Prosecution Insights
Last updated: April 19, 2026
Application No. 17/905,442

PREVENTION OR TREATMENT OF ANEURYSMS USING MIR-33B INHIBITOR

Non-Final OA §103§DP
Filed
Sep 01, 2022
Examiner
CHONG, KIMBERLY
Art Unit
1636
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
National Institutes Of Biomedical Innovation Health And Nutrition
OA Round
1 (Non-Final)
72%
Grant Probability
Favorable
1-2
OA Rounds
2y 7m
To Grant
85%
With Interview

Examiner Intelligence

Grants 72% — above average
72%
Career Allow Rate
1066 granted / 1473 resolved
+12.4% vs TC avg
Moderate +12% lift
Without
With
+12.5%
Interview Lift
resolved cases with interview
Typical timeline
2y 7m
Avg Prosecution
67 currently pending
Career history
1540
Total Applications
across all art units

Statute-Specific Performance

§101
3.9%
-36.1% vs TC avg
§103
26.8%
-13.2% vs TC avg
§102
20.6%
-19.4% vs TC avg
§112
29.5%
-10.5% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1473 resolved cases

Office Action

§103 §DP
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 Election/Restrictions Applicant's election without traverse of Group I, claims 15-24 in the reply filed on 02/26/2026 FILLIN "Enter mail date of the reply." \* MERGEFORMAT is acknowledged. Status of the Application Claims 15-24 and 26-39 are pending. Claims 15-24 are currently under examination. Claims 26-39 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Information Disclosure Statement The submission of the Information Disclosure Statement s are in compliance with 37 CFR 1.97. The information disclosure statement s ha ve been considered by the examiner and signed copies have been placed in the file. Specification – Sequence Listing The following guidelines illustrate the preferred layout for the specification of a utility application. These guidelines are suggested for the applicant’s use. Arrangement of the Specification As provided in 37 CFR 1.77(b), the specification of a utility application should include the following sections in order. Each of the lettered items should appear in upper case, without underlining or bold type, as a section heading. If no text follows the section heading, the phrase “Not Applicable” should follow the section heading: (a) TITLE OF THE INVENTION. (b) CROSS-REFERENCE TO RELATED APPLICATIONS. (c) STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT. (d) THE NAMES OF THE PARTIES TO A JOINT RESEARCH AGREEMENT. (e) INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A READ-ONLY OPTICAL DISC, AS A TEXT FILE OR AN XML FILE VIA THE PATENT ELECTRONIC SYSTEM. (emphasis added). (f) STATEMENT REGARDING PRIOR DISCLOSURES BY THE INVENTOR OR A JOINT INVENTOR. (g) BACKGROUND OF THE INVENTION. (1) Field of the Invention. (2) Description of Related Art including information disclosed under 37 CFR 1.97 and 1.98. (h) BRIEF SUMMARY OF THE INVENTION. ( i ) BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S). (j) DETAILED DESCRIPTION OF THE INVENTION. (k) CLAIM OR CLAIMS (commencing on a separate sheet). (l) ABSTRACT OF THE DISCLOSURE (commencing on a separate sheet). (m) SEQUENCE LISTING. (See MPEP § 2422.03 and 37 CFR 1.821 - 1.825). A “Sequence Listing” is required on paper if the application discloses a nucleotide or amino acid sequence as defined in 37 CFR 1.821(a) and if the required “Sequence Listing” is not submitted as an electronic document either on read-only optical disc or as a text file via the patent electronic system. 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. This requirement is necessary if the application has: ( i ) One or more ASCII plain text files, submitted via the USPTO patent electronic filing system or on one or more read-only optical discs ( see § 1.52(e)(8) ), identifying the names of each file, the date of creation of each file, and the size of each file in bytes, for the following document types: (A) A "Computer Program Listing Appendix" ( see § 1.96(c) ); (B) A “Sequence Listing" ( see § 1.821(c) ); or (C) "Large Tables" ( see § 1.58(c) ). (ii) An XML file for a " Sequence Listing XML" ( see § 1.831(a) ), submitted via the USPTO patent electronic filing system or on one or more read-only optical discs ( see § 1.52(e)(8) ), identifying the names of each file, the date of creation of each file, and the size of each file in bytes . 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 Claim Objections Claim 1 5 is objected to because of the following informalities: The claim recites “ An antisense oligonucleotide against miR-33b, consisting of: a nucleobase sequence described in SEQ ID NO: 5, AACAGCAATGCA ” and would be clearer if rephrased to “ An antisense oligonucleotide agains t targeted to miR-33b, consisting of: a nucleobase sequence described in SEQ ID NO: 5, AACAGCAATGCA ” . Appropriate correction is suggested. 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 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. The factual inquiries set forth in Graham v. John Deere Co. , 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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. Claims 15-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Naar et al. (US 20130245093) and Yahara et al . ( "Amido-Bridged Nucleic Acids ( AmNas ) Synthesis, Duplex Stability, Nuclease Resistance, and in Vitro Antisense Potency,", ChemBioChem , Vol 13, No 17, October 18, 2012, pp 2513-2516 of record IDS filed 06/05/2024). Naar et al. teach antisense oligonucleotides targeted to miR-33b for regulating lipid metabolism (see abstract). Naar et al. teach the miR-33b sequence of SEQ ID No. 2 (see col. 17). Naar et al. teach the antisense oligonucleotide can be from 12 or 13 to 30 nucleotides in length (0051), can have a phosphorothioate linkage (0054), can have base and sugar modifications (0058-0062) and teach pharmaceutical compositions comprising the antisense oligonucleotide (0101-0109). Naar et al. teach the efficacy and safety of targeting miR-33b to affect the metabolic profiles of subjects and teach other aspects such as advantages and modification are within the scope of the invention (see 0164-0167). It would have been obvious to one of ordinary skill in the art to make the claimed antisense oligonucleotide targeted to mir-33b having SEQ ID No. 5 given Naar et al. specifically teach methods of making and using the oligonucleotide wherein the preferred length starts at 12 nucleotides in length , which is instantly claimed, and teach the sequence of miR-33b. Because Naar et al. teach preferred lengths of 12 to 30 nt in length and the sequence of miR-33b is known, there is a finite number of antisense oligonucleotides that could be made and one of skill in the art would have wanted to make different sizes to test for the optimal antisense inhibition in efforts to find an optimal anti-miRNA therapeutic to regulate lipid metabolism . Furthermore, KSR states an obvious to try rationale may be proper when the possible options for solving a problem are known, finite, and predictable, with a reasonable expectation of success . KSR, 550 U.S. at 418, 82 USPQ2d at 1396. Also, see MPEP § 2143. One of skill in the art would have been capable of modifying the antisense oligonucleotide with sugars, bases or linkages. Naar et al. do not teach the antisense oligonucleotide has a sugar moiety of an amido bridged nucleic acid ( AmNa ) as in claim 18. Yahara et al. teach synthesis of AmNas and incorporation into antisense oligonucleotides to increase stability and nuclease resistance (see structure below and page 2514. Yahara et al. teach incorporation of multiple AmNas in various positions such as alternating positions as in claim 23 (see page 2515 and Tables 1 and 2). . Yahara et al. teach the antisense oligonucleotides with AmNas had greater exonuclease resistance and potency as compared to LNA and are good candidates to modify oligonucleotides (see page 2515). It would have been obvious to one of ordinary skill in the art to modify the antisense oligonucleotide with AmNas to increase exonuclease resistance and improve potency and one of ordinary skill in the art would have been capable given the teachings of Yahara . Thus in the absence of evidence to the contrary, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed. 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. See 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 reference 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. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b). The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/forms/. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA/25, or PTO/AIA/26) 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 15-24 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-20 of U.S. Applicant No. 18/288,887 (App887) . Although the conflicting claims are not identical, they are not patentably distinct from each other because the instant claims and the claims of the patent are drawn to patently indistinguishable subject matter . Claims of App887 are drawn to methods of treatment using an antisense oligonucleotide targeted to miR-33b wherein the miR-33b comprises a modified sugar moiety of AmNa and it would have been obvious to use the claimed antisense oligonucleotide targeted to miR-33b wherein the miR-33b comprises a modified sugar moiety of AmNa in the methods of App887 . T he Court of Appeals for the Federal Circuit in Pfizer Inc, v Teva pharmaceuticals USA Inc. , 86 USPQ2d 1001 at page 1008 (March 2008), indicated that there is no patentable distinction between claims to a product and a method of using that product disclosed in the specification of the application. Thus, the co-pending product could be used in the method of the instant claims. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT Kimberly Chong at FILLIN "Phone number" \* MERGEFORMAT (571)272-3111 . The examiner can normally be reached Monday thru Friday between FILLIN "Work schedule?" \* MERGEFORMAT M-F 8:00am-4:30pm . If attempts to reach the examiner by telephone are unsuccessful please contact the SPE for 1636 Neil Hammell at 571-272-5919. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. 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 more information about the PAIR system, see http://pair-direct.uspto.gov. For all other customer support, please call the USPTO Call Center (UCC) at 800-786-9199. /KIMBERLY CHONG/ Primary Examiner Art Unit 1636
Read full office action

Prosecution Timeline

Sep 01, 2022
Application Filed
Mar 29, 2026
Non-Final Rejection — §103, §DP (current)

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

1-2
Expected OA Rounds
72%
Grant Probability
85%
With Interview (+12.5%)
2y 7m
Median Time to Grant
Low
PTA Risk
Based on 1473 resolved cases by this examiner. Grant probability derived from career allow rate.

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