Prosecution Insights
Last updated: April 19, 2026
Application No. 18/267,015

COMPLEX FOR TREATING OPTIC NERVE DISEASE, AND PREPARATION METHOD THEREFOR AND USE THEREOF

Non-Final OA §101§103§112
Filed
Jun 13, 2023
Examiner
CHONG, KIMBERLY
Art Unit
1636
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Chengdu Genreze Gene Technology Co. Ltd.
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

§101 §103 §112
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 Status of the Application Claims 1-14 are pending and are currently under examination. Information Disclosure Statement The submission of the Information Disclosure Statement on 06/13/2023 is not in compliance with 37 CFR 1.97. There are several NPL documents that were filed that are not cited on the IDS and will not be considered. There are 8 NPL documents filed however only 5 are cited. Citation No. 4 is cited but has not been filed with the application. Also some of the filed NPL documents do not have any notation for the journal or year published and it cannot be ascertained where the references are published. There is a Foreign Document not in English and it cannot be determined what the title or publication date this document represents. Also the document having No. 112007044 is not in the file but is on the IDS and therefore is not considered. The information disclosure statement has been considered by the examiner and signed copies have been placed in the file. Priority Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file. However, applicant cannot rely on the foreign priority document to overcome any prior art rejections because translation of the foreign priority document has not been made of record in accordance to 37 CFR 1.55 Drawings Color photographs and color drawings filed on September 06/13/2023 are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via EFS-Web or three sets of color drawings or color photographs, as appropriate, if not submitted via EFS-Web, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification: The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee. Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2). The drawings filed 06/13/2023 are objected to under 37 CFR 1.83(a) because they are illegible for the reasons listed below: Figs. 3, 5a-d, 9 and 11-14 have text that is in small font and therefor is illegible. Figs. 11-13, 15-17 and 20-24 have multiple figures that are not delineated by a, b, c etc. in the figure or specification and therefore it is not clear what is being described in the brief description of the figures. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. Replacement drawing sheets in compliance with 37 CFR 1.84 and 1.121(d) containing figures that are of sufficient quality to be electronically reproduced are required. See 37 CFR 1.84(I). Replacement drawing sheets in compliance with 37 CFR 1.84 and 1.121(d) containing figures that are of sufficient quality to be electronically reproduced are required. MPEP § 608.02(d). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance. Specification The abstract of the disclosure filed 06/13/2023 is objected to because it contains statements of the alleged merits or value of the claimed invention or its speculative application because it recites the following “The tFNA-miR22 can effectively inhibit apoptosis of retinal ganglion cells and promote the release of a brain-derived neurotrophic factor (BDNF), thereby achieving a good protection effect for the retinal ganglion cells” “and the tFNA-miR22 has very good application prospect”. Appropriate corrected is required. Correction is required. See MPEP § 608.01(b). Sequence Compliance 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 on the attached Notice To Comply With Requirements For Patent Applications Containing Nucleotide Sequence And/Or Amino Acid Sequence Disclosures. Applicant must comply with the requirements of the sequence rules (37 CFR 1.821 - 1.825) before the application can be examined under 35 U.S.C. §§ 131 and 132. REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES Items 1) and 2) provide general guidance related to requirements for sequence disclosures. 37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," 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 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted: In accordance with 37 CFR 1.821(c)(1) 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") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying: the name of the ASCII text file; ii) the date of creation; and iii) the size of the ASCII text file in bytes; In accordance with 37 CFR 1.821(c)(1) 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 of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying: the name of the ASCII text file; the date of creation; and the size of the ASCII text file in bytes; In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended). When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824. If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical. If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical. Specific deficiencies and the required response to this Office Action are as follows: DEFECTIVE: This validation report concerns the sequence listing filed 06-13-2023 and indicates the errors found by the USPTO during validation of the sequence listing. Any resolution of the errors identified in this validation report should not be construed as meaning that the sequence listing will comply with all of the requirements of 37 CFR §§ 1.821- 1.825, WIPO Standard ST.25, 37 CFR §§ 1.831-1.835 and 1.839, or WIPO Standard ST.26. For any sequence listing related questions or concerns, the Applicant is invited to contact the USPTO Sequence Help Desk at 571-272-2510 or SequenceHelpDesk@USPTO. GOV National phase entry with international filing date before July 1, 2022. This sequence listing was submitted in a US national phase application with an international filing date before July 1, 2022. Therefore, ST.25 format is required. Sequence listings submitted in either non-provisional applications filed under 35 U.S.C. 1lll(a) or provisional applications filed under 111(b) that have a filing date BEFORE July 1, 2022 must be in ASCII text format and comply with WIPO Standard ST.25 and 37 CFR 1.821 through 1.825. Sequence listings submitted in either PCT applications or U.S. national phase applications submitted under 35 U.S.C. 371(c) that have an international filing date BEFORE July 1, 2022 must be in ASCII text format and comply with WIPO Standard ST.25 and/or 37 CFR 1.821 through 1.825. 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 8-12 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. Claims 8-12 are indefinite because they attempt to claim processes without setting forth any steps involved in the processes. Claims that recite a use without any active, positive steps delimiting how the use is actually practiced are indefinite. See MPEP 2173.05(q).See MPEP 2173.05(q). 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 8-12 are rejected under 35 U.S.C. 101 because they are improper process claims. Although a claim should be interpreted in light of the specification disclosure, it is generally considered improper to read limitations contained in the specification into the claims. See In re Prater, 415 F.2d 1393, 162 USPQ 541 (CCPA 1969) and In re Winkhaus, 527 F.2d 637, 188 USPQ 129 (CCPA 1975), which discuss the premise that one cannot rely on the specification to impart limitations to the claim that are not recited in the claim. Claims 8-12 are drawn to processes, but recite no method steps by which the processes should be carried out. Accordingly they are considered to be improper process claims under 35 USC 101. 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. Claim 3-5 and 8-12 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. Claims 3-5 recites the mir-22 is linked to either 1-4 of the 4 single stranded DNA or is linked to the single-stranded DNA and is indefinite because it is unclear how the miR-22 can be linked to all 4 of the single-stranded DNA as in claim 3 or linked to which single-stranded DNA because the claims recite the linker is between “the miRNA” and “the linked single-stranded DNA” which indicates a single DNA strand. Claims 8-12 recite "Use of the complex”, “Use of claim 8”, “The use of claim 8”, “The use of claim 10” and the “use of claim 8” and are indefinite because the claims appear to be method claims but do not recite any method steps. The claims will not be further examined on the merits because it cannot be ascertained, without assumption, what further steps are included in the claims. 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 1-3, 6, 7 and 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable Zhang et al. (Nano Lett. 2018, 18, 5652−5659), Shao et al. ("Effect of tetrahedral DNA nanostructures on osteogenic differentiation of mesenchymal stem cells via activation of the Wnt/β-catenin signaling pathway." Nanomedicine: Nanotechnology, Biology and Medicine 13.5 (2017): 1809-1819), Hu et al., "Protective effects of microRNA‐22‐3p against retinal pigment epithelial inflammatory damage by targeting NLRP3 inflammasome" Journal of Cellular Physiology, December 31, 2019 of record cited on IDS filed 06/13/2023), Feng, Liang, and Xiaorong Liu. "NLRP3 inflammasome in retinal ganglion cell loss in optic neuropathy." Neural Regeneration Research 11.7 (2016): 1077-1078) and Gu, Wei, et al. "Micro RNA‐22 regulates inflammation and angiogenesis via targeting VE‐cadherin." FEBS letters 591.3 (2017): 513-526). Zhang et al. teach DNA tetrahedral structure (TDN) has great potential;19−21 it exhibits sequence specificity, excellent biocompatibility, inherent nontoxicity to bacterial and mammalian cells, high biostability, and the potential to precisely control its size and structure, making it a promising therapeutic delivery vehicle (page 5653). Zhang et al. teach the TDN is made up of 4 DNA sequences as shown below. PNG media_image1.png 62 668 media_image1.png Greyscale Zhang et al. teach the TDN successfully delivered an antisense nucleic acid into cells (see page 5656 and Fig 3). Zhang et al. does not teach the full sequence SEQ ID No. 2 or using miR-22 to treat optic nerve diseases. Zhang et al. teach preparing the TDN and oligonucleotide by heating the complex for 10 min and then reducing the temperature (see page 5653 second col.). Shao et al. teach using a tetrahedral DNA nanostructure and state these are a new type of DNA-based biomaterial with great potential (see abstract). Shao et al. teach the tetrahedral DNA nanostructure comprises the claimed nanostructures: PNG media_image2.png 180 323 media_image2.png Greyscale It would have been obvious to try using each the sets of nanostructures to make a complex with miRNA because both Zhang et al. and Shao et al. teach these were new and revolutionary in the biosciences with S2 of Zhang et al. is a partial sequence of S2 of Shao et and one of skill in the art would want to determine which set would be more efficient. al. Hu et al. teach miR-22 plays a suppressive role against an optic nerve disease such as retinal pigment epithelial inflammatory by targeting NLRP3 inflammasome and provides evidence that miR-22 can have a regulatory effect on NLRP3 (see Fig.3). Hu et al. Hu et al. suggests that future therapeutic strategies developed toward restoring the miR‐22‐3p function would be helpful in retinal diseases (conclusion). Hu et al. does not teach miR-22 is associated with optic nerve diseases. Liang et al. teach NLRP3 inflammasome is involved in retinal ganglion cell (RGC) loss in optic neuropathy due to glaucoma and found that when NLRP3 was knocked out in mice, RGC life was extended (see conclusion). Liang et al. teach this data provides opportunities to develop drugs targeting NLRP3 to preserve vision of patients with optic neuropathy (conclusion). Gu et al. teach the known miR-22 sequence (Table 2). It would have been obvious to make a complex for treating an optic neuropathy by making a complex comprising miR-22 and a TDN given miR-22 was known to regulate the function of NLRP3 and NLRP3 expression has been shown to extend the life of RGC. One of skill in the art would have been motivated to use the method Zhang et al. to make the complex given Liang et al. suggests using miR-22 provides an opportunity to target NLR3 and preserve the vison of patients with this condition. It would have further been obvious to use the known miR-22 sequence and different temperatures and times in preparing the complex to find the optimal conditions for preparation. It would have been obvious to try to make the complex given optic nerve damage, caused by glaucoma, was a problem to be solved, Zhang et al. teach TDN efficiently delivered nucleic acids to cells, NLRP3 when targeting with miR-22 had a regulatory effect on NRP3 and given NLRP3 inflammasome is involved in retinal ganglion cell (RGC) loss in optic neuropathy due to glaucoma. There was finite number of options to making the complex and a predictable outcome of success. There is an expectation of an advantage for using the TDN to make a complex comprising a miR-22 and thus a motivation to combine the prior art references for treatment of fibrosis (see MPEP 2144). Conclusive proof of efficacy is not required to show a reasonable expectation of success and obviousness does not require absolute predictability, but at least some degree of predictability is required (MPEP 2143.02). 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. Claim Rejections - 35 USC § 112 The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph: 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 1-7, 13 and14 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 methods of treating optic nerve disease due to injury or glaucoma using a complex comprising an tetrahedral DNA linked to a miR-22 using any linker a linker in claim 5 , does not reasonably provide enablement for treatment of any optic nerve disease. 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. The following factors have been considered in the analysis of enablement: (1) the breadth of the claims, (2) the nature of the invention, (3) the state of the prior art, (4) the level of one of ordinary skill, (5) the level of predictability in the art, (6) the amount of direction provided by the inventor, (7) the existence of working examples, (8) the quantity of experimentation needed to make or use the invention based on the content of the disclosure. The breadth of the claims the nature of the invention: The claims are drawn to a complex and methods of treating any type of optic nerve disease comprising any tetrahedral DNA sequence and a miR-22 such as retinal ganglion cell injury, retinal cell apoptosis or brain-derived neurogenic factor-related signaling pathway or glaucoma. Whether the specification would have been enabling as of the filing date involves consideration of the nature of the invention, the state of the prior art, and the level of skill in the art. The state of the prior art is what one skilled in the art would have known, at the time the application was filed, about the subject matter to which the claimed invention pertains. The relative skill of those in the art refers to the skill of those in the art in relation to the subject matter to which the claimed invention pertains at the time the application was filed. See MPEP § 2164.05(b). The state of the prior art provides evidence for the degree of predictability in the art and is related to the amount of direction or guidance needed in the specification as filed to meet the enablement requirement. The state of the prior art is also related to the need for working examples in the specification. The state of the prior art: The prior art of Biousse et al. ("Diagnosis and clinical features of common optic neuropathies." The lancet neurology 15.13 (2016): 1355-1367) teach a broad range of optic nerve diseases with glaucoma being the most common (see Panet 2 page 1361). A review of the prior art does not provide a correlation between administration of miR-22 in a complex of TDN and treatment of the broad range of optic nerve diseases. The level of one of ordinary skill: While the level of one of ordinary skill practicing said invention would be high, the level of predictability is considered variable as evident in the prior art discussed above and is not considered to provide sufficient enablement to practice the claimed invention. Because the state of the prior art does not provide evidence of the degree of predictability that using any Tetrahedral DNA and miR-22 and treatment of any type of optic nerve disease, one of ordinary skill in the art would look for guidance or direction in the instant specification. The level of predictability in the art: “The “predictability or lack thereof” in the art refers to the ability of one skilled in the art to extrapolate the disclosed or known results to the claimed invention. If one skilled in the art can readily anticipate the effect of a change within the subject matter to which the claimed invention pertains, then there is predictability in the art. On the other hand, if one skilled in the art cannot readily anticipate the effect of a change within the subject matter to which that claimed invention pertains, then there is lack of predictability in the art. Accordingly, what is known in the art provides evidence as to the question of predictability.” (MPEP 2164.03). The amount of direction provided by the inventor: 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). The existence of working examples: The working embodiment in the instant application describes using a TDN having sequences 1-4 and a miR-22 wherein uptake of the complex was demonstrated in injured retinal ganglion cells (see Example 1) and inhibits NMDA induced cell injury (See Example 2). The working embodiments do not teach treatment of any optic nerve disease using the claimed complex. The standard of an enabling disclosure is not the ability to make and test if the invention works but one of the ability to make and use with a reasonable expectation of success. A patent is granted for a completed invention, not the general suggestion of an idea (MPEP 2164.03 and Chiron Corp. v. Genentech Inc., 363 F.3d 1247, 1254, 70 USPQ2d 1321, 1325-26 (Fed. Cir. 2004). The instant invention suggests administration of a complex comprising any tetrahedral DNA and miR-22 and treatment of any type of optic nerve disease without an enabling disclosure or guidance in the prior art. While the MPEP 2164.02 states 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), the lack of a working example, however, is a factor to be considered, especially in a case involving an unpredictable and undeveloped art. The quantity of experimentation needed to make or use the invention based on the content of the disclosure: The prior art is undeveloped for the role miR-22 plays in all optic nerve diseases and the specification does not provide sufficient guidance. 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. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kimberly Chong at (571)272-3111. The examiner can normally be reached Monday thru Friday between 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

Jun 13, 2023
Application Filed
Dec 14, 2025
Non-Final Rejection — §101, §103, §112 (current)

Precedent Cases

Applications granted by this same examiner with similar technology

Patent 12595481
METHODS AND COMPOSITIONS FOR NEUROPROTECTION
2y 5m to grant Granted Apr 07, 2026
Patent 12590307
TRANSLATION ENHANCING NUCLEIC ACID COMPOUNDS: ASO COUPLED TRANSLATION – UPREGULATION 1 (ACT-UP1) AND USES THEREOF
2y 5m to grant Granted Mar 31, 2026
Patent 12571052
Immunomodulatory RNA
2y 5m to grant Granted Mar 10, 2026
Patent 12559750
Methods and Compositions for Treatment of Polycystic Kidney Disease
2y 5m to grant Granted Feb 24, 2026
Patent 12539309
COMPOSITIONS COMPRISING CIRCULAR POLYRIBONUCLEOTIDES AND USES THEREOF
2y 5m to grant Granted Feb 03, 2026
Study what changed to get past this examiner. Based on 5 most recent grants.

AI Strategy Recommendation

Get an AI-powered prosecution strategy using examiner precedents, rejection analysis, and claim mapping.
Powered by AI — typically takes 5-10 seconds

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.

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