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
Response to Amendment
1. Claims 1 and 12 have been amended, claim 19 canceled and claim 20 added as requested in the amendment filed on July 22, 2025. Following the amendment, claims 1, 4-14, 16, 18 and 20 are pending in the instant application.
2. Claims 5-11, 13 and 16 stand withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention(s), there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 09/28/2022.
3. Claims 1, 4, 12, 14, 18 and 20 are under examination in the instant office action.
4. Any objection or rejection of record, which is not expressly repeated in this action has been overcome by Applicant’s response and withdrawn.
5. Applicant’s arguments filed on July 22, 2025, 2025 have been fully considered but they are not deemed to be persuasive for the reasons set forth below.
Claim Rejections - 35 USC § 112
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.
6. Claims 1, 4, 12, 14, 18 and new claim 20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement for reasons of record in Paper mailed on January 17, 2023, Paper mailed on August 15, 2023, in section 12 of Paper mailed on April 02, 2024, section 13 of Paper mailed on Sept 05, 2024 and in section 15 of Paper mailed on April 22, 2025. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Applicant traverses the rejection at pp. 9-11 of the Response. Specifically, Applicant cites MPEP §2164.02 and repeats the arguments that, “[I]t is well-settled that an Applicant need not have actually reduced the invention to practice prior to filing.” This argument has been presented earlier, fully considered and answered. Briefly, the Examiner does not dispute the statement. Note that the reduction to practice has never been required, see office actions of record as recorded above.
Applicant argues that, “additional studies have demonstrated that mNCX is associated with Alzheimer’s Disease pathology. Figure 1E and 1F from Jadiya P, et al., (iScience, 2023, 26(3):106296; hereinafter “Exhibit A”) demonstrate that mice with loss of mNCX displayed a decline in spatial working memory at 15 months of age and a decline in cued recall at 12-15 months of age compared to control mice. Exhibit A also discloses in Figure 2A and 2B that Aβ peptide, whose accumulation is a feature of Alzheimer’s disease pathology, levels increased in mNCX-knockout mice. Additionally, Exhibit A demonstrates in Figures 3 A-3E that mNCX-knockout mice have an increase in T231/S235 and S202/T205 tau phosphorylation which is a prominent characteristic of Alzheimer’s disease. Lastly, Figures 4C-4E from Exhibit A demonstrate that SYP and PSD-95 expression decreases in mNCX-knockout mice suggesting synaptic dysfunction.” Applicant’s arguments have been fully considered but found to be not persuasive for reasons that follow.
As an initial matter, Applicant is advised that the cited art, Exhibit A, has been considered only insofar as it is argued by Applicant. For proper consideration of pertinent art, filing of an IDS is suggested. Next, the article cited by Applicant represents post-filing research. 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph makes it clear that in order to satisfy the enablement requirement of section 112, an applicant must describe the manner of using the invention “in such full, clear, concise and exact terms as to enable any person skilled in the art … to make and use the same…” Thus, the invention must be enabled at the time of filing and, therefore, the enablement cannot be supported by later obtained experimental results. In re Rasmusson Court held that, “[I]f mere plausibility were the test for enablement under section 112, applicants could obtain patent rights to “inventions” consisting of little more than respectable guesses as to the likelihood of their success. When one of the guesses later proved true, the “inventor” would be rewarded the spoils instead of the party who demonstrated that the method actually worked. That scenario is not consistent with the statutory requirement that the inventor enable an invention rather than merely proposing an unproved hypothesis”. In re Rasmusson v. SmithKline Beecham Corp. 75 USPQ2D 1297, p1301.
In making a determination of whether the application complies with the enablement requirement of 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, each claimed invention must be evaluated to determine whether there is sufficient guidance provided and supported by working examples to inform a skilled artisan how to use the claimed invention without undue experimentation. In the instant case, the specification presents a working hypothesis regarding new therapeutic target, mNCX, to inhibit or reverse AD progression, p. 38, and explains experiments using AD post-mortem tissue, genetically modified cells and genetically modified mice. However, the specification fails to provide any guidance on how to treat real-life pathologies—neurodegeneration in general or neurodegeneration-related diseases or disorders—by administration of a nucleic acid, a vector, or a peptide comprising mNCX, the subject matter of claims 1, 4, 12, 14, 18 and 20. The Examiner maintains that the information provided within the specification as originally filed is not commensurate with what is currently claimed.
For reasons of record fully explained earlier and reasons above, the rejection is maintained.
Conclusion
7. No claim is allowed.
8. THIS ACTION IS MADE FINAL. 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLGA N CHERNYSHEV whose telephone number is (571)272-0870. The examiner can normally be reached 9AM to 5:30PM, Monday to Friday.
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/OLGA N CHERNYSHEV/ Primary Examiner, Art Unit 1675
September 17, 2025