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, 4, 12, 14, 21 and 22 have been amended as requested in the amendment filed on August 07, 2026. Following the amendment, claims 1, 4-14, 16, 21 and 22 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 Claims 5-11, 13 and 16 stand withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention(s), there being no allowable generic or linking claim.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, 21 and 22 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or rejection of record, which is not expressly repeated in this action has been overcome by Applicant’s response and withdrawn.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 August 07, 2026, 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 12, 14 and 22 stand 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, section 15 of Paper mailed on April 22, 2025, section 6 of Paper mailed on October 03, 2025 and in section 11 of paper mailed on May 07, 2026. 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. 6-8 of the Response. Specifically, Applicant submits that it is improper for the Examiner to require human clinical data to support the enablement of the claimed invention, p. 7, describes the difference between FDA and the Patent Office, lists four FDA- approved drugs to tread AD, and states that the data presented within the instant disclosure fully enables a skilled practitioner to administer a peptide comprising the amino acid sequence of mNCX to treat AD. Applicant’s arguments have been fully considered but found to be not persuasive for reasons that follow.
Claims 12, 14 and 22 encompass methods of treatment of Alzheimer’s disease by administration of a protein that encodes mNCX. As fully explained earlier, the specification presents limited data to support a hypothesis that “[N]euronal overexpression of NCLX restores memory and reduces AD pathology,” see Fig. 46. However, there appears to be no evidence that the results of overexpression of NCLX within a genetically modified animal directly support and provide full guidance for clinical administration of mNCX peptide to treat AD, as in claim 12, or specifically alter expression of the mNCX by increasing transcription, translation and activity of mNCX, as in claim 14, or decrease levels of amyloid, amyloid plaque or increase memory recall, as in claim 22. The Examiner maintains that it would require significant amount of undue experimentation for one skilled in the art to research the protocols, routes of administration, suitable doses, evaluation of the results (expression of mNCX, activity of mNCX, Aβ levels and assessment of amyloid plaques) in order to complete Applicant’s invention and practice the full scope of the instant claimed methods.
For reasons of record fully explained earlier and reasons above, the rejection is maintained.
Conclusion
7. Claims 1, 4 and 21 are allowed. Claims 12, 14 and 22 are rejected.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker can be reached at (571)272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/OLGA N CHERNYSHEV/ Primary Examiner, Art Unit 1675
September 2, 2026
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