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 .
Election/Restrictions
Applicant’s election without traverse of Group III (claims 17-20) in the reply filed on 9/10/2025 is acknowledged.
Claims 5, 8, 12, 15, and 25 have been canceled, claims 1-4, 6-7, 9-11, 13-14, 16 and 21-24 have been withdrawn from consideration as being drawn to non-elected subject matter, and claims 17-20 have been considered on the merits.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 17-18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product (natural phenomenon) without significantly more. The claim(s) recite(s) a composition comprising an agent inhibiting L1 RNA expression in a pharmaceutically acceptable carrier, and one type of the agent being miRNA. The agent inhibiting L1 RNA expression would include miRNA-128 that is naturally occurring as all microRNAs are. Idica et al. (2017, JBC) teach that they recently discovered miR-128 in somatic cells, and that represses the activity of L1 retrotransposons (p.2, 1st col. 2nd full para.). Chen et al. (2012, Epigenetics) teach that naturally occurring endo-siRNA silences LINE-1 retrotransposons (see entire document). Thus, there are agents occurring naturally satisfying the functionality of inhibiting L1 RNA expression including miR-128 and endo-siRNA and thus, they are directed to a natural phenomenon, a judicial exception. The claimed composition additionally contains a pharmaceutically acceptable carrier which under the broadest reasonable interpretation can be water or body fluid, and thus, the additional element of the claimed composition is not considered to add significantly more to the judicial exception.
This judicial exception is not integrated into a practical application because the claims do not disclose any other element that integrates the judicial exception to any practical application. The additional element of a pharmaceutically acceptable carrier does not add any practical application. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because there is no additional element other than the carrier which does not add significantly more to the judicial exception.
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 17-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bondarev et al. (US20150094215; IDS ref.)
Bondarev et al. teach the use of antisense strategy to suppress L1 reverse transcriptase (para. 9), and the inhibitor or antagonist of the L1RT can be an inorganic compound, an organic compound, an antisense sequence, a double-stranded RNA corresponding to a defined target region in L1RT mRNA, a dominant negative mutant of the L1RT protein, an antibody or a small molecule (para. 25).
Bondarev et al. teach antisense oligonucleotide(s) or antisense polynucleotide(s) are used as inhibitors or antagonists of L1RT (para. 32), and a series of antisense phosphorothioate oligonucleotides, 20 or more nucleotides in length, targeting the nucleic acid encoding L1RT are designed to bind to the promoter or other control regions and coding and/or non-coding regions of L1RT (para. 33).
Regarding the pharmaceutically acceptable carrier, Bondarev et al. teach that the inhibitor or antagonist is optionally administered with a pharmaceutically acceptable carrier (para. 10).
Regarding the antisense oligonucleotide (ASO) being L1 RNA, L1 ORF1 RNA and/or L1 ORF2 RNA or complementary to the fragment thereof, the teachings of Bondarev et al. as discussed above would meet the limitation.
The teaching of the antisense oligonucleotide of 20 nucleotides in length (para. 33) would meet the optional limitation in claim 20.
Thus, the reference anticipates the claimed invention.
Claim(s) 17-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Percharde et al. (2018, Cell; IDS ref.).
Percharde et al. teach siRNAs and LINE1 ASO tarting the fragments of ORF2 of LINE1 mRNA (see Figure 1C). Percharde et al. teach the use of ASO solution for microinjection (p.e4), and thus, the ASO solution is considered to inherently comprise a pharmaceutically acceptable carrier.
Thus, the reference anticipates the claimed invention.
Claim(s) 17-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Garaci et al. (WO2006/069812; IDS ref.)
Garaci et al. teach RNA interference (RNAi) specific for open reading frame (ORF) of a LINE-1 (abstract; para. 9). Garaci et al. teach that RNAi is short interfering RNA (siRNA) (para. 13). Garaci et al. teach that the RNAi may be injected directly to the target site in any suitable vehicle (para. 21), and this teaching is considered to meet the pharmaceutically acceptable carrier.
Thus, the reference anticipates the claimed invention.
Claim(s) 17-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Idica et al. (supra)
Idica et al. teach microRNA miR-128 that represses LINE-1 (L1) retrotransposition (see entire document).
Regarding the pharmaceutically acceptable carrier, while Idica et al. do not particularly disclose the limitation, however, Idica et al. transfected mZIP-miR-128 into 293T cells and the miR-128 would be expressed in the cells, and thus, the cells would be considered as a pharmaceutically acceptable carrier of the miR-128.
Thus, the reference anticipates the claimed invention.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claim(s) 17-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bachiller et al. (2017, Brain, Behavior, and Immunity) in view of Dibble et al. (US PAT. 10,174,318).
Bachiller et al. teach antisense oligonucleotides (ASOs) against L1 orf1 and orf2, i.e. orf1 ASO and orf2 ASO (p.68, 1st col.). The antisense complementary sequences to the ORF1 and ORF2 of L1 were 5’-T*T*T*GCCTTTCGCCATCTGG*T*A*-3’ and 5’-
T*G*T*TAGAGTTGGCATTCTG*T*T*-3’, respectively (p.68, 2nd col.). These ASOs are less than 24 nucleotides in length and targeting ORF1 and ORF2, respectively.
Although Bachiller et al. teach the ASOs are injected into the brain (intrahippocampal infusion) (Fig. 2), and thus, considered to be a solution, however, they do not teach the pharmaceutically acceptable carrier. However, it is extremely well known in the art that ASOs are injected along with a pharmaceutically acceptable carrier. For example, Dibble et al. teach a pharmaceutical composition comprising an antisense oligonucleotide also comprises a suitable pharmaceutically acceptable diluent or carrier including water, saline or PBS (col. 49, lines 26-47).
It would have been obvious to a person skilled in the art to inject the ASOs of Bachiller et al. in a composition comprising a pharmaceutically acceptable carrier such as water or PBS with a reasonable expectation of success.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Conclusion
No claims are allowed.
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/TAEYOON KIM/Primary Examiner, Art Unit 1631