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
Continued Examination Under 37 CFR 1.114
1. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on March 19, 2026 has been entered.
Response to Amendment
2. Claims 1, 7 and 10 have been amended as requested in the amendment filed on March 19, 2026. Following the amendment, claims 1-17 are pending in the instant application.
3. Claims 12-14 and 17 stand withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention(s), there being no allowable generic or linking claim.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 May 27, 2025.
4. Claims 1-11, 15 and 16 are under examination in the instant office action.
5. Any objection or rejection of record, which is not expressly repeated in this action has been overcome by Applicant’s response and withdrawn.
6. Applicant’s arguments filed on March 19, 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.
7. Claims 1-11, 15 and 16 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 written description requirement for reasons of record in section 5 of Paper mailed on June 06, 2025 and section 7 of Paper mailed on December 19, 2025. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
At pp. 7-8 of the Response, Applicant submits the amendment to the claims overcomes the rejection. Applicant further argues that the Examples describe HERV protease inhibitor Lopinavir, shRNA directed against HERV-W Syncytin-1, siRNA directed against HERV-W Syncytin-1 receptor SCL1A4 and an anti-HERV Env or anti-HERV Gag antibody that may bind to HERV Env or HERV Gag, thus satisfying the requirement of possession of the invention at the time of filing, pp. 8-9. Applicant’s arguments have been fully considered but found to be not persuasive for reasons that follow.
Claims 1-11, 15 and 16 encompass methods of treatment by administration of molecular embodiments that are described within independent claims 1 and 7 as follows. The embodiments, ready and suitable for clinical administration, are protease inhibitors, nucleic acids or antibodies, which act as inhibitors of human endogenous retrovirus (HERV) proteins or act as inhibitors of receptor binding to human endogenous retrovirus (HERV) proteins, wherein the HERV Env proteins are defined by reference to the amino acid sequence of 95% identity to the amino acid sequence encoded by the nucleotide sequence of SEQ ID NO: 1, 2, 4, 5, 7 or 9, and by reference to HERV Gag protein which has an amino acid sequence at least 85% identical to the amino acid sequence encoded by the nucleic sequence of SEQ ID NO: 14, 15 or 18. Thus, the structure of the HERV proteins has no relevance to the structure of the inhibitors. In fact, the claims do not require that these protease inhibitors, nucleic acids or antibodies, which act as inhibitors of human endogenous retrovirus (HERV) proteins or inhibitors of receptor binding to human endogenous retrovirus (HERV) proteins, have any specifically identified chemical structure. The only requirement is to inhibit HERV proteins of the very specific structure. The specification provides examples of preferred embodiments of the inhibitors, which are one protease inhibitor, two nucleic acids, shRNA and siRNA, and antibodies that may or may not bind to HERV. Note that there appears to be no indication that these specific examples of the inhibitors act exclusively on the HERV proteins of the claims and not on any HERV protein. The Examiner maintains that the specification as filed fails to describe the entire genus of inhibitors that are protease inhibitors, nucleic acids or antibodies that act as inhibitors of human endogenous retrovirus (HERV) proteins or act as inhibitors of receptor binding to human endogenous retrovirus (HERV) proteins, and suitable for immediate clinical administration so to treat a tauopathy or Parkinson’s disease, as currently claimed. Thus, the requirements of 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, written description requirement, have not been met.
For reasons of record fully explained earlier and reasons above, the rejection is maintained.
Conclusion
8. No claim is allowed.
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
April 21, 2026