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 .
Claim Rejections - 35 USC § 102/103
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.
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.
Claim(s) 10, 20-22, 24 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Jing et al., (CN111249235, cited in IDS).
Jing et al. teaches, “A brain targeted nanoliposome loaded with a positively charged polymer/miR-195 complex and its preparation method and application” (p. 1 of Translation), wherein the nanoliposome is used “to treat Alzheimer disease and vascular dementia, in particular to cognitive dysfunction caused by Alzheimer disease and cerebral ischemia” (Abstract).
“Pharmacodynamic evaluation showed that the liposome could significantly improve the learning and memory ability of bilateral common carotid artery ligation-induced vascular dementia in rats and APP/PS1 and miR-195 knockout mice” (p. 11, 1st paragraph).
“Any modification or equivalent replacement of the technical solutions of the present invention without departing from the spirit and scope of the technical solutions of the present invention should be included in the present invention, within the scope of protection” (p. 12, 3rd paragraph).
The nanoliposome is described as a “plasmid” (see p. 5 of Translation, 4th paragraph) and suffices as a liposome, as per claims 22 and 24.
Administration of the nanoliposome with miR-195 is administered systemically insofar as it was intravenously injected in a patient for uptake by the brain (see Example 6).
The prior art is anticipatory insofar as it teaches administering to a subject a therapeutically effective amount of a composition comprising miR-195.
Assuming, purely arguendo, that the prior art does not provide sufficient specificity to give rise to anticipation, it would have been obvious to a person having ordinary skill in the art at the time of applicant’s filing to administer a therapeutically effective amount of miR-195 to a subject.
2) Claim(s) 22, 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jing et al., (CN111249235, cited in IDS) as applied to claim 20 above, and further in view of Yang (J Pharma Investig 2015).
Jing et al., which is taught above, differs from claims 22 and 25 insofar as it does no teach use of a viral vector to deliver the miR-195.
Yang teaches an overview of viral and nonviral delivery systems for microRNA (Ti.). At that time, “both viral and nonviral miRNA delivery systems are used, and there are advantages and disadvantages for teach approach” (p. 179, left column, 2nd para.)
“Viral-based systems usually use retroviruses, lentiviruses, and adenoviruses or adeno-associated viruses (AVV) as delivery vectors. These viral vectors are modified in some specific genomic area so that they are unable to replicate, and their safety are increased. The advantage of this delivery system was to provide high transfection or infection efficiency, and a high level of constant expression of miRNAs or antagomirs” (Id. 3rd para.).
It would have been obvious to use a viral vector, e.g., an adenovirus, to deliver the miR-195 of Jing et al. for the advantage of providing high transfection or infection efficiency, as taught by Yang. The artisan would have had a reasonable expectation of success with the substitution since viral and nonviral vectors were known to be used to deliver microRNA at the time of applicant’s filing.
3) Claim(s) 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jing et al., (CN111249235, cited in IDS) as applied to claim 20 above, and further in view of Hao et al. (International Journal of Molecular Medicine 2020).
Jing et al., which is taught above, differs from claim 26 insofar as it does not teach the sequence number for miR-195. Instead, Jing et al. teaches, “the nucleic acid sequence of miR-195 is one of miR-195 mimics, modified mir-195 mimics, or miR-195 precursor mimics” (p. 6, 5th paragraph).
Hao et al. provides the sequence for “miR-195 mimic” as “5'-UAGCAG CACAGAAAUAUUGGC-3'’, as per SEQ ID 1.
Accordingly, it would have been expected or obvious to a person having ordinary skill in the art at the time of applicant’s filing to use 5'-UAGCAG CACAGAAAUAUUGGC-3 as the miR-195 mimic in the method of Jing et al.
4) Claim(s) 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jing et al., (CN111249235, cited in IDS) as applied to claim 10 above, and further in view of Ohlmeyer et al. (WO 2019/104041, cited in IDS).
Jing et al., which is taught above, differs from claim 27 insofar as it does not teach a compound selected from the group.
Ohlmeyer et al. teaches compounds “used to treat cognitive impairment or traumatic brain injury, including promoting regeneration in cases of traumatic brain injury, or for treating neurogenerative disorders” (Abstract).
Suitable compounds include:
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(p. 40, Claim 8).
Generally, it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose in order to form a third composition that is to be used for the very same purpose; the idea of combining them flows logically from their having been individually taught in prior art. See MPEP 2144.06.
Accordingly, it would have been obvious to a person having ordinary skill in the art at the time of applicant’s filing to administer the compounds of Ohlmeyer et al. in the method of Jing et al. since the patient population of Jing et al. includes those with cognitive dysfunction, and the compounds of Ohlmeyer et al. treats cognitive impairment.
Conclusion
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/WALTER E WEBB/ Primary Examiner Art Unit 1612