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 .
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, 3-4 and 6-14 are 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.
Regarding claim 1, the phrase "nRs" renders the claim indefinite because it is unclear what the limitations are for nRs as the embodiment(s) of Rs is not defined in the claim. Ultimately the meets and bounds of the claim is unclear.
Claims 3-4 and 6-13 are equally indefinite as depending from claim 1 thus having the limitation of “nRs” without further limiting.
Regarding claim 14, the phrase "and R3, R4" renders the claim indefinite because it is unclear how the limitations of R3 and R4 correspond to Formulas (1A1) and (1A2), additionally the limitations of R7 and R8 failed to be included in the claim. Ultimately, the metes and bounds of the claim is unclear.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 3-4, 6-7 and 9-12 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Tedebark (US Patent No. 20130011448).
Regarding claims 1, 3-4, 6-7 and 9-12, Tedebark teaches a system for mammalian intracellular delivery of oligonucleotides or plasmid DNA (relevant to claims 9 and 10) comprising a pharmaceutical composition of a nucleic acid and D(n)BAC (relevant to claim 11); wherein component D is an amine-containing component; n is a number of amines of at least 2; component B is a di, tri or tetra ring system, preferably naphthalene, triphenylene and benzanthracene (relevant to claims 4 and 7); component A is an aliphatic linear or branched hydrophobic chain of at least 4 carbon atoms preferably an epoxide or an alkyl halide or an acrylamide with 6-30 carbon atoms and component C is a targeting moiety for the system to reach specific cells or tissue (Para. 0021-0029, 0058, 0081).
Component D is selected from a list of compounds which includes
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which is covalently attached to component B (relevant to claims 1, 3 and 6), wherein component B may comprise one or more carboxylic groups and/or one or more additional functional groups such as but not limited to one or more amines, one or more thiols, one or more hydroxyls, one or more esters and one or more aldehydes (Para. 0035, 0039). Tedebark additionally teaches the oligonucleotides includes RNAs for gene silencing (relevant to claim 12) (para. 0059).
Claim Rejections - 35 USC § 103
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.
Claims 8 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Tedebark (US Patent No. 20130011448).
The teaching of Tedebark for the above 102 rejections of claims 1, 3-4, 6-7 and 9-12 is incorporated herein by reference. Tadebark additionally teaches the composition comprising pH buffers (para. 0041, 0078).
Tedebark fails to teach the composition as a genome editing composition, however it would have been obvious to someone of ordinary skill in the art at the time of filing to have used the composition taught by Tedebark as a genome editing composition. One would have been motivated to do so as it is known in the art DNA plasmids are the most common delivery vehicles used to introduce genome editing into target cells, in which the delivery of DNA plasmids is taught by Tedebark. There is a reasonable expectation of developing a genome editing composition from the teachings of Tedebark.
It would additionally be obvious to add a physiological buffer with a pH of 6.0 to 8.0 as Tedebrak teaches the delivery composition further contains a pH buffer and it is known in the art an ideal pH for DNA plasmids is between 7.5 and 8 and nucleic acids from 7.2 to 7.4. Additionally physiological buffers are meant to maintain a stable pH in bodily fluids. Thus, in order to maintain a stable pH in bodily fluids with delivering nucleic acids or DNA plasmid a pH buffer would need to be with a pH of 6.0 to 8.0. There is a reasonable expectation of having a physiological buffer with pH between 6.0 to 8.0 with the claimed delivery system from the teachings of Tedebark.
Conclusion
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MIKHAIL O'DONNEL. ROBINSON
Examiner
Art Unit 1627
/MIKHAIL O'DONNEL ROBINSON/Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627
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