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 7 have been amended, claims 3, 6 and 10 canceled and claim 18 added as requested in the amendment filed on August 24, 2026. Following the amendment, claims 1, 2, 4, 5, 7-9 and 11-18 are pending in the instant application.
2. Claims 12-14 and 17 stand withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention(s), there being no allowable generic or linking claim.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.
3. Claims 1, 2, 4, 5, 7-9, 11, 15, 16 and 18 are under examination.
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or rejection of record, which is not expressly repeated in this action has been overcome by Applicant’s response and withdrawn.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 24, 2026, have been fully considered but they are not deemed to be persuasive for the reasons set forth below. New grounds of rejection necessitated by Applicant’s amendment are set forth below as well.
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.
6. Claims 1, 2, 4, 5, 7-9, 11, 15, 16, as amended, 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
7. Claim 1, as currently presented, encompasses a nucleic acid that hybridizes to a nucleic sequence encoding a HERV protein wherein the protein is defined by reference to HERV Env and/or HERV Gag. First, the pertinent art recognizes that the process of hybridization of nucleic acids depends on hybridization conditions, and therefore, cannot be relied upon to define the structure of molecular embodiments suitable for clinical administration. Next, it is not obvious and cannot be determined from the claim or the specification as filed what stands for a nucleic acid that hybridizes to a nucleic acid encoding one and/or two proteins. Finally, the nucleic that hybridizes to a nucleic acid sequence encoding a HERV protein is described as comprising siRNA and shRNA. Applicant is advised that if the nucleic acid is siRNA or shRNA then this is what the claim must recite to avoid ambiguity of the interpretation.
8. Claim 7, similar to claim 1, see above, recites the limitation “the nucleic that comprises siRNA and shRNA,” which makes no sense.
9. Claims 2, 4, 5, 8, 9, 11, 15, 16 are indefinite for being dependent from indefinite claim(s).
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), fourth paragraph:
Subject to the [fifth paragraph of 35 U.S.C. 112 (pre-AIA )], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
10. Claim 4, as presented, is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Briefly, claim 4 encompasses nucleic acids which hybridize to a portion of the nucleic acid sequence encoding HERV protein while being dependent from claim 1, which, as amended, encompasses nucleic acids which hybridize to a full length of the nucleic acid sequence encoding HERV protein. Thus, claim 4 is of broader scope than the claim from which it depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
11. Claims 1, 2, 4, 5, 7-9, 11, 15, 16, as amended, and new claim 18 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 written description requirement for reasons of record in section 5 of Paper mailed on June 06, 2025, section 7 of Paper mailed on December 19, 2025, and in section 7 of Paper mailed on April 24, 2026. 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 p. 8 of the Response, Applicant submits the claims have been amended “to specify that the inhibitors are nucleic acid molecules comprising siRNA and shRNA.” While this has been fully considered, the argument is not persuasive because the base claims 1 and 7, as amended, are vague and indefinite for failing to distinctly claim the subject matter, see sections 7 and 8 earlier. Applicant is advised that claims 1 and 7, if presented to be limited to specific molecular embodiments—siRNA or shRNA, defined by reference to an unambiguous structure—would satisfy the requirements of written description.
New claim 18 specifically requires possession of a genus of molecules that are HIV protease inhibitors, all suitable for clinical administration to treat tauopathy. As fully explained earlier, description of the substrate, HERV protein, does not satisfy the description of the inhibitor specific to act on that substrate. While the instant claim is not a composition claim, the claimed method still critically depends upon knowing what molecular compounds are within the recited genus.
Vas-Cath Inc. V. Mahurkar, 19USPQ2d 1111, clearly states "applicant must convey with reasonable clarity to those skilled in the art that, as of filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed." (See page 1117). The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." (See Vas-Cath at page 1116). As explained earlier, the artisan cannot envision the detailed structure of the encompassed genus of inhibitors nor could the artisan envisage other members of the claimed genus commensurate with the breadth claimed, and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The compound itself is required. See Fiers V. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. V. Chugai
Pharmaceutical Co. Ltd., 18 USPQ2d 1016.
For reasons of record fully explained earlier and reasons above, the rejection is maintained.
Conclusion
12. No claim is allowed.
13. 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). 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 2, 2026
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