Prosecution Insights
Last updated: July 17, 2026
Application No. 18/192,593

RNA COMPRISING SECRETOMES AND METHODS OF THEIR USE

Non-Final OA §102§103§112
Filed
Mar 29, 2023
Priority
Mar 29, 2022 — provisional 63/324,910
Examiner
PERSONS, JENNA L
Art Unit
1637
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Direct Biologics LLC
OA Round
1 (Non-Final)
52%
Grant Probability
Moderate
1-2
OA Rounds
2m
Est. Remaining
99%
With Interview

Examiner Intelligence

Grants 52% of resolved cases
52%
Career Allowance Rate
30 granted / 58 resolved
-8.3% vs TC avg
Strong +58% interview lift
Without
With
+58.4%
Interview Lift
resolved cases with interview
Typical timeline
3y 6m
Avg Prosecution
40 currently pending
Career history
103
Total Applications
across all art units

Statute-Specific Performance

§101
0.4%
-39.6% vs TC avg
§103
44.9%
+4.9% vs TC avg
§102
7.3%
-32.7% vs TC avg
§112
11.6%
-28.4% vs TC avg
Black line = Tech Center average estimate • Based on career data from 58 resolved cases

Office Action

§102 §103 §112
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 . Application Status Applicant’s reply filed April 21, 2026, including remarks and amendments to the claims, is acknowledged. Claims 32 and 41 were amended. Claims 25-44 are pending. Restriction/Election Applicant’s election of Group I (claims 25-43), without traverse, in the reply filed April 21, 2026 is acknowledged. Accordingly, claim 44 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention. Claims 25-43 are under consideration hereinafter. Priority Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows: The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994). The disclosure of the prior-filed application, Application No. 63/324,910 fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for claim 41 of this application for the reasons described in the new matter rejection in paragraphs 10-11 below. The effective filing date of claim 41 is March 29, 2023, i.e., the filing date of the instant application, accordingly. Claims 25-40, and 42-43 find support in Application No. 63/324,910, and therefore, the effective filing date claims 25-40, and 42-43 is March 29, 2022. Nucleotide and/or Amino Acid Sequence Disclosures Summary of Requirements for Patent Applications Filed On Or After July 1, 2022, That Have Sequence Disclosures 37 CFR 1.831(a) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.831(b) must contain a “Sequence Listing XML”, as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.831-1.835. This “Sequence Listing XML” part of the disclosure may be submitted: 1. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter “Legal Framework”) in XML format, together with an incorporation by reference statement of the material in the XML file in a separate paragraph of the specification (an incorporation by reference paragraph) as required by 37 CFR 1.835(a)(2) or 1.835(b)(2) identifying: a. the name of the XML file b. the date of creation; and c. the size of the XML file in bytes; or 2. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation by reference statement of the material in the XML format according to 37 CFR 1.52(e)(8) and 37 CFR 1.835(a)(2) or 1.835(b)(2) in a separate paragraph of the specification identifying: a. the name of the XML file; b. the date of creation; and c. the size of the XML file in bytes. SPECIFIC DEFICIENCIES AND THE REQUIRED RESPONSE TO THIS NOTICE ARE AS FOLLOWS: Specific deficiency - The incorporation by reference paragraph required by 37 CFR 1.834(c)(1), 1.835(a)(2), or 1.835(b)(2) is missing, defective or incomplete. Specifically, USPTO records indicate that the size of the sequence listing filed March 29, 2023 is “34,883 bytes,” rather than “2914 bytes” as indicated in the incorporation by reference paragraph. Required response - Applicant must provide a substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required incorporation by reference paragraph, consisting of: • A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version); • A copy of the amended specification without markings (clean version); and • A statement that the substitute specification contains no new matter. Drawings The drawings are objected to because of the following informalities: The drawings are objected to because the single view used to illustrate the claimed invention is referred to by the abbreviation “FIG.” 37 CFR 1.84(u) states that where only a single view is used in an application to illustrate the claimed invention, it must not be numbered and the abbreviation “FIG.” must not appear. The drawings are objected to because they were submitted in color, but there is no granted petition to accept color drawings. See 37 CFR 1.84(a)(2) (“The Office will accept color drawings in utility patent applications only after granting a petition filed under this paragraph explaining why the color drawings are necessary”). Applicant must either provide that explanation via a petition and comply with all requirements of 37 CFR 1.84(a)(2)(i)-(iii) OR submit replacement sheets in black and white and include a clear instruction to replace the color drawings with the replacement sheets. The Examiner takes no position on whether color drawings are necessary as the only practical medium by which to disclose the subject matter sought to be patented in this utility patent application. Appropriate correction is required. Claim Objections Claim 26 is objected to because of the following informalities: Claim 26 recites “miR-21-5P, miR-24-3P,” whereas claim 25 and the specification recite “miR-21-5p” and “miR-24-3p.” It would be preferable to amend the claim to recite consistent terminology, i.e., “miR-21-5p[[P]], miR-24-3p[[P]].” Appropriate correction is required. Claim Rejections - 35 USC § 112(a) – Written Description The following is a quotation of the first paragraph of 35 U.S.C. 112(a): (a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention. The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112: The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention. Claim 41 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection. Claim 41 recites “the one or more EVs are about 20 nm to about 200 nm in size.” Claim 41 was introduced in the amendments to the claims filed August 5, 2025. Neither Application No. 63/324,910, to which this application claims priority, or the disclosure as filed, explicitly or implicitly disclose the range of sizes recited in claim 41. Application No. 63/324,910 and the disclosure as filed are silent as to the size of the EVs. Accordingly, the limitations of claim 41, introduced in the amendments to the claims filed August 5, 2025, fail to comply with the written description requirement. Claim Rejections - 35 USC § 112(b) 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 39 and 41 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. Claims 39 and 41 recite the term “about,” which is a relative term which is not defined by the claim. The specification, while discussing the term “about” in general (pg. 6), does not provide a standard for ascertaining the requisite degree of “about” for either the wt% of the EVs in the composition, or size of the EVs. The claims are indefinite, therefore, because the skilled artisan would not be apprised of the scope of the recited ranges, and therefore, would not be apprised of the structure of the composition. Claim Rejections - 35 USC § 102 – Traweger 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 25, 27-32, 35, 37-38, and 41-43 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Traweger (Traweger and Gimona, WO 2018/130554 A1, published 19 July 2018). Regarding claims 25 and 38, Traweger teaches a method of regulating inflammation in a subject in need thereof, where in the inflammation is related to a physical injury (“the extracellular-vesicles of the invention or the extracellular-vesicles obtained by the methods of the invention may be used in suppressing inflammation,” pg. 7 “the extracellular-vesicles obtained by the methods… for use in the treatment of (a) bone defect(s), tendon defect(s) and/or spinal cord injury… repair of bone, tendon and/or spinal cord,” pg. 31; “Various adult stem cells (e.g., MSCs) have been evaluated for their potential to augment tendon repair and reduce inflammation… extracellular vesicles derived from MSCs demonstrate beneficial therapeutic effects… similar to those seen for MSCs… the extracellular vesicles have the potential to improve tendon quality, for example, via their immunomodulatory and/or pro-angiogenic action,” pg. 31; “transplanted MSCs modify the inflammatory environment… the success of cell-based SCI therapy is due mainly due to secreted factors rather than cell implantation… secreted factors (or secretome) include a variety of proteins, lipids, microRNAs, and extracellular vesicles… the extracellular vesicles of the invention can be used in the treatment of spinal cord injury,” pg. 32-33). Traweger teaches the method comprises administering to the subject a composition comprising a therapeutically effective amount of one or more extracellular vesicles (“a method of treatment… the method comprises the administration to a subject in need… a pharmaceutical active/effective amount of the pharmaceutical composition… the pharmaceutical composition… may comprise the extracellular vesicles of the invention,” pg. 36), wherein the EVs are derived from mesenchymal stem cells (“a pharmaceutical composition comprising extracellular-vesicles derived from mesenchymal stromal cells (MSCs),” pg. 48), and wherein the EVs comprise at least miR-21-5p (“the extracellular-vesicles comprise… hsa-miR-21-5p,” pg. 48-49). Regarding claim 27, Traweger teaches the miR-21-5p is naturally occurring in the extracellular vesicles derived from the mesenchymal stem cells (“miRNA sequence of EVs from BM-MSCs… derived from different donors revealed a consistent profile that supports the observed pro-osteogenic activity observed in vitro and in vivo:… hsa-miR-21-5p,” pg. 65). Regarding claim 28, as stated above, Traweger teaches the extracellular vesicles comprise miR-21-5p (pg. 48-49; pg. 65). Regarding claim 29, as stated above, Traweger teaches the extracellular vesicles are derived from mesenchymal stem cells (pg. 48-49; pg. 65). Regarding claim 30, Traweger teaches the mesenchymal stem cells are bone marrow mesenchymal stem cells (“Experiments were performed with two different primary human BM-MSC… preparations,” pg. 56; “miRNA sequence of EVs from BM-MSCs… derived from different donors revealed a consistent profile that supports the observed pro-osteogenic activity observed in vitro and in vivo:… hsa-miR-21-5p,” pg. 65). Regarding claim 31, Traweger teaches the bone marrow mesenchymal stem cells are human bone marrow mesenchymal stem cells (“Experiments were performed with two different primary human BM-MSC… preparations,” pg. 56; “miRNA sequence of EVs from BM-MSCs… derived from different donors revealed a consistent profile that supports the observed pro-osteogenic activity observed in vitro and in vivo:… hsa-miR-21-5p,” pg. 65). Regarding claim 32, Traweger teaches the composition further comprises platelet derived growth factor (PDGF)(“the pharmaceutical composition comprises… PDGF,” pg. 49). Regarding claim 35, Traweger teaches the one or more extracellular vesicles further comprise at least miR-148-3p (“miRNA sequence of EVs from BM-MSCs… derived from different donors revealed a consistent profile that supports the observed pro-osteogenic activity observed in vitro and in vivo:… hsa-miR-21-5p… hsa-miR-148-3p,” pg. 65). Regarding claim 37, Traweger teaches compositions formulated for intravenous or topical delivery (“the pharmaceutical composition… the extracellular vesicles, the extracellular vesicles obtained by the methods… is administered or is to be administered… intravenously… topically,” pg. 43). Regarding claim 41, Traweger teaches extracellular vesicles within the recited range of sizes (“Particles from CM A display a mean diameter of 124 nm, particles from CM B of 125 nm,” pg. 55; Fig. 15; “BM-MSC were first grown in medium A… the mean diameter of EV isolated from both CM was 125 nm… (see Fig. 15),” pg. 78). Regarding claim 42, the functional limitation “wherein administering results in a reduction of IL-1β production in the subject relative to control,” is understood to be conferred by the one or more RNAs and one or more EVs provided in the administration step. The structure administered in the method taught by Traweger (i.e., one or more EVs comprising one or more RNAs, wherein the one or more RNAs comprise at least miR-21-5p) comprises the same structure shown in the specification (i.e., human miR-21-5p, see Fig. 1; “the microRNA hmiR21-5p was transfected alone since it is considered to be a primary miRNA regulatory of IL-1β,” pg. 75) which achieves the function recited in the claim. Thus, the teachings of Traweger are presumed to meet the functional limitations recited in claim 42. See MPEP 2112.01. Regarding claim 43, the functional limitation “wherein administering results in a reduction in the formation of inflammasomes in the subject relative to control,” is understood to be conferred by the one or more RNAs and one or more EVs provided in the administration step. The structure administered in the method taught by Traweger (i.e., one or more EVs comprising one or more RNAs, wherein the one or more RNAs comprise at least miR-21-5p) comprises the same structure shown in the specification (i.e., miR-21-5p, see Fig. 1; “artificially synthesized microRNAs of sequences shown to inhibit the formation of inflammasomes,” pg. 75) which achieves the function recited in the claim. Thus, the teachings of Traweger are presumed to meet the functional limitations recited in claim 43. See MPEP 2112.01. Claim Rejections - 35 USC § 102 – Traweger as evidenced by Ragni Claim 26 is rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Traweger (Traweger and Gimona, WO 2018/130554 A1, published 19 July 2018) as applied to claims 25, 27-32, 35, 37-38, and 41-43 above, and as evidenced by Ragni (Ragni et al., 2025, Extracellular Vesicles and Circulating Nucleic Acids, 2025;6:1079-99, and Supplementary Table 2). Traweger teaches that miR-21-5p and miR-221-3p are among the most abundant miRNAs comprised by the one or more extracellular vesicles derived from bone marrow mesenchymal stem cells (Table 1, pg. 67). Traweger is silent as to whether the one or more extracellular vesicles comprise miR-24-3p or miR-27b-3p, and teaches that miR-222-3p “was not determined among the 15 most abundant miRNAs” (pg. 66). However, Ragni teaches that extracellular vesicles derived from bone marrow mesenchymal stem cells comprise each of the miRNA recited in instant claim 26: miR-21-5p, miR-24-3p, miR-222-3p, miR-27b-3p, and miR-221-3p (See columns “BMSC1-EVs,” “BMSC2-EVs,” and “BMSC3-EVs,” in Supplementary Table 2). Thus, as evidenced by Ragni, Traweger’s one or more extracellular vesicles inherently comprise each of the miRNAs recited in instant claim 26. Claim Rejections - 35 USC § 102 – Staufer Claims 25, 27-28, 32, 35-36, 38, and 42-43 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Staufer (Staufer et al., WO 2021/152115 A1, published 5 August 2021). Regarding claim 25, Staufer teaches a method of regulating inflammation in a subject in need thereof (“described herein is a method for treating or ameliorating a disorder… wherein the disorder is… inflammation,” pg. 131; “synthetic extracellular vesicle… for use in treatment of… inflammation,” pg. 267). Staufer teaches the method comprises administering to the subject a composition comprising a therapeutically effective amount of one or more extracellular vesicles, wherein the one or more extracellular vesicles comprise at least miR-21-5p (“administering to a patient suffering from said disorder a therapeutically effective amount of a synthetic extracellular vesicle… comprising… miR-21,” pg. 131; “miRIDIAN micro RNA mimics… hsa-miR-21-5p,” pg. 142; “synthetic exosomes were prepared using synthetic miRIDIAN mimics of the miRNA described in the natural exosomes at a concentration typically found in the natural exosomes,” pg. 151; Fig. 1). Regarding claim 27, the term “naturally-occurring” refers to a process through which the one or more RNAs are prepared, i.e., through “natural” vs. artificial mechanisms. Staufer teaches one or more RNAs which are “mimics” of naturally-occurring human miRNAs (pg. 142; pg. 151). There is no apparent difference between the structure of a human miRNA produced through “natural” vs. artificial mechanisms. Thus, Staufer’s RNAs meet the structural features of the one or more RNAs of claim 27. Regarding claim 28, as stated above, Staufer teaches the extracellular vesicles comprise the one or more RNAs (pg. 131; pg. 151; Fig. 1). Regarding claim 32, Staufer teaches the one or more extracellular vesicles may be prepared with prostaglandin E2 (PGE2)(“lipids suitable to synthesize the synthetic extracellular vesicles according to the method disclosed herein are listed in Table 1,” pg. 63; “PGE2,” Table 1, pg. 68). Thus, Staufer teaches a composition which further comprises prostaglandin E2. Regarding claim 35, Staufer teaches the one or more extracellular vesicles further comprise at least hsa-miR-125b-5p (pg. 142; pg. 151). Regarding claim 36, Staufer teaches the one or more extracellular vesicles comprise liposomes (“the embodiments describing… “extracellular vesicles” shall include “exosomes,” “liposomes,” pg. 18). Regarding claim 38, Staufer teaches the inflammation is related to an immune response or an autoimmune disease (“The inventors aimed to synthesize synthetic extracellular vesicles with immunoregulatory properties that could be used to treat immune disorders, autoimmune disorders, inflammatory disorders, such as rheumatoid arthritis, and cancer, e.g., by cancer immunotherapy,” pg. 155). Regarding claim 42, the functional limitation “wherein administering results in a reduction of IL-1β production in the subject relative to control,” is understood to be conferred by the one or more RNAs and one or more EVs provided in the administration step. The structure administered in the method taught by Staufer (i.e., one or more EVs comprising one or more RNAs, wherein the one or more RNAs comprise at least miR-21-5p) comprises the same structure shown in the specification (i.e., human miR-21-5p, see Fig. 1; “the microRNA hmiR21-5p was transfected alone since it is considered to be a primary miRNA regulatory of IL-1β,” pg. 75) which achieves the function recited in the claim. Thus, the teachings of Staufer are presumed to meet the functional limitations recited in claim 42. See MPEP 2112.01. Regarding claim 43, the functional limitation “wherein administering results in a reduction in the formation of inflammasomes in the subject relative to control,” is understood to be conferred by the one or more RNAs and one or more EVs provided in the administration step. The structure administered in the method taught by Staufer (i.e., one or more EVs comprising one or more RNAs, wherein the one or more RNAs comprise at least miR-21-5p) comprises the same structure shown in the specification (i.e., miR-21-5p, see Fig. 1; “artificially synthesized microRNAs of sequences shown to inhibit the formation of inflammasomes,” pg. 75) which achieves the function recited in the claim. Thus, the teachings of Staufer are presumed to meet the functional limitations recited in claim 43. See MPEP 2112.01. Notice to Joint Inventors 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 Rejections - 35 USC § 103 – Traweger in view Pettine 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 39-40 are rejected under 35 U.S.C. 103 as being unpatentable over Traweger (Traweger and Gimona, WO 2018/130554 A1, published 19 July 2018) as applied to claims 25, 27-32, 35, 37-38, and 41-43 above, in view of Pettine (Pettine et al., WO 2020/160342 A1, published 6 August 2020). The teachings of Traweger are described above and applied as to claims 25, 27-32, 35, 37-38, and 41-43 therein. Traweger does not teach that the composition comprises from 0.00001 wt% to 20 wt% of EVs, or that the composition further comprises an oligosaccharide. However, Pettine teaches compositions substantially identical to those of Traweger, for use in treatment of a disease or disorder (pg. 1). Pettine’s compositions comprise one or more extracellular vesicles derived from mesenchymal stem cells (pg. 1), wherein the compositions comprise 0.00001 wt% to 20 wt% of EVs (pg. 32), and may further comprise an oligosaccharide as a protective coating to reduce degradation (pg. 35). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have prepared the composition of Traweger using the teachings of Pettine regarding substantially identical compositions, to arrive at the compositions encompassed by instant claims 39-40. It would have amounted to preparing known compositions comprising extracellular vesicles derived from mesenchymal stem cells, using known elements to prepare such compositions, by known means to yield predictable results. The skilled artisan would have had a reasonable expectation of success in preparing the compositions of Traweger using the teachings of Pettine because Traweger and Pettine teach substantially identical compositions. The skilled artisan would have been motivated to prepare the compositions of Traweger using the teachings of Pettine because Pettine provides specific elements which can be used to prepare the substantially identical compositions used in the method taught by Traweger. Claim Rejections - 35 USC § 103 – Staufer in view Li Claims 33-34 are rejected under 35 U.S.C. 103 as being unpatentable over Staufer (Staufer et al., WO 2021/152115 A1, published 5 August 2021) as applied to claims 25, 27-28, 32, 35-36, 38, and 42-43 above, in view of Li (Li et al., 2014, Chem. Soc. Rev., 2014, 43, pg. 506-517). The teachings of Staufer are described above and applied as to claims 25, 27-28, 32, 35-36, 38, and 42-43 therein. Staufer does not teach that the one or more RNAs comprise a modification to reduce degradation, wherein the modification is 2’-fluoro. However, Li teaches that “miRNA mimics are usually unstable and have low potency inside cells” (pg. 512, left col.). Li teaches chemical modifications which improve stability and activity of miRNA mimics, including 2’-fluoro (pg. 512, left col.). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have prepared the miRNA mimics in the one or more extracellular vesicles of Staufer with a modification to reduce degradation, wherein the modification comprises 2’-fluoro. It would have amounted to preparing known miRNA mimics, using known modifications, by known means to yield predictable results. The skilled artisan would have had a reasonable expectation of success in preparing the miRNA mimics of Staufer with the 2’-fluoro modification taught by Li because as evidenced by Li, miRNA mimics can be prepared using such modifications. The skilled artisan would have been motivated to prepare the miRNA mimics of Staufer with 2’-fluoro modification because Li teaches that miRNA mimics exhibit low stability and potency in cells, and 2’-fluoro modification promotes stability and activity of miRNA mimics. Conclusion No claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNA L PERSONS whose telephone number is (703)756-1334. The examiner can normally be reached M-F: 9-5pm. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JENNIFER A DUNSTON can be reached at (571) 272-2916. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /JENNA L PERSONS/Examiner, Art Unit 1637 /Soren Harward/Primary Examiner, TC 1600
Read full office action

Prosecution Timeline

Mar 29, 2023
Application Filed
May 27, 2026
Non-Final Rejection mailed — §102, §103, §112 (current)

Precedent Cases

Applications granted by this same examiner with similar technology

Patent 12674161
STAT3 TARGETING OLIGONUCLEOTIDES AND USES THEREOF
1y 1m to grant Granted Jul 07, 2026
Patent 12668800
METHODS AND COMPOSITIONS FOR TARGETED TRANS-SPLICING
1y 7m to grant Granted Jun 30, 2026
Patent 12655424
METHODS AND COMPOSITIONS FOR TRANS-SPLICING UTILIZING SMALL NUCLEAR RNAS AND SMALL NUCLEOLAR RNAS
1y 7m to grant Granted Jun 16, 2026
Patent 12644148
IN VITRO DETECTION OF NUCLEIC ACID
5y 3m to grant Granted Jun 02, 2026
Patent 12606835
AUTO-INDUCTION REGULATORY SYSTEM BASED ON QUORUM SENSING AND APPLICATION THEREOF
3y 9m to grant Granted Apr 21, 2026
Study what changed to get past this examiner. Based on 5 most recent grants.

Strategy Recommendation AI-generated — please review before filing

Get a prosecution strategy drawn from examiner precedents, rejection analysis, and claim mapping.
Typically takes 5-10 seconds — AI-generated, attorney review required before filing

Prosecution Projections

1-2
Expected OA Rounds
52%
Grant Probability
99%
With Interview (+58.4%)
3y 6m (~2m remaining)
Median Time to Grant
Low
PTA Risk
Based on 58 resolved cases by this examiner. Grant probability derived from career allowance rate.

Sign in with your work email

Enter your email to receive a magic link. No password needed.

Personal email addresses (Gmail, Yahoo, etc.) are not accepted.

Free tier: 3 strategy analyses per month