from consideration being directed to non-elected subject matter. Any prior objection or rejection of claims 1-3 and 20 is either moot or withdrawn in view of Applicant’s amendment.
Claims Summary
Claims 1-3
Claim 1 is directed to an isolated double-stranded siRNA, comprising SEQ ID NO: 22-25, that inhibits the expression of the human proline-rich domain protein 14 gene, PRDM14 gene in cancer cells. SEQ ID NO: 22 and 23 represent the sense and antisense strands of siRNA ARIZ-040. SEQ ID NO: 24 and 25 represent the sense and antisense strands of siRNA ARIZ-044. The nucleotides are RNA, DNA or a hybrid RNA:DNA combination, and are 16-30 nucleotides in length. The siRNA has one or more chemical modifications comprising site-specific base modifications (claim 2), comprising addition of an O-methyl group to the 2’ position on the sugar, addition of a fluorine atom to the 2’ position of the sugar, and a substitution of a sulfur atom for oxygen at the 3’ end of the siRNA guide antisense strand (claim 3).
Claim 20
Claim 20 is directed to a pharmaceutical composition comprises a drug delivery system loaded with an ARIZ siRNA to inhibit expression of PRDM14 to suppress growth of cancer cells. The ARIZ siRNA is selected from ARIZ-040 (SEQ ID NO: 22-23), and ARIZ-044 (SEQ ID NO: 24-25).
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.
Claims 1-3 remain 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. The metes and bounds of the claims cannot be determined.
Claim 1 is directed to a double-stranded siRNA comprising SEQ ID NO: 22-25. SEQ ID NO: 22 and 23 represent the sense and antisense strands of siRNA ARIZ-040. SEQ ID NO: 24 and 25 represent the sense and antisense strands of siRNA ARIZ-044. It appears that claim 1 is directed to an embodiment wherein the siRNA comprises SEQ ID NO: 22 and 23, or SEQ ID NO: 24 and 25. However, claim 1 is worded such that it encompasses a single sequence having all of SEQ ID NO: 22, 23, 24 and 25, which exceeds the length limitation of 16-30 nucleotides. Claims 2 and 3 are also rejected because they depend from claim 1.
Claim 1, as amended, recites “wherein the nucleotides of the siRNA may be RNA, DNA and hybrid RNA:DNA combination”. It is not clear how siRNA can be anything other than RNA. RNA is not DNA, nor is RNA a combination of RNA:DNA. Clarification and/or correction is required.
Conclusion
Claim 20 is allowable.
SEQ ID NO: 22, 23, 24 and 25 are free of the prior art of record.
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.
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/STACY B CHEN/Primary Examiner, Art Unit 1672