DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This Office action is in response to the communication filed 9-30-25.
Claims 82-97 are pending in the instant application.
Election/Restrictions
Applicant’s election without traverse of Group I, tRNA-Gly-CCC, tRNA-Gly-TCC, tRNA-Gly-GCC, tRNA-Val-CAC, and tRNA-Glu-CTC, claims 82-97, in the reply filed on 9-30-25 is acknowledged.
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 82-97 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claimed invention is directed to products of nature. The claims are drawn to nucleic acid fragments. The claims do not include any elements that add significantly more to any judicial exceptions, and do not include features that demonstrate that the recited products are markedly different from what exists in nature. The fragments perform in their natural way, serve the ends nature originally provided, and act quite independently of any effort of patentee. There are no marked differences in the function or structure of these naturally occurring molecules, and their characteristics do not change from that occurring in nature.
In sum when the relevant factors are analyzed, they weigh toward ineligibility under 35 U.S.C. 101. Therefore, the claims are non-statutory, and the rejection under 35 U.S.C. 101 is appropriate.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 82, 83, 91, 92, 94, 95 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chen et al (Science Vol. 351, No. 6271, pages 397-400 (January 2016)).
Chen et al (Science Vol. 351, No. 6271, pages 397-400 (January 2016)) teach pharmaceutical compositions comprising vesicles comprising tRNA fragments (see esp. the Abstract, text and Figure 1 on page 397, text on pages 398-399).
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.
Claim(s) 82-97 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cabillero et al (PLOS ONE, Vol. 8, No. 6, e65364 (June 2013)), Barkalina et al (Human Reproduction Update, Vol. 212, No. 25, pages 627-639 (2015)), and Chen et al (Science Vol. 351, No. 6271, pages 397-400 (January 2016)), the combination in view of Vojtech et al (Nuc.. Acid Res., Vol. 42, No. 11, pages 7290-7303 (2014)) and Lowe et al (US 2018/0171385).
The claims are drawn to pharmaceutical compositions comprising pharmaceutical compositions optionally in vaginal foam or gel comprising an autologous or heterologous sRNA-containing vesicle isolated from an epididymosome, which sRNA optionally comprises a siRNA, miRNA, piRNA, snoRNA, srRNA, U-RNA, or tRNA fragment optionally comprising a tRNA-Gly-CCC, tRNA-Gly-TCC, tRNA-Gly-GCC, tRNA-Val-CAC, tRNA-Glu-CTC, tRNA-Lys-CTT, or a tRNA-His-GTG fragment, which epididymosome is optionally selected from caput, corpus, or cauda epididymosome.
Cabillero et al (PLOS ONE, Vol. 8, No. 6, e65364 (June 2013)) teach pharmaceutical compositions comprising sRNA containing vesicles isolated from an epididymosome, CD9 positive microvessicles for mediating transfer of spermatozoa during epididymal maturation. Cabillero teaches epididysomes to be heterogeneous small membraneous vessicles which change as epididymal transit occurs along the epididymal duct. Cabillero teaches the isolation, purification, and characterization of epididysomes (see the abstract, introduction, pages 1-2, Figure 1, page 3, 8, 11).
Barkalina et al (Human Reproduction Update, Vol. 212, No. 25, pages 627-639 (2015)) teach EVs as pharmaceutical compositions for delivering cargo to target cells. Barkalina teaches the natural delivery of exosomes and microvessicles and the effect of transfer of molecules to sperm (see esp. pages 631-635).
Chen et al (Science Vol. 351, No. 6271, pages 397-400 (January 2016)) teach pharmaceutical compositions comprising vesicles comprising tRNA fragments (see esp. the Abstract, text and Figure 1 on page 397, test on pages 398-399).
The primary references do not teach the tRNAs or fragments thereof as instantly claimed.
Vojtech et al (Nucleic.Acid Res., Vol. 42, No. 11, pages 7290-7303 (2014)) teach compositions comprising exosomes obtained from semen comprising tRNA fragments comprising tRNA-Gly, tRNA-Ala. Voitech teaches the study of tRNA fragments in their role in biological functions, including immunosuppressive functions (see esp. Figures 1 and 2, page 7291, Table 2, page 7297, bridging pages 7296-7297).
Lowe et al (us 2018/0171385) teach compositions comprising tRNAs comprising tRNA-Gly-CCC and tRNA-Glu-CTC (see esp. page 1, Fig. 2, pages 7-9).
It would have been obvious to compose the instant compositions claimed because all of the components were well known in the art as exemplified in the teachings of Cabillero, Barkalina, and Chen.
Furthermore, one would have been motivated to compose these compositions for efficient transformation of target cells relying on the teachings of Voitech and Lowe. The tRNA fragments would have been incorporated into the compositions of vesicles claimed for efficient transformation and for investigating immuosuppressive and other biological effects, as taught by Voight and Lowe.
For these and aforementioned reasons, the instant invention would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application.
Conclusion
Certain papers related to this application may be submitted to Art Unit 1637 by facsimile transmission. The faxing of such papers must conform with the notices published in the Official Gazette, 1156 OG 61 (November 16, 1993) and 1157 OG 94 (December 28, 1993) (see 37 C.F.R. ' 1.6(d)). The official fax telephone number for the Group is 571-273-8300. NOTE: If Applicant does submit a paper by fax, the original signed copy should be retained by applicant or applicant's representative. NO DUPLICATE COPIES SHOULD BE SUBMITTED so as to avoid the processing of duplicate papers in the Office.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jane Zara whose telephone number is (571) 272-0765. The examiner’s office hours are generally Monday-Friday, 10:30am - 7pm. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Jennifer Dunston, can be reached on (571)-272-2916. Any inquiry of a general nature or relating to the status of this application should be directed to the Group receptionist whose telephone number is (703) 308-0196.
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Jane Zara
12-13-25
/JANE J ZARA/Primary Examiner, Art Unit 1637