DETAILED ACTION
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 .
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Any rejection or objection not reiterated in this Action is withdrawn.
This application has been assigned to a different examiner.
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 246, 247, 250, 251-254, 260, 263, 267 and 268 are rejected under 35 U.S.C. 103 as being unpatentable over Coursaget et al. (US 2012/0171290).
Coursaget et al. teach (see paragraphs 100-105) synthetic siRNAs against mRNAs encoding HPV genes. Paragraph 105 teaches modified nucleotide bases can be used in addition to the naturally occurring bases. The term modified nucleotide base encompasses nucleotides with a covalently modified base and/or sugar. For example, modified nucleotides include epimeric sugars such as arabinose, xyloses or lyxoses, pyranose sugars, furanose sugars, and sedoheptulose.
Paragraph 98 teaches siRNA sequences are selected on the basis of their homology to the target gene. The degree of homology between the siRNA and the target gene is at least 75%, at least 80%, at least 85%, at least 90%, at least 95%, at least 97%, or at least 99%, or 100%. The siRNA may be between 10 bp and 30 bp in length, or between 20 bp and 25 bp, or the siRNA is 20, 21 or 22 bp in length.
Paragraph 27 teaches the compositions of the invention may be administered topically and/or via any other suitable route (e.g., via injection, aerosol, spray, or other form of administration), which would necessitate formulation with a pharmaceutically acceptable diluent.
Coursaget et al. do not explicitly exemplify an siRNA having at least one xylose modified nucleotide, but it would have been obvious to one of ordinary skill in the art before the effective filing date to make such an siRNA because Coursaget et al. explicitly contemplate siRNAs having such a modification.
Allowable Subject Matter
Claims 248, 249, 255-259, 261, 262 and 264-266 are 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.
The following is a statement of reasons for the indication of allowable subject matter: the closest prior art is Coursaget et al., the teachings of which are described above. While this reference provides a general suggestion to include xylose-modified nucleotides in an siRNA, this reference does not teach or fairly suggest the xylose nucleotide be further modified at the 2’ position or that the xylose nucleotide be placed at specific positions within the siRNA.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Tracy Vivlemore whose telephone number is (571)272-2914. The examiner can normally be reached Mon-Fri 7:30-4:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Yvonne Eyler can be reached at 571-272-1200. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Tracy Vivlemore
Supervisory Primary Examiner
Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638
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