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 Application/Amendment/Claims
Applicant's response filed 04/16/2026 has been considered. Rejections and/or objections not reiterated from the previous office action mailed 12/07/2025 are hereby withdrawn. The following rejections and/or objections are either newly applied or are reiterated and are the only rejections and/or objections presently applied to the instant application. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
With entry of the amendment filed on 04/16/2026, claims 1, 6, 7, 13, 14 and new claims 16-31 are pending in the application.
The previous 103 rejection is withdrawn in view of Applicant’s arguments
Priority
Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d), which papers are in English and have been placed of record in the file.
Drawings
The Petition to Accept Color Drawings filed 04/16/2026 has not been decided and thus the rejection is maintained.
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).
New Claim Rejections – necessitated by claim amendments
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 14, 16-24 and 27-30 is 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 glaucoma and increasing retinal ganglion cells using a complex comprising an tetrahedral DNA linked to a miR-22,
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 methods of treating a optic nerve disease comprising glaucoma or caused by any injury 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. The broadest reasonable interpretation of the claimed invention is the optic nerve disease can be more than just glaucoma or can be any injury caused by infection.
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 of record) teach a broad range of optic nerve diseases with glaucoma being the most common (see Panel 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 or injury as claimed.
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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 and increases proliferation (See Example 2). The working embodiments do not teach treatment of any optic nerve disease using the claimed complex that encompasses the broad genus of diseases.
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.
Response to Arguments
Applicant argues the claim amendments have overcome the 112(a) enablement rejection. The rejection is reiterated in view of the new claim amendments.
Closest Prior Art and Reasons for Allowability
Claims 1, 6, 7, 13, 25, 26 and 31 are allowable.
Claims 1, 6, 7, 13, 14 and 16-31 are free of the prior and it would not have been obvious to make the formulation or use in methods of treating an optic nerve injury such as glaucoma based on Applicant’s arguments of unexpected results.
Hu et al. (cited previously) teach miR-22 plays a suppressive role against an inflammatory optic nerve disease by targeting NLRP3 inflammasome and Liang et al. teach NLRP3 inflammasome is involved in retinal ganglion cell (RGC) loss. While one of skill would expect that using miR-22 to target NLRP3 could treat optic nerve inflammation and prevent RGC loss, it would not have been expected that making a tetrahedral DNA comprising the miR-22 would significantly improve the proliferation of injured RGC-5 while tetrahedral DNA or miR22 alone did not show this effect (Figure 6D) as argued by Applicant.
Applicant presents data that using the formulation of the tetrahedral DNA and miRNA had a synergistic effect to promote cell mitosis and self-renewal. The prior art of Zhang et al., Shao et al. and Hu et al. (of record) do not teach or make obvious that the tetrahedral DNA, when combined with miR-22, would significantly improve the proliferation of injured RGC-5 or show a synergistic .
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a).
706.07(a) Final Rejection, When Proper on Second Action [R-07.2015]
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Second or any subsequent actions on the merits shall be final, except where the examiner introduces a new ground of rejection that is neither necessitated by applicant’s amendment of the claims, nor based on information submitted in an information disclosure statement filed during the period set forth in 37 CFR 1.97(c) with the fee set forth in 37 CFR 1.17(p). Where information is submitted in an information disclosure statement during the period set forth in 37 CFR 1.97(c) with a fee, the examiner may use the information submitted, e.g., a printed publication or evidence of public use, and make the next Office action final whether or not the claims have been amended, provided that no other new ground of rejection which was not necessitated by amendment to the claims is introduced by the examiner. See MPEP § 609.04(b).
Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
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 9-5 pm.
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.
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/KIMBERLY CHONG/Primary Examiner, Art Unit 1636
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