Prosecution Insights
Last updated: July 17, 2026
Application No. 18/251,571

VIRAL VECTORS AND NUCLEIC ACIDS FOR USE IN THE TREATMENT OF ILD, PF-ILD AND IPF

Non-Final OA §112§DOUBLEPATENT
Filed
May 03, 2023
Priority
Nov 04, 2020 — nonprovisional of PCTEP2020081019
Examiner
GIBBS, TERRA C
Art Unit
1635
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Boehringer Ingelheim International GmbH
OA Round
1 (Non-Final)
64%
Grant Probability
Moderate
1-2
OA Rounds
0m
Est. Remaining
74%
With Interview

Examiner Intelligence

Grants 64% of resolved cases
64%
Career Allowance Rate
611 granted / 957 resolved
+3.8% vs TC avg
Moderate +10% lift
Without
With
+10.5%
Interview Lift
resolved cases with interview
Typical timeline
2y 8m
Avg Prosecution
36 currently pending
Career history
995
Total Applications
across all art units

Statute-Specific Performance

§101
6.2%
-33.8% vs TC avg
§103
51.2%
+11.2% vs TC avg
§102
9.1%
-30.9% vs TC avg
§112
15.4%
-24.6% vs TC avg
Black line = Tech Center average estimate • Based on career data from 957 resolved cases

Office Action

§112 §DOUBLEPATENT
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 . DETAILED ACTION This Office Action is a response to Applicant’s Response to Election/Restriction filed February 10, 2026. Claim 27 has been amended. Claims 1-17, 27-29, 31-35, 37, 39-47 and 49 are pending in the present application. Election/Restrictions Applicant’s election (without traverse) of Group I in the reply filed on February 10, 2026 is acknowledged. Claims 37 and 39-47 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on February 10, 2026. The requirement is still deemed proper and is therefore made FINAL. Accordingly, claims 1-17, 27-29, 31-35 and 49 have been examined on the merits as detailed below: Information Disclosure Statement Applicant’s information disclosure statement (IDS) filed June 26, 2025 is acknowledged. The submission is in compliance with the provisions of 37 CFR §1.97. Accordingly, the Examiner has considered the information disclosure statement, and a signed copy is enclosed herewith. Applicant’s IDS filed November 4, 2024 is acknowledged. The submission is in compliance with the provisions of 37 CFR §1.97. Accordingly, the Examiner has considered the information disclosure statement, and a signed copy is enclosed herewith. Applicant’s IDS filed May 14, 2024 is acknowledged. The submission is in compliance with the provisions of 37 CFR §1.97. Accordingly, the Examiner has considered the information disclosure statement, and a signed copy is enclosed herewith. The listing of references in the specification at pages 71-76 is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered. Drawings The Drawings filed May 3, 2023 are acknowledged and have been accepted by the Examiner. Nucleotide Sequence Disclosures This application contains sequence disclosures that are encompassed by the definitions for nucleotide and/or amino acid sequences set forth in 37 C.F.R. §1.821(a)(1) and (a)(2). However, this application fails to comply with the requirements of 37 C.F.R. §1.821-1.825 for the reason(s) set forth below or on the attached Notice To Comply with Requirements for Patent Applications Containing Nucleotide Sequence and/or Amino Acid Sequence Disclosures. The disclosure contains sequences which fall under the purview of 37 CFR 1.821 through 1.825 as requiring SEQ ID NOs., but which are not so identified. For example, see Figure 11B and page 60. This is an example and does not indicate that the Examiner has made an exhaustive review of the application. Applicant must fully comply with the sequence rules for any response to this action to be considered fully responsive. 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 1-17, 27-29, 31-35 and 49 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 pre-AIA the applicant regards as the invention. The claims are indefinite because the terms, “ILD”; “PF-ILD”; “and IPF” are not clearly defined. Since abbreviations often have more than one meaning, it is suggested that inserting the full names of the interstitial lung disease; progressive fibrosing interstitial lung disease; and idiopathic pulmonary fibrosis, respectively, would be appropriate. Claims 28, 32 and 34 are further indefinite because it is unclear whether parts following the term, “optionally” are actually a part of the claims. The term, “optionally” is ambiguous and confusing since the alternatives covered by the claims are not clear. See MPEP 2173.05(h) for further explanation. Claim 15 is further indefinite because the term, “preferably” creates ambiguity regarding whether the listed feature is an essential limitation or an optional one. The term does not define the invention's boundaries and therefore renders the claim indefinite. ****** 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. Claims 1-17, 27-29, 31-35 and 49 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method of treating a disease selected from the group consisting of interstitial lung disease (ILD), progressive fibrosing interstitial lung disease (PF-ILD), and idiopathic pulmonary fibrosis (IPF), the method comprising administering to a patient in need thereof a therapeutically active amount of viral vector, wherein said viral vector comprises a capsid and a packaged nucleic acid, wherein the packaged nucleic acid codes for one or more miRNAs, wherein the one or more miRNAs comprise the miRNA of Seq ID No. 15 or a fragment thereof having the sequence of Seq ID No. 99, does not reasonably provide enablement for a method of treating or preventing a disease selected from the group consisting of ILD, PF-ILD, IPF, connective tissue disease (CTD)-associated ILD, rheumatoid arthritis ILD, chronic fibrosing hypersensitivity pneumonitis (HP), idiopathic non-specific interstitial pneumonia (iNSIP), unclassifiable idiopathic interstitial pneumonia (IIP), environmental/occupational lung disease, pulmonary hypertension (PH), fibrotic silico-sis, systemic sclerosis ILD, sarcoidosis, and fibrosarcoma, the method comprising administering to a patient in need thereof a therapeutically active amount of viral vector, wherein said viral vector comprises a capsid and a packaged nucleic acid, wherein the packaged nucleic acid codes for one or more miRNAs, wherein the one or more miRNAs comprise the miRNA of Seq ID No. 15 or a fragment thereof having the sequence of Seq ID No. 99. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims. This is a scope enablement rejection. Factors to be considered in determining whether a disclosure meets the enablement requirement of 35 USC 112, first paragraph, have been described by the court in In re Wands, 8 USPQ2d 1400 (CA FC 1988). Wands states on page 1404, “Factors to be considered in determining whether a disclosure would require undue experimentation have been summarized by the board in Ex parte Forman. They include (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.” The nature of the invention. The claims are drawn to a method of treating or preventing a disease selected from the group consisting of ILD, PF-ILD, IPF, connective tissue disease (CTD)-associated ILD, rheumatoid arthritis ILD, chronic fibrosing hypersensitivity pneumonitis (HP), idiopathic non-specific interstitial pneumonia (iNSIP), unclassifiable idiopathic interstitial pneumonia (IIP), environmental/occupational lung disease, pulmonary hypertension (PH), fibrotic silico-sis, systemic sclerosis ILD, sarcoidosis, and fibrosarcoma, the method comprising administering to a patient in need thereof. The inventions are in a class of invention which the CAFC has characterized as “the unpredictable arts such as chemistry and biology.” Mycogen Plant Sci., Inc. v. Monsanto Co., 243 F.3d 1316, 1330 (Fed. Cir. 2001). It should be made clear that, the enabling specification must teach those skilled in the art to make and use the full scope of the claimed invention without undue experimentation. “Although not explicitly stated in section 112, to be enabling, the specification of a patent must teach those skilled in the art how to make and use the full scope of the claimed invention without "undue experimentation." Vaeck, 947 F.2d at 495, 20 USPQ2d at 1444; Wands, 858 F.2d at 736-37, 8 USPQ2d at 1404; In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970) (the first paragraph of section 112 requires that the scope of protection sought in a claim bear a reasonable correlation to the scope of enablement provided by the specification).” In re Wright (CAFC) 27 USPQ2d 1510 at 1513. Although a working example is not required to enable an invention, the skilled artisan must be able to practice the claimed invention without undue experimentation. See also, MPEP §2164.02, which states in part: The specification need not contain an example if the invention is otherwise disclosed in such manner that one skilled in the art will be able to practice it without an undue amount of experimentation. In re Borkowski, 422 F.2d 904, 908, 164 USPQ 642, 645 (CCPA 1970). Lack of a working example, however, is a factor to be considered, especially in a case involving an unpredictable and undeveloped art. The breadth of the claims. Regarding disease prevention, the present description does not provide an example of preventing any disease or disorder. The unpredictability of the art and the state of the prior art. The claims are so broad to encompass fibrosarcoma. The prior art does not teach a method of preventing fibrosarcoma. In fact, Cleveland Clinic downloaded from Fibrosarcoma: Symptoms, Causes & Treatment on March 25, 2026 teach: You can’t prevent fibrosarcoma. But understanding your biological family’s medical history may help with early diagnosis and treatment The data presented in the Specification does not rise to the level of prevention. Regarding “preventing” disorder/disease, it is noted that “preventing” encompasses complete (i.e., 100%) and permanent prevention. One of skill in the art would recognize that the complete prevention of any disease, including fibrosarcoma for example, would be very difficult and there would be a low level of expectation of success (i.e., highly unpredictable). The specification does not provide any working example demonstrating a method of preventing any disease. Therefore, given the lack of knowledge present in the prior art and the lack of guidance provided in the Specification with respect to preventing fibrosarcoma for example, further experimentation would be required. Considering that the additional experimentation would require de novo experimentation without a guarantee of success, and further considering that any positive results (i.e., successful disease prevention in a subject) would amount to a significant advancement in the state of the art, the additional experimentation required is considered undue. Guidance in the specification and working examples. Regarding disease treatment of ILD, PF-ILD, IPF, connective tissue disease (CTD)-associated ILD, rheumatoid arthritis ILD, chronic fibrosing hypersensitivity pneumonitis (HP), idiopathic non-specific interstitial pneumonia (iNSIP), unclassifiable idiopathic interstitial pneumonia (IIP), environmental/occupational lung disease, pulmonary hypertension (PH), fibrotic silico-sis, systemic sclerosis ILD, sarcoidosis, and fibrosarcoma, the present application teaches in an in vitro cellular TGFβ1-induced fibrotic model and Bleomycin induced or AAV-TGFβ1 induced lung fibrosis disease mouse model, miRNAs miR-212-5p (SEQ ID NO: 15), miR-181a-5p (SEQ ID NO: 17) and miR-181b-5p (SEQ ID NO: 19) were characterized regarding their impact on the cellular production of the pro-inflammatory cytokine IL-6 and the pro-fibrotic processes fibroblast proliferation, fibroblasts-to-myofibroblasts transition (FMT), collagen expression and epithelial-to-mesenchymal transition (EMT). See Figures 14-15 and page 31, for example. It is clear from the application that the proposed therapeutic effect is relevant and limited to fibrotic lung diseases ILD, PF-ILD, IPF, and not the broad list of diseases fibroproliferative disorders, with vastly different etiologies listed in the claims. The quantity of experimentation. The amount of guidance or direction needed to enable the invention is inversely related to the amount of knowledge in the state of the art as well as the predictability in the art. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). The “amount of guidance or direction” refers to that information in the application, as originally filed, that teaches exactly how to make or use the invention. The more that is known in the prior art about the nature of the invention, how to make, and how to use the invention, and the more predictable the art is, the less information needs to be explicitly stated in the specification. In contrast, if little is known in the prior art about the nature of the invention and the art is unpredictable, the specification would need more detail as to how to make and use the invention in order to be enabling. See, e.g., Chiron Corp. v. Genentech Inc., 363 F.3d 1247, 1254, 70 USPQ2d 1321, 1326 (Fed. Cir. 2004). Furthermore, in In re Vaeck, 947 F.2d 488,495, 20 USPQ2d 1438, 1444 (Fed. Cir. 1991), the Court ruled that a rejection under 35 U.S.C. 112, first paragraph for lack of enablement was appropriate given the relatively incomplete understanding in the biotechnological field involved, and the lack of a reasonable correlation between the narrow disclosure in the specification and the broad scope of protection sought in the claims. Such is the case here where there is a relatively incomplete understanding in the biotechnological field involving preventing any disease and treating the broad list of fibroproliferative disorders with different etiologies listed in the claims, as described above, and the lack of a reasonable correlation between the narrow disclosure in the Specification and the broad scope of protection sought in the claims. Without further guidance, one of skill in the art would have to practice a substantial amount of trial and error experimentation, an amount considered undue and not routine, to practice the instantly claimed invention. Therefore, it is appropriate to reject the claims under 35 USC 112(a) for not being enabled over the scope claimed. Thus, in view of the breadth of the claims, the lack of guidance, and the lack of working examples, the instant specification is not found to be enabling for preventing any disease and treating the broad list of diseases fibroproliferative disorders listed in the claims. It would require undue experimentation and making a substantial inventive contribution for the skilled artisan to discover how to make and/or use the claimed invention in its full scope. Double Patenting The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969). A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b). The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp. Claims 1-17, 27-29, 31-35 and 49 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-6, 8-10, 12-13, 16-22, 26, 28-30, 32-42 and 45-48 of copending Application No. 17/608328 (reference application). Although the conflicting claims are not identical, they are not patentably distinct from each other because the method of treating a disease selected from the group consisting of PF-ILD, IPF, connective tissue disease (CTD)-associated ILD, rheumatoid arthritis ILD, chronic fibrosing hypersensitivity pneumonitis (HP), idiopathic non-specific interstitial pneumonia (iNSIP), unclassifiable idiopathic interstitial pneumonia (IIP), environmental/occupational lung disease, systemic sclerosis ILD, sarcoidosis, and fibrosarcoma, the method comprising administering to a patient in need thereof a therapeutically active amount of viral vector comprising: a capsid and a packaged nucleic acid, wherein the packaged nucleic acid codes for one or more miRNAs, wherein at least one of the one or more miRNAs comprises the miRNA of Seq ID No. 15, Seq ID No. 17, or Seq ID No. 19 of copending Application No. 17/608328 overlaps in scope with the method of treating or preventing a disease selected from the group consisting of ILD, PF-ILD, IPF, connective tissue disease (CTD)-associated ILD, rheumatoid arthritis ILD, chronic fibrosing hypersensitivity pneumonitis (HP), idiopathic non-specific interstitial pneumonia (iNSIP), unclassifiable idiopathic interstitial pneumonia (IIP), environmental/occupational lung disease, pulmonary hypertension (PH), fibrotic silico-sis, systemic sclerosis ILD, sarcoidosis, and fibrosarcoma, the method comprising administering to a patient in need thereof a therapeutically active amount of viral vector, wherein said viral vector comprises a capsid and a packaged nucleic acid, wherein the packaged nucleic acid codes for one or more miRNAs, wherein the one or more miRNAs comprise the miRNA of Seq ID No. 15 or a fragment thereof having the sequence of Seq ID No. 99 of the instant invention. The claims of copending U.S. Application 17/608328 overlaps in scope and fully embraces that which is claimed in the present invention. This is a provisional rejection because the patentably indistinct claims have not in fact been patented. ****** Claims 1-17, 27-29, 31-35 and 49 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17, 27-29, 31-36, 38, 40-48 and 50 of copending Application No. 18/251562 (reference application). Although the conflicting claims are not identical, they are not patentably distinct from each other because the method of treating or preventing a disease selected from the group consisting of ILD, PF-ILD, IPF, connective tissue disease (CTD)-associated ILD, rheumatoid arthritis ILD, chronic fibrosing hypersensitivity pneumonitis (HP), idiopathic non-specific interstitial pneumonia (iNSIP), unclassifiable idiopathic interstitial pneumonia (IIP), environmental/occupational lung disease, pulmonary hypertension (PH), fibrotic silico-sis, systemic sclerosis ILD, sarcoidosis, and fibrosarcoma, the method comprising: administering to a patient in need thereof a therapeutically active amount of viral vector, wherein said viral vector comprises a capsid and a packaged nucleic acid, wherein the packaged nucleic acid codes for one or more miRNAs, wherein the one or more miRNAs comprise the miRNA fragment having the sequence of Seq ID No. 99 of copending Application No. 18/251562 overlaps in scope with the method of treating or preventing a disease selected from the group consisting of ILD, PF-ILD, IPF, connective tissue disease (CTD)-associated ILD, rheumatoid arthritis ILD, chronic fibrosing hypersensitivity pneumonitis (HP), idiopathic non-specific interstitial pneumonia (iNSIP), unclassifiable idiopathic interstitial pneumonia (IIP), environmental/occupational lung disease, pulmonary hypertension (PH), fibrotic silico-sis, systemic sclerosis ILD, sarcoidosis, and fibrosarcoma, the method comprising administering to a patient in need thereof a therapeutically active amount of viral vector, wherein said viral vector comprises a capsid and a packaged nucleic acid, wherein the packaged nucleic acid codes for one or more miRNAs, wherein the one or more miRNAs comprise the miRNA of Seq ID No. 15 or a fragment thereof having the sequence of Seq ID No. 99 of the instant invention. The claims of copending U.S. Application 18/251562 overlaps in scope and fully embraces that which is claimed in the present invention. This is a provisional rejection because the patentably indistinct claims have not in fact been patented. ****** Claims 1-17, 27-29, 31-35 and 49 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 19, 27-35 and 49 of copending Application No. 18/251597 (reference application). Although the conflicting claims are not identical, they are not patentably distinct from each other because the method of treating a disease selected from the group consisting of ILD, PF- ILD, IPF, connective tissue disease (CTD)-associated ILD, rheumatoid arthritis ILD, chronic fibrosing hypersensitivity pneumonitis (HP), idiopathic non-specific interstitial pneumonia (iNSIP), unclassifiable idiopathic interstitial pneumonia (IIP), environmental/occupational lung disease, pulmonary hypertension (PH), fibrotic silicosis, systemic sclerosis ILD, sarcoidosis, and fibrosarcoma, the method comprising administering to a patient in need thereof a therapeutically active amount of Viral vector comprising: a capsid and a packaged nucleic acid, wherein the packaged nucleic acid codes for two or more miRNAs, wherein the two or more miRNAs comprise (a) the miRNA of Seq ID No. 92 and the miRNA of Seq ID No.15 or a fragment thereof having the sequence of Seq ID No. 99, or (b) the miRNA of Seq ID No. 92 and the miRNA of Seq ID No. 17 or a fragment thereof having the sequence of Seq ID No. 100 of copending Application No. 18/251597 overlaps in scope with the method of treating or preventing a disease selected from the group consisting of ILD, PF-ILD, IPF, connective tissue disease (CTD)-associated ILD, rheumatoid arthritis ILD, chronic fibrosing hypersensitivity pneumonitis (HP), idiopathic non-specific interstitial pneumonia (iNSIP), unclassifiable idiopathic interstitial pneumonia (IIP), environmental/occupational lung disease, pulmonary hypertension (PH), fibrotic silico-sis, systemic sclerosis ILD, sarcoidosis, and fibrosarcoma, the method comprising administering to a patient in need thereof a therapeutically active amount of viral vector, wherein said viral vector comprises a capsid and a packaged nucleic acid, wherein the packaged nucleic acid codes for one or more miRNAs, wherein the one or more miRNAs comprise the miRNA of Seq ID No. 15 or a fragment thereof having the sequence of Seq ID No. 99 of the instant invention. The claims of copending U.S. Application 18/251597 overlaps in scope and fully embraces that which is claimed in the present invention. This is a provisional rejection because the patentably indistinct claims have not in fact been patented. Closest Prior Art of Record The Strobel, Benjamin Dissertation (submitted on the IDS filed May 14, 2024) is the closest prior art of record. The Dissertation teaches that certain small molecules can be used as available therapeutics for ILD, PF-ILD, and IPF but as a better approach an AAV could be used to deliver and express microRNAs. The Dissertation identifies miR-181a-5p, miR-676-3p and miR-192-5p as attractive candidate therapeutics for fibrosis drug discovery research. See pages 84-85 and Figure 28, for example. The Dissertation does not identify miR-212-5p as a candidate therapeutic for fibrosis drug discovery/research. In fact, Table 4 reports that miR-212-5p is upregulated in the fibrotic phase of the Bleomycin and AAV-TGFb1 models of fibrosis, while miR-181a-5p and miR-676-3p are downregulated. Further, the Dissertation reports that miR-181a-5p and miR-676-3p are correlated with a decrease in lung function observed over time in the fibrotic phase of the Bleomycin and AAV-TGFb1 models of fibrosis. However, miR-212-5p is anti-correlated with a decrease in lung function observed over time in the fibrotic phase of the Bleomycin and AAV-TGFb1 models of fibrosis. See Table 5. It should be noted that the Benjamin Dissertation reports that like miR-181a-5p, miR-181b-5p is correlated with a decrease in lung function observed over time in the fibrotic phase of the Bleomycin and AAV-TGFb1 models of fibrosis. See Table 5. Strobel et al. (Scientific Reports, (2022) 12:12190, pages 1-17, plus Supplementary Information) which is not prior art, but Applicant’s own work reporting the same findings as The Strobel, Benjamin Dissertation. See Strobel et al. Table 1. Strobel et al. conclude that (over)expression of miR-181a-5p might be a strategy to suppress fibrosis, but makes no report or mention of the role of miR-212-5p in fibrosis treatment. Given these disclosures, a person of ordinary skill in the art would find the miR-212-5p therapeutic effects to suppress and treat fibrosis reported in the present application surprising and unexpected. Conclusion No claims are allowable at this time. Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Terra C. Gibbs whose telephone number is 571-272-0758. The Examiner can normally be reached from 8 am - 5 pm M-F. If attempts to reach the Examiner by telephone are unsuccessful, the Examiner's supervisor, Ram Shukla can be reached on 571-272-0735. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. Patent applicants with problems or questions regarding electronic images that can be viewed in the Patent Application Information Retrieval system (PAIR) can now contact the USPTO's Patent Electronic Business Center (Patent EBC) for assistance. Representatives are available to answer your questions daily from 6 am to midnight (EST). The toll free number is (866) 217-9197. When calling please have your application serial or patent number, the type of document you are having an image problem with, the number of pages and the specific nature of the problem. The Patent Electronic Business Center will notify applicants of the resolution of the problem within 5-7 business days. Applicants can also check PAIR to confirm that the problem has been corrected. The USPTO's Patent Electronic Business Center is a complete service center supporting all patent business on the Internet. The USPTO's PAIR system provides Internet-based access to patent application status and history information. It also enables applicants to view the scanned images of their own application file folder(s) as well as general patent information available to the public. For all other customer support, please call the USPTO Call Center (UCC) at 800-786-9199. /TERRA C GIBBS/Primary Examiner, Art Unit 1635
Read full office action

Prosecution Timeline

May 03, 2023
Application Filed
Apr 02, 2026
Non-Final Rejection mailed — §112, §DOUBLEPATENT (current)

Precedent Cases

Applications granted by this same examiner with similar technology

Patent 12674163
COMB SHAPED ANTIVIRALS ENDING WITH OR WITHOUT CHAIN TERMINATING BASES
3y 4m to grant Granted Jul 07, 2026
Patent 12674164
CONDITIONAL-SIRNAS AND USES THEREOF IN TREATING ACUTE MYELOID LEUKEMIA
3y 3m to grant Granted Jul 07, 2026
Patent 12674169
COMPOSITIONS AND METHODS FOR MODULATING SCAP ACTIVITY
3y 2m to grant Granted Jul 07, 2026
Patent 12662671
CONSTRUCTS AND METHODS FOR PREPARING CIRCULAR RNA
2y 3m to grant Granted Jun 23, 2026
Patent 12655428
RNAi Agents for Inhibiting Expression of Beta-ENaC, Compositions Thereof, and Methods of Use
4y 1m to grant Granted Jun 16, 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
64%
Grant Probability
74%
With Interview (+10.5%)
2y 8m (~0m remaining)
Median Time to Grant
Low
PTA Risk
Based on 957 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