DETAILED ACTION
A final Office action was mailed 26 February 2026 (“Office Action”).
Applicant’s reply to the Office Action was received 26 May 2026 (“Reply”).
The Reply was submitted with a Request for Continued Examination (RCE).
Status of the Claims
The listing of claims filed with the Reply and RCE has been entered and examined.
Claims 3–12, 20, and 21 are pending. Claim 3 is amended.
Claim 1, 2, and 13–19 are canceled.
Status of Rejections and Objections
Unless repeated herein, any objection or rejection in the Office Action is withdrawn.
Response to Arguments
Applicant’s arguments submitted with the Reply and RCE have been fully considered. With respect to the prior art rejections, Applicant argues the cited reference (Ucciferri) discloses administering lacidipine to treat high blood pressure, and although a subject in Ucciferri was infected by HIV, the lacidipine was not administered to treat the HIV infection, which was already being managed with a HIV triple therapy. (Remarks, p.9). Applicant argues Ucciferri does not disclose selecting a mammal as being in need of treatment for an HIV-1 infection, as claimed. (Id.). In view of the claim amendments and arguments, the prior art rejections are withdrawn.
Claim Rejections - 35 U.S.C. § 112 and 35 U.S.C. § 132
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. § 132(a):
(a) Whenever, on examination, any claim for a patent is rejected, or any objection or requirement made, the Director shall notify the applicant thereof, stating the reasons for such rejection, or objection or requirement, together with such information and references as may be useful in judging of the propriety of continuing the prosecution of his application; and if after receiving such notice, the applicant persists in his claim for a patent, with or without amendment, the application shall be reexamined. No amendment shall introduce new matter into the disclosure of the invention.
As shown above, 35 U.S.C. § 132(a) states: “no amendment shall introduce new matter into the disclosure of the invention.”
Claims 3–12, 20, and 21 are rejected under 35 U.S.C. § 132(a) because they introduce new matter into the disclosure and under 35 U.S.C. § 112(a) as failing to comply with the written description requirement. The claims contain subject matter that was not described in the Specification in such a way as to reasonably convey to one of ordinary skill in the art that Applicant, at the time the application was filed, had possession of the claimed invention.
The subject matter that is not supported by the original disclosure is: “selecting a mammal as being in need of treatment for an HIV-1 infection.”
None of the original [PCT] claims filed 18 April 2023 are directed to a method.
The claims filed via preliminary amendment 18 April 2023 are directed to method claims. The only step recited in the method claims is an administering step.
The specification, p.1, states: “The present invention also concerns . . . a method of therapeutic treatment comprising the administration of such an inhibitor or compound of formula (I) or (II).”
The specification also mentions the method, generally, on pp.2, 3, 14, 15, 20, and 21.
Nowhere in the original disclosure is there a disclosure of selecting a mammal as being in need of treatment for an HIV-1 infection. There is no indication by which algorithm such a mammal is selected in the disclosure. There is no guidance for the selecting step in the disclosure. Indeed, the specification does not recite “selecting” in the context of the method.
Accordingly, there is no explicit or implicit support for the claimed selecting a mammal as being in need of treatment for an HIV-1 infection.
Applicant is required to cancel the new matter in the reply to this Office Action.
Response to Remarks
Applicant does not indicate in the Reply where in the original disclosure there is support for the subject matter added to the claims by amendment. Applicant does not include a statement in the Reply attesting the claim amendments do not introduce new matter.
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). Applicant is reminded of the extension of time policy as set forth in 37 C.F.R. § 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 C.F.R. § 1.17(a)) pursuant to 37 C.F.R. § 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.
Communication
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jason Nolan at (571) 272-2480. The examiner can normally be reached Monday through Friday between 9:00–5:00.
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 submit an Automated Interview Request: http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam Milligan, can be reached on 571-270-7674.
/J.M.N./Patent Examiner, Art Unit 1623
/GEORGE W KOSTURKO/Primary Examiner, Art Unit 1621
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